I 

116TH CONGRESS 

1ST SESSION H. R. 4633 

To amend the 21st Century Cures Act to reauthorize funding for FDA 

innovation projects, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 11, 2019 

Ms. ESHOO (for herself and Mr. PETERS) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To amend the 21st Century Cures Act to reauthorize funding 

for FDA innovation projects, and for other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Investing in Safety 

5 and Innovation Act of 2019’’. 

6 SEC. 2. REAUTHORIZATION OF FDA INNOVATION 

7 PROJECTS. 

8 (a) TRANSFER OF DIRECT SPENDING SAVINGS.— 

9 Section 1002(b)(2)(A) of the 21st Century Cures Act 

10 (Public Law 114–255) is amended— 


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1 (1) in the matter preceding clause (i), by strik2 ing ‘‘2025’’ and inserting ‘‘2029’’; and 

3 (2) by striking clauses (iv) through (ix) and in4 serting the following: 

5 ‘‘(iv) For fiscal year 2020, 

6 $746,000,000. 

7 ‘‘(v) For fiscal year 2021, 

8 $551,000,000. 

9 ‘‘(vi) For each of fiscal years 2022 

10 through 2024, $531,000,000. 

11 ‘‘(vii) For fiscal year 2025, 

12 $536,000,000. 

13 ‘‘(viii) For each of fiscal years 2026 

14 through 2029, $531,000,000.’’. 

15 (b) FDA ACTIVITIES.—Paragraph (4) of section 

16 1002(b) of the 21st Century Cures Act (Public Law 114– 

17 255) is amended to read as follows: 

18 ‘‘(4) FDA ACTIVITIES.—The activities author19 ized to be funded under this section shall consist of 

20 the following, and of the total amounts authorized to 

21 be appropriated under paragraph (3) there are au22 thorized to be appropriated to each category of ac23 tivities a total amount not to exceed the following: 

24 ‘‘(A) In addition to the allocations speci25 fied in subparagraphs (B) through (K), for the 


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1 activities under subtitles A through F (includ2 ing the amendments made by such subtitles) of 

3 title III of this Act and section 1014 of the 

4 Federal Food, Drug, and Cosmetic Act, as 

5 added by section 3073 of this Act: 

6 ‘‘(i) For fiscal year 2020, 

7 $75,000,000. 

8 ‘‘(ii) For fiscal year 2021, 

9 $70,000,000. 

10 ‘‘(iii) For each of fiscal years 2022 

11 through 2024, $50,000,000. 

12 ‘‘(iv) For fiscal year 2025, 

13 $55,000,000. 

14 ‘‘(v) For each of fiscal years 2026 

15 through 2029, $50,000,000. 

16 ‘‘(B) For modernization of the technical 

17 infrastructure of the Food and Drug Adminis18 tration, including enhancements such as inter19 operability across the agency, and additional ca20 pabilities to develop an advanced information 

21 technology infrastructure to support the agen22 cy’s regulatory mission: 

23 ‘‘(i) For fiscal year 2020, 

24 $300,000,000. 


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1 ‘‘(ii) For each of fiscal years 2021 

2 through 2029, $200,000,000. 

3 ‘‘(C) For support for continuous manufac4 turing of drugs and biological products, includ5 ing complex biological products such as regen6 erative medicine therapies, through grants to 

7 institutions of higher education and nonprofit 

8 organizations and other appropriate mecha9 nisms, for each of fiscal years 2020 through 

10 2029, $50,000,000. 

11 ‘‘(D) For support for the Commissioner of 

12 Food and Drugs to engage experts, such as 

13 through the formation and operation of public14 private partnerships or other appropriate col15 laborative efforts, to advance the development 

16 and delivery of individualized human gene ther17 apy products: 

18 ‘‘(i) For fiscal year 2020, 

19 $50,000,000. 

20 ‘‘(ii) For each of fiscal years 2021 

21 through 2029, $10,000,000. 

22 ‘‘(E) For support for inspections and en23 forcement activities across the Food and Drug 

24 Administration, including foreign and domestic 


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1 facility inspections across products, for each of 

2 fiscal years 2020 through 2029, $82,500,000. 

3 ‘‘(F) For support for activities of the Food 

4 and Drug Administration related to customs 

5 and border protection to provide improvements 

6 to technologies, inspection capacity, and inter7 national mail facilities in which the Food and 

8 Drug Administration operates, for each of fiscal 

9 years 2020 through 2029, $25,000,000. 

10 ‘‘(G) To further advance the development 

11 of a coordinated postmarket surveillance system 

12 for all medical products, including drugs, bio13 logical products, and devices, linked to elec14 tronic health records in furtherance of the Food 

15 and Drug Administration’s postmarket surveil16 lance capabilities: 

17 ‘‘(i) For fiscal year 2020, 

18 $100,000,000. 

19 ‘‘(ii) For each of fiscal years 2021 

20 through 2029, $50,000,000. 

21 ‘‘(H) For support for Food and Drug Ad22 ministration activities to keep pace with the 

23 projected product development of regenerative 

24 therapies, including human somatic cellular and 


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1 gene therapies, for each of fiscal years 2020 

2 through 2029, $25,000,000. 

3 ‘‘(I) For support for the development of 

4 non-opioid pharmacological therapies as alter5 natives for opioids, for each of fiscal years 2020 

6 through 2029, $3,500,000. 

7 ‘‘(J) For carrying out section 714A of the 

8 Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 379d–3a; relating to hiring authority for 

10 scientific, technical, and professional personnel), 

11 for each of fiscal years 2020 through 2029, 

12 $20,000,000. 

13 ‘‘(K) For the Food and Drug Administra14 tion to support improvements to the techno15 logical infrastructure for reporting and analysis 

16 of adverse events associated with the use of 

17 drugs and biological products, for each of fiscal 

18 years 2020 through 2029, $15,000,000.’’. 

19 (c) ANNUAL REPORTS.—Section 1002(c)(2)(A) of the 

20 21st Century Cures Act (Public Law 114–255) is amend21 ed by striking ‘‘2026’’ and inserting ‘‘2029’’. 

22 (d) SUNSET.—Section 1002(e) of the 21st Century 

23 Cures Act (Public Law 114–255) is amended by striking 


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1 ‘‘September 30, 2026’’ and inserting ‘‘September 30, 

2 2029’’. 

Æ 


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