II 

115TH CONGRESS 

1ST SESSION S. 1062 

To increase reporting transparency and accountability with respect to Food 

and Drug Administration user fees. 

IN THE SENATE OF THE UNITED STATES 

MAY 4, 2017 

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

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

Labor, and Pensions 

A BILL 

To increase reporting transparency and accountability with 

respect to Food and Drug Administration user fees. 

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 ‘‘FDA Reporting Trans5 parency and Accountability Act’’. 

6 SEC. 2. STREAMLINING AND IMPROVING CONSISTENCY IN 

7 PERFORMANCE REPORTING. 

8 (a) PDUFA.—Section 736B(a) of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)) is amend10 ed— 


SSpencer on DSK4SPTVN1PROD with BILLS
2 

•S 1062 IS

1 (1) in paragraph (1)(B)— 

2 (A) in each of clauses (i), (ii), and (v), by 

3 inserting ‘‘and the number of complete response 

4 letters issued for such applications’’ before the 

5 semicolon; 

6 (B) in each of clauses (iii) and (iv), by in7 serting ‘‘and the number of complete response 

8 letters issued for such supplements’’ before the 

9 semicolon; 

10 (C) in clause (vi), by inserting ‘‘and the 

11 number of designations and denials issued by 

12 the agency for such applications’’ before the 

13 semicolon; 

14 (D) in clause (vii), by striking ‘‘; and’’ and 

15 inserting ‘‘and the number of designations and 

16 denials issued by the agency for such applica17 tions;’’; and 

18 (E) in clause (viii) by striking the period 

19 and inserting ‘‘and the number of designations 

20 and denials issued by the agency for such appli21 cations;’’; and 

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

24 ‘‘(3) REAL TIME REPORTING.— 


SSpencer on DSK4SPTVN1PROD with BILLS
3 

•S 1062 IS

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

2 year 2018, every 30 calendar days, the Sec3 retary shall post the data described in subpara4 graph (B) on the Internet website of the Food 

5 and Drug Administration and remove from 

6 such website duplicative data from the annual 

7 performance report. 

8 ‘‘(B) DATA.—The following data is re9 quired to be posted in accordance with subpara10 graph (A): 

11 ‘‘(i) The number and titles of draft 

12 and final guidance issued by the Center for 

13 Drug Evaluation and Research or the Cen14 ter for Biologics Evaluation and Research, 

15 and the justification for the issuance and 

16 finalization of each such guidance. 

17 ‘‘(ii) The number and titles of public 

18 meetings held by the Center for Drug 

19 Evaluation and Research and the Center 

20 for Biologics Evaluation and Research 

21 each fiscal year. 

22 ‘‘(iii) The list of standard new drug 

23 applications and biologics license applica24 tions, by fiscal year of receipt. 


SSpencer on DSK4SPTVN1PROD with BILLS
4 

•S 1062 IS

1 ‘‘(iv) The number of filed applications 

2 by each review division. 

3 ‘‘(4) CAPACITY PLANNING AND IMPROVED TIME

4 REPORTING.—Beginning with fiscal year 2020, the 

5 Secretary shall include in the annual report under 

6 paragraph (1)— 

7 ‘‘(A) the number of full-time equivalents 

8 agreed upon and the number of appropriated 

9 full time equivalents at the Food and Drug Ad10 ministration by each division within the Center 

11 for Drug Evaluation and Research, the Center 

12 for Biologics Evaluation and Research, the Of13 fice of Regulatory Affairs, and the Office of the 

14 Commissioner; 

15 ‘‘(B) identification by name of all time re16 porting categories that Food and Drug Admin17 istration uses for capacity planning and time 

18 reporting with respect to the Center for Drug 

19 Evaluation and Research, the Center for Bio20 logics Evaluation and Research, the Office of 

21 Regulatory Affairs, and the Office of the Com22 missioner, pursuant to the ‘resource capacity 

23 planning and modernized time reporting imple24 mentation plan’; 


SSpencer on DSK4SPTVN1PROD with BILLS
5 

•S 1062 IS

1 ‘‘(C) the processes by which the Center for 

2 Drug Evaluation and Research, the Center for 

3 Biologics Evaluation and Research, the Office 

4 of Regulatory Affairs, and the Office of the 

5 Commissioner require reporting on the amount 

6 of an employee’s time that is dedicated to the 

7 review of human drug applications, including 

8 information regarding employees dedicated to 

9 such activities on a full-time basis, and employ10 ees dedicated to such activities on a part-time 

11 basis; and 

12 ‘‘(D) for each of the Center for Drug Eval13 uation and Research, the Center for Biologics 

14 Evaluation and Research, the Office of Regu15 latory Affairs, and the Office of the Commis16 sioner, the number of employees described in 

17 subparagraph (C) (both full-time equivalents 

18 and employees dedicated to such activities on a 

19 part-time basis) for whom time reporting is re20 quired as described in subparagraph (C), and 

21 the number of such employees required to esti22 mate time dedicated to the review of human 

23 drug applications.’’. 


SSpencer on DSK4SPTVN1PROD with BILLS
6 

•S 1062 IS

1 (b) MDUFA.—Section 738A(a)(1)(A) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

3 1(a)(1)(A)) is amended— 

4 (1) by striking ‘‘Beginning with’’ and inserting 

5 the following: 

6 ‘‘(i) GENERAL REQUIREMENTS.—Be7 ginning with’’; and 

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

9 ‘‘(ii) ADDITIONAL INFORMATION.— 

10 Beginning with fiscal year 2018, the an11 nual report under this subparagraph shall 

12 include the progress of the Center for De13 vices and Radiological Health in achieving 

14 the goals, and future plans for meeting the 

15 goals, including, for each review division— 

16 ‘‘(I) the number of premarket ap17 plications filed under section 515 per 

18 fiscal year for each review division, 

19 and the number of approvable letters, 

20 major deficiency letters, not approv21 able letters, and denials for such ap22 plications; 

23 ‘‘(II) the number of reports filed 

24 under section 510(k) per fiscal year 

25 for each review division and the numVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
7 

•S 1062 IS

1 ber of devices cleared or not substan2 tially equivalent for such reports; and 

3 ‘‘(III) the number of expedited 

4 access pathway designations for a fis5 cal year for each review division and 

6 the number of cleared or approved de7 vices or denials for such applications. 

8 ‘‘(iii) REAL TIME REPORTING.— 

9 ‘‘(I) IN GENERAL.—Beginning 

10 with fiscal year 2018, the Secretary 

11 shall, every 30 calendar days, post the 

12 data described in subclause (II) on 

13 the Internet website of the Food and 

14 Drug Administration and remove from 

15 such website duplicative data from the 

16 annual report under this subpara17 graph. 

18 ‘‘(II) DATA.—The following data 

19 is required to be posted in accordance 

20 with subclause (I): 

21 ‘‘(aa) The number and titles 

22 of draft and final guidance issued 

23 by the Center for Devices and 

24 Radiological Health and the jusVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
8 

•S 1062 IS

1 tification for the issuance and fi2 nalization of such guidance. 

3 ‘‘(bb) The number and titles 

4 of public meetings held by the 

5 Center for Devices and Radio6 logical Health each fiscal year.’’. 

7 (c) GDUFA.—Section 744C(a) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)) is amend9 ed— 

10 (1) by striking ‘‘Beginning with’’ and inserting 

11 the following: 

12 ‘‘(1) GENERAL REQUIREMENTS.—Beginning 

13 with’’; and 

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

15 ‘‘(2) ADDITIONAL INFORMATION.—Beginning 

16 with fiscal year 2018, the report under this sub17 section shall include the progress of the Office of 

18 Generic Drugs in achieving the goals, and future 

19 plans for meeting the goals, including— 

20 ‘‘(A) the number of original abbreviated 

21 new drug applications filed per fiscal year; 

22 ‘‘(B) the number of amendments to abbre23 viated new drug applications filed per fiscal 

24 year; and 


SSpencer on DSK4SPTVN1PROD with BILLS
9 

•S 1062 IS

1 ‘‘(C) the number of actions taken delin2 eated by the type of action, including final ap3 provals, tentative approvals, complete response 

4 letters, and the number of ‘refuse to receive’ 

5 letters issued by the Food and Drug Adminis6 tration per fiscal year. 

7 ‘‘(3) REAL TIME REPORTING.— 

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

9 year 2018, the Secretary shall, every 30 cal10 endar days, post the data described in subpara11 graph (B) on the Internet website of the Food 

12 and Drug Administration and remove from 

13 such website duplicative data from the annual 

14 report under this subsection. 

15 ‘‘(B) DATA.—The following data is re16 quired to be posted in accordance with subpara17 graph (A): 

18 ‘‘(i) The number and titles of draft 

19 and final guidance issued by the Office of 

20 Generic Drugs and the justification for the 

21 issuance and finalization of such guidance. 

22 ‘‘(ii) The number and titles of public 

23 meetings held by the Office of Generic 

24 Drugs each fiscal year.’’. 


SSpencer on DSK4SPTVN1PROD with BILLS
10 

•S 1062 IS

1 (d) BsUFA.—Section 744I(a) of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)) is amend3 ed— 

4 (1) by striking ‘‘Beginning with’’ and inserting 

5 the following: 

6 ‘‘(1) GENERAL REQUIREMENTS.—Beginning 

7 with’’; and 

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

9 ‘‘(2) ADDITIONAL INFORMATION.—Beginning 

10 with fiscal year 2018, the report under this sub11 section shall include the progress of the Center for 

12 Biologics Evaluation and Research in achieving the 

13 goals, and future plans for meeting the goals, includ14 ing— 

15 ‘‘(A) information on all previous cohorts 

16 for which the Secretary has not given a com17 plete response on all biosimilar biological prod18 uct applications and supplements in the cohort; 

19 ‘‘(B) the number of original biosimilar bio20 logical product applications filed per fiscal year, 

21 and the number of approvals or complete re22 sponse letters issued by the agency for such ap23 plications; and 

24 ‘‘(C) the number of resubmitted original 

25 biosimilar biological product applications filed 


SSpencer on DSK4SPTVN1PROD with BILLS
11 

•S 1062 IS

1 per fiscal year and the number of approvals or 

2 complete response letters issued by the agency 

3 for such applications. 

4 ‘‘(3) REAL TIME REPORTING.— 

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

6 year 2018, the Secretary shall, every 30 cal7 endar days, post the data described in subpara8 graph (B) on the Internet website of the Food 

9 and Drug Administration and remove from 

10 such website duplicative data from the annual 

11 report under this subsection. 

12 ‘‘(B) DATA.—The following data is re13 quired to be posted in accordance with subpara14 graph (A): 

15 ‘‘(i) The number and titles of draft 

16 and final guidance issued by the Center for 

17 Drug Evaluation and Research and the 

18 Center for Biologics Evaluation and Re19 search and the justification for the 

20 issuance and finalization of such guidance. 

21 ‘‘(ii) The number and titles of public 

22 meetings held by the Center for Drug 

23 Evaluation and Research and the Center 

24 for Biologic Evaluation and Research each 

25 fiscal year.’’. 


SSpencer on DSK4SPTVN1PROD with BILLS
12 

•S 1062 IS

1 ‘‘(4) CAPACITY PLANNING AND TIME REPORT2 ING.—Beginning with fiscal year 2020, the Sec3 retary shall include in the annual report under this 

4 subsection— 

5 ‘‘(A) the number of full-time equivalents 

6 agreed upon and the number of appropriated 

7 full time equivalents at the Food and Drug Ad8 ministration by each division within the Center 

9 for Drug Evaluation and Research, the Center 

10 for Biologics Evaluation and Research, the Of11 fice of Regulatory Affairs, and the Office of the 

12 Commissioner; 

13 ‘‘(B) identification by name of all time re14 porting categories that the Food and Drug Ad15 ministration uses for capacity planning and 

16 time reporting under the ‘resource capacity 

17 planning and modernized time reporting imple18 mentation plan’ for the Center for Drug Eval19 uation and Research, the Center for Biologics 

20 Evaluation and Research, the Office of Regu21 latory Affairs and the Office of the Commis22 sioner; 

23 ‘‘(C) the process by which the Center for 

24 Drug Evaluation and Research, the Center for 

25 Biologics Evaluation and Research, the Office 


SSpencer on DSK4SPTVN1PROD with BILLS
13 

•S 1062 IS

1 of Regulatory Affairs, and the Office of the 

2 Commissioner require reporting on the amount 

3 of an employee’s time that is dedicated to the 

4 review of biosimilar biological product applica5 tions, including information regarding both em6 ployees dedicated to such activities on a full7 time basis, and employees dedicated to such ac8 tivities on a part-time basis; and 

9 ‘‘(D) for each of the Center for Drug Eval10 uation and Research, the Center for Biologics 

11 Evaluation and Research, the Office of Regu12 latory Affairs, and the Office of the Commis13 sioner, the actual number of employees de14 scribed in subparagraph (C) (both full-time 

15 equivalents and employees dedicated to such ac16 tivities on a part-time basis) for whom time re17 porting is required as described in subpara18 graph (C), and the number of such employees 

19 required to estimate time dedicated to the re20 view of biosimilar biological product applica21 tions.’’. 

22 SEC. 3. FDA ANALYSIS OF USE OF FUNDS. 

23 (a) PDUFA REPORTS.— 

24 (1) ANALYSIS IN PDUFA PERFORMANCE RE25 PORTS.—Section 736B(a) of the Federal Food, 


SSpencer on DSK4SPTVN1PROD with BILLS
14 

•S 1062 IS

1 Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)), as 

2 amended by section 2(a), is further amended by add3 ing at the end the following: 

4 ‘‘(5) ANALYSIS.—For each fiscal year, the Sec5 retary shall include in the report an analysis of the 

6 following: 

7 ‘‘(A) The difference between the number of 

8 human drug applications filed and the number 

9 of approvals or complete response letters issued 

10 by the agency, accounting for— 

11 ‘‘(i) such applications filed during one 

12 fiscal year for which a decision is not 

13 scheduled to be made until the following 

14 fiscal year; 

15 ‘‘(ii) such applications pending with 

16 the Center for Drug Evaluation and Re17 search and the Center for Biologics Eval18 uation and Research that did not meet the 

19 goals for the corresponding fiscal year and 

20 the future plans of the Food and Drug Ad21 ministration to meet these goals; and 

22 ‘‘(iii) the most common causes within 

23 the agency for missing such goals. 

24 ‘‘(B) Relevant data to determine whether 

25 the Center for Drug Evaluation and Research 


SSpencer on DSK4SPTVN1PROD with BILLS
15 

•S 1062 IS

1 and the Center for Biologics Evaluation and 

2 Research have met performance enhancement 

3 goals for the corresponding fiscal year. 

4 ‘‘(C) External or other circumstances im5 pacting the Center for Drug Evaluation and 

6 Research, the Center for Biologics Evaluation 

7 and Research, or the Food and Drug Adminis8 tration, that impacted the ability of the agency 

9 to meet review time and performance enhance10 ment goals.’’. 

11 (2) ISSUANCE OF CORRECTIVE ACTION RE12 PORTS.—Section 736B of the Federal Food, Drug, 

13 and Cosmetic Act (21 U.S.C. 379h–2) is amended— 

14 (A) by redesignating subsections (c) and 

15 (d) as subsections (e) and (f), respectively; and 

16 (B) inserting after subsection (b) the fol17 lowing: 

18 ‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with 

19 fiscal year 2018, and for each fiscal year for which fees 

20 are collected under this part, the Secretary shall prepare 

21 and submit a corrective action report to the Committee 

22 on Energy and Commerce and the Committee on Appro23 priations of the House of Representatives and the Com24 mittee on Health, Education, Labor, and Pensions and the 

25 Committee on Appropriations of the Senate upon submisVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
16 

•S 1062 IS

1 sion of the performance report in subsection (a) for the 

2 corresponding fiscal year. The report shall include the fol3 lowing information, as applicable: 

4 ‘‘(1) GOALS MET.—For each fiscal year, if the 

5 Secretary determines, based on the analysis under 

6 subsection (a)(3), that each of the goals for the cor7 responding fiscal year have been met, the corrective 

8 action report shall include a summary of goals met, 

9 and recommendations on ways in which the Sec10 retary can improve and streamline the human drug 

11 application review process. 

12 ‘‘(2) GOALS MISSED.—For each of the goals for 

13 the corresponding fiscal year that the Secretary de14 termines to not have been met, the corrective action 

15 report shall include a detailed justification for such 

16 determination and— 

17 ‘‘(A) a detailed description of the cir18 cumstances under which each drug application 

19 that missed the review goal time was approved 

20 during the first cycle review, as applicable; 

21 ‘‘(B) aggregate data on the circumstances 

22 for all unapproved drug applications for which 

23 the review goal time was missed; and 

24 ‘‘(C) the performance enhancement goals 

25 that were not achieved during the previous fisVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
17 

•S 1062 IS

1 cal year and a detailed description of efforts the 

2 agency has put in place for the current fiscal 

3 year to improve the ability of the agency to 

4 meet each such goal, while maintaining stand5 ards of approval, for the current fiscal year. 

6 ‘‘(d) ENHANCED COMMUNICATION.— 

7 ‘‘(1) COMMUNICATIONS WITH CONGRESS.— 

8 Each fiscal year, as applicable, representatives from 

9 the Center for Drug Evaluation and Research and 

10 the Center for Biologics Evaluation and Research 

11 shall meet with representatives from the Committee 

12 on Health, Education, Labor, and Pensions of the 

13 Senate and the Committee on Energy and Com14 merce of the House of Representatives regarding the 

15 contents of the corrective action reports described in 

16 subsection (c)(2) and the annual performance re17 ports under subsection (a). 

18 ‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR19 ING.—Each fiscal year, as applicable, representatives 

20 from the Center for Drug Evaluation and Research 

21 and the Center for Biologics Evaluation and Re22 search shall participate in a public hearing before 

23 the Committee on Health, Education, Labor, and 

24 Pensions of the Senate and the Committee on En25 ergy and Commerce of the House of RepresentaVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
18 

•S 1062 IS

1 tives, regarding the reports under this section. Such 

2 hearing shall occur not later than 120 days after the 

3 end of each fiscal year for which fees are collected 

4 under this part. 

5 ‘‘(3) PUBLICLY AVAILABLE UPDATES.—The 

6 Secretary shall provide an update on progress made 

7 for the corrective action report during the following 

8 fiscal year on the publicly available Internet website 

9 of the Food and Drug Administration every 30 busi10 ness days.’’. 

11 (b) MDUFA REPORTS.— 

12 (1) ANALYSIS IN MDUFA PERFORMANCE RE13 PORTS.—Section 738A(a)(1)(A) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

15 1(a)(1)(A)), as amended by section 2(b), is further 

16 amended by adding at the end the following: 

17 ‘‘(iv) ANALYSIS.—For each fiscal 

18 year, the Secretary shall include in the re19 port an analysis of the following: 

20 ‘‘(I) The difference between the 

21 number of premarket applications 

22 filed under section 515 and applica23 tions filed under section 510(k) and 

24 the number of major deficiency let25 ters, not approvable letters, and deniVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
19 

•S 1062 IS

1 als for such applications issued by the 

2 agency, accounting for— 

3 ‘‘(aa) such applications filed 

4 during one fiscal year for which a 

5 decision is not scheduled to be 

6 made until the following fiscal 

7 year; 

8 ‘‘(bb) such applications 

9 pending with the Center for De10 vices and Radiological Health 

11 that did not meet the goals for 

12 the corresponding fiscal year and 

13 the future plans of the Food and 

14 Drug Administration to meet 

15 these goals; and 

16 ‘‘(cc) the most common 

17 causes within the agency for 

18 missing such goals. 

19 ‘‘(II) Relevant data to determine 

20 whether the Center Devices and Radi21 ological Health have met performance 

22 enhancement goals for the cor23 responding fiscal year. 

24 ‘‘(III) External or other cir25 cumstances impacting the Center DeVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
20 

•S 1062 IS

1 vices and Radiological Health or the 

2 Food and Drug Administration that 

3 impacted the ability of the agency to 

4 meet review time and performance en5 hancement goals.’’. 

6 (2) ISSUANCE OF CORRECTIVE ACTION RE7 PORTS.—Section 738A(a) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)) is 

9 amended— 

10 (A) by redesignating paragraphs (2) and 

11 (3) as paragraphs (4) and (5), respectively; and 

12 (B) by inserting after paragraph (1) the 

13 following: 

14 ‘‘(2) CORRECTIVE ACTION REPORT.—Beginning 

15 with fiscal year 2018, and for each fiscal year for 

16 which fees are collected under this part, the Sec17 retary shall prepare and submit a corrective action 

18 report to the Committee on Energy and Commerce 

19 and the Committee on Appropriations of the House 

20 of Representatives and the Committee on Health, 

21 Education, Labor, and Pensions and the Committee 

22 on Appropriations of the Senate upon submission of 

23 the performance report in paragraph (1)(A) for the 

24 corresponding fiscal year. The report shall include 

25 the following information, as applicable: 


SSpencer on DSK4SPTVN1PROD with BILLS
21 

•S 1062 IS

1 ‘‘(A) GOALS MET.—For each fiscal year, if 

2 the Secretary determines, based on the analysis 

3 under paragraph (1)(A)(iii), that each of the 

4 goals for the corresponding fiscal year have 

5 been met, the corrective action report shall in6 clude a summary of goals met, and rec7 ommendations on ways in which the Secretary 

8 can improve and streamline the medical device 

9 application review process. 

10 ‘‘(B) GOALS MISSED.—For each of the 

11 goals for the corresponding fiscal year that the 

12 Secretary determines to not have been met, the 

13 corrective action report shall include a detailed 

14 justification for such determination and— 

15 ‘‘(i) a detailed description of the cir16 cumstances under which each application 

17 or report submitted under section 515 or 

18 section 510(k) missed the review goal time 

19 but was approved during the first cycle re20 view, as applicable; 

21 ‘‘(ii) aggregate data on the cir22 cumstances for all unapproved medical de23 vice applications for which the review goal 

24 time was missed; and 


SSpencer on DSK4SPTVN1PROD with BILLS
22 

•S 1062 IS

1 ‘‘(iii) the performance enhancement 

2 goals that were not achieved during the 

3 previous fiscal year and a detailed descrip4 tion of efforts the agency has put in place 

5 for the current fiscal year to improve the 

6 ability of the agency to meet each such 

7 goal, while maintaining standards of ap8 proval, for the current fiscal year. 

9 ‘‘(3) ENHANCED COMMUNICATION.— 

10 ‘‘(A) COMMUNICATIONS WITH CON11 GRESS.—Each fiscal year, as applicable, rep12 resentatives from the Center for Devices and 

13 Radiological Health shall meet with representa14 tives from the Committee on Health, Edu15 cation, Labor, and Pensions of the Senate and 

16 the Committee on Energy and Commerce of the 

17 House of Representatives regarding the con18 tents of the corrective action reports described 

19 in paragraph (2) and the annual performance 

20 reports under paragraph (1). 

21 ‘‘(B) PARTICIPATION IN CONGRESSIONAL

22 HEARING.—Each fiscal year, as applicable, rep23 resentatives from the Center for Devices and 

24 Radiological Health shall participate in a public 

25 hearing before the Committee on Health, EduVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
23 

•S 1062 IS

1 cation, Labor, and Pensions of the Senate and 

2 the Committee on Energy and Commerce of the 

3 House of Representatives, to report on the con4 tents described in the corrective action reports 

5 under paragraph (2). Such hearing shall occur 

6 not later than 120 days after the end of each 

7 fiscal year for which fees are collected under 

8 this part. 

9 ‘‘(C) PUBLICLY AVAILABLE UPDATES.— 

10 The Secretary shall provide an update on 

11 progress made for the corrective action report 

12 during the following fiscal year on the publicly 

13 available Internet website of the Food and 

14 Drug Administration every 30 business days.’’. 

15 (c) GDUFA REPORTS.— 

16 (1) ANALYSIS IN GDUFA PERFORMANCE RE17 PORTS.—Section 744C(a) of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)), as 

19 amended by section 2(c) is further amended by add20 ing at the end the following: 

21 ‘‘(4) ANALYSIS.—For each fiscal year, the Sec22 retary shall include in the report an analysis of the 

23 following: 

24 ‘‘(A) The difference between the number of 

25 abbreviated new drug applications filed and the 


SSpencer on DSK4SPTVN1PROD with BILLS
24 

•S 1062 IS

1 number of approvals or complete response let2 ters issued by the agency, accounting for— 

3 ‘‘(i) such applications filed during one 

4 fiscal year for which a decision is not 

5 scheduled to be made until the following 

6 fiscal year; 

7 ‘‘(ii) such applications pending with 

8 the Office of Generic Drugs that did not 

9 meet the goals for the corresponding fiscal 

10 year and the future plans of the Food and 

11 Drug Administration to meet these goals; 

12 and 

13 ‘‘(iii) the most common causes within 

14 the agency for missing such goals. 

15 ‘‘(B) Relevant data to determine whether 

16 the Office of Generic Drugs has met the per17 formance enhancement goals for the cor18 responding fiscal year. 

19 ‘‘(C) External or other circumstances im20 pacting the Office of Generic Drugs or the 

21 Food and Drug Administration that impacted 

22 the ability of the agency to meet review time 

23 and performance enhancement goals.’’. 

24 (2) ISSUANCE OF CORRECTIVE ACTION RE25 PORTS.—Section 744C of the Federal Food, Drug, 


SSpencer on DSK4SPTVN1PROD with BILLS
25 

•S 1062 IS

1 and Cosmetic Act (21 U.S.C. 379j–43) is amend2 ed— 

3 (A) by redesignating subsections (c) and 

4 (d) as subsections (e) and (f), respectively; and 

5 (B) inserting after subsection (b) the fol6 lowing: 

7 ‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with 

8 fiscal year 2018, and for each fiscal year for which fees 

9 are collected under this part, the Secretary shall prepare 

10 and submit a corrective action report to the Committee 

11 on Energy and Commerce and the Committee on Appro12 priations of the House of Representatives and the Com13 mittee on Health, Education, Labor, and Pensions and the 

14 Committee on Appropriations of the Senate upon submis15 sion of the performance report in section 744C(a) for the 

16 corresponding fiscal year. The report shall include the fol17 lowing information, as applicable: 

18 ‘‘(1) GOALS MET.—For each fiscal year, if the 

19 Secretary determines, based on the analysis under 

20 subsection (a)(4), that each of the goals for the cor21 responding fiscal year have been met, the corrective 

22 action report shall include a summary of goals met, 

23 and recommendations on ways in which the Sec24 retary can improve and streamline the abbreviated 

25 new drug application review process. 


SSpencer on DSK4SPTVN1PROD with BILLS
26 

•S 1062 IS

1 ‘‘(2) GOALS MISSED.—For each of the goals for 

2 the corresponding fiscal year that the Secretary de3 termines to not have been met, the corrective action 

4 report shall include a detailed justification for such 

5 determination and— 

6 ‘‘(A) a detailed description of the cir7 cumstances under which each abbreviated new 

8 drug application missed the review goal time 

9 but was approved during the first cycle review, 

10 as applicable; 

11 ‘‘(B) aggregate data on the circumstances 

12 for all unapproved abbreviated new drug appli13 cations for which the review goal time was 

14 missed; and 

15 ‘‘(C) the performance enhancement goals 

16 that were not achieved during the previous fis17 cal year and a detailed description of efforts the 

18 agency has put in place for the current fiscal 

19 year to improve the ability of the agency to 

20 meet each such goal for the current fiscal year. 

21 ‘‘(d) ENHANCED COMMUNICATION.— 

22 ‘‘(1) COMMUNICATIONS WITH CONGRESS.— 

23 Each fiscal year, as applicable, representatives from 

24 the Office of Generic Drugs shall meet with rep25 resentatives from the Committee on Health, EduVerDate Sep 11 2014 00:42 May 11, 2017 Jkt 069200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\S1062.IS S1062

SSpencer on DSK4SPTVN1PROD with BILLS
27 

•S 1062 IS

1 cation, Labor, and Pensions of the Senate and the 

2 Committee on Energy and Commerce of the House 

3 of Representatives regarding the contents of the cor4 rective action reports described in subsection (c)(2) 

5 and the annual performance reports under sub6 section (a). 

7 ‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR8 ING.—Each fiscal year, as applicable, representatives 

9 from the Center for Drug Evaluation and Research 

10 shall participate in a public hearing before the Com11 mittee on Health, Education, Labor, and Pensions 

12 of the Senate and the Committee on Energy and 

13 Commerce of the House of Representatives, to re14 port on the contents described in the reports under 

15 this section. Such hearing shall occur not later than 

16 120 days after the end of each fiscal year for which 

17 fees are collected under this part. 

18 ‘‘(3) PUBLICLY AVAILABLE UPDATES.—The 

19 Secretary shall provide an update on progress made 

20 for the corrective action report during the following 

21 fiscal year on the publicly available Internet website 

22 of the Food and Drug Administration every 30 busi23 ness days.’’. 

24 (d) BSUFA REPORTS.— 


SSpencer on DSK4SPTVN1PROD with BILLS
28 

•S 1062 IS

1 (1) ANALYSIS IN BsUFA PERFORMANCE RE2 PORTS.—Section 744I(a) of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 379j–53(a)) as amend4 ed by section 2(d) is further amended by adding at 

5 the end the following: 

6 ‘‘(5) ANALYSIS.—For each fiscal year, the Sec7 retary shall include in the report an analysis of the 

8 following: 

9 ‘‘(A) The difference between the number of 

10 biosimilar biological product applications and 

11 supplements filed and the number of approvals 

12 or complete response letters issued by the agen13 cy, accounting for— 

14 ‘‘(i) such applications filed during one 

15 fiscal year for which a decision is not 

16 scheduled to be made until the following 

17 fiscal year; 

18 ‘‘(ii) such applications pending with 

19 the Center for Drug Evaluation and Re20 search or the Center for Biologics Evalua21 tion and Research that did not meet the 

22 goals for the corresponding fiscal year and 

23 the future plans of the Food and Drug Ad24 ministration to meet these goals; and 


SSpencer on DSK4SPTVN1PROD with BILLS
29 

•S 1062 IS

1 ‘‘(iii) the most common causes within 

2 the agency for missing such goals. 

3 ‘‘(B) Relevant data to determine whether 

4 the Center for Drug Evaluation and Research 

5 and the Center for Biologics Evaluation and 

6 Research have met the performance enhance7 ment goals for the corresponding fiscal year. 

8 ‘‘(C) External or other circumstances im9 pacting the Center for Drug Evaluation and 

10 Research, the Center for Biologics Evaluation 

11 and Research, and the Food and Drug Admin12 istration that impacted the ability of the agency 

13 to meet review time and performance enhance14 ment goals.’’. 

15 (2) ISSUANCE OF CORRECTIVE ACTION RE16 PORTS.—Section 744I of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 379j–53) is amend18 ed— 

19 (A) by redesignating subsections (c), (d), 

20 and (e) as subsections (d), (e), and (f), respec21 tively; and 

22 (B) inserting after subsection (a) the fol23 lowing: 

24 ‘‘(b) CORRECTIVE ACTION REPORT.—Beginning with 

25 fiscal year 2018, and for each fiscal year for which fees 


SSpencer on DSK4SPTVN1PROD with BILLS
30 

•S 1062 IS

1 are collected under this part, the Secretary shall prepare 

2 and submit a corrective action report to the Committee 

3 on Energy and Commerce and Committee on Appropria4 tions of the House of Representatives and the Committee 

5 on Health, Education, Labor, and Pensions and Com6 mittee on Appropriations of the Senate upon submission 

7 of the performance report in section 744I(a) for the cor8 responding fiscal year. The report shall include the fol9 lowing information, as applicable: 

10 ‘‘(1) GOALS MET.—For each fiscal year, if the 

11 Secretary determines, based on the analysis under 

12 subsection (a)(5), that each of the goals for the cor13 responding fiscal year have been met, the corrective 

14 action report shall include a summary of goals met, 

15 and recommendations on ways in which the Sec16 retary can improve and streamline the biosimilar bi17 ological product application review process. 

18 ‘‘(2) GOALS MISSED.—For each of the goals for 

19 the corresponding fiscal year that the Secretary de20 termines to not have been met, the corrective action 

21 report shall include a detailed justification for such 

22 determination and— 

23 ‘‘(A) a detailed description of the cir24 cumstances under which each biosimilar biologi25 cal product application missed the review goal 


SSpencer on DSK4SPTVN1PROD with BILLS
31 

•S 1062 IS

1 time but was approved during the first cycle re2 view, as applicable; 

3 ‘‘(B) aggregate data on the circumstances 

4 for all biosimilar biological product applications 

5 for which the review goal time was missed; and 

6 ‘‘(C) the performance enhancement goals 

7 that were not achieved during the previous fis8 cal year and a detailed description of efforts the 

9 agency has put in place for the current fiscal 

10 year to improve the ability of the agency to 

11 meet each such goal for the current fiscal year. 

12 ‘‘(c) ENHANCED COMMUNICATION.— 

13 ‘‘(1) COMMUNICATIONS WITH CONGRESS.— 

14 Each fiscal year, as applicable, representatives from 

15 the Center for Drug Evaluation and Research and 

16 the Center for Biologics Evaluation and Research 

17 shall meet with representatives from the Committee 

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

19 Senate and the Committee on Energy and Com20 merce of the House of Representatives regarding the 

21 contents of the corrective action reports described in 

22 subsection (b) and the annual performance reports 

23 under subsection (a). 

24 ‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR25 ING.—Each fiscal year, as applicable, representatives 


SSpencer on DSK4SPTVN1PROD with BILLS
32 

•S 1062 IS

1 from the Center for Drug Evaluation and Research 

2 and the Center for Biologics Evaluation and Re3 search shall participate in a public hearing before 

4 the Committee on Health, Education, Labor, and 

5 Pensions of the Senate and the Committee on En6 ergy and Commerce of the House of Representa7 tives, to report on the contents described in the re8 ports under this section. Such hearing shall occur 

9 not later than 120 days after the end of each fiscal 

10 year for which fees are collected under this part. 

11 ‘‘(3) PUBLICLY AVAILABLE UPDATES.—The 

12 Secretary shall provide an update on progress made 

13 for the corrective action report during the following 

14 fiscal year on the publicly available Internet website 

15 of the Food and Drug Administration every 30 busi16 ness days.’’. 

17 SEC. 4. PROHIBITING USE OF FUNDS FOR FACILITY MAIN18 TENANCE. 

19 (a) PDUFA.—Section 735(7)(C) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 379g(7)(C)) is 

21 amended by striking ‘‘renovation, and repair of facilities 

22 and acquisition, maintenance, and repair of fixtures, fur23 niture, scientific equipment, and other necessary materials 

24 and supplies’’ and inserting ‘‘and necessary scientific 

25 equipment’’. 


SSpencer on DSK4SPTVN1PROD with BILLS
33 

•S 1062 IS

1 (b) MDUFA.—Section 737(9)(C) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 379i(9)) is 

3 amended by striking ‘‘renovation, and repair of facilities 

4 and acquisition, maintenance, and repair of fixtures, fur5 niture, scientific equipment, and other necessary materials 

6 and supplies’’ and inserting ‘‘and necessary scientific 

7 equipment’’. 

8 (c) GDUFA.—Section 744A(11)(C) of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

10 41(11)(C)) is amended by striking ‘‘renovation, and repair 

11 of facilities and acquisition, maintenance, and repair of 

12 fixtures, furniture, scientific equipment, and other nec13 essary materials and supplies’’ and inserting ‘‘and nec14 essary scientific equipment’’. 

15 (d) BSUFA.—Section 744G(9)(C) of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51(9)(C)) 

17 is amended by striking ‘‘renovation, and repair of facilities 

18 and acquisition, maintenance, and repair of fixtures, fur19 niture, scientific equipment, and other necessary materials 

20 and supplies’’ and inserting ‘‘and necessary scientific 

21 equipment’’. 

22 SEC. 5. INFORMATION ON IT CONTRACTING. 

23 Section 736B(b) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 378h–2(b)) is amended— 


SSpencer on DSK4SPTVN1PROD with BILLS
34 

•S 1062 IS

1 (1) by striking ‘‘report on the’’ and inserting 

2 ‘‘report on— 

3 ‘‘(1) the’’; 

4 (2) by striking the period at the end and insert5 ing ‘‘; and’’; and 

6 (3) by adding at the end the following: 

7 ‘‘(2) the amount of the fees collected that are 

8 invested in the information technology infrastructure 

9 of the Food and Drug Administration, the entities 

10 receiving contracts to develop such infrastructure, 

11 the length of such contracts (including renewals), 

12 and the progress such entities have made toward 

13 meeting the goals described in such contracts.’’. 

Æ 


SSpencer on DSK4SPTVN1PROD with BILLS