```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4633 Introduced in House (IH)]

<DOC>

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Investing in Safety and Innovation 
Act of 2019''.

SEC. 2. REAUTHORIZATION OF FDA INNOVATION PROJECTS.

    (a) Transfer of Direct Spending Savings.--Section 1002(b)(2)(A) of 
the 21st Century Cures Act (Public Law 114-255) is amended--
            (1) in the matter preceding clause (i), by striking 
        ``2025'' and inserting ``2029''; and
            (2) by striking clauses (iv) through (ix) and inserting the 
        following:
                            ``(iv) For fiscal year 2020, $746,000,000.
                            ``(v) For fiscal year 2021, $551,000,000.
                            ``(vi) For each of fiscal years 2022 
                        through 2024, $531,000,000.
                            ``(vii) For fiscal year 2025, $536,000,000.
                            ``(viii) For each of fiscal years 2026 
                        through 2029, $531,000,000.''.
    (b) FDA Activities.--Paragraph (4) of section 1002(b) of the 21st 
Century Cures Act (Public Law 114-255) is amended to read as follows:
            ``(4) FDA activities.--The activities authorized to be 
        funded under this section shall consist of the following, and 
        of the total amounts authorized to be appropriated under 
        paragraph (3) there are authorized to be appropriated to each 
        category of activities a total amount not to exceed the 
        following:
                    ``(A) In addition to the allocations specified in 
                subparagraphs (B) through (K), for the activities under 
                subtitles A through F (including the amendments made by 
                such subtitles) of title III of this Act and section 
                1014 of the Federal Food, Drug, and Cosmetic Act, as 
                added by section 3073 of this Act:
                            ``(i) For fiscal year 2020, $75,000,000.
                            ``(ii) For fiscal year 2021, $70,000,000.
                            ``(iii) For each of fiscal years 2022 
                        through 2024, $50,000,000.
                            ``(iv) For fiscal year 2025, $55,000,000.
                            ``(v) For each of fiscal years 2026 through 
                        2029, $50,000,000.
                    ``(B) For modernization of the technical 
                infrastructure of the Food and Drug Administration, 
                including enhancements such as interoperability across 
                the agency, and additional capabilities to develop an 
                advanced information technology infrastructure to 
                support the agency's regulatory mission:
                            ``(i) For fiscal year 2020, $300,000,000.
                            ``(ii) For each of fiscal years 2021 
                        through 2029, $200,000,000.
                    ``(C) For support for continuous manufacturing of 
                drugs and biological products, including complex 
                biological products such as regenerative medicine 
                therapies, through grants to institutions of higher 
                education and nonprofit organizations and other 
                appropriate mechanisms, for each of fiscal years 2020 
                through 2029, $50,000,000.
                    ``(D) For support for the Commissioner of Food and 
                Drugs to engage experts, such as through the formation 
                and operation of public-private partnerships or other 
                appropriate collaborative efforts, to advance the 
                development and delivery of individualized human gene 
                therapy products:
                            ``(i) For fiscal year 2020, $50,000,000.
                            ``(ii) For each of fiscal years 2021 
                        through 2029, $10,000,000.
                    ``(E) For support for inspections and enforcement 
                activities across the Food and Drug Administration, 
                including foreign and domestic facility inspections 
                across products, for each of fiscal years 2020 through 
                2029, $82,500,000.
                    ``(F) For support for activities of the Food and 
                Drug Administration related to customs and border 
                protection to provide improvements to technologies, 
                inspection capacity, and international mail facilities 
                in which the Food and Drug Administration operates, for 
                each of fiscal years 2020 through 2029, $25,000,000.
                    ``(G) To further advance the development of a 
                coordinated postmarket surveillance system for all 
                medical products, including drugs, biological products, 
                and devices, linked to electronic health records in 
                furtherance of the Food and Drug Administration's 
                postmarket surveillance capabilities:
                            ``(i) For fiscal year 2020, $100,000,000.
                            ``(ii) For each of fiscal years 2021 
                        through 2029, $50,000,000.
                    ``(H) For support for Food and Drug Administration 
                activities to keep pace with the projected product 
                development of regenerative therapies, including human 
                somatic cellular and gene therapies, for each of fiscal 
                years 2020 through 2029, $25,000,000.
                    ``(I) For support for the development of non-opioid 
                pharmacological therapies as alternatives for opioids, 
                for each of fiscal years 2020 through 2029, $3,500,000.
                    ``(J) For carrying out section 714A of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 379d-3a; 
                relating to hiring authority for scientific, technical, 
                and professional personnel), for each of fiscal years 
                2020 through 2029, $20,000,000.
                    ``(K) For the Food and Drug Administration to 
                support improvements to the technological 
                infrastructure for reporting and analysis of adverse 
                events associated with the use of drugs and biological 
                products, for each of fiscal years 2020 through 2029, 
                $15,000,000.''.
    (c) Annual Reports.--Section 1002(c)(2)(A) of the 21st Century 
Cures Act (Public Law 114-255) is amended by striking ``2026'' and 
inserting ``2029''.
    (d) Sunset.--Section 1002(e) of the 21st Century Cures Act (Public 
Law 114-255) is amended by striking ``September 30, 2026'' and 
inserting ``September 30, 2029''.
                                 <all>
```