II 

112TH CONGRESS 

2D SESSION S. 2292 

To promote accountability, transparency, innovation, efficiency, and timeliness 

at the Food and Drug Administration for America’s patients. 

IN THE SENATE OF THE UNITED STATES 

APRIL 17, 2012 

Mr. BURR (for himself and Mr. COBURN) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To promote accountability, transparency, innovation, efficiency, and timeliness at the Food and Drug Administration for America’s patients. 

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 ‘‘Promoting Account5 ability, Transparency, Innovation, Efficiency, and Timeli6 ness at FDA Act of 2012’’ or the ‘‘PATIENTS’ FDA 

7 Act’’. 

8 SEC. 2. TABLE OF CONTENTS. 

9 The table of contents for this Act is as follows: 


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Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—ENSURING GREATER TRANSPARENCY AND 

ACCOUNTABILITY IN FDA REGULATORY DECISIONMAKING 

Sec. 101. Advancing regulatory science to promote public health and innovation. 

Sec. 102. Reporting with respect to prescription drugs. 

Sec. 103. Reporting with respect to generic drugs. 

Sec. 104. Reporting with respect to biosimilars. 

Sec. 105. Documentation of regulatory decisions. 

Sec. 106. Review of regulations and guidance. 

Sec. 107. Leveraging information technology to fulfill FDA’s public health mission. 

TITLE II—RECALIBRATING RISK-BENEFIT CONSIDERATIONS 

Sec. 201. Devices. 

Sec. 202. Drugs. 

TITLE III—REDUCING UNNECESSARY DELAYS AND REGULATORY 

BURDENS 

Sec. 301. Optimizing global clinical trials. 

Sec. 302. Advancing American patients’ timely access to innovative devices. 

Sec. 303. Ensuring legal sufficiency and consistency of FDA enforcement policies. 

TITLE IV—STRENGTHENING ADVISORY COMMITTEES FOR 

PATIENTS 

Sec. 401. Strengthening advisory committees for patients. 

TITLE V—MEDICAL DEVICE REGULATORY IMPROVEMENTS 

Subtitle A—Premarket Predictability 

Sec. 501. Tracking and review of applications for investigational device exemptions. 

Sec. 502. Investigational Device Exemptions. 

Sec. 503. Device submission acceptance criteria. 

Sec. 504. Transparency in clearance process. 

Sec. 505. Restoring regulatory certainty with respect to 510(k) reports required 

for certain modifications. 

Sec. 506. Meeting the device needs of individual patients. 

Subtitle B—FDA Renewing Efficiency From Outside Reviewer Management 

Sec. 511. Persons accredited to review reports under section 510(k) and make 

recommendations for initial classification. 

Sec. 512. Persons accredited to conduct inspections. 

TITLE VI—STRENGTHENING MANAGEMENT TO SUPPORT FDA’S 

PUBLIC HEALTH MISSION 

Sec. 601. Integrated strategy and management plan. 

Sec. 602. Independent assessment. 


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1 TITLE I—ENSURING GREATER 

2 TRANSPARENCY AND AC3 COUNTABILITY IN FDA REGU4 LATORY DECISIONMAKING 

5 SEC. 101. ADVANCING REGULATORY SCIENCE TO PROMOTE 

6 PUBLIC HEALTH AND INNOVATION. 

7 (a) IN GENERAL.—Not later than 1 year after the 

8 date of enactment of this Act, the Secretary of Health and 

9 Human Services (referred to in this section as the ‘‘Sec10 retary’’) shall develop a strategy and implementation plan 

11 for advancing regulatory science for medical products in 

12 order to promote the public health and advance innovation 

13 in regulatory decisionmaking. 

14 (b) REQUIREMENTS.—The strategy and implementa15 tion plan developed under subsection (a) shall be con16 sistent with the user fee performance goals in the Pre17 scription Drug User Fee Agreement commitment letter, 

18 the Generic Drug User Fee Agreement commitment letter, 

19 and the Biosimilar User Fee Agreement commitment let20 ter transmitted by the Secretary to Congress on January 

21 13, 2012, and the Medical Device User Fee Agreement 

22 published in the Federal Register on March 20, 2012, and 

23 shall— 

24 (1) identify a clear vision of the fundamental 

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1 based decisions throughout regulatory decision2 making of the Food and Drug Administration with 

3 respect to medical products; 

4 (2) identify the regulatory science priorities of 

5 the Food and Drug Administration directly related 

6 to fulfilling the mission of the agency with respect 

7 to decisionmaking concerning medical products and 

8 allocation of resources towards these regulatory 

9 science priorities; 

10 (3) identify regulatory and scientific gaps that 

11 impede the timely development and review of, and 

12 regulatory certainty with respect to, the approval, li13 censure, or clearance of medical products, including 

14 with respect to companion products and new tech15 nologies, and facilitating the timely introduction and 

16 adoption of new technologies and methodologies in a 

17 safe and effective manner; 

18 (4) identify clear, measurable metrics by which 

19 progress on the priorities identified under paragraph 

20 (2) and gaps identified under paragraph (3) will be 

21 measured by the Food and Drug Administration, in22 cluding metrics specific to the integration and adop23 tion of advances in regulatory science described in 

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1 sionmaking, in a predictable and science-based man2 ner; and 

3 (5) set forth how the Food and Drug Adminis4 tration will ensure that advances in regulatory 

5 science for medical products are adopted, as appro6 priate, on an ongoing basis and in an manner inte7 grated across centers, divisions, and branches of the 

8 Food and Drug Administration, including by senior 

9 managers and reviewers, including through the— 

10 (A) development, updating, and consistent 

11 application of guidance documents that support 

12 medical product decisionmaking; and 

13 (B) the adoption of the tools, methods, and 

14 processes under section 566 of the Federal 

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

16 360bbb–5). 

17 (c) ANNUAL PERFORMANCE REPORTS.—As part of 

18 the annual performance reports by the Food and Drug 

19 Administration to Congress, the Secretary shall annually 

20 report on the progress made with respect to— 

21 (1) advancing the regulatory science priorities 

22 and resolving the gaps identified under paragraph 

23 (3) of subsection (b), including reporting on specific 

24 metrics identified under paragraph (4) of such sub25 section; 


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1 (2) the integration and adoption of advances in 

2 regulatory science as set forth in paragraph (5) of 

3 such subsection; and 

4 (3) the progress made in advancing the regu5 latory science goals outlined in the Prescription 

6 Drug User Fee Agreement commitment letter, the 

7 Generic Drug User Fee Agreement commitment let8 ter, and the Biosimilar User Fee Agreement commit9 ment letter transmitted by the Secretary to Congress 

10 on January 13, 2012, and the Medical Device User 

11 Fee Agreement published in the Federal Register on 

12 March 20, 2012. 

13 (d) INDEPENDENT ASSESSMENT.—Not later than 

14 January 1, 2016, the Comptroller General of the United 

15 States shall submit to Congress a report— 

16 (1) detailing the progress made by the Food 

17 and Drug Administration in meeting the priorities 

18 and addressing the gaps identified in subsection (b), 

19 including any outstanding gaps; and 

20 (2) containing recommendations, as appro21 priate, on how regulatory science initiatives for med22 ical products can be strengthened and improved to 

23 promote the public health and advance innovation in 

24 regulatory decisionmaking. 


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1 (e) MEDICAL PRODUCT.—In this section, the term 

2 ‘‘medical product’’ means a drug, as defined in subsection 

3 (g) of section 201 of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 321), a device, as defined in sub5 section (h) of such section, or a biological product, as de6 fined in section 351(i) of the Public Health Service Act 

7 (42 U.S.C. 262(i)). 

8 SEC. 102. REPORTING WITH RESPECT TO PRESCRIPTION 

9 DRUGS. 

10 Section 736B of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 379h–2) is amended— 

12 (1) by amending subsection (a) to read as fol13 lows: 

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

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

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

17 the Secretary shall prepare and submit to the Committee 

18 on Health Education, Labor, and Pensions of the Senate 

19 and the Committee on Energy and Commerce of the 

20 House of Representatives a report concerning— 

21 ‘‘(1) the progress of the Food and Drug Admin22 istration in achieving the goals identified in the doc23 ument entitled, ‘PDUFA Reauthorization Perform24 ance Goals and Procedures Fiscal Years 2013 

25 through 2017’, and included in the Prescription 


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1 Drug User Fee Agreement commitment letter trans2 mitted by the Secretary to Congress on January 13, 

3 2012, during such fiscal year and the future plans 

4 of the Food and Drug Administration for meeting 

5 the goals; and 

6 ‘‘(2) the progress of each review division and 

7 branch within the Center for Drug Evaluation and 

8 Research and the Center for Biologics Evaluation 

9 and Research in achieving such goals, and the plans 

10 of each such division and branch for meeting the 

11 goals, including— 

12 ‘‘(A) the number of applications for ap13 proval of a new drug under section 505(b) of 

14 this Act or a new biological product under sec15 tion 351(a) of the Public Health Service Act 

16 filed per fiscal year by each review division and 

17 branch; 

18 ‘‘(B) the number of such applications that 

19 did not meet the goals described in paragraph 

20 (1); 

21 ‘‘(C) the percentage of such applications 

22 approved by each review division and branch; 

23 ‘‘(D) the percentage of such applications 

24 found to be approvable by each review division 

25 and branch; 


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1 ‘‘(E) the percentage of such applications 

2 that were issued complete response letters by 

3 each review division and branch; 

4 ‘‘(F) the percentage of such applications 

5 that were subject to a refuse-to-file action by 

6 each review division and branch; 

7 ‘‘(G) the percentage of such applications 

8 withdrawn by each review division and branch; 

9 ‘‘(H) the total number of review cycles per 

10 such approval and the average, mean, and me11 dian number of review cycles per such applica12 tion by each review division and branch; 

13 ‘‘(I) the mean and median time to final de14 cision, including approval, per such application 

15 by each review division and branch; 

16 ‘‘(J) the average total time to decision by 

17 each review division and branch, including the 

18 number of days spent during the review by the 

19 Food and Drug Administration and days spent 

20 by the sponsor responding to a complete re21 sponse letter; 

22 ‘‘(K) the percentage of applications that 

23 are considered as fast track products under sec24 tion 506 and through accelerated approval by 

25 each review division and branch; and 


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1 ‘‘(L) the number of full-time equivalent po2 sitions and overall budget assigned to each re3 view division and branch. 

4 ‘‘(b) INCLUSION.—The report under this section for 

5 a fiscal year shall include information on all previous co6 horts for which the Secretary has not given a complete 

7 response on all human drug applications and supplements 

8 in the cohort.’’; and 

9 (2) in subsection (b), by inserting ‘‘, including 

10 a qualitative and quantitative report with respect to 

11 how user fees and appropriated funds are used for 

12 the drug review process, including the percentage of 

13 review time devoted to activities related to the review 

14 of applications under subsections (b) and (j) of sec15 tion 505 and subsections (a) and (k) of section 351 

16 of the Public Health Service Act’’ before the period 

17 at the end. 

18 SEC. 103. REPORTING WITH RESPECT TO GENERIC DRUGS. 

19 Part 2 of subchapter C of chapter VII of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) 

21 is amended by adding at the end the following: 

22 ‘‘SEC. 736C. REPORTING WITH RESPECT TO GENERIC 

23 DRUGS. 

24 ‘‘(a) IN GENERAL.—Beginning with fiscal year 2013, 

25 not later than 120 days after the end of each fiscal year 


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1 for which fees are collected under this part, the Secretary 

2 shall prepare and submit to the Committee on Health 

3 Education, Labor, and Pensions of the Senate and the 

4 Committee on Energy and Commerce of the House of 

5 Representatives a report concerning— 

6 ‘‘(1) the progress of the Food and Drug Admin7 istration in achieving the goals identified in the Ge8 neric Drug User Fee Act (GDUFA) proposal of the 

9 Food and Drug Administration, as set forth in the 

10 Generic Drug User Fee Agreement commitment let11 ter dated January 13, 2012, during such fiscal year 

12 and the future plans of the Food and Drug Adminis13 tration for meeting the goals; and 

14 ‘‘(2) the progress of the Office of Generic 

15 Drugs within the Center for Drug Evaluation and 

16 Research and the Office of Regulatory Affairs in 

17 achieving such goals, and the plans of the Office of 

18 Generic Drugs, the Center for Drug Evaluation and 

19 the Office of Regulatory Affairs in meeting the 

20 goals, including— 

21 ‘‘(A)(i) the progress in completing review 

22 of applications under section 505(j) of the Fed23 eral Food, Drug, and Cosmetic Act, amend24 ments to such applications, and prior approval 

25 supplements with respect to such applications 


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1 that have been pending for more than 10 

2 months, including applications under section 

3 505(j) that have been pending for more than 10 

4 months as of October 1, 2012, and prior ap5 proval supplements to such applications that 

6 have been pending for more than 180 days as 

7 of October 1, 2012; 

8 ‘‘(ii) the total number of applications 

9 under section 505(j), amendments to such ap10 plications, and prior approval supplements with 

11 respect to such applications that have been 

12 pending for more than 10 months; and 

13 ‘‘(iii) the average total time it takes to re14 view and reach a final decision on— 

15 ‘‘(I) applications under section 505(j); 

16 ‘‘(II) major and minor amendments to 

17 applications under section 505(j); and 

18 ‘‘(III) prior approval supplements 

19 with respect to applications under section 

20 505(j); 

21 ‘‘(B) the number of such applications that 

22 did not meet the goals described in paragraph 

23 (1); 

24 ‘‘(C) the total number of review cycles per 

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1 clause (I), (II), or (III) of subparagraph (A)(iii) 

2 and the average, mean, and median number of 

3 review cycles per such application by each re4 view division and branch; 

5 ‘‘(D) the number of meetings granted to 

6 industry and the number of meeting requests 

7 submitted by industry; 

8 ‘‘(E) the mean and median time to final 

9 decision, including approval, per such applica10 tion by the Office of Generic Drugs; 

11 ‘‘(F) the median time frames and ranges 

12 for reporting decisions with respect to good 

13 manufacturing practices to the Office of Ge14 neric Drugs following completion of inspections; 

15 ‘‘(G) the median time frames for com16 pleting requested foreign and domestic inspec17 tions; 

18 ‘‘(H) the total number of review cycles per 

19 such approval and the average, mean, and me20 dian number of review cycles per such applica21 tion; 

22 ‘‘(I) the average total time to decision by 

23 the Office of Generic Drugs, including the num24 ber of days spent during the review by the Food 


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1 and Drug Administration and days spent by the 

2 sponsor responding to a complete response; and 

3 ‘‘(J) the number of full-time equivalent po4 sitions and overall budget assigned to the Office 

5 of Generic Drugs and each unit of the Food 

6 and Drug Administration. 

7 ‘‘(b) INCLUSION.—The report under this section for 

8 a fiscal year shall include information on all previous co9 horts for which the Secretary has not given a complete 

10 response on all human drug applications and supplements 

11 in the cohort. 

12 ‘‘(c) FISCAL REPORT.—Beginning not later than fis13 cal year 2013, not later than 120 days after the end of 

14 each fiscal year, the Secretary shall prepare and submit 

15 to the Committee on Health, Education, Labor, and Pen16 sions of the Senate and the Committee on Energy and 

17 Commerce of the House of Representatives a report on 

18 the implementation of the authority for any user fees with 

19 respect to generic drugs during such fiscal year, and the 

20 use, by the Food and Drug Administration, of any such 

21 fees collected for such fiscal year, including a qualitative 

22 and quantitative report with respect to how user fees and 

23 appropriated funds are used for the drug review process, 

24 including the percentage of review time devoted to direct 

25 review of applications under section (j) of section 505.’’. 


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1 SEC. 104. REPORTING WITH RESPECT TO BIOSIMILARS. 

2 Part 2 of subchapter C of chapter VII of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), 

4 as amended by section 103, is further amended by adding 

5 at the end the following: 

6 ‘‘SEC. 736D. REPORTING WITH RESPECT TO BIOSIMILARS. 

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

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

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

10 the Secretary shall prepare and submit to the Committee 

11 on Energy and Commerce of the House of Representatives 

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

13 Pensions of the Senate a report concerning— 

14 ‘‘(1) the progress of the Food and Drug Admin15 istration in achieving the goals identified in the 

16 Biosimilars User Fee Act (BSUFA) proposal of the 

17 Food and Drug Administration, as set forth in the 

18 Biosimilar User Fee Agreement commitment letter 

19 dated January 13, 2012, during such fiscal year and 

20 the future plans of the Food and Drug Administra21 tion for meeting the goals; and 

22 ‘‘(2) the progress of each review division and 

23 branch within the Center for Drug Evaluation and 

24 Research and the Center for Biologics Evaluation 

25 and Research in achieving the goals, and the plans 


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1 of each such division and branch for meeting the 

2 goals, including— 

3 ‘‘(A) the number of applications for ap4 proval under section 351(k) of the Public 

5 Health Service Act filed per fiscal year by each 

6 review division and branch; 

7 ‘‘(B) the number of such applications that 

8 did not meet the goals described in paragraph 

9 (1) and the total time elapsed since such appli10 cations were submitted, including the time such 

11 application was with the Food and Drug Ad12 ministration and the time such application was 

13 with the sponsor; 

14 ‘‘(C) the percentage of such applications 

15 approved by each review division and branch; 

16 ‘‘(D) the percentage of such applications 

17 that were issued complete response letters by 

18 each review division and branch; 

19 ‘‘(E) the percentage of such applications 

20 that were subject to a refuse-to-file action by 

21 each review division and branch; 

22 ‘‘(F) the percentage of such applications 

23 withdrawn by the sponsor by each review divi24 sion and branch; 


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1 ‘‘(G) the total number of review cycles per 

2 each approval and the average, mean, and me3 dian review cycles per such application (or for 

4 all approvals) by each review division and 

5 branch; 

6 ‘‘(H) the mean and median time to final 

7 decision, including approval, per such applica8 tion by each review division and branch; and 

9 ‘‘(I) the number of full-time equivalent po10 sitions and overall budget assigned to each re11 view division and branch. 

12 ‘‘(b) INCLUSION.—The report under this subsection 

13 for a fiscal year shall include information on all previous 

14 cohorts for which the Secretary has not given a complete 

15 response on all applications under section 351(k) of the 

16 Public Health Service Act in the cohort. 

17 ‘‘(c) FISCAL REPORT.—Beginning not later than fis18 cal year 2013, not later than 120 days after the end of 

19 each fiscal year, the Secretary shall prepare and submit 

20 to the Committee on Health, Education, Labor, and Pen21 sions of the Senate and the Committee on Energy and 

22 Commerce of the House a report on the implementation 

23 of the authority for any user fees with respect to biological 

24 products approved under section 351(k) of the Public 

25 Health Service Act during such fiscal year, and the use, 


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1 by the Food and Drug Administration, of any such fees 

2 collected for such fiscal year, including a qualitative and 

3 quantitative report with respect to how user fees and ap4 propriated funds are used for the drug review process, in5 cluding the percentage of review time devoted to direct re6 view of applications under subsections (a) and (k) of sec7 tion 351 of the Public Health Service Act.’’. 

8 SEC. 105. DOCUMENTATION OF REGULATORY DECISIONS. 

9 Chapter V of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 351 et seq.) is amended by adding at the 

11 end the following: 

12 ‘‘SEC. 524A. AGENCY DOCUMENTATION OF SIGNIFICANT DE13 CISIONS REGARDING DRUGS AND DEVICES. 

14 ‘‘(a) DOCUMENTATION OF RATIONALE FOR SIGNIFI15 CANT DECISIONS.—The Secretary shall document the sci16 entific and regulatory rationale for any significant deci17 sion— 

18 ‘‘(1) of the Center for Drug Evaluation and Re19 search regarding an application under subsection (b) 

20 or (j) of section 505; 

21 ‘‘(2) of the Center for Biologics Evaluation and 

22 Research regarding an application under subsection 

23 (a) or (k) of section 351 of the Public Health Serv24 ice Act; and 


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1 ‘‘(3) of the Center for Devices and Radiological 

2 Health regarding submission or review of a report 

3 under section 510(k), an application under section 

4 515, or an application for an exemption under sec5 tion 520(g). 

6 ‘‘(b) PROVISION OF DOCUMENTATION.—Upon re7 quest, the Secretary shall furnish such documentation to 

8 the person who is seeking to submit, or who has sub9 mitted, such report or application.’’. 

10 SEC. 106. REVIEW OF REGULATIONS AND GUIDANCE. 

11 Not later than 1 year after the date of enactment 

12 of this Act, the Secretary of Health and Human Services 

13 shall review all regulations and guidance of the Food and 

14 Drug Administration with respect to human medical prod15 ucts (as defined in section 101) to ensure consistency 

16 with— 

17 (a) the requirements of the Federal, Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 301 et seq.); and 

19 (b) the regulatory principles of the benefits of such 

20 regulations and guidance justifying the costs and adoption 

21 of the least burdensome approaches to such regulation and 

22 guidance as outlined in Executive Order 13563, dated 

23 January 18, 2011. 


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1 SEC. 107. LEVERAGING INFORMATION TECHNOLOGY TO 

2 FULFILL FDA’S PUBLIC HEALTH MISSION. 

3 (a) HHS REPORT.—Not later than 1 year after the 

4 date of enactment of this Act, the Secretary of Health and 

5 Human Services shall— 

6 (1) report to Congress on— 

7 (A) the milestones and a completion date 

8 for developing and implementing a comprehen9 sive information technology strategic plan to 

10 align the information technology systems mod11 ernization projects with the strategic goals of 

12 the Food and Drug Administration, including 

13 results-oriented goals, strategies, milestones, 

14 performance measures; 

15 (B) efforts to finalize and approve a com16 prehensive inventory of the information tech17 nology systems of the Food and Drug Adminis18 tration that includes information describing 

19 each system, such as costs, system function or 

20 purpose, and status information, and incor21 porate use of the system portfolio into the in22 formation investment management process of 

23 the Food and Drug Administration; 

24 (C) the ways in which the Food and Drug 

25 Administration uses the plan described in sub26 paragraph (A) to guide and coordinate the 


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1 modernization projects and activities of the 

2 Food and Drug Administration, including the 

3 interdependencies among projects and activities; 

4 and 

5 (D) the extent to which the Food and 

6 Drug Administration has fulfilled or is imple7 menting recommendations of the Government 

8 Accountability Office with respect to the Food 

9 and Drug Administration and information tech10 nology; and 

11 (2) develop— 

12 (A) a documented enterprise architecture 

13 program management plan that includes the 

14 tasks, activities, and timeframes associated with 

15 developing and using the architecture and ad16 dresses how the enterprise architecture program 

17 management will be performed in coordination 

18 with other management disciplines, such as or19 ganizational strategic planning, capital planning 

20 and investment control, and performance man21 agement; and 

22 (B) a skills inventory, needs assessment, 

23 gap analysis, and initiatives to address skills 

24 gaps as part of a strategic approach to informa25 tion technology human capital planning. 


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1 (b) GAO REPORT.—Not later than January 1, 2016, 

2 the Comptroller General of the United States shall issue 

3 a report regarding the strategic plan described in sub4 section (a) and related actions carried out by the Food 

5 and Drug Administration. Such report shall assess the 

6 progress the Food and Drug Administration has made 

7 on— 

8 (1) the development and implementation of a 

9 comprehensive information technology strategic plan, 

10 including the results-oriented goals, strategies, mile11 stones, and performance measures identified in sub12 paragraph (a); 

13 (2) the effectiveness of the comprehensive infor14 mation technology strategic plan in subparagraph 

15 (a), including the results-oriented goals and perform16 ance measures; and 

17 (3) the extent to which the Food and Drug Ad18 ministration has fulfilled recommendations of the 

19 Government Accountability Office with respect to 

20 such agency and information technology. 

21 TITLE II—RECALIBRATING RISK22 BENEFIT CONSIDERATIONS 

23 SEC. 201. DEVICES. 

24 Section 513(a) of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 360(a)) is amended— 


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1 (1) in paragraph (2)— 

2 (A) by redesignating subparagraphs (A) 

3 through (C) as clauses (i) through (iii), respec4 tively, 

5 (B) by striking ‘‘(2) For’’ and inserting 

6 ‘‘(2)(A) For’’; and 

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

8 ‘‘(B) The Secretary shall assess the safety and 

9 effectiveness of a device as required under subpara10 graph (A) from the perspective of a reasonable pa11 tient in the intended use population who would as12 sign the most value to the effect the device purports 

13 to have or is represented to have under the condi14 tions of use prescribed, recommended, or suggested 

15 in the labeling or proposed labeling, and who would 

16 be willing to accept the probable risks that may be 

17 associated with the use of the device as prescribed, 

18 recommended, or suggested in the labeling or pro19 posed labeling.’’; 

20 (2) by redesignating paragraph (3) as para21 graph (4); and 

22 (3) by inserting after paragraph (2) the fol23 lowing: 

24 ‘‘(3)(A) The safety of a device is, for purposes 

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1 termined in accordance with regulations promul2 gated by the Secretary, on the basis of information 

3 contained in the application and valid scientific evi4 dence derived from well-controlled investigations. 

5 The Secretary shall not find a lack of reasonable as6 surance of safety unless information contained in the 

7 application or valid scientific evidence demonstrates 

8 that there is a reasonable probability of a risk of in9 jury or illness from the proposed use of the device 

10 that is not outweighed by the probable benefit to 

11 health from the device. 

12 ‘‘(B) The Secretary may determine there is not 

13 reasonable assurance of safety with respect to a de14 vice only after identifying in writing— 

15 ‘‘(i) the probable risk of injury or illness; 

16 ‘‘(ii) the scientific evidence that reasonably 

17 supports the Secretary’s determination; and 

18 ‘‘(iii) the type of data or information, con19 sistent with the least burdensome provisions of 

20 this Act, that would demonstrate a benefit that 

21 would exceed the probable risk.’’. 

22 SEC. 202. DRUGS. 

23 Section 505(d) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 355(d)) is amended by adding at 

25 the end the following: 


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1 ‘‘In assessing the safety and effectiveness of a drug under 

2 this subsection, the Secretary shall implement a struc3 tured benefit-risk assessment framework in the new drug 

4 approval process to facilitate the balanced consideration 

5 of benefits and risks, a consistent and systematic approach 

6 to the discussion and regulatory decisionmaking, and the 

7 communication of the benefits and risks of new drugs.’’. 

8 TITLE III—REDUCING UNNECES9 SARY DELAYS AND REGU10 LATORY BURDENS 

11 SEC. 301. OPTIMIZING GLOBAL CLINICAL TRIALS. 

12 Subchapter E of chapter V of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 

14 amended by adding at the end the following: 

15 ‘‘SEC. 568. OPTIMIZING GLOBAL CLINICAL TRIALS. 

16 ‘‘For purposes of eliminating costly and scientifically 

17 unnecessary clinical trials, enhancing the efficiency of 

18 medical products development, and facilitating the Food 

19 and Drug Administration and the acceptance of foreign 

20 clinical data of other health authorities, the Food and 

21 Drug Administration shall— 

22 ‘‘(1) work with other regulatory authorities of 

23 similar standing, medical research companies, and 

24 international organizations to foster and encourage 


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1 uniform, scientifically-driven clinical trial standards 

2 around the world; and 

3 ‘‘(2) enhance the commitment to provide the 

4 least burdensome, consistent parallel scientific advice 

5 to manufacturers seeking simultaneous global devel6 opment of new medical products in order to mini7 mize the need for conduct and duplication of clinical 

8 studies, preclinical studies, or non-clinical studies.’’. 

9 SEC. 302. ADVANCING AMERICAN PATIENTS’ TIMELY AC10 CESS TO INNOVATIVE DEVICES. 

11 Section 520(g) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 360j(g)) is amended by adding at 

13 the end the following: 

14 ‘‘(8) In the case of a person intending to inves15 tigate the safety or effectiveness of a class II or a 

16 class III device that— 

17 ‘‘(A) has a valid marketing authorization 

18 by the appropriate authority in Australia, Can19 ada, Israel, Japan, New Zealand, Switzerland, 

20 or South Africa or in the European Union or 

21 a country in the European Economic Area (the 

22 countries in the European Union and the Euro23 pean Free Trade Association), or such other 

24 authority recognized by the Secretary; and 


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1 ‘‘(B) has a history of use pursuant to its 

2 marketing authorization with no device-related 

3 serious unanticipated adverse event reports, 

4 the Secretary shall permit an exemption for clinical 

5 testing of such device for the purpose of developing 

6 data to obtain clearance or approval for the commer7 cial distribution of such device.’’. 

8 SEC. 303. ENSURING LEGAL SUFFICIENCY AND CONSIST9 ENCY OF FDA ENFORCEMENT POLICIES. 

10 Subchapter E of chapter V of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.), as 

12 amended by section 301, is further amended by adding 

13 at the end the following: 

14 ‘‘SEC. 569. WARNING LETTERS. 

15 ‘‘(a) IN GENERAL.—Before a warning letter with re16 spect to a drug or device is issued, the Office of the Chief 

17 Counsel shall review such warning letter to ensure that 

18 such warning letter is legally sufficient and consistent with 

19 all policies of the Food and Drug Administration. 

20 ‘‘(b) WARNING LETTER.—For purposes of this sec21 tion, the term ‘warning letter’ shall include all notices of 

22 alleged violations, including untitled letters.’’. 


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1 TITLE IV—STRENGTHENING AD2 VISORY COMMITTEES FOR PA3 TIENTS 

4 SEC. 401. STRENGTHENING ADVISORY COMMITTEES FOR 

5 PATIENTS. 

6 (a) FINDING.—Congress finds that— 

7 (1) as science becomes more specialized, it be8 comes more difficult for general scientists to keep up 

9 with the scientific advances in the many areas that 

10 the Food and Drug Administration regulates; 

11 (2) it is necessary for the Food and Drug Ad12 ministration to be able to draw upon essential med13 ical and scientific expertise across specialized areas 

14 in order to fulfill its public health mission; 

15 (3) the programs with respect to advisory com16 mittees under the Food and Drug Administration 

17 should be strengthened and improved to ensure that 

18 the Food and Drug Administration is able to be ad19 vised by the most qualified medical and scientific 

20 subject experts; and 

21 (4) an appropriate balance should be restored 

22 with respect to conflict of interest considerations for 

23 advisory committees and experts advising the Food 

24 and Drug Administration to ensure that the Food 


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1 and Drug Administration is able to draw upon the 

2 most qualified medical and scientific experts. 

3 (b) ADVISORY COMMITTEES AND SPECIAL GOVERN4 MENT EMPLOYEES.—Subchapter A of chapter VII of the 

5 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 

6 et seq.) is amended by adding at the end the following: 

7 ‘‘SEC. 714. STRENGTHENING ADVISORY COMMITTEES. 

8 ‘‘(a) INCREASING NUMBERS OF MEDICAL AND SCI9 ENTIFIC SPECIALISTS PROVIDING EXPERTISE AND AN10 NUAL REPORT.— 

11 ‘‘(1) SPECIAL GOVERNMENT EMPLOYEES.—In 

12 this section, the term ‘special Government employee’ 

13 has the meaning given the term in section 202 of 

14 title 18, United States Code. 

15 ‘‘(2) INCREASING NUMBERS.—The Secretary, 

16 acting through the Commissioner of Food and 

17 Drugs, shall collaborate with stakeholders, including 

18 consumer groups, patient groups, academia, and in19 dustry representatives, to increase the number of 

20 special Government employees across medical and 

21 scientific specialties in areas where the Secretary 

22 lacks specific scientific, medical, or technical exper23 tise necessary for the performance of its regulatory 

24 responsibilities. 


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1 ‘‘(3) ANNUAL REPORTS.—The Secretary, acting 

2 through the Commissioner of Food and Drugs, shall 

3 submit an annual report, as part of the annual user 

4 fee agreement performance report, on the manage5 ment of the pool of special Government employees of 

6 the Food and Drug Administration by citing— 

7 ‘‘(A) the total number of such employees; 

8 ‘‘(B) the employees’ specific areas of ex9 pertise; 

10 ‘‘(C) the turnover by resignation of such 

11 employees; 

12 ‘‘(D) new special Government employee ap13 pointments; 

14 ‘‘(E) the frequency of participation by spe15 cial Government employees in decisions by the 

16 Food and Drug Administration or advice pro17 vided to the Food and Drug Administration; 

18 and 

19 ‘‘(F) the total number of applicants not se20 lected to serve as special government employees. 

21 ‘‘(b) TEMPLATE FOR ADVISORY COMMITTEE BY22 LAWS.—The Secretary, acting through the Commissioner 

23 of Food and Drugs, shall— 


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1 ‘‘(1) publish a standardized template for the by2 laws of advisory committees established under this 

3 Act; and 

4 ‘‘(2) require each of such advisory committees 

5 to compile and publish online an annual report con6 taining, at a minimum— 

7 ‘‘(A) a list of the members of the advisory 

8 committee, the business address of each mem9 ber, and the dates of each member’s term; 

10 ‘‘(B) a list of the Chair and any other des11 ignated leaders of the Advisory Committee; 

12 ‘‘(C) a list of any vacancies on the advisory 

13 committee and the length of any vacancy; 

14 ‘‘(D) the advisory committee’s functions, 

15 expenditures, the dates and places of meetings, 

16 and the attendance of members present at such 

17 meetings; and 

18 ‘‘(E) a summary of the advisory commit19 tee’s activities and recommendations made dur20 ing the fiscal year. 

21 ‘‘(c) TEMPLATE FOR PUBLICATION OF CVS.— 

22 ‘‘(1) IN GENERAL.—The Secretary, acting 

23 through the Commissioner of Food and Drugs, shall 

24 collaborate with stakeholders, including consumer 

25 groups, patient groups, academia, and industry repVerDate Mar 15 2010 23:56 Apr 18, 2012 Jkt 099200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\S2292.IS S2292

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1 resentatives, to publish a standardized template as 

2 guidance for special Government employees of the 

3 Food and Drug Administration and members of ad4 visory committees established under this Act to use 

5 in publicizing their curriculum vitae. 

6 ‘‘(2) CONTENT OF TEMPLATE.—The standard7 ized template described in paragraph (1) shall be 

8 consistent with the following: 

9 ‘‘(A) Peer-reviewed research shall be sepa10 rated from non-peer-reviewed research. 

11 ‘‘(B) The template shall include a separate 

12 list of research that has been submitted for re13 view but not yet published. 

14 ‘‘(C) The template shall include a separate 

15 list of non-research publications. 

16 ‘‘(D) The template shall include general in17 formation about the topic and date in cases 

18 where the research or grant subject matter has 

19 been redacted. 

20 ‘‘(E) All items shall be listed in chrono21 logical order beginning with the most recent. 

22 ‘‘(d) AFFIDAVITS.—The Secretary may require mem23 bers of advisory committees established under this Act to 

24 sign an affidavit stating that the member has read the 

25 majority of the briefing materials pertinent to the decision 


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1 or advice and agrees to the code of conduct to serve as 

2 a special government employee. 

3 ‘‘(e) REPORT.— 

4 ‘‘(1) IN GENERAL.—Not later than January 1, 

5 2017, the Secretary, acting through the Commis6 sioner of Food and Drugs, shall report to Congress 

7 on the issue of temporary members serving on advi8 sory committees established under this Act. 

9 ‘‘(2) CONTENT OF REPORT.—The report de10 scribed in paragraph (1) shall include the following 

11 information: 

12 ‘‘(A) How many temporary members have 

13 served on advisory committees established 

14 under this Act and how many temporary mem15 bers served on each advisory committee. 

16 ‘‘(B) What percentage of such temporary 

17 members were called upon to offer subject mat18 ter expertise in voting or to reach a quorum. 

19 ‘‘(C) Whether temporary members offer 

20 expertise on an issue being decided. 

21 ‘‘(D) Whether temporary members being 

22 called upon merely to reach a quorum. 

23 ‘‘(E) How temporary members are se24 lected.’’. 


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1 TITLE V—MEDICAL DEVICE 

2 REGULATORY IMPROVEMENTS 

3 Subtitle A—Premarket 

4 Predictability 

5 SEC. 501. TRACKING AND REVIEW OF APPLICATIONS FOR 

6 INVESTIGATIONAL DEVICE EXEMPTIONS. 

7 Section 520(g) (21 U.S.C. 360j(g)) is amended by 

8 adding at the end the following: 

9 ‘‘(8)(A) Upon the submission of an application for 

10 an exemption for a device under this subsection, the sub11 mission of a request to classify a device under section 513, 

12 or the submission of a report for a device under section 

13 510(k), whichever occurs first, the Secretary shall assign 

14 a tracking number to the device. 

15 ‘‘(B) The Secretary shall use such tracking number 

16 to record the following interactions between the Secretary 

17 and applicant with respect to the device: 

18 ‘‘(i) Submission or approval of an application 

19 for an exemption under this subsection. 

20 ‘‘(ii) Submission of a request to classify the de21 vice under section 513. 

22 ‘‘(iii) Submission or clearance of a report under 

23 section 510(k). 


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1 ‘‘(iv) Any meeting or meeting request, including 

2 in anticipation of the submission of such an applica3 tion or report. 

4 ‘‘(v) Submission or approval of an application 

5 under section 515(c). 

6 ‘‘(vi) Any formal or informal request by the 

7 Secretary for additional information. 

8 ‘‘(vii) Any deficiency letter. 

9 ‘‘(viii) Any response by the applicant to a re10 quest described in clause (v) or a deficiency letter. 

11 ‘‘(ix) Any written submission by the applicant 

12 to the Food and Drug Administration. 

13 ‘‘(x) Any other matter, as determined appro14 priate by the Secretary. 

15 ‘‘(9) Upon the submission of an application for an 

16 exemption under this subsection for a device, the Sec17 retary shall assign, to review the application, a reviewer 

18 with prior review experience with that type of device or 

19 technology or other relevant expertise.’’. 

20 SEC. 502. INVESTIGATIONAL DEVICE EXEMPTIONS. 

21 Section 520(g) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 360j(g)) is amended— 

23 (1) in paragraph (2)(B)(ii), by inserting ‘‘safety 

24 and effectiveness’’ after ‘‘Secretary of’’; and 


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1 (2) in paragraph (4), by adding at the end the 

2 following: 

3 ‘‘(C) Consistent with paragraph (1), the 

4 Secretary shall not disapprove an application 

5 under this subsection because the Secretary de6 termines— 

7 ‘‘(i) that the investigation may not 

8 support a substantial equivalence or de 

9 novo classification determination or ap10 proval of the device; 

11 ‘‘(ii) that the investigation may not 

12 meet a requirement, including a data re13 quirement, relating to the approval or 

14 clearance of a device; or 

15 ‘‘(iii) that an additional or different 

16 investigation may be necessary to support 

17 clearance or approval of the device.’’. 

18 SEC. 503. DEVICE SUBMISSION ACCEPTANCE CRITERIA. 

19 (a) IN GENERAL.—To ensure more efficient and 

20 timely evaluation of devices, the Secretary of Health and 

21 Human Services (referred to in this section as the ‘‘Sec22 retary’’) shall revise the device submission acceptance cri23 teria utilized by the Secretary under chapter V of the Fed24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 351 et 


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1 seq.) as in effect on the date of enactment of this Act 

2 and implement such revised criteria. 

3 (b) DESCRIPTION; CONTENT.— 

4 (1) DESCRIPTION.—The revised acceptance cri5 teria described under subsection (a) shall be objec6 tive and consistent with the Federal Food, Drug, 

7 and Cosmetic Act and regulations issued under such 

8 Act (as in effect on the date of enactment of this 

9 Act). 

10 (2) CONTENT.—Under such revised criteria, the 

11 Secretary’s decision to refuse to accept or file a de12 vice submission shall be consistent with the require13 ments for such submission as set forth in the Fed14 eral Food, Drug, and Cosmetic Act and the regula15 tions issued under such Act (as in effect on the date 

16 of enactment of this Act), and shall not be based on 

17 criteria inconsistent with the Federal Food, Drug, 

18 and Cosmetic Act or such regulations. 

19 (c) REPORT.—Not later than 2 years after the date 

20 of enactment of this Act, the Comptroller General of the 

21 United States shall issue a report regarding the device 

22 submission acceptance criteria. The Comptroller General 

23 shall, in consultation with persons accredited under sec24 tion 523 of the Federal Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 360m), assess and report on the clarity of the 


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1 revised device submission acceptance criteria under this 

2 section, and the effectiveness of the outcome measures 

3 adopted by the Center for Device and Radiological Health 

4 to ensure the consistent, appropriate, and predictable ap5 plication of such device submission acceptance criteria 

6 consistent with the Federal Food, Drug, and Cosmetic Act 

7 and regulations issued under such Act (as in effect on the 

8 date of enactment of this Act). 

9 SEC. 504. TRANSPARENCY IN CLEARANCE PROCESS. 

10 (a) PUBLICATION OF DETAILED DECISION SUM11 MARIES.—Section 520(h) (21 U.S.C. 360j(h)) is amended 

12 by adding at the end the following: 

13 ‘‘(5) Subject to subsection (c) and section 301(j), the 

14 Secretary shall regularly publish detailed decision sum15 maries for each clearance of a device under section 

16 510(k).’’. 

17 (b) APPLICATION.—The requirement of section 

18 520(h)(5) of the Federal Food, Drug, and Cosmetic Act, 

19 as added by subsection (a), applies only with respect to 

20 clearance of a device occurring after the date of the enact21 ment of this Act. 


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1 SEC. 505. RESTORING REGULATORY CERTAINTY WITH RE2 SPECT TO 510(k) REPORTS REQUIRED FOR 

3 CERTAIN MODIFICATIONS. 

4 (a) IN GENERAL.—Section 510(n) of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 360(n)) is 

6 amended— 

7 (1) by striking ‘‘(n) The Secretary’’ and insert8 ing ‘‘(n)(1) The Secretary’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(2) A report under subsection (k) is not required 

11 for a modification to a device that has been classified into 

12 class I or II under subsection (f)(1) or (i) of section 513 

13 if— 

14 ‘‘(A) the change is— 

15 ‘‘(i) validated by same method applied to 

16 the classified device undergoing modification, or 

17 a current validation method that is equivalent 

18 to the validation method applied to the device 

19 undergoing modification; 

20 ‘‘(ii) the validation identified under clause 

21 (i) includes all changes to the last version of the 

22 device that the Secretary found substantially 

23 equivalent to a predicate device, within the 

24 meaning of subsections (f)(1) and (i) of section 

25 513; and 


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1 ‘‘(iii) the validation of the modified device 

2 reveals that the safety and effectiveness results 

3 are consistent with the validation results of the 

4 unmodified device; 

5 ‘‘(B) the device’s intended use remains the 

6 same; and 

7 ‘‘(C) the information identified under subpara8 graphs (A) and (B) is documented and maintained 

9 as part of the design file subject to inspection by the 

10 Secretary under section 704(a) for a period of time 

11 equal to the design life of the device, or 2 years from 

12 the date of the first commercial distribution of the 

13 modified device, whichever occurs later.’’. 

14 (b) REGULATIONS.—Not later than 1 year after the 

15 date of the enactment of this Act, the Secretary shall pro16 mulgate a final regulation to implement section 510(n)(2) 

17 of the Federal Food, Drug, and Cosmetic Act, as added 

18 by subsection (a), including to define the phrase ‘‘signifi19 cantly affect the safety or effectiveness of the device’’ con20 sistent with the substantive criteria of clauses (i) through 

21 (iii) of section 510(n)(2)(A). 

22 (c) ANNUAL REPORT.—The Secretary shall annually 

23 submit to the Committee on Health, Education, Labor, 

24 and Pensions of the Senate and the Committee on Energy 

25 and Commerce of the House of Representatives, a report 


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1 that specifies, with respect to the preceding 2-year pe2 riod— 

3 (1) the number of reports submitted under sub4 section 510(k) for a modification or change to a de5 vice that was cleared under such subsection prior to 

6 such modification or change; and 

7 (2) the number of such reports submitted in re8 sponse to— 

9 (A) a request from the Secretary, 

10 (B) an observation made by the Secretary 

11 during an inspection of an applicant’s facility; 

12 or 

13 (C) any other enforcement action initiated 

14 by the Secretary. 

15 SEC. 506. MEETING THE DEVICE NEEDS OF INDIVIDUAL PA16 TIENTS. 

17 Chapter V of the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

19 section 515A the following: 

20 ‘‘SEC. 515B. MEETING THE DEVICE NEEDS OF INDIVIDUAL 

21 PATIENTS. 

22 ‘‘(a) CUSTOM DEVICES.—Sections 514 and 515 shall 

23 not apply to any device modified to meet the individual 

24 needs of a specific patient if such device— 


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1 ‘‘(1) in order to comply with the order of an in2 dividual physician or dentist (or any other specially 

3 qualified person designated under regulations pro4 mulgated by the Secretary after an opportunity for 

5 an oral hearing), necessarily deviates from an other6 wise applicable performance standard or requirement 

7 prescribed by or under section 515; 

8 ‘‘(2) is not generally available in the United 

9 States in finished form and no other devices are do10 mestically available to treat the unique pathology or 

11 physiological condition of the specific patient; 

12 ‘‘(3) is intended to meet the special needs of 

13 such physician or dentist (or other specially qualified 

14 person so designated)— 

15 ‘‘(A) in the course of the professional prac16 tice of such physician or dentist (or other spe17 cially qualified person so designated); 

18 ‘‘(B) the need for which has been docu19 mented in the patient’s medical record by such 

20 physician or dentist (or other specially qualified 

21 person so designated); and 

22 ‘‘(C) is for use by the individual patient 

23 described in subparagraph (B); and 

24 ‘‘(4) is— 


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1 ‘‘(A) assembled from components or manu2 factured on a case-by-case basis; 

3 ‘‘(B) premanufactured and finished on a 

4 case-by-case basis; or 

5 ‘‘(C) a modification to an existing, legally 

6 marketed device. 

7 ‘‘(b) LIMITATIONS.—Subsection (a) shall apply to a 

8 device only if— 

9 ‘‘(1) such device includes particular features to 

10 accommodate a specific patient’s unique anatomical, 

11 physiological, or clinical needs; 

12 ‘‘(2) such device is for the purpose of treating 

13 sufficiently rare patient conditions, such that con14 ducting clinical investigations would be impractical; 

15 and 

16 ‘‘(3) production of such device is limited to no 

17 more than 10 units per year of a particular device 

18 meeting a specific patient need or exhibiting a spe19 cific feature.’’. 


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1 Subtitle B—FDA Renewing Effi2 ciency From Outside Reviewer 

3 Management 

4 SEC. 511. PERSONS ACCREDITED TO REVIEW REPORTS 

5 UNDER SECTION 510(k) AND MAKE REC6 OMMENDATIONS FOR INITIAL CLASSIFICA7 TION. 

8 (a) TIME PERIOD FOR REVIEW OF RECOMMENDA9 TIONS OF ACCREDITED PERSONS.—Section 523(a) (21 

10 U.S.C. 360m(a)) is amended— 

11 (1) in paragraph (1), by striking ‘‘reviewing re12 ports’’ and inserting ‘‘reviewing, and making rec13 ommendations to the Secretary regarding, reports’’; 

14 and 

15 (2) in paragraph (2), by amending subpara16 graph (B) to read as follows: 

17 ‘‘(B) TIME PERIOD FOR REVIEW.—Not 

18 later than 30 days after the date on which the 

19 Secretary is notified under subparagraph (A) by 

20 an accredited person with respect to a rec21 ommendation regarding a report submitted 

22 under section 510(k) or an initial classification 

23 of a device, the Secretary shall make a deter24 mination with respect to the recommendation.’’. 


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1 (b) ACCESS TO DEVICE INFORMATION.—Section 

2 523(a)(2) (21 U.S.C. 360m(a)(2)), as amended by sub3 section (a)(2), is amended by adding at the end the fol4 lowing: 

5 ‘‘(D) ACCESS TO DEVICE INFORMATION.— 

6 ‘‘(i) IN GENERAL.—Subject to section 

7 301(j), for the purpose of providing accred8 ited persons with additional information to 

9 review reports submitted under section 

10 510(k) and make recommendations regard11 ing the initial classification of devices, the 

12 Secretary shall regularly publish— 

13 ‘‘(I) detailed decision summaries 

14 for each substantial equivalence deter15 mination under section 513(f)(1) and 

16 each initial classification under section 

17 513(f)(2); and 

18 ‘‘(II) total product life cycles in19 formation for each device classified 

20 under section 513(f). 

21 ‘‘(ii) REQUIREMENT.—Any informa22 tion published under this subparagraph 

23 shall be consistent with the requirements 

24 of part 20 of title 21, Code of Federal 


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1 Regulations (or any successor regula2 tions).’’. 

3 (c) ACCREDITATION.—Section 523(b) (21 U.S.C. 

4 360m(b)) is amended— 

5 (1) in paragraph (2)— 

6 (A) in the heading of subparagraph (C), by 

7 inserting ‘‘AND TRAINING’’ after ‘‘AUDITING’’; 

8 (B) in subparagraph (C)— 

9 (i) in clause (i), by striking ‘‘and’’ at 

10 the end; 

11 (ii) by redesignating clause (ii) as 

12 clause (iii); and 

13 (iii) by inserting after clause (i) the 

14 following: 

15 ‘‘(ii) provide for the initial training 

16 and periodic updating of training of such 

17 person; and’’; and 

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

19 ‘‘(E) PERIODIC REACCREDITATION.— 

20 ‘‘(i) PERIOD.—Subject to suspension 

21 or withdrawal under subparagraph (B), 

22 any accreditation under this section shall 

23 be valid for a period of 3 years after its 

24 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) for which such persons are 

17 reaccredited.’’; 

18 (2) in paragraph (3)— 

19 (A) in subparagraph (A), by inserting ‘‘a 

20 sole practitioner or’’ after ‘‘may not be’’; 

21 (B) in subparagraph (B), by striking 

22 ‘‘such a manufacturer, supplier, or vendor’’ and 

23 inserting ‘‘a manufacturer, supplier, or vendor 

24 of devices of the type for which such person is 

25 accredited’’; and 


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1 (C) in subparagraph (D), by striking ‘‘de2 vices’’ and inserting ‘‘devices of the type for 

3 which such person is accredited’’; 

4 (3) by striking paragraph (4) (relating to selec5 tion of accredited persons); and 

6 (4) by redesignating paragraph (5) as para7 graph (4). 

8 (d) DURATION OF AUTHORITY.—Section 523(c) (21 

9 U.S.C. 360m(c)) is amended by striking ‘‘October 1, 

10 2012’’ and inserting ‘‘October 1, 2017’’. 

11 (e) REPORT.—Section 523(d) (21 U.S.C. 360m(d)) 

12 is amended by striking ‘‘January 10, 2007’’ and inserting 

13 ‘‘January 15, 2015’’. 

14 SEC. 512. PERSONS ACCREDITED TO CONDUCT INSPEC15 TIONS. 

16 Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amend17 ed by striking ‘‘October 1, 2012’’ and inserting ‘‘October 

18 1, 2017’’. 


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1 TITLE VI—STRENGTHENING 

2 MANAGEMENT TO SUPPORT 

3 FDA’S PUBLIC HEALTH MIS4 SION 

5 SEC. 601. INTEGRATED STRATEGY AND MANAGEMENT 

6 PLAN. 

7 (a) STRATEGIC INTEGRATED MANAGEMENT PLAN.— 

8 Not later than 1 year after the date of enactment of this 

9 Act, the Secretary shall submit to Congress a strategic 

10 integrated management plan for the Center for Drug 

11 Evaluation and Research, the Center for Biologics Evalua12 tion and Research, and the Center for Devices and Radio13 logical Health. Such strategic management plan shall— 

14 (1) identify strategic institutional goals and pri15 orities for the Center for Drug Evaluation and Re16 search, the Center for Biologics Evaluation and Re17 search, and the Center for Devices and Radiological 

18 Health; 

19 (2) describe the actions the Secretary will take 

20 to recruit, retain, train, and continue to develop the 

21 workforce at the Center for Drug Evaluation and 

22 Research, the Center for Biologics Evaluation and 

23 Research, and the Center for Devices and Radio24 logical Health to fulfill the public health mission of 

25 the Food and Drug Administration; and 


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1 (3) identify results-oriented, outcome-based 

2 measures that the Secretary will use to measure the 

3 progress of achieving the strategic goals and prior4 ities identified under paragraph (1) and the effec5 tiveness of the actions identified under paragraph 

6 (2), including metrics to ensure that managers and 

7 reviewers of the Center for Drug Evaluation and Re8 search, the Center for Biologics Evaluation and Re9 search, and the Center for Devices and Radiological 

10 Health are familiar with and appropriately and con11 sistently apply the requirements under the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

13 seq.), including new requirements under the 2012 

14 user fee agreements. 

15 (b) REPORT.—Not later than January 1, 2016, the 

16 Comptroller General of the United States shall issue a re17 port regarding the strategic management plan described 

18 in subsection (a) and related actions carried out by the 

19 Food and Drug Administration. Such report shall— 

20 (1) assess the effectiveness of the actions de21 scribed in paragraph (2) in recruiting, retaining, 

22 training, and developing the workforce at the Center 

23 for Drug Evaluation and Research, the Center for 

24 Biologics Evaluation and Research, and the Center 

25 for Devices and Radiological Health in fulfilling the 


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1 public health mission of the Food and Drug Admin2 istration; 

3 (2) assess the effectiveness of the measures 

4 identified under paragraph (2) in gauging progress 

5 against the strategic goals and priorities identified 

6 under paragraph (1); 

7 (3) assess the extent to which the Center for 

8 Drug Evaluation and Research, the Center for Bio9 logics Evaluation and Research, and the Center for 

10 Devices and Radiological Health are using the iden11 tified results-oriented set of performance measures 

12 in tracking their workload by strategic goals and the 

13 effectiveness of such measures; 

14 (4) assess the extent to which performance in15 formation is collected, analyzed, and acted on by 

16 managers; and 

17 (5) make recommendations, as appropriate, re18 garding how the strategic management plan and re19 lated actions of the Center for Drug Evaluation and 

20 Research, the Center for Biologics Evaluation and 

21 Research, and the Center for Devices and Radio22 logical Health could be improved to fulfill the public 

23 health mission of the Food and Drug Administration 

24 in as efficient and effective manner as possible. 


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1 SEC. 602. INDEPENDENT ASSESSMENT. 

2 (a) IN GENERAL.—The Secretary shall contract with 

3 a private, independent consulting firm capable of per4 forming the technical analysis, management assessment, 

5 and program evaluation tasks required to conduct a com6 prehensive assessment of the process for the review of 

7 drug applications under subsections (b) and (j) of section 

8 505 of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 355(b), (j)) and subsections (a) and (k) of section 

10 351 of the Public Health Service Act (42 U.S.C. 262(a), 

11 (k)). The assessment shall address the premarket review 

12 process of drugs by the Food and Drug Administration, 

13 using an assessment framework that draws from appro14 priate quality system standards, including management 

15 responsibility, documents controls and records manage16 ment, and corrective and preventive action. 

17 (b) PARTICIPATION.—Representatives of the Food 

18 and Drug Administration and manufacturers of drugs 

19 subject to user fees under part 2 of subchapter C of chap20 ter VII of the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 379g et seq.) shall participate in a comprehensive 

22 assessment of the process for the review of drug applica23 tions under section 505 of the Federal Food, Drug, and 

24 Cosmetic Act and section 351 of the Public Health Service 

25 Act. The assessment shall be conducted in phases. 


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1 (c) FIRST CONTRACT.—The Secretary shall award 

2 the contract for the first assessment under this section 

3 not later than March 31, 2013. Such contractor shall 

4 evaluate the implementation of recommendations and pub5 lish a written assessment not later than February 1, 2016. 

6 (d) FINDINGS AND RECOMMENDATIONS.— 

7 (1) IN GENERAL.—The Secretary shall publish 

8 the findings and recommendations under this section 

9 that are likely to have a significant impact on review 

10 times not later than 6 months after the contract is 

11 awarded. Final comprehensive findings and rec12 ommendations shall be published not later than 1 

13 year after the contract is awarded. 

14 (2) IMPLEMENTATION PLAN.—The Food and 

15 Drug Administration shall publish an implementa16 tion plan not later than 6 months after the date of 

17 receipt of each set of recommendation. 

18 (e) SCOPE OF ASSESSMENT.—The assessment under 

19 this section shall include the following: 

20 (1) Identification of process improvements and 

21 best practices for conducting predictable, efficient, 

22 and consistent premarket reviews that meet regu23 latory review standards. 


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1 (2) Analysis of elements of the review process 

2 that consume or save time to facilitate a more effi3 cient process. Such analysis shall include— 

4 (A) consideration of root causes for ineffi5 ciencies that may affect review performance and 

6 total time to decision; 

7 (B) recommended actions to correct any 

8 failures to meet user fee program goals; and 

9 (C) consideration of the impact of com10 bination products on the review process. 

11 (3) Assessment of methods and controls of the 

12 Food and Drug Administration for collecting and re13 porting information on premarket review process re14 source use and performance. 

15 (4) Assessment of effectiveness of the reviewer 

16 training program of the Food and Drug Administra17 tion. 

18 (5) Recommendations for ongoing periodic as19 sessments and any additional, more detailed or fo20 cused assessments. 

21 (f) REQUIREMENTS.—The Secretary shall— 

22 (1) analyze the recommendations for improve23 ment opportunities identified in the assessment, de24 velop and implement a corrective action plan, and 

25 ensure it effectiveness; 


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1 (2) incorporate the findings and recommenda2 tions of the contractors, as appropriate, into the 

3 management of the premarket review program of the 

4 Food and Drug Administration; and 

5 (3) incorporate the results of the assessment in 

6 a Good Review Management Practices guidance doc7 ument, which shall include initial and ongoing train8 ing of Food and Drug Administration staff, and 

9 periodic audits of compliance with the guidance. 

Æ 


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