In the House of Representatives, U. S., 

June 20, 2012. 

Resolved, That the bill from the Senate (S. 3187) entitled ‘‘An Act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.’’, do pass with the following 

AMENDMENT: 

Strike out all after the enacting clause and insert: 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Food and Drug Admin3 istration Safety and Innovation Act’’. 

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

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

6 this Act is as follows: 

Sec. 1. Short title. 

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

TITLE I—FEES RELATING TO DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

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

Sec. 104. Reauthorization; reporting requirements. 

Sec. 105. Sunset dates. 

Sec. 106. Effective date. 

Sec. 107. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 201. Short title; findings. 

Sec. 202. Definitions. 
2 

•S 3187 EAH 

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

Sec. 204. Reauthorization; reporting requirements. 

Sec. 205. Savings clause. 

Sec. 206. Effective date. 

Sec. 207. Sunset clause. 

Sec. 208. Streamlined hiring authority to support activities related to the process 

for the review of device applications. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title. 

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

Sec. 303. Reauthorization; reporting requirements. 

Sec. 304. Sunset dates. 

Sec. 305. Effective date. 

Sec. 306. Amendment with respect to misbranding. 

Sec. 307. Streamlined hiring authority to support activities related to human generic drugs. 

Sec. 308. Additional reporting requirements. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 

Sec. 401. Short title; finding. 

Sec. 402. Fees relating to biosimilar biological products. 

Sec. 403. Reauthorization; reporting requirements. 

Sec. 404. Sunset dates. 

Sec. 405. Effective date. 

Sec. 406. Savings clause. 

Sec. 407. Conforming amendment. 

Sec. 408. Additional reporting requirements. 

TITLE V—PEDIATRIC DRUGS AND DEVICES 

Sec. 501. Permanence. 

Sec. 502. Written requests. 

Sec. 503. Communication with Pediatric Review Committee. 

Sec. 504. Access to data. 

Sec. 505. Ensuring the completion of pediatric studies. 

Sec. 506. Pediatric study plans. 

Sec. 507. Reauthorizations. 

Sec. 508. Report. 

Sec. 509. Technical amendments. 

Sec. 510. Pediatric rare diseases. 

Sec. 511. Staff of Office of Pediatric Therapeutics. 

TITLE VI—MEDICAL DEVICE REGULATORY IMPROVEMENTS 

Sec. 601. Investigational device exemptions. 

Sec. 602. Clarification of least burdensome standard. 

Sec. 603. Agency documentation and review of significant decisions. 

Sec. 604. Device modifications requiring premarket notification prior to marketing. 

Sec. 605. Program to improve the device recall system. 

Sec. 606. Clinical holds on investigational device exemptions. 

Sec. 607. Modification of de novo application process. 

Sec. 608. Reclassification procedures. 
3 

•S 3187 EAH 

Sec. 609. Harmonization of device premarket review, inspection, and labeling 

symbols. 

Sec. 610. Participation in international fora. 

Sec. 611. Reauthorization of third-party review. 

Sec. 612. Reauthorization of third-party inspection. 

Sec. 613. Humanitarian device exemptions. 

Sec. 614. Unique device identifier. 

Sec. 615. Sentinel. 

Sec. 616. Postmarket surveillance. 

Sec. 617. Custom devices. 

Sec. 618. Health information technology. 

Sec. 619. Good guidance practices relating to devices. 

Sec. 620. Pediatric device consortia. 

TITLE VII—DRUG SUPPLY CHAIN 

Sec. 701. Registration of domestic drug establishments. 

Sec. 702. Registration of foreign establishments. 

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

Sec. 704. Electronic system for registration and listing. 

Sec. 705. Risk-based inspection frequency. 

Sec. 706. Records for inspection. 

Sec. 707. Prohibition against delaying, denying, limiting, or refusing inspection. 

Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs offered for 

import. 

Sec. 709. Administrative detention. 

Sec. 710. Exchange of information. 

Sec. 711. Enhancing the safety and quality of the drug supply. 

Sec. 712. Recognition of foreign government inspections. 

Sec. 713. Standards for admission of imported drugs. 

Sec. 714. Registration of commercial importers. 

Sec. 715. Notification. 

Sec. 716. Protection against intentional adulteration. 

Sec. 717. Penalties for counterfeiting drugs. 

Sec. 718. Extraterritorial jurisdiction. 

TITLE VIII—GENERATING ANTIBIOTIC INCENTIVES NOW 

Sec. 801. Extension of exclusivity period for drugs. 

Sec. 802. Priority review. 

Sec. 803. Fast track product. 

Sec. 804. Clinical trials. 

Sec. 805. Reassessment of qualified infectious disease product incentives in 5 

years. 

Sec. 806. Guidance on pathogen-focused antibacterial drug development. 

TITLE IX—DRUG APPROVAL AND PATIENT ACCESS 

Sec. 901. Enhancement of accelerated patient access to new medical treatments. 

Sec. 902. Breakthrough therapies. 

Sec. 903. Consultation with external experts on rare diseases, targeted therapies, 

and genetic targeting of treatments. 

Sec. 904. Accessibility of information on prescription drug container labels by 

visually impaired and blind consumers. 

Sec. 905. Risk-benefit framework. 

Sec. 906. Grants and Contracts for the Development of Orphan Drugs. 
4 

•S 3187 EAH 

Sec. 907. Reporting of inclusion of demographic subgroups in clinical trials and 

data analysis in applications for drugs, biologics, and devices. 

Sec. 908. Rare pediatric disease priority review voucher incentive program. 

TITLE X—DRUG SHORTAGES 

Sec. 1001. Discontinuance or interruption in the production of life-saving drugs. 

Sec. 1002. Annual reporting on drug shortages. 

Sec. 1003. Coordination; task force and strategic plan. 

Sec. 1004. Drug shortage list. 

Sec. 1005. Quotas applicable to drugs in shortage. 

Sec. 1006. Attorney General report on drug shortages. 

Sec. 1007. Hospital repackaging of drugs in shortage. 

Sec. 1008. Study on drug shortages. 

TITLE XI—OTHER PROVISIONS 

Subtitle A—Reauthorizations 

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

containing single enantiomers. 

Sec. 1102. Reauthorization of the critical path public-private partnerships. 

Subtitle B—Medical Gas Product Regulation 

Sec. 1111. Regulation of medical gases. 

Sec. 1112. Changes to regulations. 

Sec. 1113. Rules of construction. 

Subtitle C—Miscellaneous Provisions 

Sec. 1121. Guidance document regarding product promotion using the Internet. 

Sec. 1122. Combating prescription drug abuse. 

Sec. 1123. Optimizing global clinical trials. 

Sec. 1124. Advancing regulatory science to promote public health innovation. 

Sec. 1125. Information technology. 

Sec. 1126. Nanotechnology. 

Sec. 1127. Online pharmacy report to Congress. 

Sec. 1128. Report on small businesses. 

Sec. 1129. Protections for the commissioned corps of the public health service act. 

Sec. 1130. Compliance date for rule relating to sunscreen drug products for overthe-counter human use. 

Sec. 1131. Strategic integrated management plan. 

Sec. 1132. Assessment and modification of REMS. 

Sec. 1133. Extension of period for first applicant to obtain tentative approval 

without forfeiting 180-day-exclusivity period. 

Sec. 1134. Deadline for determination on certain petitions. 

Sec. 1135. Final agency action relating to petitions and civil actions. 

Sec. 1136. Electronic submission of applications. 

Sec. 1137. Patient participation in medical product discussions. 

Sec. 1138. Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups. 

Sec. 1139. Scheduling of hydrocodone. 

Sec. 1140. Study on Drug Labeling by Electronic Means. 

Sec. 1141. Recommendations on interoperability standards. 

Sec. 1142. Conflicts of interest. 
5 

•S 3187 EAH 

Sec. 1143. Notification of FDA intent to regulate laboratory-developed tests. 

Subtitle D—Synthetic Drugs 

Sec. 1151. Short title. 

Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled Substances 

Act. 

Sec. 1153. Temporary scheduling to avoid imminent hazards to public safety expansion. 

1 (b) REFERENCES IN ACT.—Except as otherwise speci2 fied, amendments made by this Act to a section or other 

3 provision of law are amendments to such section or other 

4 provision of the Federal Food, Drug, and Cosmetic Act (21 

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

6 TITLE I—FEES RELATING TO 

7 DRUGS 

8 SEC. 101. SHORT TITLE; FINDING. 

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

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

11 (b) FINDING.—The Congress finds that the fees author12 ized by the amendments made in this title will be dedicated 

13 toward expediting the drug development process and the 

14 process for the review of human drug applications, includ15 ing postmarket drug safety activities, as set forth in the 

16 goals identified for purposes of part 2 of subchapter C of 

17 chapter VII of the Federal Food, Drug, and Cosmetic Act, 

18 in the letters from the Secretary of Health and Human 

19 Services to the Chairman of the Committee on Health, Edu20 cation, Labor, and Pensions of the Senate and the Chair21 man of the Committee on Energy and Commerce of the 
6 

•S 3187 EAH 

1 House of Representatives, as set forth in the Congressional 

2 Record. 

3 SEC. 102. DEFINITIONS. 

4 Section 735(7) (21 U.S.C. 379g) is amended by strik5 ing ‘‘expenses incurred in connection with’’ and inserting 

6 ‘‘expenses in connection with’’. 

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

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

9 (1) in subsection (a)— 

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

11 by striking ‘‘fiscal year 2008’’ and inserting ‘‘fis12 cal year 2013’’; 

13 (B) in paragraph (1)(A)— 

14 (i) in clause (i), by striking ‘‘(c)(5)’’ 

15 and inserting ‘‘(c)(4)’’; and 

16 (ii) in clause (ii), by striking ‘‘(c)(5)’’ 

17 and inserting ‘‘(c)(4)’’; 

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

19 paragraph (2)(A)— 

20 (i) by striking ‘‘(c)(5)’’ and inserting 

21 ‘‘(c)(4)’’; and 

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

23 October 1 of each year’’ and inserting ‘‘due 

24 on the later of the first business day on or 

25 after October 1 of each fiscal year or the 
7 

•S 3187 EAH 

1 first business day after the enactment of an 

2 appropriations Act providing for the collec3 tion and obligation of fees for such fiscal 

4 year under this section’’; 

5 (D) in paragraph (3)— 

6 (i) in subparagraph (A)— 

7 (I) by striking ‘‘subsection (c)(5)’’ 

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

9 (II) by striking ‘‘payable on or 

10 before October 1 of each year.’’ and in11 serting ‘‘due on the later of the first 

12 business day on or after October 1 of 

13 each fiscal year or the first business 

14 day after the enactment of an appro15 priations Act providing for the collec16 tion and obligation of fees for such fis17 cal year under this section.’’; and 

18 (ii) by amending subparagraph (B) to 

19 read as follows: 

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

21 product shall not be assessed a fee under sub22 paragraph (A) if such product is— 

23 ‘‘(i) identified on the list compiled 

24 under section 505(j)(7) with a potency de25 scribed in terms of per 100 mL; 
8 

•S 3187 EAH 

1 ‘‘(ii) the same product as another 

2 product that— 

3 ‘‘(I) was approved under an ap4 plication filed under section 505(b) or 

5 505(j); and 

6 ‘‘(II) is not in the list of discon7 tinued products compiled under section 

8 505(j)(7); 

9 ‘‘(iii) the same product as another 

10 product that was approved under an abbre11 viated application filed under section 507 

12 (as in effect on the day before the date of en13 actment of the Food and Drug Administra14 tion Modernization Act of 1997); or 

15 ‘‘(iv) the same product as another 

16 product that was approved under an abbre17 viated new drug application pursuant to 

18 regulations in effect prior to the implemen19 tation of the Drug Price Competition and 

20 Patent Term Restoration Act of 1984.’’; 

21 (2) in subsection (b)— 

22 (A) in paragraph (1)— 

23 (i) in the matter preceding subpara24 graph (A), by striking ‘‘fiscal years 2008 
9 

•S 3187 EAH 

1 through 2012’’ and inserting ‘‘fiscal years 

2 2013 through 2017’’; 

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

4 ‘‘$392,783,000; and’’ and inserting 

5 ‘‘$693,099,000;’’; and 

6 (iii) by striking subparagraph (B) and 

7 inserting the following: 

8 ‘‘(B) the dollar amount equal to the infla9 tion adjustment for fiscal year 2013 (as deter10 mined under paragraph (3)(A)); and 

11 ‘‘(C) the dollar amount equal to the work12 load adjustment for fiscal year 2013 (as deter13 mined under paragraph (3)(B)).’’; and 

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

15 inserting the following: 

16 ‘‘(3) FISCAL YEAR 2013 INFLATION AND WORK17 LOAD ADJUSTMENTS.—For purposes of paragraph (1), 

18 the dollar amount of the inflation and workload ad19 justments for fiscal year 2013 shall be determined as 

20 follows: 

21 ‘‘(A) INFLATION ADJUSTMENT.—The infla22 tion adjustment for fiscal year 2013 shall be the 

23 sum of— 

24 ‘‘(i) $652,709,000 multiplied by the re25 sult of an inflation adjustment calculation 
10 

•S 3187 EAH 

1 determined using the methodology described 

2 in subsection (c)(1)(B); and 

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

4 result of an inflation adjustment calculation 

5 determined using the methodology described 

6 in subsection (c)(1)(C). 

7 ‘‘(B) WORKLOAD ADJUSTMENT.—Subject to 

8 subparagraph (C), the workload adjustment for 

9 fiscal 2013 shall be— 

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

11 the inflation adjustment calculated under 

12 subparagraph (A); multiplied by 

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

14 percentage workload adjustment for fiscal 

15 year 2013, as determined using the method16 ology described in subsection (c)(2)(A), 

17 would exceed the percentage workload ad18 justment (as so determined) for fiscal year 

19 2012, if both such adjustment percentages 

20 were calculated using the 5-year base period 

21 consisting of fiscal years 2003 through 

22 2007. 

23 ‘‘(C) LIMITATION.—Under no circumstances 

24 shall the adjustment under subparagraph (B) re25 sult in fee revenues for fiscal year 2013 that are 
11 

•S 3187 EAH 

1 less than the sum of the amount under para2 graph (1)(A) and the amount under paragraph 

3 (1)(B).’’; 

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

5 following: 

6 ‘‘(c) ADJUSTMENTS.— 

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

8 2014 and subsequent fiscal years, the revenues estab9 lished in subsection (b) shall be adjusted by the Sec10 retary by notice, published in the Federal Register, 

11 for a fiscal year by the amount equal to the sum of— 

12 ‘‘(A) one; 

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

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

15 Food and Drug Administration, of all personnel 

16 compensation and benefits paid with respect to 

17 such positions for the first 3 years of the pre18 ceding 4 fiscal years, multiplied by the propor19 tion of personnel compensation and benefits costs 

20 to total costs of the process for the review of 

21 human drug applications (as defined in section 

22 735(6)) for the first 3 years of the preceding 4 

23 fiscal years, and 

24 ‘‘(C) the average annual percent change 

25 that occurred in the Consumer Price Index for 
12 

•S 3187 EAH 

1 urban consumers (Washington-Baltimore, DC– 

2 MD–VA–WV; Not Seasonally Adjusted; All items; 

3 Annual Index) for the first 3 years of the pre4 ceding 4 years of available data multiplied by 

5 the proportion of all costs other than personnel 

6 compensation and benefits costs to total costs of 

7 the process for the review of human drug appli8 cations (as defined in section 735(6)) for the first 

9 3 years of the preceding 4 fiscal years. 

10 The adjustment made each fiscal year under this 

11 paragraph shall be added on a compounded basis to 

12 the sum of all adjustments made each fiscal year after 

13 fiscal year 2013 under this paragraph. 

14 ‘‘(2) WORKLOAD ADJUSTMENT.—For fiscal year 

15 2014 and subsequent fiscal years, after the fee reve16 nues established in subsection (b) are adjusted for a 

17 fiscal year for inflation in accordance with para18 graph (1), the fee revenues shall be adjusted further 

19 for such fiscal year to reflect changes in the workload 

20 of the Secretary for the process for the review of 

21 human drug applications. With respect to such ad22 justment: 

23 ‘‘(A) The adjustment shall be determined by 

24 the Secretary based on a weighted average of the 

25 change in the total number of human drug ap-
13 

•S 3187 EAH 

1 plications (adjusted for changes in review activi2 ties, as described in the notice that the Secretary 

3 is required to publish in the Federal Register 

4 under this subparagraph), efficacy supplements, 

5 and manufacturing supplements submitted to the 

6 Secretary, and the change in the total number of 

7 active commercial investigational new drug ap8 plications (adjusted for changes in review activi9 ties, as so described) during the most recent 12- 

10 month period for which data on such submis11 sions is available. The Secretary shall publish in 

12 the Federal Register the fee revenues and fees re13 sulting from the adjustment and the supporting 

14 methodologies. 

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 sub19 section (b)(1)(B), as adjusted for inflation under 

20 paragraph (1). 

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

22 independent accounting or consulting firm to pe23 riodically review the adequacy of the adjustment 

24 and publish the results of those reviews. The first 

25 review shall be conducted and published by the 
14 

•S 3187 EAH 

1 end of fiscal year 2013 (to examine the perform2 ance of the adjustment since fiscal year 2009), 

3 and the second review shall be conducted and 

4 published by the end of fiscal year 2015 (to ex5 amine the continued performance of the adjust6 ment). The reports shall evaluate whether the ad7 justment reasonably represents actual changes in 

8 workload volume and complexity and present op9 tions to discontinue, retain, or modify any ele10 ments of the adjustment. The reports shall be 

11 published for public comment. After review of the 

12 reports and receipt of public comments, the Sec13 retary shall, if warranted, adopt appropriate 

14 changes to the methodology. If the Secretary 

15 adopts changes to the methodology based on the 

16 first report, the changes shall be effective for the 

17 first fiscal year for which fees are set after the 

18 Secretary adopts such changes and each subse19 quent fiscal year. 

20 ‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal year 

21 2017, the Secretary may, in addition to adjustments 

22 under this paragraph and paragraphs (1) and (2), 

23 further increase the fee revenues and fees established 

24 in subsection (b) if such an adjustment is necessary 

25 to provide for not more than 3 months of operating 
15 

•S 3187 EAH 

1 reserves of carryover user fees for the process for the 

2 review of human drug applications for the first 3 

3 months of fiscal year 2018. If such an adjustment is 

4 necessary, the rationale for the amount of the increase 

5 shall be contained in the annual notice establishing 

6 fee revenues and fees for fiscal year 2017. If the Sec7 retary has carryover balances for such process in ex8 cess of 3 months of such operating reserves, the adjust9 ment under this paragraph shall not be made. 

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

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

12 fiscal year that begins after September 30, 2012, es13 tablish, for the next fiscal year, application, product, 

14 and establishment fees under subsection (a), based on 

15 the revenue amounts established under subsection (b) 

16 and the adjustments provided under this subsection. 

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

18 as adjusted under this subsection, for a fiscal year 

19 may not exceed the total costs for such fiscal year for 

20 the resources allocated for the process for the review 

21 of human drug applications.’’; and 

22 (4) in subsection (g)— 

23 (A) in paragraph (1), by striking ‘‘Fees au24 thorized’’ and inserting ‘‘Subject to paragraph 

25 (2)(C), fees authorized’’; 
16 

•S 3187 EAH 

1 (B) in paragraph (2)— 

2 (i) in subparagraph (A)(i), by striking 

3 ‘‘shall be retained’’ and inserting ‘‘subject to 

4 subparagraph (C), shall be collected and 

5 available’’; 

6 (ii) in subparagraph (A)(ii), by strik7 ing ‘‘shall only be collected and available’’ 

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

9 (iii) by adding at the end the following 

10 new subparagraph: 

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

12 Payment of fees authorized under this section for 

13 a fiscal year, prior to the due date for such fees, 

14 may be accepted by the Secretary in accordance 

15 with authority provided in advance in a prior 

16 year appropriations Act.’’; 

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

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

19 years 2013 through 2017’’; and 

20 (D) in paragraph (4)— 

21 (i) by striking ‘‘fiscal years 2008 

22 through 2010’’ and inserting ‘‘fiscal years 

23 2013 through 2015’’; 

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

25 inserting ‘‘fiscal year 2016’’; 
17 

•S 3187 EAH 

1 (iii) by striking ‘‘fiscal years 2008 

2 through 2011’’ and inserting ‘‘fiscal years 

3 2013 through 2016’’; and 

4 (iv) by striking ‘‘fiscal year 2012’’ and 

5 inserting ‘‘fiscal year 2017’’. 

6 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

8 (1) by amending subsection (a) to read as fol9 lows: 

10 ‘‘(a) PERFORMANCE REPORT.— 

11 ‘‘(1) IN GENERAL.—Beginning with fiscal year 

12 2013, not later than 120 days after the end of each 

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

14 the Secretary shall prepare and submit to the Com15 mittee on Energy and Commerce of the House of Rep16 resentatives and the Committee on Health, Education, 

17 Labor, and Pensions of the Senate a report con18 cerning— 

19 ‘‘(A) the progress of the Food and Drug Ad20 ministration in achieving the goals identified in 

21 the letters described in section 101(b) of the Pre22 scription Drug User Fee Amendments of 2012 

23 during such fiscal year and the future plans of 

24 the Food and Drug Administration for meeting 
18 

•S 3187 EAH 

1 the goals, including the status of the independent 

2 assessment described in such letters; and 

3 ‘‘(B) the progress of the Center for Drug 

4 Evaluation and Research and the Center for Bio5 logics Evaluation and Research in achieving the 

6 goals, and future plans for meeting the goals, in7 cluding, for each review division— 

8 ‘‘(i) the number of original standard 

9 new drug applications and biologics license 

10 applications filed per fiscal year for each 

11 review division; 

12 ‘‘(ii) the number of original priority 

13 new drug applications and biologics license 

14 applications filed per fiscal year for each 

15 review division; 

16 ‘‘(iii) the number of standard efficacy 

17 supplements filed per fiscal year for each re18 view division; 

19 ‘‘(iv) the number of priority efficacy 

20 supplements filed per fiscal year for each re21 view division; 

22 ‘‘(v) the number of applications filed 

23 for review under accelerated approval per 

24 fiscal year for each review division; 
19 

•S 3187 EAH 

1 ‘‘(vi) the number of applications filed 

2 for review as fast track products per fiscal 

3 year for each review division; 

4 ‘‘(vii) the number of applications filed 

5 for orphan-designated products per fiscal 

6 year for each review division; and 

7 ‘‘(viii) the number of breakthrough des8 ignations for a fiscal year for each review 

9 division. 

10 ‘‘(2) INCLUSION.—The report under this sub11 section for a fiscal year shall include information on 

12 all previous cohorts for which the Secretary has not 

13 given a complete response on all human drug applica14 tions and supplements in the cohort.’’. 

15 (2) in subsection (b), by striking ‘‘2008’’ and in16 serting ‘‘2013’’; and 

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

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

19 SEC. 105. SUNSET DATES. 

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

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

22 379h) shall cease to be effective October 1, 2017. 

23 (b) REPORTING REQUIREMENTS.—Section 736B of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h– 

25 2) shall cease to be effective January 31, 2018. 
20 

•S 3187 EAH 

1 (c) PREVIOUS SUNSET PROVISION.— 

2 (1) IN GENERAL.—Section 106 of the Food and 

3 Drug Administration Amendments Act of 2007 (Pub4 lic Law 110–85) is repealed. 

5 (2) CONFORMING AMENDMENT.—The Food and 

6 Drug Administration Amendments Act of 2007 (Pub7 lic Law 110–85) is amended in the table of contents 

8 in section 2, by striking the item relating to section 

9 106. 

10 (d) TECHNICAL CLARIFICATIONS.— 

11 (1) Effective September 30, 2007— 

12 (A) section 509 of the Prescription Drug 

13 User Fee Amendments Act of 2002 (Title V of 

14 Public Law 107–188) is repealed; and 

15 (B) the Public Health Security and Bioter16 rorism Preparedness and Response Act of 2002 

17 (Public Law 107–188) is amended in the table 

18 of contents in section 1(b), by striking the item 

19 relating to section 509. 

20 (2) Effective September 30, 2002— 

21 (A) section 107 of the Food and Drug Ad22 ministration Modernization Act of 1997 (Public 

23 Law 105–115) is repealed; and 
21 

•S 3187 EAH 

1 (B) the table of contents in section 1(c) of 

2 such Act is amended by striking the item related 

3 to section 107. 

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

5 the Prescription Drug User Fee Act of 1992 (Public 

6 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 sub11 chapter C of chapter VII of the Federal Food, Drug, and 

12 Cosmetic Act shall be assessed for all human drug applica13 tions received on or after October 1, 2012, regardless of the 

14 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 the 

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

20 effect with respect to human drug applications and supple21 ments (as defined in such part as of such day) that on or 

22 after October 1, 2007, but before October 1, 2012, were ac23 cepted by the Food and Drug Administration for filing with 

24 respect to assessing and collecting any fee required by such 

25 part for a fiscal year prior to fiscal year 2012. 
22 

•S 3187 EAH 

1 TITLE II—FEES RELATING TO 

2 DEVICES 

3 SEC. 201. SHORT TITLE; FINDINGS. 

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

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

6 (b) FINDINGS.—The Congress finds that the fees au7 thorized under the amendments made by this title will be 

8 dedicated toward expediting the process for the review of 

9 device applications and for assuring the safety and effec10 tiveness of devices, as set forth in the goals identified for 

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

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

13 the Secretary of Health and Human Services to the Chair14 man of the Committee on Health, Education, Labor, and 

15 Pensions of the Senate and the Chairman of the Committee 

16 on Energy and Commerce of the House of Representatives, 

17 as set forth in the Congressional Record. 

18 SEC. 202. DEFINITIONS. 

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

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

21 after ‘‘expenses’’; 

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

23 2001’’ and inserting ‘‘October 2011’’; and 

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

25 to register’’ and all that follows through the end of 
23 

•S 3187 EAH 

1 paragraph (13) and inserting the following: ‘‘is reg2 istered (or is required to register) with the Secretary 

3 under section 510 because such establishment is en4 gaged in the manufacture, preparation, propagation, 

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

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

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

8 379j(a)) is amended— 

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

10 2008’’ and inserting ‘‘fiscal year 2013’’; 

11 (2) in paragraph (2)(A)— 

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

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

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

15 (f)’’; 

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

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

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

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

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

21 inserting ‘‘2’’; and 

22 (3) in paragraph (3)— 

23 (A) in subparagraph (A), by inserting ‘‘and 

24 subsection (f)’’ after ‘‘subparagraph (B)’’; and 
24 

•S 3187 EAH 

1 (B) in subparagraph (C), by striking ‘‘ini2 tial registration’’ and all that follows through 

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

4 ‘‘(i) the initial or annual registration 

5 (as applicable) of the establishment under 

6 section 510; or 

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

8 date of enactment of an appropriations Act 

9 providing for the collection and obligation 

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

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

12 379j(b)) is amended to read as follows: 

13 ‘‘(b) FEE AMOUNTS.— 

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

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

16 through 2017, fees under subsection (a) shall be de17 rived from the base fee amounts specified in para18 graph (2), to generate the total revenue amounts spec19 ified in paragraph (3). 

20 ‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For pur21 poses of paragraph (1), the base fee amounts specified 

22 in this 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 
25 

•S 3187 EAH 

1 ‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.— 

2 For purposes of paragraph (1), the total revenue 

3 amounts specified in this paragraph are as follows: 

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

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

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

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

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

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

10 738(c) (21 U.S.C. 379j(c)) is amended— 

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

12 ADJUSTMENTS’’ after ‘‘SETTING’’; 

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

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

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

16 (4) by inserting before paragraph (4), as so re17 designated, the following: 

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

19 before the start of each fiscal year after September 30, 

20 2012, establish fees under subsection (a), based on 

21 amounts specified under subsection (b) and the ad22 justments provided under this subsection, and publish 

23 such fees, and the rationale for any adjustments to 

24 such fees, in the Federal Register. 

25 ‘‘(2) INFLATION ADJUSTMENTS.— 
26 

•S 3187 EAH 

1 ‘‘(A) ADJUSTMENT TO TOTAL REVENUE

2 AMOUNTS.—For fiscal year 2014 and each subse3 quent fiscal year, the Secretary shall adjust the 

4 total revenue amount specified in subsection 

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

6 amount by the applicable inflation adjustment 

7 under subparagraph (B) for such year. 

8 ‘‘(B) APPLICABLE INFLATION ADJUSTMENT

9 TO TOTAL REVENUE AMOUNTS.—The applicable 

10 inflation adjustment for a fiscal year is— 

11 ‘‘(i) for fiscal year 2014, the base infla12 tion adjustment under subparagraph (C) for 

13 such fiscal year; and 

14 ‘‘(ii) for fiscal year 2015 and each sub15 sequent fiscal year, the product of— 

16 ‘‘(I) the base inflation adjustment 

17 under subparagraph (C) for such fiscal 

18 year; and 

19 ‘‘(II) the product of the base infla20 tion adjustment under subparagraph 

21 (C) for each of the fiscal years pre22 ceding such fiscal year, beginning with 

23 fiscal year 2014. 

24 ‘‘(C) BASE INFLATION ADJUSTMENT TO

25 TOTAL REVENUE AMOUNTS.— 
27 

•S 3187 EAH 

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

2 adjustment under clause (ii), the base infla3 tion adjustment for a fiscal year is the sum 

4 of one plus— 

5 ‘‘(I) the average annual percent 

6 change in the cost, per full-time equiv7 alent position of the Food and Drug 

8 Administration, of all personnel com9 pensation and benefits paid with re10 spect to such positions for the first 3 

11 years of the preceding 4 fiscal years, 

12 multiplied by 0.60; and 

13 ‘‘(II) the average annual percent 

14 change that occurred in the Consumer 

15 Price Index for urban consumers 

16 (Washington-Baltimore, DC–MD–VA– 

17 WV; Not Seasonally Adjusted; All 

18 items; Annual Index) for the first 3 

19 years of the preceding 4 years of avail20 able data multiplied by 0.40. 

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

22 subparagraph (B), if the base inflation ad23 justment for a fiscal year under clause (i)— 
28 

•S 3187 EAH 

1 ‘‘(I) is less than 1, such adjust2 ment shall be considered to be equal to 

3 1; or 

4 ‘‘(II) is greater than 1.04, such 

5 adjustment shall be considered to be 

6 equal to 1.04. 

7 ‘‘(D) ADJUSTMENT TO BASE FEE

8 AMOUNTS.—For each of fiscal years 2014 

9 through 2017, the base fee amounts specified in 

10 subsection (b)(2) shall be adjusted as needed, on 

11 a uniform proportionate basis, to generate the 

12 total revenue amounts under subsection (b)(3), as 

13 adjusted for inflation under subparagraph (A). 

14 ‘‘(3) VOLUME-BASED ADJUSTMENTS TO ESTAB15 LISHMENT REGISTRATION BASE FEES.—For each of 

16 fiscal years 2014 through 2017, after the base fee 

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

18 under paragraph (2)(D), the base establishment reg19 istration fee amounts specified in such subsection 

20 shall be further adjusted, as the Secretary estimates is 

21 necessary in order for total fee collections for such fis22 cal year to generate the total revenue amounts, as ad23 justed under paragraph (2).’’. 

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

25 U.S.C. 379j) is amended by— 
29 

•S 3187 EAH 

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

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

3 (2) by inserting after subsection (e) the following 

4 new subsection: 

5 ‘‘(f) FEE WAIVER OR REDUCTION.— 

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

7 Secretary’s sole discretion, grant a waiver or reduc8 tion of fees under subsection (a)(2) or (a)(3) if the 

9 Secretary finds that such waiver or reduction is in 

10 the interest of public health. 

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

12 reductions granted by the Secretary in any fiscal year 

13 under paragraph (1) shall not exceed 2 percent of the 

14 total fee revenue amounts established for such year 

15 under subsection (c). 

16 ‘‘(3) DURATION.—The authority provided by this 

17 subsection terminates October 1, 2017.’’. 

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

19 379j(h)(1)(A)), as redesignated by subsection (d)(1), is 

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

21 ‘‘$280,587,000’’. 

22 (f) CREDITING AND AVAILABILITY OF FEES.—Section 

23 738(i) (21 U.S.C. 379j(i)), as redesignated by subsection 

24 (d)(1), is amended— 
30 

•S 3187 EAH 

1 (1) in paragraph (1), by striking ‘‘Fees author2 ized’’ and inserting ‘‘Subject to paragraph (2)(C), fees 

3 authorized’’; 

4 (2) in paragraph (2)— 

5 (A) in subparagraph (A)— 

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

7 retained’’ and inserting ‘‘subject to subpara8 graph (C), shall be collected and available’’; 

9 and 

10 (ii) in clause (ii)— 

11 (I) by striking ‘‘collected and’’ 

12 after ‘‘shall only be’’; and 

13 (II) by striking ‘‘fiscal year 2002’’ 

14 and inserting ‘‘fiscal year 2009’’; and 

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

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

17 Payment of fees authorized under this section for 

18 a fiscal year, prior to the due date for such fees, 

19 may be accepted by the Secretary in accordance 

20 with authority provided in advance in a prior 

21 year appropriations Act.’’; 

22 (3) by amending paragraph (3) to read as fol23 lows: 

24 ‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.— 

25 For each of the fiscal years 2013 through 2017, there 
31 

•S 3187 EAH 

1 is authorized to be appropriated for fees under this 

2 section an amount equal to the total revenue amount 

3 specified under subsection (b)(3) for the fiscal year, as 

4 adjusted under subsection (c) and, for fiscal year 

5 2017 only, as further adjusted under paragraph (4).’’; 

6 and 

7 (4) in paragraph (4)— 

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

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

10 2014, and 2015’’; 

11 (B) by striking ‘‘fiscal year 2011’’ and in12 serting ‘‘fiscal year 2016’’; 

13 (C) by striking ‘‘June 30, 2011’’ and insert14 ing ‘‘June 30, 2016’’; 

15 (D) by striking ‘‘the amount of fees specified 

16 in aggregate in’’ and inserting ‘‘the cumulative 

17 amount appropriated pursuant to’’; 

18 (E) by striking ‘‘aggregate amount in’’ be19 fore ‘‘excess shall be credited’’; and 

20 (F) by striking ‘‘fiscal year 2012’’ and in21 serting ‘‘fiscal year 2017’’. 

22 (g) CONFORMING AMENDMENT.—Section 515(c)(4)(A) 

23 (21 U.S.C. 360e(c)(4)(A)) is amended by striking ‘‘738(g)’’ 

24 and inserting ‘‘738(h)’’. 
32 

•S 3187 EAH 

1 SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 (a) REAUTHORIZATION.—Section 738A(b) (21 U.S.C. 

3 379j–1(b)) is amended— 

4 (1) in paragraph (1), by striking ‘‘2012’’ and in5 serting ‘‘2017’’; and 

6 (2) in paragraph (5), by striking ‘‘2012’’ and in7 serting ‘‘2017’’. 

8 (b) PERFORMANCE REPORTS.—Section 738A(a) (21 

9 U.S.C. 379j–1(a)) is amended— 

10 (1) by striking paragraph (1) and inserting the 

11 following: 

12 ‘‘(1) PERFORMANCE REPORT.— 

13 ‘‘(A) IN GENERAL.—Beginning with fiscal 

14 year 2013, for each fiscal year for which fees are 

15 collected under this part, the Secretary shall pre16 pare and submit to the Committee on Health, 

17 Education, Labor, and Pensions of the Senate 

18 and the Committee on Energy and Commerce of 

19 the House of Representatives annual reports con20 cerning the progress of the Food and Drug Ad21 ministration in achieving the goals identified in 

22 the letters described in section 201(b) of the Med23 ical Device User Fee Amendments of 2012 dur24 ing such fiscal year and the future plans of the 

25 Food and Drug Administration for meeting the 

26 goals. 
33 

•S 3187 EAH 

1 ‘‘(B) PUBLICATION.—With regard to infor2 mation to be reported by the Food and Drug Ad3 ministration to industry on a quarterly and an4 nual basis pursuant to the letters described in 

5 section 201(b) of the Medical Device User Fee 

6 Amendments Act of 2012, the Secretary shall 

7 make such information publicly available on the 

8 Internet Web site of the Food and Drug Admin9 istration not later than 60 days after the end of 

10 each quarter or 120 days after the end of each 

11 fiscal year, respectively, to which such informa12 tion applies. This information shall include the 

13 status of the independent assessment identified 

14 in the letters described in such section 201(b). 

15 ‘‘(C) UPDATES.—The Secretary shall in16 clude in each report under subparagraph (A) in17 formation on all previous cohorts for which the 

18 Secretary has not given a complete response on 

19 all device premarket applications and reports, 

20 supplements, and premarket notifications in the 

21 cohort.’’; and 

22 (2) in paragraph (2), by striking ‘‘2008 through 

23 2012’’ and inserting ‘‘2013 through 2017’’. 
34 

•S 3187 EAH 

1 SEC. 205. SAVINGS CLAUSE. 

2 Notwithstanding the amendments made by this title, 

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

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

5 on the day before the date of the enactment of this title, 

6 shall continue to be in effect with respect to the submissions 

7 listed in section 738(a)(2)(A) of such Act (in effect as of 

8 such day) that on or after October 1, 2007, but before Octo9 ber 1, 2012, were accepted by the Food and Drug Adminis10 tration for filing with respect to assessing and collecting 

11 any fee required by such part for a fiscal year prior to fiscal 

12 year 2013. 

13 SEC. 206. EFFECTIVE DATE. 

14 The amendments made by this title shall take effect 

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

16 Act, whichever is later, except that fees under part 3 of sub17 chapter C of chapter VII of the Federal Food, Drug, and 

18 Cosmetic Act shall be assessed for all submissions listed in 

19 section 738(a)(2)(A) of such Act received on or after October 

20 1, 2012, regardless of the date of the enactment of this Act. 

21 SEC. 207. SUNSET CLAUSE. 

22 (a) IN GENERAL.—Sections 737 and 738 of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall 

24 cease to be effective October 1, 2017. Section 738A (21 

25 U.S.C. 739j–1) of the Federal Food, Drug, and Cosmetic 
35 

•S 3187 EAH 

1 Act (regarding reauthorization and reporting requirements) 

2 shall cease to be effective January 31, 2018. 

3 (b) PREVIOUS SUNSET PROVISION.— 

4 (1) IN GENERAL.—Section 217 of the Food and 

5 Drug Administration Amendments Act of 2007 (Title 

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

7 (2) CONFORMING AMENDMENT.—The Food and 

8 Drug Administration Amendments Act of 2007 (Pub9 lic Law 110–85) is amended in the table of contents 

10 in section 2, by striking the item relating to section 

11 217. 

12 (c) TECHNICAL CLARIFICATION.—Effective September 

13 30, 2007— 

14 (1) section 107 of the Medical Device User Fee 

15 and Modernization Act of 2002 (Public Law 107– 

16 250) is repealed; and 

17 (2) the table of contents in section 1(b) of such 

18 Act is amended by striking the item related to section 

19 107. 

20 SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT 

21 ACTIVITIES RELATED TO THE PROCESS FOR 

22 THE REVIEW OF DEVICE APPLICATIONS. 

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

24 is amended by inserting after section 713 the following new 

25 section: 
36 

•S 3187 EAH 

1 ‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. 

2 ‘‘(a) IN GENERAL.—In addition to any other personnel 

3 authorities under other provisions of law, the Secretary 

4 may, without regard to the provisions of title 5, United 

5 States Code, governing appointments in the competitive 

6 service, appoint employees to positions in the Food and 

7 Drug Administration to perform, administer, or support 

8 activities described in subsection (b), if the Secretary deter9 mines that such appointments are needed to achieve the ob10 jectives specified in subsection (c). 

11 ‘‘(b) ACTIVITIES DESCRIBED.—The activities described 

12 in this subsection are activities under this Act related to 

13 the process for the review of device applications (as defined 

14 in section 737(8)). 

15 ‘‘(c) OBJECTIVES SPECIFIED.—The objectives specified 

16 in this subsection are with respect to the activities under 

17 subsection (b), the goals referred to in section 738A(a)(1). 

18 ‘‘(d) INTERNAL CONTROLS.—The Secretary shall insti19 tute appropriate internal controls for appointments under 

20 this section. 

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

22 under this section shall terminate on the date that is 3 years 

23 after the date of enactment of this section.’’. 
37 

•S 3187 EAH 

1 TITLE III—FEES RELATING TO 

2 GENERIC DRUGS 

3 SEC. 301. SHORT TITLE. 

4 (a) SHORT TITLE.—This title may be cited as the ‘‘Ge5 neric Drug User Fee Amendments of 2012’’. 

6 (b) FINDING.—The Congress finds that the fees author7 ized by the amendments made in this title will be dedicated 

8 to human generic drug activities, as set forth in the goals 

9 identified for purposes of part 7 of subchapter C of chapter 

10 VII of the Federal Food, Drug, and Cosmetic Act, in the 

11 letters from the Secretary of Health and Human Services 

12 to the Chairman of the Committee on Health, Education, 

13 Labor, and Pensions of the Senate and the Chairman of 

14 the Committee on Energy and Commerce of the House of 

15 Representatives, as set forth in the Congressional Record. 

16 SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE17 NERIC DRUG FEES. 

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

19 is amended by adding at the end the following: 

20 ‘‘PART 7—FEES RELATING TO GENERIC DRUGS 

21 ‘‘SEC. 744A. DEFINITIONS. 

22 ‘‘For purposes of this part: 

23 ‘‘(1) The term ‘abbreviated new drug applica24 tion’— 
38 

•S 3187 EAH 

1 ‘‘(A) means an application submitted under 

2 section 505(j), an abbreviated application sub3 mitted under section 507 (as in effect on the day 

4 before the date of enactment of the Food and 

5 Drug Administration Modernization Act of 

6 1997), or an abbreviated new drug application 

7 submitted pursuant to regulations in effect prior 

8 to the implementation of the Drug Price Com9 petition and Patent Term Restoration Act of 

10 1984; and 

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

12 positron emission tomography drug. 

13 ‘‘(2) The term ‘active pharmaceutical ingredient’ 

14 means— 

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

16 substance is unstable or cannot be transported on 

17 its own, intended— 

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

19 drug; and 

20 ‘‘(ii) to furnish pharmacological activ21 ity or other direct effect in the diagnosis, 

22 cure, mitigation, treatment, or prevention of 

23 disease, or to affect the structure or any 

24 function of the human body; or 
39 

•S 3187 EAH 

1 ‘‘(B) a substance intended for final crys2 tallization, purification, or salt formation, or 

3 any combination of those activities, to become a 

4 substance or mixture described in subparagraph 

5 (A). 

6 ‘‘(3) The term ‘adjustment factor’ means a factor 

7 applicable to a fiscal year that is the Consumer Price 

8 Index for all urban consumers (all items; United 

9 States city average) for October of the preceding fiscal 

10 year divided by such Index for October 2011. 

11 ‘‘(4) The term ‘affiliate’ means a business entity 

12 that has a relationship with a second business entity 

13 if, directly or indirectly— 

14 ‘‘(A) one business entity controls, or has the 

15 power to control, the other business entity; or 

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

17 control, both of the business entities. 

18 ‘‘(5)(A) The term ‘facility’— 

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

20 ‘‘(I) under one management, either di21 rect or indirect; and 

22 ‘‘(II) at one geographic location or ad23 dress engaged in manufacturing or proc24 essing an active pharmaceutical ingredient 

25 or a finished dosage form; and 
40 

•S 3187 EAH 

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

2 entity whose only manufacturing or processing 

3 activities are one or more of the following: re4 packaging, relabeling, or testing. 

5 ‘‘(B) For purposes of subparagraph (A), separate 

6 buildings within close proximity are considered to be 

7 at one geographic location or address if the activities 

8 in them are— 

9 ‘‘(i) closely related to the same business en10 terprise; 

11 ‘‘(ii) under the supervision of the same local 

12 management; and 

13 ‘‘(iii) capable of being inspected by the Food 

14 and Drug Administration during a single in15 spection. 

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

17 definition of a facility under this paragraph but for 

18 being under multiple management, the business or 

19 other entity is deemed to constitute multiple facilities, 

20 one per management entity, for purposes of this para21 graph. 

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

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

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

25 tablet, capsule, solution, or topical application; 
41 

•S 3187 EAH 

1 ‘‘(B) a drug product in a form in which re2 constitution is necessary prior to administration 

3 to a patient, such as oral suspensions or 

4 lyophilized powders; or 

5 ‘‘(C) any combination of an active pharma6 ceutical ingredient with another component of a 

7 drug product for purposes of production of a 

8 drug product described in subparagraph (A) or 

9 (B). 

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

11 an abbreviated new drug application, an amendment 

12 to an abbreviated new drug application, or a prior 

13 approval supplement to an abbreviated new drug ap14 plication. 

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

16 means the following activities of the Secretary associ17 ated with generic drugs and inspection of facilities 

18 associated with generic drugs: 

19 ‘‘(A) The activities necessary for the review 

20 of generic drug submissions, including review of 

21 drug master files referenced in such submissions. 

22 ‘‘(B) The issuance of— 

23 ‘‘(i) approval letters which approve ab24 breviated new drug applications or supple25 ments to such applications; or 
42 

•S 3187 EAH 

1 ‘‘(ii) complete response letters which set 

2 forth in detail the specific deficiencies in 

3 such applications and, where appropriate, 

4 the actions necessary to place such applica5 tions in condition for approval. 

6 ‘‘(C) The issuance of letters related to Type 

7 II active pharmaceutical drug master files 

8 which— 

9 ‘‘(i) set forth in detail the specific defi10 ciencies in such submissions, and where ap11 propriate, the actions necessary to resolve 

12 those deficiencies; or 

13 ‘‘(ii) document that no deficiencies 

14 need to be addressed. 

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

16 ‘‘(E) Monitoring of research conducted in 

17 connection with the review of generic drug sub18 missions and drug master files. 

19 ‘‘(F) Postmarket safety activities with re20 spect to drugs approved under abbreviated new 

21 drug applications or supplements, including the 

22 following activities: 

23 ‘‘(i) Collecting, developing, and review24 ing safety information on approved drugs, 

25 including adverse event reports. 
43 

•S 3187 EAH 

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 studies 

10 and clinical trials and labeling changes) 

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

13 those activities relate to abbreviated new 

14 drug applications. 

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

16 (relating to adverse-event reports and 

17 postmarket safety activities). 

18 ‘‘(G) Regulatory science activities related to 

19 generic drugs. 

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

21 drug’ has the meaning given to the term ‘compounded 

22 positron emission tomography drug’ in section 

23 201(ii), except that paragraph (1)(B) of such section 

24 shall not apply. 
44 

•S 3187 EAH 

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

2 means a request to the Secretary to approve a change 

3 in the drug substance, drug product, production proc4 ess, quality controls, equipment, or facilities covered 

5 by an approved abbreviated new drug application 

6 when that change has a substantial potential to have 

7 an adverse effect on the identity, strength, quality, 

8 purity, or potency of the drug product as these factors 

9 may relate to the safety or effectiveness of the drug 

10 product. 

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

12 generic drug activities’ means the expenses for— 

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

14 Drug Administration, contractors of the Food 

15 and Drug Administration, advisory committees, 

16 and costs related to such officers and employees 

17 and to contracts with such contractors; 

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

19 acquisition, maintenance, and repair of com20 puter resources; 

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

22 repair of facilities and acquisition, maintenance, 

23 and repair of fixtures, furniture, scientific equip24 ment, and other necessary materials and sup25 plies; and 
45 

•S 3187 EAH 

1 ‘‘(D) collecting fees under subsection (a) and 

2 accounting for resources allocated for the review 

3 of abbreviated new drug applications and sup4 plements and inspection related to generic drugs. 

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

6 ingredient drug master file’ means a submission of 

7 information to the Secretary by a person that intends 

8 to authorize the Food and Drug Administration to 

9 reference the information to support approval of a ge10 neric drug submission without the submitter having 

11 to disclose the information to the generic drug submis12 sion applicant. 

13 ‘‘SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GE14 NERIC DRUG FEES. 

15 ‘‘(a) TYPES OF FEES.—Beginning in fiscal year 2013, 

16 the Secretary shall assess and collect fees in accordance with 

17 this section as follows: 

18 ‘‘(1) ONE-TIME BACKLOG FEE FOR ABBREVIATED

19 NEW DRUG APPLICATIONS PENDING ON OCTOBER 1, 

20 2012.— 

21 ‘‘(A) IN GENERAL.—Each person that owns 

22 an abbreviated new drug application that is 

23 pending on October 1, 2012, and that has not re24 ceived a tentative approval prior to that date, 
46 

•S 3187 EAH 

1 shall be subject to a fee for each such application, 

2 as calculated under subparagraph (B). 

3 ‘‘(B) METHOD OF FEE AMOUNT CALCULA4 TION.—The amount of each one-time backlog fee 

5 shall be calculated by dividing $50,000,000 by 

6 the total number of abbreviated new drug appli7 cations pending on October 1, 2012, that have 

8 not received a tentative approval as of that date. 

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

10 2012, the Secretary shall publish in the Federal 

11 Register a notice announcing the amount of the 

12 fee required by subparagraph (A). 

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

14 subparagraph (A) shall be due no later than 30 

15 calendar days after the date of the publication of 

16 the notice specified in subparagraph (C). 

17 ‘‘(2) DRUG MASTER FILE FEE.— 

18 ‘‘(A) IN GENERAL.—Each person that owns 

19 a Type II active pharmaceutical ingredient drug 

20 master file that is referenced on or after October 

21 1, 2012, in a generic drug submission by any 

22 initial letter of authorization shall be subject to 

23 a drug master file fee. 

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

25 paid a drug master file fee for a Type II active 
47 

•S 3187 EAH 

1 pharmaceutical ingredient drug master file, the 

2 person shall not be required to pay a subsequent 

3 drug master file fee when that Type II active 

4 pharmaceutical ingredient drug master file is 

5 subsequently referenced in generic drug submis6 sions. 

7 ‘‘(C) NOTICE.— 

8 ‘‘(i) FISCAL YEAR 2013.—Not later than 

9 October 31, 2012, the Secretary shall pub10 lish in the Federal Register a notice an11 nouncing the amount of the drug master file 

12 fee for fiscal year 2013. 

13 ‘‘(ii) FISCAL YEAR 2014 THROUGH

14 2017.—Not later than 60 days before the 

15 start of each of fiscal years 2014 through 

16 2017, the Secretary shall publish in the 

17 Federal Register the amount of the drug 

18 master file fee established by this paragraph 

19 for such fiscal year. 

20 ‘‘(D) AVAILABILITY FOR REFERENCE.— 

21 ‘‘(i) IN GENERAL.—Subject to sub22 section (g)(2)(C), for a generic drug submis23 sion to reference a Type II active pharma24 ceutical ingredient drug master file, the 
48 

•S 3187 EAH 

1 drug master file must be deemed available 

2 for reference by the Secretary. 

3 ‘‘(ii) CONDITIONS.—A drug master file 

4 shall be deemed available for reference by 

5 the Secretary if— 

6 ‘‘(I) the person that owns a Type 

7 II active pharmaceutical ingredient 

8 drug master file has paid the fee re9 quired under subparagraph (A) within 

10 20 calendar days after the applicable 

11 due date under subparagraph (E); and 

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

13 failed an initial completeness assess14 ment by the Secretary, in accordance 

15 with criteria to be published by the 

16 Secretary. 

17 ‘‘(iii) LIST.—The Secretary shall make 

18 publicly available on the Internet Web site 

19 of the Food and Drug Administration a list 

20 of the drug master file numbers that cor21 respond to drug master files that have suc22 cessfully undergone an initial completeness 

23 assessment, in accordance with criteria to 

24 be published by the Secretary, and are 

25 available for reference. 
49 

•S 3187 EAH 

1 ‘‘(E) FEE DUE DATE.— 

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

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

4 later than the date on which the first ge5 neric drug submission is submitted that ref6 erences the associated Type II active phar7 maceutical ingredient drug master file. 

8 ‘‘(ii) LIMITATION.—No fee shall be due 

9 under subparagraph (A) for a fiscal year 

10 until the later of— 

11 ‘‘(I) 30 calendar days after publi12 cation of the notice provided for in 

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

14 as applicable; or 

15 ‘‘(II) 30 calendar days after the 

16 date of enactment of an appropriations 

17 Act providing for the collection and ob18 ligation of fees under this section. 

19 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION AND

20 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 sub-
50 

•S 3187 EAH 

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

3 ‘‘(B) NOTICE.— 

4 ‘‘(i) FISCAL YEAR 2013.—Not later than 

5 October 31, 2012, the Secretary shall pub6 lish in the Federal Register a notice an7 nouncing the amount of the fees under sub8 paragraph (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 provided 

18 in clause (ii), the fees required by subpara19 graphs (A) and (F) shall be due no later 

20 than the date of submission of the abbre21 viated new drug application or prior ap22 proval supplement for which such fee ap23 plies. 
51 

•S 3187 EAH 

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 sub8 paragraph (B)(i); or 

9 ‘‘(III) if an appropriations Act is 

10 not enacted providing for the collection 

11 and obligation of fees under this sec12 tion by the date of submission of the 

13 application or prior approval supple14 ment for which the fees under subpara15 graphs (A) and (F) apply, 30 calendar 

16 days after the date that such an appro17 priations Act is enacted. 

18 ‘‘(D) REFUND OF FEE IF ABBREVIATED NEW

19 DRUG APPLICATION IS NOT CONSIDERED TO

20 HAVE BEEN RECEIVED.—The Secretary shall re21 fund 75 percent of the fee paid under subpara22 graph (A) for any abbreviated new drug applica23 tion or prior approval supplement to an abbre24 viated new drug application that the Secretary 

25 considers not to have been received within the 
52 

•S 3187 EAH 

1 meaning of section 505(j)(5)(A) for a cause other 

2 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 IN17 CLUDED BY REFERENCE TO TYPE II ACTIVE

18 PHARMACEUTICAL INGREDIENT DRUG MASTER

19 FILE.—An applicant that submits a generic drug 

20 submission on or after October 1, 2012, shall pay 

21 a fee, in the amount determined under subsection 

22 (d)(3), in addition to the fee required under sub23 paragraph (A), if— 

24 ‘‘(i) such submission contains informa25 tion concerning the manufacture of an ac-
53 

•S 3187 EAH 

1 tive pharmaceutical ingredient at a facility 

2 by means other than reference by a letter of 

3 authorization to a Type II active pharma4 ceutical 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 with 

8 respect to such information. 

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

10 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

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

12 intended to be identified, in at least one generic 

13 drug submission that is pending or approved to 

14 produce a finished dosage form of a human ge15 neric drug or an active pharmaceutical ingre16 dient contained in a human generic drug shall 

17 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 pending 

22 or approved to produce one or more finished 

23 dosage forms of a human generic drug shall 

24 be assessed an annual fee for each such fa25 cility. 
54 

•S 3187 EAH 

1 ‘‘(ii) ACTIVE PHARMACEUTICAL INGRE2 DIENT FACILITY.—Each person that owns a 

3 facility which produces, or which is pending 

4 review to produce, one or more active phar5 maceutical ingredients identified, or in6 tended to be identified, in at least one ge7 neric 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 such 

12 facility. 

13 ‘‘(iii) FACILITIES PRODUCING BOTH

14 ACTIVE PHARMACEUTICAL INGREDIENTS

15 AND FINISHED DOSAGE FORMS.—Each per16 son that owns a facility identified, or in17 tended to be identified, in at least one ge18 neric drug submission that is pending or 

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

21 one or more active pharmaceutical ingredi22 ents subject to clause (ii) shall be subject to 

23 fees under both such clauses for that facility. 
55 

•S 3187 EAH 

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 (A) 

20 shall be due on the later of— 

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

22 the publication of the notice under sub23 paragraph (B); or 

24 ‘‘(II) if an appropriations Act is 

25 not enacted providing for the collection 
56 

•S 3187 EAH 

1 and obligation of fees under this sec2 tion by the date of the publication of 

3 such notice, 30 days after the date that 

4 such an appropriations Act is enacted. 

5 ‘‘(ii) FISCAL YEARS 2014 THROUGH

6 2017.—For each of fiscal years 2014 through 

7 2017, the fees under subparagraph (A) for 

8 such fiscal year shall be due on the later 

9 of— 

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

11 after October 1 of each such year; or 

12 ‘‘(II) the first business day after 

13 the enactment of an appropriations 

14 Act providing for the collection and ob15 ligation of fees under this section for 

16 such year. 

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

18 this Act, a generic drug submission or Type II phar19 maceutical master file is deemed to be ‘submitted’ to 

20 the Food and Drug Administration— 

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

22 Administration electronic gateway, on the day 

23 when transmission to that electronic gateway is 

24 completed, except that a submission or master 

25 file that arrives on a weekend, Federal holiday, 
57 

•S 3187 EAH 

1 or day when the Food and Drug Administration 

2 office that will review that submission is not oth3 erwise open for business shall be deemed to be 

4 submitted on the next day when that office is 

5 open for business; or 

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

7 form, on the day it arrives at the appropriate 

8 designated document room of the Food and Drug 

9 Administration. 

10 ‘‘(b) FEE REVENUE AMOUNTS.— 

11 ‘‘(1) IN GENERAL.— 

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

13 2013, fees under subsection (a) shall be estab14 lished to generate a total estimated revenue 

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

16 Of that amount— 

17 ‘‘(i) $50,000,000 shall be generated by 

18 the one-time backlog fee for generic drug ap19 plications pending on October 1, 2012, es20 tablished in subsection (a)(1); and 

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

22 by the fees under paragraphs (2) through 

23 (4) of subsection (a). 

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

25 For each of the fiscal years 2014 through 2017, 
58 

•S 3187 EAH 

1 fees under paragraphs (2) through (4) of sub2 section (a) shall be established to generate a total 

3 estimated revenue amount under such subsection 

4 that is equal to $299,000,000, as adjusted pursu5 ant to subsection (c). 

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

7 paragraph (1) to generate the revenue amounts speci8 fied in paragraph (1)(A)(ii) for fiscal year 2013 and 

9 paragraph (1)(B) for each of fiscal years 2014 

10 through 2017, such fees shall be derived from the fees 

11 under paragraphs (2) through (4) of subsection (a) as 

12 follows: 

13 ‘‘(A) Six percent shall be derived from fees 

14 under subsection (a)(2) (relating to drug master 

15 files). 

16 ‘‘(B) Twenty-four percent shall be derived 

17 from fees under subsection (a)(3) (relating to ab18 breviated new drug applications and supple19 ments). The amount of a fee for a prior approval 

20 supplement shall be half the amount of the fee for 

21 an abbreviated new drug application. 

22 ‘‘(C) Fifty-six percent shall be derived from 

23 fees under subsection (a)(4)(A)(i) (relating to ge24 neric drug facilities). The amount of the fee for 

25 a facility located outside the United States and 
59 

•S 3187 EAH 

1 its territories and possessions shall be not less 

2 than $15,000 and not more than $30,000 higher 

3 than the amount of the fee for a facility located 

4 in the United States and its territories and pos5 sessions, as determined by the Secretary on the 

6 basis of data concerning the difference in cost be7 tween inspections of facilities located in the 

8 United States, including its territories and pos9 sessions, and those located outside of the United 

10 States and its territories and possessions. 

11 ‘‘(D) Fourteen percent shall be derived from 

12 fees under subsection (a)(4)(A)(ii) (relating to 

13 active pharmaceutical ingredient facilities). The 

14 amount of the fee for a facility located outside 

15 the United States and its territories and posses16 sions shall be not less than $15,000 and not more 

17 than $30,000 higher than the amount of the fee 

18 for a facility located in the United States, in19 cluding its territories and possessions, as deter20 mined by the Secretary on the basis of data con21 cerning the difference in cost between inspections 

22 of facilities located in the United States and its 

23 territories and possessions and those located out24 side of the United States and its territories and 

25 possessions. 
60 

•S 3187 EAH 

1 ‘‘(c) ADJUSTMENTS.— 

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

3 2014 and subsequent fiscal years, the revenues estab4 lished in subsection (b) shall be adjusted by the Sec5 retary by notice, published in the Federal Register, 

6 for a fiscal year, by an amount equal to the sum of— 

7 ‘‘(A) one; 

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

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

10 Food and Drug Administration, of all personnel 

11 compensation and benefits paid with respect to 

12 such positions for the first 3 years of the pre13 ceding 4 fiscal years multiplied by the propor14 tion of personnel compensation and benefits costs 

15 to total costs of human generic drug activities for 

16 the first 3 years of the preceding 4 fiscal years; 

17 and 

18 ‘‘(C) the average annual percent change 

19 that occurred in the Consumer Price Index for 

20 urban consumers (Washington-Baltimore, DC– 

21 MD–VA–WV; Not Seasonally Adjusted; All items; 

22 Annual Index) for the first 3 years of the pre23 ceding 4 years of available data multiplied by 

24 the proportion of all costs other than personnel 

25 compensation and benefits costs to total costs of 
61 

•S 3187 EAH 

1 human generic drug activities for the first 3 

2 years of the preceding 4 fiscal years. 

3 The adjustment made each fiscal year under this sub4 section shall be added on a compounded basis to the 

5 sum of all adjustments made each fiscal year after fis6 cal year 2013 under this subsection. 

7 ‘‘(2) FINAL YEAR ADJUSTMENT.—For fiscal year 

8 2017, the Secretary may, in addition to adjustments 

9 under paragraph (1), further increase the fee revenues 

10 and fees established in subsection (b) if such an ad11 justment is necessary to provide for not more than 3 

12 months of operating reserves of carryover user fees for 

13 human generic drug activities for the first 3 months 

14 of fiscal year 2018. Such fees may only be used in fis15 cal year 2018. If such an adjustment is necessary, the 

16 rationale for the amount of the increase shall be con17 tained in the annual notice establishing fee revenues 

18 and fees for fiscal year 2017. If the Secretary has car19 ryover balances for such activities in excess of 3 

20 months of such operating reserves, the adjustment 

21 under this subparagraph shall not be made. 

22 ‘‘(d) ANNUAL FEE SETTING.— 

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

24 ‘‘(A) the Secretary shall establish, by Octo25 ber 31, 2012, the one-time generic drug backlog 
62 

•S 3187 EAH 

1 fee for generic drug applications pending on Oc2 tober 1, 2012, the drug master file fee, the abbre3 viated new drug application fee, and the prior 

4 approval supplement fee under subsection (a), 

5 based on the revenue amounts established under 

6 subsection (b); and 

7 ‘‘(B) the Secretary shall establish, not later 

8 than 45 days after the date to comply with the 

9 requirement for identification of facilities in sub10 section (f)(2), the generic drug facility fee and 

11 active pharmaceutical ingredient facility fee 

12 under subsection (a) based on the revenue 

13 amounts established under subsection (b). 

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

15 more than 60 days before the first day of each of fis16 cal years 2014 through 2017, the Secretary shall es17 tablish the drug master file fee, the abbreviated new 

18 drug application fee, the prior approval supplement 

19 fee, the generic drug facility fee, and the active phar20 maceutical ingredient facility fee under subsection (a) 

21 for such fiscal year, based on the revenue amounts es22 tablished under subsection (b) and the adjustments 

23 provided under subsection (c). 

24 ‘‘(3) FEE FOR ACTIVE PHARMACEUTICAL INGRE25 DIENT INFORMATION NOT INCLUDED BY REFERENCE
63 

•S 3187 EAH 

1 TO TYPE II ACTIVE PHARMACEUTICAL INGREDIENT

2 DRUG MASTER FILE.—In establishing the fees under 

3 paragraphs (1) and (2), the amount of the fee under 

4 subsection (a)(3)(F) shall be determined by multi5 plying— 

6 ‘‘(A) the sum of— 

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

8 pharmaceutical ingredients in such submis9 sion; and 

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

11 manufactured at more than one such facil12 ity, the total number of such additional fa13 cilities; and 

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

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

16 submission. 

17 ‘‘(e) LIMIT.—The total amount of fees charged, as ad18 justed under subsection (c), for a fiscal year may not exceed 

19 the total costs for such fiscal year for the resources allocated 

20 for human generic drug activities. 

21 ‘‘(f) IDENTIFICATION OF FACILITIES.— 

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

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

24 Secretary shall publish in the Federal Register a no25 tice requiring each person that owns a facility de-
64 

•S 3187 EAH 

1 scribed in subsection (a)(4)(A), or a site or organiza2 tion required to be identified by paragraph (4), to 

3 submit to the Secretary information on the identity 

4 of each such facility, site, or organization. The notice 

5 required by this paragraph shall specify the type of 

6 information to be submitted and the means and for7 mat for submission of such information. 

8 ‘‘(2) REQUIRED SUBMISSION OF FACILITY IDEN9 TIFICATION.—Each person that owns a facility de10 scribed in subsection (a)(4)(A) or a site or organiza11 tion required to be identified by paragraph (4) shall 

12 submit to the Secretary the information required 

13 under this subsection each year. Such information 

14 shall— 

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

16 later than 60 days after the publication of the 

17 notice under paragraph (1); and 

18 ‘‘(B) for each subsequent fiscal year, be sub19 mitted, updated, or reconfirmed on or before 

20 June 1 of the previous year. 

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

22 submission required by paragraph (2) shall include 

23 for each such facility— 
65 

•S 3187 EAH 

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

2 intended to be identified in an approved or 

3 pending generic drug submission; 

4 ‘‘(B) whether the facility manufactures ac5 tive pharmaceutical ingredients or finished dos6 age forms, or both; 

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

8 within the United States and its territories and 

9 possessions; 

10 ‘‘(D) whether the facility manufactures 

11 positron emission tomography drugs solely, or in 

12 addition to other drugs; and 

13 ‘‘(E) whether the facility manufactures 

14 drugs that are not generic drugs. 

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

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

17 or operates a site or organization described in 

18 subparagraph (B) shall submit to the Secretary 

19 information concerning the ownership, name, 

20 and address of the site or organization. 

21 ‘‘(B) SITES AND ORGANIZATIONS.—A site or 

22 organization is described in this subparagraph if 

23 it is identified in a generic drug submission and 

24 is— 
66 

•S 3187 EAH 

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

2 study is conducted; 

3 ‘‘(ii) a clinical research organization; 

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

5 or 

6 ‘‘(iv) a contract repackager site. 

7 ‘‘(C) NOTICE.—The Secretary may, by no8 tice published in the Federal Register, specify the 

9 means and format for submission of the informa10 tion under subparagraph (A) and may specify, 

11 as necessary for purposes of this section, any ad12 ditional information to be submitted. 

13 ‘‘(D) INSPECTION AUTHORITY.—The Sec14 retary’s inspection authority under section 

15 704(a)(1) shall extend to all such sites and orga16 nizations. 

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

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

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

20 Secretary placing the person that owns the abbre21 viated new drug application subject to that fee on a 

22 publicly available arrears list, such that no new ab23 breviated new drug applications or supplement sub24 mitted on or after October 1, 2012, from that person, 

25 or any affiliate of that person, will be received within 
67 

•S 3187 EAH 

1 the meaning of section 505(j)(5)(A) until such out2 standing fee is paid. 

3 ‘‘(2) DRUG MASTER FILE FEE.— 

4 ‘‘(A) Failure to pay the fee under subsection 

5 (a)(2) within 20 calendar days after the applica6 ble due date under subparagraph (E) of such 

7 subsection (as described in subsection 

8 (a)(2)(D)(ii)(I)) shall result in the Type II ac9 tive pharmaceutical ingredient drug master file 

10 not being deemed available for reference. 

11 ‘‘(B)(i) Any generic drug submission sub12 mitted on or after October 1, 2012, that ref13 erences, by a letter of authorization, a Type II 

14 active pharmaceutical ingredient drug master 

15 file that has not been deemed available for ref16 erence shall not be received within the meaning 

17 of section 505(j)(5)(A) unless the condition speci18 fied in clause (ii) is met. 

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

20 is that the fee established under subsection (a)(2) 

21 has been paid within 20 calendar days of the 

22 Secretary providing the notification to the spon23 sor of the abbreviated new drug application or 

24 supplement of the failure of the owner of the 

25 Type II active pharmaceutical ingredient drug 
68 

•S 3187 EAH 

1 master file to pay the drug master file fee as 

2 specified in subparagraph (C). 

3 ‘‘(C)(i) If an abbreviated new drug applica4 tion or supplement to an abbreviated new drug 

5 application references a Type II active pharma6 ceutical ingredient drug master file for which a 

7 fee under subsection (a)(2)(A) has not been paid 

8 by the applicable date under subsection 

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

10 of the abbreviated new drug application or sup11 plement of the failure of the owner of the Type 

12 II active pharmaceutical ingredient drug master 

13 file to pay the applicable fee. 

14 ‘‘(ii) If such fee is not paid within 20 cal15 endar days of the Secretary providing the notifi16 cation, the abbreviated new drug application or 

17 supplement to an abbreviated new drug applica18 tion shall not be received within the meaning of 

19 505(j)(5)(A). 

20 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION FEE

21 AND PRIOR APPROVAL SUPPLEMENT FEE.—Failure to 

22 pay a fee under subparagraph (A) or (F) of sub23 section (a)(3) within 20 calendar days of the applica24 ble due date under subparagraph (C) of such sub25 section shall result in the abbreviated new drug appli-
69 

•S 3187 EAH 

1 cation or the prior approval supplement to an abbre2 viated new drug application not being received within 

3 the meaning of section 505(j)(5)(A) until such out4 standing fee is paid. 

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

6 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

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

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

9 of the due date as specified in subparagraph (D) 

10 of such subsection shall result in the following: 

11 ‘‘(i) The Secretary shall place the facil12 ity on a publicly available arrears list, such 

13 that no new abbreviated new drug applica14 tion or supplement submitted on or after 

15 October 1, 2012, from the person that is re16 sponsible for paying such fee, or any affil17 iate of that person, will be received within 

18 the meaning of section 505(j)(5)(A). 

19 ‘‘(ii) Any new generic drug submission 

20 submitted on or after October 1, 2012, that 

21 references such a facility shall not be re22 ceived, within the meaning of section 

23 505(j)(5)(A) if the outstanding facility fee is 

24 not paid within 20 calendar days of the 

25 Secretary providing the notification to the 
70 

•S 3187 EAH 

1 sponsor of the failure of the owner of the fa2 cility to pay the facility fee under sub3 section (a)(4)(C). 

4 ‘‘(iii) All drugs or active pharma5 ceutical ingredients manufactured in such a 

6 facility or containing an ingredient manu7 factured in such a facility shall be deemed 

8 misbranded under section 502(aa). 

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

10 penalties under this paragraph shall apply until 

11 the fee established by subsection (a)(4) is paid or 

12 the facility is removed from all generic drug sub13 missions that refer to the facility. 

14 ‘‘(C) NONRECEIVAL FOR NONPAYMENT.— 

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

16 drug application or supplement to an ab17 breviated new drug application submitted 

18 on or after October 1, 2012, references a fa19 cility for which a facility fee has not been 

20 paid by the applicable date under sub21 section (a)(4)(C), the Secretary shall notify 

22 the sponsor of the generic drug submission 

23 of the failure of the owner of the facility to 

24 pay the facility fee. 
71 

•S 3187 EAH 

1 ‘‘(ii) NONRECEIVAL.—If the facility fee 

2 is not paid within 20 calendar days of the 

3 Secretary providing the notification under 

4 clause (i), the abbreviated new drug appli5 cation or supplement to an abbreviated new 

6 drug application shall not be received with7 in the meaning of section 505(j)(5)(A). 

8 ‘‘(h) LIMITATIONS.— 

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

10 shall be refunded for a fiscal year beginning after fis11 cal year 2012, unless appropriations for salaries and 

12 expenses of the Food and Drug Administration for 

13 such fiscal year (excluding the amount of fees appro14 priated for such fiscal year) are equal to or greater 

15 than the amount of appropriations for the salaries 

16 and expenses of the Food and Drug Administration 

17 for fiscal year 2009 (excluding the amount of fees ap18 propriated for such fiscal year) multiplied by the ad19 justment factor (as defined in section 744A) applica20 ble to the fiscal year involved. 

21 ‘‘(2) AUTHORITY.—If the Secretary does not as22 sess fees under subsection (a) during any portion of 

23 a fiscal year and if at a later date in such fiscal year 

24 the Secretary may assess such fees, the Secretary may 

25 assess and collect such fees, without any modification 
72 

•S 3187 EAH 

1 in the rate, for Type II active pharmaceutical ingre2 dient drug master files, abbreviated new drug appli3 cations and prior approval supplements, and generic 

4 drug facilities and active pharmaceutical ingredient 

5 facilities at any time in such fiscal year notwith6 standing the provisions of subsection (a) relating to 

7 the date fees are to be paid. 

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

9 ‘‘(1) IN GENERAL.—Fees authorized under sub10 section (a) shall be collected and available for obliga11 tion only to the extent and in the amount provided 

12 in advance in appropriations Acts, subject to para13 graph (2). Such fees are authorized to remain avail14 able until expended. Such sums as may be necessary 

15 may be transferred from the Food and Drug Adminis16 tration salaries and expenses appropriation account 

17 without fiscal year limitation to such appropriation 

18 account for salaries and expenses with such fiscal 

19 year limitation. The sums transferred shall be avail20 able solely for human generic drug activities. 

21 ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 

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

23 this section— 

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

25 (D), shall be collected and available in each 
73 

•S 3187 EAH 

1 fiscal year in an amount not to exceed the 

2 amount specified in appropriation Acts, or 

3 otherwise made available for obligation for 

4 such fiscal year; and 

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

6 beginning after fiscal year 2012 to defray 

7 the costs of human generic drug activities 

8 (including such costs for an additional 

9 number of full-time equivalent positions in 

10 the Department of Health and Human 

11 Services to be engaged in such activities), 

12 only if the Secretary allocates for such pur13 pose an amount for such fiscal year (exclud14 ing amounts from fees collected under this 

15 section) no less than $97,000,000 multiplied 

16 by the adjustment factor defined in section 

17 744A(3) applicable to the fiscal year in18 volved. 

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

20 considered to have met the requirements of sub21 paragraph (A)(ii) in any fiscal year if the costs 

22 funded by appropriations and allocated for 

23 human generic activities are not more than 10 

24 percent below the level specified in such subpara25 graph. 
74 

•S 3187 EAH 

1 ‘‘(C) FEE COLLECTION DURING FIRST PRO2 GRAM YEAR.—Until the date of enactment of an 

3 Act making appropriations through September 

4 30, 2013 for the salaries and expenses account of 

5 the Food and Drug Administration, fees author6 ized by this section for fiscal year 2013, may be 

7 collected and shall be credited to such account 

8 and remain available until expended. 

9 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

10 SUBSEQUENT YEARS.—Payment of fees author11 ized under this section for a fiscal year (after fis12 cal year 2013), prior to the due date for such 

13 fees, may be accepted by the Secretary in accord14 ance with authority provided in advance in a 

15 prior year appropriations Act. 

16 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

17 each of the fiscal years 2013 through 2017, there is 

18 authorized to be appropriated for fees under this sec19 tion an amount equivalent to the total revenue 

20 amount determined under subsection (b) for the fiscal 

21 year, as adjusted under subsection (c), if applicable, 

22 or as otherwise affected under paragraph (2) of this 

23 subsection. 

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

25 where the Secretary does not receive payment of a fee as-
75 

•S 3187 EAH 

1 sessed under subsection (a) within 30 calendar days after 

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

3 States Government subject to subchapter II of chapter 37 

4 of title 31, United States Code. 

5 ‘‘(k) CONSTRUCTION.—This section may not be con6 strued to require that the number of full-time equivalent 

7 positions in the Department of Health and Human Serv8 ices, for officers, employees, and advisory committees not 

9 engaged in human generic drug activities, be reduced to off10 set the number of officers, employees, and advisory commit11 tees so engaged. 

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

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

14 application for a positron emission tomography drug 

15 or active pharmaceutical ingredient for a positron 

16 emission tomography drug shall not require the pay17 ment of any fee under this section. Facilities that 

18 solely produce positron emission tomography drugs 

19 shall not be required to pay a facility fee as estab20 lished in subsection (a)(4). 

21 ‘‘(2) IDENTIFICATION REQUIREMENT.—Facilities 

22 that produce positron emission tomography drugs or 

23 active pharmaceutical ingredients of such drugs are 

24 required to be identified pursuant to subsection (f). 
76 

•S 3187 EAH 

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

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

3 this section, a person shall submit to the Secretary a written 

4 request justifying such return within 180 calendar days 

5 after such fee was paid. 

6 ‘‘(n) SUBSTANTIALLY COMPLETE APPLICATIONS.—An 

7 abbreviated new drug application that is not considered to 

8 be received within the meaning of section 505(j)(5)(A) be9 cause of failure to pay an applicable fee under this provi10 sion within the time period specified in subsection (g) shall 

11 be deemed not to have been ‘substantially complete’ on the 

12 date of its submission within the meaning of section 

13 505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug applica14 tion that is not substantially complete on the date of its 

15 submission solely because of failure to pay an applicable 

16 fee under the preceding sentence shall be deemed substan17 tially complete and received within the meaning of section 

18 505(j)(5)(A) as of the date such applicable fee is received.’’. 

19 SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

21 section 302 of this Act, is amended by inserting after section 

22 744B the following: 
77 

•S 3187 EAH 

1 ‘‘SEC. 744C. REAUTHORIZATION; REPORTING REQUIRE2 MENTS. 

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

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

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

6 Secretary shall prepare and submit to the Committee on 

7 Energy and Commerce of the House of Representatives and 

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

9 of the Senate a report concerning the progress of the Food 

10 and Drug Administration in achieving the goals identified 

11 in the letters described in section 301(b) of the Generic Drug 

12 User Fee Amendments of 2012 during such fiscal year and 

13 the future plans of the Food and Drug Administration for 

14 meeting the goals. 

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

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

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

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

21 of the Senate a report on the implementation of the author22 ity for such fees during such fiscal year and the use, by 

23 the Food and Drug Administration, of the fees collected for 

24 such fiscal year. 

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

26 the reports required under subsections (a) and (b) available 
78 

•S 3187 EAH 

1 to the public on the Internet Web site of the Food and Drug 

2 Administration. 

3 ‘‘(d) REAUTHORIZATION.— 

4 ‘‘(1) CONSULTATION.—In developing rec5 ommendations to present to the Congress with respect 

6 to the goals, and plans for meeting the goals, for 

7 human generic drug activities for the first 5 fiscal 

8 years after fiscal year 2017, and for the reauthoriza9 tion of this part for such fiscal years, the Secretary 

10 shall consult with— 

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

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

14 Labor, and Pensions of the Senate; 

15 ‘‘(C) scientific and academic experts; 

16 ‘‘(D) health care professionals; 

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

19 ‘‘(F) the generic drug industry. 

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

21 negotiations with the generic drug industry on the re22 authorization of this part, the Secretary shall— 

23 ‘‘(A) publish a notice in the Federal Reg24 ister requesting public input on the reauthoriza25 tion; 
79 

•S 3187 EAH 

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

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

4 the goals referred to in subsection (a); 

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

6 public meeting to obtain written comments from 

7 the public suggesting changes to this part; and 

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

9 Drug Administration’s Internet Web site. 

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

12 with the generic drug industry, the Secretary shall 

13 hold discussions with representatives of patient and 

14 consumer advocacy groups to continue discussions of 

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

17 paragraph (2). 

18 ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.— 

19 After negotiations with the generic drug industry, the 

20 Secretary shall— 

21 ‘‘(A) present the recommendations developed 

22 under paragraph (1) to the congressional com23 mittees specified in such paragraph; 

24 ‘‘(B) publish such recommendations in the 

25 Federal Register; 
80 

•S 3187 EAH 

1 ‘‘(C) provide for a period of 30 days for the 

2 public to provide written comments on such rec3 ommendations; 

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

5 may present its views on such recommendations; 

6 and 

7 ‘‘(E) after consideration of such public 

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

10 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not 

11 later than January 15, 2017, the Secretary shall 

12 transmit to the Congress the revised recommendations 

13 under paragraph (4), a summary of the views and 

14 comments received under such paragraph, and any 

15 changes made to the recommendations in response to 

16 such views and comments. 

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

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

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

21 Secretary shall make publicly available, on the 

22 Internet Web site of the Food and Drug Admin23 istration, minutes of all negotiation meetings 

24 conducted under this subsection between the Food 
81 

•S 3187 EAH 

1 and Drug Administration and the generic drug 

2 industry. 

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

4 under subparagraph (A) shall summarize any 

5 substantive proposal made by any party to the 

6 negotiations as well as significant controversies 

7 or differences of opinion during the negotiations 

8 and their resolution.’’. 

9 SEC. 304. SUNSET DATES. 

10 (a) AUTHORIZATION.—Sections 744A and 744B of the 

11 Federal Food, Drug, and Cosmetic Act, as added by section 

12 302 of this Act, shall cease to be effective October 1, 2017. 

13 (b) REPORTING REQUIREMENTS.—Section 744C of the 

14 Federal Food, Drug, and Cosmetic Act, as added by section 

15 303 of this Act, shall cease to be effective January 31, 2018. 

16 SEC. 305. EFFECTIVE DATE. 

17 The amendments made by this title shall take effect 

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

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

20 shall be assessed for all human generic drug submissions 

21 and Type II active pharmaceutical drug master files re22 ceived on or after October 1, 2012, regardless of the date 

23 of enactment of this title. 
82 

•S 3187 EAH 

1 SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING. 

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

3 at the end the following: 

4 ‘‘(aa) If it is a drug, or an active pharmaceutical in5 gredient, and it was manufactured, prepared, propagated, 

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

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

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

9 has not been submitted, or it contains an active pharma10 ceutical ingredient that was manufactured, prepared, prop11 agated, compounded, or processed in such a facility.’’. 

12 SEC. 307. STREAMLINED HIRING AUTHORITY TO SUPPORT 

13 ACTIVITIES RELATED TO HUMAN GENERIC 

14 DRUGS. 

15 Section 714, as added by section 208 of this Act, is 

16 amended— 

17 (1) by amending subsection (b) to read as fol18 lows: 

19 ‘‘(b) ACTIVITIES DESCRIBED.—The activities described 

20 in this subsection are— 

21 ‘‘(1) activities under this Act related to the proc22 ess for the review of device applications (as defined in 

23 section 737(8)); and 

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

25 generic drug activities (as defined in section 744A).’’; 

26 and 
83 

•S 3187 EAH 

1 (2) by amending subsection (c) to read as fol2 lows: 

3 ‘‘(c) OBJECTIVES SPECIFIED.—The objectives specified 

4 in this subsection are— 

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

7 738A(a)(1); and 

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

10 744C(a).’’. 

11 SEC. 308. ADDITIONAL REPORTING REQUIREMENTS. 

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

13 as amended by section 208, is further amended by adding 

14 at the end the following: 

15 ‘‘SEC. 715. REPORTING REQUIREMENTS. 

16 ‘‘(a) GENERIC DRUGS.—Beginning with fiscal year 

17 2013 and ending after fiscal year 2017, not later than 120 

18 days after the end of each fiscal year for which fees are 

19 collected under part 7 of subchapter C, the Secretary shall 

20 prepare and submit to the Committee on Health, Edu21 cation, Labor, and Pensions of the Senate and the Com22 mittee on Energy and Commerce of the House of Represent23 atives a report concerning, for all applications for approval 

24 of a generic drug under section 505(j), amendments to such 
84 

•S 3187 EAH 

1 applications, and prior approval supplements with respect 

2 to such applications filed in the previous fiscal year— 

3 ‘‘(1) the number of such applications that met 

4 the goals identified for purposes of part 7 of sub5 chapter C, in the letters from the Secretary of Health 

6 and Human Services to the Chairman of the Com7 mittee on Health, Education, Labor, and Pensions of 

8 the Senate and the Chairman of the Committee on 

9 Energy and Commerce of the House of Representa10 tives, as set forth in the Congressional Record; 

11 ‘‘(2) the average total time to decision by the 

12 Secretary for applications for approval of a generic 

13 drug under section 505(j), amendments to such appli14 cations, and prior approval supplements with respect 

15 to such applications filed in the previous fiscal year, 

16 including the number of calendar days spent during 

17 the review by the Food and Drug Administration and 

18 the number of calendar days spent by the sponsor re19 sponding to a complete response letter; 

20 ‘‘(3) the total number of applications under sec21 tion 505(j), amendments to such applications, and 

22 prior approval supplements with respect to such ap23 plications that were pending with the Secretary for 

24 more than 10 months on the date of enactment of the 
85 

•S 3187 EAH 

1 Food and Drug Administration Safety and Innova2 tion Act; and 

3 ‘‘(4) the number of applications described in 

4 paragraph (3) on which the Food and Drug Adminis5 tration took final regulatory action in the previous 

6 fiscal year.’’. 

7 TITLE IV—FEES RELATING TO 

8 BIOSIMILAR BIOLOGICAL 

9 PRODUCTS 

10 SEC. 401. SHORT TITLE; FINDING. 

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

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

13 (b) FINDING.—The Congress finds that the fees author14 ized by the amendments made in this title will be dedicated 

15 to expediting the process for the review of biosimilar biologi16 cal product applications, including postmarket safety ac17 tivities, as set forth in the goals identified for purposes of 

18 part 8 of subchapter C of chapter VII of the Federal Food, 

19 Drug, and Cosmetic Act, in the letters from the Secretary 

20 of Health and Human Services to the Chairman of the 

21 Committee on Health, Education, Labor, and Pensions of 

22 the Senate and the Chairman of the Committee on Energy 

23 and Commerce of the House of Representatives, as set forth 

24 in the Congressional Record. 
86 

•S 3187 EAH 

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 III 

5 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 a 

11 fiscal year that is the Consumer Price Index for all 

12 urban consumers (Washington-Baltimore, DC–MD– 

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

14 preceding fiscal year divided by such Index for Sep15 tember 2011. 

16 ‘‘(2) The term ‘affiliate’ means a business entity 

17 that has a relationship with a second business entity 

18 if, directly or indirectly— 

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

20 power to control, the other business entity; or 

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

22 control, both of the business entities. 

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

24 means a product for which a biosimilar biological 

25 product application has been approved. 
87 

•S 3187 EAH 

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

2 ‘biosimilar biological product application’ means an 

3 application for licensure of a biological product under 

4 section 351(k) of the Public Health Service Act. 

5 ‘‘(B) Such term does not include— 

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

7 ‘‘(ii) an application filed under section 

8 351(k) of the Public Health Service Act that cites 

9 as the reference product a bovine blood product 

10 for topical application licensed before September 

11 1, 1992, or a large volume parenteral drug prod12 uct approved before such date; 

13 ‘‘(iii) an application filed under section 

14 351(k) of the Public Health Service Act with re15 spect to— 

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

17 for transfusion; 

18 ‘‘(II) an allergenic extract product; 

19 ‘‘(III) an in vitro diagnostic biological 

20 product; or 

21 ‘‘(IV) a biological product for further 

22 manufacturing use only; or 

23 ‘‘(iv) an application for licensure under sec24 tion 351(k) of the Public Health Service Act that 

25 is submitted by a State or Federal Government 
88 

•S 3187 EAH 

1 entity for a product that is not distributed com2 mercially. 

3 ‘‘(5) The term ‘biosimilar biological product de4 velopment meeting’ means any meeting, other than a 

5 biosimilar initial advisory meeting, regarding the 

6 content of a development program, including a pro7 posed design for, or data from, a study intended to 

8 support a biosimilar biological product application. 

9 ‘‘(6) The term ‘biosimilar biological product de10 velopment program’ means the program under this 

11 part for expediting the process for the review of sub12 missions in connection with biosimilar biological 

13 product development. 

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

15 establishment’ means a foreign or domestic place of 

16 business— 

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

18 consisting of one or more buildings, all of which 

19 are within 5 miles of each other; and 

20 ‘‘(ii) at which one or more biosimilar bio21 logical products are manufactured in final dos22 age form. 

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

24 term ‘manufactured’ does not include packaging. 
89 

•S 3187 EAH 

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 program; 

11 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 the 

16 process for the review of biosimilar biological product 

17 applications’ means the expenses in connection with 

18 the process for the review of biosimilar biological 

19 product applications for— 

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

21 Drug Administration, contractors of the Food 

22 and Drug Administration, advisory committees, 

23 and costs related to such officers employees and 

24 committees and to contracts with such contrac25 tors; 
90 

•S 3187 EAH 

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 equip7 ment, and other necessary materials and sup8 plies; and 

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

10 accounting for resources allocated for the review 

11 of submissions in connection with biosimilar bio12 logical product development, biosimilar biologi13 cal product applications, and supplements. 

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

15 respect to a biosimilar biological product, a finished 

16 dosage form which is approved for administration to 

17 a patient without substantial further manufacturing 

18 (such as lyophilized products before reconstitution). 

19 ‘‘(11) The term ‘financial hold’— 

20 ‘‘(A) means an order issued by the Sec21 retary to prohibit the sponsor of a clinical inves22 tigation from continuing the investigation if the 

23 Secretary determines that the investigation is in24 tended to support a biosimilar biological product 

25 application and the sponsor has failed to pay 
91 

•S 3187 EAH 

1 any fee for the product required under subpara2 graph (A), (B), or (D) of section 744H(a)(1); 

3 and 

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

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

6 been determined by the Secretary to exist con7 cerning the investigation. 

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

9 such person. 

10 ‘‘(13) The term ‘process for the review of bio11 similar biological product applications’ means the fol12 lowing activities of the Secretary with respect to the 

13 review of submissions in connection with biosimilar 

14 biological product development, biosimilar biological 

15 product applications, and supplements: 

16 ‘‘(A) The activities necessary for the review 

17 of submissions in connection with biosimilar bio18 logical product development, biosimilar biologi19 cal product applications, and supplements. 

20 ‘‘(B) Actions related to submissions in con21 nection with biosimilar biological product devel22 opment, the issuance of action letters which ap23 prove biosimilar biological product applications 

24 or which set forth in detail the specific defi25 ciencies in such applications, and where appro-
92 

•S 3187 EAH 

1 priate, the actions necessary to place such appli2 cations in condition for approval. 

3 ‘‘(C) The inspection of biosimilar biological 

4 product establishments and other facilities un5 dertaken as part of the Secretary’s review of 

6 pending biosimilar biological product applica7 tions and supplements. 

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

9 lots of biosimilar biological products under sec10 tion 351(k) of the Public Health Service Act. 

11 ‘‘(E) Monitoring of research conducted in 

12 connection with the review of biosimilar biologi13 cal product applications. 

14 ‘‘(F) Postmarket safety activities with re15 spect to biologics approved under biosimilar bio16 logical product applications or supplements, in17 cluding the following activities: 

18 ‘‘(i) Collecting, developing, and review19 ing safety information on biosimilar bio20 logical products, including adverse-event re21 ports. 

22 ‘‘(ii) Developing and using improved 

23 adverse-event data-collection systems, in24 cluding information technology systems. 
93 

•S 3187 EAH 

1 ‘‘(iii) Developing and using improved 

2 analytical tools to assess potential safety 

3 problems, including access to external data 

4 bases. 

5 ‘‘(iv) Implementing and enforcing sec6 tion 505(o) (relating to postapproval studies 

7 and clinical trials and labeling changes) 

8 and section 505(p) (relating to risk evalua9 tion and mitigation strategies). 

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

11 (relating to adverse-event reports and 

12 postmarket safety activities). 

13 ‘‘(14) The term ‘supplement’ means a request to 

14 the Secretary to approve a change in a biosimilar bi15 ological product application which has been approved, 

16 including a supplement requesting that the Secretary 

17 determine that the biosimilar biological product meets 

18 the standards for interchangeability described in sec19 tion 351(k)(4) of the Public Health Service Act. 

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

21 BIOLOGICAL PRODUCT FEES. 

22 ‘‘(a) TYPES OF FEES.—Beginning in fiscal year 2013, 

23 the Secretary shall assess and collect fees in accordance with 

24 this section as follows: 
94 

•S 3187 EAH 

1 ‘‘(1) BIOSIMILAR DEVELOPMENT PROGRAM

2 FEES.— 

3 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

4 PRODUCT DEVELOPMENT FEE.— 

5 ‘‘(i) IN GENERAL.—Each person that 

6 submits to the Secretary a meeting request 

7 described under clause (ii) or a clinical pro8 tocol for an investigational new drug pro9 tocol described under clause (iii) shall pay 

10 for the product named in the meeting re11 quest or the investigational new drug appli12 cation the initial biosimilar biological prod13 uct development fee established under sub14 section (b)(1)(A). 

15 ‘‘(ii) MEETING REQUEST.—The meet16 ing request described in this clause is a re17 quest for a biosimilar biological product de18 velopment meeting for a product. 

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

20 A clinical protocol for an investigational 

21 new drug protocol described in this clause is 

22 a clinical protocol consistent with the provi23 sions of section 505(i), including any regu24 lations promulgated under section 505(i), 

25 (referred to in this section as ‘investiga-
95 

•S 3187 EAH 

1 tional new drug application’) describing an 

2 investigation that the Secretary determines 

3 is intended to support a biosimilar biologi4 cal product application for a product. 

5 ‘‘(iv) DUE DATE.—The initial bio6 similar biological product development fee 

7 shall be due by the earlier of the following: 

8 ‘‘(I) Not later than 5 days after 

9 the Secretary grants a request for a 

10 biosimilar biological product develop11 ment meeting. 

12 ‘‘(II) The date of submission of an 

13 investigational new drug application 

14 describing an investigation that the 

15 Secretary determines is intended to 

16 support a biosimilar biological product 

17 application. 

18 ‘‘(v) TRANSITION RULE.—Each person 

19 that has submitted an investigational new 

20 drug application prior to the date of enact21 ment of the Biosimilars User Fee Act of 

22 2012 shall pay the initial biosimilar bio23 logical product development fee by the ear24 lier of the following: 
96 

•S 3187 EAH 

1 ‘‘(I) Not later than 60 days after 

2 the date of the enactment of the 

3 Biosimilars User Fee Act of 2012, if 

4 the Secretary determines that the in5 vestigational new drug application de6 scribes an investigation that is in7 tended to support a biosimilar biologi8 cal product application. 

9 ‘‘(II) Not later than 5 days after 

10 the Secretary grants a request for a 

11 biosimilar biological product develop12 ment meeting. 

13 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

14 PRODUCT DEVELOPMENT FEE.— 

15 ‘‘(i) IN GENERAL.—A person that pays 

16 an initial biosimilar biological product de17 velopment fee for a product shall pay for 

18 such product, beginning in the fiscal year 

19 following the fiscal year in which the initial 

20 biosimilar biological product development 

21 fee was paid, an annual fee established 

22 under subsection (b)(1)(B) for biosimilar bi23 ological product development (referred to in 

24 this section as ‘annual biosimilar biological 

25 product development fee’). 
97 

•S 3187 EAH 

1 ‘‘(ii) DUE DATE.—The annual bio2 similar biological product development pro3 gram fee for each fiscal year will be due on 

4 the later of— 

5 ‘‘(I) the first business day on or 

6 after October 1 of each such year; or 

7 ‘‘(II) the first business day after 

8 the enactment of an appropriations 

9 Act providing for the collection and ob10 ligation of fees for such year under this 

11 section. 

12 ‘‘(iii) EXCEPTION.—The annual bio13 similar development program fee for each 

14 fiscal year will be due on the date specified 

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

16 ‘‘(I) submitted a marketing appli17 cation for the biological product that 

18 was accepted for filing; or 

19 ‘‘(II) discontinued participation 

20 in the biosimilar biological product de21 velopment program for the product 

22 under subparagraph (C). 

23 ‘‘(C) DISCONTINUATION OF FEE OBLIGA24 TION.—A person may discontinue participation 

25 in the biosimilar biological product development 
98 

•S 3187 EAH 

1 program for a product effective October 1 of a 

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

3 preceding fiscal year— 

4 ‘‘(i) if no investigational new drug ap5 plication concerning the product has been 

6 submitted, submitting to the Secretary a 

7 written declaration that the person has no 

8 present intention of further developing the 

9 product as a biosimilar biological product; 

10 or 

11 ‘‘(ii) if an investigational new drug 

12 application concerning the product has been 

13 submitted, withdrawing the investigational 

14 new drug application in accordance with 

15 part 312 of title 21, Code of Federal Regu16 lations (or any successor regulations). 

17 ‘‘(D) REACTIVATION FEE.— 

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

19 discontinued participation in the biosimilar 

20 biological product development program for 

21 a product under subparagraph (C) shall 

22 pay a fee (referred to in this section as ‘re23 activation fee’) by the earlier of the fol24 lowing: 
99 

•S 3187 EAH 

1 ‘‘(I) Not later than 5 days after 

2 the Secretary grants a request for a 

3 biosimilar biological product develop4 ment meeting for the product (after the 

5 date on which such participation was 

6 discontinued). 

7 ‘‘(II) Upon the date of submission 

8 (after the date on which such partici9 pation was discontinued) of an inves10 tigational new drug application de11 scribing an investigation that the Sec12 retary determines is intended to sup13 port a biosimilar biological product 

14 application for that product. 

15 ‘‘(ii) APPLICATION OF ANNUAL FEE.— 

16 A person that pays a reactivation fee for a 

17 product shall pay for such product, begin18 ning in the next fiscal year, the annual bio19 similar biological product development fee 

20 under subparagraph (B). 

21 ‘‘(E) EFFECT OF FAILURE TO PAY BIO22 SIMILAR DEVELOPMENT PROGRAM FEES.— 

23 ‘‘(i) NO BIOSIMILAR BIOLOGICAL PROD24 UCT DEVELOPMENT MEETINGS.—If a person 

25 has failed to pay an initial or annual bio-
100 

•S 3187 EAH 

1 similar biological product development fee 

2 as required under subparagraph (A) or (B), 

3 or a reactivation fee as required under sub4 paragraph (D), the Secretary shall not pro5 vide a biosimilar biological product develop6 ment meeting relating to the product for 

7 which fees are owed. 

8 ‘‘(ii) NO RECEIPT OF INVESTIGATIONAL

9 NEW DRUG APPLICATIONS.—Except in ex10 traordinary circumstances, the Secretary 

11 shall not consider an investigational new 

12 drug application to have been received 

13 under section 505(i)(2) if— 

14 ‘‘(I) the Secretary determines that 

15 the investigation is intended to support 

16 a biosimilar biological product appli17 cation; and 

18 ‘‘(II) the sponsor has failed to pay 

19 an initial or annual biosimilar bio20 logical product development fee for the 

21 product as required under subpara22 graph (A) or (B), or a reactivation fee 

23 as required under subparagraph (D). 

24 ‘‘(iii) FINANCIAL HOLD.—Notwith25 standing section 505(i)(2), except in ex-
101 

•S 3187 EAH 

1 traordinary circumstances, the Secretary 

2 shall prohibit the sponsor of a clinical in3 vestigation from continuing the investiga4 tion if— 

5 ‘‘(I) the Secretary determines that 

6 the investigation is intended to support 

7 a biosimilar biological product appli8 cation; and 

9 ‘‘(II) the sponsor has failed to pay 

10 an initial or annual biosimilar bio11 logical product development fee for the 

12 product as required under subpara13 graph (A) or (B), or a reactivation fee 

14 for the product as required under sub15 paragraph (D). 

16 ‘‘(iv) NO ACCEPTANCE OF BIOSIMILAR

17 BIOLOGICAL PRODUCT APPLICATIONS OR

18 SUPPLEMENTS.—If a person has failed to 

19 pay an initial or annual biosimilar biologi20 cal product development fee as required 

21 under subparagraph (A) or (B), or a reac22 tivation fee as required under subparagraph 

23 (D), any biosimilar biological product ap24 plication or supplement submitted by that 

25 person shall be considered incomplete and 
102 

•S 3187 EAH 

1 shall not be accepted for filing by the Sec2 retary until all such fees owed by such per3 son have been paid. 

4 ‘‘(F) LIMITS REGARDING BIOSIMILAR DE5 VELOPMENT PROGRAM FEES.— 

6 ‘‘(i) NO REFUNDS.—The Secretary 

7 shall not refund any initial or annual bio8 similar biological product development fee 

9 paid under subparagraph (A) or (B), or 

10 any reactivation fee paid under subpara11 graph (D). 

12 ‘‘(ii) NO WAIVERS, EXEMPTIONS, OR

13 REDUCTIONS.—The Secretary shall not 

14 grant a waiver, exemption, or reduction of 

15 any initial or annual biosimilar biological 

16 product development fee due or payable 

17 under subparagraph (A) or (B), or any re18 activation fee due or payable under sub19 paragraph (D). 

20 ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLICA21 TION AND SUPPLEMENT FEE.— 

22 ‘‘(A) IN GENERAL.—Each person that sub23 mits, on or after October 1, 2012, a biosimilar 

24 biological product application or a supplement 

25 shall be subject to the following fees: 
103 

•S 3187 EAH 

1 ‘‘(i) A fee for a biosimilar biological 

2 product application that is equal to— 

3 ‘‘(I) the amount of the fee estab4 lished under subsection (b)(1)(D) for a 

5 biosimilar biological product applica6 tion for which clinical data (other than 

7 comparative bioavailability studies) 

8 with respect to safety or effectiveness 

9 are required for approval; minus 

10 ‘‘(II) the cumulative amount of 

11 fees paid, if any, under subparagraphs 

12 (A), (B), and (D) of paragraph (1) for 

13 the product that is the subject of the 

14 application. 

15 ‘‘(ii) A fee for a biosimilar biological 

16 product application for which clinical data 

17 (other than comparative bioavailability 

18 studies) with respect to safety or effective19 ness are not required, that is equal to— 

20 ‘‘(I) half of the amount of the fee 

21 established under subsection (b)(1)(D) 

22 for a biosimilar biological product ap23 plication; minus 

24 ‘‘(II) the cumulative amount of 

25 fees paid, if any, under subparagraphs 
104 

•S 3187 EAH 

1 (A), (B), and (D) of paragraph (1) for 

2 that product. 

3 ‘‘(iii) A fee for a supplement for which 

4 clinical data (other than comparative bio5 availability studies) with respect to safety 

6 or effectiveness are required, that is equal to 

7 half of the amount of the fee established 

8 under subsection (b)(1)(D) for a biosimilar 

9 biological product application. 

10 ‘‘(B) REDUCTION IN FEES.—Notwith11 standing section 404 of the Biosimilars User Fee 

12 Act of 2012, any person who pays a fee under 

13 subparagraph (A), (B), or (D) of paragraph (1) 

14 for a product before October 1, 2017, but submits 

15 a biosimilar biological product application for 

16 that product after such date, shall be entitled to 

17 the reduction of any biosimilar biological prod18 uct application fees that may be assessed at the 

19 time when such biosimilar biological product ap20 plication is submitted, by the cumulative amount 

21 of fees paid under subparagraphs (A), (B), and 

22 (D) of paragraph (1) for that product. 

23 ‘‘(C) PAYMENT DUE DATE.—Any fee re24 quired by subparagraph (A) shall be due upon 
105 

•S 3187 EAH 

1 submission of the application or supplement for 

2 which such fee applies. 

3 ‘‘(D) EXCEPTION FOR PREVIOUSLY FILED

4 APPLICATION OR SUPPLEMENT.—If a biosimilar 

5 biological product application or supplement 

6 was submitted by a person that paid the fee for 

7 such application or supplement, was accepted for 

8 filing, and was not approved or was withdrawn 

9 (without a waiver), the submission of a bio10 similar biological product application or a sup11 plement for the same product by the same person 

12 (or the person’s licensee, assignee, or successor) 

13 shall not be subject to a fee under subparagraph 

14 (A). 

15 ‘‘(E) REFUND OF APPLICATION FEE IF AP16 PLICATION REFUSED FOR FILING OR WITHDRAWN

17 BEFORE FILING.—The Secretary shall refund 75 

18 percent of the fee paid under this paragraph for 

19 any application or supplement which is refused 

20 for filing or withdrawn without a waiver before 

21 filing. 

22 ‘‘(F) FEES FOR APPLICATIONS PREVIOUSLY

23 REFUSED FOR FILING OR WITHDRAWN BEFORE

24 FILING.—A biosimilar biological product appli25 cation or supplement that was submitted but was 
106 

•S 3187 EAH 

1 refused for filing, or was withdrawn before being 

2 accepted or refused for filing, shall be subject to 

3 the full fee under subparagraph (A) upon being 

4 resubmitted or filed over protest, unless the fee is 

5 waived under subsection (c). 

6 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTAB7 LISHMENT FEE.— 

8 ‘‘(A) IN GENERAL.—Except as provided in 

9 subparagraph (E), each person that is named as 

10 the applicant in a biosimilar biological product 

11 application shall be assessed an annual fee estab12 lished under subsection (b)(1)(E) for each bio13 similar biological product establishment that is 

14 listed in the approved biosimilar biological prod15 uct application as an establishment that manu16 factures the biosimilar biological product named 

17 in such application. 

18 ‘‘(B) ASSESSMENT IN FISCAL YEARS.—The 

19 establishment fee shall be assessed in each fiscal 

20 year for which the biosimilar biological product 

21 named in the application is assessed a fee under 

22 paragraph (4) unless the biosimilar biological 

23 product establishment listed in the application 

24 does not engage in the manufacture of the bio-
107 

•S 3187 EAH 

1 similar biological product during such fiscal 

2 year. 

3 ‘‘(C) DUE DATE.—The establishment fee for 

4 a fiscal year shall be due on the later of— 

5 ‘‘(i) the first business day on or after 

6 October 1 of such fiscal year; or 

7 ‘‘(ii) the first business day after the en8 actment of an appropriations Act providing 

9 for the collection and obligation of fees for 

10 such fiscal year under this section. 

11 ‘‘(D) APPLICATION TO ESTABLISHMENT.— 

12 ‘‘(i) Each biosimilar biological product 

13 establishment shall be assessed only one fee 

14 per biosimilar biological product establish15 ment, notwithstanding the number of bio16 similar biological products manufactured at 

17 the establishment, subject to clause (ii). 

18 ‘‘(ii) In the event an establishment is 

19 listed in a biosimilar biological product ap20 plication by more than one applicant, the 

21 establishment fee for the fiscal year shall be 

22 divided equally and assessed among the ap23 plicants whose biosimilar biological prod24 ucts are manufactured by the establishment 

25 during the fiscal year and assessed bio-
108 

•S 3187 EAH 

1 similar biological product fees under para2 graph (4). 

3 ‘‘(E) EXCEPTION FOR NEW PRODUCTS.—If, 

4 during the fiscal year, an applicant initiates or 

5 causes to be initiated the manufacture of a bio6 similar biological product at an establishment 

7 listed in its biosimilar biological product appli8 cation— 

9 ‘‘(i) that did not manufacture the bio10 similar biological product in the previous 

11 fiscal year; and 

12 ‘‘(ii) for which the full biosimilar bio13 logical product establishment fee has been 

14 assessed in the fiscal year at a time before 

15 manufacture of the biosimilar biological 

16 product was begun, 

17 the applicant shall not be assessed a share of the 

18 biosimilar biological product establishment fee 

19 for the fiscal year in which the manufacture of 

20 the product began. 

21 ‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 

22 ‘‘(A) IN GENERAL.—Each person who is 

23 named as the applicant in a biosimilar biologi24 cal product application shall pay for each such 
109 

•S 3187 EAH 

1 biosimilar biological product the annual fee es2 tablished under subsection (b)(1)(F). 

3 ‘‘(B) DUE DATE.—The biosimilar biological 

4 product fee for a fiscal year shall be due on the 

5 later of— 

6 ‘‘(i) the first business day on or after 

7 October 1 of each such year; or 

8 ‘‘(ii) the first business day after the en9 actment of an appropriations Act providing 

10 for the collection and obligation of fees for 

11 such year under this section. 

12 ‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 

13 The biosimilar biological product fee shall be 

14 paid only once for each product for each fiscal 

15 year. 

16 ‘‘(b) FEE SETTING AND AMOUNTS.— 

17 ‘‘(1) IN GENERAL.—Subject to paragraph (2), the 

18 Secretary shall, 60 days before the start of each fiscal 

19 year that begins after September 30, 2012, establish, 

20 for the next fiscal year, the fees under subsection (a). 

21 Except as provided in subsection (c), such fees shall 

22 be in the following amounts: 

23 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

24 PRODUCT DEVELOPMENT FEE.—The initial bio25 similar biological product development fee under 
110 

•S 3187 EAH 

1 subsection (a)(1)(A) for a fiscal year shall be 

2 equal to 10 percent of the amount established 

3 under section 736(c)(4) for a human drug appli4 cation described in section 736(a)(1)(A)(i) for 

5 that fiscal year. 

6 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

7 PRODUCT DEVELOPMENT FEE.—The annual bio8 similar biological product development fee under 

9 subsection (a)(1)(B) for a fiscal year shall be 

10 equal to 10 percent of the amount established 

11 under section 736(c)(4) for a human drug appli12 cation described in section 736(a)(1)(A)(i) for 

13 that fiscal year. 

14 ‘‘(C) REACTIVATION FEE.—The reactivation 

15 fee under subsection (a)(1)(D) for a fiscal year 

16 shall be equal to 20 percent of the amount of the 

17 fee established under section 736(c)(4) for a 

18 human drug application described in section 

19 736(a)(1)(A)(i) for that fiscal year. 

20 ‘‘(D) BIOSIMILAR BIOLOGICAL PRODUCT AP21 PLICATION FEE.—The biosimilar biological prod22 uct application fee under subsection (a)(2) for a 

23 fiscal year shall be equal to the amount estab24 lished under section 736(c)(4) for a human drug 
111 

•S 3187 EAH 

1 application described in section 736(a)(1)(A)(i) 

2 for that fiscal year. 

3 ‘‘(E) BIOSIMILAR BIOLOGICAL PRODUCT ES4 TABLISHMENT FEE.—The biosimilar biological 

5 product establishment fee under subsection (a)(3) 

6 for a fiscal year shall be equal to the amount es7 tablished under section 736(c)(4) for a prescrip8 tion drug establishment for that fiscal year. 

9 ‘‘(F) BIOSIMILAR BIOLOGICAL PRODUCT

10 FEE.—The biosimilar biological product fee 

11 under subsection (a)(4) for a fiscal year shall be 

12 equal to the amount established under section 

13 736(c)(4) for a prescription drug product for 

14 that fiscal year. 

15 ‘‘(2) LIMIT.—The total amount of fees charged 

16 for a fiscal year under this section may not exceed the 

17 total amount for such fiscal year of the costs of re18 sources allocated for the process for the review of bio19 similar biological product applications. 

20 ‘‘(c) APPLICATION FEE WAIVER FOR SMALL BUSI21 NESS.— 

22 ‘‘(1) WAIVER OF APPLICATION FEE.—The Sec23 retary shall grant to a person who is named in a bio24 similar biological product application a waiver from 

25 the application fee assessed to that person under sub-
112 

•S 3187 EAH 

1 section (a)(2)(A) for the first biosimilar biological 

2 product application that a small business or its affil3 iate submits to the Secretary for review. After a small 

4 business or its affiliate is granted such a waiver, the 

5 small business or its affiliate shall pay— 

6 ‘‘(A) application fees for all subsequent bio7 similar biological product applications submitted 

8 to the Secretary for review in the same manner 

9 as an entity that is not a small business; and 

10 ‘‘(B) all supplement fees for all supplements 

11 to biosimilar biological product applications sub12 mitted to the Secretary for review in the same 

13 manner as an entity that is not a small busi14 ness. 

15 ‘‘(2) CONSIDERATIONS.—In determining whether 

16 to grant a waiver of a fee under paragraph (1), the 

17 Secretary shall consider only the circumstances and 

18 assets of the applicant involved and any affiliate of 

19 the applicant. 

20 ‘‘(3) SMALL BUSINESS DEFINED.—In this sub21 section, the term ‘small business’ means an entity 

22 that has fewer than 500 employees, including employ23 ees of affiliates, and does not have a drug product 

24 that has been approved under a human drug applica25 tion (as defined in section 735) or a biosimilar bio-
113 

•S 3187 EAH 

1 logical product application (as defined in section 

2 744G(4)) and introduced or delivered for introduction 

3 into interstate commerce. 

4 ‘‘(d) EFFECT OF FAILURE TO PAY FEES.—A bio5 similar biological product application or supplement sub6 mitted by a person subject to fees under subsection (a) shall 

7 be considered incomplete and shall not be accepted for filing 

8 by the Secretary until all fees owed by such person have 

9 been paid. 

10 ‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

11 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

12 fees authorized under subsection (a) shall be collected 

13 and available for obligation only to the extent and in 

14 the amount provided in advance in appropriations 

15 Acts. Such fees are authorized to remain available 

16 until expended. Such sums as may be necessary may 

17 be transferred from the Food and Drug Administra18 tion salaries and expenses appropriation account 

19 without fiscal year limitation to such appropriation 

20 account for salaries and expenses with such fiscal 

21 year limitation. The sums transferred shall be avail22 able solely for the process for the review of biosimilar 

23 biological product applications. 

24 ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 
114 

•S 3187 EAH 

1 ‘‘(A) IN GENERAL.—Subject to subpara2 graphs (C) and (D), the fees authorized by this 

3 section shall be collected and available in each 

4 fiscal year in an amount not to exceed the 

5 amount specified in appropriation Acts, or oth6 erwise made available for obligation for such fis7 cal year. 

8 ‘‘(B) USE OF FEES AND LIMITATION.—The 

9 fees authorized by this section shall be available 

10 for a fiscal year beginning after fiscal year 2012 

11 to defray the costs of the process for the review 

12 of biosimilar biological product applications (in13 cluding such costs for an additional number of 

14 full-time equivalent positions in the Department 

15 of Health and Human Services to be engaged in 

16 such process), only if the Secretary allocates for 

17 such purpose an amount for such fiscal year (ex18 cluding amounts from fees collected under this 

19 section) no less than $20,000,000, multiplied by 

20 the adjustment factor applicable to the fiscal 

21 year involved. 

22 ‘‘(C) FEE COLLECTION DURING FIRST PRO23 GRAM YEAR.—Until the date of enactment of an 

24 Act making appropriations through September 

25 30, 2013, for the salaries and expenses account 
115 

•S 3187 EAH 

1 of the Food and Drug Administration, fees au2 thorized by this section for fiscal year 2013 may 

3 be collected and shall be credited to such account 

4 and remain available until expended. 

5 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

6 SUBSEQUENT YEARS.—Payment of fees author7 ized under this section for a fiscal year (after fis8 cal year 2013), prior to the due date for such 

9 fees, may be accepted by the Secretary in accord10 ance with authority provided in advance in a 

11 prior year appropriations Act. 

12 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

13 each of fiscal years 2013 through 2017, there is au14 thorized to be appropriated for fees under this section 

15 an amount equivalent to the total amount of fees as16 sessed for such fiscal year under this section. 

17 ‘‘(f) COLLECTION OF UNPAID FEES.—In any case 

18 where the Secretary does not receive payment of a fee as19 sessed under subsection (a) within 30 days after it is due, 

20 such fee shall be treated as a claim of the United States 

21 Government subject to subchapter II of chapter 37 of title 

22 31, United States Code. 

23 ‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND RE24 FUNDS.—To qualify for consideration for a waiver under 

25 subsection (c), or for a refund of any fee collected in accord-
116 

•S 3187 EAH 

1 ance with subsection (a)(2)(A), a person shall submit to the 

2 Secretary a written request for such waiver or refund not 

3 later than 180 days after such fee is due. 

4 ‘‘(h) CONSTRUCTION.—This section may not be con5 strued to require that the number of full-time equivalent 

6 positions in the Department of Health and Human Serv7 ices, for officers, employers, and advisory committees not 

8 engaged in the process of the review of biosimilar biological 

9 product applications, be reduced to offset the number of offi10 cers, employees, and advisory committees so engaged.’’. 

11 SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS. 

12 Part 8 of subchapter C of chapter VII, as added by 

13 section 402, is further amended by inserting after section 

14 744H the following: 

15 ‘‘SEC. 744I. REAUTHORIZATION; REPORTING REQUIRE16 MENTS. 

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

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

19 fiscal year for which fees are collected under this part, the 

20 Secretary shall prepare and submit to the Committee on 

21 Energy and Commerce of the House of Representatives and 

22 the Committee on Health, Education, Labor, and Pensions 

23 of the Senate a report concerning the progress of the Food 

24 and Drug Administration in achieving the goals identified 

25 in the letters described in section 401(b) of the Biosimilar 
117 

•S 3187 EAH 

1 User Fee Act of 2012 during such fiscal year and the future 

2 plans of the Food and Drug Administration for meeting 

3 such goals. The report for a fiscal year shall include infor4 mation on all previous cohorts for which the Secretary has 

5 not given a complete response on all biosimilar biological 

6 product applications and supplements in the cohort. 

7 ‘‘(b) FISCAL REPORT.—Not later than 120 days after 

8 the end of fiscal year 2013 and each subsequent fiscal year 

9 for which fees are collected under this part, the Secretary 

10 shall prepare and submit to the Committee on Energy and 

11 Commerce of the House of Representatives and the Com12 mittee on Health, Education, Labor, and Pensions of the 

13 Senate a report on the implementation of the authority for 

14 such fees during such fiscal year and the use, by the Food 

15 and Drug Administration, of the fees collected for such fiscal 

16 year. 

17 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make 

18 the reports required under subsections (a) and (b) available 

19 to the public on the Internet Web site of the Food and Drug 

20 Administration. 

21 ‘‘(d) STUDY.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall contract 

23 with an independent accounting or consulting firm to 

24 study the workload volume and full costs associated 
118 

•S 3187 EAH 

1 with the process for the review of biosimilar biological 

2 product applications. 

3 ‘‘(2) INTERIM RESULTS.—Not later than June 1, 

4 2015, the Secretary shall publish, for public comment, 

5 interim results of the study described under para6 graph (1). 

7 ‘‘(3) FINAL RESULTS.—Not later than September 

8 30, 2016, the Secretary shall publish, for public com9 ment, the final results of the study described under 

10 paragraph (1). 

11 ‘‘(e) REAUTHORIZATION.— 

12 ‘‘(1) CONSULTATION.—In developing rec13 ommendations to present to the Congress with respect 

14 to the goals described in subsection (a), and plans for 

15 meeting the goals, for the process for the review of bio16 similar biological product applications for the first 5 

17 fiscal years after fiscal year 2017, and for the reau18 thorization of this part for such fiscal years, the Sec19 retary shall consult with— 

20 ‘‘(A) the Committee on Energy and Com21 merce of the House of Representatives; 

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

23 Labor, and Pensions of the Senate; 

24 ‘‘(C) scientific and academic experts; 

25 ‘‘(D) health care professionals; 
119 

•S 3187 EAH 

1 ‘‘(E) representatives of patient and con2 sumer advocacy groups; and 

3 ‘‘(F) the regulated industry. 

4 ‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.— 

5 After negotiations with the regulated industry, the 

6 Secretary shall— 

7 ‘‘(A) present the recommendations developed 

8 under paragraph (1) to the congressional com9 mittees specified in such paragraph; 

10 ‘‘(B) publish such recommendations in the 

11 Federal Register; 

12 ‘‘(C) provide for a period of 30 days for the 

13 public to provide written comments on such rec14 ommendations; 

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

16 may present its views on such recommendations; 

17 and 

18 ‘‘(E) after consideration of such public 

19 views and comments, revise such recommenda20 tions as necessary. 

21 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.—Not 

22 later than January 15, 2017, the Secretary shall 

23 transmit to the Congress the revised recommendations 

24 under paragraph (2), a summary of the views and 

25 comments received under such paragraph, and any 
120 

•S 3187 EAH 

1 changes made to the recommendations in response to 

2 such views and comments.’’. 

3 SEC. 404. SUNSET DATES. 

4 (a) AUTHORIZATION.—Sections 744G and 744H of the 

5 Federal Food, Drug, and Cosmetic Act, as added by section 

6 402 of this Act, shall cease to be effective October 1, 2017. 

7 (b) REPORTING REQUIREMENTS.—Section 744I of the 

8 Federal Food, Drug, and Cosmetic Act, as added by section 

9 403 of this Act, shall cease to be effective January 31, 2018. 

10 SEC. 405. EFFECTIVE DATE. 

11 (a) IN GENERAL.—Except as provided under sub12 section (b), the amendments made by this title shall take 

13 effect on the later of— 

14 (1) October 1, 2012; or 

15 (2) the date of the enactment of this title. 

16 (b) EXCEPTION.—Fees under part 8 of subchapter C 

17 of chapter VII of the Federal Food, Drug, and Cosmetic Act, 

18 as added by this title, shall be assessed for all biosimilar 

19 biological product applications received on or after October 

20 1, 2012, regardless of the date of the enactment of this title. 

21 SEC. 406. SAVINGS CLAUSE. 

22 Notwithstanding the amendments made by this title, 

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

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

25 date of the enactment of this title, shall continue to be in 
121 

•S 3187 EAH 

1 effect with respect to human drug applications and supple2 ments (as defined in such part as of such day) that were 

3 accepted by the Food and Drug Administration for filing 

4 on or after October 1, 2007, but before October 1, 2012, with 

5 respect to assessing and collecting any fee required by such 

6 part for a fiscal year prior to fiscal year 2013. 

7 SEC. 407. CONFORMING AMENDMENT. 

8 Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended 

9 by striking ‘‘or (k)’’. 

10 SEC. 408. ADDITIONAL REPORTING REQUIREMENTS. 

11 Section 715, as added by section 308 of this Act, is 

12 amended by adding at the end the following: 

13 ‘‘(b) BIOSIMILAR BIOLOGICAL PRODUCTS.— 

14 ‘‘(1) IN GENERAL.—Beginning with fiscal year 

15 2014, not later than 120 days after the end of each 

16 fiscal year for which fees are collected under part 8 

17 of subchapter C, the Secretary shall prepare and sub18 mit to the Committee on Health, Education, Labor, 

19 and Pensions of the Senate and the Committee on 

20 Energy and Commerce of the House of Representa21 tives a report concerning— 

22 ‘‘(A) the number of applications for ap23 proval filed under section 351(k) of the Public 

24 Health Service Act; and 
122 

•S 3187 EAH 

1 ‘‘(B) the percentage of applications de2 scribed in subparagraph (A) that were approved 

3 by the Secretary. 

4 ‘‘(2) ADDITIONAL INFORMATION.—As part of the 

5 performance report described in paragraph (1), the 

6 Secretary shall include an explanation of how the 

7 Food and Drug Administration is managing the bio8 logical product review program to ensure that the 

9 user fees collected under part 2 are not used to review 

10 an application under section 351(k) of the Public 

11 Health Service Act.’’. 

12 TITLE V—PEDIATRIC DRUGS 

13 AND DEVICES 

14 SEC. 501. PERMANENCE. 

15 (a) PEDIATRIC STUDIES OF DRUGS.—Section 505A 

16 (21 U.S.C. 355a) is amended by striking subsection (q) (re17 lating to a sunset). 

18 (b) RESEARCH INTO PEDIATRIC USES FOR DRUGS

19 AND BIOLOGICAL PRODUCTS.—Section 505B (21 U.S.C. 

20 355c) is amended— 

21 (1) by striking subsection (m); and 

22 (2) by redesignating subsection (n) as subsection 

23 (m). 

24 SEC. 502. WRITTEN REQUESTS. 

25 (a) IN GENERAL.— 
123 

•S 3187 EAH 

1 (1) FEDERAL FOOD, DRUG, AND COSMETIC

2 ACT.—Subsection (h) of section 505A (21 U.S.C. 

3 355a) is amended to read as follows: 

4 ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE5 QUIREMENTS.—Exclusivity under this section shall only be 

6 granted for the completion of a study or studies that are 

7 the subject of a written request and for which reports are 

8 submitted and accepted in accordance with subsection 

9 (d)(3). Written requests under this section may consist of 

10 a study or studies required under section 505B.’’. 

11 (2) PUBLIC HEALTH SERVICE ACT.—Section 

12 351(m)(1) of the Public Health Service Act (42 

13 U.S.C. 262(m)(1)) is amended by striking ‘‘(f), (i), 

14 (j), (k), (l), (p), and (q)’’ and inserting ‘‘(f), (h), (i), 

15 (j), (k), (l), (n), and (p)’’. 

16 (b) NEONATES.—Subparagraph (A) of section 

17 505A(d)(1) is amended by adding at the end the following: 

18 ‘‘If a request under this subparagraph does not request stud19 ies in neonates, such request shall include a statement de20 scribing the rationale for not requesting studies in neo21 nates.’’. 

22 SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COM23 MITTEE. 

24 Not later than 1 year after the date of enactment of 

25 this Act, the Secretary of Health and Human Services (re-
124 

•S 3187 EAH 

1 ferred to in this title as the ‘‘Secretary’’) shall issue internal 

2 standard operating procedures that provide for the review 

3 by the internal review committee established under section 

4 505C of the Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 355d) of any significant modifications to initial pe6 diatric study plans, agreed initial pediatric study plans, 

7 and written requests under sections 505A and 505B of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 

9 355c). Such internal standard operating procedures shall 

10 be made publicly available on the Internet Web site of the 

11 Food and Drug Administration. 

12 SEC. 504. ACCESS TO DATA. 

13 Not later than 3 years after the date of enactment of 

14 this Act, the Secretary shall make available to the public, 

15 including through posting on the Internet Web site of the 

16 Food and Drug Administration, the medical, statistical, 

17 and clinical pharmacology reviews of, and corresponding 

18 written requests issued to an applicant, sponsor, or holder 

19 for, pediatric studies submitted between January 4, 2002, 

20 and September 27, 2007, under subsection (b) or (c) of sec21 tion 505A of the Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 355a) for which 6 months of market exclusivity was 

23 granted and that resulted in a labeling change. The Sec24 retary shall make public the information described in the 

25 preceding sentence in a manner consistent with how the 
125 

•S 3187 EAH 

1 Secretary releases information under section 505A(k) of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)). 

3 SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC 

4 STUDIES. 

5 (a) EXTENSION OF DEADLINE FOR DEFERRED STUD6 IES.—Section 505B (21 U.S.C. 355c) is amended— 

7 (1) in subsection (a)(3)— 

8 (A) by redesignating subparagraph (B) as 

9 subparagraph (C); 

10 (B) by inserting after subparagraph (A) the 

11 following: 

12 ‘‘(B) DEFERRAL EXTENSION.— 

13 ‘‘(i) IN GENERAL.—On the initiative of 

14 the Secretary or at the request of the appli15 cant, the Secretary may grant an extension 

16 of a deferral approved under subparagraph 

17 (A) for submission of some or all assess18 ments required under paragraph (1) if— 

19 ‘‘(I) the Secretary determines that 

20 the conditions described in subclause 

21 (II) or (III) of subparagraph (A)(i) 

22 continue to be met; and 

23 ‘‘(II) the applicant submits a new 

24 timeline under subparagraph 

25 (A)(ii)(IV) and any significant up-
126 

•S 3187 EAH 

1 dates to the information required 

2 under subparagraph (A)(ii). 

3 ‘‘(ii) TIMING AND INFORMATION.—If 

4 the deferral extension under this subpara5 graph is requested by the applicant, the ap6 plicant shall submit the deferral extension 

7 request containing the information de8 scribed in this subparagraph not less than 

9 90 days prior to the date that the deferral 

10 would expire. The Secretary shall respond 

11 to such request not later than 45 days after 

12 the receipt of such letter. If the Secretary 

13 grants such an extension, the specified date 

14 shall be the extended date. The sponsor of 

15 the required assessment under paragraph 

16 (1) shall not be issued a letter described in 

17 subsection (d) unless the specified or ex18 tended date of submission for such required 

19 studies has passed or if the request for an 

20 extension is pending. For a deferral that 

21 has expired prior to the date of enactment 

22 of the Food and Drug Administration Safe23 ty and Innovation Act or that will expire 

24 prior to 270 days after the date of enact25 ment of such Act, a deferral extension shall 
127 

•S 3187 EAH 

1 be requested by an applicant not later than 

2 180 days after the date of enactment of such 

3 Act. The Secretary shall respond to any 

4 such request as soon as practicable, but not 

5 later than 1 year after the date of enact6 ment of such Act. Nothing in this clause 

7 shall prevent the Secretary from updating 

8 the status of a study or studies publicly if 

9 components of such study or studies are late 

10 or delayed.’’; and 

11 (C) in subparagraph (C), as so redesig12 nated— 

13 (i) in clause (i), by adding at the end 

14 the following: 

15 ‘‘(III) Projected completion date 

16 for pediatric studies. 

17 ‘‘(IV) The reason or reasons why 

18 a deferral or deferral extension con19 tinues to be necessary.’’; and 

20 (ii) by amending clause (ii) to read as 

21 follows: 

22 ‘‘(ii) PUBLIC AVAILABILITY.—Not later 

23 than 90 days after the submission to the 

24 Secretary of the information submitted 

25 through the annual review under clause (i), 
128 

•S 3187 EAH 

1 the Secretary shall make available to the 

2 public in an easily accessible manner, in3 cluding through the Internet Web site of the 

4 Food and Drug Administration— 

5 ‘‘(I) such information; 

6 ‘‘(II) the name of the applicant 

7 for the product subject to the assess8 ment; 

9 ‘‘(III) the date on which the prod10 uct was approved; and 

11 ‘‘(IV) the date of each deferral or 

12 deferral extension under this para13 graph for the product.’’; and 

14 (2) in subsection (f)— 

15 (A) in the subsection heading, by inserting 

16 ‘‘DEFERRAL EXTENSIONS,’’ after ‘‘DEFERRALS,’’; 

17 (B) in paragraph (1), by inserting ‘‘, defer18 ral extension,’’ after ‘‘deferral’’; and 

19 (C) in paragraph (4)— 

20 (i) in the paragraph heading, by in21 serting ‘‘DEFERRAL EXTENSIONS,’’ after 

22 ‘‘DEFERRALS,’’; and 

23 (ii) by inserting ‘‘, deferral exten24 sions,’’ after ‘‘deferrals’’. 
129 

•S 3187 EAH 

1 (b) TRACKING OF EXTENSIONS; ANNUAL INFORMA2 TION.—Section 505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is 

3 amended to read as follows: 

4 ‘‘(D) aggregated on an annual basis— 

5 ‘‘(i) the total number of deferrals and 

6 deferral extensions requested and granted 

7 under this section and, if granted, the rea8 sons for each such deferral or deferral exten9 sion; 

10 ‘‘(ii) the timeline for completion of the 

11 assessments; and 

12 ‘‘(iii) the number of assessments com13 pleted and pending;’’. 

14 (c) ACTION ON FAILURE TO COMPLETE STUDIES.— 

15 (1) ISSUANCE OF LETTER.—Subsection (d) of 

16 section 505B (21 U.S.C. 355c) is amended to read as 

17 follows: 

18 ‘‘(d) SUBMISSION OF ASSESSMENTS.—If a person fails 

19 to submit a required assessment described in subsection 

20 (a)(2), fails to meet the applicable requirements in sub21 section (a)(3), or fails to submit a request for approval of 

22 a pediatric formulation described in subsection (a) or (b), 

23 in accordance with applicable provisions of subsections (a) 

24 and (b), the following shall apply: 
130 

•S 3187 EAH 

1 ‘‘(1) Beginning 270 days after the date of enact2 ment of the Food and Drug Administration Safety 

3 and Innovation Act, the Secretary shall issue a non4 compliance letter to such person informing them of 

5 such failure to submit or meet the requirements of the 

6 applicable subsection. Such letter shall require the 

7 person to respond in writing within 45 calendar days 

8 of issuance of such letter. Such response may include 

9 the person’s request for a deferral extension if appli10 cable. Such letter and the person’s written response to 

11 such letter shall be made publicly available on the 

12 Internet Web site of the Food and Drug Administra13 tion 60 calendar days after issuance, with redactions 

14 for any trade secrets and confidential commercial in15 formation. If the Secretary determines that the letter 

16 was issued in error, the requirements of this para17 graph shall not apply. 

18 ‘‘(2) The drug or biological product that is the 

19 subject of an assessment described in subsection 

20 (a)(2), applicable requirements in subsection (a)(3), 

21 or request for approval of a pediatric formulation, 

22 may be considered misbranded solely because of that 

23 failure and subject to relevant enforcement action (ex24 cept that the drug or biological product shall not be 
131 

•S 3187 EAH 

1 subject to action under section 303), but such failure 

2 shall not be the basis for a proceeding— 

3 ‘‘(A) to withdraw approval for a drug 

4 under section 505(e); or 

5 ‘‘(B) to revoke the license for a biological 

6 product under section 351 of the Public Health 

7 Service Act.’’. 

8 (2) TRACKING OF LETTERS ISSUED.—Subpara9 graph (D) of section 505B(f)(6) (21 U.S.C. 

10 355c(f)(6)), as amended by subsection (b), is further 

11 amended— 

12 (A) in clause (ii), by striking ‘‘; and’’ and 

13 inserting a semicolon; 

14 (B) in clause (iii), by adding ‘‘and’’ at the 

15 end; and 

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

17 ‘‘(iv) the number of postmarket non18 compliance letters issued pursuant to sub19 section (d), and the recipients of such let20 ters;’’. 

21 SEC. 506. PEDIATRIC STUDY PLANS. 

22 (a) IN GENERAL.—Subsection (e) of section 505B (21 

23 U.S.C. 355c) is amended to read as follows: 

24 ‘‘(e) PEDIATRIC STUDY PLANS.— 
132 

•S 3187 EAH 

1 ‘‘(1) IN GENERAL.—An applicant subject to sub2 section (a) shall submit to the Secretary an initial 

3 pediatric study plan prior to the submission of the 

4 assessments described under subsection (a)(2). 

5 ‘‘(2) TIMING; CONTENT; MEETING.— 

6 ‘‘(A) TIMING.—An applicant shall submit 

7 the initial pediatric plan under paragraph (1)— 

8 ‘‘(i) before the date on which the appli9 cant submits the assessments under sub10 section (a)(2); and 

11 ‘‘(ii) not later than— 

12 ‘‘(I) 60 calendar days after the 

13 date of the end-of-Phase 2 meeting (as 

14 such term is used in section 312.47 of 

15 title 21, Code of Federal Regulations, 

16 or successor regulations); or 

17 ‘‘(II) such other time as may be 

18 agreed upon between the Secretary and 

19 the applicant. 

20 Nothing in this section shall preclude the Sec21 retary from accepting the submission of an ini22 tial pediatric plan earlier than the date other23 wise applicable under this subparagraph. 

24 ‘‘(B) CONTENT OF INITIAL PLAN.—The ini25 tial pediatric study plan shall include— 
133 

•S 3187 EAH 

1 ‘‘(i) an outline of the pediatric study 

2 or studies that the applicant plans to con3 duct (including, to the extent practicable 

4 study objectives and design, age groups, rel5 evant endpoints, and statistical approach); 

6 ‘‘(ii) any request for a deferral, partial 

7 waiver, or waiver under this section, if ap8 plicable, along with any supporting infor9 mation; and 

10 ‘‘(iii) other information specified in 

11 the regulations promulgated under para12 graph (7). 

13 ‘‘(C) MEETING.—The Secretary— 

14 ‘‘(i) shall meet with the applicant to 

15 discuss the initial pediatric study plan as 

16 soon as practicable, but not later than 90 

17 calendar days after the receipt of such plan 

18 under subparagraph (A); 

19 ‘‘(ii) may determine that a written re20 sponse to the initial pediatric study plan is 

21 sufficient to communicate comments on the 

22 initial pediatric study plan, and that no 

23 meeting is necessary; and 

24 ‘‘(iii) if the Secretary determines that 

25 no meeting is necessary, shall so notify the 
134 

•S 3187 EAH 

1 applicant and provide written comments of 

2 the Secretary as soon as practicable, but not 

3 later than 90 calendar days after the receipt 

4 of the initial pediatric study plan. 

5 ‘‘(3) AGREED INITIAL PEDIATRIC STUDY PLAN.— 

6 Not later than 90 calendar days following the meeting 

7 under paragraph (2)(C)(i) or the receipt of a written 

8 response from the Secretary under paragraph 

9 (2)(C)(iii), the applicant shall document agreement 

10 on the initial pediatric study plan in a submission 

11 to the Secretary marked ‘Agreed Initial Pediatric 

12 Study Plan’, and the Secretary shall confirm such 

13 agreement to the applicant in writing not later than 

14 30 calendar days of receipt of such agreed initial pe15 diatric study plan. 

16 ‘‘(4) DEFERRAL AND WAIVER.—If the agreed ini17 tial pediatric study plan contains a request from the 

18 applicant for a deferral, partial waiver, or waiver 

19 under this section, the written confirmation under 

20 paragraph (3) shall include a recommendation from 

21 the Secretary as to whether such request meets the 

22 standards under paragraphs (3) or (4) of subsection 

23 (a). 

24 ‘‘(5) AMENDMENTS TO THE PLAN.—At the initia25 tive of the Secretary or the applicant, the agreed ini-
135 

•S 3187 EAH 

1 tial pediatric study plan may be amended at any 

2 time. The requirements of paragraph (2)(C) shall 

3 apply to any such proposed amendment in the same 

4 manner and to the same extent as such requirements 

5 apply to an initial pediatric study plan under para6 graph (1). The requirements of paragraphs (3) and 

7 (4) shall apply to any agreement resulting from such 

8 proposed amendment in the same manner and to the 

9 same extent as such requirements apply to an agreed 

10 initial pediatric study plan. 

11 ‘‘(6) INTERNAL COMMITTEE.—The Secretary 

12 shall consult the internal committee under section 

13 505C on the review of the initial pediatric study 

14 plan, agreed initial pediatric plan, and any signifi15 cant amendments to such plans. 

16 ‘‘(7) REQUIRED RULEMAKING.—Not later than 1 

17 year after the date of enactment of the Food and Drug 

18 Administration Safety and Innovation Act, the Sec19 retary shall promulgate proposed regulations and 

20 issue guidance to implement the provisions of this 

21 subsection.’’. 

22 (b) CONFORMING AMENDMENTS.—Section 505B (21 

23 U.S.C. 355c) is amended— 

24 (1) by amending subclause (II) of subsection 

25 (a)(3)(A)(ii) to read as follows: 
136 

•S 3187 EAH 

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 DATE.— 

19 (1) IN GENERAL.—Subject to paragraph (2), the 

20 amendments made by this section shall take effect 180 

21 calendar days after the date of enactment of this Act, 

22 irrespective of whether the Secretary has promulgated 

23 final regulations to carry out such amendments. 

24 (2) RULE OF CONSTRUCTION.—Paragraph (1) 

25 shall not be construed to affect the deadline for pro-
137 

•S 3187 EAH 

1 mulgation of proposed regulations under section 

2 505B(e)(7) of the Federal Food, Drug, and Cosmetic 

3 Act, as added by subsection (a) of this section. 

4 SEC. 507. REAUTHORIZATIONS. 

5 (a) PEDIATRIC ADVISORY COMMITTEE.—Section 14(d) 

6 of the Best Pharmaceuticals for Children Act (42 U.S.C. 

7 284m note) is amended by striking ‘‘during the five-year 

8 period beginning on the date of the enactment of the Best 

9 Pharmaceuticals for Children Act of 2007’’ and inserting 

10 ‘‘to carry out the advisory committee’s responsibilities 

11 under sections 505A, 505B, and 520(m) of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c, and 

13 360j(m))’’. 

14 (b) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

15 DRUGS ADVISORY COMMITTEE.—Section 15(a)(3) of the 

16 Best Pharmaceuticals for Children Act (Public Law 107– 

17 109), as amended by section 502(e) of the Food and Drug 

18 Administration Amendments Act of 2007 (Public Law 110– 

19 85), is amended by striking ‘‘during the five-year period 

20 beginning on the date of the enactment of the Best Pharma21 ceuticals for Children Act of 2007’’ and inserting ‘‘for the 

22 duration of the operation of the Oncologic Drugs Advisory 

23 Committee’’. 

24 (c) HUMANITARIAN DEVICE EXEMPTION EXTEN25 SION.—Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 
138 

•S 3187 EAH 

1 and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended 

2 by striking ‘‘2012’’ and inserting ‘‘2017’’. 

3 (d) PROGRAM FOR PEDIATRIC STUDY OF DRUGS IN

4 PHSA.—Section 409I(e)(1) of the Public Health Service 

5 Act (42 U.S.C. 284m(e)(1)) is amended by striking ‘‘to 

6 carry out this section’’ and all that follows through the end 

7 of paragraph (1) and inserting ‘‘to carry out this section, 

8 $25,000,000 for each of fiscal years 2013 through 2017.’’. 

9 SEC. 508. REPORT. 

10 (a) IN GENERAL.—Not later than four years after the 

11 date of enactment of this Act and every five years thereafter, 

12 the Secretary shall prepare and submit to the Committee 

13 on Health, Education, Labor, and Pensions of the Senate 

14 and the Committee on Energy and Commerce of the House 

15 of Representatives, and make publicly available, including 

16 through posting on the Internet Web site of the Food and 

17 Drug Administration, a report on the implementation of 

18 sections 505A and 505B of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 355a, 355c). 

20 (b) CONTENTS.—Each report under subsection (a) 

21 shall include— 

22 (1) an assessment of the effectiveness of sections 

23 505A and 505B of the Federal Food, Drug, and Cos24 metic Act in improving information about pediatric 

25 uses for approved drugs and biological products, in-
139 

•S 3187 EAH 

1 cluding the number and type of labeling changes 

2 made since the date of enactment of this Act and the 

3 importance of such uses in the improvement of the 

4 health of children; 

5 (2) the number of required studies under such 

6 section 505B that have not met the initial deadline 

7 provided under such section 505B, including— 

8 (A) the number of deferrals and deferral ex9 tensions granted and the reasons such extensions 

10 were granted; 

11 (B) the number of waivers and partial 

12 waivers granted; and 

13 (C) the number of letters issued under sub14 section (d) of such section 505B; 

15 (3) an assessment of the timeliness and effective16 ness of pediatric study planning since the date of en17 actment of this Act, including the number of initial 

18 pediatric study plans not submitted in accordance 

19 with the requirements of subsection (e) of such section 

20 505B and any resulting rulemaking; 

21 (4) the number of written requests issued, accept22 ed, and declined under such section 505A since the 

23 date of enactment of this Act, and a listing of any 

24 important gaps in pediatric information as a result 

25 of such declined requests; 
140 

•S 3187 EAH 

1 (5) a description and current status of referrals 

2 made under subsection (n) of such section 505A; 

3 (6) an assessment of the effectiveness of studying 

4 biological products in pediatric populations under 

5 such sections 505A and 505B and section 409I of the 

6 Public Health Service Act (42 U.S.C. 284m); 

7 (7)(A) the efforts made by the Secretary to in8 crease the number of studies conducted in the neo9 natal population (including efforts made to encourage 

10 the conduct of appropriate studies in neonates by 

11 companies with products that have sufficient safety 

12 and other information to make the conduct of the 

13 studies ethical and safe); and 

14 (B) the results of such efforts; 

15 (8)(A) the number and importance of drugs and 

16 biological products for children with cancer that are 

17 being tested as a result of the programs under such 

18 sections 505A and 505B and under section 409I of the 

19 Public Health Service Act; and 

20 (B) any recommendations for modifications to 

21 such programs that would lead to new and better 

22 therapies for children with cancer, including a de23 tailed rationale for each recommendation; 

24 (9) any recommendations for modification to 

25 such programs that would improve pediatric drug re-
141 

•S 3187 EAH 

1 search and increase pediatric labeling of drugs and 

2 biological products; 

3 (10) an assessment of the successes of and limita4 tions to studying drugs for rare diseases under such 

5 sections 505A and 505B; and 

6 (11) an assessment of the Secretary’s efforts to 

7 address the suggestions and options described in any 

8 prior report issued by the Comptroller General, Insti9 tute of Medicine, or the Secretary, and any subse10 quent reports, including recommendations therein, re11 garding the topics addressed in the reports under this 

12 section, including with respect to— 

13 (A) improving public access to information 

14 from pediatric studies conducted under such sec15 tions 505A and 505B; and 

16 (B) improving the timeliness of pediatric 

17 studies and pediatric study planning under such 

18 sections 505A and 505B. 

19 (c) STAKEHOLDER COMMENT.—At least 180 days 

20 prior to the submission of each report under subsection (a), 

21 the Secretary shall consult with representatives of patient 

22 groups (including pediatric patient groups), consumer 

23 groups, regulated industry, academia, and other interested 

24 parties to obtain any recommendations or information rel25 evant to the report including suggestions for modifications 
142 

•S 3187 EAH 

1 that would improve pediatric drug research and pediatric 

2 labeling of drugs and biological products. 

3 SEC. 509. TECHNICAL AMENDMENTS. 

4 (a) PEDIATRIC STUDIES OF DRUGS IN FFDCA.—Sec5 tion 505A (21 U.S.C. 355a) is amended— 

6 (1) in subsection (k)(2), by striking ‘‘subsection 

7 (f)(3)(F)’’ and inserting ‘‘subsection (f)(6)(F)’’; 

8 (2) in subsection (l)— 

9 (A) in paragraph (1)— 

10 (i) in the paragraph heading, by strik11 ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 

12 MONTH PERIOD’’; and 

13 (ii) by striking ‘‘one-year’’ and insert14 ing ‘‘18-month’’; 

15 (B) in paragraph (2)— 

16 (i) in the paragraph heading, by strik17 ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; and 

18 (ii) by striking ‘‘one-year period’’ and 

19 inserting ‘‘18-month period’’; 

20 (C) by redesignating paragraph (3) as 

21 paragraph (4); and 

22 (D) by inserting after paragraph (2) the fol23 lowing: 

24 ‘‘(3) PRESERVATION OF AUTHORITY.—Nothing in 

25 this subsection shall prohibit the Office of Pediatric 
143 

•S 3187 EAH 

1 Therapeutics from providing for the review of adverse 

2 event reports by the Pediatric Advisory Committee 

3 prior to the 18-month period referred to in paragraph 

4 (1), if such review is necessary to ensure safe use of 

5 a drug in a pediatric population.’’; 

6 (3) in subsection (n)— 

7 (A) in the subsection heading, by striking 

8 ‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; and 

9 (B) in paragraph (1)— 

10 (i) in the matter preceding subpara11 graph (A), by striking ‘‘have not been com12 pleted’’ and inserting ‘‘have not been sub13 mitted by the date specified in the written 

14 request issued or if the applicant or holder 

15 does not agree to the request’’; 

16 (ii) in subparagraph (A)— 

17 (I) in the first sentence, by insert18 ing ‘‘, or for which a period of exclu19 sivity eligible for extension under sub20 section (b)(1) or (c)(1) of this section 

21 or under subsection (m)(2) or (m)(3) of 

22 section 351 of the Public Health Serv23 ice Act has not ended’’ after ‘‘expired’’; 

24 and 
144 

•S 3187 EAH 

1 (II) by striking ‘‘Prior to’’ and all 

2 that follows through the period at the 

3 end; and 

4 (iii) in subparagraph (B), by striking 

5 ‘‘no listed patents or has 1 or more listed 

6 patents that have expired,’’ and inserting 

7 ‘‘no unexpired listed patents and for which 

8 no unexpired periods of exclusivity eligible 

9 for extension under subsection (b)(1) or 

10 (c)(1) of this section or under subsection 

11 (m)(2) or (m)(3) of section 351 of the Pub12 lic Health Service Act apply,’’; and 

13 (4) in subsection (o)(2), by amending subpara14 graph (B) to read as follows: 

15 ‘‘(B) a statement of any appropriate pedi16 atric contraindications, warnings, precautions, 

17 or other information that the Secretary considers 

18 necessary to assure safe use.’’. 

19 (b) RESEARCH INTO PEDIATRIC USES FOR DRUGS

20 AND BIOLOGICAL PROJECTS IN FFDCA.—Section 505B (21 

21 U.S.C. 355c) is amended— 

22 (1) in subsection (a)— 

23 (A) in paragraph (1), in the matter before 

24 subparagraph (A), by inserting ‘‘for a drug’’ 

25 after ‘‘(or supplement to an application)’’; and 
145 

•S 3187 EAH 

1 (B) in paragraph (4)(C)— 

2 (i) in the first sentence, by inserting 

3 ‘‘partial’’ before ‘‘waiver is granted’’; and 

4 (ii) in the second sentence, by striking 

5 ‘‘either a full or’’ and inserting ‘‘such a’’; 

6 (2) in subsection (b)(1), in the matter preceding 

7 subparagraph (A), by striking ‘‘After providing no8 tice’’ and all that follows through ‘‘studies), the’’ and 

9 inserting ‘‘The’’; 

10 (3) in subsection (g)— 

11 (A) in paragraph (1)(A), by inserting ‘‘that 

12 receives a priority review or 330 days after the 

13 date of the submission of an application or sup14 plement that receives a standard review’’ after 

15 ‘‘after the date of the submission of the applica16 tion or supplement’’; and 

17 (B) in paragraph (2), by striking ‘‘the label 

18 of such product’’ and inserting ‘‘the labeling of 

19 such product’’; 

20 (4) in subsection (h)(1)— 

21 (A) by inserting ‘‘an application (or sup22 plement to an application) that contains’’ after 

23 ‘‘date of submission of’’; and 

24 (B) by inserting ‘‘if the application (or sup25 plement) receives a priority review, or not later 
146 

•S 3187 EAH 

1 than 330 days after the date of submission of an 

2 application (or supplement to an application) 

3 that contains a pediatric assessment under this 

4 section, if the application (or supplement) re5 ceives a standard review,’’ after ‘‘under this sec6 tion,’’; and 

7 (5) in subsection (i)— 

8 (A) in paragraph (1)— 

9 (i) in the paragraph heading, by strik10 ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 

11 MONTH PERIOD’’; and 

12 (ii) by striking ‘‘one-year’’ and insert13 ing ‘‘18-month’’; 

14 (B) in paragraph (2)— 

15 (i) in the paragraph heading, by strik16 ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; and 

17 (ii) by striking ‘‘one-year period’’ and 

18 inserting ‘‘18-month period’’; 

19 (C) by redesignating paragraph (3) as 

20 paragraph (4); and 

21 (D) by inserting after paragraph (2) the fol22 lowing: 

23 ‘‘(3) PRESERVATION OF AUTHORITY.—Nothing in 

24 this subsection shall prohibit the Office of Pediatric 

25 Therapeutics from providing for the review of adverse 
147 

•S 3187 EAH 

1 event reports by the Pediatric Advisory Committee 

2 prior to the 18-month period referred to in paragraph 

3 (1), if such review is necessary to ensure safe use of 

4 a drug in a pediatric population.’’. 

5 (c) INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC

6 PLANS, ASSESSMENTS, DEFERRALS, DEFERRAL EXTEN7 SIONS, AND WAIVERS.—Section 505C (21 U.S.C. 355d) is 

8 amended— 

9 (1) in the section heading, by inserting ‘‘DEFER10 RAL EXTENSIONS,’’ after ‘‘DEFERRALS,’’; and 

11 (2) by inserting ‘‘neonatology,’’ after ‘‘pediatric 

12 ethics,’’. 

13 (d) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 

14 Section 409I(c) of the Public Health Service Act (42 U.S.C. 

15 284m(c)) is amended— 

16 (1) in paragraph (1)— 

17 (A) in the matter preceding subparagraph 

18 (A), by inserting ‘‘or section 351(m) of this Act,’’ 

19 after ‘‘Cosmetic Act,’’; 

20 (B) in subparagraph (A)(i), by inserting 

21 ‘‘or section 351(k) of this Act’’ after ‘‘Cosmetic 

22 Act’’; and 

23 (C) by amending subparagraph (B) to read 

24 as follows: 
148 

•S 3187 EAH 

1 ‘‘(B) there remains no patent listed pursu2 ant to section 505(b)(1) of the Federal Food, 

3 Drug, and Cosmetic Act, and every three-year 

4 and five-year period referred to in subsection 

5 (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), 

6 (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of sec7 tion 505 of the Federal Food, Drug, and Cos8 metic Act, or applicable twelve-year period re9 ferred to in section 351(k)(7) of this Act, and 

10 any seven-year period referred to in section 527 

11 of the Federal Food, Drug, and Cosmetic Act has 

12 ended for at least one form of the drug; and’’; 

13 and 

14 (2) in paragraph (2)— 

15 (A) in the paragraph heading, by striking 

16 ‘‘FOR DRUGS LACKING EXCLUSIVITY’’; 

17 (B) by striking ‘‘under section 505 of the 

18 Federal Food, Drug, and Cosmetic Act’’; and 

19 (C) by striking ‘‘505A of such Act’’ and in20 serting ‘‘505A of the Federal Food, Drug, and 

21 Cosmetic Act or section 351(m) of this Act’’. 

22 (e) PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC

23 ADVISORY COMMITTEE.—Section 15(a) of the Best Pharma24 ceuticals for Children Act (Public Law 107–109), as 

25 amended by section 502(e) of the Food and Drug Adminis-
149 

•S 3187 EAH 

1 tration Amendments Act of 2007 (Public Law 110–85), is 

2 amended in paragraph (1)(D), by striking ‘‘section 

3 505B(f)’’ and inserting ‘‘section 505C’’. 

4 (f) FOUNDATION OF NATIONAL INSTITUTES OF

5 HEALTH.—Section 499(c)(1)(C) of the Public Health Serv6 ice Act (42 U.S.C. 290b(c)(1)(C)) is amended by striking 

7 ‘‘for which the Secretary issues a certification in the affirm8 ative under section 505A(n)(1)(A) of the Federal Food, 

9 Drug, and Cosmetic Act’’. 

10 (g) APPLICATION; TRANSITION RULE.— 

11 (1) APPLICATION.—Notwithstanding any provi12 sion of section 505A and 505B of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) stat14 ing that a provision applies beginning on the date of 

15 the enactment of the Best Pharmaceuticals for Chil16 dren Act of 2007 or the date of the enactment of the 

17 Pediatric Research Equity Act of 2007, any amend18 ment made by this Act to such a provision applies be19 ginning on the date of the enactment of this Act. 

20 (2) TRANSITIONAL RULE FOR ADVERSE EVENT

21 REPORTING.—With respect to a drug for which a la22 beling change described under section 505A(l)(1) or 

23 505B(i)(1) of the Federal Food, Drug, and Cosmetic 

24 Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved or 

25 made, respectively, during the one-year period that 
150 

•S 3187 EAH 

1 ends on the day before the date of enactment of this 

2 Act, the Secretary shall apply section 505A(l) and 

3 section 505B(i), as applicable, to such drug, as such 

4 sections were in effect on such day. 

5 SEC. 510. PEDIATRIC RARE DISEASES. 

6 (a) PUBLIC MEETING.—Not later than 18 months after 

7 the date of enactment of this Act, the Secretary shall hold 

8 at least one public meeting to discuss ways to encourage 

9 and accelerate the development of new therapies for pedi10 atric rare diseases. 

11 (b) REPORT.—Not later than 180 days after the date 

12 of the public meeting under subsection (a), the Secretary 

13 shall issue a report that includes a strategic plan for en14 couraging and accelerating the development of new thera15 pies for treating pediatric rare diseases. 

16 SEC. 511. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS. 

17 Section 6 of the Best Pharmaceuticals for Children Act 

18 (21 U.S.C. 393a) is amended— 

19 (1) in subsection (c)— 

20 (A) in paragraph (1), by striking ‘‘and’’ at 

21 the end; 

22 (B) by redesignating paragraph (2) as 

23 paragraph (4); and 

24 (C) by inserting after paragraph (1) the fol25 lowing: 
151 

•S 3187 EAH 

1 ‘‘(2) subject to subsection (d), one or more addi2 tional individuals with necessary expertise in a pedi3 atric subpopulation that is, as determined through 

4 consideration of the reports and recommendations 

5 issued by the Institute of Medicine and the Comp6 troller General of the United States, less likely to be 

7 studied as a part of a written request issued under 

8 section 505A of the Federal Food, Drug, and Cosmetic 

9 Act or an assessment under section 505B of such Act; 

10 ‘‘(3) one or more additional individuals with ex11 pertise in pediatric epidemiology; and’’; and 

12 (2) by adding at the end the following: 

13 ‘‘(d) NEONATOLOGY EXPERTISE.—For the 5-year pe14 riod beginning on the date of enactment of this subsection, 

15 at least one of the individuals described in subsection (c)(2) 

16 shall have expertise in neonatology.’’. 

17 TITLE VI—MEDICAL DEVICE 

18 REGULATORY IMPROVEMENTS 

19 SEC. 601. INVESTIGATIONAL DEVICE EXEMPTIONS. 

20 Section 520(g) (21 U.S.C. 360j(g)) is amended— 

21 (1) in paragraph (2)(B)(ii), by inserting ‘‘safety 

22 or effectiveness’’ before ‘‘data obtained’’; and 

23 (2) in paragraph (4), by adding at the end the 

24 following: 
152 

•S 3187 EAH 

1 ‘‘(C) Consistent with paragraph (1), the Secretary 

2 shall not disapprove an application under this subsection 

3 because the Secretary determines that— 

4 ‘‘(i) the investigation may not support a sub5 stantial equivalence or de novo classification deter6 mination or approval of the device; 

7 ‘‘(ii) the investigation may not meet a require8 ment, including a data requirement, relating to the 

9 approval or clearance of a device; or 

10 ‘‘(iii) an additional or different investigation 

11 may be necessary to support clearance or approval of 

12 the device.’’. 

13 SEC. 602. CLARIFICATION OF LEAST BURDENSOME STAND14 ARD. 

15 (a) PREMARKET APPROVAL.—Section 513(a)(3)(D) 

16 (21 U.S.C. 360c(a)(3)(D)) is amended— 

17 (1) by redesignating clause (iii) as clause (v); 

18 and 

19 (2) by inserting after clause (ii) the following: 

20 ‘‘(iii) For purposes of clause (ii), the term ‘necessary’ 

21 means the minimum required information that would sup22 port a determination by the Secretary that an application 

23 provides reasonable assurance of the effectiveness of the de24 vice. 
153 

•S 3187 EAH 

1 ‘‘(iv) Nothing in this subparagraph shall alter the cri2 teria for evaluating an application for premarket approval 

3 of a device.’’. 

4 (b) PREMARKET NOTIFICATION UNDER SECTION

5 510(k).—Section 513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is 

6 amended— 

7 (1) by striking ‘‘(D) Whenever’’ and inserting 

8 ‘‘(D)(i) Whenever’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(ii) For purposes of clause (i), the term ‘necessary’ 

11 means the minimum required information that would sup12 port a determination of substantial equivalence between a 

13 new device and a predicate device. 

14 ‘‘(iii) Nothing in this subparagraph shall alter the 

15 standard for determining substantial equivalence between 

16 a new device and a predicate device.’’. 

17 SEC. 603. AGENCY DOCUMENTATION AND REVIEW OF SIG18 NIFICANT DECISIONS. 

19 Chapter V is amended by inserting after section 517 

20 (21 U.S.C. 360g) the following: 

21 ‘‘SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIG22 NIFICANT DECISIONS REGARDING DEVICES. 

23 ‘‘(a) DOCUMENTATION OF RATIONALE FOR SIGNIFI24 CANT DECISIONS.— 
154 

•S 3187 EAH 

1 ‘‘(1) IN GENERAL.—The Secretary shall provide 

2 a substantive summary of the scientific and regu3 latory rationale for any significant decision of the 

4 Center for Devices and Radiological Health regarding 

5 submission or review of a report under section 510(k), 

6 an application under section 515, or an application 

7 for an exemption under section 520(g), including doc8 umentation of significant controversies or differences 

9 of opinion and the resolution of such controversies or 

10 differences of opinion. 

11 ‘‘(2) PROVISION OF DOCUMENTATION.—Upon re12 quest, the Secretary shall furnish such substantive 

13 summary to the person who is seeking to submit, or 

14 who has submitted, such report or application. 

15 ‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 

16 ‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF

17 SIGNIFICANT DECISION.—Any person may request a 

18 supervisory review of the significant decision de19 scribed in subsection (a)(1). Such review may be con20 ducted at the next supervisory level or higher above 

21 the individual who made the significant decision. 

22 ‘‘(2) SUBMISSION OF REQUEST.—A person re23 questing a supervisory review under paragraph (1) 

24 shall submit such request to the Secretary not later 

25 than 30 days after such decision and shall indicate 
155 

•S 3187 EAH 

1 in the request whether such person seeks an in-person 

2 meeting or a teleconference review. 

3 ‘‘(3) TIMEFRAME.— 

4 ‘‘(A) IN GENERAL.—Except as provided in 

5 subparagraph (B), the Secretary shall schedule 

6 an in-person or teleconference review, if so re7 quested, not later than 30 days after such request 

8 is made. The Secretary shall issue a decision to 

9 the person requesting a review under this sub10 section not later than 45 days after the request 

11 is made under paragraph (1), or, in the case of 

12 a person who requests an in-person meeting or 

13 teleconference, 30 days after such meeting or tele14 conference. 

15 ‘‘(B) EXCEPTION.—Subparagraph (A) shall 

16 not apply in cases that are referred to experts 

17 outside of the Food and Drug Administration.’’. 

18 SEC. 604. DEVICE MODIFICATIONS REQUIRING PREMARKET 

19 NOTIFICATION PRIOR TO MARKETING. 

20 Section 510(n) (21 U.S.C. 360(n)) is amended by— 

21 (1) striking ‘‘(n) The Secretary’’ and inserting 

22 ‘‘(n)(1) The Secretary’’; and 

23 (2) by adding at the end the following: 

24 ‘‘(2)(A) Not later than 18 months after the date 

25 of enactment of this paragraph, the Secretary shall 
156 

•S 3187 EAH 

1 submit to the Committee on Energy and Commerce of 

2 the House of Representatives and the Committee on 

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

4 a report regarding when a premarket notification 

5 under subsection (k) should be submitted for a modi6 fication or change to a legally marketed device. The 

7 report shall include the Secretary’s interpretation of 

8 the following terms: ‘could significantly affect the 

9 safety or effectiveness of the device’, ‘a significant 

10 change or modification in design, material, chemical 

11 composition, energy source, or manufacturing proc12 ess’, and ‘major change or modification in the in13 tended use of the device’. The report also shall discuss 

14 possible processes for industry to use to determine 

15 whether a new submission under subsection (k) is re16 quired and shall analyze how to leverage existing 

17 quality system requirements to reduce premarket bur18 den, facilitate continual device improvement, and 

19 provide reasonable assurance of safety and effective20 ness of modified devices. In developing such report, 

21 the Secretary shall consider the input of interested 

22 stakeholders. 

23 ‘‘(B) The Secretary shall withdraw the Food and 

24 Drug Administration draft guidance entitled ‘Guid25 ance for Industry and FDA Staff—510(k) Device 
157 

•S 3187 EAH 

1 Modifications: Deciding When to Submit a 510(k) for 

2 a Change to an Existing Device’, dated July 27, 

3 2011, and shall not use this draft guidance as part 

4 of, or for the basis of, any premarket review or any 

5 compliance or enforcement decisions or actions. The 

6 Secretary shall not issue— 

7 ‘‘(i) any draft guidance or proposed regula8 tion that addresses when to submit a premarket 

9 notification submission for changes and modi10 fications made to a manufacturer’s previously 

11 cleared device before the receipt by the Committee 

12 on Energy and Commerce of the House of Rep13 resentatives and the Committee on Health, Edu14 cation, Labor, and Pensions of the Senate of the 

15 report required in subparagraph (A); and 

16 ‘‘(ii) any final guidance or regulation on 

17 that topic for one year after date of receipt of 

18 such report by the Committee on Energy and 

19 Commerce of the House of Representatives and 

20 the Committee on Health, Education, Labor, and 

21 Pensions of the Senate. 

22 ‘‘(C) The Food and Drug Administration guid23 ance entitled ‘Deciding When to Submit a 510(k) for 

24 a Change to an Existing Device’, dated January 10, 

25 1997, shall be in effect until the subsequent issuance 
158 

•S 3187 EAH 

1 of guidance or promulgation, if appropriate, of a reg2 ulation described in subparagraph (B), and the Sec3 retary shall interpret such guidance in a manner that 

4 is consistent with the manner in which the Secretary 

5 has interpreted such guidance since 1997.’’. 

6 SEC. 605. PROGRAM TO IMPROVE THE DEVICE RECALL SYS7 TEM. 

8 Chapter V is amended by inserting after section 518 

9 (21 U.S.C. 360h) the following: 

10 ‘‘SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL 

11 SYSTEM. 

12 ‘‘(a) IN GENERAL.—The Secretary shall— 

13 ‘‘(1) establish a program to routinely and sys14 tematically assess information relating to device re15 calls and use such information to proactively identify 

16 strategies for mitigating health risks presented by de17 fective or unsafe devices; 

18 ‘‘(2) clarify procedures for conducting device re19 call audit checks to improve the ability of investiga20 tors to perform those checks in a consistent manner; 

21 ‘‘(3) develop detailed criteria for assessing wheth22 er a person performing a device recall has performed 

23 an effective correction or action plan for the recall; 

24 and 
159 

•S 3187 EAH 

1 ‘‘(4) document the basis for each termination by 

2 the Food and Drug Administration of a device recall. 

3 ‘‘(b) ASSESSMENT CONTENT.—The program estab4 lished under subsection (a)(1) shall, at a minimum, iden5 tify— 

6 ‘‘(1) trends in the number and types of device re7 calls; 

8 ‘‘(2) devices that are most frequently the subject 

9 of a recall; and 

10 ‘‘(3) underlying causes of device recalls. 

11 ‘‘(c) TERMINATION OF RECALLS.—The Secretary shall 

12 document the basis for the termination by the Food and 

13 Drug Administration of a device recall. 

14 ‘‘(d) DEFINITION.—In this section, the term ‘recall’ 

15 means— 

16 ‘‘(1) the removal from the market of a device 

17 pursuant to an order of the Secretary under sub18 section (b) or (e) of section 518; or 

19 ‘‘(2) the correction or removal from the market 

20 of a device at the initiative of the manufacturer or 

21 importer of the device that is required to be reported 

22 to the Secretary under section 519(g).’’. 
160 

•S 3187 EAH 

1 SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE 

2 EXEMPTIONS. 

3 Section 520(g) (21 U.S.C. 360j(g)) is amended by add4 ing at the end the following: 

5 ‘‘(8)(A) At any time, the Secretary may prohibit the 

6 sponsor of an investigation from conducting the investiga7 tion (referred to in this paragraph as a ‘clinical hold’) if 

8 the Secretary makes a determination described in subpara9 graph (B). The Secretary shall specify the basis for the clin10 ical hold, including the specific information available to the 

11 Secretary which served as the basis for such clinical hold, 

12 and confirm such determination in writing. 

13 ‘‘(B) For purposes of subparagraph (A), a determina14 tion described in this subparagraph with respect to a clin15 ical hold is a determination that— 

16 ‘‘(i) the device involved represents an unreason17 able risk to the safety of the persons who are the sub18 jects of the clinical investigation, taking into account 

19 the qualifications of the clinical investigators, infor20 mation about the device, the design of the clinical in21 vestigation, the condition for which the device is to be 

22 investigated, and the health status of the subjects in23 volved; or 

24 ‘‘(ii) the clinical hold should be issued for such 

25 other reasons as the Secretary may by regulation es26 tablish. 
161 

•S 3187 EAH 

1 ‘‘(C) Any written request to the Secretary from the 

2 sponsor of an investigation that a clinical hold be removed 

3 shall receive a decision, in writing and specifying the rea4 sons therefor, within 30 days after receipt of such request. 

5 Any such request shall include sufficient information to 

6 support the removal of such clinical hold.’’. 

7 SEC. 607. MODIFICATION OF DE NOVO APPLICATION PROC8 ESS. 

9 (a) IN GENERAL.—Section 513(f)(2) (21 U.S.C. 

10 360c(f)(2)) is amended— 

11 (1) by inserting ‘‘(i)’’ after ‘‘(2)(A)’’; 

12 (2) in subparagraph (A)(i), as so designated by 

13 paragraph (1), by striking ‘‘under the criteria set 

14 forth’’ and all that follows through the end of sub15 paragraph (A) and inserting a period; 

16 (3) by adding at the end of subparagraph (A) the 

17 following: 

18 ‘‘(ii) In lieu of submitting a report under section 

19 510(k) and submitting a request for classification under 

20 clause (i) for a device, if a person determines there is no 

21 legally marketed device upon which to base a determination 

22 of substantial equivalence (as defined in subsection (i)), a 

23 person may submit a request under this clause for the Sec24 retary to classify the device. 
162 

•S 3187 EAH 

1 ‘‘(iii) Upon receipt of a request under clause (i) or 

2 (ii), the Secretary shall classify the device subject to the re3 quest under the criteria set forth in subparagraphs (A) 

4 through (C) of subsection (a)(1) within 120 days. 

5 ‘‘(iv) Notwithstanding clause (iii), the Secretary may 

6 decline to undertake a classification request submitted 

7 under clause (ii) if the Secretary identifies a legally mar8 keted device that could provide a reasonable basis for review 

9 of substantial equivalence under paragraph (1), or when the 

10 Secretary determines that the device submitted is not of low11 moderate risk or that general controls would be inadequate 

12 to control the risks and special controls to mitigate the risks 

13 cannot be developed. 

14 ‘‘(v) The person submitting the request for classifica15 tion under this subparagraph may recommend to the Sec16 retary a classification for the device and shall, if recom17 mending classification in class II, include in the request 

18 an initial draft proposal for applicable special controls, as 

19 described in subsection (a)(1)(B), that are necessary, in 

20 conjunction with general controls, to provide reasonable as21 surance of safety and effectiveness and a description of how 

22 the special controls provide such assurance. Any such re23 quest shall describe the device and provide detailed informa24 tion and reasons for the recommended classification.’’; and 
163 

•S 3187 EAH 

1 (4) in subparagraph (B), by striking ‘‘Not later 

2 than 60 days after the date of the submission of the 

3 request under subparagraph (A), the Secretary’’ and 

4 inserting ‘‘The Secretary’’. 

5 (b) CONFORMING AMENDMENTS.—Section 513(f) (21 

6 U.S.C. 360c(f)) is amended in paragraph (1)— 

7 (1) in subparagraph (A), by striking ‘‘, or’’ at 

8 the end and inserting a semicolon; 

9 (2) in subparagraph (B), by striking the period 

10 and inserting ‘‘; or’’; and 

11 (3) by inserting after subparagraph (B) the fol12 lowing: 

13 ‘‘(C) the device is classified pursuant to a request 

14 submitted under paragraph (2).’’. 

15 SEC. 608. RECLASSIFICATION PROCEDURES. 

16 (a) CLASSIFICATION CHANGES.— 

17 (1) IN GENERAL.—Section 513(e)(1) (21 U.S.C. 

18 360c(e)(1)) is amended to read as follows: 

19 ‘‘(e)(1)(A)(i) Based on new information respecting a 

20 device, the Secretary may, upon the initiative of the Sec21 retary or upon petition of an interested person, change the 

22 classification of such device, and revoke, on account of the 

23 change in classification, any regulation or requirement in 

24 effect under section 514 or 515 with respect to such device, 

25 by administrative order published in the Federal Register 
164 

•S 3187 EAH 

1 following publication of a proposed reclassification order in 

2 the Federal Register, a meeting of a device classification 

3 panel described in subsection (b), and consideration of com4 ments to a public docket, notwithstanding subchapter II of 

5 chapter 5 of title 5, United States Code. The proposed re6 classification order published in the Federal Register shall 

7 set forth the proposed reclassification, and a substantive 

8 summary of the valid scientific evidence concerning the pro9 posed reclassification, including— 

10 ‘‘(I) the public health benefit of the use of the de11 vice, and the nature and, if known, incidence of the 

12 risk of the device; 

13 ‘‘(II) in the case of a reclassification from class 

14 II to class III, why general controls pursuant to sub15 section (a)(1)(A) and special controls pursuant to 

16 subsection (a)(1)(B) together are not sufficient to pro17 vide a reasonable assurance of safety and effectiveness 

18 for such device; and 

19 ‘‘(III) in the case of reclassification from class 

20 III to class II, why general controls pursuant to sub21 section (a)(1)(A) and special controls pursuant to 

22 subsection (a)(1)(B) together are sufficient to provide 

23 a reasonable assurance of safety and effectiveness for 

24 such device. 
165 

•S 3187 EAH 

1 ‘‘(ii) An order under this subsection changing the clas2 sification of a device from class III to class II may provide 

3 that such classification shall not take effect until the effec4 tive date of a performance standard established under sec5 tion 514 for such device. 

6 ‘‘(B) Authority to issue such administrative order shall 

7 not be delegated below the Director of the Center for Devices 

8 and Radiological Health, acting in consultation with the 

9 Commissioner.’’. 

10 (2) TECHNICAL AND CONFORMING AMEND11 MENTS.— 

12 (A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) 

13 is amended by striking ‘‘regulation promul14 gated’’ and inserting ‘‘an order issued’’. 

15 (B) Section 514(a)(1) (21 U.S.C. 

16 360d(a)(1)) is amended by striking ‘‘under a 

17 regulation under section 513(e) but such regula18 tion’’ and inserting ‘‘under an administrative 

19 order under section 513(e) (or a regulation pro20 mulgated under such section prior to the date of 

21 enactment of the Food and Drug Administration 

22 Safety and Innovation Act) but such order (or 

23 regulation)’’. 

24 (C) Section 517(a)(1) (21 U.S.C. 

25 360g(a)(1)) is amended by striking ‘‘or changing 
166 

•S 3187 EAH 

1 the classification of a device to class I’’ and in2 serting ‘‘, an administrative order changing the 

3 classification of a device to class I,’’. 

4 (3) DEVICES RECLASSIFIED PRIOR TO THE DATE

5 OF ENACTMENT OF THIS ACT.— 

6 (A) IN GENERAL.—The amendments made 

7 by this subsection shall have no effect on a regu8 lation promulgated with respect to the classifica9 tion of a device under section 513(e) of the Fed10 eral Food, Drug, and Cosmetic Act prior to the 

11 date of enactment of this Act. 

12 (B) APPLICABILITY OF OTHER PROVI13 SIONS.—In the case of a device reclassified under 

14 section 513(e) of the Federal Food, Drug, and 

15 Cosmetic Act by regulation prior to the date of 

16 enactment of this Act, section 517(a)(1) of the 

17 Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 360g(a)(1)) shall apply to such regulation 

19 promulgated under section 513(e) of such Act 

20 with respect to such device in the same manner 

21 such section 517(a)(1) applies to an administra22 tive order issued with respect to a device reclassi23 fied after the date of enactment of this Act. 

24 (b) DEVICES MARKETED BEFORE MAY 28, 1976.— 
167 

•S 3187 EAH 

1 (1) PREMARKET APPROVAL.—Section 515 (21 

2 U.S.C. 360e) is amended— 

3 (A) in subsection (a), by striking ‘‘regula4 tion promulgated under subsection (b)’’ and in5 serting ‘‘an order issued under subsection (b) (or 

6 a regulation promulgated under such subsection 

7 prior to the date of enactment of the Food and 

8 Drug Administration Safety and Innovation 

9 Act)’’; 

10 (B) in subsection (b)— 

11 (i) in paragraph (1)— 

12 (I) in the heading, by striking 

13 ‘‘Regulation’’ and inserting ‘‘Order’’; 

14 and 

15 (II) in the matter following sub16 paragraph (B)— 

17 (aa) by striking ‘‘by regula18 tion, promulgated in accordance 

19 with this subsection’’ and insert20 ing ‘‘by administrative order fol21 lowing publication of a proposed 

22 order in the Federal Register, a 

23 meeting of a device classification 

24 panel described in section 513(b), 

25 and consideration of comments 
168 

•S 3187 EAH 

1 from all affected stakeholders, in2 cluding patients, payors, and pro3 viders, notwithstanding sub4 chapter II of chapter 5 of title 5, 

5 United States Code’’; and 

6 (bb) by adding at the end the 

7 following: ‘‘Authority to issue such 

8 administrative order shall not be 

9 delegated below the Director of the 

10 Center for Devices and Radio11 logical Health, acting in consulta12 tion with the Commissioner.’’; 

13 (ii) in paragraph (2)— 

14 (I) by striking subparagraph (B); 

15 and 

16 (II) in subparagraph (A)— 

17 (aa) by striking ‘‘(2)(A) A 

18 proceeding for the promulgation of 

19 a regulation under paragraph (1) 

20 respecting a device shall be initi21 ated by the publication in the 

22 Federal Register of a notice of 

23 proposed rulemaking. Such notice 

24 shall contain—’’ and inserting 

25 ‘‘(2) A proposed order required 
169 

•S 3187 EAH 

1 under paragraph (1) shall con2 tain—’’; 

3 (bb) by redesignating clauses 

4 (i) through (iv) as subparagraphs 

5 (A) through (D), respectively; 

6 (cc) in subparagraph (A), as 

7 so redesignated, by striking ‘‘regu8 lation’’ and inserting ‘‘order’’; 

9 and 

10 (dd) in subparagraph (C), as 

11 so redesignated, by striking ‘‘regu12 lation’’ and inserting ‘‘order’’; 

13 (iii) in paragraph (3)— 

14 (I) by striking ‘‘proposed regula15 tion’’ each place such term appears 

16 and inserting ‘‘proposed order’’; 

17 (II) by striking ‘‘paragraph (2) 

18 and after’’ and inserting ‘‘paragraph 

19 (2),’’; 

20 (III) by inserting ‘‘and a meeting 

21 of a device classification panel de22 scribed in section 513(b),’’ after ‘‘such 

23 proposed regulation and findings,’’; 

24 (IV) by striking ‘‘(A) promulgate 

25 such regulation’’ and inserting ‘‘(A) 
170 

•S 3187 EAH 

1 issue an administrative order under 

2 paragraph (1)’’; 

3 (V) by striking ‘‘paragraph 

4 (2)(A)(ii)’’ and inserting ‘‘paragraph 

5 (2)(B)’’; and 

6 (VI) by striking ‘‘promulgation of 

7 the regulation’’ and inserting 

8 ‘‘issuance of the administrative order’’; 

9 and 

10 (iv) by striking paragraph (4); and 

11 (C) in subsection (i)— 

12 (i) in paragraph (2)— 

13 (I) in the matter preceding sub14 paragraph (A)— 

15 (aa) by striking ‘‘December 

16 1, 1995’’ and inserting ‘‘the date 

17 that is 2 years after the date of 

18 enactment of the Food and Drug 

19 Administration Safety and Inno20 vation Act’’; and 

21 (bb) by striking ‘‘publish a 

22 regulation in the Federal Reg23 ister’’ and inserting ‘‘issue an ad24 ministrative order following pub25 lication of a proposed order in the 
171 

•S 3187 EAH 

1 Federal Register, a meeting of a 

2 device classification panel de3 scribed in section 513(b), and con4 sideration of comments from all 

5 affected stakeholders, including 

6 patients, payors, and providers, 

7 notwithstanding subchapter II of 

8 chapter 5 of title 5, United States 

9 Code,’’; 

10 (II) in subparagraph (B), by 

11 striking ‘‘final regulation has been pro12 mulgated under section 515(b)’’ and 

13 inserting ‘‘administrative order has 

14 been issued under subsection (b) (or no 

15 regulation has been promulgated under 

16 such subsection prior to the date of en17 actment of the Food and Drug Admin18 istration Safety and Innovation Act)’’; 

19 (III) in the matter following sub20 paragraph (B), by striking ‘‘regulation 

21 requires’’ and inserting ‘‘administra22 tive order issued under this paragraph 

23 requires’’; and 

24 (IV) by striking the third and 

25 fourth sentences; and 
172 

•S 3187 EAH 

1 (ii) in paragraph (3)— 

2 (I) by striking ‘‘regulation requir3 ing’’ each place such term appears and 

4 inserting ‘‘order requiring’’; and 

5 (II) by striking ‘‘promulgation of 

6 a section 515(b) regulation’’ and in7 serting ‘‘issuance of an administrative 

8 order under subsection (b)’’. 

9 (2) TECHNICAL AND CONFORMING AMEND10 MENTS.—Section 501(f) (21 U.S.C. 351(f)) is amend11 ed— 

12 (A) in subparagraph (1)(A)— 

13 (i) in subclause (i), by striking ‘‘a reg14 ulation promulgated’’ and inserting ‘‘an 

15 order issued’’; and 

16 (ii) in subclause (ii), by striking ‘‘pro17 mulgation of such regulation’’ and inserting 

18 ‘‘issuance of such order’’; 

19 (B) in subparagraph (2)(B)— 

20 (i) by striking ‘‘a regulation promul21 gated’’ and inserting ‘‘an order issued’’; and 

22 (ii) by striking ‘‘promulgation of such 

23 regulation’’ and inserting ‘‘issuance of such 

24 order’’; and 

25 (C) by adding at the end the following: 
173 

•S 3187 EAH 

1 ‘‘(3) In the case of a device with respect to which a 

2 regulation was promulgated under section 515(b) prior to 

3 the date of enactment of the Food and Drug Administration 

4 Safety and Innovation Act, a reference in this subsection 

5 to an order issued under section 515(b) shall be deemed to 

6 include such regulation.’’. 

7 (3) APPROVAL BY REGULATION PRIOR TO THE

8 DATE OF ENACTMENT OF THIS ACT.—The amend9 ments made by this subsection shall have no effect on 

10 a regulation that was promulgated prior to the date 

11 of enactment of this Act requiring that a device have 

12 an approval under section 515 of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 360e) of an appli14 cation for premarket approval. 

15 (c) REPORTING.—The Secretary of Health and 

16 Human Services shall annually post on the Internet Web 

17 site of the Food and Drug Administration— 

18 (1) the number and type of class I and class II 

19 devices reclassified as class II or class III in the pre20 vious calendar year under section 513(e)(1) of the 

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

22 360c(e)(1)); 

23 (2) the number and type of class II and class III 

24 devices reclassified as class I or class II in the pre25 vious calendar year under such section 513(e)(1); and 
174 

•S 3187 EAH 

1 (3) the number and type of devices reclassified in 

2 the previous calendar year under section 515 of the 

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

4 360e). 

5 SEC. 609. HARMONIZATION OF DEVICE PREMARKET RE6 VIEW, INSPECTION, AND LABELING SYMBOLS. 

7 Paragraph (4) of section 803(c) (21 U.S.C. 383(c)) is 

8 amended to read as follows: 

9 ‘‘(4) With respect to devices, the Secretary may, when 

10 appropriate, enter into arrangements with nations regard11 ing methods and approaches to harmonizing regulatory re12 quirements for activities, including inspections and com13 mon international labeling symbols.’’. 

14 SEC. 610. PARTICIPATION IN INTERNATIONAL FORA. 

15 Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is 

16 amended— 

17 (1) by striking ‘‘(3)’’ and inserting ‘‘(3)(A)’’; 

18 and 

19 (2) by adding at the end the following: 

20 ‘‘(B) In carrying out subparagraph (A), the Secretary 

21 may participate in appropriate fora, including the Inter22 national Medical Device Regulators Forum, and may— 

23 ‘‘(i) provide guidance to such fora on strategies, 

24 policies, directions, membership, and other activities 

25 of a forum as appropriate; 
175 

•S 3187 EAH 

1 ‘‘(ii) to the extent appropriate, solicit, review, 

2 and consider comments from industry, academia, 

3 health care professionals, and patient groups regard4 ing the activities of such fora; and 

5 ‘‘(iii) to the extent appropriate, inform the pub6 lic of the Secretary’s activities within such fora, and 

7 share with the public any documentation relating to 

8 a forum’s strategies, policies, and other activities of 

9 such fora.’’. 

10 SEC. 611. REAUTHORIZATION OF THIRD-PARTY REVIEW. 

11 (a) PERIODIC REACCREDITATION.—Section 523(b)(2) 

12 (21 U.S.C. 360m(b)(2)) is amended by adding at the end 

13 of the following: 

14 ‘‘(E) PERIODIC REACCREDITATION.— 

15 ‘‘(i) PERIOD.—Subject to suspension or 

16 withdrawal under subparagraph (B), any 

17 accreditation under this section shall be 

18 valid for a period of 3 years after its 

19 issuance. 

20 ‘‘(ii) RESPONSE TO REACCREDITATION

21 REQUEST.—Upon the submission of a re22 quest by an accredited person for reaccredi23 tation under this section, the Secretary shall 

24 approve or deny such request not later than 

25 60 days after receipt of the request. 
176 

•S 3187 EAH 

1 ‘‘(iii) CRITERIA.—Not later than 120 

2 days after the date of the enactment of this 

3 subparagraph, the Secretary shall establish 

4 and publish in the Federal Register criteria 

5 to reaccredit or deny reaccreditation to per6 sons under this section. The reaccreditation 

7 of persons under this section shall specify 

8 the particular activities under subsection 

9 (a), and the devices, for which such persons 

10 are reaccredited.’’. 

11 (b) DURATION OF AUTHORITY.—Section 523(c) (21 

12 U.S.C. 360m(c)) is amended by striking ‘‘October 1, 2012’’ 

13 and inserting ‘‘October 1, 2017’’. 

14 SEC. 612. REAUTHORIZATION OF THIRD-PARTY INSPEC15 TION. 

16 Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended 

17 by striking ‘‘October 1, 2012’’ and inserting ‘‘October 1, 

18 2017’’. 

19 SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS. 

20 (a) IN GENERAL.—Section 520(m) (21 U.S.C. 

21 360j(m)) is amended— 

22 (1) in paragraph (6)— 

23 (A) in subparagraph (A)— 

24 (i) by striking clause (i) and inserting 

25 the following: 
177 

•S 3187 EAH 

1 ‘‘(i) The device with respect to which the exemp2 tion is granted— 

3 ‘‘(I) is intended for the treatment or diag4 nosis of a disease or condition that occurs in pe5 diatric patients or in a pediatric subpopulation, 

6 and such device is labeled for use in pediatric 

7 patients or in a pediatric subpopulation in 

8 which the disease or condition occurs; or 

9 ‘‘(II) is intended for the treatment or diag10 nosis of a disease or condition that does not 

11 occur in pediatric patients or that occurs in pe12 diatric patients in such numbers that the devel13 opment of the device for such patients is impos14 sible, highly impracticable, or unsafe.’’; and 

15 (ii) by striking clause (ii) and insert16 ing the following: 

17 ‘‘(ii) During any calendar year, the number of 

18 such devices distributed during that year under each 

19 exemption granted under this subsection does not ex20 ceed the annual distribution number for such device. 

21 In this paragraph, the term ‘annual distribution 

22 number’ means the number of such devices reasonably 

23 needed to treat, diagnose, or cure a population of 

24 4,000 individuals in the United States. The Secretary 
178 

•S 3187 EAH 

1 shall determine the annual distribution number when 

2 the Secretary grants such exemption.’’; and 

3 (B) by amending subparagraph (C) to read 

4 as follows: 

5 ‘‘(C) A person may petition the Secretary to modify 

6 the annual distribution number determined by the Sec7 retary under subparagraph (A)(ii) with respect to a device 

8 if additional information arises, and the Secretary may 

9 modify such annual distribution number.’’; 

10 (2) in paragraph (7), by striking ‘‘regarding a 

11 device’’ and inserting ‘‘regarding a device described 

12 in paragraph (6)(A)(i)(I)’’; and 

13 (3) in paragraph (8), by striking ‘‘of all devices 

14 described in paragraph (6)’’ and inserting ‘‘of all de15 vices described in paragraph (6)(A)(i)(I)’’. 

16 (b) APPLICABILITY TO EXISTING DEVICES.—A sponsor 

17 of a device for which an exemption was approved under 

18 paragraph (2) of section 520(m) of the Federal Food, Drug, 

19 and Cosmetic Act (21 U.S.C. 360j(m)) before the date of 

20 enactment of this Act may seek a determination under sub21 clause (I) or (II) of section 520(m)(6)(A)(i) (as amended 

22 by subsection (a)). If the Secretary of Health and Human 

23 Services determines that such subclause (I) or (II) applies 

24 with respect to a device, clauses (ii), (iii), and (iv) of sub25 paragraph (A) and subparagraphs (B), (C), (D), and (E) 
179 

•S 3187 EAH 

1 of paragraph (6) of such section 520(m) shall apply to such 

2 device, and the Secretary shall determine the annual dis3 tribution number for purposes of clause (ii) of such sub4 paragraph (A) when making the determination under this 

5 subsection. 

6 SEC. 614. UNIQUE DEVICE IDENTIFIER. 

7 Section 519(f) (21 U.S.C. 360i(f)) is amended— 

8 (1) by striking ‘‘The Secretary shall promulgate’’ 

9 and inserting ‘‘Not later than December 31, 2012, the 

10 Secretary shall issue proposed’’; and 

11 (2) by adding at the end the following: ‘‘The Sec12 retary shall finalize the proposed regulations not later 

13 than 6 months after the close of the comment period 

14 and shall implement the final regulations with respect 

15 to devices that are implantable, life-saving, and life 

16 sustaining not later than 2 years after the regulations 

17 are finalized, taking into account patient access to 

18 medical devices and therapies.’’. 

19 SEC. 615. SENTINEL. 

20 Section 519 (21 U.S.C. 360i) is amended by adding 

21 at the end the following: 

22 ‘‘(h) INCLUSION OF DEVICES IN THE POSTMARKET

23 RISK IDENTIFICATION AND ANALYSIS SYSTEM.— 

24 ‘‘(1) IN GENERAL.— 
180 

•S 3187 EAH 

1 ‘‘(A) APPLICATION TO DEVICES.—The Sec2 retary shall amend the procedures established 

3 and maintained under clauses (i), (ii), (iii), and 

4 (v) of section 505(k)(3)(C) in order to expand the 

5 postmarket risk identification and analysis sys6 tem established under such section to include and 

7 apply to devices. 

8 ‘‘(B) EXCEPTION.—Subclause (II) of clause 

9 (i) of section 505(k)(3)(C) shall not apply to de10 vices. 

11 ‘‘(C) CLARIFICATION.—With respect to de12 vices, the private sector health-related electronic 

13 data provided under section 

14 505(k)(3)(C)(i)(III)(bb) may include medical de15 vice utilization data, health insurance claims 

16 data, and procedure and device registries. 

17 ‘‘(2) DATA.—In expanding the system as de18 scribed in paragraph (1)(A), the Secretary shall use 

19 relevant data with respect to devices cleared under 

20 section 510(k) or approved under section 515, includ21 ing claims data, patient survey data, and any other 

22 data deemed appropriate by the Secretary. 

23 ‘‘(3) STAKEHOLDER INPUT.—To help ensure ef24 fective implementation of the system as described in 

25 paragraph (1) with respect to devices, the Secretary 
181 

•S 3187 EAH 

1 shall engage outside stakeholders in development of 

2 the system, and gather information from outside 

3 stakeholders regarding the content of an effective sen4 tinel program, through a public hearing, advisory 

5 committee meeting, maintenance of a public docket, or 

6 other similar public measures. 

7 ‘‘(4) VOLUNTARY SURVEYS.—Chapter 35 of title 

8 44, United States Code, shall not apply to the collec9 tion of voluntary information from health care pro10 viders, such as voluntary surveys or questionnaires, 

11 initiated by the Secretary for purposes of postmarket 

12 risk identification, mitigation, and analysis for de13 vices.’’. 

14 SEC. 616. POSTMARKET SURVEILLANCE. 

15 Section 522 (21 U.S.C. 360l) is amended— 

16 (1) in subsection (a)(1)(A), in the matter pre17 ceding clause (i), by inserting ‘‘, at the time of ap18 proval or clearance of a device or at any time there19 after,’’ after ‘‘by order’’; and 

20 (2) in subsection (b)(1), by inserting ‘‘The man21 ufacturer shall commence surveillance under this sec22 tion not later than 15 months after the day on which 

23 the Secretary issues an order under this section.’’ 

24 after the second sentence. 
182 

•S 3187 EAH 

1 SEC. 617. CUSTOM DEVICES. 

2 Section 520(b) (21 U.S.C. 360j(b)) is amended to read 

3 as follows: 

4 ‘‘(b) CUSTOM DEVICES.— 

5 ‘‘(1) IN GENERAL.—The requirements of sections 

6 514 and 515 shall not apply to a device that— 

7 ‘‘(A) is created or modified in order to com8 ply with the order of an individual physician or 

9 dentist (or any other specially qualified person 

10 designated under regulations promulgated by the 

11 Secretary after an opportunity for an oral hear12 ing); 

13 ‘‘(B) in order to comply with an order de14 scribed in subparagraph (A), necessarily deviates 

15 from an otherwise applicable performance stand16 ard under section 514 or requirement under sec17 tion 515; 

18 ‘‘(C) is not generally available in the 

19 United States in finished form through labeling 

20 or advertising by the manufacturer, importer, or 

21 distributor for commercial distribution; 

22 ‘‘(D) is designed to treat a unique pathology 

23 or physiological condition that no other device is 

24 domestically available to treat; 

25 ‘‘(E)(i) is intended to meet the special needs 

26 of such physician or dentist (or other specially 
183 

•S 3187 EAH 

1 qualified person so designated) in the course of 

2 the professional practice of such physician or 

3 dentist (or other specially qualified person so 

4 designated); or 

5 ‘‘(ii) is intended for use by an individual 

6 patient named in such order of such physician 

7 or dentist (or other specially qualified person so 

8 designated); 

9 ‘‘(F) is assembled from components or man10 ufactured and finished on a case-by-case basis to 

11 accommodate the unique needs of individuals de12 scribed in clause (i) or (ii) of subparagraph (E); 

13 and 

14 ‘‘(G) may have common, standardized de15 sign characteristics, chemical and material com16 positions, and manufacturing processes as com17 mercially distributed devices. 

18 ‘‘(2) LIMITATIONS.—Paragraph (1) shall apply 

19 to a device only if— 

20 ‘‘(A) such device is for the purpose of treat21 ing a sufficiently rare condition, such that con22 ducting clinical investigations on such device 

23 would be impractical; 

24 ‘‘(B) production of such device under para25 graph (1) is limited to no more than 5 units per 
184 

•S 3187 EAH 

1 year of a particular device type, provided that 

2 such replication otherwise complies with this sec3 tion; and 

4 ‘‘(C) the manufacturer of such device noti5 fies the Secretary on an annual basis, in a man6 ner prescribed by the Secretary, of the manufac7 ture of such device. 

8 ‘‘(3) GUIDANCE.—Not later than 2 years after 

9 the date of enactment of this section, the Secretary 

10 shall issue final guidance on replication of multiple 

11 devices described in paragraph (2)(B).’’. 

12 SEC. 618. HEALTH INFORMATION TECHNOLOGY. 

13 (a) REPORT.—Not later than 18 months after the date 

14 of enactment of this Act, the Secretary of Health and 

15 Human Services (referred to in this section as the ‘‘Sec16 retary’’), acting through the Commissioner of Food and 

17 Drugs, and in consultation with the National Coordinator 

18 for Health Information Technology and the Chairman of 

19 the Federal Communications Commission, shall post on the 

20 Internet Web sites of the Food and Drug Administration, 

21 the Federal Communications Commission, and the Office 

22 of the National Coordinator for Health Information Tech23 nology, a report that contains a proposed strategy and rec24 ommendations on an appropriate, risk-based regulatory 

25 framework pertaining to health information technology, in-
185 

•S 3187 EAH 

1 cluding mobile medical applications, that promotes innova2 tion, protects patient safety, and avoids regulatory duplica3 tion. 

4 (b) WORKING GROUP.— 

5 (1) IN GENERAL.—In carrying out subsection 

6 (a), the Secretary may convene a working group of 

7 external stakeholders and experts to provide appro8 priate input on the strategy and recommendations re9 quired for the report under subsection (a). 

10 (2) REPRESENTATIVES.—If the Secretary con11 venes the working group under paragraph (1), the 

12 Secretary, in consultation with the Commissioner of 

13 Food and Drugs, the National Coordinator for Health 

14 Information Technology, and the Chairman of the 

15 Federal Communications Commission, shall deter16 mine the number of representatives participating in 

17 the working group, and shall, to the extent prac18 ticable, ensure that the working group is geographi19 cally diverse and includes representatives of patients, 

20 consumers, health care providers, startup companies, 

21 health plans or other third-party payers, venture cap22 ital investors, information technology vendors, health 

23 information technology vendors, small businesses, pur24 chasers, employers, and other stakeholders with rel25 evant expertise, as determined by the Secretary. 
186 

•S 3187 EAH 

1 SEC. 619. 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 indus9 try guidance letter, a notice to industry advisory let10 ter, or any similar notice sets forth initial interpreta11 tions of a regulation or policy or sets forth changes 

12 in interpretation or policy, such notice shall be treat13 ed as a guidance document for purposes of this sub14 paragraph.’’. 

15 SEC. 620. PEDIATRIC DEVICE CONSORTIA. 

16 (a) IN GENERAL.—Section 305(e) of Pediatric Medical 

17 Device Safety and Improvement Act (Public Law 110–85; 

18 42 U.S.C. 282 note)) is amended by striking ‘‘$6,000,000 

19 for each of fiscal years 2008 through 2012’’ and inserting 

20 ‘‘$5,250,000 for each of fiscal years 2013 through 2017’’. 

21 (b) FINAL RULE RELATING TO TRACKING OF PEDI22 ATRIC USES OF DEVICES.—The Secretary of Health and 

23 Human Services shall issue— 

24 (1) a proposed rule implementing section 

25 515A(a)(2) of the Federal Food, Drug, and Cosmetic 
187 

•S 3187 EAH 

1 Act (21 U.S.C. 360e–1(a)(2)) not later than December 

2 31, 2012; and 

3 (2) a final rule implementing such section not 

4 later than December 31, 2013. 

5 TITLE VII—DRUG SUPPLY CHAIN 

6 SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISH7 MENTS. 

8 Section 510 (21 U.S.C. 360) is amended— 

9 (1) in subsection (b)— 

10 (A) in paragraph (1), by striking ‘‘On or 

11 before’’ and all that follows through the period at 

12 the end and inserting the following: ‘‘During the 

13 period beginning on October 1 and ending on 

14 December 31 of each year, every person who 

15 owns or operates any establishment in any State 

16 engaged in the manufacture, preparation, propa17 gation, compounding, or processing of a drug or 

18 drugs shall register with the Secretary the name 

19 of such person, places of business of such person, 

20 all such establishments, the unique facility iden21 tifier of each such establishment, and a point of 

22 contact e-mail address.; and 

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

24 ‘‘(3) The Secretary shall specify the unique facility 

25 identifier system that shall be used by registrants under 
188 

•S 3187 EAH 

1 paragraph (1). The requirement to include a unique facility 

2 identifier in a registration under paragraph (1) shall not 

3 apply until the date that the identifier system is specified 

4 by the Secretary under the preceding sentence.’’; and 

5 (2) in subsection (c), by striking ‘‘with the Sec6 retary his name, place of business, and such establish7 ment’’ and inserting ‘‘with the Secretary— 

8 ‘‘(1) with respect to drugs, the information de9 scribed under subsection (b)(1); and 

10 ‘‘(2) with respect to devices, the information de11 scribed under subsection (b)(2).’’. 

12 SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS. 

13 (a) ENFORCEMENT OF REGISTRATION OF FOREIGN

14 ESTABLISHMENTS.—Section 502(o) (21 U.S.C. 352(o)) is 

15 amended by striking ‘‘in any State’’. 

16 (b) REGISTRATION OF FOREIGN DRUG ESTABLISH17 MENTS.—Section 510(i) (U.S.C. 360(i)) is amended— 

18 (1) in paragraph (1)— 

19 (A) by amending the matter preceding sub20 paragraph (A) to read as follows: ‘‘Every person 

21 who owns or operates any establishment within 

22 any foreign country engaged in the manufacture, 

23 preparation, propagation, compounding, or proc24 essing of a drug or device that is imported or of25 fered for import into the United States shall, 
189 

•S 3187 EAH 

1 through electronic means in accordance with the 

2 criteria of the Secretary—’’; 

3 (B) by amending subparagraph (A) to read 

4 as follows: 

5 ‘‘(A) upon first engaging in any such activity, 

6 immediately submit a registration to the Secretary 

7 that includes— 

8 ‘‘(i) with respect to drugs, the name and 

9 place of business of such person, all such estab10 lishments, the unique facility identifier of each 

11 such establishment, a point of contact e-mail ad12 dress, the name of the United States agent of 

13 each such establishment, the name of each im14 porter of such drug in the United States that is 

15 known to the establishment, and the name of 

16 each person who imports or offers for import 

17 such drug to the United States for purposes of 

18 importation; 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 establishment, 

22 the name of each importer of such device in the 

23 United States that is known to the establishment, 

24 and the name of each person who imports or of-
190 

•S 3187 EAH 

1 fers for import such device to the United States 

2 for purposes of importation; 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 year.’’; 

9 and 

10 (2) by adding at the end the following: 

11 ‘‘(4) The Secretary shall specify the unique facility 

12 identifier system that shall be used by registrants under 

13 paragraph (1) with respect to drugs. The requirement to 

14 include a unique facility identifier in a registration under 

15 paragraph (1) with respect to drugs shall not apply until 

16 the date that the identifier system is specified by the Sec17 retary under the preceding sentence.’’. 

18 SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMA19 TION WITH PRODUCT LISTING. 

20 Section 510(j) (21 U.S.C. 360(j)) is amended— 

21 (1) in paragraph (1)— 

22 (A) in subparagraph (C), by striking ‘‘; 

23 and’’ and inserting a semicolon; 

24 (B) in subparagraph (D), by striking the 

25 period at the end and inserting ‘‘; and’’; and 
191 

•S 3187 EAH 

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

2 ‘‘(E) in the case of a drug contained in the ap3 plicable list, the name and place of business of each 

4 manufacturer of an excipient of the listed drug with 

5 which the person listing the drug conducts business, 

6 including all establishments used in the production of 

7 such excipient, the unique facility identifier of each 

8 such establishment, and a point of contact e-mail ad9 dress for each such excipient manufacturer.’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(4) The Secretary shall require persons subject to this 

12 subsection to use, for purposes of this subsection, the unique 

13 facility identifier systems specified under subsections (b)(3) 

14 and (i)(4) with respect to drugs. Such requirement shall 

15 not apply until the date that the identifier system under 

16 subsection (b)(3) or (i)(4), as applicable, is specified by the 

17 Secretary.’’. 

18 SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND 

19 LISTING. 

20 Section 510(p) (21 U.S.C. 360(p)) is amended— 

21 (1) by striking ‘‘(p) Registrations and listings’’ 

22 and inserting the following: 

23 ‘‘(p) ELECTRONIC REGISTRATION AND LISTING.— 

24 ‘‘(1) IN GENERAL.—Registrations and listings’’; 

25 and 
192 

•S 3187 EAH 

1 (2) by adding at the end the following: 

2 ‘‘(2) ELECTRONIC DATABASE.—Not later than 2 

3 years after the Secretary specifies a unique facility 

4 identifier system under subsections (b) and (i), the 

5 Secretary shall maintain an electronic database, 

6 which shall not be subject to inspection under sub7 section (f), populated with the information submitted 

8 as described under paragraph (1) that— 

9 ‘‘(A) enables personnel of the Food and 

10 Drug Administration to search the database by 

11 any field of information submitted in a registra12 tion described under paragraph (1), or combina13 tion of such fields; and 

14 ‘‘(B) uses the unique facility identifier sys15 tem to link with other relevant databases within 

16 the Food and Drug Administration, including 

17 the database for submission of information under 

18 section 801(r). 

19 ‘‘(3) RISK-BASED INFORMATION AND COORDINA20 TION.—The Secretary shall ensure the accuracy and 

21 coordination of relevant Food and Drug Administra22 tion databases in order to identify and inform risk23 based inspections under section 510(h).’’. 
193 

•S 3187 EAH 

1 SEC. 705. RISK-BASED INSPECTION FREQUENCY. 

2 Section 510(h) (21 U.S.C. 360(h)) is amended to read 

3 as follows: 

4 ‘‘(h) INSPECTIONS.— 

5 ‘‘(1) IN GENERAL.—Every establishment that is 

6 required to be registered with the Secretary under this 

7 section shall be subject to inspection pursuant to sec8 tion 704. 

9 ‘‘(2) BIENNIAL INSPECTIONS FOR DEVICES.— 

10 Every establishment described in paragraph (1), in 

11 any State, that is engaged in the manufacture, propa12 gation, compounding, or processing of a device or de13 vices classified in class II or III shall be so inspected 

14 by one or more officers or employees duly designated 

15 by the Secretary, or by persons accredited to conduct 

16 inspections under section 704(g), at least once in the 

17 2-year period beginning with the date of registration 

18 of such establishment pursuant to this section and at 

19 least once in every successive 2-year period thereafter. 

20 ‘‘(3) RISK-BASED SCHEDULE FOR DRUGS.—The 

21 Secretary, acting through one or more officers or em22 ployees duly designated by the Secretary, shall inspect 

23 establishments described in paragraph (1) that are 

24 engaged in the manufacture, preparation, propaga25 tion, compounding, or processing of a drug or drugs 

26 (referred to in this subsection as ‘drug establish-
194 

•S 3187 EAH 

1 ments’) in accordance with a risk-based schedule es2 tablished by the Secretary. 

3 ‘‘(4) RISK FACTORS.—In establishing the risk4 based scheduled under paragraph (3), the Secretary 

5 shall inspect establishments according to the known 

6 safety risks of such establishments, which shall be 

7 based on the following factors: 

8 ‘‘(A) The compliance history of the estab9 lishment. 

10 ‘‘(B) The record, history, and nature of re11 calls linked to the establishment. 

12 ‘‘(C) The inherent risk of the drug manufac13 tured, prepared, propagated, compounded, or 

14 processed at the establishment. 

15 ‘‘(D) The inspection frequency and history 

16 of the establishment, including whether the estab17 lishment has been inspected pursuant to section 

18 704 within the last 4 years. 

19 ‘‘(E) Whether the establishment has been in20 spected by a foreign government or an agency of 

21 a foreign government recognized under section 

22 809. 

23 ‘‘(F) Any other criteria deemed necessary 

24 and appropriate by the Secretary for purposes of 

25 allocating inspection resources. 
195 

•S 3187 EAH 

1 ‘‘(5) EFFECT OF STATUS.—In determining the 

2 risk associated with an establishment for purposes of 

3 establishing a risk-based schedule under paragraph 

4 (3), the Secretary shall not consider whether the drugs 

5 manufactured, prepared, propagated, compounded, or 

6 processed by such establishment are drugs described in 

7 section 503(b). 

8 ‘‘(6) ANNUAL REPORT ON INSPECTIONS OF ES9 TABLISHMENTS.—Beginning in 2014, not later than 

10 February 1 of each year, the Secretary shall make 

11 available on the Internet Web site of the Food and 

12 Drug Administration a report regarding— 

13 ‘‘(A)(i) the number of domestic and foreign 

14 establishments registered pursuant to this section 

15 in the previous fiscal year; and 

16 ‘‘(ii) the number of such domestic establish17 ments and the number of such foreign establish18 ments that the Secretary inspected in the pre19 vious fiscal year; 

20 ‘‘(B) with respect to establishments that 

21 manufacture, prepare, propagate, compound, or 

22 process an active ingredient of a drug, a finished 

23 drug product, or an excipient of a drug, the 

24 number of each such type of establishment; and 
196 

•S 3187 EAH 

1 ‘‘(C) the percentage of the budget of the 

2 Food and Drug Administration used to fund the 

3 inspections described under subparagraph (A).’’. 

4 SEC. 706. RECORDS FOR INSPECTION. 

5 Section 704(a) (21 U.S.C. 374(a)) is amended by add6 ing at the end the following: 

7 ‘‘(4)(A) Any records or other information that the Sec8 retary may inspect under this section from a person that 

9 owns or operates an establishment that is engaged in the 

10 manufacture, preparation, propagation, compounding, or 

11 processing of a drug shall, upon the request of the Secretary, 

12 be provided to the Secretary by such person, in advance 

13 of or in lieu of an inspection, within a reasonable time14 frame, within reasonable limits, and in a reasonable man15 ner, and in either electronic or physical form, at the expense 

16 of such person. The Secretary’s request shall include a suffi17 cient description of the records requested. 

18 ‘‘(B) Upon receipt of the records requested under sub19 paragraph (A), the Secretary shall provide to the person 

20 confirmation of receipt. 

21 ‘‘(C) Nothing in this paragraph supplants the author22 ity of the Secretary to conduct inspections otherwise per23 mitted under this Act in order to ensure compliance with 

24 this Act.’’. 
197 

•S 3187 EAH 

1 SEC. 707. PROHIBITION AGAINST DELAYING, DENYING, LIM2 ITING, OR REFUSING INSPECTION. 

3 (a) IN GENERAL.—Section 501 (21 U.S.C. 351) is 

4 amended by adding at the end the following: 

5 ‘‘(j) If it is a drug and it has been manufactured, proc6 essed, packed, or held in any factory, warehouse, or estab7 lishment and the owner, operator, or agent of such factory, 

8 warehouse, or establishment delays, denies, or limits an in9 spection, or refuses to permit entry or inspection.’’. 

10 (b) GUIDANCE.—Not later than 1 year after the date 

11 of enactment of this section, the Secretary of Health and 

12 Human Services shall issue guidance that defines the cir13 cumstances that would constitute delaying, denying, or lim14 iting inspection, or refusing to permit entry or inspection, 

15 for purposes of section 501(j) of the Federal Food, Drug, 

16 and Cosmetic Act (as added by subsection (a)). 

17 SEC. 708. DESTRUCTION OF ADULTERATED, MISBRANDED, 

18 OR COUNTERFEIT DRUGS OFFERED FOR IM19 PORT. 

20 (a) IN GENERAL.—The sixth sentence of section 801(a) 

21 (21 U.S.C. 381(a)) is amended by inserting before the pe22 riod at the end the following: ‘‘, except that the Secretary 

23 of Health and Human Services may destroy, without the 

24 opportunity for export, any drug refused admission under 

25 this section, if such drug is valued at an amount that is 

26 $2,500 or less (or such higher amount as the Secretary of 
198 

•S 3187 EAH 

1 the Treasury may set by regulation pursuant to section 

2 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1)) 

3 and was not brought into compliance as described under 

4 subsection (b).’’. 

5 (b) NOTICE.—Subsection (a) of section 801 (21 U.S.C. 

6 381), as amended by subsection (a), is further amended by 

7 inserting after the sixth sentence the following: ‘‘The Sec8 retary of Health and Human Services shall issue regula9 tions providing for notice and an opportunity to appear 

10 before the Secretary of Health and Human Services and 

11 introduce testimony, as described in the first sentence of this 

12 subsection, on destruction of a drug under the sixth sentence 

13 of this subsection. The regulations shall provide that prior 

14 to destruction, appropriate due process is available to the 

15 owner or consignee seeking to challenge the decision to de16 stroy the drug. Where the Secretary of Health and Human 

17 Services provides notice and an opportunity to appear and 

18 introduce testimony on the destruction of a drug, the Sec19 retary of Health and Human Services shall store and, as 

20 applicable, dispose of the drug after the issuance of the no21 tice, except that the owner and consignee shall remain liable 

22 for costs pursuant to subsection (c). Such process may be 

23 combined with the notice and opportunity to appear before 

24 the Secretary and introduce testimony, as described in the 
199 

•S 3187 EAH 

1 first sentence of this subsection, as long as appropriate no2 tice is provided to the owner or consignee.’’. 

3 (c) APPLICABILITY.—The amendment made by sub4 section (a) shall apply beginning on the effective date of 

5 the regulations promulgated pursuant to the amendment 

6 made by subsection (b). 

7 (d) REGULATIONS.— 

8 (1) IN GENERAL.—Not later than 2 years after 

9 the date of enactment of this Act, the Secretary of 

10 Health and Human Services shall adopt final regula11 tions implementing the amendments made this sec12 tion. 

13 (2) PROCEDURE.—In promulgating a regulation 

14 implementing the amendments made by this section, 

15 the Secretary of Health and Human Services shall— 

16 (A) issue a notice of proposed rulemaking 

17 that includes a copy of the proposed regulation; 

18 (B) provide a period of not less than 60 

19 days for comments on the proposed regulation; 

20 and 

21 (C) publish the final regulation not less 

22 than 30 days before the effective date of the regu23 lation. 

24 (3) RESTRICTIONS.—Notwithstanding any other 

25 provision of law, the Secretary of Health and Human 
200 

•S 3187 EAH 

1 Services shall promulgate regulations implementing 

2 the amendments made by this section only as de3 scribed in paragraph (2). 

4 SEC. 709. ADMINISTRATIVE DETENTION. 

5 (a) IN GENERAL.—Section 304(g) (21 U.S.C. 335a(g)) 

6 is amended— 

7 (1) in paragraph (1), by inserting ‘‘, drug,’’ 

8 after ‘‘device’’, each place it appears; 

9 (2) in paragraph (2)(A), by inserting ‘‘, drug,’’ 

10 after ‘‘(B), a device’’; and 

11 (3) in paragraph (2)(B), by inserting ‘‘or drug’’ 

12 after ‘‘device’’ each place it appears. 

13 (b) REGULATIONS.— 

14 (1) IN GENERAL.—Not later than 2 years after 

15 the date of the enactment of this Act, the Secretary of 

16 Health and Human Services shall promulgate regula17 tions in accordance with section 304(i) of the Federal 

18 Food, Drug, and Cosmetic Act, as added by para19 graph (2) of this subsection, to implement adminis20 trative detention authority with respect to drugs, as 

21 authorized by the amendments made by subsection 

22 (a). Before promulgating such regulations, the Sec23 retary shall consult with stakeholders, including man24 ufacturers of drugs. 
201 

•S 3187 EAH 

1 (2) IN GENERAL.—Section 304 (21 U.S.C. 334) 

2 is amended by adding at the end the following: 

3 ‘‘(i) PROCEDURES FOR PROMULGATING REGULA4 TIONS.— 

5 ‘‘(1) IN GENERAL.—In promulgating a regula6 tion implementing this section, the Secretary shall— 

7 ‘‘(A) issue a notice of proposed rulemaking 

8 that includes the proposed regulation; 

9 ‘‘(B) provide a period of not less than 60 

10 days for comments on the proposed regulation; 

11 and 

12 ‘‘(C) publish the final regulation not less 

13 than 30 days before the regulation’s effective 

14 date. 

15 ‘‘(2) RESTRICTIONS.—Notwithstanding any other 

16 provision of Federal law, in implementing this sec17 tion, the Secretary shall only promulgate regulations 

18 as described in paragraph (1).’’. 

19 (c) EFFECTIVE DATE.—The amendments made by sub20 section (a) shall not take effect until the Secretary has 

21 issued a final regulation under subsection (b). 

22 SEC. 710. EXCHANGE OF INFORMATION. 

23 Section 708 (21 U.S.C. 379) is amended— 
202 

•S 3187 EAH 

1 (1) by striking ‘‘CONFIDENTIAL INFORMATION’’ 

2 and all that follows through ‘‘The Secretary may pro3 vide’’ and inserting the following: 

4 ‘‘SEC. 708. CONFIDENTIAL INFORMATION. 

5 ‘‘(a) CONTRACTORS.—The Secretary may provide’’; 

6 and 

7 (2) by adding at the end the following: 

8 ‘‘(b) ABILITY TO RECEIVE AND PROTECT CONFIDEN9 TIAL INFORMATION OBTAINED FROM FOREIGN GOVERN10 MENTS.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall not be 

12 required to disclose under section 552 of title 5, 

13 United States Code (commonly referred to as the 

14 ‘Freedom of Information Act’), or any other provision 

15 of law, any information relating to drugs obtained 

16 from a foreign government agency, if— 

17 ‘‘(A) the information concerns the inspec18 tion of a facility, is part of an investigation, 

19 alerts the United States to the potential need for 

20 an investigation, or concerns a drug that has a 

21 reasonable probability of causing serious adverse 

22 health consequences or death to humans or ani23 mals; 

24 ‘‘(B) the information is provided or made 

25 available to the United States Government vol-
203 

•S 3187 EAH 

1 untarily on the condition that it not be released 

2 to the public; and 

3 ‘‘(C) the information is covered by, and sub4 ject to, a written agreement between the Sec5 retary and the foreign government. 

6 ‘‘(2) TIME LIMITATIONS.—The written agreement 

7 described in paragraph (1)(C) shall specify the time 

8 period for which paragraph (1) shall apply to the vol9 untarily disclosed information. Paragraph (1) shall 

10 not apply with respect to such information after the 

11 date specified in such agreement, but all other appli12 cable legal protections, including the provisions of sec13 tion 552 of title 5, United States Code, and section 

14 319L(e)(1) of the Public Health Service Act, as appli15 cable, shall continue to apply to such information. If 

16 no date is specified in the written agreement, para17 graph (1) shall not apply with respect to such infor18 mation for a period of more than 36 months. 

19 ‘‘(3) DISCLOSURES NOT AFFECTED.—Nothing in 

20 this section authorizes any official to withhold, or to 

21 authorize the withholding of, information from Con22 gress or information required to be disclosed pursuant 

23 to an order of a court of the United States. 

24 ‘‘(4) RELATION TO OTHER LAW.—For purposes 

25 of section 552 of title 5, United States Code, this sub-
204 

•S 3187 EAH 

1 section shall be considered a statute described in sub2 section (b)(3)(B) of such section 552. 

3 ‘‘(c) AUTHORITY TO ENTER INTO MEMORANDA OF UN4 DERSTANDING FOR PURPOSES OF INFORMATION EX5 CHANGE.—The Secretary may enter into written agree6 ments to provide information referenced in section 301(j) 

7 to foreign governments subject to the following criteria: 

8 ‘‘(1) CERTIFICATION.—The Secretary may enter 

9 into a written agreement to provide information 

10 under this subsection to a foreign government only if 

11 the Secretary has certified such government as having 

12 the authority and demonstrated ability to protect 

13 trade secret information from disclosure. Responsi14 bility for this certification shall not be delegated to 

15 any officer or employee other than the Commissioner 

16 of Food and Drugs. 

17 ‘‘(2) WRITTEN AGREEMENT.—The written agree18 ment to provide information to the foreign govern19 ment under this subsection shall include a commit20 ment by the foreign government to protect informa21 tion exchanged under this subsection from disclosure 

22 unless and until the sponsor gives written permission 

23 for disclosure or the Secretary makes a declaration of 

24 a public health emergency pursuant to section 319 of 
205 

•S 3187 EAH 

1 the Public Health Service Act that is relevant to the 

2 information. 

3 ‘‘(3) INFORMATION EXCHANGE.—The Secretary 

4 may provide to a foreign government that has been 

5 certified under paragraph (1) and that has executed 

6 a written agreement under paragraph (2) informa7 tion referenced in section 301(j) in only the following 

8 circumstances: 

9 ‘‘(A) Information concerning the inspection 

10 of a facility may be provided to a foreign gov11 ernment if— 

12 ‘‘(i) the Secretary reasonably believes, 

13 or the written agreement described in para14 graph (2) establishes, that the government 

15 has authority to otherwise obtain such in16 formation; and 

17 ‘‘(ii) the written agreement executed 

18 under paragraph (2) limits the recipient’s 

19 use of the information to the recipient’s 

20 civil regulatory purposes. 

21 ‘‘(B) Information not described in subpara22 graph (A) may be provided as part of an inves23 tigation, or to alert the foreign government to the 

24 potential need for an investigation, if the Sec25 retary has reasonable grounds to believe that a 
206 

•S 3187 EAH 

1 drug has a reasonable probability of causing se2 rious adverse health consequences or death to hu3 mans or animals. 

4 ‘‘(4) EFFECT OF SUBSECTION.—Nothing in this 

5 subsection affects the ability of the Secretary to enter 

6 into any written agreement authorized by other provi7 sions of law to share confidential information.’’. 

8 SEC. 711. ENHANCING THE SAFETY AND QUALITY OF THE 

9 DRUG SUPPLY. 

10 Section 501 (21 U.S.C. 351) is amended by adding 

11 at the end the following flush text: 

12 ‘‘For purposes of paragraph (a)(2)(B), the term ‘current 

13 good manufacturing practice’ includes the implementation 

14 of oversight and controls over the manufacture of drugs to 

15 ensure quality, including managing the risk of and estab16 lishing the safety of raw materials, materials used in the 

17 manufacturing of drugs, and finished drug products.’’. 

18 SEC. 712. RECOGNITION OF FOREIGN GOVERNMENT IN19 SPECTIONS. 

20 Chapter VIII (21 U.S.C. 381 et seq.) is amended by 

21 adding at the end the following: 

22 ‘‘SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT IN23 SPECTIONS. 

24 ‘‘(a) INSPECTION.—The Secretary— 
207 

•S 3187 EAH 

1 ‘‘(1) may enter into arrangements and agree2 ments with a foreign government or an agency of a 

3 foreign government to recognize the inspection of for4 eign establishments registered under section 510(i) in 

5 order to facilitate risk-based inspections in accord6 ance with the schedule established in section 

7 510(h)(3); 

8 ‘‘(2) may enter into arrangements and agree9 ments with a foreign government or an agency of a 

10 foreign government under this section only with a for11 eign government or an agency of a foreign govern12 ment that the Secretary has determined as having the 

13 capability of conduction inspections that meet the ap14 plicable requirements of this Act; and 

15 ‘‘(3) shall perform such reviews and audits of 

16 drug safety programs, systems, and standards of a 

17 foreign government or agency for the foreign govern18 ment as the Secretary deems necessary to determine 

19 that the foreign government or agency of the foreign 

20 government is capable of conducting inspections that 

21 meet the applicable requirements of this Act. 

22 ‘‘(b) RESULTS OF INSPECTION.—The results of inspec23 tions performed by a foreign government or an agency of 

24 a foreign government under this section may be used as— 
208 

•S 3187 EAH 

1 ‘‘(1) evidence of compliance with section 

2 501(a)(2)(B) or section 801(r); and 

3 ‘‘(2) for any other purposes as determined ap4 propriate by the Secretary.’’. 

5 SEC. 713. STANDARDS FOR ADMISSION OF IMPORTED 

6 DRUGS. 

7 Section 801 (21 U.S.C. 381) is amended— 

8 (1) in subsection (o), by striking ‘‘drug or’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(r)(1) The Secretary may require, pursuant to the 

11 regulations promulgated under paragraph (4)(A), as a con12 dition of granting admission to a drug imported or offered 

13 for import into the United States, that the importer elec14 tronically submit information demonstrating that the drug 

15 complies with applicable requirements of this Act. 

16 ‘‘(2) The information described under paragraph (1) 

17 may include— 

18 ‘‘(A) information demonstrating the regulatory 

19 status of the drug, such as the new drug application, 

20 abbreviated new drug application, or investigational 

21 new drug or drug master file number; 

22 ‘‘(B) facility information, such as proof of reg23 istration and the unique facility identifier; 

24 ‘‘(C) indication of compliance with current good 

25 manufacturing practice, testing results, certifications 
209 

•S 3187 EAH 

1 relating to satisfactory inspections, and compliance 

2 with the country of export regulations; and 

3 ‘‘(D) any other information deemed necessary 

4 and appropriate by the Secretary to assess compli5 ance of the article being offered for import. 

6 ‘‘(3) Information requirements referred to in para7 graph (2)(C) may, at the discretion of the Secretary, be sat8 isfied— 

9 ‘‘(A) through representation by a foreign govern10 ment, if an inspection is conducted by a foreign gov11 ernment using standards and practices as determined 

12 appropriate by the Secretary; 

13 ‘‘(B) through representation by a foreign govern14 ment or an agency of a foreign government recognized 

15 under section 809; or 

16 ‘‘(C) other appropriate documentation or evi17 dence as described by the Secretary. 

18 ‘‘(4)(A) Not later than 18 months after the date of en19 actment of the Food and Drug Administration Safety and 

20 Innovation Act, the Secretary shall adopt final regulations 

21 implementing this subsection. Such requirements shall be 

22 appropriate for the type of import, such as whether the drug 

23 is for import into the United States for use in preclinical 

24 research or in a clinical investigation under an investiga25 tional new drug exemption under 505(i). 
210 

•S 3187 EAH 

1 ‘‘(B) In promulgating the regulations under subpara2 graph (A), the Secretary— 

3 ‘‘(i) may, as appropriate, take into account dif4 ferences among importers and types of imports, and, 

5 based on the level of risk posed by the imported drug, 

6 provide for expedited clearance for those importers 

7 that volunteer to participate in partnership programs 

8 for highly compliant companies and pass a review of 

9 internal controls, including sourcing of foreign manu10 facturing inputs, and plant inspections; and 

11 ‘‘(ii) shall— 

12 ‘‘(I) issue a notice of proposed rulemaking 

13 that includes the proposed regulation; 

14 ‘‘(II) provide a period of not less than 60 

15 days for comments on the proposed regulation; 

16 and 

17 ‘‘(III) publish the final regulation not less 

18 than 30 days before the effective date of the regu19 lation. 

20 ‘‘(C) Notwithstanding any other provision of law, the 

21 Secretary shall promulgate regulations implementing this 

22 subsection only as described in subparagraph (B).’’. 

23 SEC. 714. REGISTRATION OF COMMERCIAL IMPORTERS. 

24 (a) PROHIBITIONS.—Section 301 (21 U.S.C. 331) is 

25 amended by adding at the end the following: 
211 

•S 3187 EAH 

1 ‘‘(aaa) The failure to register in accordance with sec2 tion 801(s).’’. 

3 (b) REGISTRATION.—Section 801 (21 U.S.C. 381), as 

4 amended by section 713 of this Act, is further amended by 

5 adding at the end the following: 

6 ‘‘(s) REGISTRATION OF COMMERCIAL IMPORTERS.— 

7 ‘‘(1) REGISTRATION.—The Secretary shall re8 quire a commercial importer of drugs— 

9 ‘‘(A) to be registered with the Secretary in 

10 a form and manner specified by the Secretary; 

11 and 

12 ‘‘(B) subject to paragraph (4), to submit, at 

13 the time of registration, a unique identifier for 

14 the principal place of business for which the im15 porter is required to register under this sub16 section. 

17 ‘‘(2) REGULATIONS.— 

18 ‘‘(A) IN GENERAL.—The Secretary, in con19 sultation with the Secretary of Homeland Secu20 rity acting through U.S. Customs and Border 

21 Protection, shall promulgate regulations to estab22 lish good importer practices that specify the 

23 measures an importer shall take to ensure im24 ported drugs are in compliance with the require-
212 

•S 3187 EAH 

1 ments of this Act and the Public Health Service 

2 Act. 

3 ‘‘(B) PROCEDURE.—In promulgating a reg4 ulation under subparagraph (A), the Secretary 

5 shall— 

6 ‘‘(i) issue a notice of proposed rule7 making that includes the proposed regula8 tion; 

9 ‘‘(ii) provide a period of not less than 

10 60 days for comments on the proposed regu11 lation; and 

12 ‘‘(iii) publish the final regulation not 

13 less than 30 days before the regulation’s ef14 fective date. 

15 ‘‘(C) RESTRICTIONS.—Notwithstanding any 

16 other provision of Federal law, in implementing 

17 this subsection, the Secretary shall only promul18 gate regulations as described in subparagraph 

19 (B). 

20 ‘‘(3) DISCONTINUANCE OF REGISTRATION.—The 

21 Secretary shall discontinue the registration of any 

22 commercial importer of drugs that fails to comply 

23 with the regulations promulgated under this sub24 section. 
213 

•S 3187 EAH 

1 ‘‘(4) UNIQUE FACILITY IDENTIFIER.—The Sec2 retary shall specify the unique facility identifier sys3 tem that shall be used by registrants under paragraph 

4 (1). The requirement to include a unique facility 

5 identifier in a registration under paragraph (1) shall 

6 not apply until the date that the identifier system is 

7 specified by the Secretary under the preceding sen8 tence. 

9 ‘‘(5) EXEMPTIONS.—The Secretary, by notice in 

10 the Federal Register, may establish exemptions from 

11 the requirements of this subsection.’’. 

12 (c) MISBRANDING.—Section 502(o) (21 U.S.C. 352) is 

13 amended by inserting ‘‘if it is a drug and was imported 

14 or offered for import by a commercial importer of drugs 

15 not duly registered under section 801(s),’’ after ‘‘not duly 

16 registered under section 510,’’. 

17 (d) REGULATIONS.— 

18 (1) IN GENERAL.—Not later than 36 months 

19 after the date of the enactment of this Act, the Sec20 retary of Health and Human Services, in consulta21 tion with the Secretary of Homeland Security acting 

22 through U.S. Customs and Border Protection, shall 

23 promulgate the regulations required to carry out sec24 tion 801(s) of the Federal Food, Drug, and Cosmetic 

25 Act, as added by subsection (b). 
214 

•S 3187 EAH 

1 (2) PROCEDURES FOR PROMULGATING REGULA2 TIONS.— 

3 (A) IN GENERAL.—In promulgating a regu4 lation under paragraph (1), the Secretary 

5 shall— 

6 (i) issue a notice of proposed rule7 making that includes the proposed regula8 tion; 

9 (ii) provide a period of not less than 

10 60 days for comments on the proposed regu11 lation; and 

12 (iii) publish the final regulation not 

13 less than 30 days before the regulation’s ef14 fective date. 

15 (B) RESTRICTIONS.—Notwithstanding any 

16 other provision of Federal law, in implementing 

17 section 801(s) of the Federal Food, Drug, and 

18 Cosmetic Act, as added by subsection (b), the 

19 Secretary shall promulgate regulations only as 

20 described in subparagraph (A). 

21 (3) EFFECTIVE DATE.—In establishing the effec22 tive date of the regulations under paragraph (1), the 

23 Secretary of Health and Human Services shall, in 

24 consultation with the Secretary of Homeland Security 

25 acting through U.S. Customs and Border Protection, 
215 

•S 3187 EAH 

1 as determined appropriate by the Secretary of Health 

2 and Human Services, provide a reasonable period of 

3 time for an importer of a drug to comply with good 

4 importer practices, taking into account differences 

5 among importers and types of imports, including 

6 based on the level of risk posed by the imported prod7 uct. 

8 SEC. 715. NOTIFICATION. 

9 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331), 

10 as amended by section 714 of this Act, is further amended 

11 by adding at the end the following: 

12 ‘‘(bbb) The failure to notify the Secretary in violation 

13 of section 568.’’. 

14 (b) NOTIFICATION.—Subchapter E of chapter V (21 

15 U.S.C. 360bbb et seq.) is amended by adding at the end 

16 the following: 

17 ‘‘SEC. 568. NOTIFICATION. 

18 ‘‘(a) NOTIFICATION TO SECRETARY.—With respect to 

19 a drug, the Secretary may require notification to the Sec20 retary by a regulated person if the regulated person 

21 knows— 

22 ‘‘(1) that the use of such drug in the United 

23 States may result in serious injury or death; 

24 ‘‘(2) of a significant loss or known theft of such 

25 drug intended for use in the United States; or 
216 

•S 3187 EAH 

1 ‘‘(3) that— 

2 ‘‘(A) such drug has been or is being counter3 feited; and 

4 ‘‘(B)(i) the counterfeit product is in com5 merce in the United States or could be reason6 ably expected to be introduced into commerce in 

7 the United States; or 

8 ‘‘(ii) such drug has been or is being im9 ported into the United States or may reasonably 

10 be expected to be offered for import into the 

11 United States. 

12 ‘‘(b) MANNER OF NOTIFICATION.—Notification under 

13 this section shall be made in such manner and by such 

14 means as the Secretary may specify by regulation or guid15 ance. 

16 ‘‘(c) SAVINGS CLAUSE.—Nothing in this section shall 

17 be construed as limiting any other authority of the Sec18 retary to require notifications related to a drug under any 

19 other provision of this Act or the Public Health Service Act. 

20 ‘‘(d) DEFINITION.—In this section, the term ‘regulated 

21 person’ means— 

22 ‘‘(1) a person who is required to register under 

23 section 510 or 801(s); 

24 ‘‘(2) a wholesale distributor of a drug product; or 
217 

•S 3187 EAH 

1 ‘‘(3) any other person that distributes drugs ex2 cept a person that distributes drugs exclusively for re3 tail sale.’’. 

4 SEC. 716. PROTECTION AGAINST INTENTIONAL ADULTERA5 TION. 

6 Section 303(b) (21 U.S.C. 333(b)) is amended by add7 ing at the end the following: 

8 ‘‘(7) Notwithstanding subsection (a)(2), any person 

9 that knowingly and intentionally adulterates a drug such 

10 that the drug is adulterated under subsection (a)(1), (b), 

11 (c), or (d) of section 501 and has a reasonable probability 

12 of causing serious adverse health consequences or death to 

13 humans or animals shall be imprisoned for not more than 

14 20 years or fined not more than $1,000,000, or both.’’. 

15 SEC. 717. PENALTIES FOR COUNTERFEITING DRUGS. 

16 (a) COUNTERFEIT DRUG PENALTY ENHANCEMENT.— 

17 (1) OFFENSE.—Section 2320(a) of title 18, 

18 United States Code, is amended— 

19 (A) by striking ‘‘or’’ at the end of para20 graph (2); 

21 (B) by inserting ‘‘or’’ at the end of para22 graph (3); 

23 (C) by inserting after paragraph (3) the fol24 lowing: 

25 ‘‘(4) traffics in a counterfeit drug,’’; and 
218 

•S 3187 EAH 

1 (D) by striking ‘‘through (3)’’ and inserting 

2 ‘‘through (4)’’. 

3 (2) PENALTIES.—Section 2320(b)(3) of title 18, 

4 United States Code, is amended— 

5 (A) in the heading, by inserting ‘‘AND

6 COUNTERFEIT DRUGS’’ after ‘‘SERVICES’’; and 

7 (B) by inserting ‘‘or counterfeit drug’’ after 

8 ‘‘service’’. 

9 (3) DEFINITION.—Section 2320(f) of title 18, 

10 United States Code, is amended— 

11 (A) by striking ‘‘and’’ at the end of para12 graph (4); 

13 (B) by striking the period at the end of 

14 paragraph (5) and inserting ‘‘; and’’; and 

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

16 ‘‘(6) the term ‘counterfeit drug’ means a drug, as 

17 defined by section 201 of the Federal Food, Drug, and 

18 Cosmetic Act, that uses a counterfeit mark on or in 

19 connection with the drug.’’. 

20 (4) PRIORITY GIVEN TO CERTAIN INVESTIGA21 TIONS AND PROSECUTIONS.—The Attorney General 

22 shall give increased priority to efforts to investigate 

23 and prosecute offenses under section 2320 of title 18, 

24 United States Code, that involve counterfeit drugs. 

25 (b) SENTENCING COMMISSION DIRECTIVE.— 
219 

•S 3187 EAH 

1 (1) DIRECTIVE TO SENTENCING COMMISSION.— 

2 Pursuant to its authority under section 994(p) of title 

3 28, United States Code, and in accordance with this 

4 subsection, the United States Sentencing Commission 

5 shall review and amend, if appropriate, its guidelines 

6 and its policy statements applicable to persons con7 victed of an offense described in section 2320(a)(4) of 

8 title 18, United States Code, as amended by sub9 section (a), in order to reflect the intent of Congress 

10 that such penalties be increased in comparison to 

11 those currently provided by the guidelines and policy 

12 statements. 

13 (2) REQUIREMENTS.—In carrying out this sub14 section, the Commission shall— 

15 (A) ensure that the sentencing guidelines 

16 and policy statements reflect the intent of Con17 gress that the guidelines and policy statements 

18 reflect the serious nature of the offenses described 

19 in paragraph (1) and the need for an effective 

20 deterrent and appropriate punishment to prevent 

21 such offenses; 

22 (B) consider the extent to which the guide23 lines may or may not appropriately account for 

24 the potential and actual harm to the public re25 sulting from the offense; 
220 

•S 3187 EAH 

1 (C) assure reasonable consistency with other 

2 relevant directives and with other sentencing 

3 guidelines; 

4 (D) account for any additional aggravating 

5 or mitigating circumstances that might justify 

6 exceptions to the generally applicable sentencing 

7 ranges; 

8 (E) make any necessary conforming changes 

9 to the sentencing guidelines; and 

10 (F) assure that the guidelines adequately 

11 meet the purposes of sentencing as set forth in 

12 section 3553(a)(2) of title 18, United States 

13 Code. 

14 SEC. 718. EXTRATERRITORIAL JURISDICTION. 

15 Chapter III (21 U.S.C. 331 et seq.) is amended by add16 ing at the end the following: 

17 ‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 

18 ‘‘There is extraterritorial jurisdiction over any viola19 tion of this Act relating to any article regulated under this 

20 Act if such article was intended for import into the United 

21 States or if any act in furtherance of the violation was com22 mitted in the United States.’’. 
221 

•S 3187 EAH 

1 TITLE VIII—GENERATING 

2 ANTIBIOTIC INCENTIVES NOW 

3 SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. 

4 (a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.) 

5 is amended by inserting after section 505D the following: 

6 ‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 

7 QUALIFIED INFECTIOUS DISEASE PRODUCTS. 

8 ‘‘(a) EXTENSION.—If the Secretary approves an appli9 cation pursuant to section 505 for a drug that has been 

10 designated as a qualified infectious disease product under 

11 subsection (d), the 4- and 5-year periods described in sub12 sections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 

13 3-year periods described in clauses (iii) and (iv) of sub14 section (c)(3)(E) and clauses (iii) and (iv) of subsection 

15 (j)(5)(F) of section 505, or the 7-year period described in 

16 section 527, as applicable, shall be extended by 5 years. 

17 ‘‘(b) RELATION TO PEDIATRIC EXCLUSIVITY.—Any ex18 tension under subsection (a) of a period shall be in addition 

19 to any extension of the period under section 505A with re20 spect to the drug. 

21 ‘‘(c) LIMITATIONS.—Subsection (a) does not apply to 

22 the approval of— 

23 ‘‘(1) a supplement to an application under sec24 tion 505(b) for any qualified infectious disease prod-
222 

•S 3187 EAH 

1 uct for which an extension described in subsection (a) 

2 is in effect or has expired; 

3 ‘‘(2) a subsequent application filed with respect 

4 to a product approved under section 505 for a change 

5 that results in a new indication, route of administra6 tion, dosing schedule, dosage form, delivery system, 

7 delivery device, or strength; or 

8 ‘‘(3) a product that does not meet the definition 

9 of a qualified infectious disease product under sub10 section (g) based upon its approved uses. 

11 ‘‘(d) DESIGNATION.— 

12 ‘‘(1) IN GENERAL.—The manufacturer or sponsor 

13 of a drug may request the Secretary to designate a 

14 drug as a qualified infectious disease product at any 

15 time before the submission of an application under 

16 section 505(b) for such drug. The Secretary shall, not 

17 later than 60 days after the submission of such a re18 quest, determine whether the drug is a qualified infec19 tious disease product. 

20 ‘‘(2) LIMITATION.—Except as provided in para21 graph (3), a designation under this subsection shall 

22 not be withdrawn for any reason, including modifica23 tions to the list of qualifying pathogens under sub24 section (f)(2)(C). 
223 

•S 3187 EAH 

1 ‘‘(3) REVOCATION OF DESIGNATION.—The Sec2 retary may revoke a designation of a drug as a quali3 fied infectious disease product if the Secretary finds 

4 that the request for such designation contained an un5 true statement of material fact. 

6 ‘‘(e) REGULATIONS.— 

7 ‘‘(1) IN GENERAL.—Not later than 2 years after 

8 the date of enactment of the Food and Drug Adminis9 tration Safety and Innovation Act, the Secretary 

10 shall adopt final regulations implementing this sec11 tion, including developing the list of qualifying 

12 pathogens described in subsection (f). 

13 ‘‘(2) PROCEDURE.—In promulgating a regula14 tion implementing this section, the Secretary shall— 

15 ‘‘(A) issue a notice of proposed rulemaking 

16 that includes the proposed regulation; 

17 ‘‘(B) provide a period of not less than 60 

18 days for comments on the proposed regulation; 

19 and 

20 ‘‘(C) publish the final regulation not less 

21 than 30 days before the effective date of the regu22 lation. 

23 ‘‘(3) RESTRICTIONS.—Notwithstanding any other 

24 provision of law, the Secretary shall promulgate regu25 lations implementing this section only as described in 
224 

•S 3187 EAH 

1 paragraph (2), except that the Secretary may issue 

2 interim guidance for sponsors seeking designation 

3 under subsection (d) prior to the promulgation of 

4 such regulations. 

5 ‘‘(4) DESIGNATION PRIOR TO REGULATIONS.— 

6 The Secretary shall designate drugs as qualified infec7 tious disease products under subsection (d) prior to 

8 the promulgation of regulations under this subsection, 

9 if such drugs meet the definition of a qualified infec10 tious disease product described in subsection (g). 

11 ‘‘(f) QUALIFYING PATHOGEN.— 

12 ‘‘(1) DEFINITION.—In this section, the term 

13 ‘qualifying pathogen’ means a pathogen identified 

14 and listed by the Secretary under paragraph (2) that 

15 has the potential to pose a serious threat to public 

16 health, such as— 

17 ‘‘(A) resistant gram positive pathogens, in18 cluding methicillin-resistant Staphylococcus 

19 aureus, vancomycin-resistant Staphylococcus 

20 aureus, and vancomycin-resistant enterococcus; 

21 ‘‘(B) multi-drug resistant gram negative 

22 bacteria, including Acinetobacter, Klebsiella, 

23 Pseudomonas, and E. coli species; 

24 ‘‘(C) multi-drug resistant tuberculosis; and 

25 ‘‘(D) Clostridium difficile. 
225 

•S 3187 EAH 

1 ‘‘(2) LIST OF QUALIFYING PATHOGENS.— 

2 ‘‘(A) IN GENERAL.—The Secretary shall es3 tablish and maintain a list of qualifying patho4 gens, and shall make public the methodology for 

5 developing such list. 

6 ‘‘(B) CONSIDERATIONS.—In establishing 

7 and maintaining the list of pathogens described 

8 under this section, the Secretary shall— 

9 ‘‘(i) consider— 

10 ‘‘(I) the impact on the public 

11 health due to drug-resistant organisms 

12 in humans; 

13 ‘‘(II) the rate of growth of drug14 resistant organisms in humans; 

15 ‘‘(III) the increase in resistance 

16 rates in humans; and 

17 ‘‘(IV) the morbidity and mortality 

18 in humans; and 

19 ‘‘(ii) consult with experts in infectious 

20 diseases and antibiotic resistance, including 

21 the Centers for Disease Control and Preven22 tion, the Food and Drug Administration, 

23 medical professionals, and the clinical re24 search community. 
226 

•S 3187 EAH 

1 ‘‘(C) REVIEW.—Every 5 years, or more 

2 often as needed, the Secretary shall review, pro3 vide modifications to, and publish the list of 

4 qualifying pathogens under subparagraph (A) 

5 and shall by regulation revise the list as nec6 essary, in accordance with subsection (e). 

7 ‘‘(g) QUALIFIED INFECTIOUS DISEASE PRODUCT.— 

8 The term ‘qualified infectious disease product’ means an 

9 antibacterial or antifungal drug for human use intended 

10 to treat serious or life-threatening infections, including 

11 those caused by— 

12 ‘‘(1) an antibacterial or antifungal resistant 

13 pathogen, including novel or emerging infectious 

14 pathogens; or 

15 ‘‘(2) qualifying pathogens listed by the Secretary 

16 under subsection (f).’’. 

17 (b) APPLICATION.—Section 505E of the Federal Food, 

18 Drug, and Cosmetic Act, as added by subsection (a), applies 

19 only with respect to a drug that is first approved under 

20 section 505(c) of such Act (21 U.S.C. 355(c)) on or after 

21 the date of the enactment of this Act. 

22 SEC. 802. PRIORITY REVIEW. 

23 (a) AMENDMENT.—Chapter V (21 U.S.C. 351 et seq.) 

24 is amended by inserting after section 524 the following: 
227 

•S 3187 EAH 

1 ‘‘SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS 

2 DISEASE PRODUCTS. 

3 ‘‘If the Secretary designates a drug under section 

4 505E(d) as a qualified infectious disease product, then the 

5 Secretary shall give priority review to any application sub6 mitted for approval for such drug under section 505(b).’’. 

7 (b) APPLICATION.—Section 524A of the Federal Food, 

8 Drug, and Cosmetic Act, as added by subsection (a), applies 

9 only with respect to an application that is submitted under 

10 section 505(b) of such Act (21 U.S.C. 355(b)) on or after 

11 the date of the enactment of this Act. 

12 SEC. 803. FAST TRACK PRODUCT. 

13 Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended 

14 by section 901(b) of this Act, is amended by inserting ‘‘, 

15 or if the Secretary designates the drug as a qualified infec16 tious disease product under section 505E(d)’’ before the pe17 riod at the end of the first sentence. 

18 SEC. 804. CLINICAL TRIALS. 

19 (a) REVIEW AND REVISION OF GUIDANCE DOCU20 MENTS.— 

21 (1) IN GENERAL.—The Secretary of Health and 

22 Human Services (referred to in this section as the 

23 ‘‘Secretary’’) shall review and, as appropriate, revise 

24 not fewer than 3 guidance documents per year, which 

25 shall include— 
228 

•S 3187 EAH 

1 (A) reviewing the guidance documents of the 

2 Food and Drug Administration for the conduct 

3 of clinical trials with respect to antibacterial 

4 and antifungal drugs; and 

5 (B) as appropriate, revising such guidance 

6 documents to reflect developments in scientific 

7 and medical information and technology and to 

8 ensure clarity regarding the procedures and re9 quirements for approval of antibacterial and 

10 antifungal drugs under chapter V of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 

12 seq.). 

13 (2) ISSUES FOR REVIEW.—At a minimum, the 

14 review under paragraph (1) shall address the appro15 priate animal models of infection, in vitro techniques, 

16 valid microbiological surrogate markers, the use of 

17 noninferiority versus superiority trials, trial enroll18 ment, data requirements, and appropriate delta val19 ues for noninferiority trials. 

20 (3) RULE OF CONSTRUCTION.—Except to the ex21 tent to which the Secretary makes revisions under 

22 paragraph (1)(B), nothing in this section shall be 

23 construed to repeal or otherwise effect the guidance 

24 documents of the Food and Drug Administration. 

25 (b) RECOMMENDATIONS FOR INVESTIGATIONS.— 
229 

•S 3187 EAH 

1 (1) REQUEST.—The sponsor of a drug intended 

2 to be designated as a qualified infectious disease prod3 uct may request that the Secretary provide written 

4 recommendations for nonclinical and clinical inves5 tigations which the Secretary believes may be nec6 essary to be conducted with the drug before such drug 

7 may be approved under section 505 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use 

9 in treating, detecting, preventing, or identifying a 

10 qualifying pathogen, as defined in section 505E of 

11 such Act. 

12 (2) RECOMMENDATIONS.—If the Secretary has 

13 reason to believe that a drug for which a request is 

14 made under this subsection is a qualified infectious 

15 disease product, the Secretary shall provide the person 

16 making the request written recommendations for the 

17 nonclinical and clinical investigations which the Sec18 retary believes, on the basis of information available 

19 to the Secretary at the time of the request, would be 

20 necessary for approval under section 505 of the Fed21 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

22 of such drug for the use described in paragraph (1). 

23 (c) QUALIFIED INFECTIOUS DISEASE PRODUCT.—For 

24 purposes of this section, the term ‘‘qualified infectious dis25 ease product’’ has the meaning given such term in section 
230 

•S 3187 EAH 

1 505E(g) of the Federal Food, Drug, and Cosmetic Act, as 

2 added by section 801 of this Act. 

3 SEC. 805. REASSESSMENT OF QUALIFIED INFECTIOUS DIS4 EASE PRODUCT INCENTIVES IN 5 YEARS. 

5 (a) IN GENERAL.—Not later than 5 years after the 

6 date of enactment of this Act, the Secretary of Health and 

7 Human Services shall, in consultation with the Food and 

8 Drug Administration, the Centers for Disease Control and 

9 Prevention, and other appropriate agencies, submit to the 

10 Committee on Energy and Commerce of the House of Rep11 resentatives and the Committee on Health, Education, 

12 Labor, and Pensions of the Senate a report that contains 

13 the following: 

14 (1)(A) The number of initial designations of 

15 drugs as qualified infectious disease products under 

16 section 505E of the Federal Food, Drug, and Cosmetic 

17 Act. 

18 (B) The number of qualified infectious disease 

19 products approved under such section 505E. 

20 (C) Whether such products address the need for 

21 antibacterial and antifungal drugs to treat serious 

22 and life-threatening infections. 

23 (D) A list of qualified infectious disease products 

24 with information on the types of exclusivity granted 

25 for each product, consistent with the information pub-
231 

•S 3187 EAH 

1 lished under section 505(j)(7)(A)(iii) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 

3 355(j)(7)(A)(iii)). 

4 (E) The progress made regarding the review and 

5 revision of the clinical trial guidance documents re6 quired under section 804 and the impact such review 

7 and revision has had on the review and approval of 

8 qualified infectious disease products. 

9 (F) The Federal contribution, if any, to funding 

10 of the clinical trials for each qualified infectious dis11 ease product for each phase. 

12 (2) Recommendations— 

13 (A) based on the information under para14 graph (1) and any other relevant data, on any 

15 changes that should be made to the list of patho16 gens that are defined as qualifying pathogens 

17 under section 505E(f)(2) of the Federal Food, 

18 Drug, and Cosmetic Act, as added by section 801 

19 of this Act; and 

20 (B) on whether any additional program 

21 (such as the development of public-private col22 laborations to advance antibacterial drug inno23 vation) or changes to the incentives under this 

24 subtitle may be needed to promote the develop25 ment of antibacterial drugs. 
232 

•S 3187 EAH 

1 (3) An examination of— 

2 (A) the adoption of programs to measure 

3 the use of antibacterial drugs in health care set4 tings; and 

5 (B) the implementation and effectiveness of 

6 antimicrobial stewardship protocols across all 

7 health care settings. 

8 (4) Any recommendations for ways to encourage 

9 further development and establishment of stewardship 

10 programs. 

11 (5) A description of the regulatory challenges 

12 and impediments to clinical development, approval, 

13 and licensure of qualified infectious disease products, 

14 and the steps the Secretary has taken and will take 

15 to address such challenges and ensure regulatory cer16 tainty and predictability with respect to qualified in17 fectious disease products. 

18 (b) DEFINITION.—For purposes of this section, the 

19 term ‘‘qualified infectious disease product’’ has the meaning 

20 given such term in section 505E(g) of the Federal Food, 

21 Drug, and Cosmetic Act, as added by section 801 of this 

22 Act. 
233 

•S 3187 EAH 

1 SEC. 806. GUIDANCE ON PATHOGEN-FOCUSED ANTI2 BACTERIAL DRUG DEVELOPMENT. 

3 (a) DRAFT GUIDANCE.—Not later than June 30, 2013, 

4 in order to facilitate the development of antibacterial drugs 

5 for serious or life-threatening bacterial infections, particu6 larly in areas of unmet need, the Secretary of Health and 

7 Human Services shall publish draft guidance that— 

8 (1) specifies how preclinical and clinical data 

9 can be utilized to inform an efficient and streamlined 

10 pathogen-focused antibacterial drug development pro11 gram that meets the approval standards of the Food 

12 and Drug Administration; and 

13 (2) provides advice on approaches for the devel14 opment of antibacterial drugs that target a more lim15 ited spectrum of pathogens. 

16 (b) FINAL GUIDANCE.—Not later than December 31, 

17 2014, after notice and opportunity for public comment on 

18 the draft guidance under subsection (a), the Secretary of 

19 Health and Human Services shall publish final guidance 

20 consistent with this section. 

21 TITLE IX—DRUG APPROVAL AND 

22 PATIENT ACCESS 

23 SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT AC24 CESS TO NEW MEDICAL TREATMENTS. 

25 (a) FINDINGS; SENSE OF CONGRESS.— 

26 (1) FINDINGS.—Congress finds as follows: 
234 

•S 3187 EAH 

1 (A) The Food and Drug Administration (re2 ferred to in this section as the ‘‘FDA’’) serves a 

3 critical role in helping to assure that new medi4 cines are safe and effective. Regulatory innova5 tion is 1 element of the Nation’s strategy to ad6 dress serious and life-threatening diseases or con7 ditions by promoting investment in and develop8 ment of innovative treatments for unmet medical 

9 needs. 

10 (B) During the 2 decades following the es11 tablishment of the accelerated approval mecha12 nism, advances in medical sciences, including 

13 genomics, molecular biology, and bioinformatics, 

14 have provided an unprecedented understanding 

15 of the underlying biological mechanism and 

16 pathogenesis of disease. A new generation of 

17 modern, targeted medicines is under development 

18 to treat serious and life-threatening diseases, 

19 some applying drug development strategies based 

20 on biomarkers or pharmacogenomics, predictive 

21 toxicology, clinical trial enrichment techniques, 

22 and novel clinical trial designs, such as adaptive 

23 clinical trials. 

24 (C) As a result of these remarkable scientific 

25 and medical advances, the FDA should be en-
235 

•S 3187 EAH 

1 couraged to implement more broadly effective 

2 processes for the expedited development and re3 view of innovative new medicines intended to 

4 address unmet medical needs for serious or life5 threatening diseases or conditions, including 

6 those for rare diseases or conditions, using a 

7 broad range of surrogate or clinical endpoints 

8 and modern scientific tools earlier in the drug 

9 development cycle when appropriate. This may 

10 result in fewer, smaller, or shorter clinical trials 

11 for the intended patient population or targeted 

12 subpopulation without compromising or altering 

13 the high standards of the FDA for the approval 

14 of drugs. 

15 (D) Patients benefit from expedited access to 

16 safe and effective innovative therapies to treat 

17 unmet medical needs for serious or life-threat18 ening diseases or conditions. 

19 (E) For these reasons, the statutory author20 ity in effect on the day before the date of enact21 ment of this Act governing expedited approval of 

22 drugs for serious or life-threatening diseases or 

23 conditions should be amended in order to en24 hance the authority of the FDA to consider ap25 propriate scientific data, methods, and tools, and 
236 

•S 3187 EAH 

1 to expedite development and access to novel 

2 treatments for patients with a broad range of se3 rious or life-threatening diseases or conditions. 

4 (2) SENSE OF CONGRESS.—It is the sense of 

5 Congress that the Food and Drug Administration 

6 should apply the accelerated approval and fast track 

7 provisions set forth in section 506 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 356), as 

9 amended by this section, to help expedite the develop10 ment and availability to patients of treatments for se11 rious or life-threatening diseases or conditions while 

12 maintaining safety and effectiveness standards for 

13 such treatments. 

14 (b) EXPEDITED APPROVAL OF DRUGS FOR SERIOUS

15 OR LIFE-THREATENING DISEASES OR CONDITIONS.—Sec16 tion 506 (21 U.S.C. 356) is amended to read as follows: 

17 ‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 

18 OR LIFE-THREATENING DISEASES OR CONDI19 TIONS. 

20 ‘‘(a) DESIGNATION OF DRUG AS FAST TRACK PROD21 UCT.— 

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

23 request of the sponsor of a new drug, facilitate the de24 velopment and expedite the review of such drug if it 

25 is intended, whether alone or in combination with one 
237 

•S 3187 EAH 

1 or more other drugs, for the treatment of a serious or 

2 life-threatening disease or condition, and it dem3 onstrates the potential to address unmet medical 

4 needs for such a disease or condition. (In this section, 

5 such a drug is referred to as a ‘fast track product’.) 

6 ‘‘(2) REQUEST FOR DESIGNATION.—The sponsor 

7 of a new drug may request the Secretary to designate 

8 the drug as a fast track product. A request for the des9 ignation may be made concurrently with, or at any 

10 time after, submission of an application for the inves11 tigation of the drug under section 505(i) or section 

12 351(a)(3) of the Public Health Service Act. 

13 ‘‘(3) DESIGNATION.—Within 60 calendar days 

14 after the receipt of a request under paragraph (2), the 

15 Secretary shall determine whether the drug that is the 

16 subject of the request meets the criteria described in 

17 paragraph (1). If the Secretary finds that the drug 

18 meets the criteria, the Secretary shall designate the 

19 drug as a fast track product and shall take such ac20 tions as are appropriate to expedite the development 

21 and review of the application for approval of such 

22 product. 

23 ‘‘(b) ACCELERATED APPROVAL OF A DRUG FOR A SE24 RIOUS OR LIFE-THREATENING DISEASE OR CONDITION, IN25 CLUDING A FAST TRACK PRODUCT.— 
238 

•S 3187 EAH 

1 ‘‘(1) IN GENERAL.— 

2 ‘‘(A) ACCELERATED APPROVAL.—The Sec3 retary may approve an application for approval 

4 of a product for a serious or life-threatening dis5 ease or condition, including a fast track product, 

6 under section 505(c) or section 351(a) of the 

7 Public Health Service Act upon a determination 

8 that the product has an effect on a surrogate 

9 endpoint that is reasonably likely to predict clin10 ical benefit, or on a clinical endpoint that can 

11 be measured earlier than irreversible morbidity 

12 or mortality, that is reasonably likely to predict 

13 an effect on irreversible morbidity or mortality 

14 or other clinical benefit, taking into account the 

15 severity, rarity, or prevalence of the condition 

16 and the availability or lack of alternative treat17 ments. The approval described in the preceding 

18 sentence is referred to in this section as ‘acceler19 ated approval’. 

20 ‘‘(B) EVIDENCE.—The evidence to support 

21 that an endpoint is reasonably likely to predict 

22 clinical benefit under subparagraph (A) may in23 clude epidemiological, pathophysiological, thera24 peutic, pharmacologic, or other evidence devel-
239 

•S 3187 EAH 

1 oped using biomarkers, for example, or other sci2 entific methods or tools. 

3 ‘‘(2) LIMITATION.—Approval of a product under 

4 this subsection may be subject to 1 or both of the fol5 lowing requirements: 

6 ‘‘(A) That the sponsor conduct appropriate 

7 postapproval studies to verify and describe the 

8 predicted effect on irreversible morbidity or mor9 tality or other clinical benefit. 

10 ‘‘(B) That the sponsor submit copies of all 

11 promotional materials related to the product 

12 during the preapproval review period and, fol13 lowing approval and for such period thereafter 

14 as the Secretary determines to be appropriate, at 

15 least 30 days prior to dissemination of the mate16 rials. 

17 ‘‘(3) EXPEDITED WITHDRAWAL OF APPROVAL.— 

18 The Secretary may withdraw approval of a product 

19 approved under accelerated approval using expedited 

20 procedures (as prescribed by the Secretary in regula21 tions which shall include an opportunity for an infor22 mal hearing) if— 

23 ‘‘(A) the sponsor fails to conduct any re24 quired postapproval study of the drug with due 

25 diligence; 
240 

•S 3187 EAH 

1 ‘‘(B) a study required to verify and describe 

2 the predicted effect on irreversible morbidity or 

3 mortality or other clinical benefit of the product 

4 fails to verify and describe such effect or benefit; 

5 ‘‘(C) other evidence demonstrates that the 

6 product is not safe or effective under the condi7 tions of use; or 

8 ‘‘(D) the sponsor disseminates false or mis9 leading promotional materials with respect to 

10 the product. 

11 ‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR AP12 PROVAL OF A FAST TRACK PRODUCT.— 

13 ‘‘(1) IN GENERAL.—If the Secretary determines, 

14 after preliminary evaluation of clinical data sub15 mitted by the sponsor, that a fast track product may 

16 be effective, the Secretary shall evaluate for filing, and 

17 may commence review of portions of, an application 

18 for the approval of the product before the sponsor sub19 mits a complete application. The Secretary shall com20 mence such review only if the applicant— 

21 ‘‘(A) provides a schedule for submission of 

22 information necessary to make the application 

23 complete; and 

24 ‘‘(B) pays any fee that may be required 

25 under section 736. 
241 

•S 3187 EAH 

1 ‘‘(2) EXCEPTION.—Any time period for review of 

2 human drug applications that has been agreed to by 

3 the Secretary and that has been set forth in goals 

4 identified in letters of the Secretary (relating to the 

5 use of fees collected under section 736 to expedite the 

6 drug development process and the review of human 

7 drug applications) shall not apply to an application 

8 submitted under paragraph (1) until the date on 

9 which the application is complete. 

10 ‘‘(d) AWARENESS EFFORTS.—The Secretary shall— 

11 ‘‘(1) develop and disseminate to physicians, pa12 tient organizations, pharmaceutical and biotechnology 

13 companies, and other appropriate persons a descrip14 tion of the provisions of this section applicable to ac15 celerated approval and fast track products; and 

16 ‘‘(2) establish a program to encourage the devel17 opment of surrogate and clinical endpoints, including 

18 biomarkers, and other scientific methods and tools 

19 that can assist the Secretary in determining whether 

20 the evidence submitted in an application is reason21 ably likely to predict clinical benefit for serious or 

22 life-threatening conditions for which significant 

23 unmet medical needs exist. 

24 ‘‘(e) CONSTRUCTION.— 
242 

•S 3187 EAH 

1 ‘‘(1) PURPOSE.—The amendments made by the 

2 Food and Drug Administration Safety and Innova3 tion Act to this section are intended to encourage the 

4 Secretary to utilize innovative and flexible approaches 

5 to the assessment of products under accelerated ap6 proval for treatments for patients with serious or life7 threatening diseases or conditions and unmet medical 

8 needs. 

9 ‘‘(2) CONSTRUCTION.—Nothing in this section 

10 shall be construed to alter the standards of evidence 

11 under subsection (c) or (d) of section 505 (including 

12 the substantial evidence standard in section 505(d)) 

13 of this Act or under section 351(a) of the Public 

14 Health Service Act. Such sections and standards of 

15 evidence apply to the review and approval of products 

16 under this section, including whether a product is 

17 safe and effective. Nothing in this section alters the 

18 ability of the Secretary to rely on evidence that does 

19 not come from adequate and well-controlled investiga20 tions for the purpose of determining whether an end21 point is reasonably likely to predict clinical benefit as 

22 described in subsection (b)(1)(B).’’. 

23 (c) GUIDANCE; AMENDED REGULATIONS.— 

24 (1) DRAFT GUIDANCE.—Not later than 1 year 

25 after the date of enactment of this Act, the Secretary 
243 

•S 3187 EAH 

1 of Health and Human Services (referred to in this 

2 section as the ‘‘Secretary’’) shall issue draft guidance 

3 to implement the amendments made by this section. 

4 In developing such guidance, the Secretary shall spe5 cifically consider issues arising under the accelerated 

6 approval and fast track processes under section 506 

7 of the Federal Food, Drug, and Cosmetic Act, as 

8 amended by subsection (b), for drugs designated for a 

9 rare disease or condition under section 526 of such 

10 Act (21 U.S.C. 360bb) and shall also consider any 

11 unique issues associated with very rare diseases. 

12 (2) FINAL GUIDANCE.—Not later than 1 year 

13 after the issuance of draft guidance under paragraph 

14 (1), and after an opportunity for public comment, the 

15 Secretary shall— 

16 (A) issue final guidance; and 

17 (B) amend the regulations governing accel18 erated approval in parts 314 and 601 of title 21, 

19 Code of Federal Regulations, as necessary to con20 form such regulations with the amendment made 

21 by subsection (b). 

22 (3) CONSIDERATION.—In developing the guid23 ance under paragraphs (1) and (2)(A) and the 

24 amendments under paragraph (2)(B), the Secretary 

25 shall consider how to incorporate novel approaches to 
244 

•S 3187 EAH 

1 the review of surrogate endpoints based on patho2 physiologic and pharmacologic evidence in such guid3 ance, especially in instances where the low prevalence 

4 of a disease renders the existence or collection of other 

5 types of data unlikely or impractical. 

6 (4) CONFORMING CHANGES.—The Secretary shall 

7 issue, as necessary, conforming amendments to the 

8 applicable regulations under title 21, Code of Federal 

9 Regulations, governing accelerated approval. 

10 (5) NO EFFECT OF INACTION ON REQUESTS.— 

11 The issuance (or nonissuance) of guidance or con12 forming regulations implementing the amendment 

13 made by subsection (b) shall not preclude the review 

14 of, or action on, a request for designation or an ap15 plication for approval submitted pursuant to section 

16 506 of the Federal Food, Drug, and Cosmetic Act, as 

17 amended by subsection (b). 

18 (d) INDEPENDENT REVIEW.—The Secretary may, in 

19 conjunction with other planned reviews, contract with an 

20 independent entity with expertise in assessing the quality 

21 and efficiency of biopharmaceutical development and regu22 latory review programs to evaluate the Food and Drug Ad23 ministration’s application of the processes described in sec24 tion 506 of the Federal Food, Drug, and Cosmetic Act, as 

25 amended by subsection (b), and the impact of such processes 
245 

•S 3187 EAH 

1 on the development and timely availability of innovative 

2 treatments for patients suffering from serious or life-threat3 ening conditions. Any such evaluation shall include con4 sultation with regulated industries, patient advocacy and 

5 disease research foundations, and relevant academic med6 ical centers. 

7 SEC. 902. BREAKTHROUGH THERAPIES. 

8 (a) IN GENERAL.—Section 506 (21 U.S.C. 356), as 

9 amended by section 901 of this Act, is further amended— 

10 (1) by redesignating subsections (a) through (c) 

11 as subsections (b) through (d), respectively; 

12 (2) by redesignating subsection (d) as subsection 

13 (f); 

14 (3) by inserting before subsection (b), as so redes15 ignated, the following: 

16 ‘‘(a) DESIGNATION OF A DRUG AS A BREAKTHROUGH

17 THERAPY.— 

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

19 request of the sponsor of a drug, expedite the develop20 ment and review of such drug if the drug is intended, 

21 alone or in combination with 1 or more other drugs, 

22 to treat a serious or life-threatening disease or condi23 tion and preliminary clinical evidence indicates that 

24 the drug may demonstrate substantial improvement 

25 over existing therapies on 1 or more clinically signifi-
246 

•S 3187 EAH 

1 cant endpoints, such as substantial treatment effects 

2 observed early in clinical development. (In this sec3 tion, such a drug is referred to as a ‘breakthrough 

4 therapy’.) 

5 ‘‘(2) REQUEST FOR DESIGNATION.—The sponsor 

6 of a drug may request the Secretary to designate the 

7 drug as a breakthrough therapy. A request for the des8 ignation may be made concurrently with, or at any 

9 time after, the submission of an application for the 

10 investigation of the drug under section 505(i) or sec11 tion 351(a)(3) of the Public Health Service Act. 

12 ‘‘(3) DESIGNATION.— 

13 ‘‘(A) IN GENERAL.—Not later than 60 cal14 endar days after the receipt of a request under 

15 paragraph (2), the Secretary shall determine 

16 whether the drug that is the subject of the request 

17 meets the criteria described in paragraph (1). If 

18 the Secretary finds that the drug meets the cri19 teria, the Secretary shall designate the drug as 

20 a breakthrough therapy and shall take such ac21 tions as are appropriate to expedite the develop22 ment and review of the application for approval 

23 of such drug. 

24 ‘‘(B) ACTIONS.—The actions to expedite the 

25 development and review of an application under 
247 

•S 3187 EAH 

1 subparagraph (A) may include, as appro2 priate— 

3 ‘‘(i) holding meetings with the sponsor 

4 and the review team throughout the develop5 ment of the drug; 

6 ‘‘(ii) providing timely advice to, and 

7 interactive communication with, the spon8 sor regarding the development of the drug to 

9 ensure that the development program to 

10 gather the nonclinical 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 Admin18 istration review team to facilitate an effi19 cient review of the development program 

20 and to serve as a scientific liaison between 

21 the review team and the sponsor; and 

22 ‘‘(v) taking steps to ensure that the de23 sign of the clinical trials is as efficient as 

24 practicable, when scientifically appropriate, 

25 such as by minimizing the number of pa-
248 

•S 3187 EAH 

1 tients exposed to a potentially less effica2 cious treatment.’’; and 

3 (4) in subsection (f)(1), as so redesignated, by 

4 striking ‘‘applicable to accelerated approval’’ and in5 serting ‘‘applicable to breakthrough therapies, acceler6 ated approval, and’’. 

7 (b) GUIDANCE; AMENDED REGULATIONS.— 

8 (1) IN GENERAL.— 

9 (A) GUIDANCE.—Not later than 18 months 

10 after the date of enactment of this Act, the Sec11 retary of Health and Human Services (referred 

12 to in this section as the ‘‘Secretary’’) shall issue 

13 draft guidance on implementing the require14 ments with respect to breakthrough therapies, as 

15 set forth in section 506(a) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 356(a)), as 

17 amended by this section. The Secretary shall 

18 issue final guidance not later than 1 year after 

19 the close of the comment period for the draft 

20 guidance. 

21 (B) AMENDED REGULATIONS.— 

22 (i) IN GENERAL.—If the Secretary de23 termines that it is necessary to amend the 

24 regulations under title 21, Code of Federal 

25 Regulations in order to implement the 
249 

•S 3187 EAH 

1 amendments made by this section to section 

2 506(a) of the Federal Food, Drug, and Cos3 metic Act, the Secretary shall amend such 

4 regulations not later than 2 years after the 

5 date of enactment of this Act. 

6 (ii) PROCEDURE.—In amending regu7 lations under clause (i), the Secretary 

8 shall— 

9 (I) issue a notice of proposed rule10 making that includes the proposed reg11 ulation; 

12 (II) provide a period of not less 

13 than 60 days for comments on the pro14 posed regulation; and 

15 (III) publish the final regulation 

16 not less than 30 days before the effec17 tive date of the regulation. 

18 (iii) RESTRICTIONS.—Notwithstanding 

19 any other provision of law, the Secretary 

20 shall promulgate regulations implementing 

21 the amendments made by this section only 

22 as described in clause (ii). 

23 (2) REQUIREMENTS.—Guidance issued under 

24 this section shall— 
250 

•S 3187 EAH 

1 (A) specify the process and criteria by 

2 which the Secretary makes a designation under 

3 section 506(a)(3) of the Federal Food, Drug, and 

4 Cosmetic Act; and 

5 (B) specify the actions the Secretary shall 

6 take to expedite the development and review of a 

7 breakthrough therapy pursuant to such designa8 tion under such section 506(a)(3), including up9 dating good review management practices to re10 flect breakthrough therapies. 

11 (c) CONFORMING AMENDMENTS.—Section 506B(e) (21 

12 U.S.C. 356b) is amended by striking ‘‘section 506(b)(2)(A)’’ 

13 each place such term appears and inserting ‘‘section 

14 506(c)(2)(A)’’. 

15 SEC. 903. CONSULTATION WITH EXTERNAL EXPERTS ON 

16 RARE DISEASES, TARGETED THERAPIES, AND 

17 GENETIC TARGETING OF TREATMENTS. 

18 Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), 

19 as amended by section 715 of this Act, is further amended 

20 by adding at the end the following: 

21 ‘‘SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON 

22 RARE DISEASES, TARGETED THERAPIES, AND 

23 GENETIC TARGETING OF TREATMENTS. 

24 ‘‘(a) IN GENERAL.—For the purpose of promoting the 

25 efficiency of and informing the review by the Food and 
251 

•S 3187 EAH 

1 Drug Administration of new drugs and biological products 

2 for rare diseases and drugs and biological products that are 

3 genetically targeted, the following shall apply: 

4 ‘‘(1) CONSULTATION WITH STAKEHOLDERS.— 

5 Consistent with sections X.C and IX.E.4 of the 

6 PDUFA Reauthorization Performance Goals and Pro7 cedures Fiscal Years 2013 through 2017, as referenced 

8 in the letters described in section 101(b) of the Pre9 scription Drug User Fee Amendments of 2012, the 

10 Secretary shall ensure that opportunities exist, at a 

11 time the Secretary determines appropriate, for con12 sultations with stakeholders on the topics described in 

13 subsection (b). 

14 ‘‘(2) CONSULTATION WITH EXTERNAL EX15 PERTS.— 

16 ‘‘(A) IN GENERAL.—The Secretary shall de17 velop and maintain a list of external experts 

18 who, because of their special expertise, are quali19 fied to provide advice on rare disease issues, in20 cluding topics described in subsection (c). The 

21 Secretary may, when appropriate to address a 

22 specific regulatory question, consult such exter23 nal experts on issues related to the review of new 

24 drugs and biological products for rare diseases 

25 and drugs and biological products that are ge-
252 

•S 3187 EAH 

1 netically targeted, including the topics described 

2 in subsection (b), when such consultation is nec3 essary because the Secretary lacks the specific 

4 scientific, medical, or technical expertise nec5 essary for the performance of the Secretary’s reg6 ulatory responsibilities and the necessary exper7 tise can be provided by the external experts. 

8 ‘‘(B) EXTERNAL EXPERTS.—For purposes of 

9 subparagraph (A), external experts are individ10 uals who possess scientific or medical training 

11 that the Secretary lacks with respect to one or 

12 more rare diseases. 

13 ‘‘(b) TOPICS FOR CONSULTATION.—Topics for con14 sultation pursuant to this section may include— 

15 ‘‘(1) rare diseases; 

16 ‘‘(2) the severity of rare diseases; 

17 ‘‘(3) the unmet medical need associated with rare 

18 diseases; 

19 ‘‘(4) the willingness and ability of individuals 

20 with a rare disease to participate in clinical trials; 

21 ‘‘(5) an assessment of the benefits and risks of 

22 therapies to treat rare diseases; 

23 ‘‘(6) the general design of clinical trials for rare 

24 disease populations and subpopulations; and 
253 

•S 3187 EAH 

1 ‘‘(7) the demographics and the clinical descrip2 tion of patient populations. 

3 ‘‘(c) 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 ‘‘(d) PROTECTION OF CONFIDENTIAL INFORMATION

9 AND TRADE SECRETS.— 

10 ‘‘(1) RULE OF CONSTRUCTION.—Nothing in this 

11 section shall be construed to alter the protections of12 fered by laws, regulations, and policies governing dis13 closure of confidential commercial or trade secret in14 formation, and any other information exempt from 

15 disclosure pursuant to section 552(b) of title 5, 

16 United States Code, as such provisions would be ap17 plied to consultation with individuals and organiza18 tions prior to the date of enactment of this section. 

19 ‘‘(2) CONSENT REQUIRED FOR DISCLOSURE.— 

20 The Secretary shall not disclose confidential commer21 cial or trade secret information to an expert consulted 

22 under this section without the written consent of the 

23 sponsor unless the expert is a special government em24 ployee (as defined under section 202 of title 18, 
254 

•S 3187 EAH 

1 United States Code) or the disclosure is otherwise au2 thorized by law. 

3 ‘‘(e) OTHER CONSULTATION.—Nothing in this section 

4 shall be construed to limit the ability of the Secretary to 

5 consult with individuals and organizations as authorized 

6 prior to the date of enactment of this section. 

7 ‘‘(f) NO RIGHT OR OBLIGATION.— 

8 ‘‘(1) NO RIGHT TO CONSULTATION.—Nothing in 

9 this section shall be construed to create a legal right 

10 for a consultation on any matter or require the Sec11 retary to meet with any particular expert or stake12 holder. 

13 ‘‘(2) NO ALTERING OF GOALS.—Nothing in this 

14 section shall be construed to alter agreed upon goals 

15 and procedures identified in the letters described in 

16 section 101(b) of the Prescription Drug User Fee 

17 Amendments of 2012. 

18 ‘‘(3) NO CHANGE TO NUMBER OF REVIEW CY19 CLES.—Nothing in this section is intended to increase 

20 the number of review cycles as in effect before the date 

21 of enactment of this section. 

22 ‘‘(g) NO DELAY IN PRODUCT REVIEW.— 

23 ‘‘(1) IN GENERAL.—Prior to a consultation with 

24 an external expert, as described in this section, relat25 ing to an investigational new drug application under 
255 

•S 3187 EAH 

1 section 505(i), a new drug application under section 

2 505(b), or a biologics license application under sec3 tion 351 of the Public Health Service Act, the Direc4 tor of the Center for Drug Evaluation and Research 

5 or the Director of the Center for Biologics Evaluation 

6 and Research (or appropriate Division Director), as 

7 appropriate, shall determine that— 

8 ‘‘(A) such consultation will— 

9 ‘‘(i) facilitate the Secretary’s ability to 

10 complete the Secretary’s review; and 

11 ‘‘(ii) address outstanding deficiencies 

12 in the application; or 

13 ‘‘(B) the sponsor authorized such consulta14 tion. 

15 ‘‘(2) LIMITATION.—The requirements of this sub16 section shall apply only in instances where the con17 sultation is undertaken solely under the authority of 

18 this section. The requirements of this subsection shall 

19 not apply to any consultation initiated under any 

20 other authority.’’. 

21 SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIP22 TION DRUG CONTAINER LABELS BY VISUALLY 

23 IMPAIRED AND BLIND CONSUMERS. 

24 (a) ESTABLISHMENT OF WORKING GROUP.— 
256 

•S 3187 EAH 

1 (1) IN GENERAL.—The Architectural and Trans2 portation Barriers Compliance Board (referred to in 

3 this section as the ‘‘Access Board’’) shall convene a 

4 stakeholder working group (referred to in this section 

5 as the ‘‘working group’’) to develop best practices on 

6 access to information on prescription drug container 

7 labels for individuals who are blind or visually im8 paired. 

9 (2) MEMBERS.—The working group shall be 

10 comprised of representatives of national organizations 

11 representing blind and visually impaired individuals, 

12 national organizations representing the elderly, and 

13 industry groups representing stakeholders, including 

14 retail, mail-order, and independent community phar15 macies, who would be impacted by such best practices. 

16 Representation within the working group shall be di17 vided equally between consumer and industry advo18 cates. 

19 (3) BEST PRACTICES.— 

20 (A) IN GENERAL.—The working group shall 

21 develop, not later than 1 year after the date of 

22 the enactment of this Act, best practices for phar23 macies to ensure that blind and visually im24 paired individuals have safe, consistent, reliable, 
257 

•S 3187 EAH 

1 and independent access to the information on 

2 prescription drug container labels. 

3 (B) PUBLIC AVAILABILITY.—The best prac4 tices developed under subparagraph (A) may be 

5 made publicly available, including through the 

6 Internet Web sites of the working group partici7 pant organizations, and through other means, in 

8 a manner that provides access to interested indi9 viduals, including individuals with disabilities. 

10 (C) LIMITATIONS.—The best practices devel11 oped under subparagraph (A) shall not be con12 strued as accessibility guidelines or standards of 

13 the Access Board, and shall not confer any rights 

14 or impose any obligations on working group par15 ticipants or other persons. Nothing in this sec16 tion shall be construed to limit or condition any 

17 right, obligation, or remedy available under the 

18 Americans with Disabilities Act of 1990 (42 

19 U.S.C. 12101 et seq.) or any other Federal or 

20 State law requiring effective communication, 

21 barrier removal, or nondiscrimination on the 

22 basis of disability. 

23 (4) CONSIDERATIONS.—In developing and 

24 issuing the best practices under paragraph (3)(A), the 

25 working group shall consider— 
258 

•S 3187 EAH 

1 (A) the use of— 

2 (i) Braille; 

3 (ii) auditory means, such as— 

4 (I) ‘‘talking bottles’’ that provide 

5 audible container label information; 

6 (II) digital voice recorders at7 tached to the prescription drug con8 tainer; and 

9 (III) radio frequency identifica10 tion tags; 

11 (iii) enhanced visual means, such as— 

12 (I) large font labels or large font 

13 ‘‘duplicate’’ labels that are affixed or 

14 matched to a prescription drug con15 tainer; 

16 (II) high-contrast printing; and 

17 (III) sans-serf font; and 

18 (iv) other relevant alternatives as de19 termined by the working group; 

20 (B) whether there are technical, financial, 

21 manpower, or other factors unique to pharmacies 

22 with 20 or fewer retail locations which may pose 

23 significant challenges to the adoption of the best 

24 practices; and 
259 

•S 3187 EAH 

1 (C) such other factors as the working group 

2 determines to be appropriate. 

3 (5) INFORMATION CAMPAIGN.—Upon completion 

4 of development of the best practices under subsection 

5 (a)(3), the National Council on Disability, in con6 sultation with the working group, shall conduct an 

7 informational and educational campaign designed to 

8 inform individuals with disabilities, pharmacists, 

9 and the public about such best practices. 

10 (6) FACA WAIVER.—The Federal Advisory Com11 mittee Act (5 U.S.C. App.) shall not apply to the 

12 working group. 

13 (b) GAO STUDY.— 

14 (1) IN GENERAL.—Beginning 18 months after 

15 the completion of the development of best practices 

16 under subsection (a)(3)(A), the Comptroller General of 

17 the United States shall conduct a review of the extent 

18 to which pharmacies are utilizing such best practices, 

19 and the extent to which barriers to accessible informa20 tion on prescription drug container labels for blind 

21 and visually impaired individuals continue. 

22 (2) REPORT.—Not later than September 30, 

23 2016, the Comptroller General of the United States 

24 shall submit to Congress a report on the review con25 ducted under paragraph (1). Such report shall in-
260 

•S 3187 EAH 

1 clude recommendations about how best to reduce the 

2 barriers experienced by blind and visually impaired 

3 individuals to independently accessing information 

4 on prescription drug container labels. 

5 (c) DEFINITIONS.—In this section— 

6 (1) the term ‘‘pharmacy’’ includes a pharmacy 

7 that receives prescriptions and dispenses prescription 

8 drugs through an Internet Web site or by mail; 

9 (2) the term ‘‘prescription drug’’ means a drug 

10 subject to section 503(b)(1) of the Federal Food, Drug, 

11 and Cosmetic Act (21 U.S.C. 353(b)(1)); and 

12 (3) the term ‘‘prescription drug container label’’ 

13 means the label with the directions for use that is af14 fixed to the prescription drug container by the phar15 macist and dispensed to the consumer. 

16 SEC. 905. RISK-BENEFIT FRAMEWORK. 

17 Section 505(d) (21 U.S.C. 355(d)) is amended by add18 ing at the end the following: ‘‘The Secretary shall imple19 ment a structured risk-benefit assessment framework in the 

20 new drug approval process to facilitate the balanced consid21 eration of benefits and risks, a consistent and systematic 

22 approach to the discussion and regulatory decisionmaking, 

23 and the communication of the benefits and risks of new 

24 drugs. Nothing in the preceding sentence shall alter the cri-
261 

•S 3187 EAH 

1 teria for evaluating an application for premarket approval 

2 of a drug.’’. 

3 SEC. 906. GRANTS AND CONTRACTS FOR THE DEVELOP4 MENT OF ORPHAN DRUGS. 

5 (a) QUALIFIED TESTING DEFINITION.—Section 

6 5(b)(1)(A)(ii) of the Orphan Drug Act (21 U.S.C. 

7 360ee(b)(1)(A)(ii)) is amended by striking ‘‘after the date 

8 such drug is designated under section 526 of such Act and’’. 

9 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

10 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amend11 ed to read as follows: 

12 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For 

13 grants and contracts under subsection (a), there is author14 ized to be appropriated $30,000,000 for each of fiscal years 

15 2013 through 2017.’’. 

16 SEC. 907. REPORTING OF INCLUSION OF DEMOGRAPHIC 

17 SUBGROUPS IN CLINICAL TRIALS AND DATA 

18 ANALYSIS IN APPLICATIONS FOR DRUGS, BIO19 LOGICS, AND DEVICES. 

20 (a) REPORT.— 

21 (1) IN GENERAL.—Not later than 1 year after 

22 the date of enactment of this Act, the Secretary, act23 ing through the Commissioner, shall publish on the 

24 Internet Web site of the Food and Drug Administra25 tion a report, consistent with the regulations of the 
262 

•S 3187 EAH 

1 Food and Drug Administration pertaining to the pro2 tection of sponsors’ confidential commercial informa3 tion as of the date of enactment of this Act, address4 ing the extent to which clinical trial participation 

5 and the inclusion of safety and effectiveness data by 

6 demographic subgroups including sex, age, race, and 

7 ethnicity, is included in applications submitted to the 

8 Food and Drug Administration, and shall provide 

9 such publication to Congress. 

10 (2) CONTENTS OF REPORT.—The report described 

11 in paragraph (1) shall contain the following: 

12 (A) A description of existing tools to ensure 

13 that data to support demographic analyses are 

14 submitted in applications for drugs, biological 

15 products, and devices, and that these analyses 

16 are conducted by applicants consistent with ap17 plicable Food and Drug Administration require18 ments and Guidance for Industry. The report 

19 shall address how the Food and Drug Adminis20 tration makes available information about dif21 ferences in safety and effectiveness of medical 

22 products according to demographic subgroups, 

23 such as sex, age, racial, and ethnic subgroups, to 

24 health care providers, researchers, and patients. 
263 

•S 3187 EAH 

1 (B) An analysis of the extent to which de2 mographic data subset analyses on sex, age, race, 

3 and ethnicity is presented in applications for 

4 new drug applications for new molecular entities 

5 under section 505 of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 355), in biologics 

7 license applications under section 351 of the 

8 Public Health Service Act (42 U.S.C. 262), and 

9 in premarket approval applications under sec10 tion 515 of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 360e) for products ap12 proved or licensed by the Food and Drug Admin13 istration, consistent with applicable require14 ments and Guidance for Industry, and consistent 

15 with the regulations of the Food and Drug Ad16 ministration pertaining to the protection of 

17 sponsors’ confidential commercial information as 

18 of the date of enactment of this Act. 

19 (C) An analysis of the extent to which de20 mographic subgroups, including sex, age, racial, 

21 and ethnic subgroups, are represented in clinical 

22 studies to support applications for approved or 

23 licensed new molecular entities, biological prod24 ucts, and devices. 
264 

•S 3187 EAH 

1 (D) An analysis of the extent to which a 

2 summary of product safety and effectiveness data 

3 by demographic subgroups including sex, age, 

4 race, and ethnicity is readily available to the 

5 public in a timely manner by means of the prod6 uct labeling or the Food and Drug Administra7 tion’s Internet Web site. 

8 (b) ACTION PLAN.— 

9 (1) IN GENERAL.—Not later than 1 year after 

10 the publication of the report described in subsection 

11 (a), the Secretary, acting through the Commissioner, 

12 shall publish an action plan on the Internet Web site 

13 of the Food and Drug Administration, and provide 

14 such publication to Congress. 

15 (2) CONTENT OF ACTION PLAN.—The plan de16 scribed in paragraph (1) shall include— 

17 (A) recommendations, as appropriate, to 

18 improve the completeness and quality of analyses 

19 of data on demographic subgroups in summaries 

20 of product safety and effectiveness data and in 

21 labeling; 

22 (B) recommendations, as appropriate, on 

23 the inclusion of such data, or the lack of avail24 ability of such data in labeling; 
265 

•S 3187 EAH 

1 (C) recommendations, as appropriate, to 

2 otherwise improve the public availability of such 

3 data to patients, health care providers, and re4 searchers; and 

5 (D) a determination with respect to each 

6 recommendation identified in subparagraphs (A) 

7 through (C) that distinguishes between product 

8 types referenced in subsection (a)(2)(B) insofar 

9 as the applicability of each such recommendation 

10 to each type of product. 

11 (c) DEFINITIONS.—In this section: 

12 (1) The term ‘‘Commissioner’’ means the Com13 missioner of Food and Drugs. 

14 (2) The term ‘‘device’’ has the meaning given 

15 such term in section 201(h) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 321(h)). 

17 (3) The term ‘‘drug’’ has the meaning given such 

18 term in section 201(g) of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 321(g)). 

20 (4) The term ‘‘biological product’’ has the mean21 ing given such term in section 351(i) of the Public 

22 Health Service Act (42 U.S.C. 262(i)). 

23 (5) The term ‘‘Secretary’’ means the Secretary of 

24 Health and Human Services. 
266 

•S 3187 EAH 

1 SEC. 908. RARE PEDIATRIC DISEASE PRIORITY REVIEW 

2 VOUCHER INCENTIVE PROGRAM. 

3 Subchapter B of chapter V (21 U.S.C. 360aa et seq.) 

4 is amended by adding at the end the following: 

5 ‘‘SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 

6 FOR RARE PEDIATRIC DISEASES. 

7 ‘‘(a) DEFINITIONS.—In this section: 

8 ‘‘(1) PRIORITY REVIEW.—The term ‘priority re9 view’, with respect to a human drug application as 

10 defined in section 735(1), means review and action by 

11 the Secretary on such application not later than 6 

12 months after receipt by the Secretary of such applica13 tion, as described in the Manual of Policies and Pro14 cedures of the Food and Drug Administration and 

15 goals identified in the letters described in section 

16 101(b) of the Prescription Drug User Fee Amend17 ments of 2012. 

18 ‘‘(2) PRIORITY REVIEW VOUCHER.—The term 

19 ‘priority review voucher’ means a voucher issued by 

20 the Secretary to the sponsor of a rare pediatric dis21 ease product application that entitles the holder of 

22 such voucher to priority review of a single human 

23 drug application submitted under section 505(b)(1) or 

24 section 351(a) of the Public Health Service Act after 

25 the date of approval of the rare pediatric disease 

26 product application. 
267 

•S 3187 EAH 

1 ‘‘(3) RARE PEDIATRIC DISEASE.—The term ‘rare 

2 pediatric disease’ means a disease that meets each of 

3 the following criteria: 

4 ‘‘(A) The disease primarily affects individ5 uals aged from birth to 18 years, including age 

6 groups often called neonates, infants, children, 

7 and adolescents. 

8 ‘‘(B) The disease is a rare disease or condi9 tion, within the meaning of section 526. 

10 ‘‘(4) RARE PEDIATRIC DISEASE PRODUCT APPLI11 CATION.—The term ‘rare pediatric disease product 

12 application’ means a human drug application, as de13 fined in section 735(1), that— 

14 ‘‘(A) is for a drug or biological product— 

15 ‘‘(i) that is for the prevention or treat16 ment of a rare pediatric disease; and 

17 ‘‘(ii) that contains no active ingredient 

18 (including any ester or salt of the active in19 gredient) that has been previously approved 

20 in any other application under section 

21 505(b)(1), 505(b)(2), or 505(j) of this Act or 

22 section 351(a) or 351(k) of the Public 

23 Health Service Act; 
268 

•S 3187 EAH 

1 ‘‘(B) is submitted under section 505(b)(1) of 

2 this Act or section 351(a) of the Public Health 

3 Service Act; 

4 ‘‘(C) the Secretary deems eligible for pri5 ority review; 

6 ‘‘(D) that relies on clinical data derived 

7 from studies examining a pediatric population 

8 and dosages of the drug intended for that popu9 lation; 

10 ‘‘(E) that does not seek approval for an 

11 adult indication in the original rare pediatric 

12 disease product application; and 

13 ‘‘(F) is approved after the date of the enact14 ment of the Prescription Drug User Fee Amend15 ments of 2012. 

16 ‘‘(b) PRIORITY REVIEW VOUCHER.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall award a 

18 priority review voucher to the sponsor of a rare pedi19 atric disease product application upon approval by 

20 the Secretary of such rare pediatric disease product 

21 application. 

22 ‘‘(2) TRANSFERABILITY.— 

23 ‘‘(A) IN GENERAL.—The sponsor of a rare 

24 pediatric disease product application that re25 ceives a priority review voucher under this sec-
269 

•S 3187 EAH 

1 tion may transfer (including by sale) the entitle2 ment to such voucher. There is no limit on the 

3 number of times a priority review voucher may 

4 be transferred before such voucher is used. 

5 ‘‘(B) NOTIFICATION OF TRANSFER.—Each 

6 person to whom a voucher is transferred shall 

7 notify the Secretary of such change in ownership 

8 of the voucher not later than 30 days after such 

9 transfer. 

10 ‘‘(3) LIMITATION.—A sponsor of a rare pediatric 

11 disease product application may not receive a pri12 ority review voucher under this section if the rare pe13 diatric disease product application was submitted to 

14 the Secretary prior to the date that is 90 days after 

15 the date of enactment of the Prescription Drug User 

16 Fee Amendments of 2012. 

17 ‘‘(4) NOTIFICATION.— 

18 ‘‘(A) IN GENERAL.—The sponsor of a 

19 human drug application shall notify the Sec20 retary not later than 90 days prior to submis21 sion of the human drug application that is the 

22 subject of a priority review voucher of an intent 

23 to submit the human drug application, including 

24 the date on which the sponsor intends to submit 

25 the application. Such notification shall be a le-
270 

•S 3187 EAH 

1 gally binding commitment to pay for the user fee 

2 to be assessed in accordance with this section. 

3 ‘‘(B) TRANSFER AFTER NOTICE.—The spon4 sor of a human drug application that provides 

5 notification of the intent of such sponsor to use 

6 the voucher for the human drug application 

7 under subparagraph (A) may transfer the vouch8 er after such notification is provided, if such 

9 sponsor has not yet submitted the human drug 

10 application described in the notification. 

11 ‘‘(5) TERMINATION OF AUTHORITY.—The Sec12 retary may not award any priority review vouchers 

13 under paragraph (1) after the last day of the 1-year 

14 period that begins on the date that the Secretary 

15 awards the third rare pediatric disease priority 

16 voucher under this section. 

17 ‘‘(c) PRIORITY REVIEW USER FEE.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall establish 

19 a user fee program under which a sponsor of a 

20 human drug application that is the subject of a pri21 ority review voucher shall pay to the Secretary a fee 

22 determined under paragraph (2). Such fee shall be in 

23 addition to any fee required to be submitted by the 

24 sponsor under chapter VII. 
271 

•S 3187 EAH 

1 ‘‘(2) FEE AMOUNT.—The amount of the priority 

2 review user fee shall be determined each fiscal year by 

3 the Secretary, based on the difference between— 

4 ‘‘(A) the average cost incurred by the Food 

5 and Drug Administration in the review of a 

6 human drug application subject to priority re7 view in the previous fiscal year; and 

8 ‘‘(B) the average cost incurred by the Food 

9 and Drug Administration in the review of a 

10 human drug application that is not subject to 

11 priority review in the previous fiscal year. 

12 ‘‘(3) ANNUAL FEE SETTING.—The Secretary shall 

13 establish, before the beginning of each fiscal year be14 ginning after September 30, 2012, the amount of the 

15 priority review user fee for that fiscal year. 

16 ‘‘(4) PAYMENT.— 

17 ‘‘(A) IN GENERAL.—The priority review 

18 user fee required by this subsection shall be due 

19 upon the notification by a sponsor of the intent 

20 of such sponsor to use the voucher, as specified 

21 in subsection (b)(4)(A). All other user fees associ22 ated with the human drug application shall be 

23 due as required by the Secretary or under appli24 cable law. 
272 

•S 3187 EAH 

1 ‘‘(B) COMPLETE APPLICATION.—An appli2 cation described under subparagraph (A) for 

3 which the sponsor requests the use of a priority 

4 review voucher shall be considered incomplete if 

5 the fee required by this subsection and all other 

6 applicable user fees are not paid in accordance 

7 with the Secretary’s procedures for paying such 

8 fees. 

9 ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC10 TIONS, OR REFUNDS.—The Secretary may not 

11 grant a waiver, exemption, reduction, or refund 

12 of any fees due and payable under this section. 

13 ‘‘(5) OFFSETTING COLLECTIONS.—Fees collected 

14 pursuant to this subsection for any fiscal year— 

15 ‘‘(A) shall be deposited and credited as off16 setting collections to the account providing ap17 propriations to the Food and Drug Administra18 tion; and 

19 ‘‘(B) shall not be collected for any fiscal 

20 year except to the extent provided in advance in 

21 appropriations Acts. 

22 ‘‘(d) DESIGNATION PROCESS.— 

23 ‘‘(1) IN GENERAL.—Upon the request of the man24 ufacturer or the sponsor of a new drug, the Secretary 

25 may designate— 
273 

•S 3187 EAH 

1 ‘‘(A) the new drug as a drug for a rare pe2 diatric disease; and 

3 ‘‘(B) the application for the new drug as a 

4 rare pediatric disease product application. 

5 ‘‘(2) REQUEST FOR DESIGNATION.—The request 

6 for a designation under paragraph (1) shall be made 

7 at the same time a request for designation of orphan 

8 disease status under section 526 or fast-track designa9 tion under section 506 is made. Requesting designa10 tion under this subsection is not a prerequisite to re11 ceiving a priority review voucher under this section. 

12 ‘‘(3) DETERMINATION BY SECRETARY.—Not later 

13 than 60 days after a request is submitted under para14 graph (1), the Secretary shall determine whether— 

15 ‘‘(A) the disease or condition that is the 

16 subject of such request is a rare pediatric disease; 

17 and 

18 ‘‘(B) the application for the new drug is a 

19 rare pediatric disease product application. 

20 ‘‘(e) MARKETING OF RARE PEDIATRIC DISEASE PROD21 UCTS.— 

22 ‘‘(1) REVOCATION.—The Secretary may revoke 

23 any priority review voucher awarded under sub24 section (b) if the rare pediatric disease product for 

25 which such voucher was awarded is not marketed in 
274 

•S 3187 EAH 

1 the United States within the 365-day period begin2 ning on the date of the approval of such drug under 

3 section 505 of this Act or section 351 of the Public 

4 Health Service Act. 

5 ‘‘(2) POSTAPPROVAL PRODUCTION REPORT.—The 

6 sponsor of an approved rare pediatric disease product 

7 shall submit a report to the Secretary not later than 

8 5 years after the approval of the applicable rare pedi9 atric disease product application. Such report shall 

10 provide the following information, with respect to 

11 each of the first 4 years after approval of such prod12 uct: 

13 ‘‘(A) The estimated population in the 

14 United States suffering from the rare pediatric 

15 disease. 

16 ‘‘(B) The estimated demand in the United 

17 States for such rare pediatric disease product. 

18 ‘‘(C) The actual amount of such rare pedi19 atric disease product distributed in the United 

20 States. 

21 ‘‘(f) NOTICE AND REPORT.— 

22 ‘‘(1) NOTICE OF ISSUANCE OF VOUCHER AND AP23 PROVAL OF PRODUCTS UNDER VOUCHER.—The Sec24 retary shall publish a notice in the Federal Register 

25 and on the Internet Web site of the Food and Drug 
275 

•S 3187 EAH 

1 Administration not later than 30 days after the oc2 currence of each of the following: 

3 ‘‘(A) The Secretary issues a priority review 

4 voucher under this section. 

5 ‘‘(B) The Secretary approves a drug pursu6 ant to an application submitted under section 

7 505(b) of this Act or section 351(a) of the Public 

8 Health Service Act for which the sponsor of the 

9 application used a priority review voucher under 

10 this section. 

11 ‘‘(2) NOTIFICATION.—If, after the last day of the 

12 1-year period that begins on the date that the Sec13 retary awards the third rare pediatric disease pri14 ority voucher under this section, a sponsor of an ap15 plication submitted under section 505(b) of this Act 

16 or section 351(a) of the Public Health Service Act for 

17 a drug uses a priority review voucher under this sec18 tion for such application, the Secretary shall submit 

19 to the Committee on Energy and Commerce of the 

20 House of Representatives and the Committee on 

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

22 a document— 

23 ‘‘(A) notifying such Committees of the use of 

24 such voucher; and 
276 

•S 3187 EAH 

1 ‘‘(B) identifying the drug for which such 

2 priority review voucher is used. 

3 ‘‘(g) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 

4 in this section precludes a sponsor who seeks a priority re5 view voucher under this section from participating in any 

6 other incentive program, including under this Act. 

7 ‘‘(h) RELATION TO OTHER PROVISIONS.—The provi8 sions of this section shall supplement, not supplant, any 

9 other provisions of this Act or the Public Health Service 

10 Act that encourage the development of drugs for tropical 

11 diseases and rare pediatric diseases. 

12 ‘‘(i) GAO STUDY AND REPORT.— 

13 ‘‘(1) STUDY.— 

14 ‘‘(A) IN GENERAL.—Beginning on the date 

15 that the Secretary awards the third rare pedi16 atric disease priority voucher under this section, 

17 the Comptroller General of the United States 

18 shall conduct a study of the effectiveness of 

19 awarding rare pediatric disease priority vouch20 ers under this section in the development of 

21 human drug products that treat or prevent such 

22 diseases. 

23 ‘‘(B) CONTENTS OF STUDY.—In conducting 

24 the study under subparagraph (A), the Comp25 troller General shall examine the following: 
277 

•S 3187 EAH 

1 ‘‘(i) The indications for which each 

2 rare disease product for which a priority re3 view voucher was awarded was approved 

4 under section 505 or section 351 of the Pub5 lic Health Service Act. 

6 ‘‘(ii) Whether, and to what extent, an 

7 unmet need related to the treatment or pre8 vention of a rare pediatric disease was met 

9 through the approval of such a rare disease 

10 product. 

11 ‘‘(iii) The value of the priority review 

12 voucher if transferred. 

13 ‘‘(iv) Identification of each drug for 

14 which a priority review voucher was used. 

15 ‘‘(v) The length of the period of time 

16 between the date on which a priority review 

17 voucher was awarded and the date on which 

18 it was used. 

19 ‘‘(2) REPORT.—Not later than 1 year after the 

20 date under paragraph (1)(A), the Comptroller Gen21 eral shall submit to the Committee on Energy and 

22 Commerce of the House of Representatives and the 

23 Committee on Health, Education, Labor, and Pen24 sions of the Senate, a report containing the results of 

25 the study under paragraph (1).’’. 
278 

•S 3187 EAH 

1 TITLE X—DRUG SHORTAGES 

2 SEC. 1001. DISCONTINUANCE OR INTERRUPTION IN THE 

3 PRODUCTION OF LIFE-SAVING DRUGS. 

4 (a) IN GENERAL.—Section 506C (21 U.S.C. 356c) is 

5 amended to read as follows: 

6 ‘‘SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE 

7 PRODUCTION OF LIFE-SAVING DRUGS. 

8 ‘‘(a) IN GENERAL.—A manufacturer of a drug— 

9 ‘‘(1) that is— 

10 ‘‘(A) life-supporting; 

11 ‘‘(B) life-sustaining; or 

12 ‘‘(C) intended for use in the prevention or 

13 treatment of a debilitating disease or condition, 

14 including any such drug used in emergency med15 ical care or during surgery; and 

16 ‘‘(2) that is not a radio pharmaceutical drug 

17 product or any other product as designated by the 

18 Secretary, 

19 shall notify the Secretary, in accordance with subsection 

20 (b), of a permanent discontinuance in the manufacture of 

21 the drug or an interruption of the manufacture of the drug 

22 that is likely to lead to a meaningful disruption in the sup23 ply of that drug in the United States, and the reasons for 

24 such discontinuance or interruption. 
279 

•S 3187 EAH 

1 ‘‘(b) TIMING.—A notice required under subsection (a) 

2 shall be submitted to the Secretary— 

3 ‘‘(1) at least 6 months prior to the date of the 

4 discontinuance or interruption; or 

5 ‘‘(2) if compliance with paragraph (1) is not 

6 possible, as soon as practicable. 

7 ‘‘(c) DISTRIBUTION.—To the maximum extent prac8 ticable, the Secretary shall distribute, through such means 

9 as the Secretary deems appropriate, information on the dis10 continuation or interruption of the manufacture of the 

11 drugs described in subsection (a) to appropriate organiza12 tions, including physician, health provider, and patient or13 ganizations, as described in section 506E. 

14 ‘‘(d) CONFIDENTIALITY.—Nothing in this section shall 

15 be construed as authorizing the Secretary to disclose any 

16 information that is a trade secret or confidential informa17 tion subject to section 552(b)(4) of title 5, United States 

18 Code, or section 1905 of title 18, United States Code. 

19 ‘‘(e) COORDINATION WITH ATTORNEY GENERAL.—Not 

20 later than 30 days after the receipt of a notification de21 scribed in subsection (a), the Secretary shall— 

22 ‘‘(1) determine whether the notification pertains 

23 to a controlled substance subject to a production quota 

24 under section 306 of the Controlled Substances Act; 

25 and 
280 

•S 3187 EAH 

1 ‘‘(2) if necessary, as determined by the Sec2 retary— 

3 ‘‘(A) notify the Attorney General that the 

4 Secretary has received such a notification; 

5 ‘‘(B) request that the Attorney General in6 crease the aggregate and individual production 

7 quotas under section 306 of the Controlled Sub8 stances Act applicable to such controlled sub9 stance and any ingredient therein to a level the 

10 Secretary deems necessary to address a shortage 

11 of a controlled substance based on the best avail12 able market data; and 

13 ‘‘(C) if the Attorney General determines 

14 that the level requested is not necessary to ad15 dress a shortage of a controlled substance, the At16 torney General shall provide to the Secretary a 

17 written response detailing the basis for the Attor18 ney General’s determination. 

19 The Secretary shall make the written response pro20 vided under subparagraph (C) available to the public 

21 on the Internet Web site of the Food and Drug Ad22 ministration. 

23 ‘‘(f) FAILURE TO MEET REQUIREMENTS.—If a person 

24 fails to submit information required under subsection (a) 

25 in accordance with subsection (b)— 
281 

•S 3187 EAH 

1 ‘‘(1) the Secretary shall issue a letter to such 

2 person informing such person of such failure; 

3 ‘‘(2) not later than 30 calendar days after the 

4 issuance of a letter under paragraph (1), the person 

5 who receives such letter shall submit to the Secretary 

6 a written response to such letter setting forth the basis 

7 for noncompliance and providing information re8 quired under subsection (a); and 

9 ‘‘(3) not later than 45 calendar days after the 

10 issuance of a letter under paragraph (1), the Sec11 retary shall make such letter and any response to 

12 such letter under paragraph (2) available to the pub13 lic on the Internet Web site of the Food and Drug Ad14 ministration, with appropriate redactions made to 

15 protect information described in subsection (d), except 

16 that, if the Secretary determines that the letter under 

17 paragraph (1) was issued in error or, after review of 

18 such response, the person had a reasonable basis for 

19 not notifying as required under subsection (a), the re20 quirements of this paragraph shall not apply. 

21 ‘‘(g) EXPEDITED INSPECTIONS AND REVIEWS.—If, 

22 based on notifications described in subsection (a) or any 

23 other relevant information, the Secretary concludes that 

24 there is, or is likely to be, a drug shortage of a drug de25 scribed in subsection (a), the Secretary may— 
282 

•S 3187 EAH 

1 ‘‘(1) expedite the review of a supplement to a 

2 new drug application submitted under section 505(b), 

3 an abbreviated new drug application submitted under 

4 section 505(j), or a supplement to such an application 

5 submitted under section 505(j) that could help miti6 gate or prevent such shortage; or 

7 ‘‘(2) expedite an inspection or reinspection of an 

8 establishment that could help mitigate or prevent such 

9 drug shortage. 

10 ‘‘(h) DEFINITIONS.—For purposes of this section— 

11 ‘‘(1) the term ‘drug’— 

12 ‘‘(A) means a drug (as defined in section 

13 201(g)) that is intended for human use and that 

14 is subject to section 503(b)(1); and 

15 ‘‘(B) does not include biological products 

16 (as defined in section 351 of the Public Health 

17 Service Act), unless otherwise provided by the 

18 Secretary in the regulations promulgated under 

19 subsection (i); 

20 ‘‘(2) the term ‘drug shortage’ or ‘shortage’, with 

21 respect to a drug, means a period of time when the 

22 demand or projected demand for the drug within the 

23 United States exceeds the supply of the drug; and 

24 ‘‘(3) the term ‘meaningful disruption’— 
283 

•S 3187 EAH 

1 ‘‘(A) means a change in production that is 

2 reasonably likely to lead to a reduction in the 

3 supply of a drug by a manufacturer that is more 

4 than negligible and affects the ability of the 

5 manufacturer to fill orders or meet expected de6 mand for its product; and 

7 ‘‘(B) does not include interruptions in man8 ufacturing due to matters such as routine main9 tenance or insignificant changes in manufac10 turing so long as the manufacturer expects to re11 sume operations in a short period of time. 

12 ‘‘(i) REGULATIONS.— 

13 ‘‘(1) IN GENERAL.—Not later than 18 months 

14 after the date of enactment of the Food and Drug Ad15 ministration Safety and Innovation Act, the Sec16 retary shall adopt a final regulation implementing 

17 this section. 

18 ‘‘(2) CONTENTS.—Such regulation shall define, 

19 for purposes of this section, the terms ‘life-supporting’, 

20 ‘life-sustaining’, and ‘intended for use in the preven21 tion or treatment of a debilitating disease or condi22 tion’. 

23 ‘‘(3) INCLUSION OF BIOLOGICAL PRODUCTS.— 

24 ‘‘(A) IN GENERAL.—The Secretary may by 

25 regulation apply this section to biological prod-
284 

•S 3187 EAH 

1 ucts (as defined in section 351 of the Public 

2 Health Service Act), including plasma products 

3 derived from human plasma protein and their 

4 recombinant analogs, if the Secretary determines 

5 such inclusion would benefit the public health. 

6 Such regulation shall take into account any sup7 ply reporting programs and shall aim to reduce 

8 duplicative notification. 

9 ‘‘(B) RULE FOR VACCINES.—If the Sec10 retary applies this section to vaccines pursuant 

11 to subparagraph (A), the Secretary shall— 

12 ‘‘(i) consider whether the notification 

13 requirement under subsection (a) may be 

14 satisfied by submitting a notification to the 

15 Centers for Disease Control and Prevention 

16 under the vaccine shortage notification pro17 gram of such Centers; and 

18 ‘‘(ii) explain the determination made 

19 by the Secretary under clause (i) in the reg20 ulation. 

21 ‘‘(4) PROCEDURE.—In promulgating a regula22 tion implementing this section, the Secretary shall— 

23 ‘‘(A) issue a notice of proposed rulemaking 

24 that includes the proposed regulation; 
285 

•S 3187 EAH 

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 regulation’s effective 

6 date. 

7 ‘‘(5) RESTRICTIONS.—Notwithstanding any other 

8 provision of Federal law, in implementing this sec9 tion, the Secretary shall only promulgate regulations 

10 as described in paragraph (4).’’. 

11 (b) EFFECT OF NOTIFICATION.—The submission of a 

12 notification to the Secretary of Health and Human Services 

13 (referred to in this title as the ‘‘Secretary’’) for purposes 

14 of complying with the requirement in section 506C(a) of 

15 the Federal Food, Drug, and Cosmetic Act (as amended by 

16 subsection (a)) shall not be construed— 

17 (1) as an admission that any product that is the 

18 subject of such notification violates any provision of 

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

20 301 et seq.); or 

21 (2) as evidence of an intention to promote or 

22 market the product for an indication or use for which 

23 the product has not been approved by the Secretary. 
286 

•S 3187 EAH 

1 SEC. 1002. ANNUAL REPORTING ON DRUG SHORTAGES. 

2 Chapter V (21 U.S.C. 351 et seq.) is amended by in3 serting after section 506C, as amended by section 1001 of 

4 this Act, the following: 

5 ‘‘SEC. 506C–1. ANNUAL REPORTING ON DRUG SHORTAGES. 

6 ‘‘(a) ANNUAL REPORTS TO CONGRESS.—Not later than 

7 the end of calendar year 2013, and not later than the end 

8 of each calendar year thereafter, the Secretary shall submit 

9 to the Committee on Energy and Commerce of the House 

10 of Representatives and the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate a report on drug 

12 shortages that— 

13 ‘‘(1) specifies the number of manufacturers that 

14 submitted a notification to the Secretary under sec15 tion 506C(a) during such calendar year; 

16 ‘‘(2) describes the communication between the 

17 field investigators of the Food and Drug Administra18 tion and the staff of the Center for Drug Evaluation 

19 and Research’s Office of Compliance and Drug Short20 age Program, including the Food and Drug Adminis21 tration’s procedures for enabling and ensuring such 

22 communication; 

23 ‘‘(3)(A) lists the major actions taken by the Sec24 retary to prevent or mitigate the drug shortages de25 scribed in paragraph (7); 
287 

•S 3187 EAH 

1 ‘‘(B) in the list under subparagraph (A), in2 cludes— 

3 ‘‘(i) the number of applications and supple4 ments for which the Secretary expedited review 

5 under section 506C(g)(1) during such calendar 

6 year; and 

7 ‘‘(ii) the number of establishment inspec8 tions or reinspections that the Secretary expe9 dited under section 506C(g)(2) during such cal10 endar year; 

11 ‘‘(4) describes the coordination between the Food 

12 and Drug Administration and the Drug Enforcement 

13 Administration on efforts to prevent or alleviate drug 

14 shortages; 

15 ‘‘(5) identifies the number of and describes the 

16 instances in which the Food and Drug Administra17 tion exercised regulatory flexibility and discretion to 

18 prevent or alleviate a drug shortage; 

19 ‘‘(6) lists the names of manufacturers that were 

20 issued letters under section 506C(f); and 

21 ‘‘(7) specifies the number of drug shortages oc22 curring during such calendar year, as identified by 

23 the Secretary. 

24 ‘‘(b) TREND ANALYSIS.—The Secretary is authorized 

25 to retain a third party to conduct a study, if the Secretary 
288 

•S 3187 EAH 

1 believes such a study would help clarify the causes, trends, 

2 or solutions related to drug shortages. 

3 ‘‘(c) DEFINITION.—In this section, the term ‘drug 

4 shortage’ or ‘shortage’ has the meaning given such term in 

5 section 506C.’’. 

6 SEC. 1003. COORDINATION; TASK FORCE AND STRATEGIC 

7 PLAN. 

8 Chapter V (21 U.S.C. 351 et seq.) is amended by in9 serting after section 506C–1, as added by section 1002 of 

10 this Act, the following: 

11 ‘‘SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC 

12 PLAN. 

13 ‘‘(a) TASK FORCE AND STRATEGIC PLAN.— 

14 ‘‘(1) IN GENERAL.— 

15 ‘‘(A) TASK FORCE.—As soon as practicable 

16 after the date of enactment of the Food and Drug 

17 Administration Safety and Innovation Act, the 

18 Secretary shall establish a task force to develop 

19 and implement a strategic plan for enhancing 

20 the Secretary’s response to preventing and miti21 gating drug shortages. 

22 ‘‘(B) STRATEGIC PLAN.—The strategic plan 

23 described in subparagraph (A) shall include— 
289 

•S 3187 EAH 

1 ‘‘(i) plans for enhanced interagency 

2 and intra-agency coordination, communica3 tion, and decisionmaking; 

4 ‘‘(ii) plans for ensuring that drug 

5 shortages are considered when the Secretary 

6 initiates a regulatory action that could pre7 cipitate a drug shortage or exacerbate an 

8 existing drug shortage; 

9 ‘‘(iii) plans for effective communica10 tion with outside stakeholders, including 

11 who the Secretary should alert about poten12 tial or actual drug shortages, how the com13 munication should occur, and what types of 

14 information should be shared; 

15 ‘‘(iv) plans for considering the impact 

16 of drug shortages on research and clinical 

17 trials; and 

18 ‘‘(v) an examination of whether to es19 tablish a ‘qualified manufacturing partner 

20 program’, as described in subparagraph 

21 (C). 

22 ‘‘(C) DESCRIPTION OF PROGRAM.—In con23 ducting the examination of a ‘qualified manufac24 turing partner program’ under subparagraph 

25 (B)(v), the Secretary— 
290 

•S 3187 EAH 

1 ‘‘(i) shall take into account that— 

2 ‘‘(I) a ‘qualified manufacturer’, 

3 for purposes of such program, would 

4 need to have the capability and capac5 ity to supply products determined or 

6 anticipated to be in shortage; and 

7 ‘‘(II) in examining the capability 

8 and capacity to supply products in 

9 shortage, the ‘qualified manufacturer’ 

10 could have a site that manufactures a 

11 drug listed under section 506E or have 

12 the capacity to produce drugs in re13 sponse to a shortage within a rapid 

14 timeframe; and 

15 ‘‘(ii) shall examine whether incentives 

16 are necessary to encourage the participation 

17 of ‘qualified manufacturers’ in such a pro18 gram. 

19 ‘‘(D) CONSULTATION.—In carrying out this 

20 paragraph, the task force shall ensure consulta21 tion with the appropriate offices within the Food 

22 and Drug Administration, including the Office 

23 of the Commissioner, the Center for Drug Eval24 uation and Research, the Office of Regulatory 

25 Affairs, and employees within the Department of 
291 

•S 3187 EAH 

1 Health and Human Services with expertise re2 garding drug shortages. The Secretary shall en3 gage external stakeholders and experts as appro4 priate. 

5 ‘‘(2) TIMING.—Not later than 1 year after the 

6 date of enactment of the Food and Drug Administra7 tion Safety and Innovation Act, the task force shall— 

8 ‘‘(A) publish the strategic plan described in 

9 paragraph (1); and 

10 ‘‘(B) submit such plan to Congress. 

11 ‘‘(b) COMMUNICATION.—The Secretary shall ensure 

12 that, prior to any enforcement action or issuance of a warn13 ing letter that the Secretary determines could reasonably 

14 be anticipated to lead to a meaningful disruption in the 

15 supply in the United States of a drug described under sec16 tion 506C(a), there is communication with the appropriate 

17 office of the Food and Drug Administration with expertise 

18 regarding drug shortages regarding whether the action or 

19 letter could cause, or exacerbate, a shortage of the drug. 

20 ‘‘(c) ACTION.—If the Secretary determines, after the 

21 communication described in subsection (b), that an enforce22 ment action or a warning letter could reasonably cause or 

23 exacerbate a shortage of a drug described under section 

24 506C(a), then the Secretary shall evaluate the risks associ25 ated with the impact of such shortage upon patients and 
292 

•S 3187 EAH 

1 those risks associated with the violation involved before tak2 ing such action or issuing such letter, unless there is immi3 nent risk of serious adverse health consequences or death 

4 to humans. 

5 ‘‘(d) REPORTING BY OTHER ENTITIES.—The Secretary 

6 shall identify or establish a mechanism by which health care 

7 providers and other third-party organizations may report 

8 to the Secretary evidence of a drug shortage. 

9 ‘‘(e) REVIEW AND CONSTRUCTION.—No determination, 

10 finding, action, or omission of the Secretary under this sec11 tion shall— 

12 ‘‘(1) be subject to judicial review; or 

13 ‘‘(2) be construed to establish a defense to an en14 forcement action by the Secretary. 

15 ‘‘(f) SUNSET.—Subsections (a), (b), (c), and (e) shall 

16 cease to be effective on the date that is 5 years after the 

17 date of enactment of the Food and Drug Administration 

18 Safety and Innovation Act.’’. 

19 SEC. 1004. DRUG SHORTAGE LIST. 

20 Chapter V (21 U.S.C. 351 et seq.) is amended by in21 serting after section 506D, as added by section 1003 of this 

22 Act, the following: 
293 

•S 3187 EAH 

1 ‘‘SEC. 506E. DRUG SHORTAGE LIST. 

2 ‘‘(a) ESTABLISHMENT.—The Secretary shall maintain 

3 an up-to-date list of drugs that are determined by the Sec4 retary to be in shortage in the United States. 

5 ‘‘(b) CONTENTS.—For each drug on such list, the Sec6 retary shall include the following information: 

7 ‘‘(1) The name of the drug in shortage, including 

8 the National Drug Code number for such drug. 

9 ‘‘(2) The name of each manufacturer of such 

10 drug. 

11 ‘‘(3) The reason for the shortage, as determined 

12 by the Secretary, selecting from the following cat13 egories: 

14 ‘‘(A) Requirements related to complying 

15 with good manufacturing practices. 

16 ‘‘(B) Regulatory delay. 

17 ‘‘(C) Shortage of an active ingredient. 

18 ‘‘(D) Shortage of an inactive ingredient 

19 component. 

20 ‘‘(E) Discontinuation of the manufacture of 

21 the drug. 

22 ‘‘(F) Delay in shipping of the drug. 

23 ‘‘(G) Demand increase for the drug. 

24 ‘‘(4) The estimated duration of the shortage as 

25 determined by the Secretary. 

26 ‘‘(c) PUBLIC AVAILABILITY.— 
294 

•S 3187 EAH 

1 ‘‘(1) IN GENERAL.—Subject to paragraphs (2) 

2 and (3), the Secretary shall make the information in 

3 such list publicly available. 

4 ‘‘(2) TRADE SECRETS AND CONFIDENTIAL INFOR5 MATION.—Nothing in this section alters or amends 

6 section 1905 of title 18, United States Code, or section 

7 552(b)(4) of title 5 of such Code. 

8 ‘‘(3) PUBLIC HEALTH EXCEPTION.—The Sec9 retary may choose not to make information collected 

10 under this section publicly available under paragraph 

11 (1) or section 506C(c) if the Secretary determines that 

12 disclosure of such information would adversely affect 

13 the public health (such as by increasing the possi14 bility of hoarding or other disruption of the avail15 ability of drug products to patients).’’. 

16 SEC. 1005. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE. 

17 Section 306 of the Controlled Substances Act (21 

18 U.S.C. 826) is amended by adding at the end the following: 

19 ‘‘(h)(1) Not later than 30 days after the receipt of a 

20 request described in paragraph (2), the Attorney General 

21 shall— 

22 ‘‘(A) complete review of such request; and 

23 ‘‘(B)(i) as necessary to address a shortage of a 

24 controlled substance, increase the aggregate and indi25 vidual production quotas under this section applica-
295 

•S 3187 EAH 

1 ble to such controlled substance and any ingredient 

2 therein to the level requested; or 

3 ‘‘(ii) if the Attorney General determines that the 

4 level requested is not necessary to address a shortage 

5 of a controlled substance, the Attorney General shall 

6 provide a written response detailing the basis for the 

7 Attorney General’s determination. 

8 The Secretary shall make the written response provided 

9 under subparagraph (B)(ii) available to the public on the 

10 Internet Web site of the Food and Drug Administration. 

11 ‘‘(2) A request is described in this paragraph if— 

12 ‘‘(A) the request pertains to a controlled sub13 stance on the list of drugs in shortage maintained 

14 under section 506E of the Federal Food, Drug, and 

15 Cosmetic Act; 

16 ‘‘(B) the request is submitted by the manufac17 turer of the controlled substance; and 

18 ‘‘(C) the controlled substance is in schedule II.’’. 

19 SEC. 1006. ATTORNEY GENERAL REPORT ON DRUG SHORT20 AGES. 

21 Not later than 6 months after the date of the enactment 

22 of this Act, and annually thereafter, the Attorney General 

23 shall submit to the Committee on Energy and Commerce 

24 of the House of Representatives and the Committee on the 

25 Judiciary of the Senate a report on drug shortages that— 
296 

•S 3187 EAH 

1 (1) identifies the number of requests received 

2 under section 306(h) of the Controlled Substances Act 

3 (as added by section 1005 of this Act), the average re4 view time for such requests, the number of requests 

5 granted and denied under such section, and, for each 

6 of the requests denied under such section, the basis for 

7 such denial; 

8 (2) describes the coordination between the Drug 

9 Enforcement Administration and Food and Drug Ad10 ministration on efforts to prevent or alleviate drug 

11 shortages; and 

12 (3) identifies drugs containing a controlled sub13 stance subject to section 306 of the Controlled Sub14 stances Act when such a drug is determined by the 

15 Secretary to be in shortage. 

16 SEC. 1007. HOSPITAL REPACKAGING OF DRUGS IN SHORT17 AGE. 

18 Chapter V (21 U.S.C. 351 et seq.) is amended by in19 serting after section 506E, as added by section 1004 of this 

20 Act, the following: 

21 ‘‘SEC. 506F. HOSPITAL REPACKAGING OF DRUGS IN SHORT22 AGE. 

23 ‘‘(a) DEFINITIONS.—In this section: 
297 

•S 3187 EAH 

1 ‘‘(1) DRUG.—The term ‘drug’ excludes any con2 trolled substance (as such term is defined in section 

3 102 of the Controlled Substances Act). 

4 ‘‘(2) HEALTH SYSTEM.—The term ‘health system’ 

5 means a collection of hospitals that are owned and 

6 operated by the same entity and that share access to 

7 databases with drug order information for their pa8 tients. 

9 ‘‘(3) REPACKAGE.—For the purposes of this sec10 tion only, the term ‘repackage’, with respect to a 

11 drug, means to divide the volume of a drug into 

12 smaller amounts in order to— 

13 ‘‘(A) extend the supply of a drug in re14 sponse to the placement of the drug on a drug 

15 shortage list under section 506E; and 

16 ‘‘(B) facilitate access to the drug by hos17 pitals within the same health system. 

18 ‘‘(b) EXCLUSION FROM REGISTRATION.—Notwith19 standing any other provision of this Act, a hospital shall 

20 not be considered an establishment for which registration 

21 is required under section 510 solely because it repackages 

22 a drug and transfers it to another hospital within the same 

23 health system in accordance with the conditions in sub24 section (c)— 
298 

•S 3187 EAH 

1 ‘‘(1) during any period in which the drug is list2 ed on the drug shortage list under section 506E; or 

3 ‘‘(2) during the 60-day period following any pe4 riod described in paragraph (1). 

5 ‘‘(c) CONDITIONS.—Subsection (b) shall only apply to 

6 a hospital, with respect to the repackaging of a drug for 

7 transfer to another hospital within the same health system, 

8 if the following conditions are met: 

9 ‘‘(1) DRUG FOR INTRASYSTEM USE ONLY.—In no 

10 case may a drug that has been repackaged in accord11 ance with this section be sold or otherwise distributed 

12 by the health system or a hospital within the system 

13 to an entity or individual that is not a hospital with14 in such health system. 

15 ‘‘(2) COMPLIANCE WITH STATE RULES.—Repack16 aging of a drug under this section shall be done in 

17 compliance with applicable State requirements of 

18 each State in which the drug is repackaged and re19 ceived. 

20 ‘‘(d) TERMINATION.—This section shall not apply on 

21 or after the date on which the Secretary issues final guid22 ance that clarifies the policy of the Food and Drug Admin23 istration regarding hospital pharmacies repackaging and 

24 safely transferring repackaged drugs to other hospitals 

25 within the same health system during a drug shortage.’’. 
299 

•S 3187 EAH 

1 SEC. 1008. STUDY ON DRUG SHORTAGES. 

2 (a) STUDY.—The Comptroller General of the United 

3 States shall conduct a study to examine the cause of drug 

4 shortages and formulate recommendations on how to pre5 vent or alleviate such shortages. 

6 (b) CONSIDERATION.—In conducting the study under 

7 this section, the Comptroller General shall consider the fol8 lowing questions: 

9 (1) What are the dominant characteristics of 

10 drugs that have gone into a drug shortage over the 

11 preceding 3 years? 

12 (2) Are there systemic high-risk factors (such as 

13 drug pricing structure, including Federal reimburse14 ments, or the number of manufacturers producing a 

15 drug product) that have led to the concentration of 

16 drug shortages in certain drug products that have 

17 made such products vulnerable to drug shortages? 

18 (3) Is there a reason why drug shortages have oc19 curred primarily in the sterile injectable market and 

20 in certain therapeutic areas? 

21 (4)(A) How have regulations, guidance docu22 ments, regulatory practices, policies, and other ac23 tions of Federal departments and agencies (including 

24 the effectiveness of interagency and intra-agency co25 ordination, communication, strategic planning, and 
300 

•S 3187 EAH 

1 decisionmaking), including those used to enforce stat2 utory requirements, affected drug shortages? 

3 (B) Do any such regulations, guidances, policies, 

4 or practices cause, exacerbate, prevent, or mitigate 

5 drug shortages? 

6 (C) How can regulations, guidances, policies, or 

7 practices be modified, streamlined, expanded, or dis8 continued in order to reduce or prevent such drug 

9 shortages? 

10 (D) What effect would the changes described in 

11 subparagraph (C) have on the public health? 

12 (5) How does hoarding affect drug shortages? 

13 (6) How would incentives alleviate or prevent 

14 drug shortages? 

15 (7) To what extent are health care providers, in16 cluding hospitals and physicians responding to drug 

17 shortages, able to adjust care effectively to compensate 

18 for such shortages, and what impediments exist that 

19 hinder provider ability to adjust to such shortages? 

20 (8)(A) Have drug shortages led market partici21 pants to stockpile affected drugs or sell such drugs at 

22 inflated prices? 

23 (B) What has been the impact of any such ac24 tivities described in subparagraph (A) on Federal rev-
301 

•S 3187 EAH 

1 enue, and are there any economic factors that have 

2 exacerbated or created a market for such activities? 

3 (C) Is there a need for any additional reporting 

4 or enforcement actions to address such activities? 

5 (9)(A) How have the activities under section 

6 506D of the Federal Food, Drug, and Cosmetic Act 

7 (as added by section 1003 of this Act) improved the 

8 efforts of the Food and Drug Administration to miti9 gate and prevent drug shortages? 

10 (B) Is there a need to continue the task force and 

11 strategic plan under such section 506D, or are there 

12 any other recommendations to increase communica13 tion and coordination inside the Food and Drug Ad14 ministration, between the Food and Drug Adminis15 tration and other agencies, and between the Food and 

16 Drug Administration and stakeholders? 

17 (c) CONSULTATION WITH STAKEHOLDERS.—In con18 ducting the study under this section, the Comptroller Gen19 eral shall consult with relevant stakeholders, including phy20 sicians, pharmacists, hospitals, patients, drug manufactur21 ers, and other health providers. 

22 (d) REPORT.—Not later than 18 months after the date 

23 of the enactment of this Act, the Comptroller General shall 

24 submit a report to the Committee on Energy and Commerce 

25 of the House of Representatives and the Committee on 
302 

•S 3187 EAH 

1 Health, Education, Labor, and Pensions of the Senate on 

2 the results of the study under this section. 

3 TITLE XI—OTHER PROVISIONS 

4 Subtitle A—Reauthorizations 

5 SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO 

6 EXCLUSIVITY OF CERTAIN DRUGS CON7 TAINING SINGLE ENANTIOMERS. 

8 (a) IN GENERAL.—Section 505(u)(4) (21 U.S.C. 

9 355(u)(4)) is amended by striking ‘‘2012’’ and inserting 

10 ‘‘2017’’. 

11 (b) AMENDMENT.—Section 505(u)(1)(A)(ii)(II) (21 

12 U.S.C. 355(u)(1)(A)(ii)(II)) is amended by inserting ‘‘clin13 ical’’ after ‘‘any’’. 

14 SEC. 1102. REAUTHORIZATION OF THE CRITICAL PATH PUB15 LIC-PRIVATE PARTNERSHIPS. 

16 Subsection (f) of section 566 (21 U.S.C. 360bbb–5) is 

17 amended to read as follows: 

18 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To carry 

19 out this section, there is authorized to be appropriated 

20 $6,000,000 for each of fiscal years 2013 through 2017.’’. 

21 Subtitle B—Medical Gas Product 

22 Regulation 

23 SEC. 1111. REGULATION OF MEDICAL GASES. 

24 Chapter V (21 U.S.C. 351 et seq.) is amended by add25 ing at the end the following: 
303 

•S 3187 EAH 

1 ‘‘Subchapter G—Medical Gases 

2 ‘‘SEC. 575. DEFINITIONS. 

3 ‘‘In this subchapter: 

4 ‘‘(1) The term ‘designated medical gas’ means 

5 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 set 

9 forth in an official compendium. 

10 ‘‘(C) Nitrous oxide that meets the standards 

11 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 stand17 ards 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 deemed appro21 priate by the Secretary, after taking into account 

22 any investigational new drug application or in23 vestigational new animal drug application for 

24 the same medical gas submitted in accordance 

25 with regulations applicable to such applications 
304 

•S 3187 EAH 

1 in title 21 of the Code of Federal Regulations, 

2 unless any period of exclusivity under section 

3 505(c)(3)(E)(ii) or section 505(j)(5)(F)(ii), or 

4 the extension of any such period under section 

5 505A, applicable to such medical gas has not ex6 pired. 

7 ‘‘(2) The term ‘medical gas’ means a drug that— 

8 ‘‘(A) is manufactured or stored in a lique9 fied, nonliquefied, or cryogenic state; and 

10 ‘‘(B) is administered as a gas. 

11 ‘‘SEC. 576. REGULATION OF MEDICAL GASES. 

12 ‘‘(a) CERTIFICATION OF DESIGNATED MEDICAL

13 GASES.— 

14 ‘‘(1) SUBMISSION.—Beginning 180 days after the 

15 date of enactment of this section, any person may file 

16 with the Secretary a request for certification of a 

17 medical gas as a designated medical gas. Any such re18 quest shall contain the following information: 

19 ‘‘(A) A description of the medical gas. 

20 ‘‘(B) The name and address of the sponsor. 

21 ‘‘(C) The name and address of the facility 

22 or facilities where the medical gas is or will be 

23 manufactured. 
305 

•S 3187 EAH 

1 ‘‘(D) Any other information deemed appro2 priate by the Secretary to determine whether the 

3 medical gas is a designated medical gas. 

4 ‘‘(2) GRANT OF CERTIFICATION.—The certifi5 cation requested under paragraph (1) is deemed to be 

6 granted unless, within 60 days of the filing of such 

7 request, the Secretary finds that— 

8 ‘‘(A) the medical gas subject to the certifi9 cation is not a designated medical gas; 

10 ‘‘(B) the request does not contain the infor11 mation required under paragraph (1) or other12 wise lacks sufficient information to permit the 

13 Secretary to determine that the medical gas is a 

14 designated medical gas; or 

15 ‘‘(C) denying the request is necessary to 

16 protect the public health. 

17 ‘‘(3) EFFECT OF CERTIFICATION.— 

18 ‘‘(A) IN GENERAL.— 

19 ‘‘(i) APPROVED USES.—A designated 

20 medical gas for which a certification is 

21 granted under paragraph (2) is deemed, 

22 alone or in combination, as medically ap23 propriate, with another designated medical 

24 gas or gases for which a certification or cer25 tifications have been granted, to have in ef-
306 

•S 3187 EAH 

1 fect an approved application under section 

2 505 or 512, subject to all applicable post3 approval requirements, for the following in4 dications for use: 

5 ‘‘(I) In the case of oxygen, the 

6 treatment or prevention of hypoxemia 

7 or hypoxia. 

8 ‘‘(II) In the case of nitrogen, use 

9 in hypoxic challenge testing. 

10 ‘‘(III) In the case of nitrous oxide, 

11 analgesia. 

12 ‘‘(IV) In the case of carbon diox13 ide, use in extracorporeal membrane 

14 oxygenation therapy or respiratory 

15 stimulation. 

16 ‘‘(V) In the case of helium, the 

17 treatment of upper airway obstruction 

18 or increased airway resistance. 

19 ‘‘(VI) In the case of medical air, 

20 to reduce the risk of hyperoxia. 

21 ‘‘(VII) In the case of carbon mon22 oxide, use in lung diffusion testing. 

23 ‘‘(VIII) Any other indication for 

24 use for a designated medical gas or 

25 combination of designated medical 
307 

•S 3187 EAH 

1 gases deemed appropriate by the Sec2 retary, unless any period of exclusivity 

3 under clause (iii) or (iv) of section 

4 505(c)(3)(E), clause (iii) or (iv) of sec5 tion 505(j)(5)(F), or section 527, or the 

6 extension of any such period under sec7 tion 505A, applicable to such indica8 tion for use for such gas or combina9 tion of gases has not expired. 

10 ‘‘(ii) LABELING.—The requirements of 

11 sections 503(b)(4) and 502(f) are deemed to 

12 have been met for a designated medical gas 

13 if the labeling on final use container for 

14 such medical gas bears— 

15 ‘‘(I) the information required by 

16 section 503(b)(4); 

17 ‘‘(II) a warning statement con18 cerning the use of the medical gas as 

19 determined by the Secretary by regula20 tion; and 

21 ‘‘(III) appropriate directions and 

22 warnings concerning storage and han23 dling. 

24 ‘‘(B) INAPPLICABILITY OF EXCLUSIVITY

25 PROVISIONS.— 
308 

•S 3187 EAH 

1 ‘‘(i) NO EXCLUSIVITY FOR A CERTIFIED

2 MEDICAL GAS.—No designated medical gas 

3 deemed under subparagraph (A)(i) to have 

4 in effect an approved application is eligible 

5 for any period of exclusivity under section 

6 505(c), 505(j), or 527, or the extension of 

7 any such period under section 505A, on the 

8 basis of such deemed approval. 

9 ‘‘(ii) EFFECT ON CERTIFICATION.—No 

10 period of exclusivity under section 505(c), 

11 505(j), or section 527, or the extension of 

12 any such period under section 505A, with 

13 respect to an application for a drug product 

14 shall prohibit, limit, or otherwise affect the 

15 submission, grant, or effect of a certification 

16 under this section, except as provided in 

17 subsection (a)(3)(A)(i)(VIII) and section 

18 575(1)(H). 

19 ‘‘(4) WITHDRAWAL, SUSPENSION, OR REVOCA20 TION OF APPROVAL.— 

21 ‘‘(A) WITHDRAWAL, SUSPENSION OF AP22 PROVAL.—Nothing in this subchapter limits the 

23 Secretary’s authority to withdraw or suspend 

24 approval of a drug product, including a des25 ignated medical gas deemed under this section to 
309 

•S 3187 EAH 

1 have in effect an approved application under sec2 tion 505 or section 512 of this Act. 

3 ‘‘(B) REVOCATION OF CERTIFICATION.—The 

4 Secretary may revoke the grant of a certification 

5 under paragraph (2) if the Secretary determines 

6 that the request for certification contains any 

7 material omission or falsification. 

8 ‘‘(b) PRESCRIPTION REQUIREMENT.— 

9 ‘‘(1) IN GENERAL.—A designated medical gas 

10 shall be subject to the requirements of section 

11 503(b)(1) unless the Secretary exercises the authority 

12 provided in section 503(b)(3) to remove such medical 

13 gas from the requirements of section 503(b)(1), the gas 

14 is approved for use without a prescription pursuant 

15 to an application under section 505 or 512, or the use 

16 in question is authorized pursuant to another provi17 sion of this Act relating to use of medical products in 

18 emergencies. 

19 ‘‘(2) OXYGEN.— 

20 ‘‘(A) NO PRESCRIPTION REQUIRED FOR

21 CERTAIN USES.—Notwithstanding paragraph 

22 (1), oxygen may be provided without a prescrip23 tion for the following uses: 
310 

•S 3187 EAH 

1 ‘‘(i) For use in the event of depressuri2 zation or other environmental oxygen defi3 ciency. 

4 ‘‘(ii) For oxygen deficiency or for use 

5 in emergency resuscitation, when adminis6 tered by properly trained personnel. 

7 ‘‘(B) LABELING.—For oxygen provided pur8 suant to subparagraph (A), the requirements of 

9 section 503(b)(4) shall be deemed to have been 

10 met if its labeling bears a warning that the oxy11 gen can be used for emergency use only and for 

12 all other medical applications a prescription is 

13 required. 

14 ‘‘SEC. 577. INAPPLICABILITY OF DRUG FEES TO DES15 IGNATED MEDICAL GASES. 

16 ‘‘A designated medical gas, alone or in combination 

17 with another designated gas or gases (as medically appro18 priate) deemed under section 576 to have in effect an ap19 proved application shall not be assessed fees under section 

20 736(a) on the basis of such deemed approval.’’. 

21 SEC. 1112. CHANGES TO REGULATIONS. 

22 (a) REPORT.—Not later than 18 months after the date 

23 of the enactment of this Act, the Secretary, after obtaining 

24 input from medical gas manufacturers and any other inter25 ested members of the public, shall— 
311 

•S 3187 EAH 

1 (1) determine whether any changes to the Fed2 eral drug regulations are necessary for medical gases; 

3 and 

4 (2) submit to the Committee on Health, Edu5 cation, Labor, and Pensions of the Senate and the 

6 Committee on Energy and Commerce of the House of 

7 Representatives a report regarding any such changes. 

8 (b) REGULATIONS.—If the Secretary determines under 

9 subsection (a) that changes to the Federal drug regulations 

10 are necessary for medical gases, the Secretary shall issue 

11 final regulations revising the Federal drug regulations with 

12 respect to medical gases not later than 48 months after the 

13 date of the enactment of this Act. 

14 (c) DEFINITIONS.—In this section: 

15 (1) The term ‘‘Federal drug regulations’’ means 

16 regulations in title 21 of the Code of Federal Regula17 tions pertaining to drugs. 

18 (2) The term ‘‘medical gas’’ has the meaning 

19 given to such term in section 575 of the Federal Food, 

20 Drug, and Cosmetic Act, as added by section 1111 of 

21 this Act. 

22 (3) The term ‘‘Secretary’’ means the Secretary of 

23 Health and Human Services, acting through the Com24 missioner of Food and Drugs. 
312 

•S 3187 EAH 

1 SEC. 1113. RULES OF CONSTRUCTION. 

2 Nothing in this subtitle and the amendments made by 

3 this subtitle applies with respect to— 

4 (1) a drug that is approved prior to May 1, 

5 2012, pursuant to an application submitted under 

6 section 505 or 512 of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 355, 360b); 

8 (2) any gas listed in subparagraphs (A) through 

9 (G) of section 575(1) of the Federal Food, Drug, and 

10 Cosmetic Act, as added by section 1111 of this Act, 

11 or any combination of any such gases, for an indica12 tion that— 

13 (A) is not included in, or is different from, 

14 those specified in subclauses (I) through (VII) of 

15 section 576(a)(3)(A)(i) of such Act; and 

16 (B) is approved on or after May 1, 2012, 

17 pursuant to an application submitted under sec18 tion 505 or 512; or 

19 (3) any designated medical gas added pursuant 

20 to subparagraph (H) of section 575(1) of such Act for 

21 an indication that— 

22 (A) is not included in, or is different from, 

23 those originally added pursuant to subparagraph 

24 (H) of section 575(1) and section 

25 576(a)(3)(A)(i)(VIII); and 
313 

•S 3187 EAH 

1 (B) is approved on or after May 1, 2012, 

2 pursuant to an application submitted under sec3 tion 505 or 512 of such Act. 

4 Subtitle C—Miscellaneous 

5 Provisions 

6 SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT 

7 PROMOTION USING THE INTERNET. 

8 Not later than 2 years after the date of enactment of 

9 this Act, the Secretary of Health and Human Services shall 

10 issue guidance that describes Food and Drug Administra11 tion policy regarding the promotion, using the Internet (in12 cluding social media), of medical products that are regu13 lated by such Administration. 

14 SEC. 1122. COMBATING PRESCRIPTION DRUG ABUSE. 

15 (a) IN GENERAL.—To combat the significant rise in 

16 prescription drug abuse and the consequences of such abuse, 

17 the Secretary of Health and Human Services (referred to 

18 in this section as the ‘‘Secretary’’), in coordination with 

19 other Federal agencies, as appropriate, shall review current 

20 Federal initiatives and identify gaps and opportunities 

21 with respect to— 

22 (1) ensuring the safe use of prescription drugs 

23 with the potential for abuse; and 

24 (2) the treatment of prescription drug 

25 dependance. 
314 

•S 3187 EAH 

1 (b) REPORT.—Not later than 1 year after the date of 

2 enactment of this Act, the Secretary shall post on the De3 partment of Health and Human Service’s Internet Web site 

4 a report on the findings of the review under subsection (a). 

5 Such report shall include findings and recommendations 

6 on— 

7 (1) how best to leverage and build upon existing 

8 Federal and federally funded data sources, such as 

9 prescription drug monitoring program data and the 

10 sentinel initiative of the Food and Drug Administra11 tion under section 505(k)(3) of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as it 

13 relates to collection of information relevant to adverse 

14 events, patient safety, and patient outcomes, to create 

15 a centralized data clearinghouse and early warning 

16 tool; 

17 (2) how best to develop and disseminate widely 

18 best practices models and suggested standard require19 ments to States for achieving greater interoperability 

20 and effectiveness of prescription drug monitoring pro21 grams, especially with respect to provider participa22 tion, producing standardized data on adverse events, 

23 patient safety, and patient outcomes; and 

24 (3) how best to develop provider, pharmacist, 

25 and patient education tools and a strategy to widely 
315 

•S 3187 EAH 

1 disseminate such tools and assess the efficacy of such 

2 tools. 

3 (c) GUIDANCE ON ABUSE-DETERRENT PRODUCTS.— 

4 Not later than 6 months after the date of enactment of this 

5 Act, the Secretary shall promulgate guidance on the devel6 opment of abuse-deterrent drug products. 

7 SEC. 1123. OPTIMIZING GLOBAL CLINICAL TRIALS. 

8 Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), 

9 as amended by section 903 of this Act, is further amended 

10 by adding at the end the following: 

11 ‘‘SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS. 

12 ‘‘(a) IN GENERAL.—The Secretary shall— 

13 ‘‘(1) work with other regulatory authorities of 

14 similar standing, medical research companies, and 

15 international organizations to foster and encourage 

16 uniform, scientifically driven clinical trial standards 

17 with respect to medical products around the world; 

18 and 

19 ‘‘(2) enhance the commitment to provide con20 sistent parallel scientific advice to manufacturers 

21 seeking simultaneous global development of new med22 ical products in order to— 

23 ‘‘(A) enhance medical product development; 

24 ‘‘(B) facilitate the use of foreign data; and 
316 

•S 3187 EAH 

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 section 

8 351(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 ap16 plication submitted under this chapter, the Secretary shall 

17 accept data from clinical investigations conducted outside 

18 of the United States, including the European Union, if the 

19 applicant demonstrates that such data are adequate under 

20 applicable standards to support approval, licensure, or 

21 clearance of the drug or device in the United States. 

22 ‘‘(b) NOTICE TO SPONSOR.—If the Secretary finds 

23 under subsection (a) that the data from clinical investiga24 tions conducted outside the United States, including in the 

25 European Union, are inadequate for the purpose of making 
317 

•S 3187 EAH 

1 a determination on approval, clearance, or licensure of a 

2 drug or device pursuant to an application submitted under 

3 this chapter, the Secretary shall provide written notice to 

4 the sponsor of the application of such finding and include 

5 the rationale for such finding.’’. 

6 SEC. 1124. ADVANCING REGULATORY SCIENCE TO PRO7 MOTE PUBLIC HEALTH INNOVATION. 

8 (a) IN GENERAL.—Not later than 1 year after the date 

9 of enactment of this Act, the Secretary of Health and 

10 Human Services (referred to in this section as the ‘‘Sec11 retary’’) shall develop a strategy and implementation plan 

12 for advancing regulatory science for medical products in 

13 order to promote the public health and advance innovation 

14 in regulatory decisionmaking. 

15 (b) REQUIREMENTS.—The strategy and implementa16 tion plan developed under subsection (a) shall be consistent 

17 with the user fee performance goals in the Prescription 

18 Drug User Fee Agreement commitment letter, the Generic 

19 Drug User Fee Agreement commitment letter, and the Bio20 similar User Fee Agreement commitment letter transmitted 

21 by the Secretary to Congress on January 13, 2012, and the 

22 Medical Device User Fee Agreement commitment letter 

23 transmitted by the Secretary to Congress on April 20, 2012, 

24 and shall— 
318 

•S 3187 EAH 

1 (1) identify a clear vision of the fundamental 

2 role of efficient, consistent, and predictable, science3 based decisions throughout regulatory decisionmaking 

4 of the Food and Drug Administration with respect to 

5 medical products; 

6 (2) identify the regulatory science priorities of 

7 the Food and Drug Administration directly related to 

8 fulfilling the mission of the agency with respect to de9 cisionmaking concerning medical products and allo10 cation of resources toward such regulatory science pri11 orities; 

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 
319 

•S 3187 EAH 

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 Administra5 tion will ensure that advances in regulatory science 

6 for medical products are adopted, as appropriate, on 

7 an ongoing basis and in an manner integrated across 

8 centers, divisions, and branches of the Food and Drug 

9 Administration, including by senior managers and 

10 reviewers, including through the— 

11 (A) development, updating, and consistent 

12 application of guidance documents that support 

13 medical product decisionmaking; and 

14 (B) adoption of the tools, methods, and 

15 processes under section 566 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 360bbb–5). 

17 (c) PERFORMANCE REPORTS.—The annual perform18 ance reports submitted to Congress under sections 736B(a) 

19 (as amended by section 104 of this Act), 738A(a) (as 

20 amended by section 204 of this Act), 744C(a) (as added by 

21 section 303 of this Act), and 744I(a) (as added by section 

22 403 of this Act) of the Federal Food, Drug, and Cosmetic 

23 Act for each of fiscal years 2014 and 2016, shall include 

24 a report from the Secretary on the progress made with re25 spect to— 
320 

•S 3187 EAH 

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 Drug 

12 User Fee Agreement commitment letter, the Generic 

13 Drug User Fee Agreement commitment letter, and the 

14 Biosimilar User Fee Agreement commitment letter 

15 transmitted by the Secretary to Congress on January 

16 13, 2012, and the Medical Device User Fee Agreement 

17 transmitted by the Secretary to Congress on April 20, 

18 2012. 

19 (d) MEDICAL PRODUCT.—In this section, the term 

20 ‘‘medical product’’ means a drug, as defined in subsection 

21 (g) of section 201 of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 321), a device, as defined in subsection (h) 

23 of such section, or a biological product, as defined in section 

24 351(i) of the Public Health Service Act. 
321 

•S 3187 EAH 

1 SEC. 1125. INFORMATION TECHNOLOGY. 

2 (a) HHS REPORT.—Not later than 1 year after the 

3 date of enactment of this Act, the Secretary of Health and 

4 Human Services shall— 

5 (1) report to Congress on— 

6 (A) the milestones and a completion date 

7 for developing and implementing a comprehen8 sive information technology strategic plan to 

9 align the information technology systems mod10 ernization projects with the strategic goals of the 

11 Food and Drug Administration, including re12 sults-oriented goals, strategies, milestones, per13 formance measures; 

14 (B) efforts to finalize and approve a com15 prehensive inventory of the information tech16 nology systems of the Food and Drug Adminis17 tration that includes information describing each 

18 system, such as costs, system function or pur19 pose, and status information, and incorporate 

20 use of the system portfolio into the information 

21 investment management process of the Food and 

22 Drug Administration; 

23 (C) the ways in which the Food and Drug 

24 Administration uses the plan described in sub25 paragraph (A) to guide and coordinate the mod26 ernization projects and activities of the Food and 
322 

•S 3187 EAH 

1 Drug Administration, including the interdepend2 encies among projects and activities; and 

3 (D) the extent to which the Food and Drug 

4 Administration has fulfilled or is implementing 

5 recommendations of the Government Account6 ability Office with respect to the Food and Drug 

7 Administration and information technology; and 

8 (2) develop— 

9 (A) a documented enterprise architecture 

10 program management plan that includes the 

11 tasks, activities, and timeframes associated with 

12 developing and using the architecture and ad13 dresses how the enterprise architecture program 

14 management will be performed in coordination 

15 with other management disciplines, such as orga16 nizational strategic planning, capital planning 

17 and investment control, and performance man18 agement; and 

19 (B) a skills inventory, needs assessment, 

20 gap analysis, and initiatives to address skills 

21 gaps as part of a strategic approach to informa22 tion technology human capital planning. 

23 (b) GAO REPORT.—Not later than January 1, 2016, 

24 the Comptroller General of the United States shall issue a 

25 report regarding the strategic plan described in subsection 
323 

•S 3187 EAH 

1 (a)(1)(A) and related actions carried out by the Food and 

2 Drug Administration. Such report shall assess the progress 

3 the Food and Drug Administration has made on— 

4 (1) the development and implementation of a 

5 comprehensive information technology strategic plan, 

6 including the results-oriented goals, strategies, mile7 stones, and performance measures identified in sub8 section (a)(1)(A); 

9 (2) the effectiveness of the comprehensive infor10 mation technology strategic plan described in sub11 section (a)(1)(A), including the results-oriented goals 

12 and performance measures; and 

13 (3) the extent to which the Food and Drug Ad14 ministration has fulfilled recommendations of the 

15 Government Accountability Office with respect to such 

16 agency and information technology. 

17 SEC. 1126. NANOTECHNOLOGY. 

18 (a) IN GENERAL.—The Secretary of Health and 

19 Human Services (referred to in this section as the ‘‘Sec20 retary’’) shall intensify and expand activities related to en21 hancing scientific knowledge regarding nanomaterials in22 cluded or intended for inclusion in products regulated 

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

24 301 et seq.) or other statutes administered by the Food and 

25 Drug Administration, to address issues relevant to the regu-
324 

•S 3187 EAH 

1 lation of those products, including the potential toxicology 

2 of such nanomaterials, the potential benefit of new therapies 

3 derived from nanotechnology, the effects of such nanomate4 rials on biological systems, and the interaction of such 

5 nanomaterials with biological systems. 

6 (b) ACTIVITIES.—In conducting activities related to 

7 nanotechnology, the Secretary may— 

8 (1) assess scientific literature and data on gen9 eral nanomaterials interactions with biological sys10 tems and on specific nanomaterials of concern to the 

11 Food and Drug Administration; 

12 (2) in cooperation with other Federal agencies, 

13 develop and organize information using databases 

14 and models that will facilitate the identification of 

15 generalized principles and characteristics regarding 

16 the behavior of classes of nanomaterials with biologi17 cal systems; 

18 (3) promote Food and Drug Administration pro19 grams and participate in collaborative efforts, to fur20 ther the understanding of the science of novel prop21 erties of nanomaterials that might contribute to tox22 icity; 

23 (4) promote and participate in collaborative ef24 forts to further the understanding of measurement 

25 and detection methods for nanomaterials; 
325 

•S 3187 EAH 

1 (5) collect, synthesize, interpret, and disseminate 

2 scientific information and data related to the inter3 actions of nanomaterials with biological systems; 

4 (6) build scientific expertise on nanomaterials 

5 within the Food and Drug Administration, including 

6 field and laboratory expertise, for monitoring the pro7 duction and presence of nanomaterials in domestic 

8 and imported products regulated under this Act; 

9 (7) ensure ongoing training, as well as dissemi10 nation of new information within the centers of the 

11 Food and Drug Administration, and more broadly 

12 across the Food and Drug Administration, to ensure 

13 timely, informed consideration of the most current 

14 science pertaining to nanomaterials; 

15 (8) encourage the Food and Drug Administra16 tion to participate in international and national con17 sensus standards activities pertaining to nanomate18 rials; and 

19 (9) carry out other activities that the Secretary 

20 determines are necessary and consistent with the pur21 poses described in paragraphs (1) through (8). 

22 SEC. 1127. ONLINE PHARMACY REPORT TO CONGRESS. 

23 Not later than 1 year after the date of enactment of 

24 this Act, the Comptroller General of the United States shall 

25 submit to the Committee on Health, Education, Labor, and 
326 

•S 3187 EAH 

1 Pensions of the Senate and the Committee on Energy and 

2 Commerce of the House of Representatives a report that de3 scribes any problems posed by pharmacy Internet Web sites 

4 that violate Federal or State law, including— 

5 (1) the methods by which Internet Web sites are 

6 used to sell prescription drugs in violation of Federal 

7 or State law or established industry standards; 

8 (2) the harmful health effects that patients expe9 rience when they consume prescription drugs pur10 chased through such pharmacy Internet Web sites; 

11 (3) efforts by the Federal Government and State 

12 and local governments to investigate and prosecute 

13 the owners or operators of pharmacy Internet Web 

14 sites, to address the threats such Web sites pose, and 

15 to protect patients; 

16 (4) the level of success that Federal, State, and 

17 local governments have experienced in investigating 

18 and prosecuting such cases; 

19 (5) whether the law, as in effect on the date of 

20 the report, provides sufficient authorities to Federal, 

21 State, and local governments to investigate and pros22 ecute the owners and operators of pharmacy Internet 

23 Web sites that violate Federal or State law or estab24 lished industry standards; 
327 

•S 3187 EAH 

1 (6) additional authorities that could assist Fed2 eral, State, and local governments in investigating 

3 and prosecuting the owners and operators of phar4 macy Internet Web sites that violate Federal or State 

5 law or established industry standards; 

6 (7) laws, policies, and activities that would edu7 cate consumers about how to distinguish pharmacy 

8 Internet Web sites that comply with Federal and 

9 State laws and established industry standards from 

10 those pharmacy Internet Web sites that do not comply 

11 with such laws and standards; and 

12 (8) activities that private sector actors are tak13 ing to address the prevalence of illegitimate pharmacy 

14 Internet Web sites, and any policies to encourage fur15 ther activities. 

16 SEC. 1128. REPORT ON SMALL BUSINESSES. 

17 Not later than 1 year after the date of enactment of 

18 this Act, the Commissioner of Food and Drugs shall submit 

19 a report to Congress that includes— 

20 (1) a listing of and staffing levels of all small 

21 business offices at the Food and Drug Administration, 

22 including the small business liaison program; 

23 (2) the status of partnership efforts between the 

24 Food and Drug Administration and the Small Busi25 ness Administration; 
328 

•S 3187 EAH 

1 (3) a summary of outreach efforts to small busi2 nesses and small business associations, including 

3 availability of toll-free telephone help lines; 

4 (4) with respect to the program under the Or5 phan Drug Act (Public Law 97–414), the number of 

6 applications made by small businesses and number of 

7 applications approved for research grants and the 

8 number of companies receiving protocol assistance for 

9 the development of drugs for rare diseases and dis10 orders; 

11 (5) the number of small businesses submitting 

12 applications and receiving approval for unsolicited 

13 grant applications from the Food and Drug Adminis14 tration; 

15 (6) the number of small businesses submitting 

16 applications and receiving approval for solicited 

17 grant applications from the Food and Drug Adminis18 tration; and 

19 (7) barriers small businesses encounter in the 

20 drug and medical device approval process. 

21 SEC. 1129. PROTECTIONS FOR THE COMMISSIONED CORPS 

22 OF THE PUBLIC HEALTH SERVICE ACT. 

23 (a) IN GENERAL.—Section 221(a) of the Public Health 

24 Service Act (42 U.S.C. 213a(a)) is amended by adding at 

25 the end the following: 
329 

•S 3187 EAH 

1 ‘‘(18) Section 1034, Protected Communications; 

2 Prohibition of Retaliatory Personnel Actions.’’. 

3 (b) CONFORMING AMENDMENT.—Section 221(b) of the 

4 Public Health Service Act (42 U.S.C. 213a(b)) is amended 

5 by adding at the end the following: ‘‘For purposes of para6 graph (18) of subsection (a), the term ‘Inspector General’ 

7 in section 1034 of such title 10 shall mean the Inspector 

8 General of the Department of Health and Human Serv9 ices.’’. 

10 SEC. 1130. COMPLIANCE DATE FOR RULE RELATING TO 

11 SUNSCREEN DRUG PRODUCTS FOR OVER12 THE-COUNTER HUMAN USE. 

13 In accordance with the final rule issued by the Com14 missioner of Food and Drug entitled ‘‘Labeling and Effec15 tiveness Testing; Sunscreen Drug Products for Over-the16 Counter Human Use; Delay of Compliance Dates’’ (77 Fed. 

17 Reg. 27591 (May 11, 2012)), a product subject to the final 

18 rule issued by the Commissioner entitled ‘‘Labeling and Ef19 fectiveness Testing; Sunscreen Drug Products for Over-the20 Counter Human Use’’ (76 Fed. Reg. 35620 (June 17, 

21 2011)), shall comply with such rule not later than— 

22 (1) December 17, 2013, for products subject to 

23 such rule with annual sales of less than $25,000 and 

24 (2) December 17, 2012, for all other products 

25 subject to such rule. 
330 

•S 3187 EAH 

1 SEC. 1131. STRATEGIC INTEGRATED MANAGEMENT PLAN. 

2 Not later than 1 year after the date of enactment of 

3 this Act, the Secretary of Health and Human Services shall 

4 submit to Congress a strategic integrated management plan 

5 for the Center for Drug Evaluation and Research, the Cen6 ter for Biologics Evaluation and Research, and the Center 

7 for Devices and Radiological Health. Such strategic man8 agement plan shall— 

9 (1) identify strategic institutional goals, prior10 ities, and mechanisms to improve efficiency, for the 

11 Center for Drug Evaluation and Research, the Center 

12 for Biologics Evaluation and Research, and the Cen13 ter for Devices and Radiological Health; 

14 (2) describe the actions the Secretary will take to 

15 recruit, retain, train, and continue to develop the 

16 workforce at the Center for Drug Evaluation and Re17 search, the Center for Biologics Evaluation and Re18 search, and the Center for Devices and Radiological 

19 Health to fulfill the public health mission of the Food 

20 and Drug Administration; and 

21 (3) identify results-oriented, outcome-based meas22 ures that the Secretary will use to measure the 

23 progress of achieving the strategic goals, priorities, 

24 and mechanisms identified under paragraph (1) and 

25 the effectiveness of the actions identified under para26 graph (2), including metrics to ensure that managers 
331 

•S 3187 EAH 

1 and reviewers of the Center for Drug Evaluation and 

2 Research, the Center for Biologics Evaluation and Re3 search, and the Center for Devices and Radiological 

4 Health are familiar with and appropriately and con5 sistently apply the requirements under the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 

7 including new requirements under parts 2, 3, 7, and 

8 8 of subchapter C of title VII of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 379f et seq.). 

10 SEC. 1132. ASSESSMENT AND MODIFICATION OF REMS. 

11 (a) ASSESSMENT AND MODIFICATION OF APPROVED

12 STRATEGY.—Section 505–1(g) (21 U.S.C. 355–1(g)) is 

13 amended— 

14 (1) in paragraph (1), by striking ‘‘, and propose 

15 a modification to,’’; 

16 (2) in paragraph (2)— 

17 (A) in the matter before subparagraph 

18 (A)— 

19 (i) by striking ‘‘, subject to paragraph 

20 (5),’’; and 

21 (ii) by striking ‘‘, and may propose a 

22 modification to,’’; 

23 (B) in subparagraph (C), by striking ‘‘new 

24 safety or effectiveness information indicates 

25 that’’ and all that follows and inserting the fol-
332 

•S 3187 EAH 

1 lowing: ‘‘an assessment is needed to evaluate 

2 whether the approved strategy should be modified 

3 to— 

4 ‘‘(i) ensure the benefits of the drug out5 weigh the risks of the drug; or 

6 ‘‘(ii) minimize the burden on the 

7 health care delivery system of complying 

8 with the strategy.’’; and 

9 (C) by striking subparagraph (D); 

10 (3) in paragraph (3), by striking ‘‘for a drug 

11 shall include—’’ and all that follows and inserting 

12 the following ‘‘for a drug shall include, with respect 

13 to each goal included in the strategy, an assessment 

14 of the extent to which the approved strategy, includ15 ing each element of the strategy, is meeting the goal 

16 or whether 1 or more such goals or such elements 

17 should be modified.’’; and 

18 (4) by amending paragraph (4) to read as fol19 lows: 

20 ‘‘(4) MODIFICATION.— 

21 ‘‘(A) ON INITIATIVE OF RESPONSIBLE PER22 SON.—After the approval of a risk evaluation 

23 and mitigation strategy by the Secretary, the re24 sponsible person may, at any time, submit to the 

25 Secretary a proposal to modify the approved 
333 

•S 3187 EAH 

1 strategy. Such proposal may propose the addi2 tion, modification, or removal of any goal or ele3 ment of the approved strategy and shall include 

4 an adequate rationale to support such proposed 

5 addition, modification, or removal of any goal or 

6 element of the strategy. 

7 ‘‘(B) ON INITIATIVE OF SECRETARY.—After 

8 the approval of a risk evaluation and mitigation 

9 strategy by the Secretary, the Secretary may, at 

10 any time, require a responsible person to submit 

11 a proposed modification to the strategy within 

12 120 days or within such reasonable time as the 

13 Secretary specifies, if the Secretary, in consulta14 tion with the offices described in subsection 

15 (c)(2), determines that 1 or more goals or ele16 ments should be added, modified, or removed 

17 from the approved strategy to— 

18 ‘‘(i) ensure the benefits of the drug out19 weigh the risks of the drug; or 

20 ‘‘(ii) minimize the burden on the 

21 health care delivery system of complying 

22 with the strategy.’’. 

23 (b) REVIEW OF PROPOSED STRATEGIES; REVIEW OF

24 ASSESSMENTS AND MODIFICATIONS OF APPROVED STRATE-
334 

•S 3187 EAH 

1 GIES.—Section 505–1(h) (21 U.S.C. 355–1(h)) is amend2 ed— 

3 (1) in the subsection heading by inserting ‘‘AND

4 MODIFICATIONS’’ after ‘‘REVIEW OF ASSESSMENTS’’; 

5 (2) in paragraph (1)— 

6 (A) by inserting ‘‘and proposed modifica7 tion to’’ after ‘‘under subsection (a) and each as8 sessment of’’; and 

9 (B) by inserting ‘‘, and, if necessary, 

10 promptly initiate discussions with the respon11 sible person about such proposed strategy, assess12 ment, or modification’’ after ‘‘subsection (g)’’; 

13 (3) by striking paragraph (2); 

14 (4) by redesignating paragraphs (3) through (9) 

15 as paragraphs (2) through (8), respectively; 

16 (5) in paragraph (2), as redesignated by para17 graph (4)— 

18 (A) by amending subparagraph (A) to read 

19 as follows: 

20 ‘‘(A) IN GENERAL.— 

21 ‘‘(i) TIMEFRAME.—Unless the dispute 

22 resolution process described under para23 graph (3) or (4) applies, and, except as pro24 vided in clause (ii) or clause (iii) below, the 

25 Secretary, in consultation with the offices 
335 

•S 3187 EAH 

1 described in subsection (c)(2), shall review 

2 and act on the proposed risk evaluation and 

3 mitigation strategy for a drug or any pro4 posed modification to any required strategy 

5 within 180 days of receipt of the proposed 

6 strategy or modification. 

7 ‘‘(ii) MINOR MODIFICATIONS.—The 

8 Secretary shall review and act on a pro9 posed minor modification, as defined by the 

10 Secretary in guidance, within 60 days of 

11 receipt of such modification. 

12 ‘‘(iii) REMS MODIFICATION DUE TO

13 SAFETY LABEL CHANGES.—Not later than 

14 60 days after the Secretary receives a pro15 posed modification to an approved risk 

16 evaluation and mitigation strategy to con17 form the strategy to approved safety label 

18 changes, including safety labeling changes 

19 initiated by the sponsor in accordance with 

20 FDA regulatory requirements, or to a safety 

21 label change that the Secretary has directed 

22 the holder of the application to make pursu23 ant to section 505(o)(4), the Secretary shall 

24 review and act on such proposed modifica25 tion to the approved strategy. 
336 

•S 3187 EAH 

1 ‘‘(iv) GUIDANCE.—The Secretary shall 

2 establish, through guidance, that responsible 

3 persons may implement certain modifica4 tions to an approved risk evaluation and 

5 mitigation strategy following notification to 

6 the Secretary.’’; and 

7 (B) by amending subparagraph (C) to read 

8 as follows: 

9 ‘‘(C) PUBLIC AVAILABILITY.—Upon acting 

10 on a proposed risk evaluation and mitigation 

11 strategy or proposed modification to a risk eval12 uation and mitigation strategy under subpara13 graph (A), the Secretary shall make publicly 

14 available an action letter describing the actions 

15 taken by the Secretary under such subparagraph 

16 (A).’’; 

17 (6) in paragraph (4), as redesignated by para18 graph (4)— 

19 (A) in subparagraph (A)(i)— 

20 (i) by striking ‘‘Not earlier than 15 

21 days, and not later than 35 days, after dis22 cussions under paragraph (2) have begun, 

23 the’’ and inserting ‘‘The’’; and 

24 (ii) by inserting ‘‘, after the sponsor is 

25 required to make a submission under sub-
337 

•S 3187 EAH 

1 section (a)(2) or (g),’’ before ‘‘request in 

2 writing’’; and 

3 (B) in subparagraph (I)— 

4 (i) by striking clauses (i) and (ii); and 

5 (ii) by striking ‘‘if the Secretary—’’ 

6 and inserting ‘‘if the Secretary has com7 plied with the timing requirements of sched8 uling review by the Drug Safety Oversight 

9 Board, providing a written recommenda10 tion, and issuing an action letter under 

11 subparagraphs (B), (F), and (G), respec12 tively.’’; 

13 (7) in paragraph (5), as redesignated by para14 graph (4)— 

15 (A) in subparagraph (A), by striking ‘‘any 

16 of subparagraphs (B) through (D)’’ and insert17 ing ‘‘subparagraph (B) or (C)’’; and 

18 (B) in subparagraph (C), by striking 

19 ‘‘paragraph (4) or (5)’’ and inserting ‘‘para20 graph (3) or (4)’’; and 

21 (8) in paragraph (8), as redesignated by para22 graph (4), by striking ‘‘paragraphs (7) and (8)’’ and 

23 inserting ‘‘paragraphs (6) and (7).’’. 

24 (c) GUIDANCE.—Not later than 1 year after the date 

25 of enactment of this Act, the Secretary of Health and 
338 

•S 3187 EAH 

1 Human Services shall issue guidance that, for purposes of 

2 section 505–1(h)(2)(A) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 355–1(h)(2)(A)), describes the types 

4 of modifications to approved risk evaluation and mitigation 

5 strategies that shall be considered to be minor modifications 

6 of such strategies. 

7 SEC. 1133. EXTENSION OF PERIOD FOR FIRST APPLICANT 

8 TO OBTAIN TENTATIVE APPROVAL WITHOUT 

9 FORFEITING 180-DAY-EXCLUSIVITY PERIOD. 

10 (a) EXTENSION.— 

11 (1) IN GENERAL.—If a first applicant files an 

12 application during the 30-month period ending on the 

13 date of enactment of this Act and such application 

14 initially contains a certification described in para15 graph (2)(A)(vii)(IV) of section 505(j) of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), or 

17 if a first applicant files an application and the appli18 cation is amended during such period to first contain 

19 such a certification, the phrase ‘‘30 months’’ in para20 graph (5)(D)(i)(IV) of such section shall, with respect 

21 to such application, be read as meaning— 

22 (A) during the period beginning on the date 

23 of enactment of this Act, and ending on Sep24 tember 30, 2015, ‘‘40 months’’; and 
339 

•S 3187 EAH 

1 (B) during the period beginning on October 

2 1, 2015, and ending on September 30, 2016, ‘‘36 

3 months’’. 

4 (2) CONFORMING AMENDMENT.—In the case of 

5 an application to which an extended period under 

6 paragraph (1) applies, the reference to the 30-month 

7 period under section 505(q)(1)(G) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 

9 355(q)(1)(G)) shall be read to be the applicable period 

10 under paragraph (1). 

11 (b) PERIOD FOR OBTAINING TENTATIVE APPROVAL OF

12 CERTAIN APPLICATIONS.—If an application is filed on or 

13 before the date of enactment of this Act and such applica14 tion is amended during the period beginning on the day 

15 after the date of enactment of this Act and ending on Sep16 tember 30, 2017, to first contain a certification described 

17 in paragraph (2)(A)(vii)(IV) of section 505(j) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), the date 

19 of the filing of such amendment (rather than the date of 

20 the filing of such application) shall be treated as the begin21 ning of the 30-month period described in paragraph 

22 (5)(D)(i)(IV) of such section 505(j). 

23 (c) DEFINITIONS.—For the purposes of this section, the 

24 terms ‘‘application’’ and ‘‘first applicant’’ mean applica25 tion and first applicant, as such terms are used in section 
340 

•S 3187 EAH 

1 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cos2 metic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)). 

3 SEC. 1134. DEADLINE FOR DETERMINATION ON CERTAIN 

4 PETITIONS. 

5 (a) IN GENERAL.—Section 505 (21 U.S.C. 355) is 

6 amended by adding at the end the following: 

7 ‘‘(w) DEADLINE FOR DETERMINATION ON CERTAIN

8 PETITIONS.—The Secretary shall issue a final, substantive 

9 determination on a petition submitted pursuant to sub10 section (b) of section 314.161 of title 21, Code of Federal 

11 Regulations (or any successor regulations), no later than 

12 270 days after the date the petition is submitted.’’. 

13 (b) APPLICATION.—The amendment made by sub14 section (a) shall apply to any petition that is submitted 

15 pursuant to subsection (b) of section 314.161 of title 21, 

16 Code of Federal Regulations (or any successor regulations), 

17 on or after the date of enactment of this Act. 

18 SEC. 1135. FINAL AGENCY ACTION RELATING TO PETITIONS 

19 AND CIVIL ACTIONS. 

20 Section 505(q) (21 U.S.C. 355(q)) is amended— 

21 (1) in paragraph (1)— 

22 (A) in subparagraph (A), by striking ‘‘sub23 section (b)(2) or (j)’’ and inserting ‘‘subsection 

24 (b)(2) or (j) of this section or section 351(k) of 

25 the Public Health Service Act’’; and 
341 

•S 3187 EAH 

1 (B) in subparagraph (F), by striking ‘‘180 

2 days’’ and inserting ‘‘150 days’’; 

3 (2) in paragraph (2)(A)— 

4 (A) in the subparagraph heading, by strik5 ing ‘‘180’’ and inserting ‘‘150’’; and 

6 (B) in clause (i), by striking ‘‘180-day’’ and 

7 inserting ‘‘150-day’’; 

8 (3) in paragraph (4)— 

9 (A) by redesignating subparagraphs (A) 

10 and (B) as clauses (i) and (ii), respectively, and 

11 moving such clauses, as so redesignated, 2 ems to 

12 the right; 

13 (B) by striking ‘‘This subsection does not 

14 apply to—’’ and inserting the following: 

15 ‘‘(A) This subsection does not apply to—’’; 

16 and 

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

18 ‘‘(B) Paragraph (2) does not apply to a pe19 tition addressing issues concerning an applica20 tion submitted pursuant to section 351(k) of the 

21 Public Health Service Act.’’; and 

22 (4) in paragraph (5), by striking ‘‘subsection 

23 (b)(2) or (j)’’ inserting ‘‘subsection (b)(2) or (j) of the 

24 Act or 351(k) of the Public Health Service Act’’. 
342 

•S 3187 EAH 

1 SEC. 1136. ELECTRONIC SUBMISSION OF APPLICATIONS. 

2 Subchapter D of chapter VII (21 U.S.C. 379k et seq.) 

3 is amended by inserting after section 745 the following: 

4 ‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 

5 ‘‘(a) DRUGS AND BIOLOGICS.— 

6 ‘‘(1) IN GENERAL.—Beginning no earlier than 

7 24 months after the issuance of a final guidance 

8 issued after public notice and opportunity for com9 ment, submissions under subsection (b), (i), or (j) of 

10 section 505 of this Act or subsection (a) or (k) of sec11 tion 351 of the Public Health Service Act shall be 

12 submitted in such electronic format as specified by the 

13 Secretary in such guidance. 

14 ‘‘(2) GUIDANCE CONTENTS.—In the guidance 

15 under paragraph (1), the Secretary may— 

16 ‘‘(A) provide a timetable for establishment 

17 by the Secretary of further standards for elec18 tronic submission as required by such para19 graph; and 

20 ‘‘(B) set forth criteria for waivers of and ex21 emptions from the requirements of this sub22 section. 

23 ‘‘(3) EXCEPTION.—This subsection shall not 

24 apply to submissions described in section 561. 

25 ‘‘(b) DEVICES.— 
343 

•S 3187 EAH 

1 ‘‘(1) IN GENERAL.—Beginning after the issuance 

2 of final guidance implementing this paragraph, 

3 presubmissions and submissions for devices under sec4 tion 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 

5 520(g), 520(m), or 564 of this Act or section 351 of 

6 the Public Health Service Act, and any supplements 

7 to such presubmissions or submissions, shall include 

8 an electronic copy of such presubmissions or submis9 sions. 

10 ‘‘(2) GUIDANCE CONTENTS.—In the guidance 

11 under paragraph (1), the Secretary may— 

12 ‘‘(A) provide standards for the electronic 

13 copy required under such paragraph; and 

14 ‘‘(B) set forth criteria for waivers of and ex15 emptions from the requirements of this sub16 section.’’. 

17 SEC. 1137. PATIENT PARTICIPATION IN MEDICAL PRODUCT 

18 DISCUSSIONS. 

19 Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), 

20 as amended by section 1123 of this Act, is further amended 

21 by adding at the end the following: 

22 ‘‘SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PROD23 UCT DISCUSSION. 

24 ‘‘(a) IN GENERAL.—The Secretary shall develop and 

25 implement strategies to solicit the views of patients during 
344 

•S 3187 EAH 

1 the medical product development process and consider the 

2 perspectives of patients during regulatory discussions, in3 cluding by— 

4 ‘‘(1) fostering participation of a patient rep5 resentative who may serve as a special government 

6 employee in appropriate agency meetings with med7 ical product sponsors and investigators; and 

8 ‘‘(2) exploring means to provide for identifica9 tion of patient representatives who do not have any, 

10 or have minimal, financial interests in the medical 

11 products industry. 

12 ‘‘(b) PROTECTION OF PROPRIETARY INFORMATION.— 

13 Nothing in this section shall be construed to alter the protec14 tions offered by laws, regulations, or policies governing dis15 closure of confidential commercial or trade secret informa16 tion and any other information exempt from disclosure pur17 suant to section 552(b) of title 5, United States Code, as 

18 such laws, regulations, or policies would apply to consulta19 tion with individuals and organizations prior to the date 

20 of enactment of this section. 

21 ‘‘(c) OTHER CONSULTATION.—Nothing in this section 

22 shall be construed to limit the ability of the Secretary to 

23 consult with individuals and organizations as authorized 

24 prior to the date of enactment of this section. 
345 

•S 3187 EAH 

1 ‘‘(d) NO RIGHT OR OBLIGATION.—Nothing in this sec2 tion shall be construed to create a legal right for a consulta3 tion on any matter or require the Secretary to meet with 

4 any particular expert or stakeholder. Nothing in this section 

5 shall be construed to alter agreed upon goals and procedures 

6 identified in the letters described in section 101(b) of the 

7 Prescription Drug User Fee Amendments of 2012. Nothing 

8 in this section is intended to increase the number of review 

9 cycles as in effect before the date of enactment of this section. 

10 ‘‘(e) FINANCIAL INTEREST.—In this section, the term 

11 ‘financial interest’ means a financial interest under section 

12 208(a) of title 18, United States Code.’’. 

13 SEC. 1138. ENSURING ADEQUATE INFORMATION REGARD14 ING PHARMACEUTICALS FOR ALL POPU15 LATIONS, PARTICULARLY UNDERREP16 RESENTED SUBPOPULATIONS, INCLUDING 

17 RACIAL SUBGROUPS. 

18 (a) COMMUNICATION PLAN.—The Secretary of Health 

19 and Human Services (referred to in this section as the ‘‘Sec20 retary’’), acting through the Commissioner of Food and 

21 Drugs, shall review and modify, as necessary, the Food and 

22 Drug Administration’s communication plan to inform and 

23 educate health care providers and patients on the benefits 

24 and risks of medical products, with particular focus on 
346 

•S 3187 EAH 

1 underrepresented subpopulations, including racial sub2 groups. 

3 (b) CONTENT.—The communication plan described 

4 under subsection (a)— 

5 (1) shall take into account— 

6 (A) the goals and principles set forth in the 

7 Strategic Action Plan to Reduce Racial and 

8 Ethnic Health Disparities issued by the Depart9 ment of Health and Human Services; 

10 (B) the nature of the medical product; and 

11 (C) health and disease information avail12 able from other agencies within such Depart13 ment, as well as any new means of commu14 nicating health and safety benefits and risks re15 lated to medical products; 

16 (2) taking into account the nature of the medical 

17 product, shall address the best strategy for commu18 nicating safety alerts, labeled indications for the med19 ical products, changes to the label or labeling of med20 ical products (including black-box warnings, health 

21 advisories, health and safety benefits and risks), par22 ticular actions to be taken by health care professionals 

23 and patients, any information identifying particular 

24 subpopulations, and any other relevant information 

25 as determined appropriate to enhance communica-
347 

•S 3187 EAH 

1 tion, including varied means of electronic commu2 nication; and 

3 (3) shall include a process for implementation of 

4 any improvements or other modifications determined 

5 to be necessary. 

6 (c) ISSUANCE AND POSTING OF COMMUNICATION

7 PLAN.— 

8 (1) COMMUNICATION PLAN.—Not later than 1 

9 year after the date of enactment of this Act, the Sec10 retary, acting through the Commissioner of Food and 

11 Drugs, shall issue the communication plan described 

12 under this section. 

13 (2) POSTING OF COMMUNICATION PLAN ON THE

14 OFFICE OF MINORITY HEALTH WEB SITE.—The Sec15 retary, acting through the Commissioner of Food and 

16 Drugs, shall publicly post the communication plan on 

17 the Internet Web site of the Office of Minority Health 

18 of the Food and Drug Administration, and provide 

19 links to any other appropriate Internet Web site, and 

20 seek public comment on the communication plan. 

21 SEC. 1139. SCHEDULING OF HYDROCODONE. 

22 (a) IN GENERAL.—Not later than 60 days after the 

23 date of enactment of this Act, if practicable, the Secretary 

24 of Health and Human Services (referred to in this section 

25 as the ‘‘Secretary’’) shall hold a public meeting to solicit 
348 

•S 3187 EAH 

1 advice and recommendations to assist in conducting a sci2 entific and medical evaluation in connection with a sched3 uling recommendation to the Drug Enforcement Adminis4 tration regarding drug products containing hydrocodone, 

5 combined with other analgesics or as an antitussive. 

6 (b) STAKEHOLDER INPUT.—In conducting the evalua7 tion under subsection (a), the Secretary shall solicit input 

8 from a variety of stakeholders including patients, health 

9 care providers, harm prevention experts, the National Insti10 tute on Drug Abuse, the Centers for Disease Control and 

11 Prevention, and the Drug Enforcement Administration re12 garding the health benefits and risks, including the poten13 tial for abuse and the impact of up-scheduling of these prod14 ucts. 

15 (c) TRANSCRIPT.—The transcript of any public meet16 ing conducted pursuant to this section shall be published 

17 on the Internet Web site of the Food and Drug Administra18 tion. 

19 SEC. 1140. STUDY ON DRUG LABELING BY ELECTRONIC 

20 MEANS. 

21 (a) STUDY.—The Comptroller General of the United 

22 States shall conduct a study on the benefits and efficiencies 

23 of electronic patient labeling of prescription drugs, as a 

24 complete or partial substitute for patient labeling in paper 

25 form. The study shall address the implementation costs to 
349 

•S 3187 EAH 

1 the different levels of the distribution system, logistical bar2 riers to utilizing a system of electronic patient labeling, and 

3 any anticipated public health impact of movement to elec4 tronic labeling. 

5 (b) REPORT.—Not later than 1 year after the date of 

6 enactment of this Act, the Comptroller General shall submit 

7 to Congress a report on the results of the study under sub8 section (a). 

9 SEC. 1141. RECOMMENDATIONS ON INTEROPERABILITY 

10 STANDARDS. 

11 (a) IN GENERAL.—The Secretary of Health and 

12 Human Services may facilitate, and, as appropriate, may 

13 consult with the Attorney General to facilitate, the develop14 ment of recommendations on interoperability standards to 

15 inform and facilitate the exchange of prescription drug in16 formation across State lines by States receiving grant funds 

17 under— 

18 (1) the Harold Rogers Prescription Drug Moni19 toring Program established under the Departments of 

20 Commerce, Justice, and State, the Judiciary, and Re21 lated Agencies Appropriations Act, 2002 (Public Law 

22 107–77; 115 Stat. 748); and 

23 (2) the Controlled Substance Monitoring Pro24 gram established under section 399O of the Public 

25 Health Service Act (42 U.S.C. 280g–3). 
350 

•S 3187 EAH 

1 (b) REQUIREMENTS.—The Secretary of Health and 

2 Human Services shall consider the following in facilitating 

3 the development of recommendations on interoperability of 

4 prescription drug monitoring programs under subsection 

5 (a)— 

6 (1) open standards that are freely available, 

7 without cost and without restriction, in order to pro8 mote broad implementation; 

9 (2) the use of exchange intermediaries, or hubs, 

10 as necessary to facilitate interstate interoperability by 

11 accommodating State-to-hub, hub-to-hub, and direct 

12 State-to-State communication; 

13 (3) the support of transmissions that are fully 

14 secured as required, using industry standard methods 

15 of encryption, to ensure that protected health infor16 mation and personally identifiable information are 

17 not compromised at any point during such trans18 mission; 

19 (4) access control methodologies to share pro20 tected information solely in accordance with State 

21 laws and regulations; and 

22 (5) consider model interoperability standards de23 veloped by the Alliance of States with Prescription 

24 Monitoring Programs. 

25 (c) REPORT.— 
351 

•S 3187 EAH 

1 (1) IN GENERAL.—Not later than 1 year after 

2 the date of enactment of this Act, the Secretary of 

3 Health and Human Services shall submit to the Com4 mittee on Health, Education, Labor, and Pensions of 

5 the Senate and the Committee on Energy and Com6 merce of the House of Representatives a report on en7 hancing the interoperability of State prescription 

8 drug monitoring programs with other technologies 

9 and databases used for detecting and reducing fraud, 

10 diversion, and abuse of prescription drugs. 

11 (2) CONTENTS.—The report required under 

12 paragraph (1) shall include— 

13 (A) an assessment of legal, technical, fiscal, 

14 privacy, or security challenges that have an im15 pact on interoperability; 

16 (B) a discussion of how State prescription 

17 drug monitoring programs could increase the 

18 production and distribution of unsolicited re19 ports to prescribers and dispensers of prescrip20 tion drugs, law enforcement officials, and health 

21 professional licensing agencies, including the en22 hancement of such reporting through interoper23 ability with other States and relevant technology 

24 and databases; 
352 

•S 3187 EAH 

1 (C) any recommendations for addressing 

2 challenges that impact interoperability of State 

3 prescription drug monitoring programs in order 

4 to reduce fraud, diversion, and abuse of prescrip5 tion drugs; and 

6 (D) an assessment of the extent to which 

7 providers use prescription drug management 

8 programs in delivering care and preventing pre9 scription drug abuse. 

10 SEC. 1142. CONFLICTS OF INTEREST. 

11 (a) IN GENERAL.—Section 712 (21 U.S.C. 379d–1) is 

12 amended— 

13 (1) by striking subsections (b) and (c) and in14 serting the following subsections: 

15 ‘‘(b) RECRUITMENT FOR ADVISORY COMMITTEES.— 

16 ‘‘(1) IN GENERAL.—The Secretary shall— 

17 ‘‘(A) develop and implement strategies on 

18 effective outreach to potential members of advi19 sory committees at universities, colleges, other 

20 academic research centers, professional and med21 ical societies, and patient and consumer groups; 

22 ‘‘(B) seek input from professional medical 

23 and scientific societies to determine the most ef24 fective informational and recruitment activities; 
353 

•S 3187 EAH 

1 ‘‘(C) at least every 180 days, request refer2 rals for potential members of advisory commit3 tees from a variety of stakeholders, including— 

4 ‘‘(i) product developers, patient groups, 

5 and disease advocacy organizations; and 

6 ‘‘(ii) relevant— 

7 ‘‘(I) professional societies; 

8 ‘‘(II) medical societies; 

9 ‘‘(III) academic organizations; 

10 and 

11 ‘‘(IV) governmental organizations; 

12 and 

13 ‘‘(D) in carrying out subparagraphs (A) 

14 and (B), take into account the levels of activity 

15 (including the numbers of annual meetings) and 

16 the numbers of vacancies of the advisory commit17 tees. 

18 ‘‘(2) RECRUITMENT ACTIVITIES.—The recruit19 ment activities under paragraph (1) may include— 

20 ‘‘(A) advertising the process for becoming 

21 an advisory committee member at medical and 

22 scientific society conferences; 

23 ‘‘(B) making widely available, including by 

24 using existing electronic communications chan25 nels, the contact information for the Food and 
354 

•S 3187 EAH 

1 Drug Administration point of contact regarding 

2 advisory committee nominations; and 

3 ‘‘(C) developing a method through which an 

4 entity receiving funding from the National Insti5 tutes of Health, the Agency for Healthcare Re6 search and Quality, the Centers for Disease Con7 trol and Prevention, or the Veterans Health Ad8 ministration can identify a person whom the 

9 Food and Drug Administration can contact re10 garding the nomination of individuals to serve 

11 on advisory committees. 

12 ‘‘(3) EXPERTISE.—In carrying out this sub13 section, the Secretary shall seek to ensure that the 

14 Secretary has access to the most current expert advice. 

15 ‘‘(c) DISCLOSURE OF DETERMINATIONS AND CERTIFI16 CATIONS.—Notwithstanding section 107(a)(2) of the Ethics 

17 in Government Act of 1978, the following shall apply: 

18 ‘‘(1) 15 OR MORE DAYS IN ADVANCE.—As soon as 

19 practicable, but (except as provided in paragraph (2)) 

20 not later than 15 days prior to a meeting of an advi21 sory committee to which a written determination as 

22 referred to in section 208(b)(1) of title 18, United 

23 States Code, or a written certification as referred to 

24 in section 208(b)(3) of such title, applies, the Sec25 retary shall disclose (other than information exempted 
355 

•S 3187 EAH 

1 from disclosure under section 552 or section 552a of 

2 title 5, United States Code (popularly known as the 

3 Freedom of Information Act and the Privacy Act of 

4 1974, respectively)) on the Internet Web site of the 

5 Food and Drug Administration— 

6 ‘‘(A) the type, nature, and magnitude of the 

7 financial interests of the advisory committee 

8 member to which such determination or certifi9 cation applies; and 

10 ‘‘(B) the reasons of the Secretary for such 

11 determination or certification, including, as ap12 propriate, the public health interest in having 

13 the expertise of the member with respect to the 

14 particular matter before the advisory committee. 

15 ‘‘(2) LESS THAN 30 DAYS IN ADVANCE.—In the 

16 case of a financial interest that becomes known to the 

17 Secretary less than 30 days prior to a meeting of an 

18 advisory committee to which a written determination 

19 as referred to in section 208(b)(1) of title 18, United 

20 States Code, or a written certification as referred to 

21 in section 208(b)(3) of such title applies, the Sec22 retary shall disclose (other than information exempted 

23 from disclosure under section 552 or 552a of title 5, 

24 United States Code) on the Internet Web site of the 

25 Food and Drug Administration, the information de-
356 

•S 3187 EAH 

1 scribed in subparagraphs (A) and (B) of paragraph 

2 (1) as soon as practicable after the Secretary makes 

3 such determination or certification, but in no case 

4 later than the date of such meeting.’’; 

5 (2) in subsection (d), by striking ‘‘subsection 

6 (c)(3)’’ and inserting ‘‘subsection (c)’’; 

7 (3) by amending subsection (e) to read as fol8 lows: 

9 ‘‘(e) ANNUAL REPORT.— 

10 ‘‘(1) IN GENERAL.—Not later than February 1 of 

11 each year, the Secretary shall submit to the Com12 mittee on Appropriations and the Committee on 

13 Health, Education, Labor, and Pensions of the Sen14 ate, and the Committee on Appropriations and the 

15 Committee on Energy and Commerce of the House of 

16 Representatives, a report that describes— 

17 ‘‘(A) with respect to the fiscal year that 

18 ended on September 30 of the previous year, the 

19 number of persons nominated for participation 

20 at meetings for each advisory committee, the 

21 number of persons so nominated, and willing to 

22 serve, the number of vacancies on each advisory 

23 committee, and the number of persons contacted 

24 for service as members on each advisory com25 mittee meeting for each advisory committee who 
357 

•S 3187 EAH 

1 did not participate because of the potential for 

2 such participation to constitute a disqualifying 

3 financial interest under section 208 of title 18, 

4 United States Code; 

5 ‘‘(B) with respect to such year, the number 

6 of persons contacted for services as members for 

7 each advisory committee meeting for each advi8 sory committee who did not participate because 

9 of reasons other than the potential for such par10 ticipation to constitute a disqualifying financial 

11 interest under section 208 of title 18, United 

12 States Code; 

13 ‘‘(C) with respect to such year, the number 

14 of members attending meetings for each advisory 

15 committee; and 

16 ‘‘(D) with respect to such year, the aggre17 gate number of disclosures required under sub18 section (d) and the percentage of individuals to 

19 whom such disclosures did not apply who served 

20 on such committee. 

21 ‘‘(2) PUBLIC AVAILABILITY.—Not later than 30 

22 days after submitting any report under paragraph 

23 (1) to the committees specified in such paragraph, the 

24 Secretary shall make each such report available to the 

25 public.’’; 
358 

•S 3187 EAH 

1 (4) in subsection (f), by striking ‘‘shall review 

2 guidance’’ and all that follows through the end of the 

3 subsection and inserting the following: ‘‘shall— 

4 ‘‘(1) review guidance of the Food and Drug Ad5 ministration with respect to advisory committees re6 garding disclosure of conflicts of interest and the ap7 plication of section 208 of title 18, United States 

8 Code; and 

9 ‘‘(2) update such guidance as necessary to ensure 

10 that the Food and Drug Administration receives ap11 propriate access to needed scientific expertise, with 

12 due consideration of the requirements of such section 

13 208.’’; and 

14 (5) by adding at the end the following: 

15 ‘‘(g) GUIDANCE ON REPORTED DISCLOSED FINANCIAL

16 INTEREST OR INVOLVEMENT.—The Secretary shall issue 

17 guidance that describes how the Secretary reviews the finan18 cial interests and involvement of advisory committee mem19 bers that are disclosed under subsection (c) but that the Sec20 retary determines not to meet the definition of a disquali21 fying interest under section 208 of title 18, United States 

22 Code for the purposes of participating in a particular mat23 ter.’’. 

24 (b) APPLICABILITY.—The amendments made by sub25 section (a) apply beginning on October 1, 2012. 
359 

•S 3187 EAH 

1 SEC. 1143. NOTIFICATION OF FDA INTENT TO REGULATE 

2 LABORATORY-DEVELOPED TESTS. 

3 (a) IN GENERAL.—The Food and Drug Administra4 tion may not issue any draft or final guidance on the regu5 lation of laboratory-developed tests under the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) without, 

7 at least 60 days prior to such issuance— 

8 (1) notifying the Committee on Energy and 

9 Commerce of the House of Representatives and the 

10 Committee on Health, Education, Labor, and Pen11 sions of the Senate of the Administration’s intent to 

12 take such action; and 

13 (2) including in such notification the antici14 pated details of such action. 

15 (b) SUNSET.—Subsection (a) shall cease to have force 

16 or effect on the date that is 5 years after the date of enact17 ment of this Act. 

18 Subtitle D—Synthetic Drugs 

19 SEC. 1151. SHORT TITLE. 

20 This subtitle may be cited as the ‘‘Synthetic Drug 

21 Abuse Prevention Act of 2012’’. 

22 SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE 

23 I OF THE CONTROLLED SUBSTANCES ACT. 

24 (a) CANNABIMIMETIC AGENTS.—Schedule I, as set 

25 forth in section 202(c) of the Controlled Substances Act (21 
360 

•S 3187 EAH 

1 U.S.C. 812(c)) is amended by adding at the end the fol2 lowing: 

3 ‘‘(d)(1) Unless specifically exempted or unless listed in 

4 another schedule, any material, compound, mixture, or 

5 preparation which contains any quantity of 

6 cannabimimetic agents, or which contains their salts, iso7 mers, and salts of isomers whenever the existence of such 

8 salts, isomers, and salts of isomers is possible within the 

9 specific chemical designation. 

10 ‘‘(2) In paragraph (1): 

11 ‘‘(A) The term ‘cannabimimetic agents’ means 

12 any substance that is a cannabinoid receptor type 1 

13 (CB1 receptor) agonist as demonstrated by binding 

14 studies and functional assays within any of the fol15 lowing structural classes: 

16 ‘‘(i) 2-(3-hydroxycyclohexyl)phenol with 

17 substitution at the 5-position of the phenolic ring 

18 by alkyl or alkenyl, whether or not substituted on 

19 the cyclohexyl ring to any extent. 

20 ‘‘(ii) 3-(1-naphthoyl)indole or 3-(1- 

21 naphthylmethane)indole by substitution at the 

22 nitrogen atom of the indole ring, whether or not 

23 further substituted on the indole ring to any ex24 tent, whether or not substituted on the naphthoyl 

25 or naphthyl ring to any extent. 
361 

•S 3187 EAH 

1 ‘‘(iii) 3-(1-naphthoyl)pyrrole by substi2 tution at the nitrogen atom of the pyrrole ring, 

3 whether or not further substituted in the pyrrole 

4 ring to any extent, whether or not substituted on 

5 the naphthoyl ring to any extent. 

6 ‘‘(iv) 1-(1-naphthylmethylene)indene by sub7 stitution of the 3-position of the indene ring, 

8 whether or not further substituted in the indene 

9 ring to any extent, whether or not substituted on 

10 the naphthyl ring to any extent. 

11 ‘‘(v) 3-phenylacetylindole or 3-benzoylindole 

12 by substitution at the nitrogen atom of the indole 

13 ring, whether or not further substituted in the 

14 indole ring to any extent, whether or not sub15 stituted on the phenyl ring to any extent. 

16 ‘‘(B) Such term includes— 

17 ‘‘(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3- 

18 hydroxycyclohexyl]-phenol (CP–47,497); 

19 ‘‘(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3- 

20 hydroxycyclohexyl]-phenol (cannabicyclohexanol 

21 or CP–47,497 C8-homolog); 

22 ‘‘(iii) 1-pentyl-3-(1-naphthoyl)indole 

23 (JWH–018 and AM678); 

24 ‘‘(iv) 1-butyl-3-(1-naphthoyl)indole (JWH– 

25 073); 
362 

•S 3187 EAH 

1 ‘‘(v) 1-hexyl-3-(1-naphthoyl)indole (JWH– 

2 019); 

3 ‘‘(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naph4 thoyl)indole (JWH–200); 

5 ‘‘(vii) 1-pentyl-3-(2- 

6 methoxyphenylacetyl)indole (JWH–250); 

7 ‘‘(viii) 1-pentyl-3-[1-(4- 

8 methoxynaphthoyl)]indole (JWH–081); 

9 ‘‘(ix) 1-pentyl-3-(4-methyl-1-naph10 thoyl)indole (JWH–122); 

11 ‘‘(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole 

12 (JWH–398); 

13 ‘‘(xi) 1-(5-fluoropentyl)-3-(1-naph14 thoyl)indole (AM2201); 

15 ‘‘(xii) 1-(5-fluoropentyl)-3-(2- 

16 iodobenzoyl)indole (AM694); 

17 ‘‘(xiii) 1-pentyl-3-[(4-methoxy)-ben18 zoyl]indole (SR–19 and RCS–4); 

19 ‘‘(xiv) 1-cyclohexylethyl-3-(2- 

20 methoxyphenylacetyl)indole (SR–18 and RCS– 

21 8); and 

22 ‘‘(xv) 1-pentyl-3-(2- 

23 chlorophenylacetyl)indole (JWH–203).’’. 
363 

•S 3187 EAH 

1 (b) OTHER DRUGS.—Schedule I of section 202(c) of 

2 the Controlled Substances Act (21 U.S.C. 812(c)) is amend3 ed in subsection (c) by adding at the end the following: 

4 ‘‘(18) 4-methylmethcathinone (Mephedrone). 

5 ‘‘(19) 3,4-methylenedioxypyrovalerone (MDPV). 

6 ‘‘(20) 2-(2,5-Dimethoxy-4- 

7 ethylphenyl)ethanamine (2C–E). 

8 ‘‘(21) 2-(2,5-Dimethoxy-4- 

9 methylphenyl)ethanamine (2C–D). 

10 ‘‘(22) 2-(4-Chloro-2,5- 

11 dimethoxyphenyl)ethanamine (2C–C). 

12 ‘‘(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine 

13 (2C–I). 

14 ‘‘(24) 2-[4-(Ethylthio)-2,5- 

15 dimethoxyphenyl]ethanamine (2C–T–2). 

16 ‘‘(25) 2-[4-(Isopropylthio)-2,5- 

17 dimethoxyphenyl]ethanamine (2C–T–4). 

18 ‘‘(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C– 

19 H). 

20 ‘‘(27) 2-(2,5-Dimethoxy-4-nitro21 phenyl)ethanamine (2C–N). 

22 ‘‘(28) 2-(2,5-Dimethoxy-4-(n)- 

23 propylphenyl)ethanamine (2C–P).’’. 
364 

•S 3187 EAH 

1 SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT 

2 HAZARDS TO PUBLIC SAFETY EXPANSION. 

3 Section 201(h)(2) of the Controlled Substances Act (21 

4 U.S.C. 811(h)(2)) is amended— 

5 (1) by striking ‘‘one year’’ and inserting ‘‘2 

6 years’’; and 

7 (2) by striking ‘‘six months’’ and inserting ‘‘1 

8 year’’. 

Attest: 

Clerk. 

112TH CONGRESS 

2D SESSION S. 3187 

AMENDMENT