IB 

Union Calendar No. 348 

112TH CONGRESS 

2D SESSION H. R. 5651 

[Report No. 112–495] 

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

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

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

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 9, 2012 

Mr. UPTON (for himself, Mr. WAXMAN, Mr. PITTS, Mr. PALLONE, Mr. BARTON of Texas, and Mr. DINGELL) introduced the following bill; which was 

referred to the Committee on Energy and Commerce 

MAY 25, 2012 

Committed to the Committee of the Whole House on the State of the Union 

and ordered to be printed 


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A BILL 

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

revise and extend the user-fee programs for prescription 

drugs and for medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other 

purposes. 


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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food and Drug Ad5 ministration Reform Act of 2012’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents of this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. 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—MEDICAL DEVICE USER FEE AMENDMENTS OF 2012 

Sec. 201. Short title; findings. 

Sec. 202. Definitions. 

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

Sec. 204. Reauthorization; reporting requirements. 

Sec. 205. Savings clause. 

Sec. 206. Effective date. 

Sec. 207. Sunset clause. 

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

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title. 

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

Sec. 303. Reauthorization; reporting requirements. 

Sec. 304. Sunset dates. 

Sec. 305. Effective date. 

Sec. 306. Amendment with respect to misbranding. 

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

generic drugs. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL 

PRODUCTS 

Sec. 401. Short title; finding. 

Sec. 402. Fees relating to biosimilar biological products. 


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Sec. 403. Reauthorization; reporting requirements. 

Sec. 404. Sunset dates. 

Sec. 405. Effective date. 

Sec. 406. Savings clause. 

Sec. 407. Conforming amendment. 

TITLE V—REAUTHORIZATION OF BEST PHARMACEUTICALS FOR 

CHILDREN ACT AND PEDIATRIC RESEARCH EQUITY ACT 

Sec. 501. Permanent extension of Best Pharmaceuticals for Children Act and 

Pediatric Research Equity Act. 

Sec. 502. Food and Drug Administration Report. 

Sec. 503. Internal Committee for Review of Pediatric Plans, Assessments, Deferrals, Deferral Extensions, and Waivers. 

Sec. 504. Staff of Office of Pediatric Therapeutics. 

Sec. 505. Continuation of operation of Pediatric Advisory Committee. 

Sec. 506. Pediatric Subcommittee of the Oncologic Drugs Advisory Committee. 

TITLE VI—FOOD AND DRUG ADMINISTRATION ADMINISTRATIVE 

REFORMS 

Sec. 601. Public participation in issuance of FDA guidance documents. 

Sec. 602. Conflicts of interest. 

Sec. 603. Electronic submission of applications. 

Sec. 604. Notification of FDA intent to regulate laboratory-developed tests. 

TITLE VII—MEDICAL DEVICE REGULATORY IMPROVEMENTS 

Subtitle A—Premarket Predictability 

Sec. 701. Investigational device exemptions. 

Sec. 702. Clarification of least burdensome standard. 

Sec. 703. Agency documentation and review of significant decisions. 

Sec. 704. Transparency in clearance process. 

Sec. 705. Device Modifications Requiring Premarket Notification Prior to Marketing. 

Subtitle B—Patients Come First 

Sec. 711. Establishment of schedule and promulgation of regulation. 

Sec. 712. Program to improve the device recall system. 

Subtitle C—Novel Device Regulatory Relief 

Sec. 721. Modification of de novo application process. 

Subtitle D—Keeping America Competitive Through Harmonization 

Sec. 731. Harmonization of device premarket review, inspection, and labeling 

symbols; report. 

Sec. 732. Participation in international fora. 

Subtitle E—FDA Renewing Efficiency From Outside Reviewer Management 

Sec. 741. Reauthorization of Third Party Review. 

Sec. 742. Reauthorization of third party inspection. 

Subtitle F—Humanitarian Device Reform 


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Sec. 751. Expanded access to humanitarian use devices. 

Subtitle G—Records and Reports on Devices 

Sec. 761. Unique device identification system regulations. 

Sec. 762. Effective device sentinel program. 

Subtitle H—Miscellaneous 

Sec. 771. Custom devices. 

Sec. 772. Pediatric device reauthorization. 

Sec. 773. Report on regulation of health information technology. 

TITLE VIII—DRUG REGULATORY IMPROVEMENTS 

Subtitle A—Drug Supply Chain 

Sec. 801. Registration of producers of drugs. 

Sec. 802. Inspection of drugs. 

Sec. 803. Drug supply quality and safety. 

Sec. 804. Prohibition against delaying, denying, limiting, or refusing inspection. 

Sec. 805. Destruction of adulterated, misbranded, or counterfeit drugs offered 

for import. 

Sec. 806. Administrative detention. 

Sec. 807. Enhanced criminal penalty for counterfeit drugs. 

Sec. 808. Unique facility identification number. 

Sec. 809. Documentation for admissibility of imports. 

Sec. 810. Registration of commercial importers. 

Sec. 811. Notification. 

Sec. 812. Exchange of information. 

Sec. 813. Extraterritorial jurisdiction. 

Sec. 814. Protection against intentional adulteration. 

Sec. 815. Records for inspection. 

Subtitle B—Medical Gas Safety 

Sec. 821. Regulation of medical gases. 

Sec. 822. Changes to regulations. 

Sec. 823. Rules of construction. 

Subtitle C—Generating Antibiotic Incentives Now 

Sec. 831. Extension of exclusivity period for drugs. 

Sec. 832. Study on incentives for qualified infectious disease biological products. 

Sec. 833. Clinical trials. 

Sec. 834. Reassessment of qualified infectious disease product incentives in 5 

years. 

Sec. 835. Guidance on pathogen-focused antibacterial drug development. 

Subtitle D—Accelerated Approval 

Sec. 841. Expedited approval of drugs for serious or life-threatening diseases 

or conditions. 

Sec. 842. Guidance; amended regulations. 

Sec. 843. Independent review. 

Subtitle E—Critical Path Reauthorization 


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Sec. 851. Reauthorization of the critical path public-private partnerships. 

Subtitle F—Miscellaneous 

Sec. 861. Reauthorization of provision relating to exclusivity of certain drugs 

containing single enantiomers. 

Sec. 862. Extension of period for first applicant to obtain tentative approval 

without forfeiting 180-day exclusivity period. 

Sec. 863. Final agency action relating to petitions and civil actions. 

Sec. 864. Deadline for determination on certain petitions. 

Sec. 865. Rare pediatric disease priority review voucher incentive program. 

Sec. 866. Combating prescription drug abuse. 

Sec. 867. Assessment and modification of REMS. 

Sec. 868. Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments. 

Sec. 869. Breakthrough therapies. 

Sec. 870. Grants and Contracts for the Development of Orphan Drugs. 

TITLE IX—DRUG SHORTAGES 

Sec. 901. Discontinuance and interruptions of manufacturing of certain drugs. 

Sec. 902. Drug shortage list. 

Sec. 903. Quotas applicable to drugs in shortage. 

Sec. 904. Expedited review of major manufacturing changes for potential and 

verified shortages of drugs that are life-supporting, life-sustaining, or intended for use in the prevention of a debilitating 

disease or condition. 

Sec. 905. Study on drug shortages. 

Sec. 906. Annual report on drug shortages. 

Sec. 907. Attorney General report on drug shortages. 

Sec. 908. Hospital repackaging of drugs in shortage. 

1 SEC. 3. REFERENCES IN ACT. 

2 Except as otherwise specified, amendments made by 

3 this Act to a section or other provision of law are amend4 ments to such section or other provision of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

6 TITLE I—FEES RELATING TO 

7 DRUGS 

8 SEC. 101. SHORT TITLE; FINDING. 

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

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


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1 (b) FINDING.—The Congress finds that the fees au2 thorized by the amendments made in this title will be dedi3 cated toward expediting the drug development process and 

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

6 the goals identified for purposes of part 2 of subchapter 

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

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

9 Human Services to the Chairman of the Committee on 

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

11 the Chairman of the Committee on Energy and Commerce 

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

14 SEC. 102. DEFINITIONS. 

15 Section 735(7) (21 U.S.C. 379g) is amended by strik16 ing ‘‘expenses incurred in connection with’’ and inserting 

17 ‘‘expenses in connection with’’. 

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

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

20 (1) in subsection (a)— 

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

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

23 ‘‘fiscal year 2013’’; 

24 (B) in paragraph (1)(A)— 


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

2 inserting ‘‘(c)(4)’’; and 

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

4 inserting ‘‘(c)(4)’’; 

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

6 paragraph (2)(A)— 

7 (i) by striking ‘‘(c)(5)’’ inserting 

8 ‘‘(c)(4)’’; and 

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

10 October 1 of each year’’ and inserting 

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

12 on or after October 1 of such fiscal year or 

13 the first business day after the enactment 

14 of an appropriations Act providing for the 

15 collection and obligation of fees for such 

16 fiscal year under this section’’; 

17 (D) in paragraph (3)— 

18 (i) in subparagraph (A)— 

19 (I) by striking ‘‘subsection 

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

21 (c)(4)’’; and 

22 (II) by striking ‘‘payable on or 

23 before October 1 of each year.’’ and 

24 inserting ‘‘due on the later of the first 

25 business day on or after October 1 of 


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1 each such fiscal year or the first busi2 ness day after the enactment of an 

3 appropriations Act providing for the 

4 collection and obligation of fees for 

5 each such fiscal year under this sec6 tion.’’; and 

7 (ii) by amending subparagraph (B) to 

8 read as follows: 

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

10 product shall not be assessed a fee under sub11 paragraph (A) if such product is— 

12 ‘‘(i) identified on the list compiled 

13 under section 505(j)(7)(A) with a potency 

14 described in terms of per 100 mL; 

15 ‘‘(ii) the same product as another 

16 product that— 

17 ‘‘(I) was approved under an ap18 plication filed under section 505(b) or 

19 505(j); and 

20 ‘‘(II) is not in the list of discon21 tinued products compiled under sec22 tion 505(j)(7)(A); 

23 ‘‘(iii) the same product as another 

24 product that was approved under an abbre25 viated application filed under section 507 


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

2 enactment of the Food and Drug Adminis3 tration Modernization Act of 1997); or 

4 ‘‘(iv) the same product as another 

5 product that was approved under an abbre6 viated new drug application pursuant to 

7 regulations in effect prior to the implemen8 tation of the Drug Price Competition and 

9 Patent Term Restoration Act of 1984.’’; 

10 (2) in subsection (b)— 

11 (A) in paragraph (1)— 

12 (i) in the language preceding subpara13 graph (A), by striking ‘‘fiscal years 2008 

14 through 2012’’ and inserting ‘‘fiscal years 

15 2013 through 2017’’; and 

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

17 ‘‘$392,783,000; and’’ and inserting 

18 ‘‘$693,099,000;’’; and 

19 (iii) by striking subparagraph (B) and 

20 inserting the following: 

21 ‘‘(B) the dollar amount equal to the infla22 tion adjustment for fiscal year 2013 (as deter23 mined under paragraph (3)(A)); and 


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1 ‘‘(C) the dollar amount equal to the work2 load adjustment for fiscal year 2013 (as deter3 mined under paragraph (3)(B)).’’; and 

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

5 inserting the following: 

6 ‘‘(3) FISCAL YEAR 2013 INFLATION AND WORK7 LOAD ADJUSTMENTS.—For purposes of paragraph 

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

9 adjustments for fiscal year 2013 shall be determined 

10 as follows: 

11 ‘‘(A) INFLATION ADJUSTMENT.—The infla12 tion adjustment for fiscal year 2013 shall be 

13 the sum of— 

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

15 result of an inflation adjustment calcula16 tion determined using the methodology de17 scribed in subsection (c)(1)(B); and 

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

19 result of an inflation adjustment calcula20 tion determined using the methodology de21 scribed in subsection (c)(1)(C). 

22 ‘‘(B) WORKLOAD ADJUSTMENT.—Subject 

23 to subparagraph (C), the workload adjustment 

24 for fiscal 2013 shall be— 


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

2 the inflation adjustment calculated under 

3 subparagraph (A); multiplied by 

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

5 percentage workload adjustment for fiscal 

6 year 2013, as determined using the meth7 odology described in subsection (c)(2)(A), 

8 would exceed the percentage workload ad9 justment (as so determined) for fiscal year 

10 2012, if both such adjustment percentages 

11 were calculated using the 5-year base pe12 riod consisting of fiscal years 2003 

13 through 2007. 

14 ‘‘(C) LIMITATION.—Under no cir15 cumstances shall the adjustment under sub16 paragraph (B) result in fee revenues for fiscal 

17 year 2013 that are less than the sum of the 

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

19 amount under paragraph (1)(B).’’; 

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

21 following: 

22 ‘‘(c) ADJUSTMENTS.— 

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

24 2014 and subsequent fiscal years, the revenues es25 tablished in subsection (b) shall be adjusted by the 


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1 Secretary by notice, published in the Federal Reg2 ister, for a fiscal year by the amount equal to the 

3 sum of— 

4 ‘‘(A) one; 

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

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

7 Food and Drug Administration, of all personnel 

8 compensation and benefits paid with respect to 

9 such positions for the first 3 years of the pre10 ceding 4 fiscal years, multiplied by the propor11 tion of personnel compensation and benefits 

12 costs to total costs of the process for the review 

13 of human drug applications (as defined in sec14 tion 735(6)) for the first 3 years of the pre15 ceding 4 fiscal years, and 

16 ‘‘(C) the average annual percent change 

17 that occurred in the Consumer Price Index for 

18 urban consumers (Washington-Baltimore, DC– 

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

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

21 preceding 4 years of available data multiplied 

22 by the proportion of all costs other than per23 sonnel compensation and benefits costs to total 

24 costs of the process for the review of human 

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


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1 for the first 3 years of the preceding 4 fiscal 

2 years. 

3 The adjustment made each fiscal year under this 

4 paragraph shall be added on a compounded basis to 

5 the sum of all adjustments made each fiscal year 

6 after fiscal year 2013 under this paragraph. 

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

8 year 2014 and subsequent fiscal years, after the fee 

9 revenues established in subsection (b) are adjusted 

10 for a fiscal year for inflation in accordance with 

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

12 further for such fiscal year to reflect changes in the 

13 workload of the Secretary for the process for the re14 view of human drug applications. With respect to 

15 such adjustment: 

16 ‘‘(A) The adjustment shall be determined 

17 by the Secretary based on a weighted average 

18 of the change in the total number of human 

19 drug applications (adjusted for changes in re20 view activities, as described in the notice that 

21 the Secretary is required to publish in the Fed22 eral Register under this subparagraph), efficacy 

23 supplements, and manufacturing supplements 

24 submitted to the Secretary, and the change in 

25 the total number of active commercial investigaVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 tional new drug applications (adjusted for 

2 changes in review activities, as so described) 

3 during the most recent 12-month period for 

4 which data on such submissions is available. 

5 The Secretary shall publish in the Federal Reg6 ister the fee revenues and fees resulting from 

7 the adjustment and the supporting methodolo8 gies. 

9 ‘‘(B) Under no circumstances shall the ad10 justment result in fee revenues for a fiscal year 

11 that are less than the sum of the amount under 

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

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

14 under paragraph (1). 

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

16 independent accounting or consulting firm to 

17 periodically review the adequacy of the adjust18 ment and publish the results of those reviews. 

19 The first review shall be conducted and pub20 lished by the end of fiscal year 2013 (to exam21 ine the performance of the adjustment since fis22 cal year 2009), and the second review shall be 

23 conducted and published by the end of fiscal 

24 year 2015 (to examine the continued perform25 ance of the adjustment). The reports shall 


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1 evaluate whether the adjustment reasonably 

2 represents actual changes in workload volume 

3 and complexity and present options to dis4 continue, retain, or modify any elements of the 

5 adjustment. The reports shall be published for 

6 public comment. After review of the reports and 

7 receipt of public comments, the Secretary shall, 

8 if warranted, adopt appropriate changes to the 

9 methodology. If the Secretary adopts changes to 

10 the methodology based on the first report, the 

11 changes shall be effective for the first fiscal 

12 year for which fees are set after the Secretary 

13 adopts such changes and each subsequent fiscal 

14 year. 

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

16 year 2017, the Secretary may, in addition to adjust17 ments under this paragraph and paragraphs (1) and 

18 (2), further increase the fee revenues and fees estab19 lished in subsection (b) if such an adjustment is nec20 essary to provide for not more than 3 months of op21 erating reserves of carryover user fees for the proc22 ess for the review of human drug applications for 

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

24 adjustment is necessary, the rationale for the 

25 amount of the increase shall be contained in the anVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 nual notice establishing fee revenues and fees for fis2 cal year 2017. If the Secretary has carryover bal3 ances for such process in excess of 3 months of such 

4 operating reserves, the adjustment under this sub5 paragraph shall not be made. 

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

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

8 fiscal year that begins after September 30, 2012, es9 tablish, for the next fiscal year, application, product, 

10 and establishment fees under subsection (a), based 

11 on the revenue amounts established under subsection 

12 (b) and the adjustments provided under this sub13 section. 

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

15 as adjusted under this subsection, for a fiscal year 

16 may not exceed the total costs for such fiscal year 

17 for the resources allocated for the process for the re18 view of human drug applications.’’; and 

19 (4) in subsection (g)— 

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

21 authorized’’ and inserting ‘‘Subject to para22 graph (2)(C), fees authorized’’; 

23 (B) in paragraph (2)— 


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

2 ‘‘shall be retained’’ and inserting ‘‘shall be 

3 collected and available’’; 

4 (ii) in subparagraph (A)(ii), by strik5 ing ‘‘shall only be collected and available’’ 

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

7 (iii) by adding at the end the fol8 lowing new subparagraph: 

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

10 Payment of fees authorized under this section 

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

12 fees, may be accepted by the Secretary in ac13 cordance with authority provided in advance in 

14 a prior year appropriations Act.’’; 

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

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

17 years 2013 through 2017’’; and 

18 (D) in paragraph (4)— 

19 (i) by striking ‘‘fiscal years 2008 

20 through 2010’’ and inserting ‘‘fiscal years 

21 2013 through 2015’’; 

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

23 inserting ‘‘fiscal year 2016’’; 


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1 (iii) by striking ‘‘fiscal years 2008 

2 though 2011’’ and inserting ‘‘fiscal years 

3 2013 through 2016’’; and 

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

5 and 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 

14 part, the Secretary shall prepare and submit to the 

15 Committee on Energy and Commerce of the House 

16 of Representatives and the Committee on Health, 

17 Education, Labor, and Pensions of the Senate a re18 port concerning— 

19 ‘‘(A) the progress of the Food and Drug 

20 Administration in achieving the goals identified 

21 in the letters described in section 101(b) of the 

22 Prescription Drug User Fee Amendments of 

23 2012 during such fiscal year and the future 

24 plans of the Food and Drug Administration for 

25 meeting the goals, including the status of the 


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1 independent assessment described in such let2 ters; and 

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

4 Evaluation and Research and the Center for 

5 Biologics Evaluation and Research in achieving 

6 the goals, and future plans for meeting the 

7 goals, including, 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 

18 review division; 

19 ‘‘(iv) the number of priority efficacy 

20 supplements filed per fiscal year for each 

21 review division; 

22 ‘‘(v) the number of applications filed 

23 for review under accelerated approval per 

24 fiscal year for each review division; 


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1 ‘‘(vi) the number of applications filed 

2 for review as fast track products per fiscal 

3 year for each review division; and 

4 ‘‘(vii) the number of applications filed 

5 for orphan-designated products per fiscal 

6 year for each review division. 

7 ‘‘(2) INCLUSION.—The report under this sub8 section for a fiscal year shall include information on 

9 all previous cohorts for which the Secretary has not 

10 given a complete response on all human drug appli11 cations and supplements in the cohort.’’. 

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

13 inserting ‘‘2013’’; and 

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

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

16 SEC. 105. SUNSET DATES. 

17 (a) AUTHORIZATION.—Sections 735 and 736 (21 

18 U.S.C. 379g; 379h) are repealed October 1, 2017. 

19 (b) REPORTING REQUIREMENTS.—Section 736B (21 

20 U.S.C. 379h–2) is repealed January 31, 2018. 

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

22 the Prescription Drug User Fee Amendments of 2007 

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

24 (d) TECHNICAL CLARIFICATIONS.— 


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1 (1) Effective September 30, 2007, section 508 

2 of the Prescription Drug User Fee Amendments Act 

3 of 2002 (Title V of Public Law 107–188) is re4 pealed. 

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

6 of the Food and Drug Administration Modernization 

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

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

9 of the Prescription Drug User Fee Act of 1992 

10 (Public Law 102–571) is repealed. 

11 SEC. 106. EFFECTIVE DATE. 

12 The amendments made by this title shall take effect 

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

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

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

16 and Cosmetic Act shall be assessed for all human drug 

17 applications received on or after October 1, 2012, regard18 less of the date of the enactment of this Act. 

19 SEC. 107. SAVINGS CLAUSE. 

20 Notwithstanding the amendments made by this title, 

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

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

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

24 be in effect with respect to human drug applications and 

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


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

2 were accepted by the Food and Drug Administration for 

3 filing with respect to assessing and collecting any fee re4 quired by such part for a fiscal year prior to fiscal year 

5 2012. 

6 TITLE II—MEDICAL DEVICE 

7 USER FEE AMENDMENTS OF 2012 

8 SEC. 201. SHORT TITLE; FINDINGS. 

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

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

11 (b) FINDINGS.—The Congress finds that the fees au12 thorized under the amendments made by this title will be 

13 dedicated toward expediting the process for the review of 

14 device applications and for assuring the safety and effec15 tiveness of devices, as set forth in the goals identified for 

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

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

18 the Secretary of Health and Human Services to the Chair19 man of the Committee on Health, Education, Labor, and 

20 Pensions of the Senate and the Chairman of the Com21 mittee on Energy and Commerce of the House of Rep22 resentatives, as set forth in the Congressional Record. 

23 SEC. 202. DEFINITIONS. 

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


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

2 after ‘‘expenses’’; 

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

4 2001’’ and inserting ‘‘October 2011’’; and 

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

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

7 paragraph (13) and inserting the following: ‘‘is reg8 istered (or is required to register) with the Secretary 

9 under section 510 because such establishment is en10 gaged in the manufacture, preparation, propagation, 

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

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

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

14 379j(a)) is amended— 

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

16 2008’’ and inserting ‘‘fiscal year 2013’’; 

17 (2) in paragraph (2)(A)— 

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

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

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

21 and (f)’’; 

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

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

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

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


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

2 inserting ‘‘2’’; and 

3 (3) in paragraph (3)— 

4 (A) in subparagraph (A), by inserting 

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

6 and 

7 (B) in subparagraph (C), by striking ‘‘ini8 tial registration’’ and all that follows through 

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

10 ‘‘(i) the initial or annual registration 

11 (as applicable) of the establishment under 

12 section 510; or 

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

14 date of enactment of an appropriations Act 

15 providing for the collection and obligation 

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

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

18 379j(b)) is amended to read as follows: 

19 ‘‘(b) FEE AMOUNTS.— 

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

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

22 through 2017, fees under subsection (a) shall be de23 rived from the base fee amounts specified in para24 graph (2), to generate the total revenue amounts 

25 specified in paragraph (3). 


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1 ‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For 

2 purposes of paragraph (1), the base fee amounts 

3 specified 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 

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

6 specified in this paragraph are as follows: 

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

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

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

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

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

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

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

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

15 ADJUSTMENTS’’ after ‘‘SETTING’’; 

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

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

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

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

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

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


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1 based on amounts specified under subsection (b) and 

2 the adjustments provided under this subsection, and 

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

5 ‘‘(2) INFLATION ADJUSTMENTS.— 

6 ‘‘(A) ADJUSTMENT TO TOTAL REVENUE

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

9 the total revenue amount specified in subsection 

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

11 amount by the applicable inflation adjustment 

12 under subparagraph (B) for such year. 

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

16 is— 

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

19 for such fiscal year; and 

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

21 subsequent fiscal year, the product of— 

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

24 such fiscal year; and 


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

4 preceding such fiscal year, beginning 

5 with fiscal year 2014. 

6 ‘‘(C) BASE INFLATION ADJUSTMENT TO

7 TOTAL REVENUE AMOUNTS.— 

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

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

11 sum of one plus— 

12 ‘‘(I) the average annual percent 

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

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

18 years of the preceding 4 fiscal years, 

19 multiplied by 0.60; and 

20 ‘‘(II) the average annual percent 

21 change that occurred in the Consumer 

22 Price Index for urban consumers 

23 (Washington-Baltimore, DC–MD–VA– 

24 WV; Not Seasonally Adjusted; All 

25 items; Annual Index) for the first 3 


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1 years of the preceding 4 years of 

2 available data multiplied by 0.40. 

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

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

6 (i)— 

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

9 to 1; or 

10 ‘‘(II) is greater than 1.04, such 

11 adjustment shall be considered to be 

12 equal to 1.04. 

13 ‘‘(D) ADJUSTMENT TO BASE FEE

14 AMOUNTS.—For each of fiscal years 2014 

15 through 2017, the base fee amounts specified in 

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

17 on a uniform proportionate basis, to generate 

18 the total revenue amounts under subsection 

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

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

23 fiscal years 2014 through 2017, after the base fee 

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

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1 istration fee amounts specified in such subsection 

2 shall be further adjusted, as the Secretary estimates 

3 is necessary in order for total fee collections for such 

4 fiscal year to generate the total revenue amounts, as 

5 adjusted under paragraph (2).’’. 

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

7 U.S.C. 379j) is amended by— 

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

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

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

12 ‘‘(f) FEE WAIVER OR REDUCTION.— 

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

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

16 Secretary finds that such waiver or reduction is in 

17 the interest of public health. 

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

19 or reductions granted by the Secretary in any fiscal 

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

21 of the total fee revenue amounts established for such 

22 year under subsection (c). 

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

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


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

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

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

4 ‘‘$280,587,000’’. 

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

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

10 fees authorized’’; 

11 (2) in paragraph (2)— 

12 (A) in subparagraph (A)— 

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

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

17 (ii) in clause (ii)— 

18 (I) by striking ‘‘collected and’’ 

19 after ‘‘shall only be’’; and 

20 (II) by striking ‘‘fiscal year 

21 2002’’ and inserting ‘‘fiscal year 

22 2009’’; and 

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

24 ‘‘(C) PROVISION FOR EARLY YEAR PAY25 MENTS.—Payment of fees authorized under this 


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

2 for such fees, may be accepted by the Secretary 

3 in accordance with authority provided in ad4 vance in a prior year appropriations Act.’’; 

5 (3) in paragraph (3), by amending to read as 

6 follows: 

7 ‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.— 

8 For each of the fiscal years 2013 through 2017, 

9 there is authorized to be appropriated for fees under 

10 this section an amount equal to the total revenue 

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

13 fiscal year 2017 only, as further adjusted under 

14 paragraph (4).’’; and 

15 (4) in paragraph (4)— 

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

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

18 2014, and 2015’’; 

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

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

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


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

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

5 (g) CONFORMING AMENDMENT.—Section 

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

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

8 SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

10 U.S.C. 379j–1(b)) is amended— 

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

12 inserting ‘‘2017’’; and 

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

14 inserting ‘‘2017’’. 

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

16 U.S.C. 379j–1(a)) is amended— 

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

18 following: 

19 ‘‘(1) PERFORMANCE REPORT.— 

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

21 year 2013, for each fiscal year for which fees 

22 are collected under this part, the Secretary 

23 shall prepare and submit to the Committee on 

24 Health, Education, Labor, and Pensions of the 

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1 merce of the House of Representatives annual 

2 reports concerning the progress of the Food 

3 and Drug Administration in achieving the goals 

4 identified in the letters described in section 

5 201(b) of the Medical Device User Fee Amend6 ments of 2012 during such fiscal year and the 

7 future plans of the Food and Drug Administra8 tion for meeting the goals. 

9 ‘‘(B) PUBLICATION.—With regard to infor10 mation to be reported by the Food and Drug 

11 Administration to industry on a quarterly and 

12 annual basis pursuant to the letters described 

13 in section 201(b) of the Medical Device User 

14 Fee Amendments Act of 2012, the Secretary 

15 shall make such information publicly available 

16 on the Internet Website of the Food and Drug 

17 Administration not later than 60 days after the 

18 end of each quarter or 120 days after the end 

19 of each fiscal year, respectively, to which such 

20 information applies. This information shall in21 clude the status of the independent assessment 

22 identified in the letters described in such sec23 tion 201(b). 

24 ‘‘(C) UPDATES.—The Secretary shall in25 clude in each report under subparagraph (A) 


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1 information on all previous cohorts for which 

2 the Secretary has not given a complete response 

3 on all device premarket applications and re4 ports, supplements, and premarket notifications 

5 in the cohort.’’; and 

6 (2) in paragraph (2), by striking ‘‘2008 

7 through 2012’’ and inserting ‘‘2013 through 2017’’. 

8 SEC. 205. SAVINGS CLAUSE. 

9 Notwithstanding the amendments made by this title, 

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

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

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

13 title, shall continue to be in effect with respect to the sub14 missions listed in section 738(a)(2)(A) of such Act (as de15 fined in such part as of such day) that on or after October 

16 1, 2007, but before October 1, 2012, were accepted by 

17 the Food and Drug Administration for filing with respect 

18 to assessing and collecting any fee required by such part 

19 for a fiscal year prior to fiscal year 2013. 

20 SEC. 206. EFFECTIVE DATE. 

21 The amendments made by this title shall take effect 

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

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

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

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1 ed in section 738(a)(2)(A) of such Act received on or after 

2 October 1, 2012, regardless of the date of the enactment 

3 of this Act. 

4 SEC. 207. SUNSET CLAUSE. 

5 (a) IN GENERAL.—Sections 737 and 738 of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) 

7 shall cease to be effective October 1, 2017. Section 738A 

8 (21 U.S.C. 739j–1) of the Federal Food, Drug, and Cos9 metic Act (regarding reauthorization and reporting re10 quirements) are repealed January 31, 2018. 

11 (b) PREVIOUS SUNSET PROVISION.—Section 217 of 

12 the Medical Device User Fee Amendments of 2007 (Title 

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

14 (c) TECHNICAL CLARIFICATION.—Effective Sep15 tember 30, 2007, section 107 of the Medical Device User 

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

17 250) is repealed. 

18 SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT 

19 ACTIVITIES RELATED TO THE PROCESS FOR 

20 THE REVIEW OF DEVICE APPLICATIONS. 

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

22 is amended by inserting after section 713 the following 

23 new section: 


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1 ‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. 

2 ‘‘(a) IN GENERAL.—In addition to any other per3 sonnel authorities under other provisions of law, the Sec4 retary may, without regard to the provisions of title 5, 

5 United States Code, governing appointments in the com6 petitive service, appoint employees to positions in the Food 

7 and Drug Administration to perform, administer, or sup8 port activities described in subsection (b), if the Secretary 

9 determines that such appointments are needed to achieve 

10 the objectives specified in subsection (c). 

11 ‘‘(b) ACTIVITIES DESCRIBED.—The activities de12 scribed in this subsection are activities under this Act re13 lated to the process for the review of device applications 

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

15 ‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci16 fied in this subsection are with respect to the activities 

17 under subsection (b)(1), the goals referred to in section 

18 738A(a)(1). 

19 ‘‘(d) INTERNAL CONTROLS.—The Secretary shall in20 stitute appropriate internal controls for appointments 

21 under this section. 

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

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

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


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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 

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

6 (b) FINDING.—The Congress finds that the fees au7 thorized by the amendments made in this title will be dedi8 cated to human generic drug activities, as set forth in the 

9 goals identified for purposes of part 7 of subchapter C 

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

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

12 Human Services to the Chairman of the Committee on 

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

14 the Chairman of the Committee on Energy and Commerce 

15 of the House of Representatives, as set forth in the Con16 gressional Record. 

17 SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE18 NERIC DRUG FEES. 

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

20 is amended by adding at the end the following: 

21 ‘‘PART 7—FEES RELATING TO GENERIC DRUGS 

22 ‘‘SEC. 744A. DEFINITIONS. 

23 ‘‘For purposes of this part: 

24 ‘‘(1) The term ‘abbreviated new drug applica25 tion’— 


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1 ‘‘(A) means an application submitted 

2 under section 505(j), an abbreviated application 

3 submitted under section 507 (as in effect on the 

4 day before the date of enactment of the Food 

5 and Drug Administration Modernization Act of 

6 1997), or an abbreviated new drug application 

7 submitted pursuant to regulations in effect 

8 prior to the implementation of the Drug Price 

9 Competition and Patent Term Restoration Act 

10 of 1984; and 

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

12 positron emission tomography drug. 

13 ‘‘(2) The term ‘active pharmaceutical ingre14 dient’ means— 

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

16 substance is unstable or cannot be transported 

17 on 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 

23 of disease, or to affect the structure or any 

24 function of the human body; or 


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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 fac7 tor applicable to a fiscal year that is the Consumer 

8 Price Index for all urban consumers (all items; 

9 United States city average) for October of the pre10 ceding fiscal year divided by such Index for October 

11 2011. 

12 ‘‘(4) The term ‘affiliate’ means a business enti13 ty that has a relationship with a second business en14 tity if, directly or indirectly— 

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

16 the power to control, the other business entity; 

17 or 

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

19 to control, both of the business entities. 

20 ‘‘(5)(A) The term ‘facility’— 

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

22 ‘‘(I) under one management, either di23 rect or indirect; and 

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1 essing an active pharmaceutical ingredient 

2 or a finished dosage form; and 

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

4 entity whose only manufacturing or processing 

5 activities are one or more of the following: re6 packaging, relabeling, or testing. 

7 ‘‘(B) For purposes of subparagraph (A), sepa8 rate buildings within close proximity are considered 

9 to be at one geographic location or address if the ac10 tivities in them are— 

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

12 enterprise; 

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

14 local management; and 

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

16 Food and Drug Administration during a single 

17 inspection. 

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

19 the definition of a facility under this paragraph but 

20 for being under multiple management, the business 

21 or other entity is deemed to constitute multiple fa22 cilities, one per management entity, for purposes of 

23 this paragraph. 

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


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

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

3 tablet, capsule, solution, or topical application; 

4 ‘‘(B) a drug product in a form in which re5 constitution is necessary prior to administration 

6 to a patient, such as oral suspensions or 

7 lyophilized powders; or 

8 ‘‘(C) any combination of an active pharma9 ceutical ingredient with another component of a 

10 drug product for purposes of production of a 

11 drug product described in subparagraph (A) or 

12 (B). 

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

14 an abbreviated new drug application, an amendment 

15 to an abbreviated new drug application, or a prior 

16 approval supplement to an abbreviated new drug ap17 plication. 

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

19 means the following activities of the Secretary asso20 ciated with generic drugs and inspection of facilities 

21 associated with generic drugs: 

22 ‘‘(A) The activities necessary for the re23 view of generic drug submissions, including re24 view of drug master files referenced in such 

25 submissions. 


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1 ‘‘(B) The issuance of— 

2 ‘‘(i) approval letters which approve 

3 abbreviated new drug applications or sup4 plements to such applications; or 

5 ‘‘(ii) complete response letters which 

6 set forth in detail the specific deficiencies 

7 in such applications and, where appro8 priate, the actions necessary to place such 

9 applications in condition for approval. 

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

11 Type II active pharmaceutical drug master files 

12 which— 

13 ‘‘(i) set forth in detail the specific de14 ficiencies in such submissions, and where 

15 appropriate, the actions necessary to re16 solve those deficiencies; or 

17 ‘‘(ii) document that no deficiencies 

18 need to be addressed. 

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

20 ‘‘(E) Monitoring of research conducted in 

21 connection with the review of generic drug sub22 missions and drug master files. 

23 ‘‘(F) Postmarket safety activities with re24 spect to drugs approved under abbreviated new 


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1 drug applications or supplements, including the 

2 following activities: 

3 ‘‘(i) Collecting, developing, and re4 viewing safety information on approved 

5 drugs, including adverse event reports. 

6 ‘‘(ii) Developing and using improved 

7 adverse-event data-collection systems, in8 cluding information technology systems. 

9 ‘‘(iii) Developing and using improved 

10 analytical tools to assess potential safety 

11 problems, including access to external data 

12 bases. 

13 ‘‘(iv) Implementing and enforcing sec14 tion 505(o) (relating to postapproval stud15 ies and clinical trials and labeling changes) 

16 and section 505(p) (relating to risk evalua17 tion and mitigation strategies) insofar as 

18 those activities relate to abbreviated new 

19 drug applications. 

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

21 (relating to adverse-event reports and 

22 postmarket safety activities). 

23 ‘‘(G) Regulatory science activities related 

24 to generic drugs. 


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

2 drug’ has the meaning given to the term ‘com3 pounded positron emission tomography drug’ in sec4 tion 201(ii), except that paragraph (1)(B) of such 

5 section shall not apply. 

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

7 means a request to the Secretary to approve a 

8 change in the drug substance, drug product, produc9 tion process, quality controls, equipment, or facilities 

10 covered by an approved abbreviated new drug appli11 cation when that change has a substantial potential 

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

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

14 these factors may relate to the safety or effective15 ness of the drug product. 

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

17 generic drug activities’ means the expenses for— 

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

19 and Drug Administration, contractors of the 

20 Food and Drug Administration, advisory com21 mittees, and costs related to such officers and 

22 employees and to contracts with such contrac23 tors; 


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

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

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

5 repair of facilities and acquisition, maintenance, 

6 and repair of fixtures, furniture, scientific 

7 equipment, and other necessary materials and 

8 supplies; and 

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

10 and accounting for resources allocated for the 

11 review of abbreviated new drug applications and 

12 supplements and inspection related to generic 

13 drugs. 

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

15 ingredient drug master file’ means a submission of 

16 information to the Secretary by a person that in17 tends to authorize the Food and Drug Administra18 tion to reference the information to support approval 

19 of a generic drug submission without the submitter 

20 having to disclose the information to the generic 

21 drug submission applicant. 


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1 ‘‘SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GE2 NERIC DRUG FEES. 

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

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

6 ‘‘(1) ONE-TIME BACKLOG FEE FOR ABBRE7 VIATED NEW DRUG APPLICATIONS PENDING ON OC8 TOBER 1, 2012.— 

9 ‘‘(A) IN GENERAL.—Each person that 

10 owns an abbreviated new drug application that 

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

12 not received a tentative approval prior to that 

13 date, shall be subject to a fee for each such ap14 plication, as calculated under subparagraph 

15 (B). 

16 ‘‘(B) METHOD OF FEE AMOUNT CALCULA17 TION.—The amount of each one-time backlog 

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

19 by the total number of abbreviated new drug 

20 applications pending on October 1, 2012, that 

21 have not received a tentative approval as of that 

22 date. 

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

24 2012, the Secretary shall cause to be published 

25 in the Federal Register a notice announcing the 


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1 amount of the fee required by subparagraph 

2 (A). 

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

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

5 30 calendar days after the date of the publica6 tion of the notice specified in subparagraph (C). 

7 ‘‘(2) DRUG MASTER FILE FEE.— 

8 ‘‘(A) IN GENERAL.—Each person that 

9 owns a Type II active pharmaceutical ingre10 dient drug master file that is referenced on or 

11 after October 1, 2012, in a generic drug sub12 mission by any initial letter of authorization 

13 shall be subject to a drug master file fee. 

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

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

16 active pharmaceutical ingredient drug master 

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

18 subsequent drug master file fee when that Type 

19 II active pharmaceutical ingredient drug master 

20 file is subsequently referenced in generic drug 

21 submissions. 

22 ‘‘(C) NOTICE.— 

23 ‘‘(i) FISCAL YEAR 2013.—Not later 

24 than October 31, 2012, the Secretary shall 

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1 ister a notice announcing the amount of 

2 the drug master file fee for fiscal year 

3 2013. 

4 ‘‘(ii) FISCAL YEAR 2014 THROUGH

5 2017.—Not later than 60 days before the 

6 start of each of fiscal years 2014 through 

7 2017, the Secretary shall cause to be pub8 lished in the Federal Register the amount 

9 of the drug master file fee established by 

10 this paragraph for such fiscal year. 

11 ‘‘(D) AVAILABILITY FOR REFERENCE.— 

12 ‘‘(i) IN GENERAL.—Subject to sub13 section (g)(2)(C), for a generic drug sub14 mission to reference a Type II active phar15 maceutical ingredient drug master file, the 

16 drug master file must be deemed available 

17 for reference by the Secretary. 

18 ‘‘(ii) CONDITIONS.—A drug master 

19 file shall be deemed available for reference 

20 by the Secretary if— 

21 ‘‘(I) the person that owns a Type 

22 II active pharmaceutical ingredient 

23 drug master file has paid the fee re24 quired under subparagraph (A) within 

25 20 calendar days after the applicable 


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1 due date under subparagraph (E); 

2 and 

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

4 failed an initial completeness assess5 ment by the Secretary, in accordance 

6 with criteria to be published by the 

7 Secretary. 

8 ‘‘(iii) LIST.—The Secretary shall 

9 make publicly available on the Internet 

10 Web site of the Food and Drug Adminis11 tration a list of the drug master file num12 bers that correspond to drug master files 

13 that have successfully undergone an initial 

14 completeness assessment, in accordance 

15 with criteria to be published by the Sec16 retary, and are available for reference. 

17 ‘‘(E) FEE DUE DATE.— 

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

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

20 later than the date on which the first ge21 neric drug submission is submitted that 

22 references the associated Type II active 

23 pharmaceutical ingredient drug master file. 


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1 ‘‘(ii) LIMITATION.—No fee shall be 

2 due under subparagraph (A) for a fiscal 

3 year until the later of— 

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

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

7 as applicable; or 

8 ‘‘(II) 30 calendar days after the 

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

11 and obligation of fees under this sec12 tion. 

13 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION

14 AND PRIOR APPROVAL SUPPLEMENT FILING FEE.— 

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

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

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

22 ‘‘(B) NOTICE.— 

23 ‘‘(i) FISCAL YEAR 2013.—Not later 

24 than October 31, 2012, the Secretary shall 

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1 ister a notice announcing the amount of 

2 the fees under subparagraph (A) for fiscal 

3 year 2013. 

4 ‘‘(ii) FISCAL YEARS 2014 THROUGH

5 2017.—Not later than 60 days before the 

6 start of each of fiscal years 2014 through 

7 2017, the Secretary shall cause to be pub8 lished in the Federal Register the amount 

9 of the fees under subparagraph (A) for 

10 such fiscal year. 

11 ‘‘(C) FEE DUE DATE.— 

12 ‘‘(i) IN GENERAL.—Except as pro13 vided in clause (ii), the fees required by 

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

15 later than the date of submission of the 

16 abbreviated new drug application or prior 

17 approval supplement for which such fee ap18 plies. 

19 ‘‘(ii) SPECIAL RULE FOR 2013.—For 

20 fiscal year 2013, such fees shall be due on 

21 the later of— 

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

23 due under clause (i); 


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1 ‘‘(II) 30 calendar days after pub2 lication of the notice referred to in 

3 subparagraph (B)(i); or 

4 ‘‘(III) if an appropriations Act is 

5 not enacted providing for the collec6 tion and obligation of fees under this 

7 section by the date of submission of 

8 the application or prior approval sup9 plement for which the fees under sub10 paragraphs (A) and (F) apply, 30 cal11 endar days after the date that such an 

12 appropriations Act is enacted. 

13 ‘‘(D) REFUND OF FEE IF ABBREVIATED

14 NEW DRUG APPLICATION IS NOT CONSIDERED

15 TO HAVE BEEN RECEIVED.—The Secretary 

16 shall refund 75 percent of the fee paid under 

17 subparagraph (A) for any abbreviated new drug 

18 application or prior approval supplement to an 

19 abbreviated new drug application that the Sec20 retary considers not to have been received with21 in the meaning of section 505(j)(5)(A) for a 

22 cause other than failure to pay fees. 

23 ‘‘(E) FEE FOR AN APPLICATION THE SEC24 RETARY CONSIDERS NOT TO HAVE BEEN RE25 CEIVED, OR THAT HAS BEEN WITHDRAWN.—An 


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1 abbreviated new drug application or prior ap2 proval supplement that was submitted on or 

3 after October 1, 2012, and that the Secretary 

4 considers not to have been received, or that has 

5 been withdrawn, shall, upon resubmission of the 

6 application or a subsequent new submission fol7 lowing the applicant’s withdrawal of the appli8 cation, be subject to a full fee under subpara9 graph (A). 

10 ‘‘(F) ADDITIONAL FEE FOR ACTIVE PHAR11 MACEUTICAL INGREDIENT INFORMATION NOT

12 INCLUDED BY REFERENCE TO TYPE II ACTIVE

13 PHARMACEUTICAL INGREDIENT DRUG MASTER

14 FILE.—An applicant that submits a generic 

15 drug submission on or after October 1, 2012, 

16 shall pay a fee, in the amount determined under 

17 subsection (d)(3), in addition to the fee re18 quired under subparagraph (A), if— 

19 ‘‘(i) such submission contains infor20 mation concerning the manufacture of an 

21 active pharmaceutical ingredient at a facil22 ity by means other than reference by a let23 ter of authorization to a Type II active 

24 pharmaceutical drug master file; and 


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

2 drug master file fee established in para3 graph (2) has not been previously paid 

4 with respect to such information. 

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

6 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

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

8 or intended to be identified, in at least one ge9 neric drug submission that is pending or ap10 proved to produce a finished dosage form of a 

11 human generic drug or an active pharma12 ceutical ingredient contained in a human ge13 neric drug shall be subject to fees as follows: 

14 ‘‘(i) GENERIC DRUG FACILITY.—Each 

15 person that owns a facility which is identi16 fied or intended to be identified in at least 

17 one generic drug submission that is pend18 ing or approved to produce one or more 

19 finished dosage forms of a human generic 

20 drug shall be assessed an annual fee for 

21 each such facility. 

22 ‘‘(ii) ACTIVE PHARMACEUTICAL IN23 GREDIENT FACILITY.—Each person that 

24 owns a facility which produces, or which is 

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1 tive pharmaceutical ingredients identified, 

2 or intended to be identified, in at least one 

3 generic drug submission that is pending or 

4 approved or in a Type II active pharma5 ceutical ingredient drug master file ref6 erenced in such a generic drug submission, 

7 shall be assessed an annual fee for each 

8 such facility. 

9 ‘‘(iii) FACILITIES PRODUCING BOTH

10 ACTIVE PHARMACEUTICAL INGREDIENTS

11 AND FINISHED DOSAGE FORMS.—Each 

12 person that owns a facility identified, or 

13 intended to be identified, in at least one 

14 generic drug submission that is pending or 

15 approved to produce both one or more fin16 ished dosage forms subject to clause (i) 

17 and one or more active pharmaceutical in18 gredients subject to clause (ii) shall be 

19 subject to fees under both such clauses for 

20 that facility. 

21 ‘‘(B) AMOUNT.—The amount of fees estab22 lished under subparagraph (A) shall be estab23 lished under subsection (d). 

24 ‘‘(C) NOTICE.— 


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1 ‘‘(i) FISCAL YEAR 2013.—For fiscal 

2 year 2013, the Secretary shall cause to be 

3 published in the Federal Register a notice 

4 announcing the amount of the fees pro5 vided for in subparagraph (A) within the 

6 timeframe specified in subsection 

7 (d)(1)(B). 

8 ‘‘(ii) FISCAL YEARS 2014 THROUGH

9 2017.—Within the timeframe specified in 

10 subsection (d)(2), the Secretary shall cause 

11 to be published in the Federal Register the 

12 amount of the fees under subparagraph 

13 (A) for such fiscal year. 

14 ‘‘(D) FEE DUE DATE.— 

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

16 year 2013, the fees under subparagraph 

17 (A) shall be due on the later of— 

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

19 the publication of the notice under 

20 subparagraph (B); or 

21 ‘‘(II) if an appropriations Act is 

22 not enacted providing for the collec23 tion and obligation of fees under this 

24 section by the date of the publication 

25 of such notice, 30 days after the date 


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1 that such an appropriations Act is en2 acted. 

3 ‘‘(ii) FISCAL YEARS 2014 THROUGH

4 2017.—For each of fiscal years 2014 

5 through 2017, the fees under subpara6 graph (A) for such fiscal year shall be due 

7 on the later of— 

8 ‘‘(I) the first business day on or 

9 after October 1 of each such year; or 

10 ‘‘(II) the first business day after 

11 the enactment of an appropriations 

12 Act providing for the collection and 

13 obligation of fees under this section 

14 for such year. 

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

16 this part, a generic drug submission or Type II 

17 pharmaceutical master file is deemed to be ‘sub18 mitted’ to the Food and Drug Administration— 

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

20 Drug Administration electronic gateway, on the 

21 day when transmission to that electronic gate22 way is completed, except that a submission or 

23 master file that arrives on a weekend, Federal 

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1 sion is not otherwise open for business shall be 

2 deemed to be submitted on the next day when 

3 that office is open for business; and 

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

5 form, on the day it arrives at the appropriate 

6 designated document room of the Food and 

7 Drug Administration. 

8 ‘‘(b) FEE REVENUE AMOUNTS.— 

9 ‘‘(1) IN GENERAL.— 

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

11 2013, fees under subsection (a) shall be estab12 lished to generate a total estimated revenue 

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

14 Of that amount— 

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

16 by the one-time backlog fee for generic 

17 drug applications pending on October 1, 

18 2012, established in subsection (a)(1); and 

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

20 by the fees under paragraphs (2) through 

21 (4) of subsection (a). 

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

23 For each of the fiscal years 2014 through 2017, 

24 fees under paragraphs (2) through (4) of sub25 section (a) shall be established to generate a 


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1 total estimated revenue amount under such sub2 section that is equal to $299,000,000, as ad3 justed pursuant to subsection (c). 

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

5 under paragraph (1) to generate the revenue 

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

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

8 years 2014 through 2017, such fees shall be derived 

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

10 subsection (a) as follows: 

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

12 under subsection (a)(2) (relating to drug mas13 ter files). 

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

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

16 new drug applications and supplements). The 

17 amount of a fee for a prior approval supplement 

18 shall be half the amount of the fee for an ab19 breviated new drug application. 

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

21 under subsection (a)(4)(A)(i) (relating to ge22 neric drug facilities). The amount of the fee for 

23 a facility located outside the United States and 

24 its territories and possessions shall be not less 

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1 er than the amount of the fee for a facility lo2 cated in the United States and its territories 

3 and possessions, as determined by the Secretary 

4 on the basis of data concerning the difference 

5 in cost between inspections of facilities located 

6 in the United States, including its territories 

7 and possessions, and those located outside of 

8 the United States and its territories and posses9 sions. 

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

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

12 pharmaceutical ingredient facilities). The 

13 amount of the fee for a facility located outside 

14 the United States and its territories and posses15 sions shall be not less than $15,000 and not 

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

17 the fee for a facility located in the United 

18 States, including its territories and possessions, 

19 as determined by the Secretary on the basis of 

20 data concerning the difference in cost between 

21 inspections of facilities located in the United 

22 States and its territories and possessions and 

23 those located outside of the United States and 

24 its territories and possessions. 

25 ‘‘(c) ADJUSTMENTS.— 


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

2 2014 and subsequent fiscal years, the revenues es3 tablished in subsection (b) shall be adjusted by the 

4 Secretary by notice, published in the Federal Reg5 ister, for a fiscal year, by an amount equal to the 

6 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 

15 costs to total costs of human generic drug ac16 tivities for the first 3 years of the preceding 4 

17 fiscal years; 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 

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

23 preceding 4 years of available data multiplied 

24 by the proportion of all costs other than per25 sonnel compensation and benefits costs to total 


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1 costs of human generic drug activities for the 

2 first 3 years of the preceding 4 fiscal years. 

3 The adjustment made each fiscal year under this 

4 subsection shall be added on a compounded basis to 

5 the sum of all adjustments made each fiscal year 

6 after fiscal year 2013 under this subsection. 

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

8 year 2017, the Secretary may, in addition to adjust9 ments under paragraph (1), further increase the fee 

10 revenues and fees established in subsection (b) if 

11 such an adjustment is necessary to provide for not 

12 more than 3 months of operating reserves of carry13 over user fees for human generic drug activities for 

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

15 may only be used in fiscal year 2018. If such an ad16 justment is necessary, the rationale for the amount 

17 of the increase shall be contained in the annual no18 tice establishing fee revenues and fees for fiscal year 

19 2017. If the Secretary has carryover balances for 

20 such activities in excess of 3 months of such oper21 ating reserves, the adjustment under this subpara22 graph shall not be made. 

23 ‘‘(d) ANNUAL FEE SETTING.— 

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

25 2013— 


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1 ‘‘(A) the Secretary shall establish, by Octo2 ber 31, 2012, the one-time generic drug backlog 

3 fee for generic drug applications pending on Oc4 tober 1, 2012, the drug master file fee, the ab5 breviated new drug application fee, and the 

6 prior approval supplement fee under subsection 

7 (a), based on the revenue amounts established 

8 under subsection (b); and 

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

10 later than 45 days after the date to comply 

11 with the requirement for identification of facili12 ties in subsection (f)(2), the generic drug facil13 ity fee and active pharmaceutical ingredient fa14 cility fee under subsection (a) based on the rev15 enue amounts established under subsection (b). 

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

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

18 fiscal years 2014 through 2017, the Secretary shall 

19 establish the drug master file fee, the abbreviated 

20 new drug application fee, the prior approval supple21 ment fee, the generic drug facility fee, and the active 

22 pharmaceutical ingredient facility fee under sub23 section (a) for such fiscal year, based on the revenue 

24 amounts established under subsection (b) and the 

25 adjustments provided under subsection (c). 


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1 ‘‘(3) FEE FOR ACTIVE PHARMACEUTICAL IN2 GREDIENT INFORMATION NOT INCLUDED BY REF3 ERENCE TO TYPE II ACTIVE PHARMACEUTICAL IN4 GREDIENT DRUG MASTER FILE.—In establishing the 

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

6 the fee under subsection (a)(3)(F) shall be deter7 mined by multiplying— 

8 ‘‘(A) the sum of— 

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

10 pharmaceutical ingredients in such submis11 sion; and 

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

13 manufactured at more than one such facil14 ity, the total number of such additional fa15 cilities; and 

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

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

18 submission. 

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

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

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

22 allocated for human generic drug activities. 

23 ‘‘(f) IDENTIFICATION OF FACILITIES.— 

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

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


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1 Secretary shall cause to be published in the Federal 

2 Register a notice requiring each person that owns a 

3 facility described in subsection (a)(4)(A), or a site or 

4 organization required to be identified by paragraph 

5 (4), to submit to the Secretary information on the 

6 identity of each such facility, site, or organization. 

7 The notice required by this paragraph shall specify 

8 the type of information to be submitted and the 

9 means and format for submission of such informa10 tion. 

11 ‘‘(2) REQUIRED SUBMISSION OF FACILITY

12 IDENTIFICATION.—Each person that owns a facility 

13 described in subsection (a)(4)(A) or a site or organi14 zation required to be identified by paragraph (4) 

15 shall submit to the Secretary the information re16 quired under this subsection each year. Such infor17 mation shall— 

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

19 later than 60 days after the publication of the 

20 notice under paragraph (1); and 

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

22 submitted, updated, or reconfirmed on or before 

23 June 1 of the previous year. 


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

2 the submission required by paragraph (2) shall in3 clude for each such facility— 

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

5 intended to be identified in an approved or 

6 pending generic drug submission; 

7 ‘‘(B) whether the facility manufactures ac8 tive pharmaceutical ingredients or finished dos9 age forms, or both; 

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

11 within the United States and its territories and 

12 possessions; 

13 ‘‘(D) whether the facility manufactures 

14 positron emission tomography drugs solely, or 

15 in addition to other drugs; and 

16 ‘‘(E) whether the facility manufactures 

17 drugs that are not generic drugs. 

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

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

20 or operates a site or organization described in 

21 subparagraph (B) shall submit to the Secretary 

22 information concerning the ownership, name, 

23 and address of the site or organization. 

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

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1 graph if it is identified in a generic drug sub2 mission and is— 

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

4 study is conducted; 

5 ‘‘(ii) a clinical research organization; 

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

7 or 

8 ‘‘(iv) a contract repackager site. 

9 ‘‘(C) NOTICE.—The Secretary may, by no10 tice published in the Federal Register, specify 

11 the means and format for submission of the in12 formation under subparagraph (A) and may 

13 specify, as necessary for purposes of this sec14 tion, any additional information to be sub15 mitted. 

16 ‘‘(D) INSPECTION AUTHORITY.—The Sec17 retary’s inspection authority under section 

18 704(a)(1) shall extend to all such sites and or19 ganizations. 

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

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

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

23 the Secretary placing the person that owns the ab24 breviated new drug application subject to that fee on 

25 an arrears list, such that no new abbreviated new 


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1 drug applications or supplement submitted on or 

2 after October 1, 2012, from that person, or any af3 filiate of that person, will be received within the 

4 meaning of section 505(j)(5)(A) until such out5 standing fee is paid. 

6 ‘‘(2) DRUG MASTER FILE FEE.— 

7 ‘‘(A) Failure to pay the fee under sub8 section (a)(2) within 20 calendar days after the 

9 applicable due date under subparagraph (E) of 

10 such subsection (as described in subsection 

11 (a)(2)(D)(ii)(I)) shall result in the Type II ac12 tive pharmaceutical ingredient drug master file 

13 not being deemed available for reference. 

14 ‘‘(B)(i) Any generic drug submission sub15 mitted on or after October 1, 2012, that ref16 erences, by a letter of authorization, a Type II 

17 active pharmaceutical ingredient drug master 

18 file that has not been deemed available for ref19 erence shall not be received within the meaning 

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

21 specified in clause (ii) is met. 

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

23 is that the fee established under subsection 

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

25 the Secretary providing the notification to the 


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1 sponsor of the abbreviated new drug application 

2 or supplement of the failure of the owner of the 

3 Type II active pharmaceutical ingredient drug 

4 master file to pay the drug master file fee as 

5 specified in subparagraph (C). 

6 ‘‘(C)(i) If an abbreviated new drug applica7 tion or supplement to an abbreviated new drug 

8 application references a Type II active pharma9 ceutical ingredient drug master file for which a 

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

11 paid by the applicable date under subsection 

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

13 of the abbreviated new drug application or sup14 plement of the failure of the owner of the Type 

15 II active pharmaceutical ingredient drug master 

16 file to pay the applicable fee. 

17 ‘‘(ii) If such fee is not paid within 20 cal18 endar days of the Secretary providing the noti19 fication, the abbreviated new drug application 

20 or supplement to an abbreviated new drug ap21 plication shall not be received within the mean22 ing of 505(j)(5)(A). 

23 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION

24 FEE AND PRIOR APPROVAL SUPPLEMENT FEE.— 

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


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

2 applicable due date under subparagraph (C) of such 

3 subsection shall result in the abbreviated new drug 

4 application or the prior approval supplement to an 

5 abbreviated new drug application not being received 

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

7 such outstanding fee is paid. 

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

9 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

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

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

12 of the due date as specified in subparagraph 

13 (D) of such subsection shall result in the fol14 lowing: 

15 ‘‘(i) The Secretary shall place the fa16 cility on a publicly available arrears list, 

17 such that no new abbreviated new drug ap18 plication or supplement submitted on or 

19 after October 1, 2012, from the person 

20 that is responsible for paying such fee, or 

21 any affiliate of that person, will be received 

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

23 ‘‘(ii) Any new generic drug submission 

24 submitted on or after October 1, 2012, 

25 that references such a facility shall not be 


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1 received, within the meaning of section 

2 505(j)(5)(A) if the outstanding facility fee 

3 is not paid within 20 calendar days of the 

4 Secretary providing the notification to the 

5 sponsor of the failure of the owner of the 

6 facility to pay the facility fee under sub7 section (a)(4)(C). 

8 ‘‘(iii) All drugs or active pharma9 ceutical ingredients manufactured in such 

10 a facility or containing an ingredient man11 ufactured in such a facility shall be deemed 

12 misbranded under section 502(aa). 

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

14 penalties under this paragraph shall apply until 

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

16 or the facility is removed from all generic drug 

17 submissions that refer to the facility. 

18 ‘‘(C) NONRECEIVAL FOR NONPAYMENT.— 

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

20 drug application or supplement to an ab21 breviated new drug application submitted 

22 on or after October 1, 2012, references a 

23 facility for which a facility fee has not been 

24 paid by the applicable date under sub25 section (a)(4)(C), the Secretary shall notify 


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1 the sponsor of the generic drug submission 

2 of the failure of the owner of the facility 

3 to pay the facility fee. 

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

5 fee is not paid within 20 calendar days of 

6 the Secretary providing the notification 

7 under clause (i), the abbreviated new drug 

8 application or supplement to an abbre9 viated new drug application shall not be re10 ceived within the meaning of section 

11 505(j)(5)(A). 

12 ‘‘(h) LIMITATIONS.— 

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

14 shall be refunded for a fiscal year beginning after 

15 fiscal year 2012, unless appropriations for salaries 

16 and expenses of the Food and Drug Administration 

17 for such fiscal year (excluding the amount of fees 

18 appropriated for such fiscal year) are equal to or 

19 greater than the amount of appropriations for the 

20 salaries and expenses of the Food and Drug Admin21 istration for the fiscal year 2009 (excluding the 

22 amount of fees appropriated for such fiscal year) 

23 multiplied by the adjustment factor (as defined in 

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


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

2 assess fees under subsection (a) during any portion 

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

4 year the Secretary may assess such fees, the Sec5 retary may assess and collect such fees, without any 

6 modification in the rate, for Type II active pharma7 ceutical ingredient drug master files, abbreviated 

8 new drug applications and prior approval supple9 ments, and generic drug facilities and active phar10 maceutical ingredient facilities at any time in such 

11 fiscal year notwithstanding the provisions of sub12 section (a) relating to the date fees are to be paid. 

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

14 ‘‘(1) IN GENERAL.—Fees authorized under sub15 section (a) shall be collected and available for obliga16 tion only to the extent and in the amount provided 

17 in advance in appropriations Acts, subject to para18 graph (2). Such fees are authorized to remain avail19 able until expended. Such sums as may be necessary 

20 may be transferred from the Food and Drug Admin21 istration salaries and expenses appropriation account 

22 without fiscal year limitation to such appropriation 

23 account for salaries and expenses with such fiscal 

24 year limitation. The sums transferred shall be avail25 able solely for human generic drug activities. 


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1 ‘‘(2) COLLECTIONS AND APPROPRIATION

2 ACTS.— 

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

4 by this section— 

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

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

7 fiscal year in an amount not to exceed the 

8 amount specified in appropriation Acts, or 

9 otherwise made available for obligation for 

10 such fiscal year; and 

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

12 beginning after fiscal year 2012 to defray 

13 the costs of human generic drug activities 

14 (including such costs for an additional 

15 number of full-time equivalent positions in 

16 the Department of Health and Human 

17 Services to be engaged in such activities), 

18 only if the Secretary allocates for such 

19 purpose an amount for such fiscal year 

20 (excluding amounts from fees collected 

21 under this section) no less than 

22 $97,000,000 multiplied by the adjustment 

23 factor defined in section 744A(3) applica24 ble to the fiscal year involved. 


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

2 be considered to have met the requirements of 

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

4 costs funded by appropriations and allocated for 

5 human generic activities are not more than 10 

6 percent below the level specified in such sub7 paragraph. 

8 ‘‘(C) FEE COLLECTION DURING FIRST

9 PROGRAM YEAR.—Until the date of enactment 

10 of an Act making appropriations through Sep11 tember 30, 2013 for the salaries and expenses 

12 account of the Food and Drug Administration, 

13 fees authorized by this section for fiscal year 

14 2013, may be collected and shall be credited to 

15 such account and remain available until ex16 pended. 

17 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

18 SUBSEQUENT YEARS.—Payment of fees author19 ized under this section for a fiscal year (after 

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

21 fees, may be accepted by the Secretary in ac22 cordance with authority provided in advance in 

23 a prior year appropriations Act. 

24 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

25 For each of the fiscal years 2013 through 2017, 


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1 there is authorized to be appropriated for fees under 

2 this section an amount equivalent to the total rev3 enue amount determined under subsection (b) for 

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

5 applicable, or as otherwise affected under paragraph 

6 (2) of this subsection. 

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

8 where the Secretary does not receive payment of a fee as9 sessed under subsection (a) within 30 calendar days after 

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

11 States Government subject to subchapter II of chapter 37 

12 of title 31, United States Code. 

13 ‘‘(k) CONSTRUCTION.—This section may not be con14 strued to require that the number of full-time equivalent 

15 positions in the Department of Health and Human Serv16 ices, for officers, employees, and advisory committees not 

17 engaged in human generic drug activities, be reduced to 

18 offset the number of officers, employees, and advisory 

19 committees so engaged. 

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

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

22 an application for a positron emission tomography 

23 drug or active pharmaceutical ingredient for a 

24 positron emission tomography drug shall not require 

25 the payment of any fee under this section. Facilities 


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1 that solely produce positron emission tomography 

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

3 established in subsection (a)(4). 

4 ‘‘(2) IDENTIFICATION REQUIREMENT.—Facili5 ties that produce positron emission tomography 

6 drugs or active pharmaceutical ingredients of such 

7 drugs are required to be identified pursuant to sub8 section (f). 

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

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

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

12 a written request justifying such return within 180 cal13 endar days after such fee was paid. 

14 ‘‘(n) SUBSTANTIALLY COMPLETE APPLICATIONS.— 

15 An abbreviated new drug application that is not consid16 ered to be received within the meaning of section 

17 505(j)(5)(A) because of failure to pay an applicable fee 

18 under this provision within the time period specified in 

19 subsection (g) shall be deemed not to have been ‘substan20 tially complete’ on the date of its submission within the 

21 meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbre22 viated new drug application that is not substantially com23 plete on the date of its submission solely because of failure 

24 to pay an applicable fee under the preceding sentence shall 

25 be deemed substantially complete and received within the 


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1 meaning of section 505(j)(5)(A) as of the date such appli2 cable fee is received.’’. 

3 SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

5 section 302 of this Act, is amended by inserting after sec6 tion 744B the following: 

7 ‘‘SEC. 744C. REAUTHORIZATION; REPORTING REQUIRE8 MENTS. 

9 ‘‘(a) PERFORMANCE REPORT.— 

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

11 2013, not later than 120 days after the end of each 

12 fiscal year for which fees are collected under this 

13 part, the Secretary shall prepare and submit to the 

14 Committee on Energy and Commerce of the House 

15 of Representatives and the Committee on Health, 

16 Education, Labor, and Pensions of the Senate a re17 port concerning the progress of the Food and Drug 

18 Administration in achieving the goals identified in 

19 the letters described in section 301(b) of the Generic 

20 Drug User Fee Amendments of 2012 during such 

21 fiscal year and the future plans of the Food and 

22 Drug Administration for meeting the goals. 

23 ‘‘(2) REGULATORY SCIENCE ACCOUNTABILITY

24 METRICS.—The report required by paragraph (1) 

25 shall describe the amounts spent, data generated, 


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1 and activities undertaken, including any FDA Advi2 sory Committee consideration, by the Secretary for 

3 each of the local acting bioequivalence topics (Topics 

4 1–3) in the Regulatory Science Plan described in the 

5 letters described in section 301(b) of the Generic 

6 Drug User Fee Amendments of 2012. 

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

8 2013, not later than 120 days after the end of each fiscal 

9 year for which fees are collected under this part, the Sec10 retary shall prepare and submit to the Committee on En11 ergy and Commerce of the House of Representatives and 

12 the Committee on Health, Education, Labor, and Pen13 sions of the Senate a report on the implementation of the 

14 authority for such fees during such fiscal year and the 

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

16 collected for such fiscal year. 

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

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

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

20 Food and Drug Administration. 

21 ‘‘(d) REAUTHORIZATION.— 

22 ‘‘(1) CONSULTATION.—In developing rec23 ommendations to present to the Congress with re24 spect to the goals, and plans for meeting the goals, 

25 for human generic drug activities for the first 5 fisVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 cal years after fiscal year 2017, and for the reau2 thorization of this part for such fiscal years, the Sec3 retary shall consult with— 

4 ‘‘(A) the Committee on Energy and Com5 merce of the House of Representatives; 

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

7 Labor, and Pensions of the Senate; 

8 ‘‘(C) scientific and academic experts; 

9 ‘‘(D) health care professionals; 

10 ‘‘(E) representatives of patient and con11 sumer advocacy groups; and 

12 ‘‘(F) the generic drug industry. 

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

14 negotiations with the generic drug industry on the 

15 reauthorization of this part, the Secretary shall— 

16 ‘‘(A) publish a notice in the Federal Reg17 ister requesting public input on the reauthoriza18 tion; 

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

20 public may present its views on the reauthoriza21 tion, including specific suggestions for changes 

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

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

24 public meeting to obtain written comments from 

25 the public suggesting changes to this part; and 


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

2 and Drug Administration’s Internet Web site. 

3 ‘‘(3) PERIODIC CONSULTATION.—Not less fre4 quently than once every month during negotiations 

5 with the generic drug industry, the Secretary shall 

6 hold discussions with representatives of patient and 

7 consumer advocacy groups to continue discussions of 

8 their views on the reauthorization and their sugges9 tions for changes to this part as expressed under 

10 paragraph (2). 

11 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA12 TIONS.—After negotiations with the generic drug in13 dustry, the Secretary shall— 

14 ‘‘(A) present the recommendations devel15 oped under paragraph (1) to the congressional 

16 committees specified in such paragraph; 

17 ‘‘(B) publish such recommendations in the 

18 Federal Register; 

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

20 the public to provide written comments on such 

21 recommendations; 

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

23 may present its views on such recommenda24 tions; and 


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1 ‘‘(E) after consideration of such public 

2 views and comments, revise such recommenda3 tions as necessary. 

4 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

5 Not later than January 15, 2017, the Secretary 

6 shall transmit to the Congress the revised rec7 ommendations under paragraph (4), a summary of 

8 the views and comments received under such para9 graph, and any changes made to the recommenda10 tions in response to such views and comments. 

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

12 ‘‘(A) PUBLIC AVAILABILITY.—Before pre13 senting the recommendations developed under 

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

15 Secretary shall make publicly available, on the 

16 Internet Web site of the Food and Drug Ad17 ministration, minutes of all negotiation meet18 ings conducted under this subsection between 

19 the Food and Drug Administration and the ge20 neric drug industry. 

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

22 under subparagraph (A) shall summarize any 

23 substantive proposal made by any party to the 

24 negotiations as well as significant controversies 


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1 or differences of opinion during the negotiations 

2 and their resolution.’’. 

3 SEC. 304. SUNSET DATES. 

4 (a) AUTHORIZATION.—Sections 744A and 744B, as 

5 added by section 302 of this Act, are repealed October 

6 1, 2017. 

7 (b) REPORTING REQUIREMENTS.—Section 744C, as 

8 added by section 303 of this Act, is repealed January 31, 

9 2018. 

10 SEC. 305. EFFECTIVE DATE. 

11 The amendments made by this title shall take effect 

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

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

14 shall be assessed for all human generic drug submissions 

15 and Type II active pharmaceutical drug master files re16 ceived on or after October 1, 2012, regardless of the date 

17 of enactment of this title. 

18 SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING. 

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

20 at the end the following: 

21 ‘‘(aa) If it is a drug, or an active pharmaceutical in22 gredient, and it was manufactured, prepared, propagated, 

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

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

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


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1 has not been submitted, or it contains an active pharma2 ceutical ingredient that was manufactured, prepared, 

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

4 SEC. 307. STREAMLINED HIRING AUTHORITY TO SUPPORT 

5 ACTIVITIES RELATED TO HUMAN GENERIC 

6 DRUGS. 

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

8 amended— 

9 (1) by amending subsection (b) to read as fol10 lows: 

11 ‘‘(b) ACTIVITIES DESCRIBED.—The activities de12 scribed in this subsection are— 

13 ‘‘(1) activities under this Act related to the 

14 process for the review of device applications (as de15 fined in section 737(8)); and 

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

17 generic drug activities (as defined in section 

18 744A).’’; and 

19 (2) by amending subsection (c) to read as fol20 lows: 

21 ‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci22 fied in this subsection are— 

23 ‘‘(1) with respect to the activities under sub24 section (b)(1), the goals referred to in section 

25 738A(a)(1); and 


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1 ‘‘(2) with respect to the activities under sub2 section (b)(2), the goals referred to in section 

3 744C(a).’’. 

4 TITLE IV—FEES RELATING TO 

5 BIOSIMILAR BIOLOGICAL 

6 PRODUCTS 

7 SEC. 401. SHORT TITLE; FINDING. 

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

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

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

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

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

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


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1 SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL 

2 PRODUCTS. 

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

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

5 III of this Act, the following: 

6 ‘‘PART 8—FEES RELATING TO BIOSIMILAR 

7 BIOLOGICAL PRODUCTS 

8 ‘‘SEC. 744G. DEFINITIONS. 

9 ‘‘For purposes of this part: 

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

11 a fiscal year that is the Consumer Price Index for 

12 all urban consumers (Washington-Baltimore, DC– 

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

14 the preceding fiscal year divided by such Index for 

15 September 2011. 

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

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

20 the power to control, the other business entity; 

21 or 

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

23 to control, both of the business entities. 

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

25 means a product for which a biosimilar biological 

26 product application has been approved. 


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

2 ‘biosimilar biological product application’ means an 

3 application for licensure of a biological product 

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

5 Act. 

6 ‘‘(B) Such term does not include— 

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

8 ‘‘(ii) an application filed under section 

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

10 cites as the reference product a bovine blood 

11 product for topical application licensed before 

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

14 ‘‘(iii) an application filed under section 

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

16 respect to— 

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

18 for transfusion; 

19 ‘‘(II) an allergenic extract product; 

20 ‘‘(III) an in vitro diagnostic biological 

21 product; or 

22 ‘‘(IV) a biological product for further 

23 manufacturing use only; or 

24 ‘‘(iv) an application for licensure under 

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


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

3 commercially. 

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

6 a biosimilar initial advisory meeting, regarding the 

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

9 support a biosimilar biological product application. 

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

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

14 product development. 

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

16 establishment’ means a foreign or domestic place of 

17 business— 

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

19 consisting of one or more buildings, all of which 

20 are within five miles of each other; and 

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

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

25 term ‘manufactured’ does not include packaging. 


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

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

4 limited to— 

5 ‘‘(i) a general discussion regarding 

6 whether licensure under section 351(k) of 

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

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

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

14 full study reports. 

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

16 the process for the review of biosimilar biological 

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

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

21 and Drug Administration, contractors of the 

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

25 such contractors; 


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

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

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

5 repair of facilities and acquisition, maintenance, 

6 and repair of fixtures, furniture, scientific 

7 equipment, and other necessary materials and 

8 supplies; and 

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

10 and accounting for resources allocated for the 

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

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

16 respect to a biosimilar biological product, a finished 

17 dosage form which is approved for administration to 

18 a patient without substantial further manufacturing 

19 (such as lyophilized products before reconstitution). 

20 ‘‘(11) The term ‘financial hold’— 

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

24 the Secretary determines that the investigation 

25 is intended to support a biosimilar biological 


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1 product application and the sponsor has failed 

2 to pay any fee for the product required under 

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

4 744H(a)(1); and 

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

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

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

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

10 such person. 

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

13 following activities of the Secretary with respect to 

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

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

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


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

5 ‘‘(C) The inspection of biosimilar biological 

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

8 pending biosimilar biological product applica9 tions and supplements. 

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

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

13 ‘‘(E) Monitoring of research conducted in 

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

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

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

23 reports. 


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1 ‘‘(ii) Developing and using improved 

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

4 ‘‘(iii) Developing and using improved 

5 analytical tools to assess potential safety 

6 problems, including access to external data 

7 bases. 

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

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

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

14 (relating to adverse-event reports and 

15 postmarket safety activities). 

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

17 to the Secretary to approve a change in a biosimilar 

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

20 Secretary determine that the biosimilar biological 

21 product meets the standards for interchangeability 

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

23 Service Act. 


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

2 BIOLOGICAL PRODUCT FEES. 

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

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

6 ‘‘(1) BIOSIMILAR DEVELOPMENT PROGRAM

7 FEES.— 

8 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

9 PRODUCT DEVELOPMENT FEE.— 

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

11 submits to the Secretary a meeting request 

12 described under clause (ii) or a clinical 

13 protocol for an investigational new drug 

14 protocol described under clause (iii) shall 

15 pay for the product named in the meeting 

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

18 product development fee established under 

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

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

23 development meeting for a product. 

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

25 A clinical protocol for an investigational 

26 new drug protocol described in this clause 


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1 is a clinical protocol consistent with the 

2 provisions of section 505(i), including any 

3 regulations promulgated under section 

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

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

9 product. 

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

12 shall be due by the earlier of the following: 

13 ‘‘(I) Not later than 5 days after 

14 the Secretary grants a request for a 

15 biosimilar biological product develop16 ment meeting. 

17 ‘‘(II) The date of submission of 

18 an investigational new drug applica19 tion describing an investigation that 

20 the Secretary determines is intended 

21 to support a biosimilar biological 

22 product application. 

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

25 new drug application prior to the date of 


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1 enactment of the Biosimilars User Fee Act 

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

5 ‘‘(I) Not later than 60 days after 

6 the date of the enactment of the 

7 Biosimilars User Fee Act of 2012, if 

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

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

14 the Secretary grants a request for a 

15 biosimilar biological product develop16 ment meeting. 

17 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

18 PRODUCT DEVELOPMENT FEE.— 

19 ‘‘(i) IN GENERAL.—A person that 

20 pays an initial biosimilar biological product 

21 development fee for a product shall pay for 

22 such product, beginning in the fiscal year 

23 following the fiscal year in which the initial 

24 biosimilar biological product development 

25 fee was paid, an annual fee established 


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

2 biological product development (referred to 

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

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

8 the later of— 

9 ‘‘(I) the first business day on or 

10 after October 1 of each such year; or 

11 ‘‘(II) the first business day after 

12 the enactment of an appropriations 

13 Act providing for the collection and 

14 obligation of fees for such year under 

15 this section. 

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

18 fiscal year will be due on the date specified 

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

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

22 was accepted for filing; or 

23 ‘‘(II) discontinued participation 

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1 velopment program for the product 

2 under subparagraph (C). 

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

5 in the biosimilar biological product development 

6 program for a product effective October 1 of a 

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

8 preceding fiscal year— 

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

11 submitted, submitting to the Secretary a 

12 written declaration that the person has no 

13 present intention of further developing the 

14 product as a biosimilar biological product; 

15 or 

16 ‘‘(ii) if an investigational new drug 

17 application concerning the product has 

18 been submitted, by withdrawing the inves19 tigational new drug application in accord20 ance with part 312 of title 21, Code of 

21 Federal Regulations (or any successor reg22 ulations). 

23 ‘‘(D) REACTIVATION FEE.— 

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

25 discontinued participation in the biosimilar 


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1 biological product development program for 

2 a product under subparagraph (C) shall 

3 pay a fee (referred to in this section as ‘re4 activation fee’) by the earlier of the fol5 lowing: 

6 ‘‘(I) Not later than 5 days after 

7 the Secretary grants a request for a 

8 biosimilar biological product develop9 ment meeting for the product (after 

10 the date on which such participation 

11 was discontinued). 

12 ‘‘(II) Upon the date of submis13 sion (after the date on which such 

14 participation was discontinued) of an 

15 investigational new drug application 

16 describing an investigation that the 

17 Secretary determines is intended to 

18 support a biosimilar biological product 

19 application for that product. 

20 ‘‘(ii) APPLICATION OF ANNUAL

21 FEE.—A person that pays a reactivation 

22 fee for a product shall pay for such prod23 uct, beginning in the next fiscal year, the 

24 annual biosimilar biological product devel25 opment fee under subparagraph (B). 


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1 ‘‘(E) EFFECT OF FAILURE TO PAY BIO2 SIMILAR DEVELOPMENT PROGRAM FEES.— 

3 ‘‘(i) NO BIOSIMILAR BIOLOGICAL

4 PRODUCT DEVELOPMENT MEETINGS.—If a 

5 person has failed to pay an initial or an6 nual biosimilar biological product develop7 ment fee as required under subparagraph 

8 (A) or (B), or a reactivation fee as re9 quired under subparagraph (D), the Sec10 retary shall not provide a biosimilar bio11 logical product development meeting relat12 ing to the product for which fees are owed. 

13 ‘‘(ii) NO RECEIPT OF INVESTIGA14 TIONAL NEW DRUG APPLICATIONS.—Ex15 cept in extraordinary circumstances, the 

16 Secretary shall not consider an investiga17 tional new drug application to have been 

18 received under section 505(i)(2) if— 

19 ‘‘(I) the Secretary determines 

20 that the investigation is intended to 

21 support a biosimilar biological product 

22 application; and 

23 ‘‘(II) the sponsor has failed to 

24 pay an initial or annual biosimilar bio25 logical product development fee for 


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1 the product as required under sub2 paragraph (A) or (B), or a reactiva3 tion fee as required under subpara4 graph (D). 

5 ‘‘(iii) FINANCIAL HOLD.—Notwith6 standing section 505(i)(2), except in ex7 traordinary circumstances, the Secretary 

8 shall prohibit the sponsor of a clinical in9 vestigation from continuing the investiga10 tion if— 

11 ‘‘(I) the Secretary determines 

12 that the investigation is intended to 

13 support a biosimilar biological product 

14 application; and 

15 ‘‘(II) the sponsor has failed to 

16 pay an initial or annual biosimilar bio17 logical product development fee for 

18 the product as required under sub19 paragraph (A) or (B), or a reactiva20 tion fee for the product as required 

21 under subparagraph (D). 

22 ‘‘(iv) NO ACCEPTANCE OF BIOSIMILAR

23 BIOLOGICAL PRODUCT APPLICATIONS OR

24 SUPPLEMENTS.—If a person has failed to 

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1 cal product development fee as required 

2 under subparagraph (A) or (B), or a reac3 tivation fee as required under subpara4 graph (D), any biosimilar biological prod5 uct application or supplement submitted by 

6 that person shall be considered incomplete 

7 and shall not be accepted for filing by the 

8 Secretary until all such fees owed by such 

9 person have been paid. 

10 ‘‘(F) LIMITS REGARDING BIOSIMILAR DE11 VELOPMENT PROGRAM FEES.— 

12 ‘‘(i) NO REFUNDS.—The Secretary 

13 shall not refund any initial or annual bio14 similar biological product development fee 

15 paid under subparagraph (A) or (B), or 

16 any reactivation fee paid under subpara17 graph (D). 

18 ‘‘(ii) NO WAIVERS, EXEMPTIONS, OR

19 REDUCTIONS.—The Secretary shall not 

20 grant a waiver, exemption, or reduction of 

21 any initial or annual biosimilar biological 

22 product development fee due or payable 

23 under subparagraph (A) or (B), or any re24 activation fee due or payable under sub25 paragraph (D). 


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1 ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLI2 CATION AND SUPPLEMENT FEE.— 

3 ‘‘(A) IN GENERAL.—Each person that sub4 mits, on or after October 1, 2012, a biosimilar 

5 biological product application or a supplement 

6 shall be subject to the following fees: 

7 ‘‘(i) A fee for a biosimilar biological 

8 product application that is equal to— 

9 ‘‘(I) the amount of the fee estab10 lished under subsection (b)(1)(D) for 

11 a biosimilar biological product applica12 tion; minus 

13 ‘‘(II) the cumulative amount of 

14 fees paid, if any, under subparagraphs 

15 (A), (B), and (D) of paragraph (1) 

16 for the product that is the subject of 

17 the application. 

18 ‘‘(ii) A fee for a biosimilar biological 

19 product application for which clinical data 

20 (other than comparative bioavailability 

21 studies) with respect to safety or effective22 ness are not required, that is equal to— 

23 ‘‘(I) half of the amount of the fee 

24 established under subsection (b)(1)(D) 


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1 for a biosimilar biological product ap2 plication; minus 

3 ‘‘(II) the cumulative amount of 

4 fees paid, if any, under subparagraphs 

5 (A), (B), and (D) of paragraph (1) 

6 for that product. 

7 ‘‘(iii) A fee for a supplement for which 

8 clinical data (other than comparative bio9 availability studies) with respect to safety 

10 or effectiveness are required, that is equal 

11 to half of the amount of the fee established 

12 under subsection (b)(1)(D) for a biosimilar 

13 biological product application. 

14 ‘‘(B) REDUCTION IN FEES.—Notwith15 standing section 404 of the Biosimilars User 

16 Fee Act of 2012, any person who pays a fee 

17 under subparagraph (A), (B), or (D) of para18 graph (1) for a product before October 1, 2017, 

19 but submits a biosimilar biological product ap20 plication for that product after such date, shall 

21 be entitled to the reduction of any biosimilar bi22 ological product application fees that may be 

23 assessed at the time when such biosimilar bio24 logical product application is submitted, by the 

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1 graphs (A), (B), and (D) of paragraph (1) for 

2 that product. 

3 ‘‘(C) PAYMENT DUE DATE.—Any fee re4 quired by subparagraph (A) shall be due upon 

5 submission of the application or supplement for 

6 which such fee applies. 

7 ‘‘(D) EXCEPTION FOR PREVIOUSLY FILED

8 APPLICATION OR SUPPLEMENT.—If a biosimilar 

9 biological product application or supplement 

10 was submitted by a person that paid the fee for 

11 such application or supplement, was accepted 

12 for filing, and was not approved or was with13 drawn (without a waiver), the submission of a 

14 biosimilar biological product application or a 

15 supplement for the same product by the same 

16 person (or the person’s licensee, assignee, or 

17 successor) shall not be subject to a fee under 

18 subparagraph (A). 

19 ‘‘(E) REFUND OF APPLICATION FEE IF AP20 PLICATION REFUSED FOR FILING OR WITH21 DRAWN BEFORE FILING.—The Secretary shall 

22 refund 75 percent of the fee paid under this 

23 paragraph for any application or supplement 

24 which is refused for filing or withdrawn without 

25 a waiver before filing. 


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1 ‘‘(F) FEES FOR APPLICATIONS PRE2 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

3 BEFORE FILING.—A biosimilar biological prod4 uct application or supplement that was sub5 mitted but was refused for filing, or was with6 drawn before being accepted or refused for fil7 ing, shall be subject to the full fee under sub8 paragraph (A) upon being resubmitted or filed 

9 over protest, unless the fee is waived under sub10 section (c). 

11 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTAB12 LISHMENT FEE.— 

13 ‘‘(A) IN GENERAL.—Except as provided in 

14 subparagraph (E), each person that is named 

15 as the applicant in a biosimilar biological prod16 uct application shall be assessed an annual fee 

17 established under subsection (b)(1)(E) for each 

18 biosimilar biological product establishment that 

19 is listed in the approved biosimilar biological 

20 product application as an establishment that 

21 manufactures the biosimilar biological product 

22 named in such application. 

23 ‘‘(B) ASSESSMENT IN FISCAL YEARS.—The 

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1 uct named in the application is assessed a fee 

2 under paragraph (4) unless the biosimilar bio3 logical product establishment listed in the appli4 cation does not engage in the manufacture of 

5 the biosimilar biological product during such 

6 fiscal year. 

7 ‘‘(C) DUE DATE.—The establishment fee 

8 for a fiscal year shall be due on the later of— 

9 ‘‘(i) the first business day on or after 

10 October 1 of such fiscal year; or 

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

12 enactment of an appropriations Act pro13 viding for the collection and obligation of 

14 fees for such fiscal year under this section. 

15 ‘‘(D) APPLICATION TO ESTABLISHMENT.— 

16 ‘‘(i) Each biosimilar biological product 

17 establishment shall be assessed only one 

18 fee per biosimilar biological product estab19 lishment, notwithstanding the number of 

20 biosimilar biological products manufac21 tured at the establishment, subject to 

22 clause (ii). 

23 ‘‘(ii) In the event an establishment is 

24 listed in a biosimilar biological product ap25 plication by more than one applicant, the 


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1 establishment fee for the fiscal year shall 

2 be divided equally and assessed among the 

3 applicants whose biosimilar biological prod4 ucts are manufactured by the establish5 ment during the fiscal year and assessed 

6 biosimilar biological product fees under 

7 paragraph (4). 

8 ‘‘(E) EXCEPTION FOR NEW PRODUCTS.— 

9 If, during the fiscal year, an applicant initiates 

10 or causes to be initiated the manufacture of a 

11 biosimilar biological product at an establish12 ment listed in its biosimilar biological product 

13 application— 

14 ‘‘(i) that did not manufacture the bio15 similar biological product in the previous 

16 fiscal year; and 

17 ‘‘(ii) for which the full biosimilar bio18 logical product establishment fee has been 

19 assessed in the fiscal year at a time before 

20 manufacture of the biosimilar biological 

21 product was begun, 

22 the applicant shall not be assessed a share of 

23 the biosimilar biological product establishment 

24 fee for the fiscal year in which the manufacture 

25 of the product began. 


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1 ‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 

2 ‘‘(A) IN GENERAL.—Each person who is 

3 named as the applicant in a biosimilar biologi4 cal product application shall pay for each such 

5 biosimilar biological product the annual fee es6 tablished under subsection (b)(1)(F). 

7 ‘‘(B) DUE DATE.—The biosimilar biologi8 cal product fee for a fiscal year shall be due on 

9 the later of— 

10 ‘‘(i) the first business day on or after 

11 October 1 of each such year; or 

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

13 enactment of an appropriations Act pro14 viding for the collection and obligation of 

15 fees for such year under this section. 

16 ‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 

17 The biosimilar biological product fee shall be 

18 paid only once for each product for each fiscal 

19 year. 

20 ‘‘(b) FEE SETTING AND AMOUNTS.— 

21 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

22 the Secretary shall, 60 days before the start of each 

23 fiscal year that begins after September 30, 2012, es24 tablish, for the next fiscal year, the fees under subVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00110 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 section (a). Except as provided in subsection (c), 

2 such fees shall be in the following amounts: 

3 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

4 PRODUCT DEVELOPMENT FEE.—The initial bio5 similar biological product development fee under 

6 subsection (a)(1)(A) for a fiscal year shall be 

7 equal to 10 percent of the amount established 

8 under section 736(c)(4) for a human drug ap9 plication described in section 736(a)(1)(A)(i) 

10 for that fiscal year. 

11 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

12 PRODUCT DEVELOPMENT FEE.—The annual 

13 biosimilar biological product development fee 

14 under subsection (a)(1)(B) for a fiscal year 

15 shall be equal to 10 percent of the amount es16 tablished under section 736(c)(4) for a human 

17 drug application described in section 

18 736(a)(1)(A)(i) for that fiscal year. 

19 ‘‘(C) REACTIVATION FEE.—The reactiva20 tion fee under subsection (a)(1)(D) for a fiscal 

21 year shall be equal to 20 percent of the amount 

22 of the fee established under section 736(c)(4) 

23 for a human drug application described in sec24 tion 736(a)(1)(A)(i) for that fiscal year. 


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1 ‘‘(D) BIOSIMILAR BIOLOGICAL PRODUCT

2 APPLICATION FEE.—The biosimilar biological 

3 product application fee under subsection (a)(2) 

4 for a fiscal year shall be equal to the amount 

5 established under section 736(c)(4) for a 

6 human drug application described in section 

7 736(a)(1)(A)(i) for that fiscal year. 

8 ‘‘(E) BIOSIMILAR BIOLOGICAL PRODUCT

9 ESTABLISHMENT FEE.—The biosimilar biologi10 cal product establishment fee under subsection 

11 (a)(3) for a fiscal year shall be equal to the 

12 amount established under section 736(c)(4) for 

13 a prescription drug establishment for that fiscal 

14 year. 

15 ‘‘(F) BIOSIMILAR BIOLOGICAL PRODUCT

16 FEE.—The biosimilar biological product fee 

17 under subsection (a)(4) for a fiscal year shall be 

18 equal to the amount established under section 

19 736(c)(4) for a prescription drug product for 

20 that fiscal year. 

21 ‘‘(2) LIMIT.—The total amount of fees charged 

22 for a fiscal year under this section may not exceed 

23 the total amount for such fiscal year of the costs of 

24 resources allocated for the process for the review of 

25 biosimilar biological product applications. 


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1 ‘‘(c) APPLICATION FEE WAIVER FOR SMALL BUSI2 NESS.— 

3 ‘‘(1) WAIVER OF APPLICATION FEE.—The Sec4 retary shall grant to a person who is named in a bio5 similar biological product application a waiver from 

6 the application fee assessed to that person under 

7 subsection (a)(2)(A) for the first biosimilar biologi8 cal product application that a small business or its 

9 affiliate submits to the Secretary for review. After a 

10 small business or its affiliate is granted such a waiv11 er, the small business or its affiliate shall pay— 

12 ‘‘(A) application fees for all subsequent 

13 biosimilar biological product applications sub14 mitted to the Secretary for review in the same 

15 manner as an entity that is not a small busi16 ness; and 

17 ‘‘(B) all supplement fees for all supple18 ments to biosimilar biological product applica19 tions submitted to the Secretary for review in 

20 the same manner as an entity that is not a 

21 small business. 

22 ‘‘(2) CONSIDERATIONS.—In determining wheth23 er to grant a waiver of a fee under paragraph (1), 

24 the Secretary shall consider only the circumstances 


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1 and assets of the applicant involved and any affiliate 

2 of the applicant. 

3 ‘‘(3) SMALL BUSINESS DEFINED.—In this sub4 section, the term ‘small business’ means an entity 

5 that has fewer than 500 employees, including em6 ployees of affiliates, and does not have a drug prod7 uct that has been approved under a human drug ap8 plication (as defined in section 735) or a biosimilar 

9 biological product application (as defined in section 

10 744G(4)) and introduced or delivered for introduc11 tion into interstate commerce. 

12 ‘‘(d) EFFECT OF FAILURE TO PAY FEES.—A bio13 similar biological product application or supplement sub14 mitted by a person subject to fees under subsection (a) 

15 shall be considered incomplete and shall not be accepted 

16 for filing by the Secretary until all fees owed by such per17 son have been paid. 

18 ‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

19 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

20 fees authorized under subsection (a) shall be col21 lected and available for obligation only to the extent 

22 and in the amount provided in advance in appropria23 tions Acts. Such fees are authorized to remain avail24 able until expended. Such sums as may be necessary 

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1 istration salaries and expenses appropriation account 

2 without fiscal year limitation to such appropriation 

3 account for salaries and expenses with such fiscal 

4 year limitation. The sums transferred shall be avail5 able solely for the process for the review of bio6 similar biological product applications. 

7 ‘‘(2) COLLECTIONS AND APPROPRIATION

8 ACTS.— 

9 ‘‘(A) IN GENERAL.—Subject to subpara10 graphs (C) and (D), the fees authorized by this 

11 section shall be collected and available in each 

12 fiscal year in an amount not to exceed the 

13 amount specified in appropriation Acts, or oth14 erwise made available for obligation for such 

15 fiscal year. 

16 ‘‘(B) USE OF FEES AND LIMITATION.— 

17 The fees authorized by this section shall be 

18 available for a fiscal year beginning after fiscal 

19 year 2012 to defray the costs of the process for 

20 the review of biosimilar biological product appli21 cations (including such costs for an additional 

22 number of full-time equivalent positions in the 

23 Department of Health and Human Services to 

24 be engaged in such process), only if the Sec25 retary allocates for such purpose an amount for 


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1 such fiscal year (excluding amounts from fees 

2 collected under this section) no less than 

3 $20,000,000, multiplied by the adjustment fac4 tor applicable to the fiscal year involved. 

5 ‘‘(C) FEE COLLECTION DURING FIRST

6 PROGRAM YEAR.—Until the date of enactment 

7 of an Act making appropriations through Sep8 tember 30, 2013, for the salaries and expenses 

9 account of the Food and Drug Administration, 

10 fees authorized by this section for fiscal year 

11 2013 may be collected and shall be credited to 

12 such account and remain available until ex13 pended. 

14 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

15 SUBSEQUENT YEARS.—Payment of fees author16 ized under this section for a fiscal year (after 

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

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

20 a prior year appropriations Act. 

21 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

22 For each of fiscal years 2013 through 2017, there 

23 is authorized to be appropriated for fees under this 

24 section an amount equivalent to the total amount of 

25 fees assessed for such fiscal year under this section. 


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1 ‘‘(f) COLLECTION OF UNPAID FEES.—In any case 

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

4 such fee shall be treated as a claim of the United States 

5 Government subject to subchapter II of chapter 37 of title 

6 31, United States Code. 

7 ‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND RE8 FUNDS.—To qualify for consideration for a waiver under 

9 subsection (c), or for a refund of any fee collected in ac10 cordance with subsection (a)(2)(A), a person shall submit 

11 to the Secretary a written request for such waiver or re12 fund not later than 180 days after such fee is due. 

13 ‘‘(h) CONSTRUCTION.—This section may not be con14 strued to require that the number of full-time equivalent 

15 positions in the Department of Health and Human Serv16 ices, for officers, employers, and advisory committees not 

17 engaged in the process of the review of biosimilar biologi18 cal product applications, be reduced to offset the number 

19 of officers, employees, and advisory committees so en20 gaged.’’. 

21 SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS. 

22 Part 8 of subchapter C of chapter VII, as added by 

23 section 402 of this Act, is further amended by inserting 

24 after section 744H the following: 


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

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

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

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

6 the Secretary shall prepare and submit to the Committee 

7 on Energy and Commerce of the House of Representatives 

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

9 Pensions of the Senate a report concerning the progress 

10 of the Food and Drug Administration in achieving the 

11 goals identified in the letters described in section 401(b) 

12 of the Biosimilar User Fee Act of 2012 during such fiscal 

13 year and the future plans of the Food and Drug Adminis14 tration for meeting such goals. The report for a fiscal year 

15 shall include information on all previous cohorts for which 

16 the Secretary has not given a complete response on all 

17 biosimilar biological product applications and supplements 

18 in the cohort. 

19 ‘‘(b) FISCAL REPORT.—Not later than 120 days after 

20 the end of fiscal year 2013 and each subsequent fiscal year 

21 for which fees are collected under this part, the Secretary 

22 shall prepare and submit to the Committee on Energy and 

23 Commerce of the House of Representatives and the Com24 mittee on Health, Education, Labor, and Pensions of the 

25 Senate a report on the implementation of the authority 

26 for such fees during such fiscal year and the use, by the 


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1 Food and Drug Administration, of the fees collected for 

2 such fiscal year. 

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

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

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

6 Food and Drug Administration. 

7 ‘‘(d) STUDY.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall con9 tract with an independent accounting or consulting 

10 firm to study the workload volume and full costs as11 sociated with the process for the review of biosimilar 

12 biological product applications. 

13 ‘‘(2) INTERIM RESULTS.—Not later than June 

14 1, 2015, the Secretary shall publish, for public com15 ment, interim results of the study described under 

16 paragraph (1). 

17 ‘‘(3) FINAL RESULTS.—Not later than Sep18 tember 30, 2016, the Secretary shall publish, for 

19 public comment, the final results of the study de20 scribed under paragraph (1). 

21 ‘‘(e) REAUTHORIZATION.— 

22 ‘‘(1) CONSULTATION.—In developing rec23 ommendations to present to the Congress with re24 spect to the goals described in subsection (a), and 

25 plans for meeting the goals, for the process for the 


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1 review of biosimilar biological product applications 

2 for the first 5 fiscal years after fiscal year 2017, and 

3 for the reauthorization of this part for such fiscal 

4 years, the Secretary shall consult with— 

5 ‘‘(A) the Committee on Energy and Com6 merce of the House of Representatives; 

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

8 Labor, and Pensions of the Senate; 

9 ‘‘(C) scientific and academic experts; 

10 ‘‘(D) health care professionals; 

11 ‘‘(E) representatives of patient and con12 sumer advocacy groups; and 

13 ‘‘(F) the regulated industry. 

14 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA15 TIONS.—After negotiations with the regulated indus16 try, the Secretary shall— 

17 ‘‘(A) present the recommendations devel18 oped under paragraph (1) to the congressional 

19 committees specified in such paragraph; 

20 ‘‘(B) publish such recommendations in the 

21 Federal Register; 

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

23 the public to provide written comments on such 

24 recommendations; 


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

2 may present its views on such recommenda3 tions; and 

4 ‘‘(E) after consideration of such public 

5 views and comments, revise such recommenda6 tions as necessary. 

7 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

8 Not later than January 15, 2017, the Secretary 

9 shall transmit to the Congress the revised rec10 ommendations under paragraph (2), a summary of 

11 the views and comments received under such para12 graph, and any changes made to the recommenda13 tions in response to such views and comments.’’. 

14 SEC. 404. SUNSET DATES. 

15 (a) AUTHORIZATION.—Sections 744G and 744H, as 

16 added by section 402 of this Act, are repealed October 

17 1, 2017. 

18 (b) REPORTING REQUIREMENTS.—Section 744I, as 

19 added by section 403 of this Act, is repealed January 31, 

20 2018. 

21 SEC. 405. EFFECTIVE DATE. 

22 (a) IN GENERAL.—Except as provided under sub23 section (b), the amendments made by this title shall take 

24 effect on the later of— 

25 (1) October 1, 2012; or 


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1 (2) the date of the enactment of this title. 

2 (b) EXCEPTION.—Fees under part 8 of subchapter 

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

4 Act, as added by this title, shall be assessed for all bio5 similar biological product applications received on or after 

6 October 1, 2012, regardless of the date of the enactment 

7 of this title. 

8 SEC. 406. SAVINGS CLAUSE. 

9 Notwithstanding the amendments made by this title, 

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

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

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

13 be in effect with respect to human drug applications and 

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

15 were accepted by the Food and Drug Administration for 

16 filing on or after October 1, 2007, but before October 1, 

17 2012, with respect to assessing and collecting any fee re18 quired by such part for a fiscal year prior to fiscal year 

19 2013. 

20 SEC. 407. CONFORMING AMENDMENT. 

21 Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amend22 ed by striking ‘‘or (k)’’. 


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1 TITLE V—REAUTHORIZATION OF 

2 BEST PHARMACEUTICALS 

3 FOR CHILDREN ACT AND PE4 DIATRIC RESEARCH EQUITY 

5 ACT 

6 SEC. 501. PERMANENT EXTENSION OF BEST PHARMA7 CEUTICALS FOR CHILDREN ACT AND PEDI8 ATRIC RESEARCH EQUITY ACT. 

9 (a) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 

10 Section 409I(c) of the Public Health Service Act (42 

11 U.S.C. 284m(c)) is amended— 

12 (1) in subsection (c)(1)— 

13 (A) in the matter preceding subparagraph 

14 (A), by inserting ‘‘or section 351(m) of this 

15 Act,’’ after ‘‘Cosmetic Act,’’; 

16 (B) in subparagraph (A)(i), by inserting 

17 ‘‘or section 351(k) of this Act’’ after ‘‘Cosmetic 

18 Act’’; and 

19 (C) by amending subparagraph (B) to read 

20 as follows: 

21 ‘‘(B)(i) there remains no patent listed pur22 suant to section 505(b)(1) of the Federal Food, 

23 Drug, and Cosmetic Act; and 

24 ‘‘(ii) every three-year and five-year period 

25 referred to in subsection (c)(3)(E)(ii), 


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1 (c)(3)(E)(iii), (c)(3)(E(iv), (j)(5)(F)(ii), 

2 (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of 

3 the Federal Food, Drug and Cosmetic Act, or 

4 applicable twelve-year period referred to in sec5 tion 351(k)(7) of this Act, and any seven-year 

6 period referred to in section 527 of the Federal 

7 Food, Drug, and Cosmetic Act, has ended for 

8 at least one form of the drug; and’’; 

9 (2) in subsection (c)(2)— 

10 (A) in the heading of paragraph (2), by 

11 striking ‘‘FOR DRUGS LACKING EXCLUSIVITY’’; 

12 (B) by striking ‘‘under section 505 of the 

13 Federal Food, Drug, and Cosmetic Act’’; and 

14 (C) by striking ‘‘505A of such Act’’ and 

15 inserting ‘‘505A of the Federal Food, Drug, 

16 and Cosmetic Act or section 351(m) of this 

17 Act’’; and 

18 (3) in subsection (e)(1), by striking ‘‘to carry 

19 out this section’’ and all that follows through the 

20 end of paragraph (1) and inserting ‘‘$25,000,000 

21 for each of fiscal years 2013 through 2017.’’. 

22 (b) PEDIATRIC STUDIES OF DRUGS IN FFDCA.— 

23 Section 505A (21 U.S.C. 355a) is amended— 

24 (1) in subsection (d)(1)(A), by adding at the 

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1 graph does not request studies in neonates, such re2 quest shall include a statement describing the ra3 tionale for not requesting studies in neonates.’’; 

4 (2) by amending subsection (h) to read as fol5 lows: 

6 ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE7 QUIREMENTS.—Exclusivity under this section shall only be 

8 granted for the completion of a study or studies that are 

9 the subject of a written request and for which reports are 

10 submitted and accepted in accordance with subsection 

11 (d)(3). Written requests under this section may consist of 

12 a study or studies required under section 505B.’’; 

13 (3) in subsection (k)(2), by striking ‘‘subsection 

14 (f)(3)(F)’’ and inserting ‘‘subsection (f)(6)(F)’’; 

15 (4) in subsection (l)— 

16 (A) in paragraph (1)— 

17 (i) in the paragraph heading, by strik18 ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 

19 MONTH PERIOD’’; and 

20 (ii) by striking ‘‘one-year’’ and insert21 ing ‘‘18-month’’; 

22 (B) in paragraph (2)— 

23 (i) in the paragraph heading, by strik24 ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; 

25 and 


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1 (ii) by striking ‘‘one-year period’’ and 

2 inserting ‘‘18-month period’’; 

3 (C) by redesignating paragraph (3) as 

4 paragraph (4); and 

5 (D) by inserting after paragraph (2) the 

6 following: 

7 ‘‘(3) PRESERVATION OF AUTHORITY.—Nothing 

8 in this subsection shall prohibit the Office of Pedi9 atric Therapeutics from providing for the review of 

10 adverse event reports by the Pediatric Advisory 

11 Committee prior to the 18-month period referred to 

12 in paragraph (1), if such review is necessary to en13 sure safe use of a drug in a pediatric population.’’; 

14 (5) in subsection (n)— 

15 (A) in the subsection heading, by striking 

16 ‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; 

17 and 

18 (B) in paragraph (1)— 

19 (i) in the text preceding subparagraph 

20 (A), by striking ‘‘have not been completed’’ 

21 and inserting ‘‘have not been submitted by 

22 the date specified in the written request 

23 issued and agreed upon’’; and 

24 (ii) by revising subparagraphs (A) and 

25 (B) to read as follows: 


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1 ‘‘(A) For a drug for which there remains 

2 any listed patent or exclusivity protection eligi3 ble for extension under subsection (b)(1) or 

4 (c)(1) of this section, or any exclusivity protec5 tion eligible for extension under subsection 

6 (m)(2) or (m)(3) of section 351 of the Public 

7 Health Service Act, the Secretary shall make a 

8 determination regarding whether an assessment 

9 shall be required to be submitted under section 

10 505B(b). 

11 ‘‘(B) For a drug that has no remaining 

12 listed patents or exclusivity protection eligible 

13 for extension under subsection (b)(1) or (c)(1) 

14 of this section, or any exclusivity protection eli15 gible for extension under subsection (m)(2) or 

16 (m)(3) of section 351 of the Public Health 

17 Service Act, the Secretary shall refer the drug 

18 for inclusion on the list established under sec19 tion 409I of the Public Health Service Act for 

20 the conduct of studies.’’; 

21 (6) in subsection (o)(2), by amending subpara22 graph (B) to read as follows: 

23 ‘‘(B) a statement of any appropriate pedi24 atric contraindications, warnings, precautions, 


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1 or other information that the Secretary con2 siders necessary to assure safe use.’’; and 

3 (7) by striking subsection (q) (relating to a sun4 set). 

5 (c) RESEARCH INTO PEDIATRIC USES FOR DRUGS

6 AND BIOLOGICAL PROJECTS IN FFDCA.—Section 505B 

7 (21 U.S.C. 355c) is amended— 

8 (1) in subsection (a)— 

9 (A) in paragraph (1), in the matter before 

10 subparagraph (A), by inserting ‘‘for a drug’’ 

11 after ‘‘(or supplement to an application)’’; 

12 (B) in paragraph (3)— 

13 (i) by redesignating subparagraph (B) 

14 as subparagraph (D); and 

15 (ii) by inserting after subparagraph 

16 (A) the following: 

17 ‘‘(B) DEFERRAL EXTENSION.—On the ini18 tiative of the Secretary or at the request of the 

19 applicant, the Secretary may grant an extension 

20 of a deferral under subparagraph (A) if— 

21 ‘‘(i) the Secretary finds that the cri22 teria specified in subclause (II) or (III) of 

23 subparagraph (A)(i) continue to be met; 

24 and 


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1 ‘‘(ii) the applicant submits the mate2 rials required under subparagraph (A)(ii). 

3 ‘‘(C) CONSIDERATION DURING DEFERRAL

4 PERIOD.—If the Secretary has under this para5 graph deferred the date by which an assessment 

6 must be submitted, then until the date specified 

7 in the deferral under subparagraph (A) (includ8 ing any extension of such date under subpara9 graph (B))— 

10 ‘‘(i) the assessment shall not be con11 sidered late or delayed; 

12 ‘‘(ii) the Secretary shall not classify 

13 the assessment as late or delayed in any 

14 report, database, or public posting.’’; and 

15 (iii) in subparagraph (D), as redesig16 nated, by amending clause (ii) to read as 

17 follows: 

18 ‘‘(ii) PUBLIC AVAILABILITY.—Not 

19 later than 60 days after the submission to 

20 the Secretary of the information submitted 

21 through the annual review under clause (i), 

22 the Secretary shall make available to the 

23 public in an easily accessible manner, in24 cluding through the Web site of the Food 

25 and Drug Administration— 


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1 ‘‘(I) such information; 

2 ‘‘(II) the name of the applicant 

3 for the product subject to the assess4 ment; 

5 ‘‘(III) the date on which the 

6 product was approved; and 

7 ‘‘(IV) the date of each deferral or 

8 deferral extension under this para9 graph for the product.’’; and 

10 (C) in paragraph (4)(C)— 

11 (i) in the first sentence, by inserting 

12 ‘‘partial’’ before ‘‘waiver is granted’’; and 

13 (ii) in the second sentence, by striking 

14 ‘‘either a full or partial waiver’’ and insert15 ing ‘‘a partial waiver’’; 

16 (2) in subsection (b)(1), by striking ‘‘After pro17 viding notice in the form of a letter (that, for a drug 

18 approved under section 505, references a declined 

19 written request under section 505A for a labeled in20 dication which written request is not referred under 

21 section 505A(n)(1)(A) to the Foundation of the Na22 tional Institutes of Health for the pediatric studies), 

23 the Secretary’’ and inserting ‘‘The Secretary’’; 

24 (3) by amending subsection (d) to read as fol25 lows: 


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1 ‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a per2 son fails to submit a required assessment described in sub3 section (a)(2), fails to meet the applicable requirements 

4 in subsection (a)(3), or fails to submit a request for ap5 proval of a pediatric formulation described in subsection 

6 (a) or (b), in accordance with applicable provisions of sub7 sections (a) and (b)— 

8 ‘‘(1)(A) the Secretary shall issue a letter to 

9 such person informing such person of such failure; 

10 ‘‘(B) not later than 30 calendar days after the 

11 issuance of a letter under subparagraph (A), the 

12 person who receives such letter shall submit to the 

13 Secretary a written response to such letter; and 

14 ‘‘(C) not later than 45 calendar days after the 

15 issuance of a letter under subparagraph (A), the 

16 Secretary shall make such letter, and any response 

17 to such letter under subparagraph (B), available to 

18 the public on the Web site of the Food and Drug 

19 Administration, with appropriate redactions made to 

20 protect trade secrets and confidential commercial in21 formation, except that, if the Secretary determines 

22 that the letter under subparagraph (A) was issued 

23 in error, the requirements of this subparagraph shall 

24 not apply with respect to such letter; and 


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1 ‘‘(2)(A) the drug or biological product that is 

2 the subject of the required assessment, applicable re3 quirements in subsection (a)(3), or required request 

4 for approval of a pediatric formulation may be con5 sidered misbranded solely because of that failure and 

6 subject to relevant enforcement action (except that 

7 the drug or biological product shall not be subject to 

8 action under section 303); but 

9 ‘‘(B) the failure to submit the required assess10 ment, meet the applicable requirements in subsection 

11 (a)(3), or submit the required request for approval 

12 of a pediatric formulation shall not be the basis for 

13 a proceeding— 

14 ‘‘(i) to withdraw approval for a drug under 

15 section 505(e); or 

16 ‘‘(ii) to revoke the license for a biological 

17 product under section 351 of the Public Health 

18 Service Act.’’; 

19 (4) by amending subsection (e) to read as fol20 lows: 

21 ‘‘(e) INITIAL PEDIATRIC PLAN.— 

22 ‘‘(1) IN GENERAL.— 

23 ‘‘(A) SUBMISSION.—An applicant who is 

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1 section (a)(1) shall submit an initial pediatric 

2 plan. 

3 ‘‘(B) TIMING.—An applicant shall submit 

4 the initial pediatric plan under paragraph (1)— 

5 ‘‘(i) before the date on which the ap6 plicant submits the assessments under sub7 section (a)(2); and 

8 ‘‘(ii) not later than— 

9 ‘‘(I) 60 calendar days after the 

10 date of end-of-Phase 2 meeting (as 

11 such term is used in section 312.47 of 

12 title 21, Code of Federal Regulations, 

13 or successor regulations); or 

14 ‘‘(II) such other time as may be 

15 agreed upon between the Secretary 

16 and the applicant. 

17 Nothing in this section shall preclude the Sec18 retary from accepting the submission of an ini19 tial pediatric plan earlier than the date other20 wise applicable under this subparagraph. 

21 ‘‘(C) CONTENTS.—The initial pediatric 

22 plan shall include— 

23 ‘‘(i) an outline of the pediatric studies 

24 that the applicant plans to conduct; 


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1 ‘‘(ii) any request for a deferral, partial 

2 waiver, or waiver under this section, along 

3 with supporting information; and 

4 ‘‘(iii) other information the Secretary 

5 determines necessary, including any infor6 mation specified in regulations under para7 graph (5). 

8 ‘‘(2) MEETING.— 

9 ‘‘(A) IN GENERAL.—Subject to subpara10 graph (B), not later than 90 calendar days 

11 after receiving an initial pediatric plan under 

12 paragraph (1), the Secretary shall meet with 

13 the applicant to discuss the plan. 

14 ‘‘(B) WRITTEN RESPONSE.—If the Sec15 retary determines that a written response to the 

16 initial pediatric plan is sufficient to commu17 nicate comments on the initial pediatric plan, 

18 and that no meeting is necessary the Secretary 

19 shall, not later than 90 days after receiving an 

20 initial pediatric plan under paragraph (1)— 

21 ‘‘(i) notify the applicant of such deter22 mination; and 

23 ‘‘(ii) provide to the applicant the Sec24 retary’s written comments on the plan. 

25 ‘‘(3) AGREED PEDIATRIC PLAN.— 


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1 ‘‘(A) SUBMISSION.—The applicant shall 

2 submit to the Secretary a document reflecting 

3 the agreement between the Secretary and the 

4 applicant on the initial pediatric plan (referred 

5 to in this subsection as an ‘agreed pediatric 

6 plan’). 

7 ‘‘(B) CONFIRMATION.—Not later than 30 

8 days after receiving the agreed pediatric plan 

9 under subparagraph (A), the Secretary shall 

10 provide written confirmation to the applicant 

11 that such plan reflects the agreement of the 

12 Secretary. 

13 ‘‘(C) DEFERRAL AND WAIVER.—If the 

14 agreed pediatric plan contains a request from 

15 the applicant for a deferral, partial waiver, or 

16 waiver under this section, the written confirma17 tion under subparagraph (B) shall include a 

18 recommendation from the Secretary as to 

19 whether such request meets the standards 

20 under paragraphs (3) or (4) of subsection (a). 

21 ‘‘(D) AMENDMENTS TO THE PLAN.—At 

22 the initiative of the Secretary or the applicant, 

23 the agreed pediatric plan may be amended at 

24 any time. The requirements of paragraph (2) 

25 shall apply to any such proposed amendment in 


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1 the same manner and to the same extent as 

2 such requirements apply to an initial pediatric 

3 plan under paragraph (1). The requirements of 

4 subparagraphs (A) through (C) of this para5 graph shall apply to any agreement resulting 

6 from such proposed amendment in the same 

7 manner and to the same extent as such require8 ments apply to an agreed pediatric plan. 

9 ‘‘(4) INTERNAL COMMITTEE.—The Secretary 

10 shall consult the internal committee under section 

11 505C on the review of the initial pediatric plan, 

12 agreed pediatric plan, and any amendments to such 

13 plans. 

14 ‘‘(5) MANDATORY RULEMAKING.—Not later 

15 than one year after the date of enactment of the 

16 Food and Drug Administration Reform Act of 2012, 

17 the Secretary shall promulgate proposed regulations 

18 and guidance to implement the provisions of this 

19 subsection. 

20 ‘‘(6) EFFECTIVE DATE.—The provisions of this 

21 subsection shall take effect 180 calendar days after 

22 the date of enactment of the Food and Drug Admin23 istration Reform Act of 2012, irrespective of wheth24 er the Secretary has promulgated final regulations 

25 to carry out this subsection by such date.’’; 


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1 (5) in subsection (f)— 

2 (A) in the subsection heading, by inserting 

3 ‘‘DEFERRAL EXTENSIONS,’’ after ‘‘DEFER4 RALS,’’; 

5 (B) in paragraph (4)— 

6 (i) in the paragraph heading, by in7 serting ‘‘DEFERRAL EXTENSIONS,’’ after 

8 ‘‘DEFERRALS,’’; and 

9 (ii) in the second sentence, by insert10 ing ‘‘, deferral extensions,’’ after ‘‘defer11 rals’’; and 

12 (C) in paragraph (6)(D)— 

13 (i) by inserting ‘‘and deferral exten14 sions’’ before ‘‘requested and granted’’; 

15 and 

16 (ii) by inserting ‘‘and deferral exten17 sions’’ after ‘‘the reasons for such defer18 rals’’; 

19 (6) in subsection (g)— 

20 (A) in paragraph (1)(A), by striking ‘‘after 

21 the date of the submission of the application or 

22 supplement’’ and inserting ‘‘after the date of 

23 the submission of an application or supplement 

24 that receives a priority review or 330 days after 

25 the date of the submission of an application or 


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1 supplement that receives a standard review’’; 

2 and 

3 (B) in paragraph (2), by striking ‘‘the 

4 label of such product’’ and inserting ‘‘the label5 ing of such product’’; 

6 (7) in subsection (h)(1)— 

7 (A) by inserting ‘‘an application (or sup8 plement to an application) that contains’’ after 

9 ‘‘date of submission of’’; and 

10 (B) by inserting ‘‘if the application (or 

11 supplement) receives a priority review, or not 

12 later than 330 days after the date of submis13 sion of an application (or supplement to an ap14 plication) that contains a pediatric assessment 

15 under this section, if the application (or supple16 ment) receives a standard review,’’ after ‘‘under 

17 this section,’’; 

18 (8) in subsection (i)— 

19 (A) in paragraph (1)— 

20 (i) in the paragraph heading, by strik21 ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 

22 MONTH PERIOD’’; and 

23 (ii) by striking ‘‘one-year’’ and insert24 ing ‘‘18-month’’; 

25 (B) in paragraph (2)— 


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1 (i) in the paragraph heading, by strik2 ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; 

3 and 

4 (ii) by striking ‘‘one-year period’’ and 

5 inserting ‘‘18-month period’’; 

6 (C) by redesignating paragraph (3) as 

7 paragraph (4); and 

8 (D) by inserting after paragraph (2) the 

9 following: 

10 ‘‘(3) PRESERVATION OF AUTHORITY.—Nothing 

11 in this subsection shall prohibit the Office of Pedi12 atric Therapeutics from providing for the review of 

13 adverse event reports by the Pediatric Advisory 

14 Committee prior to the 18-month period referred to 

15 in paragraph (1), if such review is necessary to en16 sure safe use of a drug in a pediatric population.’’; 

17 (9) by striking subsection (m) (relating to inte18 gration with other pediatric studies); and 

19 (10) by redesignating subsection (n) as sub20 section (m). 

21 (d) PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS

22 IN PHSA.—Section 351(m)(1) of the Public Health Serv23 ice Act (42 U.S.C. 262(m)(1)) is amended by striking ‘‘(f), 

24 (i), (j), (k), (l), (p), and (q)’’ and inserting ‘‘(f), (h), (i), 

25 (j), (k), (l), (n), and (p)’’. 


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1 (e) APPLICATION; TRANSITION RULE.— 

2 (1) APPLICATION.—Notwithstanding any provi3 sion of section 505A and 505B of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) 

5 stating that a provision applies beginning on the 

6 date of the enactment of the Best Pharmaceuticals 

7 for Children Act of 2007 or the date of the enact8 ment of the Pediatric Research Equity Act of 2007, 

9 any amendment made by this Act to such a provi10 sion applies beginning on the date of the enactment 

11 of this Act. 

12 (2) TRANSITIONAL RULE FOR ADVERSE EVENT

13 REPORTING.—With respect to a drug for which a la14 beling change described under section 505A(l)(1) or 

15 505B(i)(1) of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is approved 

17 or made, respectively, during the one-year period 

18 that ends on the day before the date of enactment 

19 of this Act, the Secretary shall apply section 505A(l) 

20 and section 505B(i), as applicable, to such drug, as 

21 such sections were in effect on such day. 

22 (f) CONFORMING AMENDMENT.—Section 

23 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 

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1 tion 505A(n)(1)(A) of the Federal Food, Drug, and Cos2 metic Act’’. 

3 (g) PUBLIC MEETING ON PEDIATRIC CANCERS.— 

4 Not later than December 31, 2013, the Secretary of 

5 Health and Human Services shall hold a public meeting 

6 on the impact of sections 505A and 505B of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) 

8 on the development of new therapies for children with can9 cer. 

10 SEC. 502. FOOD AND DRUG ADMINISTRATION REPORT. 

11 (a) IN GENERAL.—Not later than four years after 

12 the date of enactment of this Act and every five years 

13 thereafter, the Secretary of Health and Human Services 

14 shall prepare and submit to the Committee on Health, 

15 Education, Labor and Pensions of the Senate and the 

16 Committee on Energy and Commerce of the House of 

17 Representatives, and make publicly available, including 

18 through posting on the Web site of the Food and Drug 

19 Administration, a report on the implementation of section 

20 505A and 505B. 

21 (b) CONTENTS.—The report described in paragraph 

22 (1) shall include— 

23 (1) an assessment of the effectiveness of sec24 tions 505A and 505B in improving information 

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1 logics, including the number and type of labeling 

2 changes made since the date of enactment of this 

3 Act; 

4 (2) the number of waivers and partial waivers 

5 granted under section 505B since the date of enact6 ment of this Act, and the reasons such waivers and 

7 partial waivers were granted; 

8 (3) the number of deferrals and deferral exten9 sions granted under section 505B since the date of 

10 enactment of this Act, and the reasons such defer11 rals and deferral extensions were granted; 

12 (4) the number of letters issued under section 

13 505B(d); 

14 (5) an assessment of the timeliness and effec15 tiveness of pediatric study planning since the date of 

16 enactment of this Act, including the number of pedi17 atric plans not submitted in accordance with the re18 quirements of section 505B(e) and any resulting 

19 rulemaking; 

20 (6) the number of written requests issued, ac21 cepted, and declined under section 505A since the 

22 date of enactment of this Act, and a listing of any 

23 important gaps in pediatric information as a result 

24 of such declined requests; 


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1 (7) a description and current status of referrals 

2 made under section 505A(n); 

3 (8) an assessment of the effectiveness of study4 ing drugs for rare diseases under 505A; 

5 (9) an assessment of the effectiveness of study6 ing drugs for children with cancer under 505A and 

7 505B, and any recommendations for modifications 

8 to the programs under such sections that would lead 

9 to new and better therapies for children with cancer; 

10 (10) an assessment of the effectiveness of 

11 studying drugs in the neonate population under 

12 505A and 505B; 

13 (11) an assessment of the effectiveness of 

14 studying biological products in pediatric populations 

15 under 505A and 505B; 

16 (12) an assessment of the Secretary’s efforts to 

17 address the suggestions and options described in the 

18 report required under 505A(p); 

19 (13) any suggestions for modification to the 

20 programs that would improve pediatric drug re21 search and increase pediatric labeling of drugs and 

22 biologics that the Secretary determines to be appro23 priate. 

24 (c) STAKEHOLDER COMMENT.—At least 180 days 

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1 graph (1), the Secretary shall consult with representatives 

2 of patient groups, including pediatric patient groups, con3 sumer groups, regulated industry, academia, and other in4 terested parties to obtain any recommendations or infor5 mation relevant to the study and report including sugges6 tions for modifications that would improve pediatric drug 

7 research and pediatric labeling of drugs and biologics. 

8 SEC. 503. INTERNAL COMMITTEE FOR REVIEW OF PEDI9 ATRIC PLANS, ASSESSMENTS, DEFERRALS, 

10 DEFERRAL EXTENSIONS, AND WAIVERS. 

11 Section 505C (21 U.S.C. 355d) is amended— 

12 (1) in the section heading, by inserting ‘‘DE13 FERRAL EXTENSIONS,’’ after ‘‘DEFERRALS,’’; 

14 and 

15 (2) by inserting ‘‘neonatology’’ after ‘‘pediatric 

16 ethics’’. 

17 SEC. 504. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS. 

18 Section 6(c) of the Best Pharmaceuticals for Children 

19 Act (21 U.S.C. 393a(c)) is amended— 

20 (1) in paragraph (1), by striking ‘‘and’’ at the 

21 end; 

22 (2) by redesignating paragraph (2) as para23 graph (4); 

24 (3) by inserting after paragraph (1) the fol25 lowing: 


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1 ‘‘(2) one or more additional individuals with ex2 pertise in neonatology; 

3 ‘‘(3) one or more additional individuals with ex4 pertise in pediatric epidemiology; and’’. 

5 SEC. 505. CONTINUATION OF OPERATION OF PEDIATRIC 

6 ADVISORY COMMITTEE. 

7 Section 14(d) of the Best Pharmaceuticals for Chil8 dren Act (42 U.S.C. 284m note) is amended by striking 

9 ‘‘during the five-year period beginning on the date of the 

10 enactment of the Best Pharmaceuticals for Children Act 

11 of 2007’’ and inserting ‘‘to carry out the advisory commit12 tee’s responsibilities under sections 505A, 505B, and 

13 520(m) of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 355a, 355c, and 360j(m))’’. 

15 SEC. 506. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC 

16 DRUGS ADVISORY COMMITTEE. 

17 Section 15(a) of the Best Pharmaceuticals for Chil18 dren Act (Public Law 107–109), as amended by section 

19 502(e) of the Food and Drug Administration Amendments 

20 Act of 2007 (Public Law 110–85), is amended— 

21 (1) in paragraph (1)(D), by striking ‘‘section 

22 505B(f)’’ and inserting ‘‘section 505C’’; and 

23 (2) in paragraph (3), by striking ‘‘during the 

24 five-year period beginning on the date of the enact25 ment of the Best Pharmaceuticals for Children Act 


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1 of 2007’’ and inserting ‘‘to carry out the Sub2 committee’s responsibilities under this section’’. 

3 TITLE VI—FOOD AND DRUG AD4 MINISTRATION ADMINISTRA5 TIVE REFORMS 

6 SEC. 601. PUBLIC PARTICIPATION IN ISSUANCE OF FDA 

7 GUIDANCE DOCUMENTS. 

8 Section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended 

9 by striking subparagraph (C) and inserting the following: 

10 ‘‘(C) For any guidance document that sets 

11 forth initial interpretations of a statute or regu12 lation, sets forth changes in interpretation or 

13 policy that are of more than a minor nature, in14 cludes complex scientific issues, or covers highly 

15 controversial issues— 

16 ‘‘(i) the Secretary— 

17 ‘‘(I) at least 30 days before 

18 issuance of a draft of such guidance 

19 document, shall publish notice in the 

20 Federal Register of the Secretary’s in21 tent to prepare such guidance docu22 ment; and 

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1 holders, including industry, medical, 

2 and scientific experts and others, and 

3 solicit public comment; 

4 ‘‘(ii) if the Secretary for good cause 

5 finds that, with respect to such guidance 

6 document, compliance with clause (i) is im7 practicable, unnecessary, or contrary to the 

8 public interest— 

9 ‘‘(I) the Secretary shall publish 

10 such finding and a brief statement of 

11 the reasons for such finding in the 

12 Federal Register; 

13 ‘‘(II) clause (i) shall not apply 

14 with respect to such guidance docu15 ment; and 

16 ‘‘(III) during a 90-day period be17 ginning not later than the date of 

18 issuance of the draft of such guidance 

19 document, the Secretary may meet 

20 with interested stakeholders, including 

21 industry, medical, and scientific ex22 perts and others, and shall solicit pub23 lic comment; 

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1 tion Reform Act of 2012, upon issuance of 

2 a draft guidance document under clause (i) 

3 or (ii), the Secretary shall— 

4 ‘‘(I) designate the document as 

5 draft or final; and 

6 ‘‘(II) not later than 18 months 

7 after the close of the comment period 

8 for such guidance, issue a final 

9 version of such guidance document in 

10 accordance with clauses (i) and (ii); 

11 ‘‘(iv) the Secretary may extend the 

12 deadline for issuing final guidance under 

13 clause (iii)(II) by not more than 180 days 

14 upon submission by the Secretary of a no15 tification of such extension in the Federal 

16 Register; 

17 ‘‘(v) if the Secretary issues a draft 

18 guidance document and fails to finalize the 

19 draft by the deadline determined under 

20 clause (iii)(II), as extended under clause 

21 (iv), the Secretary shall, beginning on the 

22 date of such deadline, treat the draft as 

23 null and void; and 

24 ‘‘(vi) not less than every 5 years after 

25 the issuance of a final guidance document 


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1 in accordance with clause (iii), the Sec2 retary shall— 

3 ‘‘(I) conduct a retrospective anal4 ysis of such guidance document to en5 sure it is not outmoded, ineffective, 

6 insufficient, or excessively burden7 some; and 

8 ‘‘(II) based on such analysis, 

9 modify, streamline, expand, or repeal 

10 the guidance document in accordance 

11 with what has been learned. 

12 ‘‘(D) With respect to devices, a notice to 

13 industry guidance letter, a notice to industry 

14 advisory letter, and any similar notice that sets 

15 forth initial interpretations of a statute or regu16 lation or sets forth changes in interpretation or 

17 policy shall be treated as a guidance document 

18 for purposes of subparagraph (C). 

19 ‘‘(E) The following shall not be treated as 

20 a guidance document for purposes of subpara21 graph (C): 

22 ‘‘(i) Any document that does not set 

23 forth an initial interpretation or a reinter24 pretation of a statute or regulation. 


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1 ‘‘(ii) Any document that sets forth or 

2 changes a policy relating to internal proce3 dures of the Food and Drug Administra4 tion. 

5 ‘‘(iii) Agency reports, general informa6 tion documents provided to consumers or 

7 health professionals, speeches, journal arti8 cles and editorials, media interviews, press 

9 materials, warning letters, memoranda of 

10 understanding, or communications directed 

11 to individual persons or firms.’’. 

12 SEC. 602. CONFLICTS OF INTEREST. 

13 (a) IN GENERAL.—Section 712 (21 U.S.C. 379d–1) 

14 is amended— 

15 (1) by striking subsections (b) and (c) and in16 serting the following subsections: 

17 ‘‘(b) RECRUITMENT FOR ADVISORY COMMITTEES.— 

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

19 ‘‘(A) develop and implement strategies on 

20 effective outreach to potential members of advi21 sory committees at universities, colleges, other 

22 academic research centers, professional and 

23 medical societies, and patient and consumer 

24 groups; 


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1 ‘‘(B) seek input from professional medical 

2 and scientific societies to determine the most ef3 fective informational and recruitment activities; 

4 ‘‘(C) at least every 180 days, request refer5 rals for potential members of advisory commit6 tees from a variety of stakeholders, including— 

7 ‘‘(i) product developers, patient 

8 groups, and disease advocacy organiza9 tions; and 

10 ‘‘(ii) relevant— 

11 ‘‘(I) professional societies; 

12 ‘‘(II) medical societies; 

13 ‘‘(III) academic organizations; 

14 and 

15 ‘‘(IV) governmental organiza16 tions; and 

17 ‘‘(D) in carrying out subparagraphs (A) 

18 and (B), take into account the levels of activity 

19 (including the numbers of annual meetings) and 

20 the numbers of vacancies of the advisory com21 mittees. 

22 ‘‘(2) RECRUITMENT ACTIVITIES.—The recruit23 ment activities under paragraph (1) may include— 


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1 ‘‘(A) advertising the process for becoming 

2 an advisory committee member at medical and 

3 scientific society conferences; 

4 ‘‘(B) making widely available, including by 

5 using existing electronic communications chan6 nels, the contact information for the Food and 

7 Drug Administration point of contact regarding 

8 advisory committee nominations; and 

9 ‘‘(C) developing a method through which 

10 an entity receiving funding from the National 

11 Institutes of Health, the Agency for Healthcare 

12 Research and Quality, the Centers for Disease 

13 Control and Prevention, or the Veterans Health 

14 Administration can identify a person whom the 

15 Food and Drug Administration can contact re16 garding the nomination of individuals to serve 

17 on advisory committees. 

18 ‘‘(3) EXPERTISE.—In carrying out this sub19 section, the Secretary shall seek to ensure that the 

20 Secretary has access to the most current expert ad21 vice. 

22 ‘‘(c) DISCLOSURE OF DETERMINATIONS AND CER23 TIFICATIONS.—Notwithstanding section 107(a)(2) of the 

24 Ethics in Government Act of 1978, the following shall 

25 apply: 


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1 ‘‘(1) 15 OR MORE DAYS IN ADVANCE.—As soon 

2 as practicable, but (except as provided in paragraph 

3 (2)) not later than 15 days prior to a meeting of an 

4 advisory committee to which a written determination 

5 as referred to in section 208(b)(1) of title 18, 

6 United States Code, or a written certification as re7 ferred to in section 208(b)(3) of such title, applies, 

8 the Secretary shall disclose (other than information 

9 exempted from disclosure under section 552 or sec10 tion 552a of title 5, United States Code (popularly 

11 known as the Freedom of Information Act and the 

12 Privacy Act of 1974, respectively)) on the Internet 

13 Website of the Food and Drug Administration— 

14 ‘‘(A) the type, nature, and magnitude of 

15 the financial interests of the advisory committee 

16 member to which such determination or certifi17 cation applies; and 

18 ‘‘(B) the reasons of the Secretary for such 

19 determination or certification, including, as ap20 propriate, the public health interest in having 

21 the expertise of the member with respect to the 

22 particular matter before the advisory com23 mittee. 

24 ‘‘(2) LESS THAN 30 DAYS IN ADVANCE.—In the 

25 case of a financial interest that becomes known to 


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1 the Secretary less than 30 days prior to a meeting 

2 of an advisory committee to which a written deter3 mination as referred to in section 208(b)(1) of title 

4 18, United States Code, or a written certification as 

5 referred to in section 208(b)(3) of such title applies, 

6 the Secretary shall disclose (other than information 

7 exempted from disclosure under section 552 or 552a 

8 of title 5, United States Code) on the Internet 

9 Website of the Food and Drug Administration, the 

10 information described in subparagraphs (A), (B), 

11 and (C) of paragraph (1) as soon as practicable 

12 after the Secretary makes such determination or cer13 tification, but in no case later than the date of such 

14 meeting.’’; 

15 (2) in subsection (d), by striking ‘‘subsection 

16 (c)(3)’’ and inserting ‘‘subsection (c)’’; 

17 (3) by amending subsection (e) to read as fol18 lows: 

19 ‘‘(e) ANNUAL REPORT.— 

20 ‘‘(1) IN GENERAL.—Not later than February 1 

21 of each year, the Secretary shall submit to the Com22 mittee on Appropriations and the Committee on 

23 Health, Education, Labor, and Pensions of the Sen24 ate, and the Committee on Appropriations and the 


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1 Committee on Energy and Commerce of the House 

2 of Representatives, a report that describes— 

3 ‘‘(A) with respect to the fiscal year that 

4 ended on September 30 of the previous year, 

5 the number of persons nominated for participa6 tion at meetings for each advisory committee, 

7 the number of persons so nominated, and will8 ing to serve, the number of vacancies on each 

9 advisory committee, and the number of persons 

10 contacted for service as members on each advi11 sory committee meeting for each advisory com12 mittee who did not participate because of the 

13 potential for such participation to constitute a 

14 disqualifying financial interest under section 

15 208 of title 18, United States Code; 

16 ‘‘(B) with respect to such year, the number 

17 of persons contacted for services as members 

18 for each advisory committee meeting for each 

19 advisory committee who did not participate be20 cause of reasons other than the potential for 

21 such participation to constitute a disqualifying 

22 financial interest under section 208 of title 18, 

23 United States Code; 


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1 ‘‘(C) with respect to such year, the number 

2 of members attending meetings for each advi3 sory committee; and 

4 ‘‘(D) with respect to such year, the aggre5 gate number of disclosures required under sub6 section (d) and the percentage of individuals to 

7 whom such disclosures did not apply who served 

8 on such committee. 

9 ‘‘(2) PUBLIC AVAILABILITY.—Not later than 30 

10 days after submitting any report under paragraph 

11 (1) to the committees specified in such paragraph, 

12 the Secretary shall make each such report available 

13 to the public.’’; and 

14 (4) in subsection (f), by striking ‘‘shall review 

15 guidance’’ and all that follows through the end of 

16 the subsection and inserting the following: ‘‘shall— 

17 ‘‘(1) review guidance of the Food and Drug Ad18 ministration with respect to advisory committees re19 garding disclosure of conflicts of interest and the ap20 plication of section 208 of title 18, United States 

21 Code; and 

22 ‘‘(2) update such guidance as necessary to en23 sure that the Food and Drug Administration re24 ceives appropriate access to needed scientific experVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00156 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 tise, with due consideration of the requirements of 

2 such section 208.’’. 

3 (b) APPLICABILITY.—The amendments made by sub4 section (a) apply beginning on October 1, 2012. 

5 SEC. 603. ELECTRONIC SUBMISSION OF APPLICATIONS. 

6 Subchapter D of chapter VII (21 U.S.C. 379k et 

7 seq.) is amended by inserting after section 745 the fol8 lowing: 

9 ‘‘SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS. 

10 ‘‘(a) DRUGS AND BIOLOGICS.— 

11 ‘‘(1) IN GENERAL.—Beginning no earlier than 

12 24 months after the issuance of a final guidance 

13 issued after public notice and opportunity for com14 ment, submissions under subsection (b), (i), or (j) of 

15 section 505 of this Act or subsection (a) or (k) of 

16 section 351 of the Public Health Service Act shall 

17 be submitted in such electronic format as specified 

18 by the Secretary in such guidance. 

19 ‘‘(2) GUIDANCE CONTENTS.—In the guidance 

20 under paragraph (1), the Secretary may— 

21 ‘‘(A) provide a timetable for establishment 

22 by the Secretary of further standards for elec23 tronic submission as required by such para24 graph; and 


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1 ‘‘(B) set forth criteria for waivers of and 

2 exemptions from the requirements of this sub3 section. 

4 ‘‘(3) EXCEPTION.—This subsection shall not 

5 apply to submissions described in section 561. 

6 ‘‘(b) DEVICES.— 

7 ‘‘(1) IN GENERAL.—Beginning after the 

8 issuance of final guidance implementing this para9 graph, pre-submissions and submissions for devices 

10 under section 510(k), 513(f)(2)(A), 515(c), 515(d), 

11 515(f), 520(g), 520(m), or 564 of this Act or section 

12 351 of the Public Health Service Act, and any sup13 plements to such pre-submissions or submissions, 

14 shall include an electronic copy of such pre-submis15 sions or submissions. 

16 ‘‘(2) GUIDANCE CONTENTS.—In the guidance 

17 under paragraph (1), the Secretary may— 

18 ‘‘(A) provide standards for the electronic 

19 copy required under such paragraph; and 

20 ‘‘(B) set forth criteria for waivers of and 

21 exemptions from the requirements of this sub22 section.’’. 


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1 SEC. 604. NOTIFICATION OF FDA INTENT TO REGULATE 

2 LABORATORY-DEVELOPED TESTS. 

3 The Food and Drug Administration may not issue 

4 any draft or final guidance on the regulation of laboratory5 developed tests under the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 301 et seq.) without, at least 60 

7 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 TITLE VII—MEDICAL DEVICE 

16 REGULATORY IMPROVEMENTS 

17 Subtitle A—Premarket 

18 Predictability 

19 SEC. 701. 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: 


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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 

12 of the device.’’. 

13 SEC. 702. 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 

21 term ‘necessary’ means the minimum re22 quired information that would support a 

23 determination by the Secretary that an ap24 plication provides reasonable assurance of 

25 the effectiveness of the device. 


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1 ‘‘(iv) Nothing in this subparagraph 

2 shall alter the criteria for evaluating an 

3 application for premarket approval of a de4 vice.’’. 

5 (b) PREMARKET NOTIFICATION UNDER SECTION

6 510(k).—Section 513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) 

7 is amended— 

8 (1) by striking ‘‘(D) Whenever’’ and inserting 

9 ‘‘(D)(i) Whenever’’; and 

10 (2) by adding at the end the following: 

11 ‘‘(ii) For purposes of clause (i), the term ‘necessary’ 

12 means the minimum required information that would sup13 port a determination of substantial equivalence between 

14 a new device and a predicate device. 

15 ‘‘(iii) Nothing in this subparagraph shall alter the 

16 standard for determining substantial equivalence between 

17 a new device and a predicate device.’’. 

18 SEC. 703. AGENCY DOCUMENTATION AND REVIEW OF SIG19 NIFICANT DECISIONS. 

20 Chapter V is amended by inserting after section 517 

21 (21 U.S.C. 360g) the following: 


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1 ‘‘SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF 

2 SIGNIFICANT DECISIONS REGARDING DE3 VICES. 

4 ‘‘(a) DOCUMENTATION OF RATIONALE FOR SIGNIFI5 CANT DECISIONS.— 

6 ‘‘(1) IN GENERAL.—The Secretary shall com7 pletely document the scientific and regulatory ration8 ale for any significant decision of the Center for De9 vices and Radiological Health regarding submission 

10 or review of a report under section 510(k), an appli11 cation under section 515, or an application for an 

12 exemption under section 520(g), including docu13 mentation of significant controversies or differences 

14 of opinion and the resolution of such controversies 

15 or differences of opinion. 

16 ‘‘(2) PROVISION OF DOCUMENTATION.—Upon 

17 request, the Secretary shall furnish such complete 

18 documentation to the person who is seeking to sub19 mit, or who has submitted, such report or applica20 tion. 

21 ‘‘(b) REVIEW OF SIGNIFICANT DECISIONS.— 

22 ‘‘(1) REQUEST FOR SUPERVISORY REVIEW OF

23 SIGNIFICANT DECISION.—Any person may request a 

24 supervisory review of the significant decision de25 scribed in subsection (a)(1). Such review may be 

26 conducted at the next supervisory level or higher 


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1 above the individual who made the significant deci2 sion. 

3 ‘‘(2) SUBMISSION OF REQUEST.—A person re4 questing a supervisory review under paragraph (1) 

5 shall submit such request to the Secretary not later 

6 than 30 days after such decision and shall indicate 

7 in the request whether such person seeks an in-per8 son meeting or a teleconference review. 

9 ‘‘(3) TIMEFRAME.— 

10 ‘‘(A) IN GENERAL.—Except as provided in 

11 subparagraph (B), the Secretary shall schedule 

12 an in-person or teleconference review, if so re13 quested, not later than 30 days after such re14 quest is made. The Secretary shall issue a deci15 sion to the person requesting a review under 

16 this subsection not later than 45 days after the 

17 request is made under paragraph (1), or, in the 

18 case of a person who requests an in-person 

19 meeting or teleconference, 30 days after such 

20 meeting or teleconference. 

21 ‘‘(B) EXCEPTION.—Subparagraph (A) 

22 shall not apply in cases that are referred to ex23 perts outside of the Food and Drug Adminis24 tration.’’. 


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1 SEC. 704. TRANSPARENCY IN CLEARANCE PROCESS. 

2 (a) PUBLICATION OF DETAILED DECISION SUM3 MARIES.—Section 520(h) (21 U.S.C. 360j(h)) is amended 

4 by adding at the end the following: 

5 ‘‘(5) Subject to subsection (c) and section 301(j), the 

6 Secretary shall regularly publish detailed decision sum7 maries for each clearance of a device under section 510(k) 

8 requiring clinical data.’’. 

9 (b) APPLICATION.—The requirement of section 

10 520(h)(5) of the Federal Food, Drug, and Cosmetic Act, 

11 as added by subsection (a), applies only with respect to 

12 clearance of a device occurring after the date of the enact13 ment of this Act. 

14 SEC. 705. DEVICE MODIFICATIONS REQUIRING PREMARKET 

15 NOTIFICATION PRIOR TO MARKETING. 

16 Section 510(n) (21 U.S.C. 360(n)) is amended by— 

17 (1) striking ‘‘(n) The Secretary’’ and inserting 

18 ‘‘(n)(1) The Secretary’’; and 

19 (2) by adding at the end the following: 

20 ‘‘(2)(A) Not later than 18 months after the en21 actment of this paragraph, the Secretary shall sub22 mit to the Committee on Energy and Commerce of 

23 the House of Representatives and the Committee on 

24 Health, Education, Labor, and Pensions of the Sen25 ate a report regarding when a premarket notification 

26 under subsection (k) should be submitted for a 


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1 modification or change to a legally marketed device. 

2 The report shall include the Secretary’s interpreta3 tion of the following terms: ‘could significantly affect 

4 the safety or effectiveness of the device’, ‘a signifi5 cant change or modification in design, material, 

6 chemical composition, energy source, or manufac7 turing process,’, and ‘major change or modification 

8 in the intended use of the device’. The report also 

9 shall discuss possible processes for industry to use to 

10 determine whether a new submission under sub11 section (k) is required and shall analyze how to le12 verage existing quality system requirements to re13 duce premarket burden, facilitate continual device 

14 improvement. and provide reasonable assurance of 

15 safety and effectiveness of modified devices. In de16 veloping such report, the Secretary shall consider the 

17 input of interested stakeholders. 

18 ‘‘(B) The Secretary shall withdraw the Food 

19 and Drug Administration draft guidance entitled 

20 ‘Guidance for Industry and FDA Staff—510(k) De21 vice Modifications: Deciding When to Submit a 

22 510(k) for a Change to an Existing Device’, dated 

23 July 27, 2011, and shall not use this draft guidance 

24 as part of, or for the basis of, any premarket review 


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1 or any compliance or enforcement decisions or ac2 tions. The Secretary shall not issue— 

3 ‘‘(i) any draft guidance or proposed regula4 tion that addresses when to submit a premarket 

5 notification submission for changes and modi6 fications made to a manufacturer’s previously 

7 cleared device before the receipt by the Com8 mittee on Energy and Commerce of the House 

9 of Representatives and the Committee on 

10 Health, Education, Labor, and Pensions of the 

11 Senate of the report required in subparagraph 

12 (A); and 

13 ‘‘(ii) any final guidance or regulation on 

14 that topic for one year after date of receipt of 

15 such report by the Committee on Energy and 

16 Commerce of the House of Representatives and 

17 the Committee on Health, Education, Labor, 

18 and Pensions of the Senate. 

19 ‘‘(C) The Food and Drug Administration guid20 ance entitled ‘Deciding When to Submit a 510(k) for 

21 a Change to an Existing Device’, dated January 10, 

22 1997, shall be in effect until the subsequent issuance 

23 of guidance or promulgation, if appropriate, of a 

24 regulation described in subparagraph (B), and the 

25 Secretary shall interpret such guidance in a manner 


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1 that is consistent with the manner in which the Sec2 retary has interpreted such guidance since 1997.’’. 

3 Subtitle B—Patients Come First 

4 SEC. 711. ESTABLISHMENT OF SCHEDULE AND PROMULGA5 TION OF REGULATION. 

6 (a) ESTABLISHMENT OF SCHEDULE.—Not later than 

7 90 days after the date of enactment of this Act, the Sec8 retary of Health and Human Services shall establish the 

9 schedule referred to in section 515(i)(3) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)). 

11 (b) REGULATION.—Not later than one year after the 

12 date that the schedule is established under such section 

13 515(i)(3) (as required by subsection (a)) the Secretary 

14 shall issue a final regulation under section 515(b) of such 

15 Act for each device that the Secretary requires to remain 

16 in class III through a determination under section 

17 515(i)(2) of such Act. 

18 SEC. 712. PROGRAM TO IMPROVE THE DEVICE RECALL SYS19 TEM. 

20 Chapter V is amended by inserting after section 518 

21 (21 U.S.C. 360h) the following: 

22 ‘‘SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL 

23 SYSTEM. 

24 ‘‘(a) IN GENERAL.—The Secretary shall— 


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1 ‘‘(1) establish a program to routinely and sys2 tematically assess information relating to device re3 calls and use such information to proactively identify 

4 strategies for mitigating health risks presented by 

5 defective or unsafe devices; 

6 ‘‘(2) clarify procedures for conducting device re7 call audit checks to improve the ability of investiga8 tors to perform those checks in a consistent manner; 

9 ‘‘(3) develop detailed criteria for assessing 

10 whether a person performing a device recall has per11 formed an effective correction or action plan for the 

12 recall; and 

13 ‘‘(4) document the basis for each termination 

14 by the Food and Drug Administration of a device re15 call. 

16 ‘‘(b) ASSESSMENT CONTENT.—The program estab17 lished under subsection (a)(1) shall, at a minimum, iden18 tify— 

19 ‘‘(1) trends in the number and types of device 

20 recalls; 

21 ‘‘(2) devices that are most frequently the sub22 ject of a recall; and 

23 ‘‘(3) underlying causes of device recalls. 

24 ‘‘(c) DEFINITION.—In this section, the term ‘recall’ 

25 means— 


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1 ‘‘(1) the removal from the market of a device 

2 pursuant to an order of the Secretary under sub3 section (b) or (e) of section 518; or 

4 ‘‘(2) the correction or removal from the market 

5 of a device at the initiative of the manufacturer or 

6 importer of the device that is required to be reported 

7 to the Secretary under section 519(g).’’. 

8 Subtitle C—Novel Device 

9 Regulatory Relief 

10 SEC. 721. MODIFICATION OF DE NOVO APPLICATION PROC11 ESS. 

12 (a) IN GENERAL.—Section 513(f)(2) (21 U.S.C. 

13 360c(f)(2)) is amended— 

14 (1) by inserting ‘‘(i)’’ after ‘‘(2)(A)’’; 

15 (2) in subparagraph (A)(i), as so designated by 

16 paragraph (1), by striking ‘‘under the criteria set 

17 forth’’ and all that follows through the end of sub18 paragraph (A) and inserting a period; 

19 (3) by adding at the end of subparagraph (A) 

20 the following: 

21 ‘‘(ii) In lieu of submitting a report under section 

22 510(k) and submitting a request for classification under 

23 clause (i) for a device, if a person determines there is no 

24 legally marketed device upon which to base a determina25 tion of substantial equivalence (as defined in subsection 


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1 (i)), a person may submit a request under this clause for 

2 the Secretary to classify the device. 

3 ‘‘(iii) Upon receipt of a request under clause (i) or 

4 (ii), the Secretary shall classify the device subject to the 

5 request under the criteria set forth in subparagraphs (A) 

6 through (C) of subsection (a)(1) within 120 days. 

7 ‘‘(iv) Notwithstanding clause (iii), the Secretary may 

8 decline to undertake a classification of a device pursuant 

9 to a request under clause (ii) if the Secretary— 

10 ‘‘(I) identifies a legally marketed device that 

11 would permit a substantial equivalence determina12 tion under paragraph (1) for the device; or 

13 ‘‘(II) determines that the device submitted is 

14 not of low-moderate risk or special controls to miti15 gate the risks cannot be developed for the device. 

16 ‘‘(v) The person submitting the request for classifica17 tion under this subparagraph may recommend to the Sec18 retary a classification for the device and shall, if recom19 mending classification in class II, include in the request 

20 an initial draft proposal for applicable special controls, as 

21 described in subsection (a)(1)(B), that are necessary, in 

22 conjunction with general controls, to provide reasonable 

23 assurance of safety and effectiveness and a description of 

24 how the special controls provide such assurance. Any such 

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1 formation and reasons for the recommended classifica2 tion.’’; and 

3 (4) in subparagraph (B), by striking ‘‘Not later 

4 than 60 days after the date of the submission of the 

5 request under subparagraph (A), the Secretary’’ and 

6 inserting ‘‘The Secretary’’. 

7 (b) CONFORMING AMENDMENTS.—Section 513(f) of 

8 such Act (21 U.S.C. 360c(f)) is amended in paragraph 

9 (1)— 

10 (1) in subparagraph (A), by striking ‘‘, or’’ at 

11 the end and inserting a semicolon; 

12 (2) in subparagraph (B), by striking the period 

13 and inserting ‘‘; or’’; and 

14 (3) by inserting after subparagraph (B) the fol15 lowing: 

16 ‘‘(C) the device is classified pursuant to a 

17 request submitted under paragraph (2).’’. 

18 Subtitle D—Keeping America Com19 petitive Through Harmonization 

20 SEC. 731. HARMONIZATION OF DEVICE PREMARKET RE21 VIEW, INSPECTION, AND LABELING SYMBOLS; 

22 REPORT. 

23 (a) IN GENERAL.—Paragraph (4) of section 803(c) 

24 (21 U.S.C. 383(c)) is amended to read as follows: 


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1 ‘‘(4) With respect to devices, the Secretary may, 

2 when appropriate, enter into arrangements with nations 

3 regarding methods and approaches to harmonizing regu4 latory requirements for activities, including inspections 

5 and common international labeling symbols’’. 

6 (b) REPORT.—Not later than 3 years after the date 

7 of enactment of this Act, the Secretary of Health and 

8 Human Services shall submit to the Committee on Health, 

9 Education, Labor, and Pensions of the Senate and the 

10 Committee on Energy and Commerce of the House of 

11 Representatives a report on the Food and Drug Adminis12 tration’s harmonization activities, itemizing methods and 

13 approaches that have been harmonized pursuant to section 

14 803(c)(4) of the Federal Food, Drug, and Cosmetic Act, 

15 as amended by subsection (a). 

16 SEC. 732. PARTICIPATION IN INTERNATIONAL FORA. 

17 Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) 

18 is amended— 

19 (1) by striking ‘‘(3)’’ and inserting ‘‘(3)(A)’’; 

20 and 

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

22 ‘‘(B) In carrying out subparagraph (A), the Secretary 

23 may participate in appropriate fora, including the Inter24 national Medical Device Regulators Forum, and may— 


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1 ‘‘(i) provide guidance to such fora on strategies, 

2 policies, directions, membership, and other activities 

3 of a forum as appropriate; 

4 ‘‘(ii) to the extent appropriate, solicit, review, 

5 and consider comments from industry, academia, 

6 health care professionals, and patient groups regard7 ing the activities of such fora; and 

8 ‘‘(iii) to the extent appropriate, inform the pub9 lic of the Secretary’s activities within such fora, and 

10 share with the public any documentation relating to 

11 a forum’s strategies, policies, and other activities of 

12 such fora.’’. 

13 Subtitle E—FDA Renewing Effi14 ciency From Outside Reviewer 

15 Management 

16 SEC. 741. REAUTHORIZATION OF THIRD PARTY REVIEW. 

17 (a) PERIODIC REACCREDITATION.—Section 

18 523(b)(2) (21 U.S.C. 360m(b)(2)) is amended by adding 

19 at the end of the following: 

20 ‘‘(E) PERIODIC REACCREDITATION.— 

21 ‘‘(i) PERIOD.—Subject to suspension 

22 or withdrawal under subparagraph (B), 

23 any accreditation under this section shall 

24 be valid for a period of 3 years after its 

25 issuance. 


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1 ‘‘(ii) RESPONSE TO REACCREDITATION

2 REQUEST.—Upon the submission of a re3 quest by an accredited person for re4 accreditation under this section, the Sec5 retary shall approve or deny such request 

6 not later than 60 days after receipt of the 

7 request. 

8 ‘‘(iii) CRITERIA.—Not later than 120 

9 days after the date of the enactment of 

10 this subparagraph, the Secretary shall es11 tablish and publish in the Federal Register 

12 criteria to reaccredit or deny reaccredita13 tion to persons under this section. The re14 accreditation of persons under this section 

15 shall specify the particular activities under 

16 subsection (a), and the devices, for which 

17 such persons are reaccredited.’’. 

18 (b) DURATION OF AUTHORITY.—Section 523(c) (21 

19 U.S.C. 360m(c)) is amended by striking ‘‘October 1, 

20 2012’’ and inserting ‘‘October 1, 2017’’. 

21 SEC. 742. REAUTHORIZATION OF THIRD PARTY INSPEC22 TION. 

23 Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amend24 ed by striking ‘‘October 1, 2012’’ and inserting ‘‘October 

25 1, 2017’’. 


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1 Subtitle F—Humanitarian Device 

2 Reform 

3 SEC. 751. EXPANDED ACCESS TO HUMANITARIAN USE DE4 VICES. 

5 (a) IN GENERAL.—Section 520(m) (21 U.S.C. 

6 360j(m)) is amended— 

7 (1) in paragraph (6)— 

8 (A) in subparagraph (A)— 

9 (i) in the matter preceding clause (i), 

10 by striking ‘‘subparagraph (D)’’ and in11 serting ‘‘subparagraph (C)’’; 

12 (ii) by striking clause (i) and inserting 

13 the following: 

14 ‘‘(i) The device with respect to which the ex15 emption is granted— 

16 ‘‘(I) is intended for the treatment or diag17 nosis of a disease or condition that occurs in 

18 pediatric patients or in a pediatric subpopula19 tion, and such device is labeled for use in pedi20 atric patients or in a pediatric subpopulation in 

21 which the disease or condition occurs; or 

22 ‘‘(II) is intended for the treatment or diag23 nosis of a disease or condition that does not 

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1 opment of the device for such patients is impos2 sible, highly impracticable, or unsafe.’’; 

3 (iii) by striking clause (ii) and insert4 ing the following: 

5 ‘‘(ii) During any calendar year, the number of 

6 such devices distributed during that year under each 

7 exemption granted under this subsection does not 

8 exceed the number of such devices needed to treat, 

9 diagnose, or cure a population of 4,000 individuals 

10 in the United States (referred to in this paragraph 

11 as the ‘annual distribution number’).’’; and 

12 (iv) in clause (iv), by striking ‘‘2012’’ 

13 and inserting ‘‘2017’’; 

14 (B) by striking subparagraph (C); 

15 (C) by redesignating subparagraphs (D) 

16 and (E) as subparagraphs (C) and (D), respec17 tively; and 

18 (D) in subparagraph (C), as so redesig19 nated, by striking ‘‘and modified under sub20 paragraph (C), if applicable,’’; 

21 (2) in paragraph (7), by striking ‘‘regarding a 

22 device’’ and inserting ‘‘regarding a device described 

23 in paragraph (6)(A)(i)(I)’’; and 


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1 (3) in paragraph (8), by striking ‘‘of all devices 

2 described in paragraph (6)’’ and inserting ‘‘of all de3 vices described in paragraph (6)(A)(i)(I)’’. 

4 (b) APPLICABILITY TO EXISTING DEVICES.—A spon5 sor of a device for which an exemption was approved under 

6 paragraph (2) of section 520(m) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the 

8 date of enactment of this Act may seek a determination 

9 under subclause (I) or (II) of paragraph (6)(A)(i) of such 

10 section 520(m) (as amended by subsection (a)). If the Sec11 retary determines that such subclause (I) or (II) applies 

12 with respect to a device, then clauses (ii), (iii), and (iv) 

13 of subparagraph (A) and subparagraphs (B), (C), and (D) 

14 of paragraph (6) of such section 520(m) shall apply to 

15 such device. 

16 (c) REPORT.—Not later than January 1, 2017, the 

17 Comptroller General of the United States shall submit to 

18 Congress a report that evaluates and describes— 

19 (1) the effectiveness of the amendments made 

20 by subsection (a) in stimulating innovation with re21 spect to medical devices, including any favorable or 

22 adverse impact on pediatric device development; 

23 (2) the impact of such amendments on pediatric 

24 device approvals for devices that received a humani25 tarian use designation under section 520(m) of the 


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

2 360j(m)) prior to the date of enactment of this Act; 

3 (3) the status of public and private insurance 

4 coverage of devices granted an exemption under 

5 paragraph (2) of such section 520(m) and costs to 

6 patients of such devices; 

7 (4) the impact that paragraph (4) of such sec8 tion 520(m) has had on access to and insurance cov9 erage of devices granted an exemption under para10 graph (2) of such section 520(m); and 

11 (5) the effect of the amendments made by sub12 section (a) on patients described in such section 

13 520(m). 

14 Subtitle G—Records and Reports 

15 on Devices 

16 SEC. 761. UNIQUE DEVICE IDENTIFICATION SYSTEM REGU17 LATIONS. 

18 Not later than 120 days after the date of enactment 

19 of this Act, the Secretary of Health and Human Services 

20 shall promulgate the regulations required by section 

21 519(f) of the Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 360i(f)). 

23 SEC. 762. EFFECTIVE DEVICE SENTINEL PROGRAM. 

24 (a) INCLUSION OF DEVICES IN POSTMARKET RISK

25 IDENTIFICATION AND ANALYSIS SYSTEM.—Section 519 


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1 (21 U.S.C. 360i) is amended by adding at the end the 

2 following: 

3 ‘‘(h) INCLUSION OF DEVICES IN POSTMARKET RISK

4 IDENTIFICATION AND ANALYSIS SYSTEM.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall amend 

6 the procedures established and maintained under 

7 clauses (i), (ii), (iii), and (v) of section 505(k)(3)(C) 

8 in order to expand the postmarket risk identification 

9 and analysis system established under such section 

10 to include and apply to devices. 

11 ‘‘(2) DATA.—In expanding the system as de12 scribed in paragraph (1), the Secretary shall use rel13 evant data with respect to devices cleared under sec14 tion 510(k) or approved under section 515, which 

15 may include claims data, patient survey data, and 

16 standardized analytic files that allow for the pooling 

17 and analysis of data from disparate data environ18 ments. 

19 ‘‘(3) STAKEHOLDER INPUT.—To help ensure ef20 fective implementation of the system as described in 

21 paragraph (1) with respect to devices, the Secretary 

22 shall engage outside stakeholders in development of 

23 the system, and gather information from outside 

24 stakeholders regarding the content of an effective 

25 sentinel program, through a public hearing, advisory 


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1 committee meeting, maintenance of a public docket, 

2 or other similar public measures. 

3 ‘‘(4) VOLUNTARY SURVEYS.—Chapter 35 of 

4 title 44, United States Code, shall not apply to the 

5 collection of voluntary information from health care 

6 providers, such as voluntary surveys or question7 naires, initiated by the Secretary for purposes of 

8 postmarket risk identification, mitigation, and anal9 ysis for devices.’’. 

10 (b) AMENDMENTS TO POSTMARKET RISK IDENTI11 FICATION AND ANALYSIS SYSTEM.—Section 

12 505(k)(3)(C)(i) (21 U.S.C. 355(k)(3)(C)(i)) is amended— 

13 (1) by striking subclause (II); 

14 (2) by redesignating subclauses (III) through 

15 (VI) as subclauses (II) through (V), respectively; 

16 and 

17 (3) in item (bb) of subclause (II), as so redesig18 nated, by striking ‘‘pharmaceutical purchase data 

19 and health insurance claims data’’ and inserting 

20 ‘‘medical device utilization data, health insurance 

21 claims data, and procedure and device registries’’. 

22 Subtitle H—Miscellaneous 

23 SEC. 771. CUSTOM DEVICES. 

24 Section 520(b) (21 U.S.C. 360j) is amended to read 

25 as follows: 


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1 ‘‘(b) CUSTOM DEVICES.— 

2 ‘‘(1) IN GENERAL.—The requirements of sec3 tions 514 and 515 shall not apply to a device that— 

4 ‘‘(A) is created or modified in order to 

5 comply with the order of an individual physician 

6 or dentist (or any other specially qualified per7 son designated under regulations promulgated 

8 by the Secretary after an opportunity for an 

9 oral hearing); 

10 ‘‘(B) in order to comply with an order de11 scribed in subparagraph (A), necessarily devi12 ates from an otherwise applicable performance 

13 standard under section 514 or requirement 

14 under section 515; 

15 ‘‘(C) is not generally available in the 

16 United States in finished form through labeling 

17 or advertising by the manufacturer, importer, 

18 or distributor for commercial distribution; 

19 ‘‘(D) is designed to treat a unique pathol20 ogy or physiological condition that no other de21 vice is domestically available to treat; 

22 ‘‘(E)(i) is intended to meet the special 

23 needs of such physician or dentist (or other spe24 cially qualified person so designated) in the 

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1 sician or dentist (or other specially qualified 

2 person so designated); or 

3 ‘‘(ii) is intended for use by an individual 

4 patient named in such order of such physician 

5 or dentist (or other specially qualified person so 

6 designated); 

7 ‘‘(F) is assembled from components or 

8 manufactured and finished on a case-by-case 

9 basis to accommodate the unique needs of indi10 viduals described in clause (i) or (ii) of subpara11 graph (E); and 

12 ‘‘(G) may have common, standardized de13 sign characteristics, chemical and material com14 positions, and manufacturing processes as com15 mercially distributed devices. 

16 ‘‘(2) LIMITATIONS.—Paragraph (1) shall apply 

17 to a device only if— 

18 ‘‘(A) such device is for the purpose of 

19 treating a sufficiently rare condition, such that 

20 conducting clinical investigations on such device 

21 would be impractical; and 

22 ‘‘(B) production of such device under para23 graph (1) is limited to no more than 5 units per 

24 year of a particular device type, provided that 


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1 such replication otherwise complies with this 

2 section. 

3 ‘‘(3) GUIDANCE.—Not later than 2 years after 

4 the date of enactment of this section, the Secretary 

5 shall issue final guidance on replication of multiple 

6 devices described in paragraph (2)(B). 

7 ‘‘(4) NOTIFICATION TO THE SECRETARY.—The 

8 manufacturer of such device created or modified as 

9 described in paragraph (1) shall notify the Secretary 

10 on an annual basis, in a manner prescribed by the 

11 Secretary, of the manufacture of such device.’’. 

12 SEC. 772. PEDIATRIC DEVICE REAUTHORIZATION. 

13 (a) FINAL RULE RELATING TO TRACKING OF PEDI14 ATRIC USES OF DEVICES.—The Secretary of Health and 

15 Human Services shall issue— 

16 (1) a proposed rule implementing section 

17 515A(a)(2) of the Federal Food, Drug and Cosmetic 

18 Act (21 U.S.C. 360e–1(a)(2)) not later than Decem19 ber 31, 2012; and 

20 (2) a final rule implementing such section not 

21 later than December 31, 2013. 

22 (b) DEMONSTRATION GRANTS TO IMPROVE PEDI23 ATRIC DEVICE AVAILABILITY.—Section 305(e) of the Pe24 diatric Medical Device Safety and Improvement Act of 

25 2007 (Title III of Public Law 110–85) is amended by 


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1 striking ‘‘2008 through 2012’’ and inserting ‘‘2013 

2 through 2017’’. 

3 SEC. 773. REPORT ON REGULATION OF HEALTH INFORMA4 TION TECHNOLOGY. 

5 (a) REPORT.—Not later than 18 months after the 

6 date of the enactment of this Act, the Secretary of Health 

7 and Human Services, in consultation with the Commis8 sioner of Food and Drugs, the National Coordinator for 

9 Health Information Technology, and the Chairman of the 

10 Federal Communications Commission, shall submit to the 

11 Committee on Energy and Commerce of the House of 

12 Representatives and the appropriate committees of the 

13 Senate a report that contains— 

14 (1) a strategy for coordinating the regulation of 

15 health information technology in order to avoid regu16 latory duplication; and 

17 (2) recommendations on an appropriate regu18 latory framework for health information technology, 

19 including a risk-based framework. 

20 (b) DEFINITION.—In this section, the terms ‘‘health 

21 information technology’’ has the meaning given such term 

22 in section 3000(5) of the Public Health Service Act and 

23 includes technologies such as electronic health records, 

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1 puterized health care provider order entry systems, and 

2 clinical decision support. 

3 TITLE VIII—DRUG REGULATORY 

4 IMPROVEMENTS 

5 Subtitle A—Drug Supply Chain 

6 SEC. 801. REGISTRATION OF PRODUCERS OF DRUGS. 

7 (a) TIMING.—Section 510 (21 U.S.C. 360) is amend8 ed— 

9 (1) in subsection (b)(1), by striking ‘‘On or be10 fore’’ and inserting ‘‘During the period beginning on 

11 October 1 and ending on’’; and 

12 (2) in subsection (i)(1)(B)(i), by striking ‘‘on or 

13 before’’ and inserting ‘‘during the period beginning 

14 on October 1 and ending on’’. 

15 (b) ESTABLISHMENTS NOT DULY REGISTERED; MIS16 BRANDING.—Section 502(o) (21 U.S.C. 352(o)) is amend17 ed by striking ‘‘in any State’’. 

18 SEC. 802. INSPECTION OF DRUGS. 

19 Subsection (h) of section 510 (21 U.S.C. 360) is 

20 amended— 

21 (1) by striking ‘‘(h)’’ and inserting ‘‘(h)(1)’’; 

22 (2) by inserting ‘‘with respect to the manufac23 ture, preparation, propagation, compounding, or 

24 processing of a device’’ after ‘‘registered with the 

25 Secretary pursuant to this section’’; 


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1 (3) by striking ‘‘of a drug or drugs or’’; and 

2 (4) by adding at the end the following: 

3 ‘‘(2) INSPECTIONS WITH RESPECT TO DRUG ESTAB4 LISHMENTS.—With respect to the manufacture, prepara5 tion, propagation, compounding, or processing of a drug: 

6 ‘‘(A) IN GENERAL.—Every establishment that 

7 is required to be registered with the Secretary under 

8 this section shall be subject to inspection pursuant 

9 to section 704. 

10 ‘‘(B) RISK-BASED SCHEDULE.—In the case of 

11 an establishment that is engaged in the manufac12 ture, preparation, propagation, compounding, or 

13 processing of a drug or drugs (referred to in this 

14 subsection as a ‘drug establishment’), the inspec15 tions required under subparagraph (A) shall be con16 ducted by officers or employees duly designated by 

17 the Secretary, on a risk-based schedule established 

18 by the Secretary. 

19 ‘‘(C) RISK FACTORS.—In establishing the risk20 based schedule under subparagraph (B), the Sec21 retary shall allocate resources to inspect establish22 ments according to the known safety risks of such 

23 establishments, based on the following factors: 

24 ‘‘(i) The compliance history of the estab25 lishment. 


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1 ‘‘(ii) The inspection frequency and history 

2 of the establishment, including whether it has 

3 been inspected pursuant to section 704 within 

4 the last four years. 

5 ‘‘(iii) The record, history, and nature of re6 calls linked to the establishment. 

7 ‘‘(iv) The inherent risk of the drug manu8 factured, prepared, propagated, compounded, or 

9 processed at the establishment. 

10 ‘‘(v) Any other criteria deemed necessary 

11 and appropriate by the Secretary for purposes 

12 of allocating inspection resources. 

13 ‘‘(D) EFFECT OF STATUS.—In determining the 

14 risk associated with an establishment for purposes of 

15 establishing a risk-based schedule under subpara16 graph (B), the Secretary shall not consider whether 

17 the drugs manufactured, prepared, propagated, com18 pounded, or processed by such establishment are 

19 drugs described in section 503(b)(1). 

20 ‘‘(E) ANNUAL REPORT ON INSPECTIONS OF ES21 TABLISHMENTS.—Not later than February 1 of each 

22 year, the Secretary shall submit to Congress a re23 port that contains the following: 


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1 ‘‘(i) The number of domestic and foreign 

2 establishments registered pursuant to this sec3 tion in the previous calendar year. 

4 ‘‘(ii) The number of such registered domes5 tic and foreign establishments that the Sec6 retary inspected in the previous calendar year. 

7 ‘‘(iii) The number of such registered estab8 lishments that list one or more drugs approved 

9 pursuant to an application filed under section 

10 505(j). 

11 ‘‘(iv) The number of such registered estab12 lishments that list one or more drugs approved 

13 pursuant to an application filed under section 

14 505(b). 

15 ‘‘(v) The number of registered establish16 ments that list both drug products approved 

17 pursuant to an application filed under section 

18 505(j) and drug products approved pursuant to 

19 an application filed under section 505(b). 

20 ‘‘(vi) A description of how the Secretary 

21 implemented the risk-based schedule under sub22 paragraph (B) utilizing the factors under sub23 paragraph (C). 

24 ‘‘(F) PUBLIC AVAILABILITY OF ANNUAL RE25 PORTS.—The Secretary shall make the report reVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00188 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 quired under subparagraph (E) available to the pub2 lic on the Internet Web site of the Food and Drug 

3 Administration.’’. 

4 SEC. 803. DRUG SUPPLY QUALITY AND SAFETY. 

5 Paragraph (a) of section 501 (21 U.S.C. 351) is 

6 amended by adding at the end the following: ‘‘For pur7 poses of subparagraph (2)(B), the term ‘current good 

8 manufacturing practice’ includes the implementation of 

9 oversight and controls over the manufacture of drugs to 

10 ensure quality, including managing the risk of and estab11 lishing the safety of raw materials, materials used in the 

12 manufacturing of drugs, and finished drug products.’’. 

13 SEC. 804. PROHIBITION AGAINST DELAYING, DENYING, LIM14 ITING, OR REFUSING INSPECTION. 

15 (a) IN GENERAL.—Section 501 (21 U.S.C. 351) is 

16 amended by adding at the end the following: 

17 ‘‘(j) If it is a drug and it has been manufactured, 

18 processed, packed, or held in any factory, warehouse, or 

19 establishment and the owner, operator, or agent of such 

20 factory, warehouse, or establishment delays, denies, or 

21 limits an inspection, or refuses to permit entry or inspec22 tion.’’. 

23 (b) GUIDANCE.—Not later than 1 year after the date 

24 of enactment of this section, the Secretary of Health and 

25 Human Services shall issue guidance that defines the cirVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00189 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 cumstances that would constitute delaying, denying, or 

2 limiting inspection, or refusing to permit entry or inspec3 tion, for purposes of section 501(j) of the Federal Food, 

4 Drug, and Cosmetic Act (as added by subsection (a)). 

5 SEC. 805. DESTRUCTION OF ADULTERATED, MISBRANDED, 

6 OR COUNTERFEIT DRUGS OFFERED FOR IM7 PORT. 

8 (a) IN GENERAL.—The sixth sentence of section 

9 801(a) (21 U.S.C. 381(a)) is amended by inserting before 

10 the period at the end the following: ‘‘, except that the Sec11 retary of Health and Human Services, in consultation with 

12 the Secretary of Homeland Security, may cause the de13 struction, without the opportunity for export, of any drug 

14 refused admission that has reasonable probability of caus15 ing serious adverse health consequences or death, as deter16 mined by the Secretary of Health and Human Services, 

17 or that is valued at an amount that is $2,000 or less (or 

18 such higher amount as the Secretary of Homeland Secu19 rity may set by regulation pursuant to section 1498 of 

20 title 19, United States Code)’’. 

21 (b) NOTICE.—Section 801(a) (21 U.S.C. 381(a)), as 

22 amended by subsection (a), is further amended by insert23 ing after the sixth sentence the following: ‘‘The Secretary 

24 of Health and Human Services shall issue regulations pro25 viding for notice and an opportunity for a hearing on the 


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1 destruction of a drug under the previous sentence. For a 

2 drug with a value less than and or equal to $2,000 (or, 

3 as described in the sixth sentence of this subsection, such 

4 higher amount as the Secretary of Homeland Security 

5 may set by regulation pursuant to section 1498 of title 

6 19, United States Code) the regulations under the pre7 vious sentence shall provide for prompt notice and an op8 portunity for a hearing for the owner or consignee before 

9 or after the destruction has occurred. For a drug with a 

10 value greater than $2,000 (or, as described in the sixth 

11 sentence of this subsection, such higher amount as the 

12 Secretary of Homeland Security may set by regulation 

13 pursuant to section 1498 of title 19, United States Code) 

14 that has reasonable probability of causing serious adverse 

15 health consequences or death as determined by the Sec16 retary of Health and Human Services, the regulations 

17 under the seventh sentence of this subsection shall provide 

18 for notice and an opportunity for a hearing to the owner 

19 or consignee before the destruction occurs.’’. 

20 (c) RESTITUTION.—In the regulations described in 

21 the seventh sentence of section 801(a) of the Federal 

22 Food, Drug, and Cosmetic Act (as added by subsection 

23 (b)), the Secretary of Health and Human Services shall 

24 establish an administrative process whereby an owner or 

25 consignee of a drug destroyed without an opportunity for 


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1 a hearing on destruction may obtain restitution for the 

2 value of the drug destroyed under the sixth sentence of 

3 such section upon demonstration that such drug was 

4 wrongfully destroyed. 

5 (d) CONFORMING AMENDMENT.—The first sentence 

6 of section 801(a) (21 U.S.C. 381(a)) is amended by insert7 ing ‘‘, except as otherwise described in the sixth and sev8 enth sentences of this subsection,’’ after ‘‘giving notice 

9 thereof’’. 

10 SEC. 806. ADMINISTRATIVE DETENTION. 

11 (a) IN GENERAL.—Section 304(g) (21 U.S.C. 

12 335a(g)) is amended— 

13 (1) in paragraph (1), by inserting ‘‘, drug,’’ 

14 after ‘‘device’’, each place it appears; 

15 (2) in paragraph (2)(A), by inserting ‘‘, drug,’’ 

16 after ‘‘(B), a device’’; and 

17 (3) in paragraph (2)(B), by inserting ‘‘or drug’’ 

18 after ‘‘device’’ each place it appears. 

19 (b) REGULATION.—Not later than 2 years after the 

20 date of the enactment of this Act, the Secretary of Health 

21 and Human Services shall promulgate regulations to im22 plement administrative detention authority with respect to 

23 drugs, as authorized by the amendments made by sub24 section (a). Before promulgating such regulations, the 


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1 Secretary shall consult with stakeholders, including manu2 facturers of drugs. 

3 (c) EFFECTIVE DATE.—The amendments made by 

4 subsection (a) shall not take effect until the Secretary has 

5 issued a final regulation under subsection (b). 

6 SEC. 807. ENHANCED CRIMINAL PENALTY FOR COUNTER7 FEIT DRUGS. 

8 (a) IN GENERAL.—Section 303(a) (21 U.S.C. 

9 333(a)) is amended by adding at the end the following: 

10 ‘‘(3) Notwithstanding paragraph (2), any person who 

11 engages in any conduct described in section 301(i)(2) 

12 knowing or having reason to know that the conduct con13 cerns the rendering of a drug as a counterfeit drug, or 

14 who engages in conduct described in section 301(i)(3) 

15 knowing or having reason to know that the conduct will 

16 cause a drug to be a counterfeit drug or knowing or having 

17 reason to know that a drug held, sold, or dispensed is a 

18 counterfeit drug, shall be fined in accordance with title 

19 18, United States Code, or imprisoned not more than 20 

20 years, or both, except that if the use of the counterfeit 

21 drug by a consumer is the proximate cause of the death 

22 of the consumer, the term of imprisonment shall be any 

23 term of years or for life.’’. 

24 (b) CONFORMING AMENDMENT.—Section 201(g)(2) 

25 (21 U.S.C. 321(g)(2)) is amended by adding at the end 


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1 the following sentence: ‘‘The term ‘counterfeit drug’ shall 

2 not include a drug or placebo intended for use in a clinical 

3 trial that is intentionally labeled or marked to maintain 

4 proper blinding of the study.’’. 

5 SEC. 808. UNIQUE FACILITY IDENTIFICATION NUMBER. 

6 (a) DOMESTIC ESTABLISHMENTS.—Section 510 (21 

7 U.S.C. 360) is amended— 

8 (1) in subsection (b)(1), by striking ‘‘and all 

9 such establishments’’ and inserting ‘‘all such estab10 lishments, and the unique facility identifier of each 

11 such establishment’’; and 

12 (2) in subsection (c), by striking ‘‘and such es13 tablishment’’ and inserting ‘‘such establishment, and 

14 the unique facility identifier of such establishment’’. 

15 (b) FOREIGN ESTABLISHMENTS.—Subparagraph (A) 

16 of section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by 

17 inserting ‘‘the unique facility identifier of the establish18 ment,’’ after ‘‘the name and place of business of the estab19 lishment,’’. 

20 (c) GUIDANCE.—Section 510 (21 U.S.C. 360) is 

21 amended by adding at the end the following: 

22 ‘‘(q) GUIDANCE ON SUBMISSION OF UNIQUE FACIL23 ITY IDENTIFIERS.— 


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1 ‘‘(1) IN GENERAL.—Not later than 2 years 

2 after the date of the enactment of this subsection, 

3 the Secretary shall, by guidance, specify— 

4 ‘‘(A) the unique facility identifier system 

5 to be used to meet the requirements of— 

6 ‘‘(i) subsections (b)(1), (c), and 

7 (i)(1)(A) of this section; and 

8 ‘‘(ii) section 801(s) (relating to reg9 istration of commercial importers); and 

10 ‘‘(B) the form, manner, and timing of sub11 missions of unique facility identifiers under the 

12 provisions specified in subparagraph (A). 

13 ‘‘(2) CONSIDERATION.—In developing the guid14 ance under paragraph (1), the Secretary shall take 

15 into account the utilization of existing unique identi16 fication schemes and compatibility with customs 

17 automated systems.’’. 

18 (d) IMPORTATION.—Section 801(a) (21 U.S.C. 

19 381(a)) is amended by inserting ‘‘or (5) for an article that 

20 is a drug, the appropriate unique facility identifiers under 

21 subsection (s) (relating to commercial importers) and sec22 tion 510(i) (relating to foreign establishments), as speci23 fied by the Secretary, are not provided,’’ before ‘‘then such 

24 article shall be refused admission’’. 


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1 SEC. 809. DOCUMENTATION FOR ADMISSIBILITY OF IM2 PORTS. 

3 Section 801 (21 U.S.C. 381) is amended by adding 

4 at the end the following: 

5 ‘‘(r) DOCUMENTATION.— 

6 ‘‘(1) SUBMISSION.—The Secretary may require, 

7 in consultation with the Secretary of Homeland Se8 curity acting through U.S. Customs and Border Pro9 tection as determined appropriate by the Secretary, 

10 the submission of documentation or other informa11 tion for a drug that is imported or offered for im12 port into the United States. 

13 ‘‘(2) REFUSAL OF ADMISSION.—A drug im14 ported or offered for import into the United States 

15 shall be refused admission unless all documentation 

16 and information the Secretary requires under this 

17 Act, the Public Health Service Act, or both, as ap18 propriate, for such article is submitted. 

19 ‘‘(3) REGULATIONS.— 

20 ‘‘(A) DOCUMENTS AND INFORMATION.— 

21 The Secretary shall issue a regulation to specify 

22 the documentation or other information that is 

23 described in paragraph (1). Such information 

24 may include— 

25 ‘‘(i) information demonstrating the 

26 regulatory status of the drug, such as the 


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1 new drug application, abbreviated new 

2 drug application, or investigational new 

3 drug or Drug Master File number; 

4 ‘‘(ii) facility information, such as 

5 proof of registration and the unique facility 

6 identifier; and 

7 ‘‘(iii) indication of compliance with 

8 current good manufacturing practice, such 

9 as satisfactory testing results, certifi10 cations relating to satisfactory inspections, 

11 and compliance with the country of export 

12 regulations. 

13 ‘‘(B) EXEMPTION.—The Secretary may, by 

14 regulation, exempt drugs imported for research 

15 purposes only and other types of drug imports 

16 from some or all of the requirements of this 

17 subsection. 

18 ‘‘(4) EFFECTIVE DATE.—The final rule under 

19 paragraph (3)(A) shall take effect not less than 180 

20 days after the Secretary promulgates such final 

21 rule.’’. 

22 SEC. 810. REGISTRATION OF COMMERCIAL IMPORTERS. 

23 (a) PROHIBITIONS.—Section 301 (21 U.S.C. 331) is 

24 amended by adding at the end the following: 


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1 ‘‘(aaa) The failure to register in accordance with sec2 tion 801(s).’’. 

3 (b) REGISTRATION.—Section 801 (21 U.S.C. 381), 

4 as amended by section 810, is further amended by adding 

5 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) consistent with the guidance under 

13 section 510(q), to submit, at the time of reg14 istration, a unique identifier for the principal 

15 place of business for which the importer is re16 quired to register under this subsection. 

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 es22 tablish good importer practices that specify the 

23 measures an importer shall take to ensure im24 ported drugs are in compliance with the reVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00198 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 quirements of this Act and the Public Health 

2 Service Act. 

3 ‘‘(B) EXPEDITED CLEARANCE FOR CER4 TAIN IMPORTERS.—In promulgating good im5 porter practice regulations under subparagraph 

6 (A), the Secretary may, as appropriate, take 

7 into account differences among importers and 

8 types of imports, and, based on the level of risk 

9 posed by the imported drug, provide for expe10 dited clearance for those importers that volun11 teer to participate in partnership programs for 

12 highly compliant companies. 

13 ‘‘(3) DISCONTINUANCE OF REGISTRATION.— 

14 The Secretary shall discontinue the registration of 

15 any commercial importer of drugs that fails to com16 ply with the regulations promulgated under this sub17 section. 

18 ‘‘(4) EXEMPTIONS.—The Secretary, by notice 

19 in the Federal Register, may establish exemptions 

20 from the requirements of this subsection.’’. 

21 (c) MISBRANDING.—Section 502(o) (21 U.S.C. 352) 

22 is amended by inserting ‘‘if it is a drug and was imported 

23 or offered for import by a commercial importer of drugs 

24 not duly registered under section 801(s),’’ after ‘‘not duly 

25 registered under section 510,’’. 


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1 (d) REGULATIONS.— 

2 (1) IN GENERAL.—Not later than 36 months 

3 after the date of the enactment of this Act, the Sec4 retary of Health and Human Services, in consulta5 tion with the Secretary of Homeland Security acting 

6 through U.S. Customs and Border Protection, shall 

7 promulgate the regulations required to carry out sec8 tion 801(s) of the Federal Food, Drug, and Cos9 metic Act, as added by subsection (b). 

10 (2) EFFECTIVE DATE.—In establishing the ef11 fective date of the regulations under paragraph (1), 

12 the Secretary of Health and Human Services shall, 

13 in consultation with the Secretary of Homeland Se14 curity acting through U.S. Customs and Border Pro15 tection, as determined appropriate by the Secretary 

16 of Health and Human Services, provide a reasonable 

17 period of time for an importer of a drug to comply 

18 with good importer practices, taking into account 

19 differences among importers and types of imports, 

20 including based on the level of risk posed by the im21 ported product. 

22 SEC. 811. NOTIFICATION. 

23 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 

24 331), as amended by section 811, is further amended by 

25 adding at the end the following: 


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1 ‘‘(bbb) The failure to notify the Secretary in violation 

2 of section 568.’’. 

3 (b) NOTIFICATION.—Subchapter E of chapter V (21 

4 U.S.C. 360bbb et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘SEC. 568 NOTIFICATION. 

7 ‘‘(a) NOTIFICATION TO SECRETARY.—With respect 

8 to a drug, the Secretary may require notification to the 

9 Secretary by a regulated person if the regulated person 

10 knows— 

11 ‘‘(1) that the use of such drug in the United 

12 States may result in serious injury or death; 

13 ‘‘(2) of a significant loss or known theft of such 

14 drug intended for use in the United States; or 

15 ‘‘(3) that— 

16 ‘‘(A) such drug has been or is being coun17 terfeited; and 

18 ‘‘(B)(i) the counterfeit product is in com19 merce in the United States or could be reason20 ably expected to be introduced into commerce; 

21 or 

22 ‘‘(ii) such drug has been or is being im23 ported into the United States or may reason24 ably be expected to be offered for import into 

25 the United States. 


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1 ‘‘(b) MANNER OF NOTIFICATION.—Notification 

2 under this section shall be made in such manner and by 

3 such means as the Secretary may specify by regulation 

4 or guidance. 

5 ‘‘(c) SAVINGS CLAUSE.—Nothing in this section shall 

6 be construed as limiting any other authority of the Sec7 retary to require notifications related to a drug under any 

8 other provision of this Act or the Public Health Service 

9 Act. 

10 ‘‘(d) DEFINITION.—In this section, the term ‘regu11 lated person’ means— 

12 ‘‘(1) a person who is required to register under 

13 section 510 or 801(s); 

14 ‘‘(2) a wholesale distributor of a drug product; 

15 or 

16 ‘‘(3) any other person that distributes drugs ex17 cept a person that distributes drugs exclusively for 

18 retail sale.’’. 

19 SEC. 812. EXCHANGE OF INFORMATION. 

20 Section 708 (21 U.S.C. 379) is amended— 

21 (1) by striking ‘‘The Secretary may provide’’ 

22 and inserting the following: 

23 ‘‘(a) CONTRACTORS.—The Secretary may provide’’; 

24 and 

25 (2) by adding at the end the following: 


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1 ‘‘(b) ABILITY TO RECEIVE AND PROTECT CON2 FIDENTIAL INFORMATION.—Except pursuant to an order 

3 of a court of the United States, the Secretary shall not 

4 be required to disclose under section 552 of title 5, United 

5 States Code, or any other provision of law, any informa6 tion relating to drugs obtained from a Federal, State, or 

7 local government agency, or from a foreign government 

8 agency, if the agency has requested that the information 

9 be kept confidential. For purposes of section 552 of title 

10 5, United States Code, this subsection shall be considered 

11 a statute described in section 552(b)(3)(B). 

12 ‘‘(c) AUTHORITY TO ENTER INTO MEMORANDA OF

13 UNDERSTANDING FOR PURPOSES OF INFORMATION EX14 CHANGE.—The Secretary may enter into written agree15 ments regarding the exchange of information referenced 

16 in section 301(j) subject to the following criteria: 

17 ‘‘(1) CERTIFICATION.—The Secretary may only 

18 enter into written agreements under this subsection 

19 with foreign governments that the Secretary has cer20 tified as having the authority and demonstrated abil21 ity to protect trade secret information from disclo22 sure. Responsibility for this certification shall not be 

23 delegated to any officer or employee other than the 

24 Commissioner of Food and Drugs. 


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1 ‘‘(2) WRITTEN AGREEMENT.—The written 

2 agreement under this subsection shall include a com3 mitment by the foreign government to protect infor4 mation exchanged under this subsection from disclo5 sure unless and until the sponsor gives written per6 mission for disclosure or the Secretary makes a dec7 laration of a public health emergency pursuant to 

8 section 319 of the Public Health Service Act that is 

9 relevant to the information. 

10 ‘‘(3) INFORMATION EXCHANGE.—The Secretary 

11 may provide to a foreign government that has been 

12 certified under paragraph (1), and that has executed 

13 a written agreement under paragraph (2), informa14 tion referenced in section 301(j) in the following cir15 cumstances: 

16 ‘‘(A) Information concerning the inspection 

17 of a facility may be provided if— 

18 ‘‘(i) the Secretary reasonably believes, 

19 or the written agreement described in 

20 paragraph (2) establishes, that the govern21 ment has authority to otherwise obtain 

22 such information; and 

23 ‘‘(ii) the written agreement executed 

24 under paragraph (2) limits the recipient’s 


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1 use of the information to the recipient’s 

2 civil regulatory purposes. 

3 ‘‘(B) Information not described in sub4 paragraph (A) may be provided as part of an 

5 investigation, or to alert the foreign government 

6 to the potential need for an investigation, if the 

7 Secretary has reasonable grounds to believe 

8 that a drug has a reasonable probability of 

9 causing serious adverse health consequences or 

10 death. 

11 ‘‘(d) NO LIMITATION ON AUTHORITY.—This section 

12 shall not affect the authority of the Secretary to provide 

13 or disclose information under any other provision of law.’’. 

14 SEC. 813. EXTRATERRITORIAL JURISDICTION. 

15 Chapter III (21 U.S.C. 331 et seq.) is amended by 

16 adding at the end the following: 

17 ‘‘SEC. 311. EXTRATERRITORIAL JURISDICTION. 

18 ‘‘There is extraterritorial jurisdiction over any viola19 tion of this Act relating to any article regulated under this 

20 Act if such article was intended for import into the United 

21 States or if any act in furtherance of the violation was 

22 committed in the United States.’’. 


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1 SEC. 814. PROTECTION AGAINST INTENTIONAL ADULTERA2 TION. 

3 Section 303(b) (21 U.S.C. 333(b)) is amended by 

4 adding at the end the following: 

5 ‘‘(7) Notwithstanding subsection (a)(2), any 

6 person that knowingly and intentionally engages in 

7 an activity that results in a drug becoming adulter8 ated under subsection (a)(1), (b), (c), or (d) of sec9 tion 501 and having a reasonable probability of 

10 causing serious adverse health consequences or 

11 death shall be imprisoned for not more than 20 

12 years or fined not more than $1,000,000, or both.’’. 

13 SEC. 815. RECORDS FOR INSPECTION. 

14 Section 704(a) (21 U.S.C. 374(a)) is amended by 

15 adding at the end the following: 

16 ‘‘(4)(A) Any records or other information that the 

17 Secretary may inspect under this section from a person 

18 that owns or operates an establishment that is engaged 

19 in the manufacture, preparation, propagation, 

20 compounding, or processing of a drug shall, upon the re21 quest of the Secretary, be provided to the Secretary by 

22 such person, in advance of or in lieu of an inspection, with23 in a reasonable timeframe, within reasonable limits, and 

24 in a reasonable manner, and in either electronic or phys25 ical form, at the expense of such person. The Secretary’s 


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1 request shall include a sufficient description of the records 

2 requested. 

3 ‘‘(B) Upon receipt of the records requested under 

4 subparagraph (A), the Secretary shall provide to the per5 son confirmation of receipt. 

6 ‘‘(C) Nothing in this paragraph supplants the author7 ity of the Secretary to conduct inspections otherwise per8 mitted under this Act in order to ensure compliance with 

9 this Act.’’. 

10 Subtitle B—Medical Gas Safety 

11 SEC. 821. REGULATION OF MEDICAL GASES. 

12 Chapter V (21 U.S.C. 351 et seq.) is amended by 

13 adding at the end the following: 

14 ‘‘Subchapter G—Medical Gases 

15 ‘‘SEC. 575. DEFINITIONS. 

16 ‘‘In this subchapter: 

17 ‘‘(1) The term ‘designated medical gas’ means 

18 any of the following: 

19 ‘‘(A) Oxygen that meets the standards set 

20 forth in an official compendium. 

21 ‘‘(B) Nitrogen that meets the standards 

22 set forth in an official compendium. 

23 ‘‘(C) Nitrous oxide that meets the stand24 ards set forth in an official compendium. 


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1 ‘‘(D) Carbon dioxide that meets the stand2 ards set forth in an official compendium. 

3 ‘‘(E) Helium that meets the standards set 

4 forth in an official compendium. 

5 ‘‘(F) Carbon monoxide that meets the 

6 standards set forth in an official compendium. 

7 ‘‘(G) Medical air that meets the standards 

8 set forth in an official compendium. 

9 ‘‘(H) Any other medical gas deemed appro10 priate by the Secretary, after taking into ac11 count any investigational new drug application 

12 or investigational new animal drug application 

13 for the same medical gas submitted in accord14 ance with regulations applicable to such appli15 cations in title 21 of the Code of Federal Regu16 lations, unless any period of exclusivity under 

17 section 505(c)(3)(E)(ii) or section 

18 505(j)(5)(F)(ii), or the extension of any such 

19 period under section 505A, applicable to such 

20 medical gas has not expired. 

21 ‘‘(2) The term ‘medical gas’ means a drug 

22 that— 

23 ‘‘(A) is manufactured or stored in a lique24 fied, nonliquefied, or cryogenic state; and 

25 ‘‘(B) is administered as a gas. 


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1 ‘‘SEC. 576. REGULATION OF MEDICAL GASES. 

2 ‘‘(a) CERTIFICATION OF DESIGNATED MEDICAL

3 GASES.— 

4 ‘‘(1) SUBMISSION.—Beginning 180 days after 

5 the date of enactment of this section, any person 

6 may file with the Secretary a request for certifi7 cation of a medical gas as a designated medical gas. 

8 Any such request shall contain the following infor9 mation: 

10 ‘‘(A) A description of the medical gas. 

11 ‘‘(B) The name and address of the spon12 sor. 

13 ‘‘(C) The name and address of the facility 

14 or facilities where the medical gas is or will be 

15 manufactured. 

16 ‘‘(D) Any other information deemed appro17 priate by the Secretary to determine whether 

18 the medical gas is a designated medical gas. 

19 ‘‘(2) GRANT OF CERTIFICATION.—The certifi20 cation requested under paragraph (1) is deemed to 

21 be granted unless, within 60 days of the filing of 

22 such request, the Secretary finds that— 

23 ‘‘(A) the medical gas subject to the certifi24 cation is not a designated medical gas; 

25 ‘‘(B) the request does not contain the in26 formation required under paragraph (1) or othVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00209 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 erwise lacks sufficient information to permit the 

2 Secretary to determine that the medical gas is 

3 a designated medical gas; or 

4 ‘‘(C) denying the request is necessary to 

5 protect the public health. 

6 ‘‘(3) EFFECT OF CERTIFICATION.— 

7 ‘‘(A) IN GENERAL.— 

8 ‘‘(i) APPROVED USES.—A designated 

9 medical gas for which a certification is 

10 granted under paragraph (2) is deemed, 

11 alone or in combination, as medically ap12 propriate, with another designated medical 

13 gas or gases for which a certification or 

14 certifications have been granted, to have in 

15 effect an approved application under sec16 tion 505 or 512, subject to all applicable 

17 post-approval requirements, for the fol18 lowing indications for use: 

19 ‘‘(I) In the case of oxygen, the 

20 treatment or prevention of hypoxemia 

21 or hypoxia. 

22 ‘‘(II) In the case of nitrogen, use 

23 in hypoxic challenge testing. 

24 ‘‘(III) In the case of nitrous 

25 oxide, analgesia. 


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1 ‘‘(IV) In the case of carbon diox2 ide, use in extracorporeal membrane 

3 oxygenation therapy or respiratory 

4 stimulation. 

5 ‘‘(V) In the case of helium, the 

6 treatment of upper airway obstruction 

7 or increased airway resistance. 

8 ‘‘(VI) In the case of medical air, 

9 to reduce the risk of hyperoxia. 

10 ‘‘(VII) In the case of carbon 

11 monoxide, use in lung diffusion test12 ing. 

13 ‘‘(VIII) Any other indication for 

14 use for a designated medical gas or 

15 combination of designated medical 

16 gases deemed appropriate by the Sec17 retary, unless any period of exclusivity 

18 under clause (iii) or (iv) of section 

19 505(c)(3)(E), clause (iii) or (iv) of 

20 section 505(j)(5)(F), or section 527, 

21 or the extension of any such period 

22 under section 505A, applicable to 

23 such indication for use for such gas or 

24 combination of gases has not expired. 


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1 ‘‘(ii) LABELING.—The requirements 

2 of sections 503(b)(4) and 502(f) are 

3 deemed to have been met for a designated 

4 medical gas if the labeling on final use 

5 container for such medical gas bears— 

6 ‘‘(I) the information required by 

7 section 503(b)(4); 

8 ‘‘(II) a warning statement con9 cerning the use of the medical gas as 

10 determined by the Secretary by regu11 lation; and 

12 ‘‘(III) appropriate directions and 

13 warnings concerning storage and han14 dling. 

15 ‘‘(B) INAPPLICABILITY OF EXCLUSIVITY

16 PROVISIONS.— 

17 ‘‘(i) NO EXCLUSIVITY FOR A CER18 TIFIED MEDICAL GAS.—No designated 

19 medical gas deemed under subparagraph 

20 (A)(i) to have in effect an approved appli21 cation is eligible for any period of exclu22 sivity under section 505(c), 505(j), or 527, 

23 or the extension of any such period under 

24 section 505A, on the basis of such deemed 

25 approval. 


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1 ‘‘(ii) EFFECT ON CERTIFICATION.— 

2 No period of exclusivity under section 

3 505(c), 505(j), or section 527, or the ex4 tension of any such period under section 

5 505A, with respect to an application for a 

6 drug product shall prohibit, limit, or other7 wise affect the submission, grant, or effect 

8 of a certification under this section, except 

9 as provided in subsection (a)(3)(A)(i)(VIII) 

10 and section 575(1)(H). 

11 ‘‘(4) WITHDRAWAL, SUSPENSION, OR REVOCA12 TION OF APPROVAL.— 

13 ‘‘(A) WITHDRAWAL, SUSPENSION OF AP14 PROVAL.—Nothing in this subchapter limits the 

15 Secretary’s authority to withdraw or suspend 

16 approval of a drug product, including a des17 ignated medical gas deemed under this section 

18 to have in effect an approved application under 

19 section 505 or section 512 of this Act. 

20 ‘‘(B) REVOCATION OF CERTIFICATION.— 

21 The Secretary may revoke the grant of a certifi22 cation under paragraph (2) if the Secretary de23 termines that the request for certification con24 tains any material omission or falsification. 

25 ‘‘(b) PRESCRIPTION REQUIREMENT.— 


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1 ‘‘(1) IN GENERAL.—A designated medical gas 

2 shall be subject to the requirements of section 

3 503(b)(1) unless the Secretary exercises the author4 ity provided in section 503(b)(3) to remove such 

5 medical gas from the requirements of section 

6 503(b)(1), the gas is approved for use without a pre7 scription pursuant to an application under section 

8 505 or 512, or the use in question is authorized pur9 suant to another provision of this Act relating to use 

10 of medical products in emergencies. 

11 ‘‘(2) OXYGEN.— 

12 ‘‘(A) NO PRESCRIPTION REQUIRED FOR

13 CERTAIN USES.—Notwithstanding paragraph 

14 (1), oxygen may be provided without a prescrip15 tion for the following uses: 

16 ‘‘(i) For use in the event of depres17 surization or other environmental oxygen 

18 deficiency. 

19 ‘‘(ii) For oxygen deficiency or for use 

20 in emergency resuscitation, when adminis21 tered by properly trained personnel. 

22 ‘‘(B) LABELING.—For oxygen provided 

23 pursuant to subparagraph (A), the require24 ments of section 503(b)(4) shall be deemed to 

25 have been met if its labeling bears a warning 


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1 that the oxygen can be used for emergency use 

2 only and for all other medical applications a 

3 prescription is required. 

4 ‘‘SEC. 577. INAPPLICABILITY OF DRUG FEES TO DES5 IGNATED MEDICAL GASES. 

6 ‘‘A designated medical gas, alone or in combination 

7 with another designated gas or gases (as medically appro8 priate) deemed under section 576 to have in effect an ap9 proved application shall not be assessed fees under section 

10 736(a) on the basis of such deemed approval.’’. 

11 SEC. 822. CHANGES TO REGULATIONS. 

12 (a) REPORT.—Not later than 18 months after the 

13 date of the enactment of this Act, the Secretary, after ob14 taining input from medical gas manufacturers and any 

15 other interested members of the public, shall— 

16 (1) determine whether any changes to the Fed17 eral drug regulations are necessary for medical 

18 gases; and 

19 (2) submit to the Committee on Health, Edu20 cation, Labor and Pensions of the Senate and the 

21 Committee on Energy and Commerce of the House 

22 of Representatives a report regarding any such 

23 changes. 

24 (b) REGULATIONS.—If the Secretary determines 

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1 ulations are necessary for medical gases, the Secretary 

2 shall issue final regulations revising the Federal drug reg3 ulations with respect to medical gases not later than 48 

4 months after the date of the enactment of this Act. 

5 (c) DEFINITIONS.—In this section: 

6 (1) The term ‘‘Federal drug regulations’’ means 

7 regulations in title 21 of the Code of Federal Regu8 lations pertaining to drugs. 

9 (2) The term ‘‘medical gas’’ has the meaning 

10 given to such term in section 575 of the Federal 

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

12 821 of this Act. 

13 (3) The term ‘‘Secretary’’ means the Secretary 

14 of Health and Human Services, acting through the 

15 Commissioner of Food and Drugs. 

16 SEC. 823. RULES OF CONSTRUCTION. 

17 Nothing in this subtitle and the amendments made 

18 by this subtitle applies with respect to— 

19 (1) a drug that is approved prior to May 1, 

20 2012, pursuant to an application submitted under 

21 section 505 or 512 of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 355, 360b); 

23 (2) any gas listed in subparagraphs (A) through 

24 (G) of section 575(1) of the Federal Food, Drug, 

25 and Cosmetic Act, as added by section 821 of this 


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1 Act, or any combination of any such gases, for an 

2 indication that— 

3 (A) is not included in, or is different from, 

4 those specified in subclauses (I) through (VII) 

5 of section 576(a)(3)(A)(i) of such Act; and 

6 (B) is approved on or after May 1, 2012, 

7 pursuant to an application submitted under 

8 Section 505 or 512; or 

9 (3) any designated medical gas added pursuant 

10 to subparagraph (H) of section 575(1) of such Act 

11 for an indication that— 

12 (A) is not included in, or is different from, 

13 those originally added pursuant to subpara14 graph (H) of section 575(1) and section 

15 576(a)(3)(A)(i)(VIII); and 

16 (B) is approved on or after May 1, 2012, 

17 pursuant to an application submitted under sec18 tion 505 or 512 of such Act. 

19 Subtitle C—Generating Antibiotic 

20 Incentives Now 

21 SEC. 831. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. 

22 (a) IN GENERAL.—The Federal Food, Drug, and 

23 Cosmetic Act is amended by inserting after section 505D 

24 (21 U.S.C. 355e) the following: 


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1 ‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 

2 QUALIFIED INFECTIOUS DISEASE PRODUCTS. 

3 ‘‘(a) EXTENSION.—If the Secretary approves an ap4 plication pursuant to section 505 for a drug that has been 

5 determined to be a qualified infectious disease product 

6 under subsection (d), then the four- and five-year periods 

7 described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of 

8 section 505, the three-year periods described in clauses 

9 (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and 

10 (iv) of subsection (j)(5)(F) of section 505, or the seven 

11 year period described in section 527, as applicable, shall 

12 be extended by five years. 

13 ‘‘(b) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 

14 extension under subsection (a) of a period shall be in addi15 tion to any extension of the period under section 505A 

16 with respect to the drug. 

17 ‘‘(c) LIMITATIONS.—Subsection (a) does not apply to 

18 the approval of— 

19 ‘‘(1) a supplement to an application under sec20 tion 505(b) for any qualified infectious disease prod21 uct for which an extension described in subsection 

22 (a) is in effect or has expired; 

23 ‘‘(2) a subsequent application filed by the same 

24 sponsor or manufacturer of a qualified infectious 

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1 censor, predecessor in interest, or other related enti2 ty) for— 

3 ‘‘(A) a change (not including a modifica4 tion to the active moiety of the qualified infec5 tious disease product) that results in a new in6 dication, route of administration, dosing sched7 ule, dosage form, delivery system, delivery de8 vice, or strength; or 

9 ‘‘(B) a modification to the active moiety of 

10 the qualified infectious disease product that 

11 does not result in a change in safety or effec12 tiveness; or 

13 ‘‘(3) a product that does not meet the definition 

14 of a qualified infectious disease product under sub15 section (f) based upon its approved uses. 

16 ‘‘(d) DETERMINATION.—The manufacturer or spon17 sor of a drug may request that the Secretary designate 

18 a drug as a qualified infectious disease product at any 

19 time in the drug development process prior to the submis20 sion of an application under section 505(b) for the drug, 

21 but not later than 45 days before the submission of such 

22 application. The Secretary shall, not later than 30 days 

23 after the submission of such request, determine whether 

24 the drug is a qualified infectious disease product. 


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1 ‘‘(e) REGULATIONS.—The Secretary shall promulgate 

2 regulations for carrying out this section. The Secretary 

3 shall promulgate the initial regulations for carrying out 

4 this section not later than 12 months after the date of 

5 the enactment of this section. 

6 ‘‘(f) DEFINITIONS.—In this section: 

7 ‘‘(1) QUALIFIED INFECTIOUS DISEASE PROD8 UCT.—The term ‘qualified infectious disease prod9 uct’ means an antibacterial or antifungal drug for 

10 human use that treats or prevents an infection 

11 caused by a qualifying pathogen. 

12 ‘‘(2) QUALIFYING PATHOGEN.—The term 

13 ‘qualifying pathogen’ means— 

14 ‘‘(A) resistant gram-positive pathogens, in15 cluding methicillin-resistant Staphylococcus 

16 aureus (MRSA), vancomycin-resistant Staphy17 lococcus aureus (VRSA), and vancomycin-resist18 ant enterococcus (VRE); 

19 ‘‘(B) multidrug resistant gram-negative 

20 bacteria, including Acinetobacter, Klebsiella, 

21 Pseudomonas, and E. coli species; 

22 ‘‘(C) multi-drug resistant tuberculosis; or 

23 ‘‘(D) any other infectious pathogen identi24 fied for purposes of this section by the Sec25 retary.’’. 


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1 (b) APPLICATION.—Section 505E of the Federal 

2 Food, Drug, and Cosmetic Act, as added by subsection 

3 (a), applies only with respect to a drug that is first ap4 proved under section 505(c) of such Act (21 U.S.C. 

5 355(c)) on or after the date of the enactment of this Act. 

6 SEC. 832. STUDY ON INCENTIVES FOR QUALIFIED INFEC7 TIOUS DISEASE BIOLOGICAL PRODUCTS. 

8 (a) IN GENERAL.—The Comptroller General of the 

9 United States shall— 

10 (1) conduct a study on the need for incentives 

11 to encourage research on and development and mar12 keting of qualified infectious disease biological prod13 ucts; and 

14 (2) not later than 1 year after the date of the 

15 enactment of this Act, submit a report to the Con16 gress on the results of such study, including any rec17 ommendations of the Comptroller General on appro18 priate incentives for addressing such need. 

19 (b) DEFINITIONS.—In this section: 

20 (1) The term ‘‘biological product’’ has the 

21 meaning given to such term in section 351 of the 

22 Public Health Service Act (42 U.S.C. 262). 

23 (2) The term ‘‘qualified infectious disease bio24 logical product’’ means a biological product for 


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1 human use that treats or prevents an infection 

2 caused by a qualifying pathogen. 

3 (3) The term ‘‘qualifying pathogen’’ has the 

4 meaning given to such term in section 505E of the 

5 Federal Food, Drug, and Cosmetic Act, as added by 

6 section 831 of this Act. 

7 SEC. 833. CLINICAL TRIALS. 

8 (a) REVIEW AND REVISION OF GUIDELINES.— 

9 (1) IN GENERAL.—Not later than 1 year after 

10 the date of the enactment of this Act, and not later 

11 than 4 years thereafter, the Secretary shall— 

12 (A) review the guidance of the Food and 

13 Drug Administration for the conduct of clinical 

14 trials with respect to antibacterial and 

15 antifungal drugs; and 

16 (B) as appropriate, revise such guidance to 

17 reflect developments in scientific and medical 

18 information and technology and to ensure clar19 ity regarding the procedures and requirements 

20 for approval of an antibiotic and antifungal 

21 drug under chapter V of the Federal Food, 

22 Drug, and Cosmetic Act (21 U.S.C. 351 et 

23 seq.). 

24 (2) ISSUES FOR REVIEW.—At a minimum, the 

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1 priate animal models of infection, in vitro tech2 niques, valid microbiological surrogate markers, the 

3 use of noninferiority versus superiority trials, and 

4 appropriate delta values for noninferiority trials. 

5 (3) RULE OF CONSTRUCTION.—Except to the 

6 extent to which the Secretary of Health and Human 

7 Services makes revisions under paragraph (1)(B), 

8 nothing in this section shall be construed to repeal 

9 or otherwise affect the guidance of the Food and 

10 Drug Administration. 

11 (b) RECOMMENDATIONS FOR INVESTIGATIONS.— 

12 (1) REQUEST.—The sponsor of a drug intended 

13 to be used to treat or prevent a qualifying pathogen 

14 may request that the Secretary provide written rec15 ommendations for nonclinical and clinical investiga16 tions which may be conducted with the drug before 

17 it may be approved for such use under section 505 

18 of the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 355). 

20 (2) RECOMMENDATIONS.—If the Secretary has 

21 reason to believe that a drug for which a request is 

22 made under this subsection is a qualified infectious 

23 disease product, the Secretary shall provide the per24 son making the request written recommendations for 

25 the nonclinical and clinical investigations which the 


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1 Secretary believes, on the basis of information avail2 able to the Secretary at the time of the request, 

3 would be necessary for approval under section 505 

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

5 U.S.C. 355) of such drug for the use described in 

6 paragraph (1). 

7 (c) DEFINITIONS.—In this section: 

8 (1) The term ‘‘drug’’ has the meaning given to 

9 such term in section 201 of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 321). 

11 (2) The term ‘‘qualified infectious disease prod12 uct’’ has the meaning given to such term in section 

13 505E of the Federal Food, Drug, and Cosmetic Act, 

14 as added by section 831 of this Act. 

15 (3) The term ‘‘qualifying pathogen’’ has the 

16 meaning given to such term in section 505E of the 

17 Federal Food, Drug, and Cosmetic Act, as added by 

18 section 831 of this Act. 

19 (4) The term ‘‘Secretary’’ means the Secretary 

20 of Health and Human Services, acting through the 

21 Commissioner of Food and Drugs. 

22 SEC. 834. REASSESSMENT OF QUALIFIED INFECTIOUS DIS23 EASE PRODUCT INCENTIVES IN 5 YEARS. 

24 Not later than five years after the date of enactment 

25 of this Act, the Secretary of Health and Human Services 


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1 shall, in consultation with the Food and Drug Administra2 tion, Centers for Disease Control and Prevention and 

3 other appropriate agencies, submit to the Committee on 

4 Energy and Commerce of the House of Representatives 

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

6 Pensions of the Senate a report that contains the fol7 lowing: 

8 (1)(A) The number of initial designations of 

9 drugs as qualified infectious disease products under 

10 section 505E of the Federal Food, Drug, and Cos11 metic Act; 

12 (B) the number of qualified infectious disease 

13 products approved under this program; and 

14 (C) whether such products address the need for 

15 antibacterial and antifungal drugs to treat serious 

16 and life-threatening infections. 

17 (2) Recommendations— 

18 (A) based on the information in paragraph 

19 (1) and any other relevant data, on any changes 

20 that should be made to the list of pathogens 

21 that are defined as qualifying pathogens under 

22 section 505E(f)(2) of the Federal Food, Drug, 

23 and Cosmetic Act, as added by section 831; and 

24 (B) on whether any additional program 

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1 laborations to advance antibacterial drug inno2 vation) or changes to the incentives under this 

3 subtitle may be needed to promote the develop4 ment of antibacterial drugs. 

5 (3) An examination of— 

6 (A) the adoption of programs to measure 

7 the use of antibacterial drugs in health care set8 tings; and 

9 (B) the implementation and effectiveness 

10 of antimicrobial stewardship protocols across all 

11 health care settings. 

12 (4) Any recommendations for ways to encour13 age further development and establishment of stew14 ardship programs. 

15 SEC. 835. GUIDANCE ON PATHOGEN-FOCUSED ANTI16 BACTERIAL DRUG DEVELOPMENT. 

17 (a) DRAFT GUIDANCE.—Not later than June 30, 

18 2013, in order to facilitate the development of anti19 bacterial drugs for serious or life-threatening bacterial in20 fections, particularly in areas of unmet need, the Secretary 

21 of Health and Human Services shall publish draft guid22 ance that— 

23 (1) specifies how preclinical and clinical data 

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1 ment program that meets the approval standards of 

2 the Food and Drug Administration; and 

3 (2) provides advice on approaches for the devel4 opment of antibacterial drugs that target a more 

5 limited spectrum of pathogens. 

6 (b) FINAL GUIDANCE.—Not later than December 31, 

7 2014, after notice and opportunity for public comment on 

8 the draft guidance under subsection (a), the Secretary of 

9 Health and Human Services shall publish final guidance 

10 consistent with this section. 

11 Subtitle D—Accelerated Approval 

12 SEC. 841. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 

13 OR LIFE-THREATENING DISEASES OR CONDI14 TIONS. 

15 (a) FINDINGS; SENSE OF CONGRESS.— 

16 (1) FINDINGS.—The Congress finds as follows: 

17 (A) The Food and Drug Administration 

18 (referred to in this subsection as the ‘‘FDA’’) 

19 serves a critical role in helping to assure that 

20 new medicines are safe and effective. Regu21 latory innovation is 1 element of the Nation’s 

22 strategy to address serious and life-threatening 

23 diseases or conditions by promoting investment 

24 in and development of innovative treatments for 

25 unmet medical needs. 


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1 (B) During the 2 decades following the es2 tablishment of the accelerated approval mecha3 nism, advances in medical sciences, including 

4 genomics, molecular biology, and bioinformatics, 

5 have provided an unprecedented understanding 

6 of the underlying biological mechanism and 

7 pathogenesis of disease. A new generation of 

8 modern, targeted medicines is under develop9 ment to treat serious and life-threatening dis10 eases, some applying drug development strate11 gies based on biomarkers or pharmacogenomics, 

12 predictive toxicology, clinical trial enrichment 

13 techniques, and novel clinical trial designs, such 

14 as adaptive clinical trials. 

15 (C) As a result of these remarkable sci16 entific and medical advances, the FDA should 

17 be encouraged to implement more broadly effec18 tive processes for the expedited development 

19 and review of innovative new medicines in20 tended to address unmet medical needs for seri21 ous or life-threatening diseases or conditions, 

22 including those for rare diseases or conditions, 

23 using a broad range of surrogate or clinical 

24 endpoints and modern scientific tools earlier in 

25 the drug development cycle when appropriate. 


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1 This may result in fewer, smaller, or shorter 

2 clinical trials for the intended patient popu3 lation or targeted subpopulation without com4 promising or altering the high standards of the 

5 FDA for the approval of drugs. 

6 (D) Patients benefit from expedited access 

7 to safe and effective innovative therapies to 

8 treat unmet medical needs for serious or life9 threatening diseases or conditions. 

10 (E) For these reasons, the statutory au11 thority in effect on the day before the date of 

12 enactment of this Act governing expedited ap13 proval of drugs for serious or life-threatening 

14 diseases or conditions should be amended in 

15 order to enhance the authority of the FDA to 

16 consider appropriate scientific data, methods, 

17 and tools, and to expedite development and ac18 cess to novel treatments for patients with a 

19 broad range of serious or life-threatening dis20 eases or conditions. 

21 (2) SENSE OF CONGRESS.—It is the sense of 

22 the Congress that the FDA should apply the acceler23 ated approval and fast track provisions set forth in 

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1 tion, to help expedite the development and avail2 ability to patients of treatments for serious or life3 threatening diseases or conditions while maintaining 

4 safety and effectiveness standards for such treat5 ments. 

6 (b) EXPEDITED APPROVAL.—Section 506 (21 U.S.C. 

7 356) is amended to read as follows: 

8 ‘‘SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS 

9 OR LIFE-THREATENING DISEASES OR CONDI10 TIONS. 

11 ‘‘(a) DESIGNATION OF DRUG AS A FAST TRACK

12 PRODUCT.— 

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

14 request of the sponsor of a new drug, facilitate the 

15 development and expedite the review of such drug if 

16 it is intended, whether alone or in combination with 

17 one or more other drugs, for the treatment of a seri18 ous or life-threatening disease or condition, and it 

19 demonstrates the potential to address unmet medical 

20 needs for such a disease or condition. (In this sec21 tion, such a drug is referred to as a ‘fast track prod22 uct’.) 

23 ‘‘(2) REQUEST FOR DESIGNATION.—The spon24 sor of a new drug may request the Secretary to des25 ignate the drug as a fast track product. A request 


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1 for the designation may be made concurrently with, 

2 or at any time after, submission of an application 

3 for the investigation of the drug under section 505(i) 

4 of this Act or section 351(a)(3) of the Public Health 

5 Service Act. 

6 ‘‘(3) DESIGNATION.—Within 60 calendar days 

7 after the receipt of a request under paragraph (2), 

8 the Secretary shall determine whether the drug that 

9 is the subject of the request meets the criteria de10 scribed in paragraph (1). If the Secretary finds that 

11 the drug meets the criteria, the Secretary shall des12 ignate the drug as a fast track product and shall 

13 take such actions as are appropriate to expedite the 

14 development and review of the application for ap15 proval of such product. 

16 ‘‘(b) ACCELERATED APPROVAL OF A DRUG FOR A

17 SERIOUS OR LIFE-THREATENING DISEASE OR CONDI18 TION, INCLUDING A FAST TRACK PRODUCT.— 

19 ‘‘(1) IN GENERAL.—The Secretary may approve 

20 an application for approval of a product for a seri21 ous or life-threatening disease or condition, including 

22 a fast track product, under section 505(c) of this 

23 Act or section 351(a) of the Public Health Service 

24 Act upon making a determination that the product 

25 has an effect on— 


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1 ‘‘(A) a surrogate endpoint that is reason2 ably likely to predict clinical benefit; or 

3 ‘‘(B) a clinical endpoint that can be meas4 ured earlier than irreversible morbidity or mor5 tality, that is reasonably likely to predict an ef6 fect on irreversible morbidity or mortality or 

7 other clinical benefit, 

8 taking into account the severity or rarity of the dis9 ease or condition and the availability of alternative 

10 treatments. The evidence to support that an end11 point is reasonably likely to predict clinical benefit 

12 may include epidemiological, pathophysiologic, phar13 macologic, therapeutic or other evidence developed 

14 using, for example, biomarkers, or other scientific 

15 methods or tools. 

16 ‘‘(2) LIMITATION.—Approval of a product 

17 under this subsection may, as determined by the 

18 Secretary, be subject to the following require19 ments— 

20 ‘‘(A) that the sponsor conduct appropriate 

21 post-approval studies to verify and describe the 

22 predicted effect of the product on irreversible 

23 morbidity or mortality or other clinical benefit; 

24 and 


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1 ‘‘(B) that the sponsor submit copies of all 

2 promotional materials related to the product, at 

3 least 30 days prior to dissemination of the ma4 terials— 

5 ‘‘(i) during the preapproval review pe6 riod; and 

7 ‘‘(ii) following approval, for a period 

8 that the Secretary determines to be appro9 priate. 

10 ‘‘(3) EXPEDITED WITHDRAWAL OF AP11 PROVAL.—The Secretary may withdraw approval of 

12 a product approved pursuant to this subsection 

13 using expedited procedures (as prescribed by the 

14 Secretary in regulations, which shall include an op15 portunity for an informal hearing) if— 

16 ‘‘(A) the sponsor fails to conduct any re17 quired post-approval study of the product with 

18 due diligence; 

19 ‘‘(B) a study required to verify and de20 scribe the predicted effect on irreversible mor21 bidity or mortality or other clinical benefit of 

22 the product fails to verify and describe such ef23 fect or benefit; 


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1 ‘‘(C) other evidence demonstrates that the 

2 product is not safe or effective under the condi3 tions of use; or 

4 ‘‘(D) the sponsor disseminates false or 

5 misleading promotional materials with respect 

6 to the product. 

7 ‘‘(c) REVIEW OF INCOMPLETE APPLICATIONS FOR

8 APPROVAL OF A FAST TRACK PRODUCT.— 

9 ‘‘(1) IN GENERAL.—If the Secretary deter10 mines, after preliminary evaluation of clinical data 

11 submitted by the sponsor, that a fast track product 

12 may be effective, the Secretary shall evaluate for fil13 ing, and may commence review of portions of, an ap14 plication for the approval of the product before the 

15 sponsor submits a complete application. The Sec16 retary shall commence such review only if the appli17 cant— 

18 ‘‘(A) provides a schedule for submission of 

19 information necessary to make the application 

20 complete; and 

21 ‘‘(B) pays any fee that may be required 

22 under section 736. 

23 ‘‘(2) EXCEPTION.—Any time period for review 

24 of human drug applications that has been agreed to 

25 by the Secretary and that has been set forth in goals 


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1 identified in letters of the Secretary (relating to the 

2 use of fees collected under section 736 to expedite 

3 the drug development process and the review of 

4 human drug applications) shall not apply to an ap5 plication submitted under paragraph (1) until the 

6 date on which the application is complete. 

7 ‘‘(d) AWARENESS EFFORTS.—The Secretary shall— 

8 ‘‘(1) develop and disseminate to physicians, pa9 tient organizations, pharmaceutical and bio10 technology companies, and other appropriate persons 

11 a description of the provisions of this section appli12 cable to accelerated approval and fast track prod13 ucts; and 

14 ‘‘(2) establish a program to encourage the de15 velopment of surrogate and clinical endpoints, in16 cluding biomarkers, and other scientific methods and 

17 tools that can assist the Secretary in determining 

18 whether the evidence submitted in an application is 

19 reasonably likely to predict clinical benefit for seri20 ous or life-threatening conditions for which there 

21 exist significant unmet medical needs.’’. 

22 SEC. 842. GUIDANCE; AMENDED REGULATIONS. 

23 (a) INITIAL GUIDANCE.—Not later than one year 

24 after the date of enactment of this Act, the Secretary of 

25 Health and Human Services (in this subtitle referred to 


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1 as the ‘‘Secretary’’) shall issue draft guidance to imple2 ment the amendment made by section 841. 

3 (b) FINAL GUIDANCE.—Not later than one year after 

4 the issuance of draft guidance under subsection (a), after 

5 an opportunity for public comment, the Secretary shall— 

6 (1) issue final guidance to implement the 

7 amendment made by section 841; and 

8 (2) amend the regulations governing accelerated 

9 approval in parts 314 and 601 of title 21, Code of 

10 Federal Regulations, as necessary to conform such 

11 regulations with the amendments made by section 

12 841. 

13 (c) CONSIDERATIONS.—In developing the guidance 

14 under subsections (a) and (b)(1) and the amendments 

15 under subsection (b)(2), the Secretary shall consider— 

16 (1) issues arising under the accelerated ap17 proval and fast track processes under section 506 of 

18 the Federal Food, Drug, and Cosmetic Act (as 

19 amended by section 841) for drugs designated for a 

20 rare disease or condition under section 526 of the 

21 Federal, Food, Drug, and Cosmetic Act; and 

22 (2) how to incorporate novel approaches to the 

23 review of surrogate endpoints based on patho24 physiologic and pharmacologic evidence in such guid25 ance, especially in instances where the low prevaVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00236 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 lence of a disease renders the existence or collection 

2 of other types of data unlikely or impractical. 

3 (d) NO DELAY IN REVIEW OR APPROVAL.—The 

4 issuance (or non-issuance) of guidance or conforming reg5 ulations implementing the amendments made by section 

6 841 shall not preclude the review of, or action on, a re7 quest for designation or an application for approval sub8 mitted pursuant to section 506 of the Federal Food, Drug, 

9 and Cosmetic Act, as amended by section 841. 

10 SEC. 843. INDEPENDENT REVIEW. 

11 (a) IN GENERAL.—The Secretary may, in conjunc12 tion with other planned reviews of the new drug review 

13 process, contract with an independent entity with expertise 

14 in assessing the quality and efficiency of biopharma15 ceutical development and regulatory review programs, to 

16 evaluate the Food and Drug Administration’s application 

17 of the processes described in section 506 of the Federal 

18 Food, Drug, and Cosmetic Act, as amended by section 

19 841, and the impact of such processes on the development 

20 and timely availability of innovative treatments for pa21 tients suffering from serious or life-threatening conditions. 

22 (b) CONSULTATION.—Any evaluation under sub23 section (a) shall include consultation with regulated indus24 tries, patient advocacy and disease research foundations, 

25 and relevant academic medical centers. 


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1 Subtitle E—Critical Path 

2 Reauthorization 

3 SEC. 851. REAUTHORIZATION OF THE CRITICAL PATH PUB4 LIC-PRIVATE PARTNERSHIPS. 

5 Subsection (f) of section 566 (21 U.S.C. 360bbb–5) 

6 is amended to read as follows: 

7 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To 

8 carry out this section, there is authorized to be appro9 priated $6,000,000 for each of fiscal years 2013 through 

10 2017.’’. 

11 Subtitle F—Miscellaneous 

12 SEC. 861. REAUTHORIZATION OF PROVISION RELATING TO 

13 EXCLUSIVITY OF CERTAIN DRUGS CON14 TAINING SINGLE ENANTIOMERS. 

15 Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended 

16 by striking ‘‘2012’’ and inserting ‘‘2017’’. 

17 SEC. 862. EXTENSION OF PERIOD FOR FIRST APPLICANT TO 

18 OBTAIN TENTATIVE APPROVAL WITHOUT 

19 FORFEITING 180-DAY EXCLUSIVITY PERIOD. 

20 (a) EXTENSION OF PERIOD.— 

21 (1) IN GENERAL.—Subclause (IV) of section 

22 505(j)(5)(D)(i) (21 U.S.C. 355(j)(5)(D)(i)) is 

23 amended to read as follows: 

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1 cant fails to obtain tentative approval 

2 of the application within 45 months 

3 after the date on which— 

4 ‘‘(aa) the application is filed 

5 and initially contains a certifi6 cation described in paragraph 

7 (2)(A)(vii)(IV), or 

8 ‘‘(bb) the application is 

9 amended to first contain such a 

10 certification, 

11 unless the failure is caused by a 

12 change in or a review of the require13 ments for approval of the application 

14 imposed after the date on which the 

15 application is so filed or amended.’’. 

16 (2) APPLICABILITY.— 

17 (A) IN GENERAL.—Subject to subsection 

18 (b), the amendment made by paragraph (1) ap19 plies— 

20 (i) only with respect to an application 

21 that is filed under section 505(j) of the 

22 Federal Food, Drug, and Cosmetic Act (21 

23 U.S.C. 355(j)) on or after the day that is 

24 30 months prior to the date of the enact25 ment of this Act; and 


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1 (ii) only if no certification under para2 graph (2)(A)(vii)(IV) of such section 

3 505(j) was made before such day with re4 spect to the listed drug (as such term is 

5 used in such section 505(j)). 

6 (B) CERTAIN APPLICATIONS.—If an appli7 cation was filed under section 505(j) of the 

8 Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 355(j)) prior to the day specified in sub10 paragraph (A)(i) and, on such day, contained a 

11 certification described in paragraph 

12 (2)(A)(vii)(IV), the application shall be subject 

13 to paragraph (5)(D)(i)(IV) of such section 

14 505(j) as in effect on the day before the date 

15 of the enactment of this Act. 

16 (b) INCREMENTAL REDUCTION OF EXTENDED PE17 RIOD.— 

18 (1) PERIOD DURATION.— 

19 (A) Effective on October 1, 2013, sub20 clause (IV) of section 505(j)(5)(D)(i) (21 

21 U.S.C. 355(j)(5)(D)(i)), as amended by sub22 section (a)(1) of this section, is amended by 

23 striking ‘‘45 months’’ and inserting ‘‘42 

24 months’’. 


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1 (B) Effective on October 1, 2014, sub2 clause (IV) of section 505(j)(5)(D)(i) (21 

3 U.S.C. 355(j)(5)(D)(i)), as amended by sub4 paragraph (A) of this paragraph, is amended by 

5 striking ‘‘42 months’’ and inserting ‘‘39 

6 months’’. 

7 (C) Effective on October 1, 2015, sub8 clause (IV) of section 505(j)(5)(D)(i) (21 

9 U.S.C. 355(j)(5)(D)(i)), as amended by sub10 paragraph (B) of this paragraph, is amended by 

11 striking ‘‘39 months’’ and inserting ‘‘36 

12 months’’. 

13 (D) Effective on October 1, 2016, sub14 clause (IV) of section 505(j)(5)(D)(i) (21 

15 U.S.C. 355(j)(5)(D)(i)), as amended by sub16 paragraph (C) of this paragraph, is amended by 

17 striking ‘‘36 months’’ and inserting ‘‘33 

18 months’’. 

19 (E) Effective on October 1, 2017, sub20 clause (IV) of section 505(j)(5)(D)(i) (21 

21 U.S.C. 355(j)(5)(D)(i)), as amended by sub22 paragraph (D) of this paragraph, is amended 

23 by striking ‘‘33 months’’ and inserting ‘‘30 

24 months’’. 

25 (2) APPLICABILITY.— 


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1 (A) The amendments made by subpara2 graphs (A), (B), (C), and (D) of paragraph (1) 

3 apply only with respect to an application under 

4 section 505(j) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 355(j)) that— 

6 (i) is filed and initially contains a cer7 tification described in paragraph 

8 (2)(A)(vii)(IV) during the period of one 

9 fiscal year beginning on the effective date 

10 of the respective amendment; or 

11 (ii) is amended to initially contain 

12 such a certification during such period. 

13 (B) The amendment made by paragraph 

14 (1)(E) applies only with respect to an applica15 tion under section 505(j) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 355(j)) 

17 that— 

18 (i) is filed and initially contains a cer19 tification described in paragraph 

20 (2)(A)(vii)(IV) on or after October 1, 

21 2017; or 

22 (ii) is amended to initially contain 

23 such a certification on or after October 1, 

24 2017. 


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1 (c) CONFORMING AMENDMENT.—Subparagraph (G) 

2 of section 505(q)(1) (21 U.S.C. 355(q)(1)) is amended— 

3 (1) in the subparagraph heading, by striking 

4 ‘‘30-MONTH PERIOD’’ and inserting ‘‘PERIOD’’; and 

5 (2) by striking ‘‘the 30-month period’’ and in6 serting ‘‘the period’’. 

7 SEC. 863. FINAL AGENCY ACTION RELATING TO PETITIONS 

8 AND CIVIL ACTIONS. 

9 Section 505(q) (21 U.S.C. 355(q)) is amended— 

10 (1) in paragraph (1)(F), by striking ‘‘180 

11 days’’ and inserting ‘‘150 days’’; and 

12 (2) in paragraph (2)(A)— 

13 (A) in the subparagraph heading, by strik14 ing ‘‘180’’ and inserting ‘‘150’’; and 

15 (B) in clause (i), by striking ‘‘180-day’’ 

16 and inserting ‘‘150-day’’. 

17 SEC. 864. DEADLINE FOR DETERMINATION ON CERTAIN PE18 TITIONS. 

19 (a) IN GENERAL.—Section 505 (21 U.S.C. 355) is 

20 amended by adding at the end the following: 

21 ‘‘(w) DEADLINE FOR DETERMINATION ON CERTAIN

22 PETITIONS.—The Secretary shall issue a final, substantive 

23 determination on a petition submitted pursuant to sub24 section (b) of section 314.161 of title 21, Code of Federal 


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1 Regulations (or any successor regulations), no later than 

2 270 days after the date the petition is submitted.’’. 

3 (b) APPLICATION.—The amendment made by sub4 section (a) shall apply to any petition that is submitted 

5 pursuant to subsection (b) of section 314.161 of title 21, 

6 Code of Federal Regulations (or any successor regula7 tions), on or after the date of enactment of this Act. 

8 SEC. 865. RARE PEDIATRIC DISEASE PRIORITY REVIEW 

9 VOUCHER INCENTIVE PROGRAM. 

10 Subchapter B of Chapter V (21 U.S.C. 360aa et seq.) 

11 is amended by adding at the end the following: 

12 ‘‘SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 

13 FOR RARE PEDIATRIC DISEASES. 

14 ‘‘(a) DEFINITIONS.—In this section: 

15 ‘‘(1) PRIORITY REVIEW.—The term ‘priority re16 view’, with respect to a human drug application as 

17 defined in section 735(1), means review and action 

18 by the Secretary on such application not later than 

19 6 months after receipt by the Secretary of such ap20 plication, as described in the Manual of Policies and 

21 Procedures of the Food and Drug Administration 

22 and goals identified in the letters described in sec23 tion 101(b) of the Prescription Drug User Fee 

24 Amendments of 2012. 


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1 ‘‘(2) PRIORITY REVIEW VOUCHER.—The term 

2 ‘priority review voucher’ means a voucher issued by 

3 the Secretary to the sponsor of a rare pediatric dis4 ease product application that entitles the holder of 

5 such voucher to priority review of a single human 

6 drug application submitted under section 505(b)(1) 

7 or section 351(a) of the Public Health Service Act 

8 after the date of approval of the rare pediatric dis9 ease product application. 

10 ‘‘(3) RARE PEDIATRIC DISEASE.—The term 

11 ‘rare pediatric disease’ means a disease that meets 

12 each of the following criteria: 

13 ‘‘(A) The disease primarily affects individ14 uals aged from birth to 18 years, including age 

15 groups often called neonates, infants, children, 

16 and adolescents. 

17 ‘‘(B) The disease is a rare disease or con18 dition, within the meaning of section 526. 

19 ‘‘(4) RARE PEDIATRIC DISEASE PRODUCT AP20 PLICATION.—The term ‘rare pediatric disease prod21 uct application’ means a human drug application, as 

22 defined in section 735(1), that— 

23 ‘‘(A) is for a drug or biological product— 

24 ‘‘(i) that is for the prevention or 

25 treatment of a rare pediatric disease; 


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1 ‘‘(ii) that contains no active ingredient 

2 (including any ester or salt of the active 

3 ingredient) that has been previously ap4 proved in any other application under sec5 tion 505(b)(1), 505(b)(2), or 505(j) of this 

6 Act or section 351(a) or 351(k) of the 

7 Public Health Service Act; 

8 ‘‘(B) is submitted under section 505(b)(1) 

9 of this Act or section 351(a) of the Public 

10 Health Service Act; 

11 ‘‘(C) the Secretary deems eligible for pri12 ority review; 

13 ‘‘(D) that relies on clinical data derived 

14 from studies examining a pediatric population 

15 and dosages of the drug intended for that popu16 lation; 

17 ‘‘(E) that does not seek approval for an 

18 adult indication in the original rare pediatric 

19 disease product application; and 

20 ‘‘(F) is approved after the date of the en21 actment of the Prescription Drug User Fee 

22 Amendments of 2012. 

23 ‘‘(b) PRIORITY REVIEW VOUCHER.— 

24 ‘‘(1) IN GENERAL.—The Secretary shall award 

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1 diatric disease product application upon approval by 

2 the Secretary of such rare pediatric disease product 

3 application. 

4 ‘‘(2) TRANSFERABILITY.— 

5 ‘‘(A) IN GENERAL.—The sponsor of a rare 

6 pediatric disease product application that re7 ceives a priority review voucher under this sec8 tion may transfer (including by sale) the enti9 tlement to such voucher. There is no limit on 

10 the number of times a priority review voucher 

11 may be transferred before such voucher is used. 

12 ‘‘(B) NOTIFICATION OF TRANSFER.—Each 

13 person to whom a voucher is transferred shall 

14 notify the Secretary of such change in owner15 ship of the voucher not later than 30 days after 

16 such transfer. 

17 ‘‘(3) LIMITATION.—A sponsor of a rare pedi18 atric disease product application may not receive a 

19 priority review voucher under this section if the rare 

20 pediatric disease product application was submitted 

21 to the Secretary prior to the date that is 90 days 

22 after the date of enactment of the Prescription Drug 

23 User Fee Amendments of 2012. 

24 ‘‘(4) NOTIFICATION.— 


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1 ‘‘(A) IN GENERAL.—The sponsor of a 

2 human drug application shall notify the Sec3 retary not later than 90 days prior to submis4 sion of the human drug application that is the 

5 subject of a priority review voucher of an intent 

6 to submit the human drug application, includ7 ing the date on which the sponsor intends to 

8 submit the application. Such notification shall 

9 be a legally binding commitment to pay for the 

10 user fee to be assessed in accordance with this 

11 section. 

12 ‘‘(B) TRANSFER AFTER NOTICE.—The 

13 sponsor of a human drug application that pro14 vides notification of the intent of such sponsor 

15 to use the voucher for the human drug applica16 tion under subparagraph (A) may transfer the 

17 voucher after such notification is provided, if 

18 such sponsor has not yet submitted the human 

19 drug application described in the notification. 

20 ‘‘(5) TERMINATION OF AUTHORITY.—The Sec21 retary may not award any priority review vouchers 

22 under paragraph (1) after the last day of the 1-year 

23 period that begins on the date that the Secretary 

24 awards the third rare pediatric disease priority 

25 voucher under this section. 


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1 ‘‘(c) PRIORITY REVIEW USER FEE.— 

2 ‘‘(1) IN GENERAL.—The Secretary shall estab3 lish a user fee program under which a sponsor of a 

4 human drug application that is the subject of a pri5 ority review voucher shall pay to the Secretary a fee 

6 determined under paragraph (2). Such fee shall be 

7 in addition to any fee required to be submitted by 

8 the sponsor under chapter VII. 

9 ‘‘(2) FEE AMOUNT.—The amount of the pri10 ority review user fee shall be determined each fiscal 

11 year by the Secretary, based on the difference be12 tween— 

13 ‘‘(A) the average cost incurred by the Food 

14 and Drug Administration in the review of a 

15 human drug application subject to priority re16 view in the previous fiscal year; and 

17 ‘‘(B) the average cost incurred by the 

18 Food and Drug Administration in the review of 

19 a human drug application that is not subject to 

20 priority review in the previous fiscal year. 

21 ‘‘(3) ANNUAL FEE SETTING.—The Secretary 

22 shall establish, before the beginning of each fiscal 

23 year beginning after September 30, 2012, the 

24 amount of the priority review user fee for that fiscal 

25 year. 


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1 ‘‘(4) PAYMENT.— 

2 ‘‘(A) IN GENERAL.—The priority review 

3 user fee required by this subsection shall be due 

4 upon the notification by a sponsor of the intent 

5 of such sponsor to use the voucher, as specified 

6 in subsection (b)(4)(A). All other user fees as7 sociated with the human drug application shall 

8 be due as required by the Secretary or under 

9 applicable law. 

10 ‘‘(B) COMPLETE APPLICATION.—An appli11 cation described under subparagraph (A) for 

12 which the sponsor requests the use of a priority 

13 review voucher shall be considered incomplete if 

14 the fee required by this subsection and all other 

15 applicable user fees are not paid in accordance 

16 with the Secretary’s procedures for paying such 

17 fees. 

18 ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC19 TIONS, OR REFUNDS.—The Secretary may not 

20 grant a waiver, exemption, reduction, or refund 

21 of any fees due and payable under this section. 

22 ‘‘(5) OFFSETTING COLLECTIONS.—Fees col23 lected pursuant to this subsection for any fiscal 

24 year— 


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1 ‘‘(A) shall be deposited and credited as off2 setting collections to the account providing ap3 propriations to the Food and Drug Administra4 tion; and 

5 ‘‘(B) shall not be collected for any fiscal 

6 year except to the extent provided in advance in 

7 appropriation Acts. 

8 ‘‘(d) DESIGNATION PROCESS.— 

9 ‘‘(1) IN GENERAL.—Upon the request of the 

10 manufacturer or the sponsor of a new drug, the Sec11 retary may designate— 

12 ‘‘(A) the new drug as a drug for a rare pe13 diatric disease; and 

14 ‘‘(B) the application for the new drug as a 

15 rare pediatric disease product application. 

16 ‘‘(2) REQUEST FOR DESIGNATION.—The re17 quest for a designation under paragraph (1), shall 

18 be made at the same time a request for designation 

19 of orphan disease status under section 526 or fast20 track designation under section 506 is made. Re21 questing designation under this subsection is not a 

22 prerequisite to receiving a priority review voucher 

23 under this section. 

24 ‘‘(3) DETERMINATION BY SECRETARY.—Not 

25 later than 60 days after a request is submitted 


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1 under paragraph (1), the Secretary shall determine 

2 whether— 

3 ‘‘(A) the disease or condition that is the 

4 subject of such request is a rare pediatric dis5 ease; and 

6 ‘‘(B) the application for the new drug is a 

7 rare pediatric disease product application. 

8 ‘‘(e) MARKETING OF RARE PEDIATRIC DISEASE

9 PRODUCTS.— 

10 ‘‘(1) IN GENERAL.—The Secretary shall deem a 

11 rare pediatric disease product application incomplete 

12 if such application does not contain a description of 

13 the plan of the sponsor of such application to mar14 ket the product in the United States. 

15 ‘‘(2) REVOCATION.—The Secretary may revoke 

16 any priority review voucher awarded under sub17 section (b) if the rare pediatric disease product for 

18 which such voucher was awarded is not marketed in 

19 the United States within the 365 day period begin20 ning on the date of the approval of such drug under 

21 section 505 of this Act or section 351 of the Public 

22 Health Service Act. 

23 ‘‘(3) POSTAPPROVAL PRODUCTION REPORT.— 

24 The sponsor of an approved rare pediatric disease 

25 product shall submit a report to the Secretary not 


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1 later than 5 years after the approval of the applica2 ble rare pediatric disease product application. Such 

3 report shall provide the following information, with 

4 respect to each of the first 4 years after approval of 

5 such product: 

6 ‘‘(A) The estimated population in the 

7 United States suffering from the rare pediatric 

8 disease. 

9 ‘‘(B) The estimated demand in the United 

10 States for such rare pediatric disease product. 

11 ‘‘(C) The actual amount of such rare pedi12 atric disease product distributed in the United 

13 States. 

14 ‘‘(f) NOTICE AND REPORT.— 

15 ‘‘(1) NOTICE OF ISSUANCE OF VOUCHER AND

16 APPROVAL OF PRODUCTS UNDER VOUCHER.—The 

17 Secretary shall publish a notice in the Federal Reg18 ister and on the Web site of the Food and Drug Ad19 ministration not later than 30 days after the occur20 rence of each of the following: 

21 ‘‘(A) The Secretary issues a priority review 

22 voucher under this section. 

23 ‘‘(B) The Secretary approves a drug pur24 suant to an application submitted under section 

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1 lic Health Service Act for which the sponsor of 

2 the application used a priority review voucher 

3 under this section. 

4 ‘‘(2) REPORT.—If, after the last day of the 1- 

5 year period that begins on the date that the Sec6 retary awards the third rare pediatric disease pri7 ority voucher under this section, a sponsor of an ap8 plication submitted under section 505(b) of this Act 

9 or section 351(a) of the Public Health Service Act 

10 for a drug uses a priority review voucher under this 

11 section for such application, the Secretary shall sub12 mit to the Committee on Energy and Commerce of 

13 the House of Representatives and the Committee on 

14 Health, Education, Labor, and Pensions of the Sen15 ate a document— 

16 ‘‘(A) notifying such Committees of the use 

17 of such voucher; and 

18 ‘‘(B) identifying the drug for which such 

19 priority review voucher is used. 

20 ‘‘(g) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 

21 in this section precludes a sponsor who seeks a priority 

22 review voucher under this section from participating in 

23 any other incentive program, including under this Act. 

24 ‘‘(h) RELATION TO OTHER PROVISIONS.—The provi25 sions of this section shall supplement, not supplant, any 


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1 other provisions of this Act or the Public Health Service 

2 Act that encourage the development of drugs for tropical 

3 diseases and rare pediatric diseases. 

4 ‘‘(i) GAO STUDY AND REPORT.— 

5 ‘‘(1) STUDY.— 

6 ‘‘(A) IN GENERAL.—Beginning on the date 

7 that the Secretary awards the third rare pedi8 atric disease priority voucher under this section, 

9 the Comptroller General of the United States 

10 shall conduct a study of the effectiveness of 

11 awarding rare pediatric disease priority vouch12 ers under this section in the development of on 

13 human drug products that treat or prevent such 

14 diseases. 

15 ‘‘(B) CONTENTS OF STUDY.—In con16 ducting the study under subparagraph (A), the 

17 Comptroller General shall examine the fol18 lowing: 

19 ‘‘(i) The indications for which each 

20 rare disease product for which a priority 

21 review voucher was awarded was approved 

22 under section 505 or section 351 of the 

23 Public Health Service Act. 

24 ‘‘(ii) Whether, and to what extent, an 

25 unmet need related to the treatment or 


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1 prevention of a rare pediatric disease was 

2 met through the approval of such a rare 

3 disease product. 

4 ‘‘(iii) The value of the priority review 

5 voucher if transferred. 

6 ‘‘(iv) Identification of each drug for 

7 which a priority review voucher was used. 

8 ‘‘(v) The length of the period of time 

9 between the date on which a priority re10 view voucher was awarded and the date on 

11 which it was used. 

12 ‘‘(2) REPORT.—Not later than 1 year after the 

13 date under paragraph (1)(A), the Comptroller Gen14 eral shall submit to the Committee on Energy and 

15 Commerce of the House of Representatives and the 

16 Committee on Health, Education, Labor, and Pen17 sions of the Senate, a report containing the results 

18 of the study under paragraph (1).’’. 

19 SEC. 866. COMBATING PRESCRIPTION DRUG ABUSE. 

20 (a) IN GENERAL.—To combat the significant rise in 

21 prescription drug abuse and the consequences of such 

22 abuse, the Secretary of Health and Human Services (re23 ferred to in this section as the ‘‘Secretary’’), acting 

24 through the Commissioner of Food and Drugs (referred 

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1 tion with other Federal agencies, as appropriate, shall re2 view current Federal initiatives and identify gaps and op3 portunities with respect to ensuring the safe use of pre4 scription drugs with the potential for abuse. 

5 (b) REPORT.—Not later than 1 year after the date 

6 of enactment of this Act, the Secretary shall issue a report 

7 to Congress on the findings of the review under subsection 

8 (a). Such report shall include recommendations on— 

9 (1) how best to leverage and build upon existing 

10 Federal and federally funded data sources, such as 

11 prescription drug monitoring program data and the 

12 sentinel initiative of the Food and Drug Administra13 tion under section 505(k)(3) of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as 

15 it relates to collection of information relevant to ad16 verse events, patient safety, and patient outcomes, to 

17 create a centralized data clearinghouse and early 

18 warning tool; 

19 (2) how best to develop and disseminate widely 

20 best practices models and suggested standard re21 quirements to States for achieving greater interoper22 ability and effectiveness of prescription drug moni23 toring programs, especially with respect to producing 

24 standardized data on adverse events, patient safety, 

25 and patient outcomes; and 


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1 (3) how best to develop provider and patient 

2 education tools and a strategy to widely disseminate 

3 such tools and assess the efficacy of such tools. 

4 (c) GUIDANCE ON TAMPER-DETERRENT PROD5 UCTS.—Not later than 6 months after the date of enact6 ment of this Act, the Secretary, acting through the Com7 missioner, shall promulgate guidance on the development 

8 of tamper-deterrent drug products. 

9 SEC. 867. ASSESSMENT AND MODIFICATION OF REMS. 

10 (a) ASSESSMENT AND MODIFICATION OF APPROVED

11 STRATEGY.—Section 505–1(g) (21 U.S.C. 355–1(g)) is 

12 amended— 

13 (1) in paragraph (1), by striking ‘‘, and propose 

14 a modification to,’’; 

15 (2) in paragraph (2)— 

16 (A) in the matter before subparagraph 

17 (A)— 

18 (i) by striking ‘‘, subject to paragraph 

19 (5),’’; and 

20 (ii) by striking ‘‘, and may propose a 

21 modification to,’’; 

22 (B) in subparagraph (C), by striking ‘‘new 

23 safety or effectiveness information indicates 

24 that’’ and all that follows and inserting the fol25 lowing: ‘‘an assessment is needed to evaluate 


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1 whether the approved strategy should be modi2 fied to— 

3 ‘‘(i) ensure the benefits of the drug 

4 outweigh the risks of the drug; or 

5 ‘‘(ii) minimize the burden on the 

6 health care delivery system of complying 

7 with the strategy.’’; and 

8 (C) by striking subparagraph (D); 

9 (3) in paragraph (3), by striking ‘‘for a drug 

10 shall include—’’ and all that follows and inserting 

11 the following ‘‘for a drug shall include, with respect 

12 to each goal included in the strategy, an assessment 

13 of the extent to which the approved strategy, includ14 ing each element of the strategy, is meeting the goal 

15 or whether 1 or more such goals or such elements 

16 should be modified.’’; and 

17 (4) by amending paragraph (4) to read as fol18 lows: 

19 ‘‘(4) MODIFICATION.— 

20 ‘‘(A) ON INITIATIVE OF RESPONSIBLE

21 PERSON.—After the approval of a risk evalua22 tion and mitigation strategy by the Secretary, 

23 the responsible person may, at any time, submit 

24 to the Secretary a proposal to modify the ap25 proved strategy. Such proposal may propose the 


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1 addition, modification, or removal of any goal 

2 or element of the approved strategy and shall 

3 include an adequate rationale to support such 

4 proposed addition, modification, or removal of 

5 any goal or element of the strategy. 

6 ‘‘(B) ON INITIATIVE OF SECRETARY.— 

7 After the approval of a risk evaluation and 

8 mitigation strategy by the Secretary, the Sec9 retary may, at any time, require a responsible 

10 person to submit a proposed modification to the 

11 strategy within 120 days or within such reason12 able time as the Secretary specifies, if the Sec13 retary, in consultation with the offices described 

14 in subsection (c)(2), determines that 1 or more 

15 goals or elements should be added, modified, or 

16 removed from the approved strategy to— 

17 ‘‘(i) ensure the benefits of the drug 

18 outweigh the risks of the drug; or 

19 ‘‘(ii) minimize the burden on the 

20 health care delivery system of complying 

21 with the strategy.’’. 

22 (b) REVIEW OF PROPOSED STRATEGIES; REVIEW OF

23 ASSESSMENTS AND MODIFICATIONS OF APPROVED

24 STRATEGIES.—Section 505–1(h) (21 U.S.C. 355–1(h)) is 

25 amended— 


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1 (1) in the subsection heading by inserting ‘‘AND

2 MODIFICATIONS’’ after ‘‘REVIEW OF ASSESS3 MENTS’’; 

4 (2) in paragraph (1)— 

5 (A) by inserting ‘‘and proposed modifica6 tion to’’ after ‘‘under subsection (a) and each 

7 assessment of’’; and 

8 (B) by inserting ‘‘, and, if necessary, 

9 promptly initiate discussions with the respon10 sible person about such proposed strategy, as11 sessment, or modification’’ after ‘‘subsection 

12 (g)’’; 

13 (3) by striking paragraph (2); 

14 (4) by redesignating paragraphs (3) through 

15 (9) 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 

24 provided in clause (ii) or clause (iii) below, 

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1 fices described in subsection (c)(2), shall 

2 review and act on the proposed risk evalua3 tion and mitigation strategy for a drug or 

4 any proposed modification to any required 

5 strategy within 180 days of receipt of the 

6 proposed strategy or modification. 

7 ‘‘(ii) MINOR MODIFICATIONS.—The 

8 Secretary shall review and act on a pro9 posed minor modification, as defined by 

10 the Secretary in guidance, within 60 days 

11 of 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 safe21 ty label change that the Secretary has di22 rected the holder of the application to 

23 make pursuant to section 505(o)(4), the 

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1 posed modification to the approved strat2 egy. 

3 ‘‘(iv) GUIDANCE.—The Secretary shall 

4 establish, through guidance, that respon5 sible persons may implement certain modi6 fications to an approved risk evaluation 

7 and mitigation strategy following notifica8 tion to the Secretary.’’; and 

9 (B) by amending subparagraph (C) to read 

10 as follows: 

11 ‘‘(C) PUBLIC AVAILABILITY.—Upon acting 

12 on a proposed risk evaluation and mitigation 

13 strategy or proposed modification to a risk eval14 uation and mitigation strategy under subpara15 graph (A), the Secretary shall make publicly 

16 available an action letter describing the actions 

17 taken by the Secretary under such subpara18 graph (A).’’. 

19 (6) in paragraph (4), as redesignated by para20 graph (4)— 

21 (A) in subparagraph (A)(i)— 

22 (i) by striking ‘‘Not earlier than 15 

23 days, and not later than 35 days, after dis24 cussions under paragraph (2) have begun, 

25 the’’ and inserting ‘‘The’’; and 


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1 (ii) by inserting ‘‘, after the sponsor is 

2 required to make a submission under sub3 section (a)(2) or (g),’’ before ‘‘request in 

4 writing’’; and 

5 (B) in subparagraph (I)— 

6 (i) by striking clauses (i) and (ii); and 

7 (ii) by striking ‘‘if the Secretary—’’ 

8 and inserting ‘‘if the Secretary has com9 plied with the timing requirements of 

10 scheduling review by the Drug Safety 

11 Oversight Board, providing a written rec12 ommendation, and issuing an action letter 

13 under subparagraphs (B), (F), and (G), 

14 respectively.’’; 

15 (7) in paragraph (5), as redesignated by para16 graph (4)— 

17 (A) in subparagraph (A), by striking ‘‘any 

18 of subparagraph (B) through (D)’’ and insert19 ing ‘‘subparagraph (B) or (C)’’; and 

20 (B) in subparagraph (C), by striking 

21 ‘‘paragraph (4) or (5)’’ and inserting ‘‘para22 graph (3) or (4)’’; and 

23 (8) in paragraph (8), as redesignated by para24 graph (4), by striking ‘‘paragraphs (7) and (8)’’ and 

25 inserting ‘‘paragraphs (6) and (7).’’. 


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1 (c) GUIDANCE.—Not later than 1 year after the date 

2 of enactment of this Act, the Secretary of Health and 

3 Human Services shall issue guidance that, for purposes 

4 of section 505–1(h)(2)(A) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 355–1(h)(2)(A)), describes the 

6 types of modifications to approved risk evaluation and 

7 mitigation strategies that shall be considered to be minor 

8 modifications of such strategies. 

9 SEC. 868. CONSULTATION WITH EXTERNAL EXPERTS ON 

10 RARE DISEASES, TARGETED THERAPIES, AND 

11 GENETIC TARGETING OF TREATMENTS. 

12 Subchapter E of chapter V (21 U.S.C. 360bbb et 

13 seq.) is amended by adding at the end the following: 

14 ‘‘SEC. 568. CONSULTATION WITH EXTERNAL EXPERTS ON 

15 RARE DISEASES, TARGETED THERAPIES, AND 

16 GENETIC TARGETING OF TREATMENTS. 

17 ‘‘(a) IN GENERAL.—For the purpose of promoting 

18 the efficiency of and informing the review by the Food 

19 and Drug Administration of new drugs and biological 

20 products for rare diseases and drugs and biological prod21 ucts that are genetically targeted, the following shall 

22 apply: 

23 ‘‘(1) CONSULTATION WITH STAKEHOLDERS.— 

24 Consistent with sections X.C and IX.E.4 of the 

25 PDUFA Reauthorization Performance Goals and 


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1 Procedures Fiscal Years 2013 through 2017, as ref2 erenced in the letters described in section 101(b) of 

3 the Prescription Drug User Fee Amendments of 

4 2012, the Secretary shall ensure that opportunities 

5 exist, at a time the Secretary determines appro6 priate, for consultations with stakeholders on the 

7 topics described in subsection (b). 

8 ‘‘(2) CONSULTATION WITH EXTERNAL EX9 PERTS.— 

10 ‘‘(A) IN GENERAL.—The Secretary shall 

11 develop and maintain a list of external experts 

12 who, because of their special expertise, are 

13 qualified to provide advice on rare disease 

14 issues, including topics described in subsection 

15 (c). The Secretary may, when appropriate to 

16 address a specific regulatory question, consult 

17 such external experts on issues related to the 

18 review of new drugs and biological products for 

19 rare diseases and drugs and biological products 

20 that are genetically targeted, including the top21 ics described in subsection (b), when such con22 sultation is necessary because the Secretary 

23 lacks the specific scientific, medical, or tech24 nical expertise necessary for the performance of 

25 the Secretary’s regulatory responsibilities and 


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1 the necessary expertise can be provided by the 

2 external experts. 

3 ‘‘(B) EXTERNAL EXPERTS.—For purposes 

4 of subparagraph (A), external experts are indi5 viduals who possess scientific or medical train6 ing that the Secretary lacks with respect to one 

7 or more rare diseases. 

8 ‘‘(b) TOPICS FOR CONSULTATION.—Topics for con9 sultation pursuant to this section may include— 

10 ‘‘(1) rare diseases; 

11 ‘‘(2) the severity of rare diseases; 

12 ‘‘(3) the unmet medical need associated with 

13 rare diseases; 

14 ‘‘(4) the willingness and ability of individuals 

15 with a rare disease to participate in clinical trials; 

16 ‘‘(5) an assessment of the benefits and risks of 

17 therapies to treat rare diseases; 

18 ‘‘(6) the general design of clinical trials for rare 

19 disease populations and subpopulations; and 

20 ‘‘(7) the demographics and the clinical descrip21 tion of patient populations. 

22 ‘‘(c) CLASSIFICATION AS SPECIAL GOVERNMENT EM23 PLOYEES.—The external experts who are consulted under 

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1 ees, as defined under section 202 of title 18, United States 

2 Code. 

3 ‘‘(d) PROTECTION OF CONFIDENTIAL INFORMATION

4 AND TRADE SECRETS.— 

5 ‘‘(1) RULE OF CONSTRUCTION.—Nothing in 

6 this section shall be construed to alter the protec7 tions offered by laws, regulations, and policies gov8 erning disclosure of confidential commercial or trade 

9 secret information, and any other information ex10 empt from disclosure pursuant to section 552(b) of 

11 title 5, United States Code, as such provisions would 

12 be applied to consultation with individuals and orga13 nizations prior to the date of enactment of this sec14 tion. 

15 ‘‘(2) CONSENT REQUIRED FOR DISCLOSURE.— 

16 The Secretary shall not disclose confidential com17 mercial or trade secret information to an expert con18 sulted under this section without the written consent 

19 of the sponsor unless the expert is a special govern20 ment employee (as defined under section 202 of title 

21 18, United States Code) or the disclosure is other22 wise authorized by law. 

23 ‘‘(e) OTHER CONSULTATION.—Nothing in this sec24 tion shall be construed to limit the ability of the Secretary 


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1 to consult with individuals and organizations as authorized 

2 prior to the date of enactment of this section. 

3 ‘‘(f) NO RIGHT OR OBLIGATION.— 

4 ‘‘(1) NO RIGHT TO CONSULTATION.—Nothing 

5 in this section shall be construed to create a legal 

6 right for a consultation on any matter or require the 

7 Secretary to meet with any particular expert or 

8 stakeholder. 

9 ‘‘(2) NO ALTERING OF GOALS.—Nothing in this 

10 section shall be construed to alter agreed upon goals 

11 and procedures identified in the letters described in 

12 section 101(b) of the Prescription Drug User Fee 

13 Amendments of 2012. 

14 ‘‘(3) NO CHANGE TO NUMBER OF REVIEW CY15 CLES.—Nothing in this section is intended to in16 crease the number of review cycles as in effect before 

17 the date of enactment of this section. 

18 ‘‘(g) NO DELAY IN PRODUCT REVIEW.—Prior to a 

19 consultation with an external expert, as described in this 

20 section, relating to an investigational new drug application 

21 under section 505(i), a new drug application under section 

22 505(b), or a biologics license application under section 351 

23 of the Public Health Service Act, the Director of the Cen24 ter for Drug Evaluation and Research or the Director of 

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1 propriate Division Director), as appropriate, shall deter2 mine that— 

3 ‘‘(1) such consultation will— 

4 ‘‘(A) facilitate the Secretary’s ability to 

5 complete the Secretary’s review; 

6 ‘‘(B) address outstanding deficiencies in 

7 the application; and 

8 ‘‘(C) increase the likelihood of an approval 

9 decision in the current review cycle; or 

10 ‘‘(2) the sponsor authorized such consultation.’’. 

11 SEC. 869. BREAKTHROUGH THERAPIES. 

12 (a) IN GENERAL.—Section 506 (21 U.S.C. 356), as 

13 amended by section 841, is further amended— 

14 (1) by redesignating subsection (d) as sub15 section (f); 

16 (2) by redesignating subsections (a) through (c) 

17 as subsections (b) through (d), respectively; 

18 (3) by inserting before subsection (b), as so re19 designated, the following: 

20 ‘‘(a) DESIGNATION OF A DRUG AS A BREAKTHROUGH

21 THERAPY.— 

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

23 request of the sponsor of a drug, expedite the devel24 opment and review of such drug if the drug is in25 tended, alone or in combination with 1 or more other 


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1 drugs, to treat a serious or life-threatening disease 

2 or condition and preliminary clinical evidence indi3 cates that the drug may demonstrate substantial im4 provement over existing therapies on 1 or more clini5 cally significant endpoints, such as substantial treat6 ment effects observed early in clinical development. 

7 (In this section, such a drug is referred to as a 

8 ‘breakthrough therapy’.) 

9 ‘‘(2) REQUEST FOR DESIGNATION.—The spon10 sor of a drug may request the Secretary to designate 

11 the drug as a breakthrough therapy. A request for 

12 the designation may be made concurrently with, or 

13 at any time after, the submission of an application 

14 for the investigation of the drug under section 505(i) 

15 or section 351(a)(3) of the Public Health Service 

16 Act. 

17 ‘‘(3) DESIGNATION.— 

18 ‘‘(A) IN GENERAL.—Not later than 60 cal19 endar days after the receipt of a request under 

20 paragraph (2), the Secretary shall determine 

21 whether the drug that is the subject of the re22 quest meets the criteria described in paragraph 

23 (1). If the Secretary finds that the drug meets 

24 the criteria, the Secretary shall designate the 

25 drug as a breakthrough therapy and shall take 


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1 such actions as are appropriate to expedite the 

2 development and review of the application for 

3 approval of such drug. 

4 ‘‘(B) ACTIONS.—The actions to expedite 

5 the development and review of an application 

6 under subparagraph (A) may include, as appro7 priate— 

8 ‘‘(i) holding meetings with the sponsor 

9 and the review team throughout the devel10 opment of the drug; 

11 ‘‘(ii) providing timely advice to, and 

12 interactive communication with, the spon13 sor regarding the development of the drug 

14 to ensure that the development program to 

15 gather the non-clinical and clinical data 

16 necessary for approval is as efficient as 

17 practicable; 

18 ‘‘(iii) involving senior managers and 

19 experienced review staff, as appropriate, in 

20 a collaborative, cross-disciplinary review; 

21 ‘‘(iv) assigning a cross-disciplinary 

22 project lead for the Food and Drug Ad23 ministration review team to facilitate an 

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1 tween the review team and the sponsor; 

2 and 

3 ‘‘(v) taking steps to ensure that the 

4 design of the clinical trials is as efficient as 

5 practicable, when scientifically appropriate, 

6 such as by minimizing the number of pa7 tients exposed to a potentially less effica8 cious treatment.’’; 

9 (4) in subsection (f)(1), as so redesignated, by 

10 striking ‘‘applicable to accelerated approval’’ and in11 serting ‘‘applicable to breakthrough therapies, accel12 erated approval, and’’; and 

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

14 ‘‘(g) REPORT.—Beginning in fiscal year 2013, the 

15 Secretary shall annually prepare and submit to the Com16 mittee on Health, Education, Labor, and Pensions of the 

17 Senate and the Committee on Energy and Commerce of 

18 the House of Representatives, and make publicly available, 

19 with respect to this section for the previous fiscal year— 

20 ‘‘(1) the number of drugs for which a sponsor 

21 requested designation as a breakthrough therapy; 

22 ‘‘(2) the number of products designated as a 

23 breakthrough therapy; and 


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1 ‘‘(3) for each product designated as a break2 through therapy, a summary of the actions taken 

3 under subsection (a)(3).’’. 

4 (b) GUIDANCE; AMENDED REGULATIONS.— 

5 (1) IN GENERAL.— 

6 (A) GUIDANCE.—Not later than 18 

7 months after the date of enactment of this Act, 

8 the Secretary of Health and Human Services 

9 (referred to in this section as the ‘‘Secretary’’) 

10 shall issue draft guidance on implementing the 

11 requirements with respect to breakthrough 

12 therapies, as set forth in section 506(a) of the 

13 Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 356(a)), as amended by this section. 

15 The Secretary shall issue final guidance not 

16 later than 1 year after the close of the comment 

17 period for the draft guidance. 

18 (B) AMENDED REGULATIONS.— 

19 (i) IN GENERAL.—If the Secretary de20 termines that it is necessary to amend the 

21 regulations under title 21, Code of Federal 

22 Regulations in order to implement the 

23 amendments made by this section to sec24 tion 506(a) of the Federal Food, Drug, 

25 and Cosmetic Act, the Secretary shall 


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1 amend such regulations not later than 2 

2 years after the date of enactment of this 

3 Act. 

4 (ii) PROCEDURE.—In amending regu5 lations under clause (i), the Secretary 

6 shall— 

7 (I) issue a notice of proposed 

8 rulemaking that includes the proposed 

9 regulation; 

10 (II) provide a period of not less 

11 than 60 days for comments on the 

12 proposed regulation; and 

13 (III) publish the final regulation 

14 not less than 30 days before the effec15 tive date of the regulation. 

16 (iii) RESTRICTIONS.—Notwithstanding 

17 any other provision of law, the Secretary 

18 shall promulgate regulations implementing 

19 the amendments made by section only as 

20 described in clause (ii). 

21 (2) REQUIREMENTS.—Guidance issued under 

22 this section shall— 

23 (A) specify the process and criteria by 

24 which the Secretary makes a designation under 


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1 section 506(a)(3) of the Federal Food, Drug, 

2 and Cosmetic Act; and 

3 (B) specify the actions the Secretary shall 

4 take to expedite the development and review of 

5 a breakthrough therapy pursuant to such des6 ignation under such section 506(a)(3), includ7 ing updating good review management practices 

8 to reflect breakthrough therapies. 

9 (c) INDEPENDENT REVIEW.—Not later than 3 years 

10 after the date of enactment of this Act, the Comptroller 

11 General of the United States, in consultation with appro12 priate experts, shall assess the manner by which the Food 

13 and Drug Administration has applied the processes de14 scribed in section 506(a) of the Federal Food, Drug, and 

15 Cosmetic Act, as amended by this section, and the impact 

16 of such processes on the development and timely avail17 ability of innovative treatments for patients affected by se18 rious or life-threatening conditions. Such assessment shall 

19 be made publicly available upon completion. 

20 (d) CONFORMING AMENDMENTS.—Section 506B(e) 

21 (21 U.S.C. 356b) is amended by striking ‘‘section 

22 506(b)(2)(A)’’ each place such term appears and inserting 

23 ‘‘section 506(c)(2)(A)’’. 


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1 SEC. 870. GRANTS AND CONTRACTS FOR THE DEVELOP2 MENT OF ORPHAN DRUGS. 

3 (a) QUALIFIED TESTING DEFINITION.—Section 

4 5(b)(1)(A)(ii) of the Orphan Drug Act (21 U.S.C. 

5 360ee(b)(1)(A)(ii)) is amended by striking ‘‘after the date 

6 such drug is designated under section 526 of such Act 

7 and’’. 

8 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

9 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is 

10 amended to read as follows: 

11 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For 

12 grants and contracts under subsection (a), there is author13 ized to be appropriated $30,000,000 for each of fiscal 

14 years 2013 through 2017.’’. 

15 TITLE IX—DRUG SHORTAGES 

16 SEC. 901. DISCONTINUANCE AND INTERRUPTIONS OF MAN17 UFACTURING OF CERTAIN DRUGS. 

18 (a) IN GENERAL.—Section 506C (21 U.S.C. 356c) 

19 is amended to read as follows: 

20 ‘‘SEC. 506C. DISCONTINUANCE AND INTERRUPTIONS OF 

21 MANUFACTURING OF CERTAIN DRUGS. 

22 ‘‘(a) IN GENERAL.—A manufacturer of a drug sub23 ject to section 503(b)(1)— 

24 ‘‘(1) that is— 

25 ‘‘(A) life-supporting; 

26 ‘‘(B) life-sustaining; or 


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1 ‘‘(C) intended for use in the prevention or 

2 treatment of a debilitating disease or condition; 

3 and 

4 ‘‘(2) that is not a radio pharmaceutical drug 

5 product, a product derived from human plasma pro6 tein and their recombinant analogs, or any other 

7 product as designated by the Secretary, 

8 shall notify the Secretary of a discontinuance of the manu9 facture of the drug, or an interruption of the manufacture 

10 of the drug that is likely to lead to a meaningful disruption 

11 in the manufacturer’s supply of the drug, and the reason 

12 for such discontinuance or interruption, in accordance 

13 with subsection (b). 

14 ‘‘(b) TIMING.—A notice required by subsection (a) 

15 shall be submitted to the Secretary— 

16 ‘‘(1) at least 6 months prior to the date of the 

17 discontinuance or interruption; or 

18 ‘‘(2) if compliance with paragraph (1) is not 

19 possible, as soon as practicable. 

20 ‘‘(c) DISTRIBUTION.—To the maximum extent prac21 ticable, the Secretary shall distribute information on the 

22 discontinuation or interruption of the manufacture of the 

23 drugs described in subsection (a) to appropriate organiza24 tions, including physician, health provider, and patient or25 ganizations, as described in section 506D. 


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1 ‘‘(d) CONFIDENTIALITY.—Nothing in this section 

2 shall be construed as authorizing the Secretary to disclose 

3 any information that is a trade secret or confidential infor4 mation subject to section 552(b)(4) of title 5, United 

5 States Code, or section 1905 of title 18, United States 

6 Code. 

7 ‘‘(e) COORDINATION WITH ATTORNEY GENERAL.— 

8 Not later than 30 days after the receipt of a notification 

9 described in subsection (a), the Secretary shall— 

10 ‘‘(1) determine whether the notification pertains 

11 to a controlled substance subject to a production 

12 quota under section 306 of the Controlled Sub13 stances Act; and 

14 ‘‘(2) if necessary, as determined by the Sec15 retary— 

16 ‘‘(A) notify the Attorney General that the 

17 Secretary has received such a notification; 

18 ‘‘(B) request that the Attorney General in19 crease the aggregate and individual production 

20 quotas under section 306 of the Controlled Sub21 stances Act applicable to such controlled sub22 stance and any ingredient therein to a level the 

23 Secretary deems necessary to address a short24 age of a controlled substance based on the best 

25 available market data; and 


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1 ‘‘(C) if the Attorney General determines 

2 that the level requested is not necessary to ad3 dress a shortage of a controlled substance, the 

4 Attorney General shall provide to the Secretary 

5 a written response detailing the basis for the 

6 Attorney General’s determination. 

7 The Secretary shall make the written response pro8 vided under subparagraph (C) available to the public 

9 on the Web site of the Food and Drug Administra10 tion. 

11 ‘‘(f) FAILURE TO MEET REQUIREMENTS.—If a per12 son fails to submit information required under subsection 

13 (a) in accordance with subsection (b)— 

14 ‘‘(1) the Secretary shall issue a letter to such 

15 person informing such person of such failure; 

16 ‘‘(2) not later than 30 calendar days after the 

17 issuance of a letter under paragraph (1), the person 

18 who receives such letter shall submit to the Sec19 retary a written response to such letter setting forth 

20 the basis for noncompliance and providing informa21 tion required under subsection (a); and 

22 ‘‘(3) not later than 45 calendar days after the 

23 issuance of a letter under paragraph (1), the Sec24 retary shall make such letter and any response to 

25 such letter under paragraph (2) available to the pubVerDate Mar 15 2010 22:01 May 25, 2012 Jkt 019200 PO 00000 Frm 00280 Fmt 6652 Sfmt 6201 E:\BILLS\H5651.RH H5651

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1 lic on the Web site of the Food and Drug Adminis2 tration, with appropriate redactions made to protect 

3 information described in subsection (d), except that, 

4 if the Secretary determines that the letter under 

5 paragraph (1) was issued in error or, after review of 

6 such response, the person had a reasonable basis for 

7 not notifying as required under subsection (a), the 

8 requirements of this paragraph shall not apply.’’. 

9 (b) REGULATIONS.— 

10 (1) IN GENERAL.—Not later than 18 months 

11 after the date of the enactment of this Act, the Sec12 retary of Health and Human Services, after issuing 

13 a notice of proposed rule and holding a public hear14 ing, shall promulgate final regulations that imple15 ment the amendment made by subsection (a). 

16 (2) CONTENTS.—Such regulations shall, for 

17 purposes of section 506C of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 356c)— 

19 (A) define the terms ‘‘life-supporting’’, 

20 ‘‘life-sustaining’’, and ‘‘intended for use in the 

21 prevention or treatment of a debilitating disease 

22 or condition’’; and 

23 (B) define the term ‘‘interruption of the 

24 manufacture of the drug that is likely to lead 

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1 er’s supply of the drug’’ to mean a change in 

2 production that is highly likely to lead to more 

3 than a negligible reduction in the supply of the 

4 drug and affects the ability of the manufacturer 

5 to meet demand for such drug, but not to in6 clude a change in production due to matters 

7 such as routine maintenance or insignificant 

8 changes in manufacturing so long as the manu9 facturer expects to resume operations in a short 

10 period of time. 

11 SEC. 902. DRUG SHORTAGE LIST. 

12 Title V (21 U.S.C. 351 et seq.) is amended by insert13 ing after section 506C the following new section: 

14 ‘‘SEC. 506D. DRUG SHORTAGE LIST. 

15 ‘‘(a) ESTABLISHMENT.—The Secretary shall main16 tain an up-to-date list of drugs that are determined by 

17 the Secretary to be in shortage in the United States. 

18 ‘‘(b) CONTENTS.—For each drug on such list, the 

19 Secretary shall include the following information: 

20 ‘‘(1) The name of the drug in shortage. 

21 ‘‘(2) The name of each manufacturer of such 

22 drug. 

23 ‘‘(3) The reason for the shortage, as determined 

24 by the Secretary, selecting from the following cat25 egories: 


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1 ‘‘(A) Requirements related to complying 

2 with good manufacturing practices. 

3 ‘‘(B) Regulatory delay. 

4 ‘‘(C) Shortage of an active ingredient. 

5 ‘‘(D) Shortage of an inactive ingredient 

6 component. 

7 ‘‘(E) Discontinuation of the manufacture 

8 of the drug. 

9 ‘‘(F) Delay in shipping of the drug. 

10 ‘‘(G) Demand increase for the drug. 

11 ‘‘(4) The estimated duration of the shortage as 

12 determined by the Secretary. 

13 ‘‘(c) PUBLIC AVAILABILITY.— 

14 ‘‘(1) IN GENERAL.—Subject to paragraphs (2) 

15 and (3), the Secretary shall make the information in 

16 such list publicly available. 

17 ‘‘(2) TRADE SECRETS AND CONFIDENTIAL IN18 FORMATION.—Nothing in this section alters or 

19 amends section 1905 of title 18, United States Code, 

20 or section 552(b)(4) of title 5 of such Code. 

21 ‘‘(3) PUBLIC HEALTH EXCEPTION.—The Sec22 retary may choose not to make information collected 

23 under this section publicly available under paragraph 

24 (1) if the Secretary determines that disclosure of 

25 such information would adversely affect the public 


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1 health (such as by increasing the possibility of 

2 hoarding or other disruption of the availability of 

3 drug products to patients).’’. 

4 SEC. 903. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE. 

5 Section 306 of the Controlled Substances Act (21 

6 U.S.C. 826) is amended by adding at the end the fol7 lowing: 

8 ‘‘(h)(1) Not later than 30 days after the receipt of 

9 a request described in paragraph (2), the Attorney Gen10 eral shall— 

11 ‘‘(A) complete review of such request; and 

12 ‘‘(B)(i) as necessary to address a shortage of a 

13 controlled substance, increase the aggregate and in14 dividual production quotas under this section appli15 cable to such controlled substance and any ingre16 dient therein to the level requested; or 

17 ‘‘(ii) if the Attorney General determines that 

18 the level requested is not necessary to address a 

19 shortage of a controlled substance, the Attorney 

20 General shall provide a written response detailing 

21 the basis for the Attorney General’s determination. 

22 The Secretary shall make the written response pro23 vided under subparagraph (B)(ii) available to the 

24 public on the Web site of the Food and Drug Ad25 ministration. 


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1 ‘‘(2) A request is described in this paragraph if— 

2 ‘‘(A) the request pertains to a controlled sub3 stance on the list of drugs in shortage maintained 

4 under section 506D of the Federal Food, Drug, and 

5 Cosmetic Act; 

6 ‘‘(B) the request is submitted by the manufac7 turer of the controlled substance; and 

8 ‘‘(C) the controlled substance is in schedule 

9 II.’’. 

10 SEC. 904. EXPEDITED REVIEW OF MAJOR MANUFACTURING 

11 CHANGES FOR POTENTIAL AND VERIFIED 

12 SHORTAGES OF DRUGS THAT ARE LIFE-SUP13 PORTING, LIFE-SUSTAINING, OR INTENDED 

14 FOR USE IN THE PREVENTION OF A DEBILI15 TATING DISEASE OR CONDITION. 

16 Subsection (c) of section 506A (21 U.S.C. 356a) is 

17 amended by adding at the end the following new para18 graph: 

19 ‘‘(3) CHANGES ADDRESSING A DRUG SHORT20 AGE.— 

21 ‘‘(A) CERTIFICATION.— 

22 ‘‘(i) DESCRIPTION.—A certification is 

23 described in this subparagraph if the man24 ufacturer, having notified the Secretary of 

25 an interruption or discontinuance of a drug 


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1 in accordance with Section 506C, certifies 

2 (in such certification) that the major man3 ufacturing change for which approval is 

4 being sought may prevent or alleviate a 

5 discontinuance or interruption of such 

6 drug. 

7 ‘‘(ii) BAD FAITH EXCEPTION.—Sub8 paragraphs (B) and (C) do not apply in 

9 the case of a certification which the Sec10 retary determines to be made in bad faith. 

11 ‘‘(B) EXPEDITED REVIEW.—If a certifi12 cation described in subparagraph (A) is sub13 mitted in connection with a supplemental appli14 cation for a major manufacturing change, the 

15 Secretary shall— 

16 ‘‘(i) expedite any technical review or 

17 inspection necessary for consideration of 

18 the supplemental application; 

19 ‘‘(ii) provide any technical assistance 

20 necessary to facilitate approval of the sup21 plemental application; and 

22 ‘‘(iii) not later than 60 days after re23 ceipt of the certification, complete review 

24 of the supplemental application.’’. 


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1 SEC. 905. 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 

8 following questions: 

9 (1) What are the dominant characteristics of 

10 drugs that have gone into actual shortage over the 

11 preceding three years? 

12 (2) Are there systemic high-risk factors (such 

13 as drug pricing structure, including Federal reim14 bursements, or the number of manufacturers pro15 ducing a drug product) that have led to the con16 centration of drug shortages in certain drug prod17 ucts that have made such products vulnerable to 

18 drug shortages? 

19 (3) Is there a reason why drug shortages have 

20 occurred primarily in the sterile injectable market 

21 and in certain therapeutic areas? 

22 (4) How have regulations, guidance documents, 

23 regulatory practices, and other actions of Federal 

24 departments and agencies (including the effective25 ness of interagency and intraagency coordination, 


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1 communication, strategic planning, and decision2 making) affected drug shortages? 

3 (5) How does hoarding affect drug shortages? 

4 (6) How would incentives alleviate or prevent 

5 drug shortages? 

6 (7) How are healthcare providers, including 

7 hospitals and physicians responding to drug short8 ages, to what extent are such providers able to ad9 just care effectively to compensate for such short10 ages, and what impediments exist that hinder pro11 vider ability to adjust to such shortages? 

12 (c) CONSULTATION WITH STAKEHOLDERS.—In con13 ducting the study under this section, the Comptroller Gen14 eral shall consult with relevant stakeholders, including 

15 physicians, pharmacists, hospitals, patients, drug manu16 facturers, and other health providers. 

17 (d) REPORT.—Note later than 18 months after the 

18 date of the enactment of this Act, the Comptroller General 

19 shall submit a report to the Committee on Energy and 

20 Commerce of the House of Representatives and the Com21 mittee on Health, Education, Labor, and Pensions of the 

22 Senate on the results of the study under this section. 

23 SEC. 906. ANNUAL REPORT ON DRUG SHORTAGES. 

24 Not later than 18 months after the date of the enact25 ment of this Act, and annually thereafter, the Secretary 


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1 of Health and Human Services shall submit to the Com2 mittee on Energy and Commerce of the House of Rep3 resentatives and the Committee on Health, Education, 

4 Labor, and Pensions of the Senate a report on drug short5 ages that— 

6 (1) describes the communication between the 

7 field investigators of the Food and Drug Administra8 tion and the staff of the Center for Drug Evaluation 

9 and Research’s Office of Compliance and Drug 

10 Shortage Program, including the Food and Drug 

11 Administration’s procedures for enabling and ensur12 ing such communication; 

13 (2) describes the Food and Drug Administra14 tion’s efforts to expedite the review of new manufac15 turing sites, new suppliers, and specification changes 

16 to prevent or alleviate a drug shortage; 

17 (3) describes the coordination between the Food 

18 and Drug Administration and the Drug Enforce19 ment Administration on efforts to prevent or allevi20 ate drug shortages; 

21 (4) identifies the number of, and describes the 

22 instances in which the Food and Drug Administra23 tion exercised regulatory flexibility and discretion to 

24 prevent or alleviate a drug shortage; 


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1 (5) identifies the number of instances in which 

2 the Food and Drug Administration asked firms to 

3 increase production to prevent or alleviate a short4 age; 

5 (6) identifies the number of notifications sub6 mitted to the Secretary under section 506C of the 

7 Federal Food, Drug, and Cosmetic Act, as amended 

8 by section 901 of this Act, including the percentage 

9 of such notifications for a drug that is a sterile 

10 injectable; 

11 (7) describes the Food and Drug Administra12 tion’s implementation of section 506D of the Fed13 eral Food, Drug, and Cosmetic Act (relating to a 

14 drug shortage list), as added by section 902 of this 

15 Act, and identifies— 

16 (A) the name of each drug on the list 

17 under such section 506D at any point during 

18 the period covered by the report; 

19 (B) the name of each manufacturer of 

20 each such drug; 

21 (C) the reason for the shortage of each 

22 such drug; and 

23 (D) the anticipated or, if known, actual 

24 duration of the shortage of each such drug; 


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1 (8) identifies whether, and how, the Food and 

2 Drug Administration expedited the review of regu3 latory submissions to prevent or alleviate shortages, 

4 including how the Administration utilized the au5 thority in section 506A(c)(3) of the Federal Food, 

6 Drug, and Cosmetic Act, as added by section 904 of 

7 this Act; 

8 (9) identifies the number of certifications sub9 mitted under such section 506A(c)(3) and, for each 

10 such certification, whether the Food and Drug Ad11 ministration completed expedited review within 60 

12 days as required by subparagraph (B) of such sec13 tion 506A(c)(3); 

14 (10) describes the Secretary’s public engage15 ment on drug shortages with stakeholders, including 

16 physicians, pharmacists, patients, hospitals, drug 

17 manufacturers, and other health providers; and 

18 (11) contains the Secretary’s plan for address19 ing drug shortages in the upcoming year, including 

20 with respect to the issues described in paragraphs 

21 (1) through (10). 

22 SEC. 907. ATTORNEY GENERAL REPORT ON DRUG SHORT23 AGES. 

24 Not later than 6 months after the date of the enact25 ment of this Act, and annually thereafter, the Attorney 


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1 General shall submit to the Committee on Energy and 

2 Commerce of the House of Representatives and the Com3 mittee on the Judiciary of the Senate a report on drug 

4 shortages that— 

5 (1) identifies the number of requests received 

6 under section 306(h) of the Controlled Substances 

7 Act (as added by section 903 of this Act), the aver8 age review time for such requests, the number of re9 quests granted and denied under such section, and, 

10 for each of the requests denied under such section, 

11 the basis for such denial; 

12 (2) describes the coordination between the Drug 

13 Enforcement Administration and Food and Drug 

14 Administration on efforts to prevent or alleviate 

15 drug shortages; and 

16 (3) identifies drugs containing a controlled sub17 stance subject to section 306 of the Controlled Sub18 stances Act when such a drug is determined by the 

19 Secretary of Health and Human Services to be in 

20 shortage. 

21 SEC. 908. HOSPITAL REPACKAGING OF DRUGS IN SHORT22 AGE. 

23 Chapter V (21 U.S.C. 351 et seq.), as amended by 

24 section 902 of this Act, is further amended by inserting 

25 after section 506D the following: 


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1 ‘‘SEC. 506E. HOSPITAL REPACKAGING OF DRUGS IN SHORT2 AGE. 

3 ‘‘(a) DEFINITIONS.—In this section: 

4 ‘‘(1) DRUG.—The term ‘drug’ excludes any con5 trolled substance (as such term is defined in section 

6 102 of the Controlled Substances Act). 

7 ‘‘(2) HEALTH SYSTEM.—The term ‘health sys8 tem’ means a collection of hospitals that are owned 

9 and operated by the same entity and that share ac10 cess to databases with drug order information for 

11 their patients. 

12 ‘‘(3) REPACKAGE.—For the purposes of this 

13 section only, the term ‘repackage’, with respect to a 

14 drug, means to divide the volume of a drug into 

15 smaller amounts in order to— 

16 ‘‘(A) extend the supply of a drug in re17 sponse to the placement of the drug on a drug 

18 shortage list described in subsection (b); and 

19 ‘‘(B) facilitate access to the drug by hos20 pitals within the same health system. 

21 ‘‘(b) EXCLUSION FROM REGISTRATION.—Notwith22 standing any other provision of this Act, a hospital shall 

23 not be considered an establishment for which registration 

24 is required under section 510 solely because it repackages 

25 a drug and transfers it to another hospital within the same 


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1 health system in accordance with the conditions in sub2 section (c)— 

3 ‘‘(1) during any period in which the drug is list4 ed on the Drug Shortage List of the Food and Drug 

5 Administration; or 

6 ‘‘(2) during the 60-day period following any pe7 riod described in paragraph (1). 

8 ‘‘(c) CONDITIONS.—Subsection (b) shall only apply to 

9 a hospital, with respect to the repackaging of a drug for 

10 transfers to another hospital within the same health sys11 tem, if the following conditions are met: 

12 ‘‘(1) DRUG FOR INTRASYSTEM USE ONLY.—In 

13 no case may a drug that has been repackaged in ac14 cordance with this section be sold or otherwise dis15 tributed by the health system or a hospital within 

16 the system to an entity or individual that is not a 

17 hospital within such health system. 

18 ‘‘(2) COMPLIANCE WITH STATE RULES.—Re19 packaging of a drug under this section shall be done 

20 in compliance with applicable State requirements in 

21 which the health system is located. 

22 ‘‘(d) TERMINATION.—This section shall not apply on 

23 or after the date on which the Secretary issues final guid24 ance that clarifies the policy of the Food and Drug Admin25 istration regarding hospital pharmacies repackaging and 


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1 safely transferring repackaged drugs to other hospitals 

2 within the same health system during a drug shortage.’’. 


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Union Calendar No. 348 

112TH CONGRESS 

2D SESSION H. R. 5651 

[Report No. 112–495] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

biosimilars, and for other purposes. establish user-fee programs for generic drugs and for prescription drugs and for medical devices, to Act to revise and extend the user-fee programs 

MAY 25, 2012 

Committed to the Committee of the Whole House on the 

State of the Union and ordered to be printed 


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