II 

Calendar No. 400 

112TH CONGRESS 

2D SESSION S. 3187 

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 

the user-fee programs for prescription drugs and medical devices, to 

establish user-fee programs for generic drugs and biosimilars, and for 

other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 15, 2012 

Mr. HARKIN (for himself and Mr. ENZI) introduced the following bill; which 

was read the first time 

MAY 16, 2012 

Read the second time and placed on the calendar 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food and Drug Ad5 ministration Safety and Innovation Act’’. 


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

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

3 this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents; references in Act. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use drug fees. 

Sec. 104. Reauthorization; reporting requirements. 

Sec. 105. Sunset dates. 

Sec. 106. Effective date. 

Sec. 107. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 201. Short title; findings. 

Sec. 202. Definitions. 

Sec. 203. Authority to assess and use device fees. 

Sec. 204. Reauthorization; reporting requirements. 

Sec. 205. Savings clause. 

Sec. 206. Effective date. 

Sec. 207. Sunset dates. 

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

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title. 

Sec. 302. Authority to assess and use human generic drug fees. 

Sec. 303. Reauthorization; reporting requirements. 

Sec. 304. Sunset dates. 

Sec. 305. Effective date. 

Sec. 306. Amendment with respect to misbranding. 

Sec. 307. Streamlined hiring authority of the Food and Drug Administration 

to support activities related to human generic drugs. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL 

PRODUCTS 

Sec. 401. Short title; finding. 

Sec. 402. Fees relating to biosimilar biological products. 

Sec. 403. Reauthorization; reporting requirements. 

Sec. 404. Sunset dates. 

Sec. 405. Effective date. 

Sec. 406. Savings clause. 

Sec. 407. Conforming amendment. 

TITLE V—PEDIATRIC DRUGS AND DEVICES 

Sec. 501. Permanence. 

Sec. 502. Written requests. 


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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 

Sec. 701. Registration of domestic drug establishments. 

Sec. 702. Registration of foreign establishments. 

Sec. 703. Identification of drug excipient information with product listing. 

Sec. 704. Electronic system for registration and listing. 

Sec. 705. Risk-based inspection frequency. 

Sec. 706. Records for inspection. 

Sec. 707. Failure to allow foreign inspection. 

Sec. 708. Exchange of information. 

Sec. 709. Enhancing the safety and quality of the drug supply. 

Sec. 710. Accreditation of third-party auditors for drug establishments. 

Sec. 711. Standards for admission of imported drugs. 

Sec. 712. Notification. 

Sec. 713. Protection against intentional adulteration. 

Sec. 714. Enhanced criminal penalty for counterfeiting drugs. 

Sec. 715. Extraterritorial jurisdiction. 

Sec. 716. Compliance with international agreements. 

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. 


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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. 

TITLE X—DRUG SHORTAGES 

Sec. 1001. Drug shortages. 

TITLE XI—OTHER PROVISIONS 

Subtitle A—Reauthorizations 

Sec. 1101. Reauthorization of provision relating to exclusivity of certain drugs 

containing single enantiomers. 

Sec. 1102. Reauthorization of the Critical Path Public-Private Partnerships. 

Subtitle B—Medical Gas Product Regulation 

Sec. 1111. Regulation of medical gas products. 

Sec. 1112. Regulations. 

Sec. 1113. Applicability. 

Subtitle C—Miscellaneous Provisions 

Sec. 1121. Advisory committee conflicts of interest. 

Sec. 1122. Guidance document regarding product promotion using the Internet. 

Sec. 1123. Electronic submission of applications. 

Sec. 1124. Combating prescription drug abuse. 

Sec. 1125. Tanning bed labeling. 

Sec. 1126. Optimizing global clinical trials. 

Sec. 1127. Advancing regulatory science to promote public health innovation. 

Sec. 1128. Information technology. 

Sec. 1129. Reporting requirements. 

Sec. 1130. Strategic integrated management plan. 

Sec. 1131. Drug development and bioequivalence testing. 

Sec. 1132. Patient participation in medical product discussions. 

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 


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

2 (21 U.S.C. 301 et seq.). 

3 TITLE I—FEES RELATING TO 

4 DRUGS 

5 SEC. 101. SHORT TITLE; FINDING. 

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

7 ‘‘Prescription Drug User Fee Amendments of 2012’’. 

8 (b) FINDING.—The Congress finds that the fees au9 thorized by the amendments made in this title will be dedi10 cated toward expediting the drug development process and 

11 the process for the review of human drug applications, in12 cluding postmarket drug safety activities, as set forth in 

13 the goals identified for purposes of part 2 of subchapter 

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

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

16 Human Services to the Chairman of the Committee on 

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

18 the Chairman of the Committee on Energy and Commerce 

19 of the House of Representatives, as set forth in the Con20 gressional Record. 

21 SEC. 102. DEFINITIONS. 

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

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

24 striking ‘‘incurred’’. 


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

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

3 (1) in subsection (a)— 

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

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

6 ‘‘fiscal year 2013’’; 

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

8 of subparagraph (A), by striking ‘‘subsection 

9 (c)(5)’’ each place such term appears and in10 serting ‘‘subsection (c)(4)’’; 

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

12 paragraph (2)(A)— 

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

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

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

16 October 1 of each year’’ and inserting 

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

18 on or after October 1 of each fiscal year or 

19 the first business day after the enactment 

20 of an appropriations Act providing for the 

21 collection and obligation of fees for such 

22 fiscal year under this section’’; and 

23 (D) in paragraph (3)— 

24 (i) in subparagraph (A)— 


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1 (I) by striking ‘‘subsection 

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

3 (c)(4)’’; and 

4 (II) by striking ‘‘payable on or 

5 before October 1 of each year.’’ and 

6 inserting ‘‘due on the later of the first 

7 business day on or after October 1 of 

8 each fiscal year or the first business 

9 day after the enactment of an appro10 priations Act providing for the collec11 tion and obligation of fees for such 

12 fiscal year under this section.’’; and 

13 (ii) by amending subparagraph (B) to 

14 read as follows: 

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

16 product shall not be assessed a fee under sub17 paragraph (A) if such product is— 

18 ‘‘(i) identified on the list compiled 

19 under section 505(j)(7) with a potency de20 scribed in terms of per 100 mL; 

21 ‘‘(ii) the same product as another 

22 product that— 

23 ‘‘(I) was approved under an ap24 plication filed under section 505(b) or 

25 505(j); and 


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1 ‘‘(II) is not in the list of discon2 tinued products compiled under sec3 tion 505(j)(7); 

4 ‘‘(iii) the same product as another 

5 product that was approved under an abbre6 viated application filed under section 507 

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

8 enactment of the Food and Drug Adminis9 tration Modernization Act of 1997); or 

10 ‘‘(iv) the same product as another 

11 product that was approved under an abbre12 viated new drug application pursuant to 

13 regulations in effect prior to the implemen14 tation of the Drug Price Competition and 

15 Patent Term Restoration Act of 1984.’’; 

16 (2) in subsection (b)— 

17 (A) in paragraph (1)— 

18 (i) in the matter preceding subpara19 graph (A), by striking ‘‘fiscal years 2008 

20 through 2012’’ and inserting ‘‘fiscal years 

21 2013 through 2017’’; 

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

23 ‘‘$392,783,000; and’’ and inserting 

24 ‘‘$693,099,000;’’; and 


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1 (iii) by striking subparagraph (B) and 

2 inserting the following: 

3 ‘‘(B) the dollar amount equal to the infla4 tion adjustment for fiscal year 2013 (as deter5 mined under paragraph (3)(A)); and 

6 ‘‘(C) the dollar amount equal to the work7 load adjustment for fiscal year 2013 (as deter8 mined under paragraph (3)(B)).’’; and 

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

10 inserting the following: 

11 ‘‘(3) FISCAL YEAR 2013 INFLATION AND WORK12 LOAD ADJUSTMENTS.—For purposes of paragraph 

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

14 adjustments for fiscal year 2013 shall be determined 

15 as follows: 

16 ‘‘(A) INFLATION ADJUSTMENT.—The infla17 tion adjustment for fiscal year 2013 shall be 

18 the sum of— 

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

20 result of an inflation adjustment calcula21 tion determined using the methodology de22 scribed in subsection (c)(1)(B); and 

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

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1 tion determined using the methodology de2 scribed in subsection (c)(1)(C). 

3 ‘‘(B) WORKLOAD ADJUSTMENT.—Subject 

4 to subparagraph (C), the workload adjustment 

5 for fiscal 2013 shall be— 

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

7 the inflation adjustment calculated under 

8 subparagraph (A); multiplied by 

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

10 percentage workload adjustment for fiscal 

11 year 2013, as determined using the meth12 odology described in subsection (c)(2)(A), 

13 would exceed the percentage workload ad14 justment (as so determined) for fiscal year 

15 2012, if both such adjustment percentages 

16 were calculated using the 5-year base pe17 riod consisting of fiscal years 2003 

18 through 2007. 

19 ‘‘(C) LIMITATION.—Under no cir20 cumstances shall the adjustment under sub21 paragraph (B) result in fee revenues for fiscal 

22 year 2013 that are less than the sum of the 

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

24 amount under paragraph (1)(B).’’; 


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

2 following: 

3 ‘‘(c) ADJUSTMENTS.— 

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

5 2014 and subsequent fiscal years, the revenues es6 tablished in subsection (b) shall be adjusted by the 

7 Secretary by notice, published in the Federal Reg8 ister, for a fiscal year by the amount equal to the 

9 sum of— 

10 ‘‘(A) one; 

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

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

13 Food and Drug Administration, of all personnel 

14 compensation and benefits paid with respect to 

15 such positions for the first 3 years of the pre16 ceding 4 fiscal years, multiplied by the propor17 tion of personnel compensation and benefits 

18 costs to total costs of the process for the review 

19 of human drug applications (as defined in sec20 tion 735(6)) for the first 3 years of the pre21 ceding 4 fiscal years; and 

22 ‘‘(C) the average annual percent change 

23 that occurred in the Consumer Price Index for 

24 urban consumers (Washington-Baltimore, DC– 

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


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

2 preceding 4 years of available data, multiplied 

3 by the proportion of all costs other than per4 sonnel compensation and benefits costs to total 

5 costs of the process for the review of human 

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

7 for the first 3 years of the preceding 4 fiscal 

8 years. 

9 The adjustment made each fiscal year under this 

10 paragraph shall be added on a compounded basis to 

11 the sum of all adjustments made each fiscal year 

12 after fiscal year 2013 under this paragraph. 

13 ‘‘(2) WORKLOAD ADJUSTMENT.—For fiscal 

14 year 2014 and subsequent fiscal years, after the fee 

15 revenues established in subsection (b) are adjusted 

16 for a fiscal year for inflation in accordance with 

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

18 further for such fiscal year to reflect changes in the 

19 workload of the Secretary for the process for the re20 view of human drug applications. With respect to 

21 such adjustment: 

22 ‘‘(A) The adjustment shall be determined 

23 by the Secretary based on a weighted average 

24 of the change in the total number of human 

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1 view activities, as described in the notice that 

2 the Secretary is required to publish in the Fed3 eral Register under this subparagraph), efficacy 

4 supplements, and manufacturing supplements 

5 submitted to the Secretary, and the change in 

6 the total number of active commercial investiga7 tional new drug applications (adjusted for 

8 changes in review activities, as so described) 

9 during the most recent 12-month period for 

10 which data on such submissions is available. 

11 The Secretary shall publish in the Federal Reg12 ister the fee revenues and fees resulting from 

13 the adjustment and the supporting methodolo14 gies. 

15 ‘‘(B) Under no circumstances shall the ad16 justment result in fee revenues for a fiscal year 

17 that are less than the sum of the amount under 

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

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

20 under paragraph (1). 

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

22 independent accounting or consulting firm to 

23 periodically review the adequacy of the adjust24 ment and publish the results of those reviews. 

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1 lished by the end of fiscal year 2013 (to exam2 ine the performance of the adjustment since fis3 cal year 2009), and the second review shall be 

4 conducted and published by the end of fiscal 

5 year 2015 (to examine the continued perform6 ance of the adjustment). The reports shall 

7 evaluate whether the adjustment reasonably 

8 represents actual changes in workload volume 

9 and complexity and present options to dis10 continue, retain, or modify any elements of the 

11 adjustment. The reports shall be published for 

12 public comment. After review of the reports and 

13 receipt of public comments, the Secretary shall, 

14 if warranted, adopt appropriate changes to the 

15 methodology. If the Secretary adopts changes to 

16 the methodology based on the first report, the 

17 changes shall be effective for the first fiscal 

18 year for which fees are set after the Secretary 

19 adopts such changes and each subsequent fiscal 

20 year. 

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

22 year 2017, the Secretary may, in addition to adjust23 ments under this paragraph and paragraphs (1) and 

24 (2), further increase the fee revenues and fees estab25 lished in subsection (b) if such an adjustment is necVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 essary to provide for not more than 3 months of op2 erating reserves of carryover user fees for the proc3 ess for the review of human drug applications for 

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

5 adjustment is necessary, the rationale for the 

6 amount of the increase shall be contained in the an7 nual notice establishing fee revenues and fees for fis8 cal year 2017. If the Secretary has carryover bal9 ances for such process in excess of 3 months of such 

10 operating reserves, the adjustment under this para11 graph shall not be made. 

12 ‘‘(4) ANNUAL FEE SETTING.—The Secretary 

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

14 fiscal year that begins after September 30, 2012, es15 tablish, for the next fiscal year, application, product, 

16 and establishment fees under subsection (a), based 

17 on the revenue amounts established under subsection 

18 (b) and the adjustments provided under this sub19 section. 

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

21 as adjusted under this subsection, for a fiscal year 

22 may not exceed the total costs for such fiscal year 

23 for the resources allocated for the process for the re24 view of human drug applications.’’; and 

25 (4) in subsection (g)— 


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

2 authorized’’ and inserting ‘‘Subject to para3 graph (2)(C), fees authorized’’; 

4 (B) in paragraph (2)— 

5 (i) in subparagraph (A)— 

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

7 ‘‘shall be retained’’ and inserting 

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

9 collected and available’’; and 

10 (II) in clause (ii), by striking 

11 ‘‘shall only be collected and available’’ 

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

13 (ii) by adding at the end the following 

14 new subparagraph: 

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

16 Payment of fees authorized under this section 

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

18 fees, may be accepted by the Secretary in ac19 cordance with authority provided in advance in 

20 a prior year appropriations Act.’’; 

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

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

23 years 2013 through 2017’’; and 

24 (D) in paragraph (4)— 


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1 (i) by striking ‘‘fiscal years 2008 

2 through 2010’’ and inserting ‘‘fiscal years 

3 2013 through 2015’’; 

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

5 inserting ‘‘fiscal year 2016’’; 

6 (iii) by striking ‘‘fiscal years 2008 

7 though 2011’’ and inserting ‘‘fiscal years 

8 2013 through 2016’’; and 

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

10 and inserting ‘‘fiscal year 2017’’. 

11 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

13 (1) by amending subsection (a) to read as fol14 lows: 

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

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

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

18 the Secretary shall prepare and submit to the Committee 

19 on Energy and Commerce of the House of Representatives 

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

21 Pensions of the Senate a report concerning the progress 

22 of the Food and Drug Administration in achieving the 

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

24 of the Prescription Drug User Fee Amendments of 2012 

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


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1 and Drug Administration for meeting the goals. The re2 port under this subsection for a fiscal year shall include 

3 information on all previous cohorts for which the Sec4 retary has not given a complete response on all human 

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

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

7 inserting ‘‘2013’’; and 

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

9 place it appears and inserting ‘‘2017’’. 

10 SEC. 105. SUNSET DATES. 

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

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

13 379h) shall cease to be effective October 1, 2017. 

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

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

16 379h–2) shall cease to be effective January 31, 2018. 

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

18 the Prescription Drug User Fee Amendments of 2007 

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

20 (d) TECHNICAL CLARIFICATIONS.— 

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

22 of the Prescription Drug User Fee Amendments Act 

23 of 2002 (Title V of Public Law 107–188) is re24 pealed. 


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

2 of the Food and Drug Administration Modernization 

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

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

5 of the Prescription Drug User Fee Act of 1992 

6 (Public Law 102–571) is repealed. 

7 SEC. 106. EFFECTIVE DATE. 

8 The amendments made by this title shall take effect 

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

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

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

12 and Cosmetic Act shall be assessed for all human drug 

13 applications received on or after October 1, 2012, regard14 less of the date of the enactment of this Act. 

15 SEC. 107. SAVINGS CLAUSE. 

16 Notwithstanding the amendments made by this title, 

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

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

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

20 be in effect with respect to human drug applications and 

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

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

23 were accepted by the Food and Drug Administration for 

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1 quired by such part for a fiscal year prior to fiscal year 

2 2012. 

3 TITLE II—FEES RELATING TO 

4 DEVICES 

5 SEC. 201. SHORT TITLE; FINDINGS. 

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

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

8 (b) FINDINGS.—The Congress finds that the fees au9 thorized under the amendments made by this title will be 

10 dedicated toward expediting the process for the review of 

11 device applications and for assuring the safety and effec12 tiveness of devices, as set forth in the goals identified for 

13 purposes of part 3 of subchapter C of chapter VII of the 

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

15 the Secretary of Health and Human Services to the Chair16 man of the Committee on Health, Education, Labor, and 

17 Pensions of the Senate and the Chairman of the Com18 mittee on Energy and Commerce of the House of Rep19 resentatives, as set forth in the Congressional Record. 

20 SEC. 202. DEFINITIONS. 

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

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

23 after ‘‘expenses’’; 

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

25 2001’’ and inserting ‘‘October 2011’’; and 


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

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

3 paragraph (13) and inserting the following: ‘‘is reg4 istered (or is required to register) with the Secretary 

5 under section 510 because such establishment is en6 gaged in the manufacture, preparation, propagation, 

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

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

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

10 379j(a)) is amended— 

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

12 2008’’ and inserting ‘‘fiscal year 2013’’; 

13 (2) in paragraph (2)(A)— 

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

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

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

17 and (f)’’; 

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

19 inserting ‘‘October 1, 2012’’; and 

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

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

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

23 inserting ‘‘2’’; and 

24 (3) in paragraph (3)— 

25 (A) in subparagraph (A)— 


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

2 after ‘‘subparagraph (B)’’; and 

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

4 ‘‘2013’’; and 

5 (B) in subparagraph (C), by striking ‘‘ini6 tial registration’’ and all that follows through 

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

8 ‘‘(i) the initial or annual registration 

9 (as applicable) of the establishment under 

10 section 510; or 

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

12 date of enactment of an appropriations Act 

13 providing for the collection and obligation 

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

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

16 379j(b)) is amended to read as follows: 

17 ‘‘(b) FEE AMOUNTS.— 

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

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

20 through 2017, fees under subsection (a) shall be de21 rived from the base fee amounts specified in para22 graph (2), to generate the total revenue amounts 

23 specified in paragraph (3). 


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

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

3 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 

4 ‘‘(3) TOTAL REVENUE AMOUNTS.—For pur5 poses of paragraph (1), the total revenue amounts 

6 specified in this paragraph are as follows: 

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

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

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

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

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

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

13 738(c) (21 U.S.C. 379j(c)) is amended— 

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

15 ADJUSTMENTS’’ after ‘‘SETTING’’; 

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

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

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

19 (4) by inserting before paragraph (4), as so re20 designated, the following: 

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

22 days before the start of each fiscal year after Sep23 tember 30, 2012, establish fees under subsection (a), 


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1 based on amounts specified under subsection (b) and 

2 the adjustments provided under this subsection, and 

3 publish such fees, and the rationale for any adjust4 ments to such fees, in the Federal Register. 

5 ‘‘(2) INFLATION ADJUSTMENTS.— 

6 ‘‘(A) ADJUSTMENT TO TOTAL REVENUE

7 AMOUNTS.—For fiscal year 2014 and each sub8 sequent fiscal year, the Secretary shall adjust 

9 the total revenue amount specified in subsection 

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

11 amount by the applicable inflation adjustment 

12 under subparagraph (B) for such year. 

13 ‘‘(B) APPLICABLE INFLATION ADJUST14 MENT TO TOTAL REVENUE AMOUNTS.—The ap15 plicable inflation adjustment for a fiscal year 

16 is— 

17 ‘‘(i) for fiscal year 2014, the base in18 flation adjustment under subparagraph (C) 

19 for such fiscal year; and 

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

21 subsequent fiscal year, the product of— 

22 ‘‘(I) the base inflation adjust23 ment under subparagraph (C) for 

24 such fiscal year; and 


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1 ‘‘(II) the product of the base in2 flation adjustment under subpara3 graph (C) for each of the fiscal years 

4 preceding such fiscal year, beginning 

5 with fiscal year 2014. 

6 ‘‘(C) BASE INFLATION ADJUSTMENT TO

7 TOTAL REVENUE AMOUNTS.— 

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

9 adjustment under clause (ii), the base in10 flation adjustment for a fiscal year is the 

11 sum of one plus— 

12 ‘‘(I) the average annual percent 

13 change in the cost, per full-time equiv14 alent position of the Food and Drug 

15 Administration, of all personnel com16 pensation and benefits paid with re17 spect to such positions for the first 3 

18 years of the preceding 4 fiscal years, 

19 multiplied by 0.60; and 

20 ‘‘(II) the average annual percent 

21 change that occurred in the Consumer 

22 Price Index for urban consumers 

23 (Washington-Baltimore, DC–MD–VA– 

24 WV; Not Seasonally Adjusted; All 

25 items; Annual Index) for the first 3 


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1 years of the preceding 4 years of 

2 available data multiplied by 0.40. 

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

4 subparagraph (B), if the base inflation ad5 justment for a fiscal year under clause 

6 (i)— 

7 ‘‘(I) is less than 1, such adjust8 ment shall be considered to be equal 

9 to 1; or 

10 ‘‘(II) is greater than 1.04, such 

11 adjustment shall be considered to be 

12 equal to 1.04. 

13 ‘‘(D) ADJUSTMENT TO BASE FEE

14 AMOUNTS.—For each of fiscal years 2014 

15 through 2017, the base fee amounts specified in 

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

17 on a uniform proportionate basis, to generate 

18 the total revenue amounts under subsection 

19 (b)(3), as adjusted for inflation under subpara20 graph (A). 

21 ‘‘(3) VOLUME-BASED ADJUSTMENTS TO ESTAB22 LISHMENT REGISTRATION BASE FEES.—For each of 

23 fiscal years 2014 through 2017, after the base fee 

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

25 under paragraph (2)(D), the base establishment regVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 istration fee amounts specified in such subsection 

2 shall be further adjusted, as the Secretary estimates 

3 is necessary in order for total fee collections for such 

4 fiscal year to generate the total revenue amounts, as 

5 adjusted under paragraph (2).’’. 

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

7 U.S.C. 379j) is amended by— 

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

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

10 (2) by inserting after subsection (e) the fol11 lowing new subsection: 

12 ‘‘(f) FEE WAIVER OR REDUCTION.— 

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

14 Secretary’s sole discretion, grant a waiver or reduc15 tion of fees under subsection (a)(2) or (a)(3) if the 

16 Secretary finds that such waiver or reduction is in 

17 the interest of public health. 

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

19 or reductions granted by the Secretary in any fiscal 

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

21 of the total fee revenue amounts established for such 

22 year under subsection (c). 

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

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


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

2 379j(h)(1)(A)), as redesignated by subsection (d)(1), is 

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

4 ‘‘$280,587,000’’. 

5 (f) CREDITING AND AVAILABILITY OF FEES.—Sec6 tion 738(i) (21 U.S.C. 379j(i)), as redesignated by sub7 section (d)(1), is amended— 

8 (1) in paragraph (1), by striking ‘‘Fees author9 ized’’ and inserting ‘‘Subject to paragraph (2)(C), 

10 fees authorized’’; 

11 (2) in paragraph (2)— 

12 (A) in subparagraph (A)— 

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

14 retained’’ and inserting ‘‘subject to sub15 paragraph (C), shall be collected and avail16 able’’; and 

17 (ii) in clause (ii)— 

18 (I) by striking ‘‘collected and’’ 

19 after ‘‘shall only be’’; and 

20 (II) by striking ‘‘fiscal year 

21 2002’’ and inserting ‘‘fiscal year 

22 2009’’; and 

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

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

25 Payment of fees authorized under this section 


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

2 fees, may be accepted by the Secretary in ac3 cordance with authority provided in advance in 

4 a prior year appropriations Act.’’; 

5 (3) by amending paragraph (3) to read as fol6 lows: 

7 ‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.— 

8 For each of the fiscal years 2013 through 2017, 

9 there is authorized to be appropriated for fees under 

10 this section an amount equal to the total revenue 

11 amount specified under subsection (b)(3) for the fis12 cal year, as adjusted under subsection (c) and, for 

13 fiscal year 2017 only, as further adjusted under 

14 paragraph (4).’’; and 

15 (4) in paragraph (4)— 

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

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

18 2014, and 2015’’; 

19 (B) by striking ‘‘fiscal year 2011’’ and in20 serting ‘‘fiscal year 2016’’; 

21 (C) by striking ‘‘June 30, 2011’’ and in22 serting ‘‘June 30, 2016’’; 

23 (D) by striking ‘‘the amount of fees speci24 fied in aggregate in’’ and inserting ‘‘the cumu25 lative amount appropriated pursuant to’’; 


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1 (E) by striking ‘‘aggregate amount in’’ be2 fore ‘‘excess shall be credited’’; and 

3 (F) by striking ‘‘fiscal year 2012’’ and in4 serting ‘‘fiscal year 2017’’. 

5 (g) CONFORMING AMENDMENT.—Section 

6 515(c)(4)(A) (21 U.S.C. 360e(c)(4)(A)) is amended by 

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

8 SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

10 U.S.C. 379j–1(b)) is amended— 

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

12 inserting ‘‘2017’’; and 

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

14 inserting ‘‘2017’’. 

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

16 1(a)) is amended— 

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

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

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

20 Drug Administration Amendments Act of 2007’’ and 

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

22 Fee Amendments of 2012’’. 

23 SEC. 205. SAVINGS CLAUSE. 

24 Notwithstanding the amendments made by this title, 

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


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

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

3 title, shall continue to be in effect with respect to submis4 sions described in section 738(a)(2)(A) of the Federal 

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

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

7 1, 2012, were accepted by the Food and Drug Administra8 tion for filing with respect to assessing and collecting any 

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

10 year 2013. 

11 SEC. 206. EFFECTIVE DATE. 

12 The amendments made by this title shall take effect 

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

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

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

16 and Cosmetic Act shall be assessed for submissions de17 scribed in section 738(a)(2)(A) of the Federal Food, 

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

19 2012, regardless of the date of the enactment of this Act. 

20 SEC. 207. SUNSET DATES. 

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

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

23 2017. 


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

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

3 2018. 

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

5 the Medical Device User Fee Amendments of 2007 (Title 

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

7 (d) TECHNICAL CLARIFICATION.—Effective Sep8 tember 30, 2007, section 107 of the Medical Device User 

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

10 250) is repealed. 

11 SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT 

12 ACTIVITIES RELATED TO THE PROCESS FOR 

13 THE REVIEW OF DEVICE APPLICATIONS. 

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

15 is amended by inserting after section 713 the following 

16 new section: 

17 ‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. 

18 ‘‘(a) IN GENERAL.—In addition to any other per19 sonnel authorities under other provisions of law, the Sec20 retary may, without regard to the provisions of title 5, 

21 United States Code, governing appointments in the com22 petitive service, appoint employees to positions in the Food 

23 and Drug Administration to perform, administer, or sup24 port activities described in subsection (b), if the Secretary 


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1 determines that such appointments are needed to achieve 

2 the objectives specified in subsection (c). 

3 ‘‘(b) ACTIVITIES DESCRIBED.—The activities de4 scribed in this subsection are activities under this Act re5 lated to the process for the review of device applications 

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

7 ‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci8 fied in this subsection are with respect to the activities 

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

10 738A(a)(1). 

11 ‘‘(d) INTERNAL CONTROLS.—The Secretary shall in12 stitute appropriate internal controls for appointments 

13 under this section. 

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

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

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

17 TITLE III—FEES RELATING TO 

18 GENERIC DRUGS 

19 SEC. 301. SHORT TITLE. 

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

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

22 (b) FINDING.—The Congress finds that the fees au23 thorized by the amendments made in this title will be dedi24 cated to human generic drug activities, as set forth in the 

25 goals identified for purposes of part 7 of subchapter C 


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

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

3 Human Services to the Chairman of the Committee on 

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

5 the Chairman of the Committee on Energy and Commerce 

6 of the House of Representatives, as set forth in the Con7 gressional Record. 

8 SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE9 NERIC DRUG FEES. 

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

11 is amended by adding at the end the following: 

12 ‘‘PART 7—FEES RELATING TO GENERIC DRUGS 

13 ‘‘SEC. 744A. DEFINITIONS. 

14 ‘‘For purposes of this part: 

15 ‘‘(1) The term ‘abbreviated new drug applica16 tion’— 

17 ‘‘(A) means an application submitted 

18 under section 505(j), an abbreviated application 

19 submitted under section 507 (as in effect on the 

20 day before the date of enactment of the Food 

21 and Drug Administration Modernization Act of 

22 1997), or an abbreviated new drug application 

23 submitted pursuant to regulations in effect 

24 prior to the implementation of the Drug Price 


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1 Competition and Patent Term Restoration Act 

2 of 1984; and 

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

4 positron emission tomography drug. 

5 ‘‘(2) The term ‘active pharmaceutical ingre6 dient’ means— 

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

8 substance is unstable or cannot be transported 

9 on its own, intended— 

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

11 drug; and 

12 ‘‘(ii) to furnish pharmacological activ13 ity or other direct effect in the diagnosis, 

14 cure, mitigation, treatment, or prevention 

15 of disease, or to affect the structure or any 

16 function of the human body; or 

17 ‘‘(B) a substance intended for final crys18 tallization, purification, or salt formation, or 

19 any combination of those activities, to become a 

20 substance or mixture described in subparagraph 

21 (A). 

22 ‘‘(3) The term ‘adjustment factor’ means a fac23 tor applicable to a fiscal year that is the Consumer 

24 Price Index for all urban consumers (all items; 

25 United States city average) for October of the preVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 ceding fiscal year divided by such Index for October 

2 2011. 

3 ‘‘(4) The term ‘affiliate’ means a business enti4 ty that has a relationship with a second business en5 tity if, directly or indirectly— 

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

7 the power to control, the other business entity; 

8 or 

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

10 to control, both of the business entities. 

11 ‘‘(5)(A) The term ‘facility’— 

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

13 ‘‘(I) under one management, either di14 rect or indirect; and 

15 ‘‘(II) at one geographic location or ad16 dress engaged in manufacturing or proc17 essing an active pharmaceutical ingredient 

18 or a finished dosage form; and 

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

20 entity whose only manufacturing or processing 

21 activities are one or more of the following: re22 packaging, relabeling, or testing. 

23 ‘‘(B) For purposes of subparagraph (A), sepa24 rate buildings within close proximity are considered 


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1 to be at one geographic location or address if the ac2 tivities in them are— 

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

4 enterprise; 

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

6 local management; and 

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

8 Food and Drug Administration during a single 

9 inspection. 

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

11 the definition of a facility under this paragraph but 

12 for being under multiple management, the business 

13 or other entity is deemed to constitute multiple fa14 cilities, one per management entity, for purposes of 

15 this paragraph. 

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

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

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

19 tablet, capsule, solution, or topical application; 

20 ‘‘(B) a drug product in a form in which re21 constitution is necessary prior to administration 

22 to a patient, such as oral suspensions or 

23 lyophilized powders; or 

24 ‘‘(C) any combination of an active pharma25 ceutical ingredient with another component of a 


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1 drug product for purposes of production of a 

2 drug product described in subparagraph (A) or 

3 (B). 

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

5 an abbreviated new drug application, an amendment 

6 to an abbreviated new drug application, or a prior 

7 approval supplement to an abbreviated new drug ap8 plication. 

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

10 means the following activities of the Secretary asso11 ciated with generic drugs and inspection of facilities 

12 associated with generic drugs: 

13 ‘‘(A) The activities necessary for the re14 view of generic drug submissions, including re15 view of drug master files referenced in such 

16 submissions. 

17 ‘‘(B) The issuance of— 

18 ‘‘(i) approval letters which approve 

19 abbreviated new drug applications or sup20 plements to such applications; or 

21 ‘‘(ii) complete response letters which 

22 set forth in detail the specific deficiencies 

23 in such applications and, where appro24 priate, the actions necessary to place such 

25 applications in condition for approval. 


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

2 Type II active pharmaceutical drug master files 

3 which— 

4 ‘‘(i) set forth in detail the specific de5 ficiencies in such submissions, and where 

6 appropriate, the actions necessary to re7 solve those deficiencies; or 

8 ‘‘(ii) document that no deficiencies 

9 need to be addressed. 

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

11 ‘‘(E) Monitoring of research conducted in 

12 connection with the review of generic drug sub13 missions and drug master files. 

14 ‘‘(F) Postmarket safety activities with re15 spect to drugs approved under abbreviated new 

16 drug applications or supplements, including the 

17 following activities: 

18 ‘‘(i) Collecting, developing, and re19 viewing safety information on approved 

20 drugs, including adverse event reports. 

21 ‘‘(ii) Developing and using improved 

22 adverse-event data-collection systems, in23 cluding information technology systems. 

24 ‘‘(iii) Developing and using improved 

25 analytical tools to assess potential safety 


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1 problems, including access to external data 

2 bases. 

3 ‘‘(iv) Implementing and enforcing sec4 tion 505(o) (relating to postapproval stud5 ies and clinical trials and labeling changes) 

6 and section 505(p) (relating to risk evalua7 tion and mitigation strategies) insofar as 

8 those activities relate to abbreviated new 

9 drug applications. 

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

11 (relating to adverse-event reports and 

12 postmarket safety activities). 

13 ‘‘(G) Regulatory science activities related 

14 to generic drugs. 

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

16 drug’ has the meaning given to the term ‘com17 pounded positron emission tomography drug’ in sec18 tion 201(ii), except that paragraph (1)(B) of such 

19 section shall not apply. 

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

21 means a request to the Secretary to approve a 

22 change in the drug substance, drug product, produc23 tion process, quality controls, equipment, or facilities 

24 covered by an approved abbreviated new drug appli25 cation when that change has a substantial potential 


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

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

3 these factors may relate to the safety or effective4 ness of the drug product. 

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

6 generic drug activities’ means the expenses for— 

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

8 and Drug Administration, contractors of the 

9 Food and Drug Administration, advisory com10 mittees, and costs related to such officers and 

11 employees and to contracts with such contrac12 tors; 

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

14 acquisition, maintenance, and repair of com15 puter resources; 

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

17 repair of facilities and acquisition, maintenance, 

18 and repair of fixtures, furniture, scientific 

19 equipment, and other necessary materials and 

20 supplies; and 

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

22 and accounting for resources allocated for the 

23 review of abbreviated new drug applications and 

24 supplements and inspection related to generic 

25 drugs. 


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

2 ingredient drug master file’ means a submission of 

3 information to the Secretary by a person that in4 tends to authorize the Food and Drug Administra5 tion to reference the information to support approval 

6 of a generic drug submission without the submitter 

7 having to disclose the information to the generic 

8 drug submission applicant. 

9 ‘‘SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GE10 NERIC DRUG FEES. 

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

12 2013, the Secretary shall assess and collect fees in accord13 ance with this section as follows: 

14 ‘‘(1) ONE-TIME BACKLOG FEE FOR ABBRE15 VIATED NEW DRUG APPLICATIONS PENDING ON OC16 TOBER 1, 2012.— 

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

18 owns an abbreviated new drug application that 

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

20 not received a tentative approval prior to that 

21 date, shall be subject to a fee for each such ap22 plication, as calculated under subparagraph 

23 (B). 

24 ‘‘(B) METHOD OF FEE AMOUNT CALCULA25 TION.—The amount of each one-time backlog 


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

2 by the total number of abbreviated new drug 

3 applications pending on October 1, 2012, that 

4 have not received a tentative approval as of that 

5 date. 

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

7 2012, the Secretary shall publish in the Federal 

8 Register a notice announcing the amount of the 

9 fee required by subparagraph (A). 

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

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

12 30 calendar days after the date of the publica13 tion of the notice specified in subparagraph (C). 

14 ‘‘(2) DRUG MASTER FILE FEE.— 

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

16 owns a Type II active pharmaceutical ingre17 dient drug master file that is referenced on or 

18 after October 1, 2012, in a generic drug sub19 mission by any initial letter of authorization 

20 shall be subject to a drug master file fee. 

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

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

23 active pharmaceutical ingredient drug master 

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

25 subsequent drug master file fee when that Type 


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1 II active pharmaceutical ingredient drug master 

2 file is subsequently referenced in generic drug 

3 submissions. 

4 ‘‘(C) NOTICE.— 

5 ‘‘(i) FISCAL YEAR 2013.—Not later 

6 than October 31, 2012, the Secretary shall 

7 publish in the Federal Register a notice 

8 announcing the amount of the drug master 

9 file fee for fiscal year 2013. 

10 ‘‘(ii) FISCAL YEAR 2014 THROUGH

11 2017.—Not later than 60 days before the 

12 start of each of fiscal years 2014 through 

13 2017, the Secretary shall publish in the 

14 Federal Register the amount of the drug 

15 master file fee established by this para16 graph for such fiscal year. 

17 ‘‘(D) AVAILABILITY FOR REFERENCE.— 

18 ‘‘(i) IN GENERAL.—Subject to sub19 section (g)(2)(C), for a generic drug sub20 mission to reference a Type II active phar21 maceutical ingredient drug master file, the 

22 drug master file must be deemed available 

23 for reference by the Secretary. 


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1 ‘‘(ii) CONDITIONS.—A drug master 

2 file shall be deemed available for reference 

3 by the Secretary if— 

4 ‘‘(I) the person that owns a Type 

5 II active pharmaceutical ingredient 

6 drug master file has paid the fee re7 quired under subparagraph (A) within 

8 20 calendar days after the applicable 

9 due date under subparagraph (E); 

10 and 

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

12 failed an initial completeness assess13 ment by the Secretary, in accordance 

14 with criteria to be published by the 

15 Secretary. 

16 ‘‘(iii) LIST.—The Secretary shall 

17 make publicly available on the Internet 

18 Web site of the Food and Drug Adminis19 tration a list of the drug master file num20 bers that correspond to drug master files 

21 that have successfully undergone an initial 

22 completeness assessment, in accordance 

23 with criteria to be published by the Sec24 retary, and are available for reference. 

25 ‘‘(E) FEE DUE DATE.— 


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

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

3 later than the date on which the first ge4 neric drug submission is submitted that 

5 references the associated Type II active 

6 pharmaceutical ingredient drug master file. 

7 ‘‘(ii) LIMITATION.—No fee shall be 

8 due under subparagraph (A) for a fiscal 

9 year until the later of— 

10 ‘‘(I) 30 calendar days after publi11 cation of the notice provided for in 

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

13 as applicable; or 

14 ‘‘(II) 30 calendar days after the 

15 date of enactment of an appropria16 tions Act providing for the collection 

17 and obligation of fees under this sec18 tion. 

19 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION

20 AND PRIOR APPROVAL SUPPLEMENT FILING FEE.— 

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

22 submits, on or after October 1, 2012, an abbre23 viated new drug application or a prior approval 

24 supplement to an abbreviated new drug applica25 tion shall be subject to a fee for each such subVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00046 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 mission in the amount established under sub2 section (d). 

3 ‘‘(B) NOTICE.— 

4 ‘‘(i) FISCAL YEAR 2013.—Not later 

5 than October 31, 2012, the Secretary shall 

6 publish in the Federal Register a notice 

7 announcing the amount of the fees under 

8 subparagraph (A) for fiscal year 2013. 

9 ‘‘(ii) FISCAL YEARS 2014 THROUGH

10 2017.—Not later than 60 days before the 

11 start of each of fiscal years 2014 through 

12 2017, the Secretary shall publish in the 

13 Federal Register the amount of the fees 

14 under subparagraph (A) for such fiscal 

15 year. 

16 ‘‘(C) FEE DUE DATE.— 

17 ‘‘(i) IN GENERAL.—Except as pro18 vided in clause (ii), the fees required by 

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

20 later than the date of submission of the 

21 abbreviated new drug application or prior 

22 approval supplement for which such fee ap23 plies. 


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1 ‘‘(ii) SPECIAL RULE FOR 2013.—For 

2 fiscal year 2013, such fees shall be due on 

3 the later of— 

4 ‘‘(I) the date on which the fee is 

5 due under clause (i); 

6 ‘‘(II) 30 calendar days after pub7 lication of the notice referred to in 

8 subparagraph (B)(i); or 

9 ‘‘(III) if an appropriations Act is 

10 not enacted providing for the collec11 tion and obligation of fees under this 

12 section by the date of submission of 

13 the application or prior approval sup14 plement for which the fees under sub15 paragraphs (A) and (F) apply, 30 cal16 endar days after the date that such an 

17 appropriations Act is enacted. 

18 ‘‘(D) REFUND OF FEE IF ABBREVIATED

19 NEW DRUG APPLICATION IS NOT CONSIDERED

20 TO HAVE BEEN RECEIVED.—The Secretary 

21 shall refund 75 percent of the fee paid under 

22 subparagraph (A) for any abbreviated new drug 

23 application or prior approval supplement to an 

24 abbreviated new drug application that the Sec25 retary considers not to have been received withVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 in the meaning of section 505(j)(5)(A) for a 

2 cause other than failure to pay fees. 

3 ‘‘(E) FEE FOR AN APPLICATION THE SEC4 RETARY CONSIDERS NOT TO HAVE BEEN RE5 CEIVED, OR THAT HAS BEEN WITHDRAWN.—An 

6 abbreviated new drug application or prior ap7 proval supplement that was submitted on or 

8 after October 1, 2012, and that the Secretary 

9 considers not to have been received, or that has 

10 been withdrawn, shall, upon resubmission of the 

11 application or a subsequent new submission fol12 lowing the applicant’s withdrawal of the appli13 cation, be subject to a full fee under subpara14 graph (A). 

15 ‘‘(F) ADDITIONAL FEE FOR ACTIVE PHAR16 MACEUTICAL INGREDIENT INFORMATION NOT

17 INCLUDED BY REFERENCE TO TYPE II ACTIVE

18 PHARMACEUTICAL INGREDIENT DRUG MASTER

19 FILE.—An applicant that submits a generic 

20 drug submission on or after October 1, 2012, 

21 shall pay a fee, in the amount determined under 

22 subsection (d)(3), in addition to the fee re23 quired under subparagraph (A), if— 

24 ‘‘(i) such submission contains infor25 mation concerning the manufacture of an 


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1 active pharmaceutical ingredient at a facil2 ity by means other than reference by a let3 ter of authorization to a Type II active 

4 pharmaceutical drug master file; and 

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

6 drug master file fee established in para7 graph (2) has not been previously paid 

8 with respect to such information. 

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

10 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

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

12 or intended to be identified, in at least one ge13 neric drug submission that is pending or ap14 proved to produce a finished dosage form of a 

15 human generic drug or an active pharma16 ceutical ingredient contained in a human ge17 neric drug shall be subject to fees as follows: 

18 ‘‘(i) GENERIC DRUG FACILITY.—Each 

19 person that owns a facility which is identi20 fied or intended to be identified in at least 

21 one generic drug submission that is pend22 ing or approved to produce one or more 

23 finished dosage forms of a human generic 

24 drug shall be assessed an annual fee for 

25 each such facility. 


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1 ‘‘(ii) ACTIVE PHARMACEUTICAL IN2 GREDIENT FACILITY.—Each person that 

3 owns a facility which produces, or which is 

4 pending review to produce, one or more ac5 tive pharmaceutical ingredients identified, 

6 or intended to be identified, in at least one 

7 generic drug submission that is pending or 

8 approved or in a Type II active pharma9 ceutical ingredient drug master file ref10 erenced in such a generic drug submission, 

11 shall be assessed an annual fee for each 

12 such facility. 

13 ‘‘(iii) FACILITIES PRODUCING BOTH

14 ACTIVE PHARMACEUTICAL INGREDIENTS

15 AND FINISHED DOSAGE FORMS.—Each 

16 person that owns a facility identified, or 

17 intended to be identified, in at least one 

18 generic drug submission that is pending or 

19 approved to produce both one or more fin20 ished dosage forms subject to clause (i) 

21 and one or more active pharmaceutical in22 gredients subject to clause (ii) shall be 

23 subject to fees under both such clauses for 

24 that facility. 


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1 ‘‘(B) AMOUNT.—The amount of fees estab2 lished under subparagraph (A) shall be estab3 lished under subsection (d). 

4 ‘‘(C) NOTICE.— 

5 ‘‘(i) FISCAL YEAR 2013.—For fiscal 

6 year 2013, the Secretary shall publish in 

7 the Federal Register a notice announcing 

8 the amount of the fees provided for in sub9 paragraph (A) within the timeframe speci10 fied in subsection (d)(1)(B). 

11 ‘‘(ii) FISCAL YEARS 2014 THROUGH

12 2017.—Within the timeframe specified in 

13 subsection (d)(2), the Secretary shall pub14 lish in the Federal Register the amount of 

15 the fees under subparagraph (A) for such 

16 fiscal year. 

17 ‘‘(D) FEE DUE DATE.— 

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

19 year 2013, the fees under subparagraph 

20 (A) shall be due on the later of— 

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

22 the publication of the notice under 

23 subparagraph (B); or 

24 ‘‘(II) if an appropriations Act is 

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1 tion and obligation of fees under this 

2 section by the date of the publication 

3 of such notice, 30 days after the date 

4 that such an appropriations Act is en5 acted. 

6 ‘‘(ii) FISCAL YEARS 2014 THROUGH

7 2017.—For each of fiscal years 2014 

8 through 2017, the fees under subpara9 graph (A) for such fiscal year shall be due 

10 on the later of— 

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

12 after October 1 of each such year; or 

13 ‘‘(II) the first business day after 

14 the enactment of an appropriations 

15 Act providing for the collection and 

16 obligation of fees under this section 

17 for such year. 

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

19 this Act, a generic drug submission or Type II phar20 maceutical master file is deemed to be ‘submitted’ to 

21 the Food and Drug Administration— 

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

23 Drug Administration electronic gateway, on the 

24 day when transmission to that electronic gate25 way is completed, except that a submission or 


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1 master file that arrives on a weekend, Federal 

2 holiday, or day when the Food and Drug Ad3 ministration office that will review that submis4 sion is not otherwise open for business shall be 

5 deemed to be submitted on the next day when 

6 that office is open for business; or 

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

8 form, on the day it arrives at the appropriate 

9 designated document room of the Food and 

10 Drug Administration. 

11 ‘‘(b) FEE REVENUE AMOUNTS.— 

12 ‘‘(1) IN GENERAL.— 

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

14 2013, fees under subsection (a) shall be estab15 lished to generate a total estimated revenue 

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

17 Of that amount— 

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

19 by the one-time backlog fee for generic 

20 drug applications pending on October 1, 

21 2012, established in subsection (a)(1); and 

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

23 by the fees under paragraphs (2) through 

24 (4) of subsection (a). 


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

2 For each of the fiscal years 2014 through 2017, 

3 fees under paragraphs (2) through (4) of sub4 section (a) shall be established to generate a 

5 total estimated revenue amount under such sub6 section that is equal to $299,000,000, as ad7 justed pursuant to subsection (c). 

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

9 under paragraph (1) to generate the revenue 

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

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

12 years 2014 through 2017, such fees shall be derived 

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

14 subsection (a) as follows: 

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

16 under subsection (a)(2) (relating to drug mas17 ter files). 

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

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

20 new drug applications and supplements). The 

21 amount of a fee for a prior approval supplement 

22 shall be half the amount of the fee for an ab23 breviated new drug application. 

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

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1 neric drug facilities). The amount of the fee for 

2 a facility located outside the United States and 

3 its territories and possessions shall be not less 

4 than $15,000 and not more than $30,000 high5 er than the amount of the fee for a facility lo6 cated in the United States and its territories 

7 and possessions, as determined by the Secretary 

8 on the basis of data concerning the difference 

9 in cost between inspections of facilities located 

10 in the United States, including its territories 

11 and possessions, and those located outside of 

12 the United States and its territories and posses13 sions. 

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

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

16 pharmaceutical ingredient facilities). The 

17 amount of the fee for a facility located outside 

18 the United States and its territories and posses19 sions shall be not less than $15,000 and not 

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

21 the fee for a facility located in the United 

22 States, including its territories and possessions, 

23 as determined by the Secretary on the basis of 

24 data concerning the difference in cost between 

25 inspections of facilities located in the United 


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1 States and its territories and possessions and 

2 those located outside of the United States and 

3 its territories and possessions. 

4 ‘‘(c) ADJUSTMENTS.— 

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

6 2014 and subsequent fiscal years, the revenues es7 tablished in subsection (b) shall be adjusted by the 

8 Secretary by notice, published in the Federal Reg9 ister, for a fiscal year, by an amount equal to the 

10 sum of— 

11 ‘‘(A) one; 

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

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

14 Food and Drug Administration, of all personnel 

15 compensation and benefits paid with respect to 

16 such positions for the first 3 years of the pre17 ceding 4 fiscal years multiplied by the propor18 tion of personnel compensation and benefits 

19 costs to total costs of human generic drug ac20 tivities for the first 3 years of the preceding 4 

21 fiscal years; and 

22 ‘‘(C) the average annual percent change 

23 that occurred in the Consumer Price Index for 

24 urban consumers (Washington-Baltimore, DC– 

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


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

2 preceding 4 years of available data multiplied 

3 by the proportion of all costs other than per4 sonnel compensation and benefits costs to total 

5 costs of human generic drug activities for the 

6 first 3 years of the preceding 4 fiscal years. 

7 The adjustment made each fiscal year under this 

8 subsection shall be added on a compounded basis to 

9 the sum of all adjustments made each fiscal year 

10 after fiscal year 2013 under this subsection. 

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

12 year 2017, the Secretary may, in addition to adjust13 ments under paragraph (1), further increase the fee 

14 revenues and fees established in subsection (b) if 

15 such an adjustment is necessary to provide for not 

16 more than 3 months of operating reserves of carry17 over user fees for human generic drug activities for 

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

19 may only be used in fiscal year 2018. If such an ad20 justment is necessary, the rationale for the amount 

21 of the increase shall be contained in the annual no22 tice establishing fee revenues and fees for fiscal year 

23 2017. If the Secretary has carryover balances for 

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1 ating reserves, the adjustment under this subpara2 graph shall not be made. 

3 ‘‘(d) ANNUAL FEE SETTING.— 

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

5 2013— 

6 ‘‘(A) the Secretary shall establish, by Octo7 ber 31, 2012, the one-time generic drug backlog 

8 fee for generic drug applications pending on Oc9 tober 1, 2012, the drug master file fee, the ab10 breviated new drug application fee, and the 

11 prior approval supplement fee under subsection 

12 (a), based on the revenue amounts established 

13 under subsection (b); and 

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

15 later than 45 days after the date to comply 

16 with the requirement for identification of facili17 ties in subsection (f)(2), the generic drug facil18 ity fee and active pharmaceutical ingredient fa19 cility fee under subsection (a) based on the rev20 enue amounts established under subsection (b). 

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

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

23 fiscal years 2014 through 2017, the Secretary shall 

24 establish the drug master file fee, the abbreviated 

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1 ment fee, the generic drug facility fee, and the active 

2 pharmaceutical ingredient facility fee under sub3 section (a) for such fiscal year, based on the revenue 

4 amounts established under subsection (b) and the 

5 adjustments provided under subsection (c). 

6 ‘‘(3) FEE FOR ACTIVE PHARMACEUTICAL IN7 GREDIENT INFORMATION NOT INCLUDED BY REF8 ERENCE TO TYPE II ACTIVE PHARMACEUTICAL IN9 GREDIENT DRUG MASTER FILE.—In establishing the 

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

11 the fee under subsection (a)(3)(F) shall be deter12 mined by multiplying— 

13 ‘‘(A) the sum of— 

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

15 pharmaceutical ingredients in such submis16 sion; and 

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

18 manufactured at more than one such facil19 ity, the total number of such additional fa20 cilities; and 

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

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

23 submission. 

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

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


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

2 allocated for human generic drug activities. 

3 ‘‘(f) IDENTIFICATION OF FACILITIES.— 

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

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

6 Secretary shall publish in the Federal Register a no7 tice requiring each person that owns a facility de8 scribed in subsection (a)(4)(A), or a site or organi9 zation required to be identified by paragraph (4), to 

10 submit to the Secretary information on the identity 

11 of each such facility, site, or organization. The no12 tice required by this paragraph shall specify the type 

13 of information to be submitted and the means and 

14 format for submission of such information. 

15 ‘‘(2) REQUIRED SUBMISSION OF FACILITY

16 IDENTIFICATION.—Each person that owns a facility 

17 described in subsection (a)(4)(A) or a site or organi18 zation required to be identified by paragraph (4) 

19 shall submit to the Secretary the information re20 quired under this subsection each year. Such infor21 mation shall— 

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

23 later than 60 days after the publication of the 

24 notice under paragraph (1); and 


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

2 submitted, updated, or reconfirmed on or before 

3 June 1 of the previous year. 

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

5 the submission required by paragraph (2) shall in6 clude for each such facility— 

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

8 intended to be identified in an approved or 

9 pending generic drug submission; 

10 ‘‘(B) whether the facility manufactures ac11 tive pharmaceutical ingredients or finished dos12 age forms, or both; 

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

14 within the United States and its territories and 

15 possessions; 

16 ‘‘(D) whether the facility manufactures 

17 positron emission tomography drugs solely, or 

18 in addition to other drugs; and 

19 ‘‘(E) whether the facility manufactures 

20 drugs that are not generic drugs. 

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

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

23 or operates a site or organization described in 

24 subparagraph (B) shall submit to the Secretary 


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1 information concerning the ownership, name, 

2 and address of the site or organization. 

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

4 or organization is described in this subpara5 graph if it is identified in a generic drug sub6 mission and is— 

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

8 study is conducted; 

9 ‘‘(ii) a clinical research organization; 

10 ‘‘(iii) a contract analytical testing site; 

11 or 

12 ‘‘(iv) a contract repackager site. 

13 ‘‘(C) NOTICE.—The Secretary may, by no14 tice published in the Federal Register, specify 

15 the means and format for submission of the in16 formation under subparagraph (A) and may 

17 specify, as necessary for purposes of this sec18 tion, any additional information to be sub19 mitted. 

20 ‘‘(D) INSPECTION AUTHORITY.—The Sec21 retary’s inspection authority under section 

22 704(a)(1) shall extend to all such sites and or23 ganizations. 

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


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

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

3 the Secretary placing the person that owns the ab4 breviated new drug application subject to that fee on 

5 an arrears list, such that no new abbreviated new 

6 drug applications or supplement submitted on or 

7 after October 1, 2012, from that person, or any af8 filiate of that person, will be received within the 

9 meaning of section 505(j)(5)(A) until such out10 standing fee is paid. 

11 ‘‘(2) DRUG MASTER FILE FEE.— 

12 ‘‘(A) Failure to pay the fee under sub13 section (a)(2) within 20 calendar days after the 

14 applicable due date under subparagraph (E) of 

15 such subsection (as described in subsection 

16 (a)(2)(D)(ii)(I)) shall result in the Type II ac17 tive pharmaceutical ingredient drug master file 

18 not being deemed available for reference. 

19 ‘‘(B)(i) Any generic drug submission sub20 mitted on or after October 1, 2012, that ref21 erences, by a letter of authorization, a Type II 

22 active pharmaceutical ingredient drug master 

23 file that has not been deemed available for ref24 erence shall not be received within the meaning 


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

2 specified in clause (ii) is met. 

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

4 is that the fee established under subsection 

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

6 the Secretary providing the notification to the 

7 sponsor of the abbreviated new drug application 

8 or supplement of the failure of the owner of the 

9 Type II active pharmaceutical ingredient drug 

10 master file to pay the drug master file fee as 

11 specified in subparagraph (C). 

12 ‘‘(C)(i) If an abbreviated new drug applica13 tion or supplement to an abbreviated new drug 

14 application references a Type II active pharma15 ceutical ingredient drug master file for which a 

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

17 paid by the applicable date under subsection 

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

19 of the abbreviated new drug application or sup20 plement of the failure of the owner of the Type 

21 II active pharmaceutical ingredient drug master 

22 file to pay the applicable fee. 

23 ‘‘(ii) If such fee is not paid within 20 cal24 endar days of the Secretary providing the noti25 fication, the abbreviated new drug application 


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1 or supplement to an abbreviated new drug ap2 plication shall not be received within the mean3 ing of 505(j)(5)(A). 

4 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION

5 FEE AND PRIOR APPROVAL SUPPLEMENT FEE.— 

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

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

8 applicable due date under subparagraph (C) of such 

9 subsection shall result in the abbreviated new drug 

10 application or the prior approval supplement to an 

11 abbreviated new drug application not being received 

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

13 such outstanding fee is paid. 

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

15 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

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

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

18 of the due date as specified in subparagraph 

19 (D) of such subsection shall result in the fol20 lowing: 

21 ‘‘(i) The Secretary shall place the fa22 cility on a publicly available arrears list, 

23 such that no new abbreviated new drug ap24 plication or supplement submitted on or 

25 after October 1, 2012, from the person 


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1 that is responsible for paying such fee, or 

2 any affiliate of that person, will be received 

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

4 ‘‘(ii) Any new generic drug submission 

5 submitted on or after October 1, 2012, 

6 that references such a facility shall not be 

7 received, within the meaning of section 

8 505(j)(5)(A) if the outstanding facility fee 

9 is not paid within 20 calendar days of the 

10 Secretary providing the notification to the 

11 sponsor of the failure of the owner of the 

12 facility to pay the facility fee under sub13 section (a)(4)(C). 

14 ‘‘(iii) All drugs or active pharma15 ceutical ingredients manufactured in such 

16 a facility or containing an ingredient man17 ufactured in such a facility shall be deemed 

18 misbranded under section 502(aa). 

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

20 penalties under this paragraph shall apply until 

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

22 or the facility is removed from all generic drug 

23 submissions that refer to the facility. 

24 ‘‘(C) NONRECEIVAL FOR NONPAYMENT.— 


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

2 drug application or supplement to an ab3 breviated new drug application submitted 

4 on or after October 1, 2012, references a 

5 facility for which a facility fee has not been 

6 paid by the applicable date under sub7 section (a)(4)(C), the Secretary shall notify 

8 the sponsor of the generic drug submission 

9 of the failure of the owner of the facility 

10 to pay the facility fee. 

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

12 fee is not paid within 20 calendar days of 

13 the Secretary providing the notification 

14 under clause (i), the abbreviated new drug 

15 application or supplement to an abbre16 viated new drug application shall not be re17 ceived within the meaning of section 

18 505(j)(5)(A). 

19 ‘‘(h) LIMITATIONS.— 

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

21 shall be refunded for a fiscal year beginning after 

22 fiscal year 2012, unless appropriations for salaries 

23 and expenses of the Food and Drug Administration 

24 for such fiscal year (excluding the amount of fees 

25 appropriated for such fiscal year) are equal to or 


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1 greater than the amount of appropriations for the 

2 salaries and expenses of the Food and Drug Admin3 istration for the fiscal year 2009 (excluding the 

4 amount of fees appropriated for such fiscal year) 

5 multiplied by the adjustment factor (as defined in 

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

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

8 assess fees under subsection (a) during any portion 

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

10 year the Secretary may assess such fees, the Sec11 retary may assess and collect such fees, without any 

12 modification in the rate, for Type II active pharma13 ceutical ingredient drug master files, abbreviated 

14 new drug applications and prior approval supple15 ments, and generic drug facilities and active phar16 maceutical ingredient facilities at any time in such 

17 fiscal year notwithstanding the provisions of sub18 section (a) relating to the date fees are to be paid. 

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

20 ‘‘(1) IN GENERAL.—Fees authorized under sub21 section (a) shall be collected and available for obliga22 tion only to the extent and in the amount provided 

23 in advance in appropriations Acts, subject to para24 graph (2). Such fees are authorized to remain avail25 able until expended. Such sums as may be necessary 


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1 may be transferred from the Food and Drug Admin2 istration salaries and expenses appropriation account 

3 without fiscal year limitation to such appropriation 

4 account for salaries and expenses with such fiscal 

5 year limitation. The sums transferred shall be avail6 able solely for human generic drug activities. 

7 ‘‘(2) COLLECTIONS AND APPROPRIATION

8 ACTS.— 

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

10 by this section— 

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

12 (D), shall be collected and available in each 

13 fiscal year in an amount not to exceed the 

14 amount specified in appropriation Acts, or 

15 otherwise made available for obligation for 

16 such fiscal year; and 

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

18 beginning after fiscal year 2012 to defray 

19 the costs of human generic drug activities 

20 (including such costs for an additional 

21 number of full-time equivalent positions in 

22 the Department of Health and Human 

23 Services to be engaged in such activities), 

24 only if the Secretary allocates for such 

25 purpose an amount for such fiscal year 


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1 (excluding amounts from fees collected 

2 under this section) no less than 

3 $97,000,000 multiplied by the adjustment 

4 factor, as defined in section 744A(3), ap5 plicable to the fiscal year involved. 

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

7 be considered to have met the requirements of 

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

9 costs funded by appropriations and allocated for 

10 human generic activities are not more than 10 

11 percent below the level specified in such sub12 paragraph. 

13 ‘‘(C) FEE COLLECTION DURING FIRST

14 PROGRAM YEAR.—Until the date of enactment 

15 of an Act making appropriations through Sep16 tember 30, 2013 for the salaries and expenses 

17 account of the Food and Drug Administration, 

18 fees authorized by this section for fiscal year 

19 2013, may be collected and shall be credited to 

20 such account and remain available until ex21 pended. 

22 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

23 SUBSEQUENT YEARS.—Payment of fees author24 ized under this section for a fiscal year (after 

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


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1 fees, may be accepted by the Secretary in ac2 cordance with authority provided in advance in 

3 a prior year appropriations Act. 

4 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

5 For each of the fiscal years 2013 through 2017, 

6 there is authorized to be appropriated for fees under 

7 this section an amount equivalent to the total rev8 enue amount determined under subsection (b) for 

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

10 applicable, or as otherwise affected under paragraph 

11 (2) of this subsection. 

12 ‘‘(j) COLLECTION OF UNPAID FEES.—In any case 

13 where the Secretary does not receive payment of a fee as14 sessed under subsection (a) within 30 calendar days after 

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

16 States Government subject to subchapter II of chapter 37 

17 of title 31, United States Code. 

18 ‘‘(k) CONSTRUCTION.—This section may not be con19 strued to require that the number of full-time equivalent 

20 positions in the Department of Health and Human Serv21 ices, for officers, employees, and advisory committees not 

22 engaged in human generic drug activities, be reduced to 

23 offset the number of officers, employees, and advisory 

24 committees so engaged. 

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


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

2 an application for a positron emission tomography 

3 drug or active pharmaceutical ingredient for a 

4 positron emission tomography drug shall not require 

5 the payment of any fee under this section. Facilities 

6 that solely produce positron emission tomography 

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

8 established in subsection (a)(4). 

9 ‘‘(2) IDENTIFICATION REQUIREMENT.—Facili10 ties that produce positron emission tomography 

11 drugs or active pharmaceutical ingredients of such 

12 drugs are required to be identified pursuant to sub13 section (f). 

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

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

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

17 a written request justifying such return within 180 cal18 endar days after such fee was paid. 

19 ‘‘(n) SUBSTANTIALLY COMPLETE APPLICATIONS.— 

20 An abbreviated new drug application that is not consid21 ered to be received within the meaning of section 

22 505(j)(5)(A) because of failure to pay an applicable fee 

23 under this provision within the time period specified in 

24 subsection (g) shall be deemed not to have been ‘substan25 tially complete’ on the date of its submission within the 


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1 meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbre2 viated new drug application that is not substantially com3 plete on the date of its submission solely because of failure 

4 to pay an applicable fee under the preceding sentence shall 

5 be deemed substantially complete and received within the 

6 meaning of section 505(j)(5)(A) as of the date such appli7 cable fee is received.’’. 

8 SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

10 section 302 of this Act, is amended by inserting after sec11 tion 744B the following: 

12 ‘‘SEC. 744C. REAUTHORIZATION; REPORTING REQUIRE13 MENTS. 

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

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

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

17 the Secretary shall prepare and submit to the Committee 

18 on Energy and Commerce of the House of Representatives 

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

20 Pensions of the Senate a report concerning the progress 

21 of the Food and Drug Administration in achieving the 

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

23 of the Generic Drug User Fee Amendments of 2012 dur24 ing such fiscal year and the future plans of the Food and 

25 Drug Administration for meeting the goals. 


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

2 2013, not later than 120 days after the end of each fiscal 

3 year for which fees are collected under this part, the Sec4 retary shall prepare and submit to the Committee on En5 ergy and Commerce of the House of Representatives and 

6 the Committee on Health, Education, Labor, and Pen7 sions of the Senate a report on the implementation of the 

8 authority for such fees during such fiscal year and the 

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

10 collected for such fiscal year. 

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

12 make the reports required under subsections (a) and (b) 

13 available to the public on the Internet Web site of the 

14 Food and Drug Administration. 

15 ‘‘(d) REAUTHORIZATION.— 

16 ‘‘(1) CONSULTATION.—In developing rec17 ommendations to present to the Congress with re18 spect to the goals, and plans for meeting the goals, 

19 for human generic drug activities for the first 5 fis20 cal years after fiscal year 2017, and for the reau21 thorization of this part for such fiscal years, the Sec22 retary shall consult with— 

23 ‘‘(A) the Committee on Energy and Com24 merce of the House of Representatives; 


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

2 Labor, and Pensions of the Senate; 

3 ‘‘(C) scientific and academic experts; 

4 ‘‘(D) health care professionals; 

5 ‘‘(E) representatives of patient and con6 sumer advocacy groups; and 

7 ‘‘(F) the generic drug industry. 

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

9 negotiations with the generic drug industry on the 

10 reauthorization of this part, the Secretary shall— 

11 ‘‘(A) publish a notice in the Federal Reg12 ister requesting public input on the reauthoriza13 tion; 

14 ‘‘(B) hold a public meeting at which the 

15 public may present its views on the reauthoriza16 tion, including specific suggestions for changes 

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

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

19 public meeting to obtain written comments from 

20 the public suggesting changes to this part; and 

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

22 and Drug Administration’s Internet Web site. 

23 ‘‘(3) PERIODIC CONSULTATION.—Not less fre24 quently than once every month during negotiations 

25 with the generic drug industry, the Secretary shall 


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1 hold discussions with representatives of patient and 

2 consumer advocacy groups to continue discussions of 

3 their views on the reauthorization and their sugges4 tions for changes to this part as expressed under 

5 paragraph (2). 

6 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA7 TIONS.—After negotiations with the generic drug in8 dustry, the Secretary shall— 

9 ‘‘(A) present the recommendations devel10 oped under paragraph (1) to the congressional 

11 committees specified in such paragraph; 

12 ‘‘(B) publish such recommendations in the 

13 Federal Register; 

14 ‘‘(C) provide for a period of 30 days for 

15 the public to provide written comments on such 

16 recommendations; 

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

18 may present its views on such recommenda19 tions; and 

20 ‘‘(E) after consideration of such public 

21 views and comments, revise such recommenda22 tions as necessary. 

23 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

24 Not later than January 15, 2017, the Secretary 

25 shall transmit to the Congress the revised recVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00077 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 ommendations under paragraph (4), a summary of 

2 the views and comments received under such para3 graph, and any changes made to the recommenda4 tions in response to such views and comments. 

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

6 ‘‘(A) PUBLIC AVAILABILITY.—Before pre7 senting the recommendations developed under 

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

9 Secretary shall make publicly available, on the 

10 Internet Web site of the Food and Drug Ad11 ministration, minutes of all negotiation meet12 ings conducted under this subsection between 

13 the Food and Drug Administration and the ge14 neric drug industry. 

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

16 under subparagraph (A) shall summarize any 

17 substantive proposal made by any party to the 

18 negotiations as well as significant controversies 

19 or differences of opinion during the negotiations 

20 and their resolution.’’. 

21 SEC. 304. SUNSET DATES. 

22 (a) AUTHORIZATION.—The amendments made by 

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


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1 (b) REPORTING REQUIREMENTS.—The amendments 

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

3 2018. 

4 SEC. 305. EFFECTIVE DATE. 

5 The amendments made by this title shall take effect 

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

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

8 shall be assessed for all human generic drug submissions 

9 and Type II active pharmaceutical drug master files re10 ceived on or after October 1, 2012, regardless of the date 

11 of enactment of this title. 

12 SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING. 

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

14 at the end the following: 

15 ‘‘(aa) If it is a drug, or an active pharmaceutical in16 gredient, and it was manufactured, prepared, propagated, 

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

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

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

20 has not been submitted, or it contains an active pharma21 ceutical ingredient that was manufactured, prepared, 

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


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1 SEC. 307. STREAMLINED HIRING AUTHORITY OF THE FOOD 

2 AND DRUG ADMINISTRATION TO SUPPORT 

3 ACTIVITIES RELATED TO HUMAN GENERIC 

4 DRUGS. 

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

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

7 (1) in subsection (b)— 

8 (A) by striking ‘‘are activities’’ and insert9 ing ‘‘are— 

10 ‘‘(1) activities’’; 

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

12 inserting ‘‘; and’’; and 

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

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

15 generic drug activities (as defined in section 

16 744A).’’; and 

17 (2) by amending subsection (c) to read as fol18 lows: 

19 ‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci20 fied in this subsection are— 

21 ‘‘(1) with respect to the activities under sub22 section (b)(1), the goals referred to in section 

23 738A(a)(1); and 

24 ‘‘(2) with respect to the activities under sub25 section (b)(2), the performance goals with respect to 

26 section 744A (regarding assessment and use of 


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

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

3 User Fee Amendments of 2012.’’. 

4 TITLE IV—FEES RELATING TO 

5 BIOSIMILAR BIOLOGICAL 

6 PRODUCTS 

7 SEC. 401. SHORT TITLE; FINDING. 

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

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

10 (b) FINDING.—The Congress finds that the fees au11 thorized by the amendments made in this title will be dedi12 cated to expediting the process for the review of biosimilar 

13 biological product applications, including postmarket safe14 ty activities, as set forth in the goals identified for pur15 poses of part 8 of subchapter C of chapter VII of the Fed16 eral Food, Drug, and Cosmetic Act, in the letters from 

17 the Secretary of Health and Human Services to the Chair18 man of the Committee on Health, Education, Labor, and 

19 Pensions of the Senate and the Chairman of the Com20 mittee on Energy and Commerce of the House of Rep21 resentatives, as set forth in the Congressional Record. 


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1 SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL 

2 PRODUCTS. 

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

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

5 III of this Act, the following: 

6 ‘‘PART 8—FEES RELATING TO BIOSIMILAR 

7 BIOLOGICAL PRODUCTS 

8 ‘‘SEC. 744G. DEFINITIONS. 

9 ‘‘For purposes of this part: 

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

11 a fiscal year that is the Consumer Price Index for 

12 all urban consumers (Washington-Baltimore, DC– 

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

14 the preceding fiscal year divided by such Index for 

15 September 2011. 

16 ‘‘(2) The term ‘affiliate’ means a business enti17 ty that has a relationship with a second business en18 tity if, directly or indirectly— 

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

20 the power to control, the other business entity; 

21 or 

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

23 to control, both of the business entities. 

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

25 means a product for which a biosimilar biological 

26 product application has been approved. 


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

2 ‘biosimilar biological product application’ means an 

3 application for licensure of a biological product 

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

5 Act. 

6 ‘‘(B) Such term does not include— 

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

8 ‘‘(ii) an application filed under section 

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

10 cites as the reference product a bovine blood 

11 product for topical application licensed before 

12 September 1, 1992, or a large volume paren13 teral drug product approved before such date; 

14 ‘‘(iii) an application filed under section 

15 351(k) of the Public Health Service Act with 

16 respect to— 

17 ‘‘(I) whole blood or a blood component 

18 for transfusion; 

19 ‘‘(II) an allergenic extract product; 

20 ‘‘(III) an in vitro diagnostic biological 

21 product; or 

22 ‘‘(IV) a biological product for further 

23 manufacturing use only; or 

24 ‘‘(iv) an application for licensure under 

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


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1 that is submitted by a State or Federal Govern2 ment entity for a product that is not distributed 

3 commercially. 

4 ‘‘(5) The term ‘biosimilar biological product de5 velopment meeting’ means any meeting, other than 

6 a biosimilar initial advisory meeting, regarding the 

7 content of a development program, including a pro8 posed design for, or data from, a study intended to 

9 support a biosimilar biological product application. 

10 ‘‘(6) The term ‘biosimilar biological product de11 velopment program’ means the program under this 

12 part for expediting the process for the review of sub13 missions in connection with biosimilar biological 

14 product development. 

15 ‘‘(7)(A) The term ‘biosimilar biological product 

16 establishment’ means a foreign or domestic place of 

17 business— 

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

19 consisting of one or more buildings, all of which 

20 are within five miles of each other; and 

21 ‘‘(ii) at which one or more biosimilar bio22 logical products are manufactured in final dos23 age form. 

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

25 term ‘manufactured’ does not include packaging. 


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1 ‘‘(8) The term ‘biosimilar initial advisory meet2 ing’— 

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

4 limited to— 

5 ‘‘(i) a general discussion regarding 

6 whether licensure under section 351(k) of 

7 the Public Health Service Act may be fea8 sible for a particular product; and 

9 ‘‘(ii) if so, general advice on the ex10 pected content of the development pro11 gram; and 

12 ‘‘(B) does not include any meeting that in13 volves substantive review of summary data or 

14 full study reports. 

15 ‘‘(9) The term ‘costs of resources allocated for 

16 the process for the review of biosimilar biological 

17 product applications’ means the expenses in connec18 tion with the process for the review of biosimilar bio19 logical product applications for— 

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

21 and Drug Administration, contractors of the 

22 Food and Drug Administration, advisory com23 mittees, and costs related to such officers em24 ployees and committees and to contracts with 

25 such contractors; 


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

2 acquisition, maintenance, and repair of com3 puter resources; 

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

5 repair of facilities and acquisition, maintenance, 

6 and repair of fixtures, furniture, scientific 

7 equipment, and other necessary materials and 

8 supplies; and 

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

10 and accounting for resources allocated for the 

11 review of submissions in connection with bio12 similar biological product development, bio13 similar biological product applications, and sup14 plements. 

15 ‘‘(10) The term ‘final dosage form’ means, with 

16 respect to a biosimilar biological product, a finished 

17 dosage form which is approved for administration to 

18 a patient without substantial further manufacturing 

19 (such as lyophilized products before reconstitution). 

20 ‘‘(11) The term ‘financial hold’— 

21 ‘‘(A) means an order issued by the Sec22 retary to prohibit the sponsor of a clinical in23 vestigation from continuing the investigation if 

24 the Secretary determines that the investigation 

25 is intended to support a biosimilar biological 


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1 product application and the sponsor has failed 

2 to pay any fee for the product required under 

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

4 744H(a)(1); and 

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

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

7 been determined by the Secretary to exist con8 cerning the investigation. 

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

10 such person. 

11 ‘‘(13) The term ‘process for the review of bio12 similar biological product applications’ means the 

13 following activities of the Secretary with respect to 

14 the review of submissions in connection with bio15 similar biological product development, biosimilar bi16 ological product applications, and supplements: 

17 ‘‘(A) The activities necessary for the re18 view of submissions in connection with bio19 similar biological product development, bio20 similar biological product applications, and sup21 plements. 

22 ‘‘(B) Actions related to submissions in con23 nection with biosimilar biological product devel24 opment, the issuance of action letters which ap25 prove biosimilar biological product applications 


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1 or which set forth in detail the specific defi2 ciencies in such applications, and where appro3 priate, the actions necessary to place such ap4 plications in condition for approval. 

5 ‘‘(C) The inspection of biosimilar biological 

6 product establishments and other facilities un7 dertaken as part of the Secretary’s review of 

8 pending biosimilar biological product applica9 tions and supplements. 

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

11 lots of biosimilar biological products under sec12 tion 351(k) of the Public Health Service Act. 

13 ‘‘(E) Monitoring of research conducted in 

14 connection with the review of biosimilar biologi15 cal product applications. 

16 ‘‘(F) Postmarket safety activities with re17 spect to biologics approved under biosimilar bio18 logical product applications or supplements, in19 cluding the following activities: 

20 ‘‘(i) Collecting, developing, and re21 viewing safety information on biosimilar bi22 ological products, including adverse-event 

23 reports. 


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1 ‘‘(ii) Developing and using improved 

2 adverse-event data-collection systems, in3 cluding information technology systems. 

4 ‘‘(iii) Developing and using improved 

5 analytical tools to assess potential safety 

6 problems, including access to external data 

7 bases. 

8 ‘‘(iv) Implementing and enforcing sec9 tion 505(o) (relating to postapproval stud10 ies and clinical trials and labeling changes) 

11 and section 505(p) (relating to risk evalua12 tion and mitigation strategies). 

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

14 (relating to adverse-event reports and 

15 postmarket safety activities). 

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

17 to the Secretary to approve a change in a biosimilar 

18 biological product application which has been ap19 proved, including a supplement requesting that the 

20 Secretary determine that the biosimilar biological 

21 product meets the standards for interchangeability 

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

23 Service Act. 


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

2 BIOLOGICAL PRODUCT FEES. 

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

4 2013, the Secretary shall assess and collect fees in accord5 ance with this section as follows: 

6 ‘‘(1) BIOSIMILAR DEVELOPMENT PROGRAM

7 FEES.— 

8 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

9 PRODUCT DEVELOPMENT FEE.— 

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

11 submits to the Secretary a meeting request 

12 described under clause (ii) or a clinical 

13 protocol for an investigational new drug 

14 protocol described under clause (iii) shall 

15 pay for the product named in the meeting 

16 request or the investigational new drug ap17 plication the initial biosimilar biological 

18 product development fee established under 

19 subsection (b)(1)(A). 

20 ‘‘(ii) MEETING REQUEST.—The meet21 ing request described in this clause is a re22 quest for a biosimilar biological product 

23 development meeting for a product. 

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

25 A clinical protocol for an investigational 

26 new drug protocol described in this clause 


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1 is a clinical protocol consistent with the 

2 provisions of section 505(i), including any 

3 regulations promulgated under section 

4 505(i), (referred to in this section as ‘in5 vestigational new drug application’) de6 scribing an investigation that the Secretary 

7 determines is intended to support a bio8 similar biological product application for a 

9 product. 

10 ‘‘(iv) DUE DATE.—The initial bio11 similar biological product development fee 

12 shall be due by the earlier of the following: 

13 ‘‘(I) Not later than 5 days after 

14 the Secretary grants a request for a 

15 biosimilar biological product develop16 ment meeting. 

17 ‘‘(II) The date of submission of 

18 an investigational new drug applica19 tion describing an investigation that 

20 the Secretary determines is intended 

21 to support a biosimilar biological 

22 product application. 

23 ‘‘(v) TRANSITION RULE.—Each per24 son that has submitted an investigational 

25 new drug application prior to the date of 


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1 enactment of the Biosimilars User Fee Act 

2 of 2012 shall pay the initial biosimilar bio3 logical product development fee by the ear4 lier of the following: 

5 ‘‘(I) Not later than 60 days after 

6 the date of the enactment of the 

7 Biosimilars User Fee Act of 2012, if 

8 the Secretary determines that the in9 vestigational new drug application de10 scribes an investigation that is in11 tended to support a biosimilar biologi12 cal product application. 

13 ‘‘(II) Not later than 5 days after 

14 the Secretary grants a request for a 

15 biosimilar biological product develop16 ment meeting. 

17 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

18 PRODUCT DEVELOPMENT FEE.— 

19 ‘‘(i) IN GENERAL.—A person that 

20 pays an initial biosimilar biological product 

21 development fee for a product shall pay for 

22 such product, beginning in the fiscal year 

23 following the fiscal year in which the initial 

24 biosimilar biological product development 

25 fee was paid, an annual fee established 


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

2 biological product development (referred to 

3 in this section as ‘annual biosimilar bio4 logical product development fee’). 

5 ‘‘(ii) DUE DATE.—The annual bio6 similar biological product development pro7 gram fee for each fiscal year will be due on 

8 the later of— 

9 ‘‘(I) the first business day on or 

10 after October 1 of each such year; or 

11 ‘‘(II) the first business day after 

12 the enactment of an appropriations 

13 Act providing for the collection and 

14 obligation of fees for such year under 

15 this section. 

16 ‘‘(iii) EXCEPTION.—The annual bio17 similar development program fee for each 

18 fiscal year will be due on the date specified 

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

20 ‘‘(I) submitted a marketing appli21 cation for the biological product that 

22 was accepted for filing; or 

23 ‘‘(II) discontinued participation 

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1 velopment program for the product 

2 under subparagraph (C). 

3 ‘‘(C) DISCONTINUATION OF FEE OBLIGA4 TION.—A person may discontinue participation 

5 in the biosimilar biological product development 

6 program for a product effective October 1 of a 

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

8 preceding fiscal year— 

9 ‘‘(i) if no investigational new drug ap10 plication concerning the product has been 

11 submitted, submitting to the Secretary a 

12 written declaration that the person has no 

13 present intention of further developing the 

14 product as a biosimilar biological product; 

15 or 

16 ‘‘(ii) if an investigational new drug 

17 application concerning the product has 

18 been submitted, by withdrawing the inves19 tigational new drug application in accord20 ance with part 312 of title 21, Code of 

21 Federal Regulations (or any successor reg22 ulations). 

23 ‘‘(D) REACTIVATION FEE.— 

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

25 discontinued participation in the biosimilar 


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1 biological product development program for 

2 a product under subparagraph (C) shall 

3 pay a fee (referred to in this section as ‘re4 activation fee’) by the earlier of the fol5 lowing: 

6 ‘‘(I) Not later than 5 days after 

7 the Secretary grants a request for a 

8 biosimilar biological product develop9 ment meeting for the product (after 

10 the date on which such participation 

11 was discontinued). 

12 ‘‘(II) Upon the date of submis13 sion (after the date on which such 

14 participation was discontinued) of an 

15 investigational new drug application 

16 describing an investigation that the 

17 Secretary determines is intended to 

18 support a biosimilar biological product 

19 application for that product. 

20 ‘‘(ii) APPLICATION OF ANNUAL

21 FEE.—A person that pays a reactivation 

22 fee for a product shall pay for such prod23 uct, beginning in the next fiscal year, the 

24 annual biosimilar biological product devel25 opment fee under subparagraph (B). 


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1 ‘‘(E) EFFECT OF FAILURE TO PAY BIO2 SIMILAR DEVELOPMENT PROGRAM FEES.— 

3 ‘‘(i) NO BIOSIMILAR BIOLOGICAL

4 PRODUCT DEVELOPMENT MEETINGS.—If a 

5 person has failed to pay an initial or an6 nual biosimilar biological product develop7 ment fee as required under subparagraph 

8 (A) or (B), or a reactivation fee as re9 quired under subparagraph (D), the Sec10 retary shall not provide a biosimilar bio11 logical product development meeting relat12 ing to the product for which fees are owed. 

13 ‘‘(ii) NO RECEIPT OF INVESTIGA14 TIONAL NEW DRUG APPLICATIONS.—Ex15 cept in extraordinary circumstances, the 

16 Secretary shall not consider an investiga17 tional new drug application to have been 

18 received under section 505(i)(2) if— 

19 ‘‘(I) the Secretary determines 

20 that the investigation is intended to 

21 support a biosimilar biological product 

22 application; and 

23 ‘‘(II) the sponsor has failed to 

24 pay an initial or annual biosimilar bio25 logical product development fee for 


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1 the product as required under sub2 paragraph (A) or (B), or a reactiva3 tion fee as required under subpara4 graph (D). 

5 ‘‘(iii) FINANCIAL HOLD.—Notwith6 standing section 505(i)(2), except in ex7 traordinary circumstances, the Secretary 

8 shall prohibit the sponsor of a clinical in9 vestigation from continuing the investiga10 tion if— 

11 ‘‘(I) the Secretary determines 

12 that the investigation is intended to 

13 support a biosimilar biological product 

14 application; and 

15 ‘‘(II) the sponsor has failed to 

16 pay an initial or annual biosimilar bio17 logical product development fee for 

18 the product as required under sub19 paragraph (A) or (B), or a reactiva20 tion fee for the product as required 

21 under subparagraph (D). 

22 ‘‘(iv) NO ACCEPTANCE OF BIOSIMILAR

23 BIOLOGICAL PRODUCT APPLICATIONS OR

24 SUPPLEMENTS.—If a person has failed to 

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1 cal product development fee as required 

2 under subparagraph (A) or (B), or a reac3 tivation fee as required under subpara4 graph (D), any biosimilar biological prod5 uct application or supplement submitted by 

6 that person shall be considered incomplete 

7 and shall not be accepted for filing by the 

8 Secretary until all such fees owed by such 

9 person have been paid. 

10 ‘‘(F) LIMITS REGARDING BIOSIMILAR DE11 VELOPMENT PROGRAM FEES.— 

12 ‘‘(i) NO REFUNDS.—The Secretary 

13 shall not refund any initial or annual bio14 similar biological product development fee 

15 paid under subparagraph (A) or (B), or 

16 any reactivation fee paid under subpara17 graph (D). 

18 ‘‘(ii) NO WAIVERS, EXEMPTIONS, OR

19 REDUCTIONS.—The Secretary shall not 

20 grant a waiver, exemption, or reduction of 

21 any initial or annual biosimilar biological 

22 product development fee due or payable 

23 under subparagraph (A) or (B), or any re24 activation fee due or payable under sub25 paragraph (D). 


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1 ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLI2 CATION AND SUPPLEMENT FEE.— 

3 ‘‘(A) IN GENERAL.—Each person that sub4 mits, on or after October 1, 2012, a biosimilar 

5 biological product application or a supplement 

6 shall be subject to the following fees: 

7 ‘‘(i) A fee for a biosimilar biological 

8 product application that is equal to— 

9 ‘‘(I) the amount of the fee estab10 lished under subsection (b)(1)(D) for 

11 a biosimilar biological product applica12 tion; minus 

13 ‘‘(II) the cumulative amount of 

14 fees paid, if any, under subparagraphs 

15 (A), (B), and (D) of paragraph (1) 

16 for the product that is the subject of 

17 the application. 

18 ‘‘(ii) A fee for a biosimilar biological 

19 product application for which clinical data 

20 (other than comparative bioavailability 

21 studies) with respect to safety or effective22 ness are not required, that is equal to— 

23 ‘‘(I) half of the amount of the fee 

24 established under subsection (b)(1)(D) 


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1 for a biosimilar biological product ap2 plication; minus 

3 ‘‘(II) the cumulative amount of 

4 fees paid, if any, under subparagraphs 

5 (A), (B), and (D) of paragraph (1) 

6 for that product. 

7 ‘‘(iii) A fee for a supplement for which 

8 clinical data (other than comparative bio9 availability studies) with respect to safety 

10 or effectiveness are required, that is equal 

11 to half of the amount of the fee established 

12 under subsection (b)(1)(D) for a biosimilar 

13 biological product application. 

14 ‘‘(B) REDUCTION IN FEES.—Notwith15 standing section 404 of the Biosimilars User 

16 Fee Act of 2012, any person who pays a fee 

17 under subparagraph (A), (B), or (D) of para18 graph (1) for a product before October 1, 2017, 

19 but submits a biosimilar biological product ap20 plication for that product after such date, shall 

21 be entitled to the reduction of any biosimilar bi22 ological product application fees that may be 

23 assessed at the time when such biosimilar bio24 logical product application is submitted, by the 

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1 graphs (A), (B), and (D) of paragraph (1) for 

2 that product. 

3 ‘‘(C) PAYMENT DUE DATE.—Any fee re4 quired by subparagraph (A) shall be due upon 

5 submission of the application or supplement for 

6 which such fee applies. 

7 ‘‘(D) EXCEPTION FOR PREVIOUSLY FILED

8 APPLICATION OR SUPPLEMENT.—If a biosimilar 

9 biological product application or supplement 

10 was submitted by a person that paid the fee for 

11 such application or supplement, was accepted 

12 for filing, and was not approved or was with13 drawn (without a waiver), the submission of a 

14 biosimilar biological product application or a 

15 supplement for the same product by the same 

16 person (or the person’s licensee, assignee, or 

17 successor) shall not be subject to a fee under 

18 subparagraph (A). 

19 ‘‘(E) REFUND OF APPLICATION FEE IF AP20 PLICATION REFUSED FOR FILING OR WITH21 DRAWN BEFORE FILING.—The Secretary shall 

22 refund 75 percent of the fee paid under this 

23 paragraph for any application or supplement 

24 which is refused for filing or withdrawn without 

25 a waiver before filing. 


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1 ‘‘(F) FEES FOR APPLICATIONS PRE2 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

3 BEFORE FILING.—A biosimilar biological prod4 uct application or supplement that was sub5 mitted but was refused for filing, or was with6 drawn before being accepted or refused for fil7 ing, shall be subject to the full fee under sub8 paragraph (A) upon being resubmitted or filed 

9 over protest, unless the fee is waived under sub10 section (c). 

11 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTAB12 LISHMENT FEE.— 

13 ‘‘(A) IN GENERAL.—Except as provided in 

14 subparagraph (E), each person that is named 

15 as the applicant in a biosimilar biological prod16 uct application shall be assessed an annual fee 

17 established under subsection (b)(1)(E) for each 

18 biosimilar biological product establishment that 

19 is listed in the approved biosimilar biological 

20 product application as an establishment that 

21 manufactures the biosimilar biological product 

22 named in such application. 

23 ‘‘(B) ASSESSMENT IN FISCAL YEARS.—The 

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1 uct named in the application is assessed a fee 

2 under paragraph (4) unless the biosimilar bio3 logical product establishment listed in the appli4 cation does not engage in the manufacture of 

5 the biosimilar biological product during such 

6 fiscal year. 

7 ‘‘(C) DUE DATE.—The establishment fee 

8 for a fiscal year shall be due on the later of— 

9 ‘‘(i) the first business day on or after 

10 October 1 of such fiscal year; or 

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

12 enactment of an appropriations Act pro13 viding for the collection and obligation of 

14 fees for such fiscal year under this section. 

15 ‘‘(D) APPLICATION TO ESTABLISHMENT.— 

16 ‘‘(i) Each biosimilar biological product 

17 establishment shall be assessed only one 

18 fee per biosimilar biological product estab19 lishment, notwithstanding the number of 

20 biosimilar biological products manufac21 tured at the establishment, subject to 

22 clause (ii). 

23 ‘‘(ii) In the event an establishment is 

24 listed in a biosimilar biological product ap25 plication by more than one applicant, the 


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1 establishment fee for the fiscal year shall 

2 be divided equally and assessed among the 

3 applicants whose biosimilar biological prod4 ucts are manufactured by the establish5 ment during the fiscal year and assessed 

6 biosimilar biological product fees under 

7 paragraph (4). 

8 ‘‘(E) EXCEPTION FOR NEW PRODUCTS.— 

9 If, during the fiscal year, an applicant initiates 

10 or causes to be initiated the manufacture of a 

11 biosimilar biological product at an establish12 ment listed in its biosimilar biological product 

13 application— 

14 ‘‘(i) that did not manufacture the bio15 similar biological product in the previous 

16 fiscal year; and 

17 ‘‘(ii) for which the full biosimilar bio18 logical product establishment fee has been 

19 assessed in the fiscal year at a time before 

20 manufacture of the biosimilar biological 

21 product was begun, 

22 the applicant shall not be assessed a share of 

23 the biosimilar biological product establishment 

24 fee for the fiscal year in which the manufacture 

25 of the product began. 


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1 ‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 

2 ‘‘(A) IN GENERAL.—Each person who is 

3 named as the applicant in a biosimilar biologi4 cal product application shall pay for each such 

5 biosimilar biological product the annual fee es6 tablished under subsection (b)(1)(F). 

7 ‘‘(B) DUE DATE.—The biosimilar biologi8 cal product fee for a fiscal year shall be due on 

9 the later of— 

10 ‘‘(i) the first business day on or after 

11 October 1 of each such year; or 

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

13 enactment of an appropriations Act pro14 viding for the collection and obligation of 

15 fees for such year under this section. 

16 ‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 

17 The biosimilar biological product fee shall be 

18 paid only once for each product for each fiscal 

19 year. 

20 ‘‘(b) FEE SETTING AND AMOUNTS.— 

21 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

22 the Secretary shall, 60 days before the start of each 

23 fiscal year that begins after September 30, 2012, es24 tablish, for the next fiscal year, the fees under subVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00105 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 section (a). Except as provided in subsection (c), 

2 such fees shall be in the following amounts: 

3 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

4 PRODUCT DEVELOPMENT FEE.—The initial bio5 similar biological product development fee under 

6 subsection (a)(1)(A) for a fiscal year shall be 

7 equal to 10 percent of the amount established 

8 under section 736(c)(4) for a human drug ap9 plication described in section 736(a)(1)(A)(i) 

10 for that fiscal year. 

11 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

12 PRODUCT DEVELOPMENT FEE.—The annual 

13 biosimilar biological product development fee 

14 under subsection (a)(1)(B) for a fiscal year 

15 shall be equal to 10 percent of the amount es16 tablished under section 736(c)(4) for a human 

17 drug application described in section 

18 736(a)(1)(A)(i) for that fiscal year. 

19 ‘‘(C) REACTIVATION FEE.—The reactiva20 tion fee under subsection (a)(1)(D) for a fiscal 

21 year shall be equal to 20 percent of the amount 

22 of the fee established under section 736(c)(4) 

23 for a human drug application described in sec24 tion 736(a)(1)(A)(i) for that fiscal year. 


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1 ‘‘(D) BIOSIMILAR BIOLOGICAL PRODUCT

2 APPLICATION FEE.—The biosimilar biological 

3 product application fee under subsection (a)(2) 

4 for a fiscal year shall be equal to the amount 

5 established under section 736(c)(4) for a 

6 human drug application described in section 

7 736(a)(1)(A)(i) for that fiscal year. 

8 ‘‘(E) BIOSIMILAR BIOLOGICAL PRODUCT

9 ESTABLISHMENT FEE.—The biosimilar biologi10 cal product establishment fee under subsection 

11 (a)(3) for a fiscal year shall be equal to the 

12 amount established under section 736(c)(4) for 

13 a prescription drug establishment for that fiscal 

14 year. 

15 ‘‘(F) BIOSIMILAR BIOLOGICAL PRODUCT

16 FEE.—The biosimilar biological product fee 

17 under subsection (a)(4) for a fiscal year shall be 

18 equal to the amount established under section 

19 736(c)(4) for a prescription drug product for 

20 that fiscal year. 

21 ‘‘(2) LIMIT.—The total amount of fees charged 

22 for a fiscal year under this section may not exceed 

23 the total amount for such fiscal year of the costs of 

24 resources allocated for the process for the review of 

25 biosimilar biological product applications. 


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1 ‘‘(c) APPLICATION FEE WAIVER FOR SMALL BUSI2 NESS.— 

3 ‘‘(1) WAIVER OF APPLICATION FEE.—The Sec4 retary shall grant to a person who is named in a bio5 similar biological product application a waiver from 

6 the application fee assessed to that person under 

7 subsection (a)(2)(A) for the first biosimilar biologi8 cal product application that a small business or its 

9 affiliate submits to the Secretary for review. After a 

10 small business or its affiliate is granted such a waiv11 er, the small business or its affiliate shall pay— 

12 ‘‘(A) application fees for all subsequent 

13 biosimilar biological product applications sub14 mitted to the Secretary for review in the same 

15 manner as an entity that is not a small busi16 ness; and 

17 ‘‘(B) all supplement fees for all supple18 ments to biosimilar biological product applica19 tions submitted to the Secretary for review in 

20 the same manner as an entity that is not a 

21 small business. 

22 ‘‘(2) CONSIDERATIONS.—In determining wheth23 er to grant a waiver of a fee under paragraph (1), 

24 the Secretary shall consider only the circumstances 


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1 and assets of the applicant involved and any affiliate 

2 of the applicant. 

3 ‘‘(3) SMALL BUSINESS DEFINED.—In this sub4 section, the term ‘small business’ means an entity 

5 that has fewer than 500 employees, including em6 ployees of affiliates, and does not have a drug prod7 uct that has been approved under a human drug ap8 plication (as defined in section 735) or a biosimilar 

9 biological product application (as defined in section 

10 744G(4)) and introduced or delivered for introduc11 tion into interstate commerce. 

12 ‘‘(d) EFFECT OF FAILURE TO PAY FEES.—A bio13 similar biological product application or supplement sub14 mitted by a person subject to fees under subsection (a) 

15 shall be considered incomplete and shall not be accepted 

16 for filing by the Secretary until all fees owed by such per17 son have been paid. 

18 ‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

19 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

20 fees authorized under subsection (a) shall be col21 lected and available for obligation only to the extent 

22 and in the amount provided in advance in appropria23 tions Acts. Such fees are authorized to remain avail24 able until expended. Such sums as may be necessary 

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1 istration salaries and expenses appropriation account 

2 without fiscal year limitation to such appropriation 

3 account for salaries and expenses with such fiscal 

4 year limitation. The sums transferred shall be avail5 able solely for the process for the review of bio6 similar biological product applications. 

7 ‘‘(2) COLLECTIONS AND APPROPRIATION

8 ACTS.— 

9 ‘‘(A) IN GENERAL.—Subject to subpara10 graphs (C) and (D), the fees authorized by this 

11 section shall be collected and available in each 

12 fiscal year in an amount not to exceed the 

13 amount specified in appropriation Acts, or oth14 erwise made available for obligation for such 

15 fiscal year. 

16 ‘‘(B) USE OF FEES AND LIMITATION.— 

17 The fees authorized by this section shall be 

18 available for a fiscal year beginning after fiscal 

19 year 2012 to defray the costs of the process for 

20 the review of biosimilar biological product appli21 cations (including such costs for an additional 

22 number of full-time equivalent positions in the 

23 Department of Health and Human Services to 

24 be engaged in such process), only if the Sec25 retary allocates for such purpose an amount for 


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1 such fiscal year (excluding amounts from fees 

2 collected under this section) no less than 

3 $20,000,000, multiplied by the adjustment fac4 tor applicable to the fiscal year involved. 

5 ‘‘(C) FEE COLLECTION DURING FIRST

6 PROGRAM YEAR.—Until the date of enactment 

7 of an Act making appropriations through Sep8 tember 30, 2013, for the salaries and expenses 

9 account of the Food and Drug Administration, 

10 fees authorized by this section for fiscal year 

11 2013 may be collected and shall be credited to 

12 such account and remain available until ex13 pended. 

14 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

15 SUBSEQUENT YEARS.—Payment of fees author16 ized under this section for a fiscal year (after 

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

18 fees, may be accepted by the Secretary in ac19 cordance with authority provided in advance in 

20 a prior year appropriations Act. 

21 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

22 For each of fiscal years 2013 through 2017, there 

23 is authorized to be appropriated for fees under this 

24 section an amount equivalent to the total amount of 

25 fees assessed for such fiscal year under this section. 


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1 ‘‘(f) 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 days after it is due, 

4 such fee shall be treated as a claim of the United States 

5 Government subject to subchapter II of chapter 37 of title 

6 31, United States Code. 

7 ‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND RE8 FUNDS.—To qualify for consideration for a waiver under 

9 subsection (c), or for a refund of any fee collected in ac10 cordance with subsection (a)(2)(A), a person shall submit 

11 to the Secretary a written request for such waiver or re12 fund not later than 180 days after such fee is due. 

13 ‘‘(h) CONSTRUCTION.—This section may not be con14 strued to require that the number of full-time equivalent 

15 positions in the Department of Health and Human Serv16 ices, for officers, employers, and advisory committees not 

17 engaged in the process of the review of biosimilar biologi18 cal product applications, be reduced to offset the number 

19 of officers, employees, and advisory committees so en20 gaged.’’. 

21 SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS. 

22 Part 8 of subchapter C of chapter VII, as added by 

23 section 402, is further amended by inserting after section 

24 744H the following: 


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1 ‘‘SEC. 744I. 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 401(b) 

12 of the Biosimilar User Fee Act of 2012 during such fiscal 

13 year and the future plans of the Food and Drug Adminis14 tration for meeting such goals. The report for a fiscal year 

15 shall include information on all previous cohorts for which 

16 the Secretary has not given a complete response on all 

17 biosimilar biological product applications and supplements 

18 in the cohort. 

19 ‘‘(b) FISCAL REPORT.—Not later than 120 days after 

20 the end of fiscal year 2013 and each subsequent fiscal year 

21 for which fees are collected under this part, the Secretary 

22 shall prepare and submit to the Committee on Energy and 

23 Commerce of the House of Representatives and the Com24 mittee on Health, Education, Labor, and Pensions of the 

25 Senate a report on the implementation of the authority 

26 for such fees during such fiscal year and the use, by the 


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1 Food and Drug Administration, of the fees collected for 

2 such fiscal year. 

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

4 make the reports required under subsections (a) and (b) 

5 available to the public on the Internet Web site of the 

6 Food and Drug Administration. 

7 ‘‘(d) STUDY.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall con9 tract with an independent accounting or consulting 

10 firm to study the workload volume and full costs as11 sociated with the process for the review of biosimilar 

12 biological product applications. 

13 ‘‘(2) INTERIM RESULTS.—Not later than June 

14 1, 2015, the Secretary shall publish, for public com15 ment, interim results of the study described under 

16 paragraph (1). 

17 ‘‘(3) FINAL RESULTS.—Not later than Sep18 tember 30, 2016, the Secretary shall publish, for 

19 public comment, the final results of the study de20 scribed under paragraph (1). 

21 ‘‘(e) REAUTHORIZATION.— 

22 ‘‘(1) CONSULTATION.—In developing rec23 ommendations to present to the Congress with re24 spect to the goals described in subsection (a), and 

25 plans for meeting the goals, for the process for the 


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1 review of biosimilar biological product applications 

2 for the first 5 fiscal years after fiscal year 2017, and 

3 for the reauthorization of this part for such fiscal 

4 years, the Secretary shall consult with— 

5 ‘‘(A) the Committee on Energy and Com6 merce of the House of Representatives; 

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

8 Labor, and Pensions of the Senate; 

9 ‘‘(C) scientific and academic experts; 

10 ‘‘(D) health care professionals; 

11 ‘‘(E) representatives of patient and con12 sumer advocacy groups; and 

13 ‘‘(F) the regulated industry. 

14 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA15 TIONS.—After negotiations with the regulated indus16 try, the Secretary shall— 

17 ‘‘(A) present the recommendations devel18 oped under paragraph (1) to the congressional 

19 committees specified in such paragraph; 

20 ‘‘(B) publish such recommendations in the 

21 Federal Register; 

22 ‘‘(C) provide for a period of 30 days for 

23 the public to provide written comments on such 

24 recommendations; 


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

2 may present its views on such recommenda3 tions; and 

4 ‘‘(E) after consideration of such public 

5 views and comments, revise such recommenda6 tions as necessary. 

7 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

8 Not later than January 15, 2017, the Secretary 

9 shall transmit to the Congress the revised rec10 ommendations under paragraph (2), a summary of 

11 the views and comments received under such para12 graph, and any changes made to the recommenda13 tions in response to such views and comments.’’. 

14 SEC. 404. SUNSET DATES. 

15 (a) AUTHORIZATION.—The amendment made by sec16 tion 402 shall cease to be effective October 1, 2017. 

17 (b) REPORTING REQUIREMENTS.—The amendment 

18 made by section 403 shall cease to be effective January 

19 31, 2018. 

20 SEC. 405. EFFECTIVE DATE. 

21 (a) IN GENERAL.—Except as provided under sub22 section (b), the amendments made by this title shall take 

23 effect on the later of— 

24 (1) October 1, 2012; or 

25 (2) the date of the enactment of this title. 


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1 (b) EXCEPTION.—Fees under part 8 of subchapter 

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

3 Act, as added by this title, shall be assessed for all bio4 similar biological product applications received on or after 

5 October 1, 2012, regardless of the date of the enactment 

6 of this title. 

7 SEC. 406. SAVINGS CLAUSE. 

8 Notwithstanding the amendments made by this title, 

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

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

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

12 be in effect with respect to human drug applications and 

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

14 were accepted by the Food and Drug Administration for 

15 filing on or after October 1, 2007, but before October 1, 

16 2012, with respect to assessing and collecting any fee re17 quired by such part for a fiscal year prior to fiscal year 

18 2013. 

19 SEC. 407. CONFORMING AMENDMENT. 

20 Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amend21 ed by striking ‘‘or (k)’’. 


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1 TITLE V—PEDIATRIC DRUGS 

2 AND DEVICES 

3 SEC. 501. PERMANENCE. 

4 (a) PEDIATRIC STUDIES OF DRUGS.—Subsection (q) 

5 of section 505A (21 U.S.C. 355a) is amended— 

6 (1) in the subsection heading, by striking 

7 ‘‘SUNSET’’ and inserting ‘‘PERMANENCE’’; 

8 (2) in paragraph (1), by striking ‘‘on or before 

9 October 1, 2012,’’; and 

10 (3) in paragraph (2), by striking ‘‘on or before 

11 October 1, 2012,’’. 

12 (b) RESEARCH INTO PEDIATRIC USES FOR DRUGS

13 AND BIOLOGICAL PRODUCTS.—Section 505B (21 U.S.C. 

14 355c) is amended— 

15 (1) by striking subsection (m); and 

16 (2) by redesignating subsection (n) as sub17 section (m). 

18 SEC. 502. WRITTEN REQUESTS. 

19 (a) FEDERAL FOOD, DRUG, AND COSMETIC ACT.— 

20 Subsection (h) of section 505A (21 U.S.C. 355a) is 

21 amended to read as follows: 

22 ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE23 QUIREMENTS.—Exclusivity under this section shall only be 

24 granted for the completion of a study or studies that are 

25 the subject of a written request and for which reports are 


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1 submitted and accepted in accordance with subsection 

2 (d)(3). Written requests under this section may consist of 

3 a study or studies required under section 505B.’’. 

4 (b) PUBLIC HEALTH SERVICE ACT.—Section 

5 351(m)(1) of the Public Health Service Act (42 U.S.C. 

6 262(m)(1)) is amended by striking ‘‘(f), (i), (j), (k), (l), 

7 (p), and (q)’’ and inserting ‘‘(f), (h), (i), (j), (k), (l), (n), 

8 and (p)’’. 

9 SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COM10 MITTEE. 

11 Not later than 1 year after the date of enactment 

12 of this Act, the Secretary of Health and Human Services 

13 (referred to in this title as the ‘‘Secretary’’) shall issue 

14 internal standard operating procedures that provide for 

15 the review by the internal review committee established 

16 under section 505C of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355d) of any significant modifica18 tions to initial pediatric study plans, agreed initial pedi19 atric study plans, and written requests under sections 

20 505A and 505B of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 355c). Such internal standard operating 

22 procedures shall be made publicly available on the Internet 

23 website of the Food and Drug Administration. 


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1 SEC. 504. ACCESS TO DATA. 

2 Not later than 3 years after the date of enactment 

3 of this Act, the Secretary shall make available to the pub4 lic, including through posting on the Internet website of 

5 the Food and Drug Administration, the medical, statis6 tical, and clinical pharmacology reviews of, and cor7 responding written requests issued to an applicant, spon8 sor, or holder for, pediatric studies submitted between 

9 January 4, 2002 and September 27, 2007 under sub10 section (b) or (c) of section 505A of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 355a) for which 6 

12 months of market exclusivity was granted and that re13 sulted in a labeling change. The Secretary shall make pub14 lic the information described in the preceding sentence in 

15 a manner consistent with how the Secretary releases infor16 mation under section 505A(k) of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 355a(k)). 

18 SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC 

19 STUDIES. 

20 (a) EXTENSION OF DEADLINE FOR DEFERRED

21 STUDIES.—Section 505B (21 U.S.C. 355c) is amended— 

22 (1) in subsection (a)(3)— 

23 (A) by redesignating subparagraph (B) as 

24 subparagraph (C); 

25 (B) by inserting after subparagraph (A) 

26 the following: 


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1 ‘‘(B) DEFERRAL EXTENSION.— 

2 ‘‘(i) IN GENERAL.—On the initiative 

3 of the Secretary or at the request of the 

4 applicant, the Secretary may grant an ex5 tension of a deferral approved under sub6 paragraph (A) for submission of some or 

7 all assessments required under paragraph 

8 (1) if— 

9 ‘‘(I) the Secretary determines 

10 that the conditions described in sub11 clause (II) or (III) of subparagraph 

12 (A)(i) continue to be met; and 

13 ‘‘(II) the applicant submits a new 

14 timeline under subparagraph 

15 (A)(ii)(IV) and any significant up16 dates to the information required 

17 under subparagraph (A)(ii). 

18 ‘‘(ii) TIMING AND INFORMATION.—If 

19 the deferral extension under this subpara20 graph is requested by the applicant, the 

21 applicant shall submit the deferral exten22 sion request containing the information de23 scribed in this subparagraph not less than 

24 90 days prior to the date that the deferral 

25 would expire. The Secretary shall respond 


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1 to such request not later than 45 days 

2 after the receipt of such letter. If the Sec3 retary grants such an extension, the speci4 fied date shall be the extended date. The 

5 sponsor of the required assessment under 

6 paragraph (1) shall not be issued a letter 

7 described in subsection (d) unless the spec8 ified or extended date of submission for 

9 such required studies has passed or if the 

10 request for an extension is pending. For a 

11 deferral that has expired prior to the date 

12 of enactment of the Food and Drug Ad13 ministration Safety and Innovation Act or 

14 that will expire prior to 270 days after the 

15 date of enactment of such Act, a deferral 

16 extension shall be requested by an appli17 cant not later than 180 days after the date 

18 of enactment of such Act. The Secretary 

19 shall respond to any such request as soon 

20 as practicable, but not later than 1 year 

21 after the date of enactment of such Act. 

22 Nothing in this clause shall prevent the 

23 Secretary from updating the status of a 

24 study or studies publicly if components of 


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1 such study or studies are late or delayed.’’; 

2 and 

3 (C) in subparagraph (C), as so redesig4 nated— 

5 (i) in clause (i), by adding at the end 

6 the following: 

7 ‘‘(III) Projected completion date 

8 for pediatric studies. 

9 ‘‘(IV) The reason or reasons why 

10 a deferral or deferral extension con11 tinues to be necessary.’’; and 

12 (ii) in clause (ii)— 

13 (I) by inserting ‘‘, as well as the 

14 date of each deferral or deferral ex15 tension, as applicable,’’ after ‘‘clause 

16 (i)’’; and 

17 (II) by inserting ‘‘not later than 

18 90 days after submission to the Sec19 retary or with the next routine quar20 terly update’’ after ‘‘Administration’’; 

21 and 

22 (2) in subsection (f)— 

23 (A) in the subsection heading, by inserting 

24 ‘‘DEFERRAL EXTENSIONS,’’ after ‘‘DEFER25 RALS,’’; 


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1 (B) in paragraph (1), by inserting ‘‘, defer2 ral extension,’’ after ‘‘deferral’’; and 

3 (C) in paragraph (4)— 

4 (i) in the paragraph heading, by in5 serting ‘‘DEFERRAL EXTENSIONS,’’ after 

6 ‘‘DEFERRALS,’’; and 

7 (ii) by inserting ‘‘, deferral exten8 sions,’’ after ‘‘deferrals’’. 

9 (b) TRACKING OF EXTENSIONS; ANNUAL INFORMA10 TION.—Section 505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) 

11 is amended to read as follows: 

12 ‘‘(D) aggregated on an annual basis— 

13 ‘‘(i) the total number of deferrals and 

14 deferral extensions requested and granted 

15 under this section and, if granted, the rea16 sons for each such deferral or deferral ex17 tension; 

18 ‘‘(ii) the timeline for completion of the 

19 assessments; and 

20 ‘‘(iii) the number of assessments com21 pleted and pending;’’. 

22 (c) ACTION ON FAILURE TO COMPLETE STUDIES.— 

23 (1) ISSUANCE OF LETTER.—Subsection (d) of 

24 section 505B (21 U.S.C. 355c) is amended to read 

25 as follows: 


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1 ‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person 

2 fails to submit a required assessment described in sub3 section (a)(2), fails to meet the applicable requirements 

4 in subsection (a)(3), or fails to submit a request for ap5 proval of a pediatric formulation described in subsection 

6 (a) or (b), in accordance with applicable provisions of sub7 sections (a) and (b), the following shall apply: 

8 ‘‘(1) Beginning 270 days after the date of en9 actment of the Food and Drug Administration Safe10 ty and Innovation Act, the Secretary shall issue a 

11 non-compliance letter to such person informing them 

12 of such failure to submit or meet the requirements 

13 of the applicable subsection. Such letter shall require 

14 the person to respond in writing within 45 calendar 

15 days of issuance of such letter. Such response may 

16 include the person’s request for a deferral extension 

17 if applicable. Such letter and the person’s written re18 sponse to such letter shall be made publicly available 

19 on the Internet Web site of the Food and Drug Ad20 ministration 45 calendar days after issuance, with 

21 redactions for any trade secrets and confidential 

22 commercial information. If the Secretary determines 

23 that the letter was issued in error, the requirements 

24 of this paragraph shall not apply. 


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1 ‘‘(2) The drug or biological product that is the 

2 subject of an assessment described in subsection 

3 (a)(2), applicable requirements in subsection (a)(3), 

4 or request for approval of a pediatric formulation, 

5 may be considered misbranded solely because of that 

6 failure and subject to relevant enforcement action 

7 (except that the drug or biological product shall not 

8 be subject to action under section 303), but such 

9 failure shall not be the basis for a proceeding— 

10 ‘‘(A) to withdraw approval for a drug 

11 under section 505(e); or 

12 ‘‘(B) to revoke the license for a biological 

13 product under section 351 of the Public Health 

14 Service Act.’’. 

15 (2) TRACKING OF LETTERS ISSUED.—Subpara16 graph (D) of section 505B(f)(6) (21 U.S.C. 

17 355c(f)(6)), as amended by subsection (b), is further 

18 amended— 

19 (A) in clause (ii), by striking ‘‘; and’’ and 

20 inserting a semicolon; 

21 (B) in clause (iii), by adding ‘‘and’’ at the 

22 end; and 

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

24 ‘‘(iv) the number of postmarket non25 compliance letters issued pursuant to subVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00126 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 section (d), and the recipients of such let2 ters;’’. 

3 SEC. 506. PEDIATRIC STUDY PLANS. 

4 (a) IN GENERAL.—Subsection (e) of section 505B 

5 (21 U.S.C. 355c) is amended to read as follows: 

6 ‘‘(e) PEDIATRIC STUDY PLANS.— 

7 ‘‘(1) IN GENERAL.—An applicant subject to 

8 subsection (a) shall submit to the Secretary an ini9 tial pediatric study plan prior to the submission of 

10 the assessments described under subsection (a)(2). 

11 ‘‘(2) TIMING; CONTENT; MEETING.— 

12 ‘‘(A) TIMING.—An applicant shall submit 

13 an initial pediatric study plan to the Secretary 

14 not later than 60 calendar days after the date 

15 of the end of phase II meeting or such other 

16 equivalent time agreed upon between the Sec17 retary and the applicant. Nothing in this para18 graph shall preclude the Secretary from accept19 ing the submission of an initial pediatric study 

20 plan earlier than the date described under the 

21 preceding sentence. 

22 ‘‘(B) CONTENT OF INITIAL PLAN.—The 

23 initial pediatric study plan shall include— 

24 ‘‘(i) an outline of the pediatric study 

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1 duct (including, to the extent practicable 

2 study objectives and design, age groups, 

3 relevant endpoints, and statistical ap4 proach); 

5 ‘‘(ii) any request for a deferral, partial 

6 waiver, or waiver under this section, if ap7 plicable, along with any supporting infor8 mation; and 

9 ‘‘(iii) other information specified in 

10 the regulations promulgated under para11 graph (4). 

12 ‘‘(C) MEETING.—The Secretary— 

13 ‘‘(i) shall meet with the applicant to 

14 discuss the initial pediatric study plan as 

15 soon as practicable, but not later than 90 

16 calendar days after the receipt of such plan 

17 under subparagraph (A); 

18 ‘‘(ii) may determine that a written re19 sponse to the initial pediatric study plan is 

20 sufficient to communicate comments on the 

21 initial pediatric study plan, and that no 

22 meeting is necessary; and 

23 ‘‘(iii) if the Secretary determines that 

24 no meeting is necessary, shall so notify the 

25 applicant and provide written comments of 


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1 the Secretary as soon as practicable, but 

2 not later than 90 calendar days after the 

3 receipt of the initial pediatric study plan. 

4 ‘‘(3) AGREED INITIAL PEDIATRIC STUDY

5 PLAN.—Not later than 90 calendar days following 

6 the meeting under paragraph (2)(C)(i) or the receipt 

7 of a written response from the Secretary under para8 graph (2)(C)(iii), the applicant shall document 

9 agreement on the initial pediatric study plan in a 

10 submission to the Secretary marked ‘Agreed Initial 

11 Pediatric Study Plan’, and the Secretary shall con12 firm such agreement to the applicant in writing not 

13 later than 30 calendar days of receipt of such agreed 

14 initial pediatric study plan. 

15 ‘‘(4) DEFERRAL AND WAIVER.—If the agreed 

16 initial pediatric study plan contains a request from 

17 the applicant for a deferral, partial waiver, or waiver 

18 under this section, the written confirmation under 

19 paragraph (3) shall include a recommendation from 

20 the Secretary as to whether such request meets the 

21 standards under paragraphs (3) or (4) of subsection 

22 (a). 

23 ‘‘(5) AMENDMENTS TO THE PLAN.—At the ini24 tiative of the Secretary or the applicant, the agreed 

25 initial pediatric study plan may be amended at any 


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1 time. The requirements of paragraph (2)(C) shall 

2 apply to any such proposed amendment in the same 

3 manner and to the same extent as such require4 ments apply to an initial pediatric study plan under 

5 paragraph (1). The requirements of paragraphs (3) 

6 and (4) shall apply to any agreement resulting from 

7 such proposed amendment in the same manner and 

8 to the same extent as such requirements apply to an 

9 agreed initial pediatric study plan. 

10 ‘‘(6) INTERNAL COMMITTEE.—The Secretary 

11 shall consult the internal committee under section 

12 505C on the review of the initial pediatric study 

13 plan, agreed initial pediatric plan, and any signifi14 cant amendments to such plans. 

15 ‘‘(7) REQUIRED RULEMAKING.—Not later than 

16 1 year after the date of enactment of the Food and 

17 Drug Administration Safety and Innovation Act, the 

18 Secretary shall promulgate proposed regulations and 

19 issue proposed guidance to implement the provisions 

20 of this subsection.’’. 

21 (b) CONFORMING AMENDMENTS.—Section 505B (21 

22 U.S.C. 355c)is amended— 

23 (1) by amending subclause (II) of subsection 

24 (a)(3)(A)(ii) to read as follows: 


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1 ‘‘(II) a pediatric study plan as 

2 described in subsection (e);’’; and 

3 (2) in subsection (f)— 

4 (A) in the subsection heading, by striking 

5 ‘‘PEDIATRIC PLANS,’’ and inserting ‘‘PEDIATRIC

6 STUDY PLANS,’’; 

7 (B) in paragraph (1), by striking ‘‘all pedi8 atric plans’’ and inserting ‘‘initial pediatric 

9 study plans, agreed initial pediatric study 

10 plans,’’; and 

11 (C) in paragraph (4)— 

12 (i) in the paragraph heading, by strik13 ing ‘‘PEDIATRIC PLANS,’’ and inserting 

14 ‘‘PEDIATRIC STUDY PLANS,’’; and 

15 (ii) by striking ‘‘pediatric plans’’ and 

16 inserting ‘‘initial pediatric study plans, 

17 agreed initial pediatric study plans,’’. 

18 (c) EFFECTIVE DATES.— 

19 (1) PEDIATRIC STUDY PLANS.—Subsection (e) 

20 of section 505B of the Federal Food, Drug, and 

21 Cosmetic Act (other than paragraph (4) of such sub22 section), as amended by subsection (a), shall take ef23 fect 180 days after the date of enactment of this 

24 Act, without regard to whether the Secretary has 


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1 promulgated final regulations under paragraph (4) 

2 of such subsection by such date. 

3 (2) CONFORMING AMENDMENTS.—The amend4 ments made by subsection (b) shall take effect 180 

5 days after the date of enactment of this Act. 

6 SEC. 507. REAUTHORIZATIONS. 

7 (a) PEDIATRIC ADVISORY COMMITTEE.—Section 

8 14(d) of the Best Pharmaceuticals for Children Act (42 

9 U.S.C. 284m note) is amended by striking ‘‘Notwith10 standing section 14 of the Federal Advisory Committee 

11 Act, the advisory committee shall continue to operate dur12 ing the five-year period beginning on the date of the enact13 ment of the Best Pharmaceuticals for Children Act of 

14 2007’’ and inserting ‘‘Section 14 of the Federal Advisory 

15 Committee Act shall not apply to the advisory committee’’. 

16 (b) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

17 DRUGS ADVISORY COMMITTEE.—Section 15(a)(3) of the 

18 Best Pharmaceuticals for Children Act (42 U.S.C. 284m 

19 note) is amended by striking ‘‘during the five-year period 

20 beginning on the date of the enactment of the Best Phar21 maceuticals for Children Act of 2007’’ and inserting ‘‘for 

22 the duration of the operation of the Oncologic Drugs Advi23 sory Committee’’. 

24 (c) HUMANITARIAN DEVICE EXEMPTION EXTEN25 SION.—Section 520(m)(6)(A)(iv) of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is 

2 amended by striking ‘‘2012’’ and inserting ‘‘2017’’. 

3 (d) DEMONSTRATION GRANTS TO IMPROVE PEDI4 ATRIC DEVICE AVAILABILITY.—Section 305(e) of Pedi5 atric Medical Device Safety and Improvement Act (Public 

6 Law 110–85; 42 U.S.C. 282 note)) is amended by striking 

7 ‘‘$6,000,000 for each of fiscal years 2008 through 2012’’ 

8 and inserting ‘‘$4,500,000 for each of fiscal years 2013 

9 through 2017’’. 

10 (e) PROGRAM FOR PEDIATRIC STUDY OF DRUGS IN

11 PHSA.—Section 409I(e)(1) of the Public Health Service 

12 Act (42 U.S.C. 284m(e)(1)) is amended by striking ‘‘to 

13 carry out this section’’ and all that follows through the 

14 end of paragraph (1) and inserting ‘‘to carry out this sec15 tion $25,000,000 for each of fiscal years 2012 through 

16 2017.’’. 

17 SEC. 508. REPORT. 

18 (a) IN GENERAL.—Not later than October 31, 2016, 

19 and at the end of each subsequent 5-year period, the Sec20 retary shall submit to Congress a report that evaluates 

21 the effectiveness of sections 505A and 505B of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 

23 355c) and section 409I of the Public Health Service Act 

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1 dren are tested in pediatric populations and properly la2 beled for use in children. 

3 (b) CONTENTS.—The report under subsection (a) 

4 shall include— 

5 (1) the number and importance of drugs and 

6 biological products for children for which studies 

7 have been requested or required (as of the date of 

8 such report) under 505A and 505B of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 

10 355c) and section 409I of the Public Health Service 

11 Act (42 U.S.C. 284m), including— 

12 (A) the number of labeling changes made 

13 to drugs and biological products pursuant to 

14 such sections since the date of enactment of 

15 this Act; and 

16 (B) the importance of such drugs and bio17 logical products in the improvement of the 

18 health of children; 

19 (2) the number of required studies under such 

20 section 505B that have not met the initial deadline 

21 provided under such section, including— 

22 (A) the number of deferrals and deferral 

23 extensions granted and the reasons such exten24 sions were granted; 


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1 (B) the number of waivers and partial 

2 waivers granted; and 

3 (C) the number of letters issued under 

4 subsection (d) of such section 505B; 

5 (3) the number of written requests issued, de6 clined, and referred to the National Institutes of 

7 Health under such section 505A since the date of 

8 enactment of this Act (including the reasons for 

9 such declination), and a description and status of re10 ferrals made under subsection (n) of such section 

11 505A; 

12 (4) the number of proposed pediatric study 

13 plans submitted and agreed to as identified in the 

14 marketing application under such section 505B; 

15 (5) any labeling changes recommended by the 

16 Pediatric Advisory Committee as a result of the re17 view by such Committee of adverse events reports; 

18 (6) the number and current status of pediatric 

19 postmarketing requirements; 

20 (7) the number and importance of drugs and 

21 biological products for children that are not being 

22 tested for use in pediatric populations, notwith23 standing the existence of the programs under such 

24 sections 505A and 505B and section 409I of the 

25 Public Health Service Act; 


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1 (8) the possible reasons for the lack of testing 

2 reported under paragraph (7); 

3 (9) the number of drugs and biological products 

4 for which testing is being done (as of the date of the 

5 report) and for which a labeling change is required 

6 under the programs described in paragraph (7), in7 cluding— 

8 (A) the date labeling changes are made; 

9 (B) which labeling changes required the 

10 use of the dispute resolution process; and 

11 (C) for labeling changes that required such 

12 dispute resolution process, a description of— 

13 (i) the disputes; 

14 (ii) the recommendations of the Pedi15 atric Advisory Committee; and 

16 (iii) the outcomes of such process; and 

17 (D) an assessment of the effectiveness in 

18 improving information about pediatric uses of 

19 drugs and biological products; 

20 (10)(A) the efforts made by the Secretary to in21 crease the number of studies conducted in the neo22 natal population (including efforts made to encour23 age the conduct of appropriate studies in neonates 

24 by companies with products that have sufficient 


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1 safety and other information to make the conduct of 

2 the studies ethical and safe); and 

3 (B) the results of such efforts; 

4 (11)(A) the number and importance of drugs 

5 and biological products for children with cancer that 

6 are being tested as a result of the programs de7 scribed in paragraph (7); and 

8 (B) any recommendations for modifications to 

9 such programs that would lead to new and better 

10 therapies for children with cancer, including a de11 tailed rationale for each recommendation; 

12 (12) an assessment of progress made in ad13 dressing the recommendations and findings of any 

14 prior report issued by the Comptroller General, the 

15 Institute of Medicine, or the Secretary regarding the 

16 topics addressed in the report under this section, in17 cluding with respect to— 

18 (A) improving public access to information 

19 from pediatric studies conducted under such 

20 sections 505A and 505B; and 

21 (B) improving the timeliness of pediatric 

22 studies and pediatric study planning under such 

23 sections 505A and 505B; 

24 (13) any recommendations for modification to 

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1 search and increase pediatric labeling of drugs and 

2 biological products; and 

3 (14) an assessment of the successes of and limi4 tations to studying drugs for rare diseases under 

5 such sections 505A and 505B. 

6 (c) CONSULTATION ON RECOMMENDATIONS.—At 

7 least 180 days before the report is due under subsection 

8 (a), and no sooner than 4 years after the date of enact9 ment of this Act, the Secretary shall consult with rep10 resentatives of patient groups, including pediatric patient 

11 groups, consumer groups, regulated industry, scientific 

12 and medical communities, academia, and other interested 

13 parties to obtain any recommendations or information rel14 evant to the effectiveness of the programs described in 

15 subsection (b)(7), including suggestions for modifications 

16 to such programs. 

17 SEC. 509. TECHNICAL AMENDMENTS. 

18 (a) PEDIATRIC STUDIES OF DRUGS IN FFDCA.— 

19 Section 505A (21 U.S.C. 355a) is amended— 

20 (1) in subsection (k)(2), by striking ‘‘subsection 

21 (f)(3)(F)’’ and inserting ‘‘subsection (f)(6)(F)’’; 

22 (2) in subsection (n)— 

23 (A) in the subsection heading, by striking 

24 ‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; 

25 and 


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1 (B) in paragraph (1)— 

2 (i) in the matter preceding subpara3 graph (A), by striking ‘‘have not been com4 pleted’’ and inserting ‘‘have not been sub5 mitted by the date specified in the written 

6 request issued or if the applicant or holder 

7 does not agree to the request’’; 

8 (ii) in subparagraph (A)— 

9 (I) in the first sentence, by in10 serting ‘‘, or for which a period of ex11 clusivity eligible for extension under 

12 subsection (b)(1) or (c)(1) of this sec13 tion or under subsection (m)(2) or 

14 (m)(3) of section 351 of the Public 

15 Health Service Act has not ended’’ 

16 after ‘‘expired’’; and 

17 (II) by striking ‘‘Prior to’’ and 

18 all that follows through the period at 

19 the end; and 

20 (iii) in subparagraph (B), by striking 

21 ‘‘no listed patents or has 1 or more listed 

22 patents that have expired,’’ and inserting 

23 ‘‘no unexpired listed patents and for which 

24 no unexpired periods of exclusivity eligible 

25 for extension under subsection (b)(1) or 


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1 (c)(1) of this section or under subsection 

2 (m)(2) or (m)(3) of section 351 of the 

3 Public Health Service Act apply,’’; and 

4 (3) in subsection (o)(2), by amendment sub5 paragraph (B) to read as follows: 

6 ‘‘(B) a statement of any appropriate pedi7 atric contraindications, warnings, precautions, 

8 or other information that the Secretary con9 siders necessary to assure safe use.’’. 

10 (b) RESEARCH INTO PEDIATRIC USES FOR DRUGS

11 AND BIOLOGICAL PROJECTS IN FFDCA.—Section 505B 

12 (21 U.S.C. 355c) is amended— 

13 (1) in subsection (a)— 

14 (A) in paragraph (1)— 

15 (i) in the matter preceding subpara16 graph (A), by inserting ‘‘for a drug’’ after 

17 ‘‘(or supplement to an application)’’; 

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

19 ‘‘for a’’ and inserting ‘‘, including, with re20 spect to a drug, an application (or supple21 ment to an application) for a’’; 

22 (iii) in subparagraph (B), by striking 

23 ‘‘for a’’ and inserting ‘‘, including, with re24 spect to a drug, an application (or supple25 ment to an application) for a’’; and 


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1 (iv) in the matter following subpara2 graph (B), by inserting ‘‘(or supplement)’’ 

3 after ‘‘application’’; and 

4 (B) in paragraph (4)(C)— 

5 (i) in the first sentence, by inserting 

6 ‘‘partial’’ before ‘‘waiver is granted’’; and 

7 (ii) in the second sentence, by striking 

8 ‘‘either a full or’’ and inserting ‘‘such a’’; 

9 (2) in subsection (b)(1), in the matter pre10 ceding subparagraph (A), by striking ‘‘After pro11 viding notice’’ and all that follows through ‘‘studies), 

12 the’’ and inserting ‘‘The’’; 

13 (3) in subsection (g)— 

14 (A) in paragraph (1)(A), by inserting 

15 ‘‘that receives a priority review or 330 days 

16 after the date of the submission of an applica17 tion or supplement that receives a standard re18 view’’ after ‘‘after the date of the submission of 

19 the application or supplement’’; and 

20 (B) in paragraph (2), by striking ‘‘the 

21 label of such product’’ and inserting ‘‘the label22 ing of such product’’; and 

23 (4) in subsection (h)(1)— 


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1 (A) by inserting ‘‘an application (or sup2 plement to an application) that contains’’ after 

3 ‘‘date of submission of’’; and 

4 (B) by inserting ‘‘, if the application (or 

5 supplement) receives a priority review, or not 

6 later than 330 days after the date of submis7 sion of an application (or supplement to an ap8 plication) that contains a pediatric assessment 

9 under this section, if the application (or supple10 ment) receives a standard review,’’ after ‘‘under 

11 this section,’’. 

12 (c) INTERNAL REVIEW COMMITTEE.—The heading of 

13 section 505C (21 U.S.C. 355d) is amended by inserting 

14 ‘‘AND DEFERRAL EXTENSIONS’’ after ‘‘DEFERRALS’’. 

15 (d) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 

16 Section 409I(c) of the Public Health Service Act (42 

17 U.S.C. 284m(c)) is amended— 

18 (1) in paragraph (1)— 

19 (A) in the matter preceding subparagraph 

20 (A), by inserting ‘‘or section 351(m) of this 

21 Act,’’ after ‘‘Cosmetic Act,’’; 

22 (B) in subparagraph (A)(i), by inserting 

23 ‘‘or section 351(k) of this Act’’ after ‘‘Cosmetic 

24 Act’’; and 


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1 (C) by amending subparagraph (B) to read 

2 as follows: 

3 ‘‘(B) there remains no patent listed pursu4 ant to section 505(b)(1) of the Federal Food, 

5 Drug, and Cosmetic Act, and every three-year 

6 and five-year period referred to in subsection 

7 (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), 

8 (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of 

9 section 505 of the Federal Food, Drug, and 

10 Cosmetic Act, or applicable twelve-year period 

11 referred to in section 351(k)(7) of this Act, and 

12 any seven-year period referred to in section 527 

13 of the Federal Food, Drug, and Cosmetic Act 

14 has ended for at least one form of the drug; 

15 and’’; and 

16 (2) in paragraph (2)— 

17 (A) in the paragraph heading, by striking 

18 ‘‘FOR DRUGS LACKING EXCLUSIVITY’’; and 

19 (B) by striking ‘‘under section 505 of the 

20 Federal Food, Drug, and Cosmetic Act’’; and 

21 (C) by striking ‘‘505A of such Act’’ and 

22 inserting ‘‘505A of the Federal Food, Drug, 

23 and Cosmetic Act or section 351(m) of this 

24 Act’’. 


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1 (e) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

2 ADVISORY COMMITTEE.—Section 15(a) of the Best Phar3 maceuticals for Children Act (Public Law 107–109), as 

4 amended by section 502(e) of the Food and Drug Admin5 istration Amendments Act of 2007 (Public Law 110–85), 

6 is amended in paragraph (1)(D), by striking ‘‘section 

7 505B(f)’’ and inserting ‘‘ ‘section 505C’ ’’. 

8 (f) FOUNDATION OF NATIONAL INSTITUTES OF

9 HEALTH.—Section 499(c)(1)(C) of the Public Health 

10 Service Act (42 U.S.C. 290b(c)(1)(C)) is amended by 

11 striking ‘‘for which the Secretary issues a certification in 

12 the affirmative under section 505A(n)(1)(A) of the Fed13 eral Food, Drug, and Cosmetic Act’’. 

14 (g) APPLICATION.—Notwithstanding any provision of 

15 section 505A and 505B of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 355a, 355c) stating that a provi17 sion applies beginning on the date of the enactment of the 

18 Best Pharmaceuticals for Children Act of 2007 or the date 

19 of the enactment of the Pediatric Research Equity Act of 

20 2007, any amendment made by this title to such a provi21 sion applies beginning on the date of the enactment of this 

22 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 

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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 

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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 ‘‘adminisVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00156 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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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 web 

24 site 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 particiVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00180 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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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 SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISH21 MENTS. 

22 Section 510 (21 U.S.C. 360) is amended— 

23 (1) in subsection (b)— 

24 (A) in paragraph (1), by striking ‘‘On or 

25 before’’ and all that follows through the period 


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1 at the end and inserting the following: ‘‘During 

2 the period beginning on October 1 and ending 

3 on December 31 of each year, every person who 

4 owns or operates any establishment in any 

5 State engaged in the manufacture, preparation, 

6 propagation, compounding, or processing of a 

7 drug or drugs shall register with the Sec8 retary— 

9 ‘‘(A) the name of such person, places of busi10 ness of such person, all such establishments, the 

11 unique facility identifier of each such establishment, 

12 and a point of contact e-mail address; and 

13 ‘‘(B) the name and place of business of each 

14 importer that takes physical possession of and sup15 plies a drug (other than an excipient) to such per16 son, including all establishments of each such drug 

17 importer, the unique facility identifier of each such 

18 drug importer establishment, and a point of contact 

19 e-mail address for each such drug importer.’’; and 

20 (B) by adding at the end the following: 

21 ‘‘(3) The Secretary may specify the unique facility 

22 identifier system that shall be used by registrants under 

23 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 

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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) that 

23 is engaged in the manufacture, propagation, 

24 compounding, or processing of a device or devices 

25 classified in class II or III shall be so inspected by 


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1 one or more officers or employees duly designated by 

2 the Secretary, or by persons accredited to conduct 

3 inspections under section 704(g), at least once in the 

4 2-year period beginning with the date of registration 

5 of such establishment pursuant to this section and 

6 at least once in every successive 2-year period there7 after. 

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 

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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 

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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 CONFIDEN12 TIAL INFORMATION.—The Secretary shall not be required 

13 to disclose under section 552 of title 5, United States 

14 Code, or any other provision of law, any information relat15 ing to drugs obtained from a Federal, State or local gov16 ernment agency, or from a foreign government agency, if 

17 the agency has requested that the information be kept con18 fidential, except pursuant to an order of a court of the 

19 United States. For purposes of section 552 of title 5, 

20 United States Code, this subsection shall be considered a 

21 statute described in section 552(b)(3)(B). 

22 ‘‘(c) AUTHORITY TO ENTER INTO MEMORANDA OF

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1 ments regarding the exchange of information referenced 

2 in section 301(j) subject to the following criteria: 

3 ‘‘(1) CERTIFICATION.—The Secretary may only 

4 enter into written agreements under this subsection 

5 with foreign governments that the Secretary has cer6 tified as having the authority and demonstrated abil7 ity to protect trade secret information from disclo8 sure. Responsibility for this certification shall not be 

9 delegated to any officer or employee other than the 

10 Commissioner. 

11 ‘‘(2) WRITTEN AGREEMENT.—The written 

12 agreement under this subsection shall include a com13 mitment by the foreign government to protect infor14 mation exchanged under this subsection from disclo15 sure unless and until the sponsor gives written per16 mission for disclosure or the Secretary makes a dec17 laration of a public health emergency pursuant to 

18 section 319 of the Public Health Service Act that is 

19 relevant to the information. 

20 ‘‘(3) INFORMATION EXCHANGE.—The Secretary 

21 may provide to a foreign government that has been 

22 certified under paragraph (1) and that has executed 

23 a written agreement under paragraph (2) informa24 tion referenced in section 301(j) in the following cir25 cumstances: 


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1 ‘‘(A) Information concerning the inspection 

2 of a facility may be provided if— 

3 ‘‘(i) the Secretary reasonably believes, 

4 or that the written agreement described in 

5 paragraph (2) establishes, that the govern6 ment has authority to otherwise obtain 

7 such information; and 

8 ‘‘(ii) the written agreement executed 

9 under paragraph (2) limits the recipient’s 

10 use of the information to the recipient’s 

11 civil regulatory purposes. 

12 ‘‘(B) Information not described in sub13 paragraph (A) may be provided as part of an 

14 investigation, or to alert the foreign government 

15 to the potential need for an investigation, if the 

16 Secretary has reasonable grounds to believe 

17 that a drug has a reasonable probability of 

18 causing serious adverse health consequences or 

19 death to humans or animals. 

20 ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 

21 subsection affects the ability of the Secretary to 

22 enter into any written agreement authorized by 

23 other provisions of law to share confidential informa24 tion.’’. 


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1 SEC. 709. ENHANCING THE SAFETY AND QUALITY OF THE 

2 DRUG SUPPLY. 

3 Section 501 (21 U.S.C. 351) is amended by adding 

4 at the end the following flush text: 

5 ‘‘For purposes of subsection (a)(2)(B), the term ‘current 

6 good manufacturing practice’ includes the implementation 

7 of oversight and controls over the manufacture of drugs 

8 to ensure quality, including managing the risk of and es9 tablishing the safety of raw materials, materials used in 

10 the manufacturing of drugs, and finished drug products.’’. 

11 SEC. 710. ACCREDITATION OF THIRD-PARTY AUDITORS FOR 

12 DRUG ESTABLISHMENTS. 

13 (a) IN GENERAL.—Chapter VIII (21 U.S.C. 381 et 

14 seq.) is amended by adding at the end the following: 

15 ‘‘SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS 

16 FOR DRUG ESTABLISHMENTS. 

17 ‘‘(a) DEFINITIONS.—In this section: 

18 ‘‘(1) ACCREDITATION BODY.—The term ‘ac19 creditation body’ means an authority that performs 

20 accreditation of third-party auditors. 

21 ‘‘(2) ACCREDITED THIRD-PARTY AUDITOR.— 

22 The term ‘accredited third-party auditor’ means a 

23 third-party auditor (which may be an individual) ac24 credited by an accreditation body to conduct drug 

25 safety and quality audits. 


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1 ‘‘(3) AUDIT AGENT.—The term ‘audit agent’ 

2 means an individual who is an employee or agent of 

3 an accredited third-party auditor and, although not 

4 individually accredited, is qualified to conduct drug 

5 safety and quality audits on behalf of an accredited 

6 third-party auditor. 

7 ‘‘(4) CONSULTATIVE AUDIT.—The term ‘con8 sultative audit’ means an audit of an eligible entity 

9 intended for internal purposes only to determine 

10 whether an establishment is in compliance with the 

11 provisions of this Act and applicable industry prac12 tices, or any other such service. 

13 ‘‘(5) DRUG SAFETY AND QUALITY AUDIT.—The 

14 term ‘drug safety and quality audit’— 

15 ‘‘(A) means an audit of an eligible entity 

16 to certify that the eligible entity meets the re17 quirements of this Act applicable to drugs, in18 cluding the requirements of section 501 with re19 spect to drugs; and 

20 ‘‘(B) is not a consultative audit. 

21 ‘‘(6) ELIGIBLE ENTITY.—The term ‘eligible en22 tity’ means an entity, including a foreign drug estab23 lishment registered under section 510(c), in the drug 

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1 credited third-party auditor or the audit agent of 

2 such accredited third-party auditor. 

3 ‘‘(7) THIRD-PARTY AUDITOR.—The term ‘third4 party auditor’ means a foreign government, agency 

5 of a foreign government or any other third party 

6 (which may be an individual), as the Secretary de7 termines appropriate in accordance with the criteria 

8 described in subsection (c)(1), that is eligible to be 

9 considered for accreditation to conduct drug safety 

10 and quality audits. 

11 ‘‘(b) ACCREDITATION SYSTEM.— 

12 ‘‘(1) RECOGNITION OF ACCREDITATION BOD13 IES.— 

14 ‘‘(A) IN GENERAL.—Not later than 2 years 

15 after date of enactment of the Food and Drug 

16 Administration Safety and Innovation Act, the 

17 Secretary shall establish a system for the rec18 ognition of accreditation bodies that accredit 

19 third-party auditors to conduct drug safety and 

20 quality audits. 

21 ‘‘(B) DIRECT ACCREDITATION.— 

22 ‘‘(i) IN GENERAL.—If, by the date 

23 that is 2 years after the date of establish24 ment of the system described in subpara25 graph (A), the Secretary has not identified 


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1 and recognized an accreditation body to 

2 meet the requirements of this section, the 

3 Secretary may directly accredit third-party 

4 auditors. 

5 ‘‘(ii) CERTAIN DIRECT ACCREDITA6 TIONS.—Notwithstanding subparagraph 

7 (A) or clause (i), the Secretary may di8 rectly accredit any foreign government or 

9 any agency of a foreign government as a 

10 third-party auditor at any time after the 

11 date of enactment of the Food and Drug 

12 Administration Safety and Innovation Act. 

13 ‘‘(2) NOTIFICATION.—Each accreditation body 

14 recognized by the Secretary shall submit to the Sec15 retary— 

16 ‘‘(A) a list of all accredited third-party 

17 auditors accredited by such body (including the 

18 name, contact information, and scope and dura19 tion of accreditation for each such auditor), and 

20 the audit agents of such auditors; and 

21 ‘‘(B) updated lists as needed to ensure the 

22 list held by the Secretary is accurate. 

23 ‘‘(3) REVOCATION OF RECOGNITION AS AN AC24 CREDITATION BODY.—The Secretary shall promptly 

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1 ing, the recognition of any accreditation body found 

2 not to be in compliance with the requirements of this 

3 section. 

4 ‘‘(4) REINSTATEMENT.—The Secretary shall es5 tablish procedures to reinstate recognition of an ac6 creditation body if the Secretary determines, based 

7 on evidence presented by such accreditation body, 

8 that revocation was inappropriate or that the body 

9 meets the requirements for recognition under this 

10 section. 

11 ‘‘(5) MODEL ACCREDITATION STANDARDS.— 

12 ‘‘(A) IN GENERAL.—Not later than 18 

13 months after the date of enactment of the Food 

14 and Drug Administration Safety and Innova15 tion Act, the Secretary shall develop model 

16 standards, including standards for drug safety 

17 and quality audit results, reports, and certifi18 cations, and each recognized accreditation body 

19 shall ensure that third-party auditors and audit 

20 agents of such auditors meet such standards in 

21 order to qualify such third-party auditors as ac22 credited third-party auditors under this section. 

23 ‘‘(B) CONTENT.—The standards developed 

24 under subparagraph (A) may— 


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1 ‘‘(i) include a description of required 

2 standards relating to the training proce3 dures, competency, management respon4 sibilities, quality control, and conflict of in5 terest requirements of accredited third6 party auditors; and 

7 ‘‘(ii) set forth procedures for the peri8 odic renewal of the accreditation of accred9 ited third-party auditors. 

10 ‘‘(C) REQUIREMENT TO PROVIDE RESULTS

11 AND REPORTS TO THE SECRETARY.—An ac12 creditation body (or, in the case of direct ac13 creditation under subsection (b)(1)(B), the Sec14 retary) may not accredit a third-party auditor 

15 unless such third-party auditor agrees to pro16 vide to the Secretary, upon request, the results 

17 and reports of any drug safety and quality 

18 audit conducted pursuant to the accreditation 

19 provided under this section. 

20 ‘‘(6) DISCLOSURE.—The Secretary shall main21 tain on the Internet Web site of the Food and Drug 

22 Administration a list of recognized accreditation 

23 bodies and accredited third-party auditors under this 

24 section. 

25 ‘‘(c) ACCREDITED THIRD-PARTY AUDITORS.— 


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1 ‘‘(1) REQUIREMENTS FOR ACCREDITATION AS A

2 THIRD-PARTY AUDITOR.— 

3 ‘‘(A) FOREIGN GOVERNMENTS.—Prior to 

4 accrediting a foreign government or an agency 

5 of a foreign government as an accredited third6 party auditor, the accreditation body (or, in the 

7 case of direct accreditation under subsection 

8 (b)(1)(B), the Secretary) shall perform such re9 views and audits of drug safety programs, sys10 tems, and standards of the government or agen11 cy of the government as the Secretary deems 

12 necessary, including requirements under the 

13 standards developed under subsection (b)(5), to 

14 determine that the foreign government or agen15 cy of the foreign government is capable of ade16 quately ensuring that eligible entities or drugs 

17 certified by such government or agency meet 

18 the requirements of this Act. 

19 ‘‘(B) OTHER THIRD PARTIES.—Prior to 

20 accrediting any other third party to be an ac21 credited third-party auditor, the accreditation 

22 body (or, in the case of direct accreditation 

23 under subsection (b)(1)(B), the Secretary) shall 

24 perform such reviews and audits of the training 

25 and qualifications of audit agents used by that 


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1 party and conduct such reviews of internal sys2 tems and such other investigation of the party 

3 as the Secretary deems necessary, including re4 quirements under the standards developed 

5 under subsection (b)(5), to determine that the 

6 third-party auditor is capable of adequately en7 suring that an eligible entity or drug certified 

8 by such third-party auditor meets the require9 ments of this Act. 

10 ‘‘(2) USE OF AUDIT AGENTS.—An accredited 

11 third-party auditor may conduct drug safety and 

12 quality audits and may employ or use audit agents 

13 to conduct drug safety and quality audits, but must 

14 ensure that such audit agents comply with all re15 quirements the Secretary deems necessary, including 

16 requirements under paragraph (1) and subsection 

17 (b)(5). 

18 ‘‘(3) REVOCATION OF ACCREDITATION.— 

19 ‘‘(A) IN GENERAL.—The Secretary shall 

20 promptly revoke, after the opportunity for an 

21 informal hearing, the accreditation of an ac22 credited third-party auditor— 

23 ‘‘(i) if, following an evaluation, the 

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1 party auditor is not in compliance with the 

2 requirements of this section; or 

3 ‘‘(ii) following a refusal to allow 

4 United States officials to conduct such au5 dits and investigations as may be necessary 

6 to determine compliance with the require7 ments set forth in this section. 

8 ‘‘(B) ADDITIONAL BASIS FOR REVOCATION

9 OF ACCREDITATION.—The Secretary may re10 voke accreditation from an accredited third11 party auditor in the case that such third-party 

12 auditor is accredited by an accreditation body 

13 for which recognition as an accreditation body 

14 under subsection (b)(3) is revoked, if the Sec15 retary determines that there is good cause for 

16 the revocation of accreditation. 

17 ‘‘(4) REACCREDITATION.—The Secretary shall 

18 establish procedures to reinstate the accreditation of 

19 a third-party auditor for which accreditation has 

20 been revoked under paragraph (3)— 

21 ‘‘(A) if the Secretary determines, based on 

22 evidence presented, that— 

23 ‘‘(i) the third-party auditor satisfies 

24 the requirements of this section; and 


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1 ‘‘(ii) adequate grounds for revocation 

2 no longer exist; and 

3 ‘‘(B) in the case of a third-party auditor 

4 accredited by an accreditation body for which 

5 recognition as an accreditation body is revoked 

6 under subsection (b)(3)— 

7 ‘‘(i) if the third-party auditor becomes 

8 accredited not later than 1 year after rev9 ocation of accreditation under paragraph 

10 (3), through direct accreditation under 

11 subsection (b)(1)(B), or by an accredita12 tion body in good standing; or 

13 ‘‘(ii) under such other conditions as 

14 the Secretary may require. 

15 ‘‘(5) REQUIREMENT TO ISSUE CERTIFICATION

16 OF ELIGIBLE ENTITIES FOR COMPLIANCE WITH CUR17 RENT GOOD MANUFACTURING PRACTICE.— 

18 ‘‘(A) IN GENERAL.—An accreditation body 

19 (or, in the case of direct accreditation under 

20 subsection (b)(1)(B), the Secretary) may not 

21 accredit a third-party auditor unless such third22 party auditor agrees to issue a written and, as 

23 appropriate, electronic, document or certifi24 cation, as the Secretary may require under this 

25 Act, regarding compliance with section 501. 


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1 The Secretary may consider any such document 

2 or certification to satisfy requirements under 

3 section 801(r) and to target inspection re4 sources under section 510(h). 

5 ‘‘(B) REQUIREMENTS FOR ISSUING CER6 TIFICATION.— 

7 ‘‘(i) IN GENERAL.—An accredited 

8 third-party auditor shall issue a drug cer9 tification described in subparagraph (A) 

10 only after conducting a drug safety and 

11 quality audit and such other activities that 

12 may be necessary to establish compliance 

13 with the provisions of section 501. 

14 ‘‘(ii) PROVISION OF CERTIFICATION.— 

15 Only an accredited third-party auditor or 

16 the Secretary may provide a drug certifi17 cation described in subparagraph (A). 

18 ‘‘(C) RECORDS.—Following any accredita19 tion of a third-party auditor, the Secretary 

20 may, at any time, require the accredited third21 party auditor or any audit agent of such audi22 tor to submit to the Secretary a drug safety 

23 and quality audit report and such other reports 

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1 tity for which the accredited third-party auditor 

2 or audit agent of such auditor performed a 

3 drug safety and quality audit. The Secretary 

4 may require documentation that the eligible en5 tity is in compliance with any applicable reg6 istration requirements. 

7 ‘‘(D) LIMITATION.—The requirement 

8 under subparagraph (C) shall not include any 

9 report or other documents resulting from a con10 sultative audit, except that the Secretary may 

11 access the results of a consultative audit in ac12 cordance with section 704. 

13 ‘‘(E) DECLARATION OF AUDIT TYPE.—Be14 fore an accredited third-party auditor begins 

15 any audit or provides any consultative service to 

16 an eligible entity, both the accredited third17 party auditor and eligible entity shall establish 

18 in writing whether the audit is intended to be 

19 a drug safety and quality audit. Any audit, in20 spection, or consultative service of any type pro21 vided by an accredited third-party auditor on 

22 behalf of an eligible entity shall be presumed to 

23 be a drug safety and quality audit in the ab24 sence of such a written agreement. Once a drug 

25 safety and quality audit is initiated, it shall be 


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1 subject to the requirements of this section, and 

2 no person may withhold from the Secretary any 

3 document subject to subparagraph (C) on the 

4 grounds that the audit was a consultative audit 

5 or otherwise not a drug safety and quality 

6 audit. 

7 ‘‘(F) RULE OF CONSTRUCTION.—Nothing 

8 in this section shall be construed to limit the 

9 authority of the Secretary under section 704. 

10 ‘‘(6) REQUIREMENTS REGARDING SERIOUS

11 RISKS TO THE PUBLIC HEALTH.—If, at any time 

12 during a drug safety and quality audit, an accredited 

13 third-party auditor or an audit agent of such auditor 

14 discovers a condition that could cause or contribute 

15 to a serious risk to the public health, such auditor 

16 shall immediately notify the Secretary of— 

17 ‘‘(A) the identity and location of the eligi18 ble entity subject to the drug safety and quality 

19 audit; and 

20 ‘‘(B) such condition. 

21 ‘‘(7) LIMITATIONS.— 

22 ‘‘(A) IN GENERAL.—An audit agent of an 

23 accredited third-party auditor may not perform 

24 a drug safety and quality audit of an eligible 

25 entity if such audit agent has performed a drug 


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1 safety and quality audit or consultative audit of 

2 such eligible entity during the previous 13- 

3 month period. 

4 ‘‘(B) WAIVER.—The Secretary may waive 

5 the application of subparagraph (A) if the Sec6 retary determines that there is insufficient ac7 cess to accredited third-party auditors in a 

8 country or region or that the use of the same 

9 audit agent or accredited third-party auditor is 

10 otherwise necessary. 

11 ‘‘(8) CONFLICTS OF INTEREST.— 

12 ‘‘(A) ACCREDITATION BODIES.—A recog13 nized accreditation body shall— 

14 ‘‘(i) not be owned, managed, or con15 trolled by any person that owns or operates 

16 a third-party auditor to be accredited by 

17 such body; 

18 ‘‘(ii) in carrying out accreditation of 

19 third-party auditors under this section, 

20 have procedures to ensure against the use 

21 of any officer or employee of such body 

22 that has a financial conflict of interest re23 garding a third-party auditor to be accred24 ited by such body; and 


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1 ‘‘(iii) annually make available to the 

2 Secretary disclosures of the extent to 

3 which such body and the officers and em4 ployees of such body have maintained com5 pliance with clauses (i) and (ii) relating to 

6 financial conflicts of interest. 

7 ‘‘(B) ACCREDITED THIRD-PARTY AUDI8 TORS.—An accredited third-party auditor 

9 shall— 

10 ‘‘(i) not be owned, managed, or con11 trolled by any person that owns or operates 

12 an eligible entity to be certified by such 

13 auditor; 

14 ‘‘(ii) in carrying out drug safety and 

15 quality audits of eligible entities under this 

16 section, have procedures to ensure against 

17 the use of any officer or employee of such 

18 auditor that has a financial conflict of in19 terest regarding an eligible entity to be 

20 certified by such auditor; and 

21 ‘‘(iii) annually make available to the 

22 Secretary disclosures of the extent to 

23 which such auditor and the officers and 

24 employees of such auditor have maintained 


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1 compliance with clauses (i) and (ii) relat2 ing to financial conflicts of interest. 

3 ‘‘(C) AUDIT AGENTS.—An audit agent 

4 shall— 

5 ‘‘(i) not own or operate an eligible en6 tity to be audited by such agent; 

7 ‘‘(ii) in carrying out audits of eligible 

8 entities under this section, have procedures 

9 to ensure that such agent does not have a 

10 financial conflict of interest regarding an 

11 eligible entity to be audited by such agent; 

12 and 

13 ‘‘(iii) annually make available to the 

14 Secretary disclosures of the extent to 

15 which such agent has maintained compli16 ance with clauses (i) and (ii) relating to fi17 nancial conflicts of interest. 

18 ‘‘(d) FALSE STATEMENTS.—Any statement or rep19 resentation made— 

20 ‘‘(1) by an employee or agent of an eligible enti21 ty to an accredited third-party auditor or audit 

22 agent; or 

23 ‘‘(2) by an accreditation body, accredited third24 party auditor, or audit agent of such auditor to the 


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1 Secretary, shall be subject to section 1001 of title 

2 18, United States Code. 

3 ‘‘(e) MONITORING.—To ensure compliance with the 

4 requirements of this section, the Secretary— 

5 ‘‘(1) shall periodically, or at least once every 4 

6 years, reevaluate the accreditation bodies described 

7 in subsection (b)(1); 

8 ‘‘(2) shall periodically, or at least once every 4 

9 years, evaluate the performance of each accredited 

10 third-party auditor, through the review of regulatory 

11 audit reports by such auditors, the compliance his12 tory as available of eligible entities certified by such 

13 auditors, and any other measures deemed necessary 

14 by the Secretary; 

15 ‘‘(3) may at any time, conduct an onsite audit 

16 of any eligible entity certified by an accredited third17 party auditor, with or without the auditor present; 

18 and 

19 ‘‘(4) shall take any other measures deemed nec20 essary by the Secretary. 

21 ‘‘(f) EFFECT OF AUDIT.—The results of a drug safe22 ty and quality audit by an accredited third-party auditor 

23 under this section— 

24 ‘‘(1) may be used by the eligible entity— 


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1 ‘‘(A) as documentation of compliance with 

2 section 501(a)(2)(B) or section 801(r); and 

3 ‘‘(B) for other purposes as determined ap4 propriate by the Secretary; and 

5 ‘‘(2) shall be used by the Secretary in estab6 lishing the risk-based inspection schedules under sec7 tion 510(h). 

8 ‘‘(g) COSTS.— 

9 ‘‘(1) AUTHORIZED FEES OF SECRETARY.—The 

10 Secretary may assess fees on accreditation bodies 

11 and accredited third-party auditors in such an 

12 amount necessary to establish and administer the 

13 recognition and accreditation program under this 

14 section. The Secretary may require accredited third15 party auditors and audit agents to reimburse the 

16 Food and Drug Administration for the work per17 formed to carry out this section. The Secretary shall 

18 not generate surplus revenue from such a reimburse19 ment mechanism. Fees authorized under this para20 graph shall be collected and available for obligation 

21 only to the extent and in the amount provided in ad22 vance in appropriation Acts. Such fees are author23 ized to remain available until expended. 

24 ‘‘(2) AUTHORIZED FEES FOR RECOGNIZED AC25 CREDITATION BODIES.—An accreditation body recVerDate Mar 15 2010 23:27 May 16, 2012 Jkt 019200 PO 00000 Frm 00212 Fmt 6652 Sfmt 6201 E:\BILLS\S3187.PCS S3187

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1 ognized by the Secretary under subsection (b) may 

2 assess a reasonable fee to accredit third-party audi3 tors. 

4 ‘‘(h) LIMITATIONS.— 

5 ‘‘(1) NO EFFECT ON SECTION 704 INSPEC6 TIONS.—The drug safety and quality audits per7 formed under this section shall not be considered in8 spections under section 704. 

9 ‘‘(2) NO EFFECT ON INSPECTION AUTHOR10 ITY.—Nothing in this section affects the authority of 

11 the Secretary to inspect any eligible entity pursuant 

12 to this Act. 

13 ‘‘(i) REGULATIONS.— 

14 ‘‘(1) IN GENERAL.—Not later than 18 months 

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 the regula20 tions implementing this section, the Secretary 

21 shall— 

22 ‘‘(A) issue a notice of proposed rulemaking 

23 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 Section 303(b) (21 U.S.C. 333(b)), as amended by 

16 section 713, is further amended by adding at the end the 

17 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 SEC. 715. EXTRATERRITORIAL JURISDICTION. 

23 Chapter III (21 U.S.C. 331 et seq.) is amended by 

24 adding at the end the following: 


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1 ‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 

2 ‘‘There is extraterritorial jurisdiction over any viola3 tion of this Act relating to any article regulated under this 

4 Act if such article was intended for import into the United 

5 States or if any act in furtherance of the violation was 

6 committed in the United States.’’. 

7 SEC. 716. COMPLIANCE WITH INTERNATIONAL AGREE8 MENTS. 

9 Nothing in this title (or an amendment made by this 

10 title) shall be construed in a manner inconsistent with the 

11 obligations of the United States under the Agreement Es12 tablishing the World Trade Organization, or any other 

13 treaty or international agreement to which the United 

14 States is a party. 

15 TITLE VIII—GENERATING 

16 ANTIBIOTIC INCENTIVES NOW 

17 SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. 

18 (a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) 

19 is amended by inserting after section 505D the following: 

20 ‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 

21 QUALIFIED INFECTIOUS DISEASE PRODUCTS. 

22 ‘‘(a) EXTENSION.—If the Secretary approves an ap23 plication pursuant to section 505 for a drug that has been 

24 designated as a qualified infectious disease product under 

25 subsection (d), the 4- and 5-year periods described in sub26 sections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 


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1 3-year periods described in clauses (iii) and (iv) of sub2 section (c)(3)(E) and clauses (iii) and (iv) of subsection 

3 (j)(5)(F) of section 505, or the 7-year period described 

4 in section 527, as applicable, shall be extended by 5 years. 

5 ‘‘(b) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 

6 extension under subsection (a) of a period shall be in addi7 tion to any extension of the period under section 505A 

8 with respect to the drug. 

9 ‘‘(c) LIMITATIONS.—Subsection (a) does not apply to 

10 the approval of— 

11 ‘‘(1) a supplement to an application under sec12 tion 505(b) for any qualified infectious disease prod13 uct for which an extension described in subsection 

14 (a) is in effect or has expired; 

15 ‘‘(2) a subsequent application filed with respect 

16 to a product approved under section 505 for a 

17 change that results in a new indication, route of ad18 ministration, dosing schedule, dosage form, delivery 

19 system, delivery device, or strength; or 

20 ‘‘(3) an application for a product that is not ap21 proved for the use for which it received a designa22 tion under subsection (d). 

23 ‘‘(d) DESIGNATION.— 

24 ‘‘(1) IN GENERAL.—The manufacturer or spon25 sor of a drug may request the Secretary to designate 


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1 a drug as a qualified infectious disease product at 

2 any time before the submission of an application 

3 under section 505(b) for such drug. The Secretary 

4 shall, not later than 60 days after the submission of 

5 such a request, determine whether the drug is a 

6 qualified infectious disease product. 

7 ‘‘(2) LIMITATION.—Except as provided in para8 graph (3), a designation under this subsection shall 

9 not be withdrawn for any reason, including modifica10 tions to the list of qualifying pathogens under sub11 section (f)(2)(C). 

12 ‘‘(3) REVOCATION OF DESIGNATION.—The Sec13 retary may revoke a designation of a drug as a 

14 qualified infectious disease product if the Secretary 

15 finds that the request for such designation contained 

16 an untrue statement of material fact. 

17 ‘‘(e) REGULATIONS.— 

18 ‘‘(1) IN GENERAL.—Not later than 2 years 

19 after the date of enactment of the Food and Drug 

20 Administration Safety and Innovation Act, the Sec21 retary shall adopt final regulations implementing 

22 this section. 

23 ‘‘(2) PROCEDURE.—In promulgating a regula24 tion implementing this section, the Secretary shall— 


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1 ‘‘(A) issue a notice of proposed rulemaking 

2 that includes 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), except that the Sec13 retary may issue interim guidance for sponsors seek14 ing designation under subsection (d) prior to the 

15 promulgation of such regulations. 

16 ‘‘(4) DESIGNATION PRIOR TO REGULATIONS.— 

17 The Secretary may designate drugs as qualified in18 fectious disease products under subsection (d) prior 

19 to the promulgation of regulations under this sub20 section. 

21 ‘‘(f) QUALIFYING PATHOGEN.— 

22 ‘‘(1) DEFINITION.—In this section, the term 

23 ‘qualifying pathogen’ means a pathogen identified 

24 and listed by the Secretary under paragraph (2) that 


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1 has the potential to pose a serious threat to public 

2 health, such as— 

3 ‘‘(A) resistant gram positive pathogens, in4 cluding methicillin-resistant Staphylococcus 

5 aureus, vancomycin-resistant Staphylococcus 

6 aureus, and vancomycin-resistant enterococcus; 

7 ‘‘(B) multi-drug resistant gram negative 

8 bacteria, including Acinetobacter, Klebsiella, 

9 Pseudomonas, and E. coli species; 

10 ‘‘(C) multi-drug resistant tuberculosis; and 

11 ‘‘(D) Clostridium difficile. 

12 ‘‘(2) LIST OF QUALIFYING PATHOGENS.— 

13 ‘‘(A) IN GENERAL.—The Secretary shall 

14 establish and maintain a list of qualifying 

15 pathogens, and shall make public the method16 ology for developing such list. 

17 ‘‘(B) CONSIDERATIONS.—In establishing 

18 and maintaining the list of pathogens described 

19 under this section the Secretary shall— 

20 ‘‘(i) consider— 

21 ‘‘(I) the impact on the public 

22 health due to drug-resistant orga23 nisms in humans; 

24 ‘‘(II) the rate of growth of drug25 resistant organisms in humans; 


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1 ‘‘(III) the increase in resistance 

2 rates in humans; and 

3 ‘‘(IV) the morbidity and mor4 tality in humans; and 

5 ‘‘(ii) consult with experts in infectious 

6 diseases and antibiotic resistance, includ7 ing the Centers for Disease Control and 

8 Prevention, the Food and Drug Adminis9 tration, medical professionals, and the clin10 ical research community. 

11 ‘‘(C) REVIEW.—Every 5 years, or more 

12 often as needed, the Secretary shall review, pro13 vide modifications to, and publish the list of 

14 qualifying pathogens under subparagraph (A) 

15 and shall by regulation revise the list as nec16 essary, in accordance with subsection (e). 

17 ‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 

18 The term ‘qualified infectious disease product’ means an 

19 antibacterial or antifungal drug for human use intended 

20 to treat serious or life-threatening infections, including 

21 those caused by— 

22 ‘‘(1) an antibacterial or antifungal resistant 

23 pathogen, including novel or emerging infectious 

24 pathogens; or 


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1 ‘‘(2) qualifying pathogens listed by the Sec2 retary under subsection (f).’’. 

3 (b) APPLICATION.—Section 505E of the Federal 

4 Food, Drug, and Cosmetic Act, as added by subsection 

5 (a), applies only with respect to a drug that is first ap6 proved under section 505(c) of such Act (21 U.S.C. 

7 355(c)) on or after the date of the enactment of this Act. 

8 SEC. 802. PRIORITY REVIEW. 

9 (a) AMENDMENT.—Chapter V (21 U.S.C. 351 et 

10 seq.) is amended by inserting after section 524 the fol11 lowing: 

12 ‘‘SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS 

13 DISEASE PRODUCTS. 

14 ‘‘If the Secretary designates a drug under section 

15 505E(d) as a qualified infectious disease product, then the 

16 Secretary shall give priority review to any application sub17 mitted for approval for such drug under section 505(b).’’. 

18 (b) APPLICATION.—Section 524A of the Federal 

19 Food, Drug, and Cosmetic Act, as added by subsection 

20 (a), applies only with respect to an application that is sub21 mitted under section 505(b) of such Act (21 U.S.C. 

22 355(b)) on or after the date of the enactment of this Act. 

23 SEC. 803. FAST TRACK PRODUCT. 

24 Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended 

25 by section 901(b), is amended by inserting ‘‘, or if the 


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1 Secretary designates the drug as a qualified infectious dis2 ease product under section 505E(d)’’ before the period at 

3 the end of the first sentence. 

4 SEC. 804. GAO STUDY. 

5 (a) IN GENERAL.—The Comptroller General of the 

6 United States shall— 

7 (1) conduct a study— 

8 (A) on the need for, and public health im9 pact of, incentives to encourage the research, 

10 development, and marketing of qualified infec11 tious disease biological products and antifungal 

12 products; and 

13 (B) consistent with trade and confiden14 tiality data protections, assessing, for all anti15 bacterial and antifungal drugs, including bio16 logical products, the average or aggregate— 

17 (i) costs of all clinical trials for each 

18 phase; 

19 (ii) percentage of success or failure at 

20 each phase of clinical trials; and 

21 (iii) public versus private funding lev22 els of the trials for each phase; and 

23 (2) not later than 1 year after the date of en24 actment of this Act, submit a report to Congress on 

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1 ommendations of the Comptroller General on appro2 priate incentives for addressing such need. 

3 (b) CONTENTS.—The part of the study described in 

4 subsection (a)(1)(A) shall include— 

5 (1) an assessment of any underlying regulatory 

6 issues related to qualified infectious disease prod7 ucts, including qualified infectious disease biological 

8 products; 

9 (2) an assessment of the management by the 

10 Food and Drug Administration of the review of 

11 qualified infectious disease products, including quali12 fied infectious disease biological products and the 

13 regulatory certainty of related regulatory pathways 

14 for such products; 

15 (3) a description of any regulatory impediments 

16 to the clinical development of new qualified infec17 tious disease products, including qualified infectious 

18 disease biological products, and the efforts of the 

19 Food and Drug Administration to address such im20 pediments; and 

21 (4) recommendations with respect to— 

22 (A) improving the review and predictability 

23 of regulatory pathways for such products; and 

24 (B) overcoming any regulatory impedi25 ments identified in paragraph (3). 


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1 (c) DEFINITIONS.—In this section: 

2 (1) The term ‘‘biological product’’ has the 

3 meaning given to such term in section 351 of the 

4 Public Health Service Act (42 U.S.C. 262). 

5 (2) The term ‘‘qualified infectious disease bio6 logical product’’ means a biological product intended 

7 to treat a serious or life-threatening infection de8 scribed in section 505E(g) of the Federal Food, 

9 Drug, and Cosmetic Act, as added by section 801. 

10 (3) The term ‘‘qualified infectious disease prod11 uct’’ has the meaning given such term in section 

12 505E(g) of the Federal Food, Drug, and Cosmetic 

13 Act, as added by section 801. 

14 SEC. 805. CLINICAL TRIALS. 

15 (a) REVIEW AND REVISION OF GUIDANCE DOCU16 MENTS.— 

17 (1) IN GENERAL.—The Secretary of Health and 

18 Human Services (referred to in this section as the 

19 ‘‘Secretary’’) shall review and, as appropriate, revise 

20 not fewer than 3 guidance documents per year, 

21 which shall include— 

22 (A) reviewing the guidance documents of 

23 the Food and Drug Administration for the con24 duct of clinical trials with respect to anti25 bacterial and antifungal drugs; and 


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1 (B) as appropriate, revising such guidance 

2 documents to reflect developments in scientific 

3 and medical information and technology and to 

4 ensure clarity regarding the procedures and re5 quirements for approval of antibacterial and 

6 antifungal drugs under chapter V of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

8 351 et seq.). 

9 (2) ISSUES FOR REVIEW.—At a minimum, the 

10 review under paragraph (1) shall address the appro11 priate animal models of infection, in vitro tech12 niques, valid micro-biological surrogate markers, the 

13 use of non-inferiority versus superiority trials, trial 

14 enrollment, data requirements, and appropriate delta 

15 values for non-inferiority trials. 

16 (3) RULE OF CONSTRUCTION.—Except to the 

17 extent to which the Secretary makes revisions under 

18 paragraph (1)(B), nothing in this section shall be 

19 construed to repeal or otherwise effect the guidance 

20 documents of the Food and Drug Administration. 

21 (b) RECOMMENDATIONS FOR INVESTIGATIONS.— 

22 (1) REQUEST.—The sponsor of a drug intended 

23 to be designated as a qualified infectious disease 

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1 vestigations which the Secretary believes may be 

2 necessary to be conducted with the drug before such 

3 drug may be approved under section 505 of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

5 for use in treating, detecting, preventing, or identi6 fying a qualifying pathogen, as defined in section 

7 505E of such Act. 

8 (2) RECOMMENDATIONS.—If the Secretary has 

9 reason to believe that a drug for which a request is 

10 made under this subsection is a qualified infectious 

11 disease product, the Secretary shall provide the per12 son making the request written recommendations for 

13 the nonclinical and clinical investigations which the 

14 Secretary believes, on the basis of information avail15 able to the Secretary at the time of the request, 

16 would be necessary for approval under section 505 

17 of the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 355) of such drug for the use described in 

19 paragraph (1). 

20 (c) GAO STUDY.—Not later than January 1, 2016, 

21 the Comptroller General of the United States shall submit 

22 to Congress a report— 

23 (1) regarding the review and revision of the 

24 clinical trial guidance documents required under 

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1 sion has had on the review and approval of qualified 

2 infectious disease products; 

3 (2) assessing— 

4 (A) the effectiveness of the results-oriented 

5 metrics managers employ to ensure that review6 ers of such products are familiar with, and con7 sistently applying, clinical trial guidance docu8 ments; and 

9 (B) the predictability of related regulatory 

10 pathways and review; 

11 (3) identifying any outstanding regulatory im12 pediments to the clinical development of qualified in13 fectious disease products; 

14 (4) reporting on the progress the Food and 

15 Drug Administration has made in addressing the im16 pediments identified under paragraph (3); and 

17 (5) containing recommendations regarding how 

18 to improve the review of, and regulatory pathway 

19 for, such products. 

20 (d) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 

21 For purposes of this section, the term ‘‘qualified infectious 

22 disease product’’ has the meaning given such term in sec23 tion 505E(g) of the Federal Food, Drug, and Cosmetic 

24 Act, as added by section 801. 


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1 SEC. 806. REGULATORY CERTAINTY AND PREDICTABILITY. 

2 (a) INITIAL STRATEGY AND IMPLEMENTATION

3 PLAN.—Not later than 1 year after the date of enactment 

4 of this Act, the Secretary of Health and Human Services 

5 (referred to in this section as the ‘‘Secretary’’) shall sub6 mit to Congress a strategy and implementation plan with 

7 respect to the requirements of this Act. The strategy and 

8 implementation plan shall include— 

9 (1) a description of the regulatory challenges to 

10 clinical development, approval, and licensure of 

11 qualified infectious disease products; 

12 (2) the regulatory and scientific priorities of the 

13 Secretary with respect to such challenges; and 

14 (3) the steps the Secretary will take to ensure 

15 regulatory certainty and predictability with respect 

16 to qualified infectious disease products, including 

17 steps the Secretary will take to ensure managers and 

18 reviewers are familiar with related regulatory path19 ways, requirements of the Food and Drug Adminis20 tration, guidance documents related to such prod21 ucts, and applying such requirements consistently. 

22 (b) SUBSEQUENT REPORT.—Not later than 3 years 

23 after the date of enactment of this Act, the Secretary shall 

24 submit to Congress a report on— 

25 (1) the progress made toward the priorities 

26 identified under subsection (a)(2); 


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1 (2) the number of qualified infectious disease 

2 products that have been submitted for approval or li3 censure on or after the date of enactment of this 

4 Act; 

5 (3) a list of qualified infectious disease products 

6 with information on the types of exclusivity granted 

7 for each product, consistent with the information 

8 published under section 505(j)(7)(A)(iii) of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

10 355(j)(7)(A)(iii)); 

11 (4) the number of such qualified infectious dis12 ease products and that have been approved or li13 censed on or after the date of enactment of this Act; 

14 and 

15 (5) the number of calendar days it took for the 

16 approval or licensure of the qualified infectious dis17 ease products approved or licensed on or after the 

18 date of enactment of this Act. 

19 (c) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 

20 For purposes of this section, the term ‘‘qualified infectious 

21 disease product’’ has the meaning given such term in sec22 tion 505E(g) of the Federal Food, Drug, and Cosmetic 

23 Act, as added by section 801. 


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1 TITLE IX—DRUG APPROVAL AND 

2 PATIENT ACCESS 

3 SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT AC4 CESS TO NEW MEDICAL TREATMENTS. 

5 (a) FINDINGS; SENSE OF CONGRESS.— 

6 (1) FINDINGS.—Congress finds as follows: 

7 (A) The Food and Drug Administration 

8 (referred to in this section as the ‘‘FDA’’) 

9 serves a critical role in helping to assure that 

10 new medicines are safe and effective. Regu11 latory innovation is 1 element of the Nation’s 

12 strategy to address serious and life-threatening 

13 diseases or conditions by promoting investment 

14 in and development of innovative treatments for 

15 unmet medical needs. 

16 (B) During the 2 decades following the es17 tablishment of the accelerated approval mecha18 nism, advances in medical sciences, including 

19 genomics, molecular biology, and bioinformatics, 

20 have provided an unprecedented understanding 

21 of the underlying biological mechanism and 

22 pathogenesis of disease. A new generation of 

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1 gies based on biomarkers or pharmacogenomics, 

2 predictive toxicology, clinical trial enrichment 

3 techniques, and novel clinical trial designs, such 

4 as adaptive clinical trials. 

5 (C) As a result of these remarkable sci6 entific and medical advances, the FDA should 

7 be encouraged to implement more broadly effec8 tive processes for the expedited development 

9 and review of innovative new medicines in10 tended to address unmet medical needs for seri11 ous or life-threatening diseases or conditions, 

12 including those for rare diseases or conditions, 

13 using a broad range of surrogate or clinical 

14 endpoints and modern scientific tools earlier in 

15 the drug development cycle when appropriate. 

16 This may result in fewer, smaller, or shorter 

17 clinical trials for the intended patient popu18 lation or targeted subpopulation without com19 promising or altering the high standards of the 

20 FDA for the approval of drugs. 

21 (D) Patients benefit from expedited access 

22 to safe and effective innovative therapies to 

23 treat unmet medical needs for serious or life24 threatening diseases or conditions. 


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1 (E) For these reasons, the statutory au2 thority in effect on the day before the date of 

3 enactment of this Act governing expedited ap4 proval of drugs for serious or life-threatening 

5 diseases or conditions should be amended in 

6 order to enhance the authority of the FDA to 

7 consider appropriate scientific data, methods, 

8 and tools, and to expedite development and ac9 cess to novel treatments for patients with a 

10 broad range of serious or life-threatening dis11 eases or conditions. 

12 (2) SENSE OF CONGRESS.—It is the sense of 

13 Congress that the Food and Drug Administration 

14 should apply the accelerated approval and fast track 

15 provisions set forth in section 506 of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 356), as 

17 amended by this section, to help expedite the devel18 opment and availability to patients of treatments for 

19 serious or life-threatening diseases or conditions 

20 while maintaining safety and effectiveness standards 

21 for such treatments. 

22 (b) EXPEDITED APPROVAL OF DRUGS FOR SERIOUS

23 OR LIFE-THREATENING DISEASES OR CONDITIONS.—Sec24 tion 506 (21 U.S.C. 356) is amended to read as follows: 


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1 ‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 

2 OR LIFE-THREATENING DISEASES OR CONDI3 TIONS. 

4 ‘‘(a) DESIGNATION OF DRUG AS FAST TRACK PROD5 UCT.— 

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

7 request of the sponsor of a new drug, facilitate the 

8 development and expedite the review of such drug if 

9 it is intended, whether alone or in combination with 

10 one or more other drugs, for the treatment of a seri11 ous or life-threatening disease or condition, and it 

12 demonstrates the potential to address unmet medical 

13 needs for such a disease or condition. (In this sec14 tion, such a drug is referred to as a ‘fast track prod15 uct’.) 

16 ‘‘(2) REQUEST FOR DESIGNATION.—The spon17 sor of a new drug may request the Secretary to des18 ignate the drug as a fast track product. A request 

19 for the designation may be made concurrently with, 

20 or at any time after, submission of an application 

21 for the investigation of the drug under section 505(i) 

22 or section 351(a)(3) of the Public Health Service 

23 Act. 

24 ‘‘(3) DESIGNATION.—Within 60 calendar days 

25 after the receipt of a request under paragraph (2), 

26 the Secretary shall determine whether the drug that 


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1 is the subject of the request meets the criteria de2 scribed in paragraph (1). If the Secretary finds that 

3 the drug meets the criteria, the Secretary shall des4 ignate the drug as a fast track product and shall 

5 take such actions as are appropriate to expedite the 

6 development and review of the application for ap7 proval of such product. 

8 ‘‘(b) ACCELERATED APPROVAL OF A DRUG FOR A

9 SERIOUS OR LIFE-THREATENING DISEASE OR CONDI10 TION, INCLUDING A FAST TRACK PRODUCT.— 

11 ‘‘(1) IN GENERAL.— 

12 ‘‘(A) ACCELERATED APPROVAL.—The Sec13 retary may approve an application for approval 

14 of a product for a serious or life-threatening 

15 disease or condition, including a fast track 

16 product, under section 505(c) or section 351(a) 

17 of the Public Health Service Act upon a deter18 mination that the product has an effect on a 

19 surrogate endpoint that is reasonably likely to 

20 predict clinical benefit, or on a clinical endpoint 

21 that can be measured earlier than irreversible 

22 morbidity or mortality, that is reasonably likely 

23 to predict an effect on irreversible morbidity or 

24 mortality or other clinical benefit, taking into 

25 account the severity, rarity, or prevalence of the 


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1 condition and the availability or lack of alter2 native treatments. The approval described in 

3 the preceding sentence is referred to in this sec4 tion as ‘accelerated approval’. 

5 ‘‘(B) EVIDENCE.—The evidence to support 

6 that an endpoint is reasonably likely to predict 

7 clinical benefit under subparagraph (A) may in8 clude epidemiological, pathophysiological, thera9 peutic, pharmacologic, or other evidence devel10 oped using biomarkers, for example, or other 

11 scientific methods or tools. 

12 ‘‘(2) LIMITATION.—Approval of a product 

13 under this subsection may be subject to 1 or both 

14 of the following requirements: 

15 ‘‘(A) That the sponsor conduct appropriate 

16 post-approval studies to verify and describe the 

17 predicted effect on irreversible morbidity or 

18 mortality or other clinical benefit. 

19 ‘‘(B) That the sponsor submit copies of all 

20 promotional materials related to the product 

21 during the preapproval review period and, fol22 lowing approval and for such period thereafter 

23 as the Secretary determines to be appropriate, 

24 at least 30 days prior to dissemination of the 

25 materials. 


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1 ‘‘(3) EXPEDITED WITHDRAWAL OF AP2 PROVAL.—The Secretary may withdraw approval of 

3 a product approved under accelerated approval using 

4 expedited procedures (as prescribed by the Secretary 

5 in regulations which shall include an opportunity for 

6 an informal hearing) if— 

7 ‘‘(A) the sponsor fails to conduct any re8 quired post-approval study of the drug with due 

9 diligence; 

10 ‘‘(B) a study required to verify and de11 scribe the predicted effect on irreversible mor12 bidity or mortality or other clinical benefit of 

13 the product fails to verify and describe such ef14 fect or benefit; 

15 ‘‘(C) other evidence demonstrates that the 

16 product is not safe or effective under the condi17 tions of use; or 

18 ‘‘(D) the sponsor disseminates false or 

19 misleading promotional materials with respect 

20 to the product. 

21 ‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR

22 APPROVAL OF A FAST TRACK PRODUCT.— 

23 ‘‘(1) IN GENERAL.—If the Secretary deter24 mines, after preliminary evaluation of clinical data 

25 submitted by the sponsor, that a fast track product 


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1 may be effective, the Secretary shall evaluate for fil2 ing, and may commence review of portions of, an ap3 plication for the approval of the product before the 

4 sponsor submits a complete application. The Sec5 retary shall commence such review only if the appli6 cant— 

7 ‘‘(A) provides a schedule for submission of 

8 information necessary to make the application 

9 complete; and 

10 ‘‘(B) pays any fee that may be required 

11 under section 736. 

12 ‘‘(2) EXCEPTION.—Any time period for review 

13 of human drug applications that has been agreed to 

14 by the Secretary and that has been set forth in goals 

15 identified in letters of the Secretary (relating to the 

16 use of fees collected under section 736 to expedite 

17 the drug development process and the review of 

18 human drug applications) shall not apply to an ap19 plication submitted under paragraph (1) until the 

20 date on which the application is complete. 

21 ‘‘(d) AWARENESS EFFORTS.—The Secretary shall— 

22 ‘‘(1) develop and disseminate to physicians, pa23 tient organizations, pharmaceutical and bio24 technology companies, and other appropriate persons 

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1 cable to accelerated approval and fast track prod2 ucts; and 

3 ‘‘(2) establish a program to encourage the de4 velopment of surrogate and clinical endpoints, in5 cluding biomarkers, and other scientific methods and 

6 tools that can assist the Secretary in determining 

7 whether the evidence submitted in an application is 

8 reasonably likely to predict clinical benefit for seri9 ous or life-threatening conditions for which signifi10 cant unmet medical needs exist. 

11 ‘‘(e) CONSTRUCTION.— 

12 ‘‘(1) PURPOSE.—The amendments made by the 

13 Food and Drug Administration Safety and Innova14 tion Act to this section are intended to encourage 

15 the Secretary to utilize innovative and flexible ap16 proaches to the assessment of products under accel17 erated approval for treatments for patients with seri18 ous or life-threatening diseases or conditions and 

19 unmet medical needs. 

20 ‘‘(2) CONSTRUCTION.—Nothing in this section 

21 shall be construed to alter the standards of evidence 

22 under subsection (c) or (d) of section 505 (including 

23 the substantial evidence standard in section 505(d)) 

24 of this Act or under section 351(a) of the Public 

25 Health Service Act. Such sections and standards of 


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1 evidence apply to the review and approval of prod2 ucts under this section, including whether a product 

3 is safe and effective. Nothing in this section alters 

4 the ability of the Secretary to rely on evidence that 

5 does not come from adequate and well-controlled in6 vestigations for the purpose of determining whether 

7 an endpoint is reasonably likely to predict clinical 

8 benefit as described in subsection (b)(1)(B).’’. 

9 (c) GUIDANCE; AMENDED REGULATIONS.— 

10 (1) DRAFT GUIDANCE.—Not later than 1 year 

11 after the date of enactment of this Act, the Sec12 retary of Health and Human Services (referred to in 

13 this section as the ‘‘Secretary’’) shall issue draft 

14 guidance to implement the amendments made by 

15 this section. In developing such guidance, the Sec16 retary shall specifically consider issues arising under 

17 the accelerated approval and fast track processes 

18 under section 506 of the Federal Food, Drug, and 

19 Cosmetic Act, as amended by subsection (b), for 

20 drugs designated for a rare disease or condition 

21 under section 526 of such Act (21 U.S.C. 360bb) 

22 and shall also consider any unique issues associated 

23 with very rare diseases. 

24 (2) FINAL GUIDANCE.—Not later than 1 year 

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1 graph (1), and after an opportunity for public com2 ment, the Secretary shall issue final guidance. 

3 (3) CONFORMING CHANGES.—The Secretary 

4 shall issue, as necessary, conforming amendments to 

5 the applicable regulations under title 21, Code of 

6 Federal Regulations, governing accelerated approval. 

7 (4) NO EFFECT OF INACTION ON REQUESTS.— 

8 If the Secretary fails to issue final guidance or 

9 amended regulations as required by this subsection, 

10 such failure shall not preclude the review of, or ac11 tion on, a request for designation or an application 

12 for approval submitted pursuant to section 506 of 

13 the Federal Food, Drug, and Cosmetic Act, as 

14 amended by subsection (b). 

15 (d) INDEPENDENT REVIEW.—The Secretary may, in 

16 conjunction with other planned reviews, contract with an 

17 independent entity with expertise in assessing the quality 

18 and efficiency of biopharmaceutical development and regu19 latory review programs to evaluate the Food and Drug Ad20 ministration’s application of the processes described in 

21 section 506 of the Federal Food, Drug, and Cosmetic Act, 

22 as amended by subsection (b), and the impact of such 

23 processes on the development and timely availability of in24 novative treatments for patients suffering from serious or 

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1 clude consultation with regulated industries, patient advo2 cacy and disease research foundations, and relevant aca3 demic medical centers. 

4 SEC. 902. BREAKTHROUGH THERAPIES. 

5 (a) IN GENERAL.—Section 506 (21 U.S.C. 356), as 

6 amended by section 901, is further amended— 

7 (1) by redesignating subsections (a) through (c) 

8 as subsections (b) through (d), respectively; 

9 (2) by redesignating subsection (d) as sub10 section (f); 

11 (3) by inserting before subsection (b), as so re12 designated, the following: 

13 ‘‘(a) DESIGNATION OF A DRUG AS A BREAKTHROUGH

14 THERAPY.— 

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

16 request of the sponsor of a drug, expedite the devel17 opment and review of such drug if the drug is in18 tended, alone or in combination with 1 or more other 

19 drugs, to treat a serious or life-threatening disease 

20 or condition and preliminary clinical evidence indi21 cates that the drug may demonstrate substantial im22 provement over existing therapies on 1 or more clini23 cally significant endpoints, such as substantial treat24 ment effects observed early in clinical development. 


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1 (In this section, such a drug is referred to as a 

2 ‘breakthrough therapy’.) 

3 ‘‘(2) REQUEST FOR DESIGNATION.—The spon4 sor of a drug may request the Secretary to designate 

5 the drug as a breakthrough therapy. A request for 

6 the designation may be made concurrently with, or 

7 at any time after, the submission of an application 

8 for the investigation of the drug under section 505(i) 

9 or section 351(a)(3) of the Public Health Service 

10 Act. 

11 ‘‘(3) DESIGNATION.— 

12 ‘‘(A) IN GENERAL.—Not later than 60 cal13 endar days after the receipt of a request under 

14 paragraph (2), the Secretary shall determine 

15 whether the drug that is the subject of the re16 quest meets the criteria described in paragraph 

17 (1). If the Secretary finds that the drug meets 

18 the criteria, the Secretary shall designate the 

19 drug as a breakthrough therapy and shall take 

20 such actions as are appropriate to expedite the 

21 development and review of the application for 

22 approval of such drug. 

23 ‘‘(B) ACTIONS.—The actions to expedite 

24 the development and review of an application 


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1 under subparagraph (A) may include, as appro2 priate— 

3 ‘‘(i) holding meetings with the sponsor 

4 and the review team throughout the devel5 opment of the drug; 

6 ‘‘(ii) providing timely advice to, and 

7 interactive communication with, the spon8 sor regarding the development of the drug 

9 to ensure that the development program to 

10 gather the non-clinical and clinical data 

11 necessary for approval is as efficient as 

12 practicable; 

13 ‘‘(iii) involving senior managers and 

14 experienced review staff, as appropriate, in 

15 a collaborative, cross-disciplinary review; 

16 ‘‘(iv) assigning a cross-disciplinary 

17 project lead for the Food and Drug Ad18 ministration review team to facilitate an 

19 efficient review of the development pro20 gram and to serve as a scientific liaison be21 tween the review team and the sponsor; 

22 and 

23 ‘‘(v) taking steps to ensure that the 

24 design of the clinical trials is as efficient as 

25 practicable, when scientifically appropriate, 


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1 such as by minimizing the number of pa2 tients exposed to a potentially less effica3 cious treatment.’’; 

4 (4) in subsection (f)(1), as so redesignated, by 

5 striking ‘‘applicable to accelerated approval’’ and in6 serting ‘‘applicable to breakthrough therapies, accel7 erated approval, and’’; and 

8 (5) by adding at the end the following: 

9 ‘‘(g) REPORT.—Beginning in fiscal year 2013, the 

10 Secretary shall annually prepare and submit to the Com11 mittee on Health, Education, Labor, and Pensions of the 

12 Senate and the Committee on Energy and Commerce of 

13 the House of Representatives, and make publicly available, 

14 with respect to this section for the previous fiscal year— 

15 ‘‘(1) the number of drugs for which a sponsor 

16 requested designation as a breakthrough therapy; 

17 ‘‘(2) the number of products designated as a 

18 breakthrough therapy; and 

19 ‘‘(3) for each product designated as a break20 through therapy, a summary of the actions taken 

21 under subsection (a)(3).’’. 

22 (b) GUIDANCE; AMENDED REGULATIONS.— 

23 (1) IN GENERAL.— 

24 (A) GUIDANCE.—Not later than 18 

25 months after the date of enactment of this Act, 


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1 the Secretary of Health and Human Services 

2 (referred to in this section as the ‘‘Secretary’’) 

3 shall issue draft guidance on implementing the 

4 requirements with respect to breakthrough 

5 therapies, as set forth in section 506(a) of the 

6 Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 356(a)), as amended by this section. 

8 The Secretary shall issue final guidance not 

9 later than 1 year after the close of the comment 

10 period for the draft guidance. 

11 (B) AMENDED REGULATIONS.— 

12 (i) IN GENERAL.—If the Secretary de13 termines that it is necessary to amend the 

14 regulations under title 21, Code of Federal 

15 Regulations in order to implement the 

16 amendments made by this section to sec17 tion 506(a) of the Federal Food, Drug, 

18 and Cosmetic Act, the Secretary shall 

19 amend such regulations not later than 2 

20 years after the date of enactment of this 

21 Act. 

22 (ii) PROCEDURE.—In amending regu23 lations under clause (i), the Secretary 

24 shall— 


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1 (I) issue a notice of proposed 

2 rulemaking that includes the proposed 

3 regulation; 

4 (II) provide a period of not less 

5 than 60 days for comments on the 

6 proposed regulation; and 

7 (III) publish the final regulation 

8 not less than 30 days before the effec9 tive date of the regulation. 

10 (iii) RESTRICTIONS.—Notwithstanding 

11 any other provision of law, the Secretary 

12 shall promulgate regulations implementing 

13 the amendments made by section only as 

14 described in clause (ii). 

15 (2) REQUIREMENTS.—Guidance issued under 

16 this section shall— 

17 (A) specify the process and criteria by 

18 which the Secretary makes a designation under 

19 section 506(a)(3) of the Federal Food, Drug, 

20 and Cosmetic Act; and 

21 (B) specify the actions the Secretary shall 

22 take to expedite the development and review of 

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1 ing updating good review management practices 

2 to reflect breakthrough therapies. 

3 (c) INDEPENDENT REVIEW.—Not later than 3 years 

4 after the date of enactment of this Act, the Comptroller 

5 General of the United States, in consultation with appro6 priate experts, shall assess the manner by which the Food 

7 and Drug Administration has applied the processes de8 scribed in section 506(a) of the Federal Food, Drug, and 

9 Cosmetic Act, as amended by this section, and the impact 

10 of such processes on the development and timely avail11 ability of innovative treatments for patients affected by se12 rious or life-threatening conditions. Such assessment shall 

13 be made publicly available upon completion. 

14 (d) CONFORMING AMENDMENTS.—Section 506B(e) 

15 (21 U.S.C. 356b) is amended by striking ‘‘section 

16 506(b)(2)(A)’’ each place such term appears and inserting 

17 ‘‘section 506(c)(2)(A)’’. 

18 SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON 

19 RARE DISEASES, TARGETED THERAPIES, AND 

20 GENETIC TARGETING OF TREATMENTS. 

21 Subchapter E of chapter V (21 U.S.C. 360bbb et 

22 seq.), as amended by section 712, is further amended by 

23 adding at the end the following: 


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1 ‘‘SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON 

2 RARE DISEASES, TARGETED THERAPIES, AND 

3 GENETIC TARGETING OF TREATMENTS. 

4 ‘‘(a) IN GENERAL.—For the purpose of promoting 

5 the efficiency of and informing the review by the Food 

6 and Drug Administration of new drugs and biological 

7 products for rare diseases and drugs and biological prod8 ucts that are genetically targeted, the following shall 

9 apply: 

10 ‘‘(1) CONSULTATION WITH STAKEHOLDERS.— 

11 Consistent with sections X.C and IX.E.4 of the 

12 PDUFA Reauthorization Performance Goals and 

13 Procedures Fiscal Years 2013 through 2017, as ref14 erenced in the letters described in section 101(b) of 

15 the Prescription Drug User Fee Amendments of 

16 2012, the Secretary shall ensure that opportunities 

17 exist, at a time the Secretary determines appro18 priate, for consultations with stakeholders on the 

19 topics described in subsection (c). 

20 ‘‘(2) CONSULTATION WITH EXTERNAL EX21 PERTS.—The Secretary shall develop and maintain a 

22 list of external experts who, because of their special 

23 expertise, are qualified to provide advice on rare dis24 ease issues, including topics described in subsection 

25 (c). The Secretary may, when appropriate to address 

26 a specific regulatory question, consult such external 


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1 experts on issues related to the review of new drugs 

2 and biological products for rare diseases and drugs 

3 and biological products that are genetically targeted, 

4 including the topics described in subsection (c), 

5 when such consultation is necessary because the Sec6 retary lacks specific scientific, medical, or technical 

7 expertise necessary for the performance of its regu8 latory responsibilities and the necessary expertise 

9 can be provided by the external experts. 

10 ‘‘(b) EXTERNAL EXPERTS.—For purposes of sub11 section (a)(2), external experts are those who possess sci12 entific or medical training that the Secretary lacks with 

13 respect to one or more rare diseases. 

14 ‘‘(c) TOPICS FOR CONSULTATION.—Topics for con15 sultation pursuant to this section may include— 

16 ‘‘(1) rare diseases; 

17 ‘‘(2) the severity of rare diseases; 

18 ‘‘(3) the unmet medical need associated with 

19 rare diseases; 

20 ‘‘(4) the willingness and ability of individuals 

21 with a rare disease to participate in clinical trials; 

22 ‘‘(5) an assessment of the benefits and risks of 

23 therapies to treat rare diseases; 

24 ‘‘(6) the general design of clinical trials for rare 

25 disease populations and subpopulations; and 


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1 ‘‘(7) demographics and the clinical description 

2 of patient populations. 

3 ‘‘(d) CLASSIFICATION AS SPECIAL GOVERNMENT EM4 PLOYEES.—The external experts who are consulted under 

5 this section may be considered special government employ6 ees, as defined under section 202 of title 18, United States 

7 Code. 

8 ‘‘(e) PROTECTION OF PROPRIETARY INFORMA9 TION.—Nothing in this section shall be construed to alter 

10 the protections offered by laws, regulations, and policies 

11 governing disclosure of confidential commercial or trade 

12 secret information, and any other information exempt 

13 from disclosure pursuant to section 552(b) of title 5, 

14 United States Code, as such provisions would be applied 

15 to consultation with individuals and organizations prior to 

16 the date of enactment of this section. 

17 ‘‘(f) OTHER CONSULTATION.—Nothing in this sec18 tion shall be construed to limit the ability of the Secretary 

19 to consult with individuals and organizations as authorized 

20 prior to the date of enactment of this section. 

21 ‘‘(g) NO RIGHT OR OBLIGATION.—Nothing in this 

22 section shall be construed to create a legal right for a con23 sultation on any matter or require the Secretary to meet 

24 with any particular expert or stakeholder. Nothing in this 

25 section shall be construed to alter agreed upon goals and 


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1 procedures identified in the letters described in section 

2 101(b) of the Prescription Drug User Fee Amendments 

3 of 2012. Nothing in this section is intended to increase 

4 the number of review cycles as in effect before the date 

5 of enactment of this section.’’. 

6 SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIP7 TION DRUG CONTAINER LABELS BY VIS8 UALLY-IMPAIRED AND BLIND CONSUMERS. 

9 (a) ESTABLISHMENT OF WORKING GROUP.— 

10 (1) IN GENERAL.—The Architectural and 

11 Transportation Barriers Compliance Board (referred 

12 to in this section as the ‘‘Access Board’’) shall con13 vene a stakeholder working group (referred to in this 

14 section as the ‘‘working group’’) to develop best 

15 practices on access to information on prescription 

16 drug container labels for individuals who are blind 

17 or visually impaired. 

18 (2) MEMBERS.—The working group shall be 

19 comprised of representatives of national organiza20 tions representing blind and visually-impaired indi21 viduals, national organizations representing the el22 derly, and industry groups representing stake23 holders, including retail, mail order, and independent 

24 community pharmacies, who would be impacted by 

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1 ing group shall be divided equally between consumer 

2 and industry advocates. 

3 (3) BEST PRACTICES.— 

4 (A) IN GENERAL.—The working group 

5 shall develop, not later than 1 year after the 

6 date of the enactment of this Act, best practices 

7 for pharmacies to ensure that blind and vis8 ually-impaired individuals have safe, consistent, 

9 reliable, and independent access to the informa10 tion on prescription drug container labels. 

11 (B) PUBLIC AVAILABILITY.—The best 

12 practices developed under subparagraph (A) 

13 may be made publicly available, including 

14 through the Internet Web sites of the working 

15 group participant organizations, and through 

16 other means, in a manner that provides access 

17 to interested individuals, including individuals 

18 with disabilities. 

19 (C) LIMITATIONS.—The best practices de20 veloped under subparagraph (A) shall not be 

21 construed as accessibility guidelines or stand22 ards of the Access Board, and shall not confer 

23 any rights or impose any obligations on working 

24 group participants or other persons. Nothing in 

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1 tion any right, obligation, or remedy available 

2 under the Americans with Disabilities Act of 

3 1990 (42 U.S.C. 12101 et seq.) or any other 

4 Federal or State law requiring effective commu5 nication, barrier removal, or nondiscrimination 

6 on the basis of disability. 

7 (4) CONSIDERATIONS.—In developing and 

8 issuing the best practices under paragraph (3)(A), 

9 the working group shall consider— 

10 (A) the use of— 

11 (i) Braille; 

12 (ii) auditory means, such as— 

13 (I) ‘‘talking bottles’’ that provide 

14 audible container label information; 

15 (II) digital voice recorders at16 tached to the prescription drug con17 tainer; and 

18 (III) radio frequency identifica19 tion tags; 

20 (iii) enhanced visual means, such as— 

21 (I) large font labels or large font 

22 ‘‘duplicate’’ labels that are affixed or 

23 matched to a prescription drug con24 tainer; 

25 (II) high-contrast printing; and 


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1 (III) sans-serf font; and 

2 (iv) other relevant alternatives as de3 termined by the working group; 

4 (B) whether there are technical, financial, 

5 manpower, or other factors unique to phar6 macies with 20 or fewer retail locations which 

7 may pose significant challenges to the adoption 

8 of the best practices; and 

9 (C) such other factors as the working 

10 group determines to be appropriate. 

11 (5) INFORMATION CAMPAIGN.—Upon comple12 tion of development of the best practices under sub13 section (a)(3), the National Council on Disability, in 

14 consultation with the working group, shall conduct 

15 an informational and educational campaign designed 

16 to inform individuals with disabilities, pharmacists, 

17 and the public about such best practices. 

18 (6) FACA WAIVER.—The Federal Advisory 

19 Committee Act (5 U.S.C. App.) shall not apply to 

20 the working group. 

21 (b) GAO STUDY.— 

22 (1) IN GENERAL.—Beginning 18 months after 

23 the completion of the development of best practices 

24 under subsection (a)(3)(A), the Comptroller General 

25 of the United States shall conduct a review of the 


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1 extent to which pharmacies are utilizing such best 

2 practices, and the extent to which barriers to acces3 sible information on prescription drug container la4 bels for blind and visually-impaired individuals con5 tinue. 

6 (2) REPORT.—Not later than September 30, 

7 2016, the Comptroller General of the United States 

8 shall submit to Congress a report on the review con9 ducted under paragraph (1). Such report shall in10 clude recommendations about how best to reduce the 

11 barriers experienced by blind and visually-impaired 

12 individuals to independently accessing information 

13 on prescription drug container labels. 

14 (c) DEFINITIONS.—In this section— 

15 (1) the term ‘‘pharmacy’’ includes a pharmacy 

16 that receives prescriptions and dispenses prescription 

17 drugs through an Internet Web site or by mail; 

18 (2) the term ‘‘prescription drug’’ means a drug 

19 subject to section 503(b)(1) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)); and 

21 (3) the term ‘‘prescription drug container label’’ 

22 means the label with the directions for use that is 

23 affixed to the prescription drug container by the 

24 pharmacist and dispensed to the consumer. 


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1 SEC. 905. RISK-BENEFIT FRAMEWORK. 

2 Section 505(d) (21 U.S.C. 355(d)) is amended by 

3 adding at the end the following: ‘‘The Secretary shall im4 plement a structured risk-benefit assessment framework 

5 in the new drug approval process to facilitate the balanced 

6 consideration of benefits and risks, a consistent and sys7 tematic approach to the discussion and regulatory deci8 sionmaking, and the communication of the benefits and 

9 risks of new drugs. Nothing in the preceding sentence 

10 shall alter the criteria for evaluating an application for 

11 premarket approval of a drug.’’. 

12 SEC. 906. INDEPENDENT STUDY ON MEDICAL INNOVATION 

13 INDUCEMENT MODEL. 

14 (a) IN GENERAL.—The Secretary of Health and 

15 Human Services shall enter into an agreement with the 

16 National Academies to provide expert consultation and 

17 conduct a study that evaluates the feasibility and possible 

18 consequences of the use of innovation inducement prizes 

19 to reward successful medical innovations. Under the 

20 agreement, the National Academies shall submit to the 

21 Secretary a report on such study not later than 15 months 

22 after the date of enactment of this Act. 

23 (b) REQUIREMENTS.— 

24 (1) IN GENERAL.—The study conducted under 

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1 didate targets for the new incentive system and con2 sider different medical innovation inducement prize 

3 design issues, including the challenges presented in 

4 the implementation of prizes for end products, open 

5 source dividend prizes, and prizes for upstream re6 search. 

7 (2) MARKET SEGMENTS.—The segments on the 

8 medical technologies market that shall be considered 

9 under paragraph (1) include— 

10 (A) all pharmaceutical and biologic drugs 

11 and vaccines; 

12 (B) drugs and vaccines used solely for the 

13 treatment of HIV/AIDS; and 

14 (C) antibiotics. 

15 (c) ELEMENTS.—The study conducted under sub16 section (a) shall include consideration of each of the fol17 lowing: 

18 (1) Whether a system of large innovation in19 ducement prizes could work as a replacement for the 

20 existing product monopoly/patent-based system, as 

21 in effect on the date of enactment of this Act. 

22 (2) How large the innovation prize funds would 

23 have to be in order to induce at least as much re24 search and development investment in innovation as 

25 is induced under the current system of time-limited 


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1 market exclusivity, as in effect on the date of enact2 ment of this Act. 

3 (3) Whether a system of large innovation in4 ducement prizes would be more or less expensive 

5 than the current system of time-limited market ex6 clusivity, as in effect on the date of enactment of 

7 this Act, calculated over different time periods. 

8 (4) Whether a system of large innovation in9 ducement prizes would expand access to new prod10 ucts and improve health outcomes. 

11 (5) The type of information and decisionmaking 

12 skills that would be necessary to manage end prod13 uct prizes. 

14 (6) Whether there would there be major advan15 tages in rewarding the incremental impact of innova16 tions, as benchmarked against existing products. 

17 (7) How open-source dividend prizes could be 

18 managed, and whether such prizes would increase 

19 access to knowledge, materials, data and tech20 nologies. 

21 (8) Whether a system of competitive inter22 mediaries for interim research prizes would provide 

23 an acceptable solution to the valuation challenges for 

24 interim prizes. 


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1 SEC. 907. ORPHAN PRODUCT GRANTS PROGRAM. 

2 (a) REAUTHORIZATION OF PROGRAM.—Section 5(c) 

3 of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended 

4 by striking ‘‘2008 through 2012’’ and inserting ‘‘2013 

5 through 2017’’. 

6 (b) HUMAN CLINICAL TESTING.—Section 

7 5(b)(1)(A)(ii)) of the Orphan Drug Act (21 U.S.C. 

8 360ee(b)(1)(A)(ii)) is amended by striking ‘‘after the date 

9 such drug is designated under section 526 of such Act 

10 and’’. 

11 TITLE X—DRUG SHORTAGES 

12 SEC. 1001. DRUG SHORTAGES. 

13 (a) IN GENERAL.—Section 506C (21 U.S.C. 356c) 

14 is amended to read as follows: 

15 ‘‘SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE 

16 PRODUCTION OF LIFE-SAVING DRUGS. 

17 ‘‘(a) IN GENERAL.—A manufacturer of a drug— 

18 ‘‘(1) that is— 

19 ‘‘(A) life-supporting; 

20 ‘‘(B) life-sustaining; 

21 ‘‘(C) intended for use in the prevention of 

22 a debilitating disease or condition; 

23 ‘‘(D) a sterile injectable product; or 

24 ‘‘(E) used in emergency medical care or 

25 during surgery; and 


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1 ‘‘(2) that is not a radio pharmaceutical drug 

2 product, a human tissue replaced by a recombinant 

3 product, a product derived from human plasma pro4 tein, or any other product as designated by the Sec5 retary, 

6 shall notify the Secretary, in accordance with subsection 

7 (b), of a permanent discontinuance in the manufacture of 

8 the drug or an interruption of the manufacture of the drug 

9 that could lead to a meaningful disruption in the supply 

10 of that drug in the United States. 

11 ‘‘(b) TIMING.—A notice required under subsection (a) 

12 shall be submitted to the Secretary— 

13 ‘‘(1) at least 6 months prior to the date of the 

14 discontinuance or interruption; or 

15 ‘‘(2) if compliance with paragraph (1) is not 

16 possible, as soon as practicable. 

17 ‘‘(c) EXPEDITED INSPECTIONS AND REVIEWS.—If, 

18 based on notifications described in subsection (a) or any 

19 other relevant information, the Secretary concludes that 

20 there is, or is likely to be, a drug shortage of a drug de21 scribed in subsection (a), the Secretary may— 

22 ‘‘(1) expedite the review of a supplement to a 

23 new drug application submitted under section 

24 505(b), an abbreviated new drug application sub25 mitted under section 505(j), or a supplement to such 


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1 an application submitted under section 505(j) that 

2 could help mitigate or prevent such shortage; or 

3 ‘‘(2) expedite an inspection or reinspection of 

4 an establishment that could help mitigate or prevent 

5 such drug shortage. 

6 ‘‘(d) COORDINATION.— 

7 ‘‘(1) TASK FORCE AND STRATEGIC PLAN.— 

8 ‘‘(A) IN GENERAL.— 

9 ‘‘(i) TASK FORCE.—As soon as prac10 ticable after the date of enactment of the 

11 Food and Drug Administration Safety and 

12 Innovation Act, the Secretary shall estab13 lish a Task Force to develop and imple14 ment a strategic plan for enhancing the 

15 Secretary’s response to preventing and 

16 mitigating drug shortages. 

17 ‘‘(ii) STRATEGIC PLAN.—The strategic 

18 plan described in clause (i) shall include— 

19 ‘‘(I) plans for enhanced inter20 agency and intraagency coordination, 

21 communication, and decisionmaking; 

22 ‘‘(II) plans for ensuring that 

23 drug shortages are considered when 

24 the Secretary initiates a regulatory 

25 action that could precipitate a drug 


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1 shortage or exacerbate an existing 

2 drug shortage; 

3 ‘‘(III) plans for effective commu4 nication with outside stakeholders, in5 cluding who the Secretary should alert 

6 about potential or actual drug short7 ages, how the communication should 

8 occur, and what types of information 

9 should be shared; and 

10 ‘‘(IV) plans for considering the 

11 impact of drug shortages on research 

12 and clinical trials. 

13 ‘‘(iii) CONSULTATION.—In carrying 

14 out this subparagraph, the Task Force 

15 shall ensure consultation with the appro16 priate offices within the Food and Drug 

17 Administration, including the Office of the 

18 Commissioner, the Center for Drug Eval19 uation and Research, the Office of Regu20 latory Affairs, and employees within the 

21 Department of Health and Human Serv22 ices with expertise regarding drug short23 ages. The Secretary shall engage external 

24 stakeholders and experts as appropriate. 


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1 ‘‘(B) TIMING.—Not later than 1 year after 

2 the date of enactment Food and Drug Adminis3 tration Safety and Innovation Act, the Task 

4 Force shall— 

5 ‘‘(i) publish the strategic plan de6 scribed in subparagraph (A); and 

7 ‘‘(ii) submit such plan to Congress. 

8 ‘‘(2) COMMUNICATION.—The Secretary shall 

9 ensure that, prior to any enforcement action or 

10 issuance of a warning letter that the Secretary de11 termines could reasonably be anticipated to lead to 

12 a meaningful disruption in the supply in the United 

13 States of a drug described under subsection (a), 

14 there is communication with the appropriate office 

15 of the Food and Drug Administration with expertise 

16 regarding drug shortages regarding whether the ac17 tion or letter could cause, or exacerbate, a shortage 

18 of the drug. 

19 ‘‘(3) ACTION.—If the Secretary determines, 

20 after the communication described in paragraph (2), 

21 that an enforcement action or a warning letter could 

22 reasonably cause or exacerbate a shortage of a drug 

23 described under subsection (a), then the Secretary 

24 shall evaluate the risks associated with the impact of 

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1 ated with the violation involved before taking such 

2 action or issuing such letter, unless there is immi3 nent risk of serious adverse health consequences or 

4 death to humans. 

5 ‘‘(4) REPORTING BY OTHER ENTITIES.—The 

6 Secretary shall identify or establish a mechanism by 

7 which healthcare providers and other third-party or8 ganizations may report to the Secretary evidence of 

9 a drug shortage. 

10 ‘‘(5) REVIEW AND CONSTRUCTION.—No deter11 mination, finding, action, or omission of the Sec12 retary under this subsection shall— 

13 ‘‘(A) be subject to judicial review; or 

14 ‘‘(B) be construed to establish a defense to 

15 an enforcement action by the Secretary. 

16 ‘‘(e) RECORDKEEPING AND REPORTING.— 

17 ‘‘(1) RECORDKEEPING.—The Secretary shall 

18 maintain records related to drug shortages, includ19 ing with respect to each of the following: 

20 ‘‘(A) The number of manufacturers that 

21 submitted a notification to the Secretary under 

22 subsection (a) in each calendar year. 

23 ‘‘(B) The number of drug shortages that 

24 occurred in each calendar year and a list of 


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1 drug names, drug types, and classes that were 

2 the subject of such shortages. 

3 ‘‘(C) A list of the known factors contrib4 uting to the drug shortages described in sub5 paragraph (B). 

6 ‘‘(D)(i) A list of major actions taken by 

7 the Secretary to prevent or mitigate the drug 

8 shortages described in subparagraph (B). 

9 ‘‘(ii) The Secretary shall include in the list 

10 under clause (i) the following: 

11 ‘‘(I) The number of applications for 

12 which the Secretary expedited review under 

13 subsection (c)(1) in each calendar year. 

14 ‘‘(II) The number of establishment in15 spections or reinspections that the Sec16 retary expedited under subsection (c)(2) in 

17 each calendar year. 

18 ‘‘(E) The number of notifications sub19 mitted to the Secretary under subsection (a) in 

20 each calendar year. 

21 ‘‘(F) The names of manufacturers that the 

22 Secretary has learned did not comply with the 

23 notification requirement under subsection (a) in 

24 each calendar year. 


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1 ‘‘(G) The number of times in each cal2 endar year that the Secretary determined under 

3 subsection (d)(3) that an enforcement action or 

4 a warning letter could reasonably cause or exac5 erbate a shortage of a drug described under 

6 subsection (a), but did not evaluate the risks 

7 associated with the impact of such shortage 

8 upon patients and those risks associated with 

9 the violation involved before taking such action 

10 or issuing such letter on the grounds that there 

11 was imminent risk of serious adverse health 

12 consequences or death to humans, and a sum13 mary of the determinations. 

14 ‘‘(H) A summary of the communications 

15 made and actions taken under subsection (d) in 

16 each calendar year. 

17 ‘‘(I) Any other information the Secretary 

18 deems appropriate to better prevent and miti19 gate drug shortages. 

20 ‘‘(2) TREND ANALYSIS.—The Secretary is au21 thorized to retain a third party to conduct a study, 

22 if the Secretary believes such a study would help 

23 clarify the causes, trends, or solutions related to 

24 drug shortages. 


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1 ‘‘(3) ANNUAL SUMMARY.—Not later than 18 

2 months after the date of enactment of the Food and 

3 Drug Administration Safety and Innovation Act, and 

4 annually thereafter, the Secretary shall submit to 

5 the Committee on Health, Education, Labor, and 

6 Pensions of the Senate and the Committee on En7 ergy and Commerce of the House of Representatives 

8 a report summarizing, with respect to the 1-year pe9 riod preceding such report, the information de10 scribed in paragraph (1). Such report shall not in11 clude any information that is exempt from disclosure 

12 under subsection (a) of section 552 of title 5, United 

13 States Code, by reason of subsection (b)(4) of such 

14 section. 

15 ‘‘(f) DEFINITIONS.—For purposes of this section— 

16 ‘‘(1) the term ‘drug’— 

17 ‘‘(A) means a drug (as defined in section 

18 201(g)) that is intended for human use; and 

19 ‘‘(B) does not include biological products 

20 (as defined in section 351 of the Public Health 

21 Service Act), unless otherwise provided by the 

22 Secretary in the regulations promulgated under 

23 subsection (h); 

24 ‘‘(2) the term ‘drug shortage’ or ‘shortage’, 

25 with respect to a drug, means a period of time when 


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1 the demand or projected demand for the drug within 

2 the United States exceeds the supply of the drug; 

3 and 

4 ‘‘(3) the term ‘meaningful disruption’— 

5 ‘‘(A) means a change in production that is 

6 reasonably likely to lead to a reduction in the 

7 supply of a drug by a manufacturer that is 

8 more than negligible and impacts the ability of 

9 the manufacturer to fill orders or meet expected 

10 demand for its product; and 

11 ‘‘(B) does not include interruptions in 

12 manufacturing due to matters such as routine 

13 maintenance or insignificant changes in manu14 facturing so long as the manufacturer expects 

15 to resume operations in a short period of time. 

16 ‘‘(g) DISTRIBUTION.—To the maximum extent prac17 ticable, the Secretary may distribute information on drug 

18 shortages and on the permanent discontinuation of the 

19 drugs described in this section to appropriate provider and 

20 patient organizations, except that any such distribution 

21 shall not include any information that is exempt from dis22 closure under section 552 of title 5, United States Code, 

23 by reason of subsection (b)(4) of such section. 

24 ‘‘(h) REGULATIONS.— 


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1 ‘‘(1) IN GENERAL.—Not later than 18 months 

2 after the date of enactment of the Food and Drug 

3 Administration Safety and Innovation Act, the Sec4 retary shall adopt a final regulation implementing 

5 this section. 

6 ‘‘(2) INCLUSION OF BIOLOGICAL PRODUCTS.— 

7 ‘‘(A) IN GENERAL.—The Secretary may by 

8 regulation apply this section to biological prod9 ucts (as defined in section 351 of the Public 

10 Health Service Act) if the Secretary determines 

11 such inclusion would benefit the public health. 

12 ‘‘(B) RULE FOR VACCINES.—If the Sec13 retary applies this section to vaccines pursuant 

14 to subparagraph (A), the Secretary shall— 

15 ‘‘(i) consider whether the notification 

16 requirement under subsection (a) may be 

17 satisfied by submitting a notification to the 

18 Centers for Disease Control and Preven19 tion under the vaccine shortage notification 

20 program of such Centers; and 

21 ‘‘(ii) explain the determination made 

22 by the Secretary under clause (i) in the 

23 regulation. 

24 ‘‘(3) PROCEDURE.—In promulgating a regula25 tion implementing this section, the Secretary shall— 


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1 ‘‘(A) issue a notice of proposed rulemaking 

2 that includes 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 regulation’s effective 

8 date. 

9 ‘‘(4) RESTRICTIONS.—Notwithstanding any 

10 other provision of Federal law, in implementing this 

11 section, the Secretary shall only promulgate regula12 tions as described in paragraph (3).’’. 

13 (b) EFFECT OF NOTIFICATION.—The submission of 

14 a notification to the Secretary of Health and Human Serv15 ices (referred to in this section as the ‘‘Secretary’’) for 

16 purposes of complying with the requirement in section 

17 506C(a) of the Federal Food, Drug, and Cosmetic Act (as 

18 amended by subsection (a)) shall not be construed— 

19 (1) as an admission that any product that is 

20 the subject of such notification violates any provision 

21 of the Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 301 et seq.); or 

23 (2) as evidence of an intention to promote or 

24 market the product for an indication or use for 


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1 which the product has not been approved by the Sec2 retary. 

3 (c) INTERNAL REVIEW.—Not later than 2 years after 

4 the date of enactment of this Act, the Secretary shall— 

5 (1) analyze and review the regulations promul6 gated under the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 301 et seq.), the guidances or poli8 cies issued under such Act related to drugs intended 

9 for human use, and the practices of the Food and 

10 Drug Administration regarding enforcing such Act 

11 related to manufacturing of such drugs, to identify 

12 any such regulations, guidances, policies, or prac13 tices that cause, exacerbate, prevent, or mitigate 

14 drug shortages (as defined in section 506C of the 

15 Federal Food, Drug, and Cosmetic Act (as amended 

16 by subsection (a)); and 

17 (2) determine how regulations, guidances, poli18 cies, or practices identified under paragraph (1) 

19 should be modified, streamlined, expanded, or dis20 continued in order to reduce or prevent such drug 

21 shortages, taking into consideration the effect of any 

22 changes on the public health. 

23 (d) STUDY ON MARKET FACTORS CONTRIBUTING TO

24 DRUG SHORTAGES AND STOCKPILING.— 


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1 (1) IN GENERAL.—Not later than 1 year after 

2 the date of enactment of this Act, the Comptroller 

3 General of the United States, in consultation with 

4 the Secretary, the Department of Health and 

5 Human Services Office of the Inspector General, the 

6 Attorney General, and Chairman of the Federal 

7 Trade Commission, shall publish a report reviewing 

8 any findings that drug shortages (as so defined) 

9 have led market participants to stockpile affected 

10 drugs or sell them at significantly increased prices, 

11 the impact of such activities on Federal revenue, and 

12 any economic factors that have exacerbated or cre13 ated a market for such actions. 

14 (2) CONTENT.—The report under paragraph 

15 (1) shall include— 

16 (A) an analysis of the incidence of any of 

17 the activities described in paragraph (1) and 

18 the effect of such activities on the public health; 

19 (B) an evaluation of whether in such cases 

20 there is a correlation between drugs in shortage 

21 and— 

22 (i) the number of manufacturers pro23 ducing such drugs; 

24 (ii) the pricing structure, including 

25 Federal reimbursements, for such drugs 


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1 before such drugs were in shortage, and to 

2 the extent possible, revenue received by 

3 each such manufacturer of such drugs; 

4 (iii) pricing structure and revenue, to 

5 the extent possible, for the same drugs 

6 when sold under the conditions described 

7 in paragraph (1); and 

8 (iv) the impact of contracting prac9 tices by market participants (including 

10 manufacturers, distributors, group pur11 chasing organizations, and providers) on 

12 competition, access to drugs, and pricing 

13 of drugs; 

14 (C) whether the activities described in 

15 paragraph (1) are consistent with applicable 

16 law; and 

17 (D) recommendations to Congress on what, 

18 if any, additional reporting or enforcement ac19 tions are necessary. 

20 (3) TRADE SECRET AND CONFIDENTIAL INFOR21 MATION.—Nothing in this subsection alters or 

22 amends section 1905 of title 18, United States Code, 

23 or section 552(b)(4) of title 5, United States Code. 

24 (e) GUIDANCE REGARDING REPACKAGING.—Not 

25 later than 1 year after the date of enactment of this Act, 


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1 the Secretary shall issue guidance that clarifies the policy 

2 of the Food and Drug Administration regarding hospital 

3 pharmacies repackaging and safely transferring repack4 aged drugs among hospitals within a common health sys5 tem during a drug shortage, as identified by the Secretary. 

6 TITLE XI—OTHER PROVISIONS 

7 Subtitle A—Reauthorizations 

8 SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO 

9 EXCLUSIVITY OF CERTAIN DRUGS CON10 TAINING SINGLE ENANTIOMERS. 

11 (a) IN GENERAL.—Section 505(u)(4) (21 U.S.C. 

12 355(u)(4)) is amended by striking ‘‘2012’’ and inserting 

13 ‘‘2017’’. 

14 (b) AMENDMENT.—Section 505(u)(1)(A)(ii)(II) (21 

15 U.S.C. 355(u)(1)(A)(ii)(II)) is amended by inserting 

16 ‘‘clinical’’ after ‘‘any’’. 

17 SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH 

18 PUBLIC-PRIVATE PARTNERSHIPS. 

19 Section 566(f) (21 U.S.C. 360bbb–5(f)) is amended 

20 by striking ‘‘2012’’ and inserting ‘‘2017’’. 

21 Subtitle B—Medical Gas Product 

22 Regulation 

23 SEC. 1111. REGULATION OF MEDICAL GAS PRODUCTS. 

24 (a) REGULATION.—Chapter V (21 U.S.C. 351 et 

25 seq.) is amended by adding at the end the following: 


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1 ‘‘Subchapter G—Medical Gas Products 

2 ‘‘SEC. 575. DEFINITIONS. 

3 ‘‘In this subchapter: 

4 ‘‘(1) The term ‘designated medical gas product’ 

5 means any of the following: 

6 ‘‘(A) Oxygen, that meets the standards set 

7 forth in an official compendium. 

8 ‘‘(B) Nitrogen, that meets the standards 

9 set forth in an official compendium. 

10 ‘‘(C) Nitrous oxide, that meets the stand11 ards set forth in an official compendium. 

12 ‘‘(D) Carbon dioxide, that meets the stand13 ards set forth in an official compendium. 

14 ‘‘(E) Helium, that meets the standards set 

15 forth in an official compendium. 

16 ‘‘(F) Carbon monoxide, that meets the 

17 standards set forth in an official compendium. 

18 ‘‘(G) Medical air, that meets the standards 

19 set forth in an official compendium. 

20 ‘‘(H) Any other medical gas product 

21 deemed appropriate by the Secretary, unless 

22 any period of exclusivity under section 

23 505(c)(3)(E)(ii) or 505(j)(5)(F)(ii), or the ex24 tension of any such period under section 505A, 


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1 applicable to such medical gas product has not 

2 expired. 

3 ‘‘(2) The term ‘medical gas product’ means a 

4 drug that— 

5 ‘‘(A) is manufactured or stored in a lique6 fied, nonliquefied, or cryogenic state; and 

7 ‘‘(B) is administered as a gas. 

8 ‘‘SEC. 576. REGULATION OF MEDICAL GAS PRODUCTS. 

9 ‘‘(a) CERTIFICATION OF DESIGNATED MEDICAL GAS

10 PRODUCTS.— 

11 ‘‘(1) SUBMISSION.— 

12 ‘‘(A) IN GENERAL.—Beginning on the date 

13 of enactment of this section, any person may 

14 file with the Secretary a request for a certifi15 cation of a designated medical gas product. 

16 ‘‘(B) CONTENT.—A request under sub17 paragraph (A) shall contain— 

18 ‘‘(i) a description of the medical gas 

19 product; 

20 ‘‘(ii) the name and address of the 

21 sponsor; 

22 ‘‘(iii) the name and address of the fa23 cility or facilities where the gas product is 

24 or will be manufactured; and 


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1 ‘‘(iv) any other information deemed 

2 appropriate by the Secretary to determine 

3 whether the medical gas product is a des4 ignated medical gas product. 

5 ‘‘(2) GRANT OF CERTIFICATION.—A certifi6 cation described under paragraph (1)(A) shall be de7 termined to have been granted unless, not later than 

8 60 days after the filing of a request under para9 graph (1), the Secretary finds that— 

10 ‘‘(A) the medical gas product subject to 

11 the certification is not a designated medical gas 

12 product; 

13 ‘‘(B) the request does not contain the in14 formation required under paragraph (1) or oth15 erwise lacks sufficient information to permit the 

16 Secretary to determine that the gas product is 

17 a designated medical gas product; or 

18 ‘‘(C) granting the request would be con19 trary to public health. 

20 ‘‘(3) EFFECT OF CERTIFICATION.— 

21 ‘‘(A) IN GENERAL.— 

22 ‘‘(i) APPROVED USES.—A designated 

23 medical gas product for which a certifi24 cation is granted under paragraph (2) is 

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1 other designated gas product or products 

2 as medically appropriate, to have in effect 

3 an approved application under section 505 

4 or 512, subject to all applicable post5 approval requirements, for the following in6 dications for use: 

7 ‘‘(I) Oxygen for the treatment or 

8 prevention of hypoxemia or hypoxia. 

9 ‘‘(II) Nitrogen for use in hypoxic 

10 challenge testing. 

11 ‘‘(III) Nitrous oxide for analge12 sia. 

13 ‘‘(IV) Carbon dioxide for use in 

14 extracorporeal membrane oxygenation 

15 therapy or respiratory stimulation. 

16 ‘‘(V) Helium for the treatment of 

17 upper airway obstruction or increased 

18 airway resistance. 

19 ‘‘(VI) Medical air to reduce the 

20 risk of hyperoxia. 

21 ‘‘(VII) Carbon monoxide for use 

22 in lung diffusion testing. 

23 ‘‘(VIII) Any other indication for 

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1 ical gas products deemed appropriate 

2 by the Secretary, unless any period of 

3 exclusivity under clause (iii) or (iv) of 

4 section 505(c)(3)(E), under clause 

5 (iii) or (iv) of section 505(j)(5)(F), or 

6 under section 527, or the extension of 

7 any such period under section 505A, 

8 applicable to such indication for use 

9 for such gas product or combination 

10 of products has not expired. 

11 ‘‘(ii) LABELING.—The requirements 

12 established in sections 503(b)(4) and 

13 502(f) shall be deemed to have been met 

14 for a designated medical gas product if the 

15 labeling on final use containers of such gas 

16 product bears the information required by 

17 section 503(b)(4) and a warning statement 

18 concerning the use of the gas product, as 

19 determined by the Secretary by regulation, 

20 as well as appropriate directions and warn21 ings concerning storage and handling. 

22 ‘‘(B) INAPPLICABILITY OF EXCLUSIVITY

23 PROVISIONS.— 

24 ‘‘(i) EFFECT ON INELIGIBILITY.—No 

25 designated medical gas product deemed 


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1 under paragraph (3)(A)(i) to have in effect 

2 an approved application shall be eligible for 

3 any periods of exclusivity under sections 

4 505(c), 505(j), or 527, or the extension of 

5 any such period under section 505A, on 

6 the basis of such deemed approval. 

7 ‘‘(ii) EFFECT ON CERTIFICATION.— 

8 No period of exclusivity under sections 

9 505(c), 505(j), or section 527, or the ex10 tension of any such period under section 

11 505A, with respect to an application for a 

12 drug shall prohibit, limit, or otherwise af13 fect the submission, grant, or effect of a 

14 certification under this section, except as 

15 provided in paragraph (3)(A)(i)(VIII). 

16 ‘‘(4) WITHDRAWAL, SUSPENSION, OR REVOCA17 TION OF APPROVAL.— 

18 ‘‘(A) IN GENERAL.—Nothing in this sub19 chapter limits the authority of the Secretary to 

20 withdraw or suspend approval of a drug, includ21 ing a designated medical gas product deemed 

22 under this section to have in effect an approved 

23 application, under section 505 or section 512. 

24 ‘‘(B) REVOCATION.—The Secretary may 

25 revoke the grant of a certification under this 


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1 section if the Secretary determines that the re2 quest for certification contains any material 

3 omission or falsification. 

4 ‘‘(b) PRESCRIPTION REQUIREMENT.— 

5 ‘‘(1) IN GENERAL.—A designated medical gas 

6 product shall be subject to section 503(b)(1) unless 

7 the Secretary exercises the authority provided in sec8 tion 503(b)(3) to remove such gas product from the 

9 requirements of section 503(b)(1) or the use in ques10 tion is authorized pursuant to another provision of 

11 this Act relating to use of medical products in emer12 gencies. 

13 ‘‘(2) EXCEPTION FOR OXYGEN.— 

14 ‘‘(A) IN GENERAL.—Notwithstanding para15 graph (1), oxygen may be provided without a 

16 prescription for the following uses: 

17 ‘‘(i) The use in the event of depres18 surization or other environmental oxygen 

19 deficiency. 

20 ‘‘(ii) The use in the event of oxygen 

21 deficiency or use in emergency resuscita22 tion, when administered by properly 

23 trained personnel. 

24 ‘‘(B) LABELING.—For oxygen provided 

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1 ments established in section 503(b)(4) shall be 

2 deemed to have been met if the labeling of the 

3 oxygen bears a warning that the medical gas 

4 product can be used for emergency use only and 

5 for all other medical applications a prescription 

6 is required. 

7 ‘‘(c) INAPPLICABILITY OF DRUGS FEES TO DES8 IGNATED MEDICAL GAS PRODUCTS.—A designated med9 ical gas product deemed under this section to have in ef10 fect an approved application shall not be assessed fees 

11 under section 736(a) on the basis of such deemed ap12 proval.’’. 

13 SEC. 1112. REGULATIONS. 

14 (a) REVIEW OF REGULATIONS.—Not later than 18 

15 months after the date of enactment of this Act, the Sec16 retary of Health and Human Services (referred to in this 

17 section as the ‘‘Secretary’’) shall, after obtaining input 

18 from medical gas product manufacturers, and any other 

19 interested members of the public, submit a report to the 

20 Committee on Health, Education, Labor, and Pensions of 

21 the Senate and the Committee on Energy and Commerce 

22 of the House of Representatives regarding any changes to 

23 the Federal drug regulations in title 21, Code of Federal 

24 Regulations that the Secretary determines to be necessary. 


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1 (b) AMENDED REGULATIONS.—If the Secretary de2 termines that changes to the Federal drug regulations in 

3 title 21, Code of Federal Regulations are necessary under 

4 subsection (a), the Secretary shall issue final regulations 

5 implementing such changes not later than 4 years after 

6 the date of enactment of this Act. 

7 SEC. 1113. APPLICABILITY. 

8 Nothing in this subtitle or the amendments made by 

9 this subtitle shall apply to— 

10 (1) a drug that is covered by an application 

11 under section 505 or 512 of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 355, 360b) ap13 proved prior to May 1, 2012; or 

14 (2) any of the gases listed in subparagraphs (A) 

15 through (G) of section 575(1) of such Act (as added 

16 by section 1111), or any mixture of any such gases, 

17 for an indication that— 

18 (A) is not included in, or is different from, 

19 those specified in subclauses (I) through (VII) 

20 of section 576(a)(3)(i) of such Act (as added by 

21 section 1111); and 

22 (B) is approved on or after May 1, 2012, 

23 pursuant to an application submitted under sec24 tion 505 or 512 of such Act. 


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1 Subtitle C—Miscellaneous 

2 Provisions 

3 SEC. 1121. ADVISORY COMMITTEE CONFLICTS OF INTER4 EST. 

5 Section 712 (21 U.S.C. 379d–1) is amended— 

6 (1) in subsection (b)— 

7 (A) by striking paragraph (2); and 

8 (B) in paragraph (1)— 

9 (i) by redesignating subparagraph (B) 

10 as paragraph (2) and moving such para11 graph, as so redesignated, 2 ems to the 

12 left; 

13 (ii) in subparagraph (A), by redesig14 nating clauses (i) through (iii) as subpara15 graphs (A) through (C), respectively, and 

16 moving such subparagraphs, as so redesig17 nated, 2 ems to the left; 

18 (iii) in subparagraph (A), as so redes19 ignated, by inserting ‘‘, including strategies 

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1 latory responsibilities’’ before the semicolon 

2 at the end; 

3 (iv) by striking ‘‘(1) RECRUITMENT.— 

4 ’’ and inserting ‘‘(1) RECRUITMENT IN

5 GENERAL.—The Secretary shall—’’; 

6 (v) by striking ‘‘(A) IN GENERAL.— 

7 The Secretary shall—’’; 

8 (vi) by redesignating clauses (i) 

9 through (iii) of paragraph (2) (as so redes10 ignated) as subparagraphs (A) through 

11 (C), respectively, and moving such sub12 paragraphs, as so redesignated, 2 ems to 

13 the left; 

14 (vii) in paragraph (2) (as so redesig15 nated), in the matter before subparagraph 

16 (A) (as so redesignated), by striking ‘‘sub17 paragraph (A)’’ and inserting ‘‘paragraph 

18 (1)’’; and 

19 (viii) by adding at the end the fol20 lowing: 

21 ‘‘(3) RECRUITMENT THROUGH REFERRALS.—In 

22 carrying out paragraph (1), the Secretary shall, in 

23 order to further the goal of including in advisory 

24 committees highly qualified and specialized experts 

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1 visory committees, at least every 180 days, request 

2 referrals from a variety of stakeholders, such as the 

3 Institute of Medicine, the National Institutes of 

4 Health, product developers, patient groups, disease 

5 advocacy organizations, professional societies, med6 ical societies, including the American Academy of 

7 Medical Colleges, and other governmental organiza8 tions.’’; 

9 (2) by amending subsection (c)(2)(C) to read as 

10 follows: 

11 ‘‘(C) CONSIDERATION BY SECRETARY.— 

12 The Secretary shall ensure that each determina13 tion made under subparagraph (B) considers 

14 the type, nature, and magnitude of the financial 

15 interests at issue and the public health interest 

16 in having the expertise of the member with re17 spect to the particular matter before the advi18 sory committee.’’; 

19 (3) in subsection (e), by inserting ‘‘, and shall 

20 make publicly available,’’ after ‘‘House of Represent21 atives’’; and 

22 (4) by adding at the end the following: 

23 ‘‘(g) GUIDANCE ON REPORTED FINANCIAL INTEREST

24 OR INVOLVEMENT.—The Secretary shall issue guidance 

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1 terests and involvement of advisory committee members 

2 that are reported under subsection (c)(1) but that the Sec3 retary determines not to meet the definition of a disquali4 fying interest under section 208 of title 18, United States 

5 Code for the purposes of participating in a particular mat6 ter.’’. 

7 SEC. 1122. GUIDANCE DOCUMENT REGARDING PRODUCT 

8 PROMOTION USING THE INTERNET. 

9 Not later than 2 years after the date of enactment 

10 this Act, the Secretary of Health and Human Services 

11 shall issue guidance that describes Food and Drug Admin12 istration policy regarding the promotion, using the Inter13 net (including social media), of medical products that are 

14 regulated by such Administration. 

15 SEC. 1123. ELECTRONIC SUBMISSION OF APPLICATIONS. 

16 Subchapter D of chapter VII (21 U.S.C. 379k et 

17 seq.) is amended by inserting after section 745 the fol18 lowing: 

19 ‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 

20 ‘‘(a) DRUGS AND BIOLOGICS.— 

21 ‘‘(1) IN GENERAL.—Beginning no earlier than 

22 24 months after the issuance of a final guidance 

23 issued after public notice and opportunity for com24 ment, submissions under subsection (b), (i), or (j) of 

25 section 505 of this Act or subsection (a) or (k) of 


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1 section 351 of the Public Health Service Act shall 

2 be submitted in such electronic format as specified 

3 by the Secretary in such guidance. 

4 ‘‘(2) GUIDANCE CONTENTS.—In the guidance 

5 under paragraph (1), the Secretary may— 

6 ‘‘(A) provide a timetable for establishment 

7 by the Secretary of further standards for elec8 tronic submission as required by such para9 graph; and 

10 ‘‘(B) set forth criteria for waivers of and 

11 exemptions from the requirements of this sub12 section. 

13 ‘‘(3) EXCEPTION.—This subsection shall not 

14 apply to submissions described in section 561. 

15 ‘‘(b) DEVICES.— 

16 ‘‘(1) IN GENERAL.—Beginning after the 

17 issuance of final guidance implementing this para18 graph, pre-submissions and submissions for devices 

19 under section 510(k), 513(f)(2)(A), 515(c), 515(d), 

20 515(f), 520(g), 520(m), or 564 of this Act or section 

21 351 of the Public Health Service Act, and any sup22 plements to such pre-submissions or submissions, 

23 shall include an electronic copy of such pre-submis24 sions or submissions. 


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1 ‘‘(2) GUIDANCE CONTENTS.—In the guidance 

2 under paragraph (1), the Secretary may— 

3 ‘‘(A) provide standards for the electronic 

4 copy required under such paragraph; and 

5 ‘‘(B) set forth criteria for waivers of and 

6 exemptions from the requirements of this sub7 section.’’. 

8 SEC. 1124. COMBATING PRESCRIPTION DRUG ABUSE. 

9 (a) IN GENERAL.—To combat the significant rise in 

10 prescription drug abuse and the consequences of such 

11 abuse, the Secretary of Health and Human Services (re12 ferred to in this section as the ‘‘Secretary’’), acting 

13 through the Commissioner of Food and Drugs (referred 

14 to in this section as the ‘‘Commissioner’’) and in coordina15 tion with other Federal agencies, as appropriate, shall re16 view current Federal initiatives and identify gaps and op17 portunities with respect to ensuring the safe use of pre18 scription drugs with the potential for abuse. 

19 (b) REPORT.—Not later than 1 year after the date 

20 of enactment of this Act, the Secretary shall issue a report 

21 to Congress on the findings of the review under subsection 

22 (a). Such report shall include recommendations on— 

23 (1) how best to leverage and build upon existing 

24 Federal and federally funded data sources, such as 

25 prescription drug monitoring program data and the 


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1 sentinel initiative of the Food and Drug Administra2 tion under section 505(k)(3) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as 

4 it relates to collection of information relevant to ad5 verse events, patient safety, and patient outcomes, to 

6 create a centralized data clearinghouse and early 

7 warning tool; 

8 (2) how best to develop and disseminate widely 

9 best practices models and suggested standard re10 quirements to States for achieving greater interoper11 ability and effectiveness of prescription drug moni12 toring programs, especially with respect to producing 

13 standardized data on adverse events, patient safety, 

14 and patient outcomes; and 

15 (3) how best to develop provider and patient 

16 education tools and a strategy to widely disseminate 

17 such tools and assess the efficacy of such tools. 

18 (c) GUIDANCE ON TAMPER-DETERRENT PROD19 UCTS.—Not later than 6 months after the date of enact20 ment of this Act, the Secretary, acting through the Com21 missioner, shall promulgate guidance on the development 

22 of tamper-deterrent drug products. 

23 SEC. 1125. TANNING BED LABELING. 

24 Not later than 18 months after the date of enactment 

25 of this Act, the Secretary of Health and Human Services 


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1 shall determine whether to amend the warning label re2 quirements for sunlamp products to include specific re3 quirements to more clearly and effectively convey the risks 

4 that such products pose for the development of irreversible 

5 damage to the eyes and skin, including skin cancer. 

6 SEC. 1126. OPTIMIZING GLOBAL CLINICAL TRIALS. 

7 Subchapter E of chapter V (21 U.S.C. 360bbb et 

8 seq.), as amended by section 903, is further amended by 

9 adding at the end the following: 

10 ‘‘SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS. 

11 ‘‘(a) IN GENERAL.—The Secretary shall— 

12 ‘‘(1) work with other regulatory authorities of 

13 similar standing, medical research companies, and 

14 international organizations to foster and encourage 

15 uniform, scientifically-driven clinical trial standards 

16 with respect to medical products around the world; 

17 and 

18 ‘‘(2) enhance the commitment to provide con19 sistent parallel scientific advice to manufacturers 

20 seeking simultaneous global development of new 

21 medical products in order to— 

22 ‘‘(A) enhance medical product develop23 ment; 

24 ‘‘(B) facilitate the use of foreign data; and 


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1 ‘‘(C) minimize the need to conduct duplica2 tive clinical studies, preclinical studies, or non3 clinical studies. 

4 ‘‘(b) MEDICAL PRODUCT.—In this section, the term 

5 ‘medical product’ means a drug, as defined in subsection 

6 (g) of section 201, a device, as defined in subsection (h) 

7 of such section, or a biological product, as defined in sec8 tion 351(i) of the Public Health Service Act. 

9 ‘‘(c) SAVINGS CLAUSE.—Nothing in this section shall 

10 alter the criteria for evaluating the safety or effectiveness 

11 of a medical product under this Act. 

12 ‘‘SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM 

13 OUTSIDE THE UNITED STATES. 

14 ‘‘(a) IN GENERAL.—In determining whether to ap15 prove, license, or clear a drug or device pursuant to an 

16 application submitted under this chapter, the Secretary 

17 shall accept data from clinical investigations conducted 

18 outside of the United States, including the European 

19 Union, if the applicant demonstrates that such data are 

20 adequate under applicable standards to support approval, 

21 licensure, or clearance of the drug or device in the United 

22 States. 

23 ‘‘(b) NOTICE TO SPONSOR.—If the Secretary finds 

24 under subsection (a) that the data from clinical investiga25 tions conducted outside the United States, including in the 


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1 European Union, are inadequate for the purpose of mak2 ing a determination on approval, clearance, or licensure 

3 of a drug or device pursuant to an application submitted 

4 under this chapter, the Secretary shall provide written no5 tice to the sponsor of the application of such finding and 

6 include the rationale for such finding.’’. 

7 SEC. 1127. ADVANCING REGULATORY SCIENCE TO PRO8 MOTE PUBLIC HEALTH INNOVATION. 

9 (a) IN GENERAL.—Not later than 1 year after the 

10 date of enactment of this Act, the Secretary of Health and 

11 Human Services (referred to in this section as the ‘‘Sec12 retary’’) shall develop a strategy and implementation plan 

13 for advancing regulatory science for medical products in 

14 order to promote the public health and advance innovation 

15 in regulatory decisionmaking. 

16 (b) REQUIREMENTS.—The strategy and implementa17 tion plan developed under subsection (a) shall be con18 sistent with the user fee performance goals in the Pre19 scription Drug User Fee Agreement commitment letter, 

20 the Generic Drug User Fee Agreement commitment letter, 

21 and the Biosimilar User Fee Agreement commitment let22 ter transmitted by the Secretary to Congress on January 

23 13, 2012, and the Medical Device User Fee Agreement 

24 commitment letter transmitted by the Secretary to Con25 gress on April 20, 2012, and shall— 


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1 (1) identify a clear vision of the fundamental 

2 role of efficient, consistent, and predictable, science3 based decisions throughout regulatory decision4 making of the Food and Drug Administration with 

5 respect to medical products; 

6 (2) identify the regulatory science priorities of 

7 the Food and Drug Administration directly related 

8 to fulfilling the mission of the agency with respect 

9 to decisionmaking concerning medical products and 

10 allocation of resources towards such regulatory 

11 science priorities; 

12 (3) identify regulatory and scientific gaps that 

13 impede the timely development and review of, and 

14 regulatory certainty with respect to, the approval, li15 censure, or clearance of medical products, including 

16 with respect to companion products and new tech17 nologies, and facilitating the timely introduction and 

18 adoption of new technologies and methodologies in a 

19 safe and effective manner; 

20 (4) identify clear, measurable metrics by which 

21 progress on the priorities identified under paragraph 

22 (2) and gaps identified under paragraph (3) will be 

23 measured by the Food and Drug Administration, in24 cluding metrics specific to the integration and adop25 tion of advances in regulatory science described in 


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1 paragraph (5) and improving medical product deci2 sionmaking, in a predictable and science-based man3 ner; and 

4 (5) set forth how the Food and Drug Adminis5 tration will ensure that advances in regulatory 

6 science for medical products are adopted, as appro7 priate, on an ongoing basis and in an manner inte8 grated across centers, divisions, and branches of the 

9 Food and Drug Administration, including by senior 

10 managers and reviewers, including through the— 

11 (A) development, updating, and consistent 

12 application of guidance documents that support 

13 medical product decisionmaking; and 

14 (B) the adoption of the tools, methods, and 

15 processes under section 566 of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 

17 360bbb–5). 

18 (c) ANNUAL PERFORMANCE REPORTS.—As part of 

19 the annual performance reports submitted to Congress 

20 under sections 736B(a) (as amended by section 104), 

21 738A(a) (as amended by section 204), 744C(a) (as added 

22 by section 303), and 744I(a) (as added by section 403) 

23 of the Federal Food, Drug, and Cosmetic Act for each 

24 of fiscal years 2013 through 2017, the Secretary shall an25 nually report on the progress made with respect to— 


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1 (1) advancing the regulatory science priorities 

2 identified under paragraph (2) of subsection (b) and 

3 resolving the gaps identified under paragraph (3) of 

4 such subsection, including reporting on specific 

5 metrics identified under paragraph (4) of such sub6 section; 

7 (2) the integration and adoption of advances in 

8 regulatory science as set forth in paragraph (5) of 

9 such subsection; and 

10 (3) the progress made in advancing the regu11 latory science goals outlined in the Prescription 

12 Drug User Fee Agreement commitment letter, the 

13 Generic Drug User Fee Agreement commitment let14 ter, and the Biosimilar User Fee Agreement commit15 ment letter transmitted by the Secretary to Congress 

16 on January 13, 2012, and the Medical Device User 

17 Fee Agreement transmitted by the Secretary to Con18 gress on April 20, 2012. 

19 (d) INDEPENDENT ASSESSMENT.—Not later than 

20 January 1, 2016, the Comptroller General of the United 

21 States shall submit to Congress a report— 

22 (1) detailing the progress made by the Food 

23 and Drug Administration in meeting the priorities 

24 and addressing the gaps identified in subsection (b), 

25 including any outstanding gaps; and 


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1 (2) containing recommendations, as appro2 priate, on how regulatory science initiatives for med3 ical products can be strengthened and improved to 

4 promote the public health and advance innovation in 

5 regulatory decisionmaking. 

6 (e) MEDICAL PRODUCT.—In this section, the term 

7 ‘‘medical product’’ means a drug, as defined in subsection 

8 (g) of section 201 of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 321), a device, as defined in sub10 section (h) of such section, or a biological product, as de11 fined in section 351(i) of the Public Health Service Act. 

12 SEC. 1128. INFORMATION TECHNOLOGY. 

13 (a) HHS REPORT.—Not later than 1 year after the 

14 date of enactment of this Act, the Secretary of Health and 

15 Human Services shall— 

16 (1) report to Congress on— 

17 (A) the milestones and a completion date 

18 for developing and implementing a comprehen19 sive information technology strategic plan to 

20 align the information technology systems mod21 ernization projects with the strategic goals of 

22 the Food and Drug Administration, including 

23 results-oriented goals, strategies, milestones, 

24 performance measures; 


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1 (B) efforts to finalize and approve a com2 prehensive inventory of the information tech3 nology systems of the Food and Drug Adminis4 tration that includes information describing 

5 each system, such as costs, system function or 

6 purpose, and status information, and incor7 porate use of the system portfolio into the in8 formation investment management process of 

9 the Food and Drug Administration; 

10 (C) the ways in which the Food and Drug 

11 Administration uses the plan described in sub12 paragraph (A) to guide and coordinate the 

13 modernization projects and activities of the 

14 Food and Drug Administration, including the 

15 interdependencies among projects and activities; 

16 and 

17 (D) the extent to which the Food and 

18 Drug Administration has fulfilled or is imple19 menting recommendations of the Government 

20 Accountability Office with respect to the Food 

21 and Drug Administration and information tech22 nology; and 

23 (2) develop— 

24 (A) a documented enterprise architecture 

25 program management plan that includes the 


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1 tasks, activities, and timeframes associated with 

2 developing and using the architecture and ad3 dresses how the enterprise architecture program 

4 management will be performed in coordination 

5 with other management disciplines, such as or6 ganizational strategic planning, capital planning 

7 and investment control, and performance man8 agement; and 

9 (B) a skills inventory, needs assessment, 

10 gap analysis, and initiatives to address skills 

11 gaps as part of a strategic approach to informa12 tion technology human capital planning. 

13 (b) GAO REPORT.—Not later than January 1, 2016, 

14 the Comptroller General of the United States shall issue 

15 a report regarding the strategic plan described in sub16 section (a)(1)(A) and related actions carried out by the 

17 Food and Drug Administration. Such report shall assess 

18 the progress the Food and Drug Administration has made 

19 on— 

20 (1) the development and implementation of a 

21 comprehensive information technology strategic plan, 

22 including the results-oriented goals, strategies, mile23 stones, and performance measures identified in sub24 section (a)(1)(A); 


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1 (2) the effectiveness of the comprehensive infor2 mation technology strategic plan described in sub3 section (a)(1)(A), including the results-oriented 

4 goals and performance measures; and 

5 (3) the extent to which the Food and Drug Ad6 ministration has fulfilled recommendations of the 

7 Government Accountability Office with respect to 

8 such agency and information technology. 

9 SEC. 1129. REPORTING REQUIREMENTS. 

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

11 as amended by section 208, is further amended by adding 

12 at the end the following: 

13 ‘‘SEC. 715. REPORTING REQUIREMENTS. 

14 ‘‘(a) NEW DRUGS.—Beginning with fiscal year 2013 

15 and ending with fiscal year 2017, not later than 120 days 

16 after the end of each fiscal year for which fees are col17 lected under part 2 of subchapter C, the Secretary shall 

18 prepare and submit to the Committee on Health Edu19 cation, Labor, and Pensions of the Senate and the Com20 mittee on Energy and Commerce of the House of Rep21 resentatives a report concerning, for all applications for 

22 approval of a new drug under section 505(b) of this Act 

23 or a new biological product under section 351(a) of the 

24 Public Health Service Act filed in the previous fiscal 

25 year— 


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1 ‘‘(1) the number of such applications that met 

2 the goals identified for purposes of part 2 of sub3 chapter C in the letters from the Secretary of 

4 Health and Human Services to the Chairman of the 

5 Committee on Health, Education, Labor, and Pen6 sions of the Senate and the Chairman of the Com7 mittee on Energy and Commerce of the House of 

8 Representatives, as set forth in the Congressional 

9 Record; 

10 ‘‘(2) the percentage of such applications that 

11 were approved; 

12 ‘‘(3) the percentage of such applications that 

13 were issued complete response letters; 

14 ‘‘(4) the percentage of such applications that 

15 were subject to a refuse-to-file action; 

16 ‘‘(5) the percentage of such applications that 

17 were withdrawn; and 

18 ‘‘(6) the average total time to decision by the 

19 Secretary for all applications for approval of a new 

20 drug under section 505(b) of this Act or a new bio21 logical product under section 351(a) of the Public 

22 Health Service Act filed in the previous fiscal year, 

23 including the number of calendar days spent during 

24 the review by the Food and Drug Administration 


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1 and the number of calendar days spent by the spon2 sor responding to a complete response letter.’’. 

3 ‘‘(b) GENERIC DRUGS.—Beginning with fiscal year 

4 2013 and ending after fiscal year 2017, not later than 

5 120 days after the end of each fiscal year for which fees 

6 are collected under part 7 of subchapter C, the Secretary 

7 shall prepare and submit to the Committee on Health 

8 Education, Labor, and Pensions of the Senate and the 

9 Committee on Energy and Commerce of the House of 

10 Representatives a report concerning, for all applications 

11 for approval of a generic drug under section 505(j), 

12 amendments to such applications, and prior approval sup13 plements with respect to such applications filed in the pre14 vious fiscal year— 

15 ‘‘(1) the number of such applications that met 

16 the goals identified for purposes of part 7 of sub17 chapter C, in the letters from the Secretary of 

18 Health and Human Services to the Chairman of the 

19 Committee on Health, Education, Labor, and Pen20 sions of the Senate and the Chairman of the Com21 mittee on Energy and Commerce of the House of 

22 Representatives, as set forth in the Congressional 

23 Record; 

24 ‘‘(2) the average total time to decision by the 

25 Secretary for applications for approval of a generic 


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1 drug under section 505(j), amendments to such ap2 plications, and prior approval supplements with re3 spect to such applications filed in the previous fiscal 

4 year, including the number of calendar days spent 

5 during the review by the Food and Drug Adminis6 tration and the number of calendar days spent by 

7 the sponsor responding to a complete response let8 ter; 

9 ‘‘(3) the total number of applications under sec10 tion 505(j), amendments to such applications, and 

11 prior approval supplements with respect to such ap12 plications that were pending with the Secretary for 

13 more than 10 months on the date of enactment of 

14 the Food and Drug Administration Safety and Inno15 vation Act; and 

16 ‘‘(4) the number of applications described in 

17 paragraph (3) on which the Food and Drug Admin18 istration took final regulatory action in the previous 

19 fiscal year. 

20 ‘‘(c) BIOSIMILAR BIOLOGICAL PRODUCTS.— 

21 ‘‘(1) IN GENERAL.—Beginning with fiscal year 

22 2014, not later than 120 days after the end of each 

23 fiscal year for which fees are collected under part 8 

24 of subchapter C, the Secretary shall prepare and 

25 submit to the Committee on Health Education, 


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1 Labor, and Pensions of the Senate and the Com2 mittee on Energy and Commerce of the House of 

3 Representatives a report concerning— 

4 ‘‘(A) the number of applications for ap5 proval filed under section 351(k) of the Public 

6 Health Service Act; and 

7 ‘‘(B) the percentage of applications de8 scribed in subparagraph (A) that were approved 

9 by the Secretary. 

10 ‘‘(2) ADDITIONAL INFORMATION.—As part of 

11 the performance report described in paragraph (1), 

12 the Secretary shall include an explanation of how the 

13 Food and Drug Administration is managing the bio14 logical product review program to ensure that the 

15 user fees collected under part 2 are not used to re16 view an application under section 351(k) of the Pub17 lic Health Service Act.’’. 

18 SEC. 1130. STRATEGIC INTEGRATED MANAGEMENT PLAN. 

19 (a) STRATEGIC INTEGRATED MANAGEMENT PLAN.— 

20 Not later than 1 year after the date of enactment of this 

21 Act, the Secretary of Health and Human Services (re22 ferred to in this section as the ‘‘Secretary’’) shall submit 

23 to Congress a strategic integrated management plan for 

24 the Center for Drug Evaluation and Research, the Center 

25 for Biologics Evaluation and Research, and the Center for 


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1 Devices and Radiological Health. Such strategic manage2 ment plan shall— 

3 (1) identify strategic institutional goals and pri4 orities for the Center for Drug Evaluation and Re5 search, the Center for Biologics Evaluation and Re6 search, and the Center for Devices and Radiological 

7 Health; 

8 (2) describe the actions the Secretary will take 

9 to recruit, retain, train, and continue to develop the 

10 workforce at the Center for Drug Evaluation and 

11 Research, the Center for Biologics Evaluation and 

12 Research, and the Center for Devices and Radio13 logical Health to fulfill the public health mission of 

14 the Food and Drug Administration; and 

15 (3) identify results-oriented, outcome-based 

16 measures that the Secretary will use to measure the 

17 progress of achieving the strategic goals and prior18 ities identified under paragraph (1) and the effec19 tiveness of the actions identified under paragraph 

20 (2), including metrics to ensure that managers and 

21 reviewers of the Center for Drug Evaluation and Re22 search, the Center for Biologics Evaluation and Re23 search, and the Center for Devices and Radiological 

24 Health are familiar with and appropriately and con25 sistently apply the requirements under the Federal 


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1 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

2 seq.), including new requirements under parts 2, 3, 

3 7, and 8 of subchapter C of title VII of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379f et 

5 seq.). 

6 (b) REPORT.—Not later than January 1, 2016, the 

7 Comptroller General of the United States shall issue a re8 port regarding the strategic management plan described 

9 in subsection (a) and related actions carried out by the 

10 Food and Drug Administration. Such report shall— 

11 (1) assess the effectiveness of the actions de12 scribed in subsection (a)(2) in recruiting, retaining, 

13 training, and developing the workforce at the Center 

14 for Drug Evaluation and Research, the Center for 

15 Biologics Evaluation and Research, and the Center 

16 for Devices and Radiological Health in fulfilling the 

17 public health mission of the Food and Drug Admin18 istration; 

19 (2) assess the effectiveness of the measures 

20 identified under subsection (a)(3) in gauging 

21 progress against the strategic goals and priorities 

22 identified under subsection (a)(1); 

23 (3) assess the extent to which the Center for 

24 Drug Evaluation and Research, the Center for Bio25 logics Evaluation and Research, and the Center for 


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1 Devices and Radiological Health are using the iden2 tified results-oriented set of performance measures 

3 in tracking their workload by strategic goals and the 

4 effectiveness of such measures; 

5 (4) assess the extent to which performance in6 formation is collected, analyzed, and acted on by 

7 managers; and 

8 (5) make recommendations, as appropriate, re9 garding how the strategic management plan and re10 lated actions of the Center for Drug Evaluation and 

11 Research, the Center for Biologics Evaluation and 

12 Research, and the Center for Devices and Radio13 logical Health could be improved to fulfill the public 

14 health mission of the Food and Drug Administration 

15 in as efficient and effective manner as possible. 

16 SEC. 1131. DRUG DEVELOPMENT AND BIOEQUIVALENCE 

17 TESTING. 

18 (a) IN GENERAL.—Section 505–1 (21 U.S.C. 355– 

19 1) is amended by adding at the end the following: 

20 ‘‘(k) DRUG DEVELOPMENT AND BIOEQUIVALENCE

21 TESTING.— 

22 ‘‘(1) IN GENERAL.—Notwithstanding any other 

23 provision of law, if a drug is a covered drug, no ele24 ments to ensure safe use shall prohibit, or be con25 strued or applied to prohibit, supply of such drug to 


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1 any eligible drug developer for the purpose of devel2 oping, or conducting bioequivalence testing necessary 

3 to support, an application under subsection (b)(2) or 

4 (j) of section 505 of this Act or section 351(k) of 

5 the Public Health Service Act, if the Secretary has 

6 issued a written notice described in paragraph (2), 

7 and the eligible drug developer has agreed to comply 

8 with the terms of the notice. 

9 ‘‘(2) WRITTEN NOTICE.—For purposes of this 

10 subsection, the Secretary shall issue a written notice 

11 to an eligible drug developer and the holder of an 

12 application for a covered drug authorizing the supply 

13 of a drug to such eligible drug developer for pur14 poses of bioequivalence testing if— 

15 ‘‘(A) the eligible drug developer has agreed 

16 to comply with any conditions the Secretary 

17 considers necessary; and 

18 ‘‘(B) the eligible drug developer has sub19 mitted and the Secretary has approved a pro20 tocol for bioequivalence testing that includes 

21 protections that the Secretary finds will provide 

22 assurance of safety comparable to the assurance 

23 of safety provided by the elements to ensure 

24 safe use in the risk evaluation and mitigation 

25 strategy for the covered drug. 


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1 ‘‘(3) ADDITIONAL REQUIRED ELEMENT.—The 

2 Secretary shall require as an element of each risk 

3 evaluation and mitigation strategy approved by the 

4 Secretary that the holder of an application for a cov5 ered drug shall not restrict the resale of the covered 

6 drug to an eligible drug developer that receives a 

7 written notice from the Secretary under paragraph 

8 (2). 

9 ‘‘(4) PENALTIES.—For purposes of subsection 

10 (f)(8) and sections 301, 303(f)(4), 502(y), and 

11 505(p), it shall be a violation of the risk evaluation 

12 and mitigation strategy for the holder of the applica13 tion for a covered drug to restrict the sale of the 

14 drug to an eligible drug developer. The Secretary 

15 shall provide written notice to the Committee on 

16 Health, Education, Labor, and Pensions of the Sen17 ate and the Committee on Energy and Commerce of 

18 the House of Representatives of any penalty as19 sessed under this subsection within 7 days of such 

20 assessment. 

21 ‘‘(5) LIABILITY.—Unless the holder of the ap22 plication for a covered drug and the eligible devel23 oper are the same entity, the holder of an applica24 tion for a covered drug shall not be liable for any 

25 claim arising out of the eligible drug developer’s 


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1 testing necessary to support an application under 

2 subsection (b)(2) or (j) of section 505 of this Act or 

3 section 351(k) of the Public Health Service Act for 

4 a drug obtained under this subsection. Nothing in 

5 this subsection shall be construed to expand or limit 

6 the liability of the eligible drug developer or the 

7 holder of an application for a covered drug for any 

8 other claim. 

9 ‘‘(6) DEFINITIONS.— 

10 ‘‘(A) COVERED DRUG.—Notwithstanding 

11 subsection (b)(2), for purposes of this sub12 section, the term ‘covered drug’ means a drug, 

13 including a biological product licensed under 

14 section 351(a) of the Public Health Service Act, 

15 that is subject to a risk evaluation and mitiga16 tion strategy with elements to ensure safe use 

17 under subsection (f), or a drug, including a bio18 logical product licensed under section 351(a) of 

19 the Public Health Service Act, required to have 

20 a risk evaluation and mitigation strategy with 

21 elements to ensure safe use under section 

22 909(b) of the Food and Drug Administration 

23 Amendments Act of 2007. 

24 ‘‘(B) ELIGIBLE DRUG DEVELOPER.—For 

25 purposes of this subsection, the term ‘eligible 


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1 drug developer’ means a sponsor seeking to de2 velop an application for submission under sub3 section (b)(2) or (j) of section 505 of this Act 

4 or section 351(k) of the Public Health Service 

5 Act. 

6 ‘‘(7) EFFECT ON OTHER LAW.—Nothing in this 

7 subsection shall affect the authority of the Federal 

8 Trade Commission to enforce the Federal Trade 

9 Commission Act (15 U.S.C. 41–58), the Sherman 

10 Act (15 U.S.C. 1–7)), or any other statute properly 

11 under such Commission’s jurisdiction.’’. 

12 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

13 Section 505–1(c)(2) (21 U.S.C. 355–1(c)(2)) is amended 

14 by striking ‘‘(e) and (f)’’ and inserting ‘‘(e), (f), and 

15 (k)(3)’’. 

16 SEC. 1132. PATIENT PARTICIPATION IN MEDICAL PRODUCT 

17 DISCUSSIONS. 

18 Subchapter E of chapter V (21 U.S.C. 360bbb et 

19 seq.), as amended by section 1126, is further amended by 

20 adding at the end the following: 

21 ‘‘SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PROD22 UCT DISCUSSION. 

23 ‘‘(a) IN GENERAL.—The Secretary shall develop and 

24 implement strategies to solicit the views of patients during 

25 the medical product development process and consider the 


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1 perspectives of patients during regulatory discussions, in2 cluding by— 

3 ‘‘(1) fostering participation of a patient rep4 resentative who may serve as a special government 

5 employee in appropriate agency meetings with med6 ical product sponsors and investigators; and 

7 ‘‘(2) exploring means to provide for identifica8 tion of patient representatives who do not have any, 

9 or have minimal, financial interests in the medical 

10 products industry. 

11 ‘‘(b) FINANCIAL INTEREST.—In this section, the 

12 term ‘financial interest’ means a financial interest under 

13 section 208(a) of title 18, United States Code.’’. 


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Calendar No. 400 

112TH CONGRESS 

2D SESSION S. 3187 

A BILL 

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 

MAY 16, 2012 

Read the second time and placed on the calendar 


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