Title: Medical Innovation Never Stops Act of 2019
Policy area: Health

Summary:
Medical Innovation Never Stops Act of 2019
This bill requires the Food and Drug Administration (FDA)	to accept and review new medical device applications and associated user fees during a lapse in appropriations.	Under current law, the FDA is prohibited from accepting new user fees and reviewing medical device submissions during an appropriations lapse.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1362 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 1362

 To amend the Federal Food, Drug, and Cosmetic Act to allow, during a 
 lapse in appropriations, acceptance of certain device submissions and 
registrations with the corresponding fees made available for obligation 
and expenditure for the process for the review of device applications, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 26, 2019

  Mr. Emmer introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to allow, during a 
 lapse in appropriations, acceptance of certain device submissions and 
registrations with the corresponding fees made available for obligation 
and expenditure for the process for the review of device applications, 
                        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 ``Medical Innovation Never Stops Act 
of 2019''.

SEC. 2. AUTHORITY DURING A LAPSE IN APPROPRIATIONS.

    Chapter VII of the Federal Food, Drug, and Cosmetic Act is amended 
by inserting after section 738A (21 U.S.C. 379j-1) the following:

``SEC. 738B. AUTHORITY DURING A LAPSE IN APPROPRIATIONS.

    ``(a) Acceptance of Submissions and Registrations; Application of 
Fees.--During any period in which appropriations are not in effect for 
the Food and Drug Administration, the Secretary shall--
            ``(1) accept a submission described in section 738(a)(2) 
        and a registration described in section 738(a)(3) if an 
        applicable fee has been submitted for such submission or 
        registration;
            ``(2) collect such fees in accordance with this part, 
        notwithstanding any limitation with respect to the availability 
        of appropriations in section 738; and
            ``(3) obligate and expend such fees as may be so collected 
        for the process for the review of device applications.
    ``(b) Application of Previously Paid Fees.--
            ``(1) In general.--During any period in which 
        appropriations are not in effect for the Food and Drug 
        Administration, the Secretary may obligate and expend for the 
        process for the review of device applications any fees--
                    ``(A) that were paid before such period began for 
                submissions described in section 738(a)(2), but with 
                respect to which a submission has not been received; 
                and
                    ``(B) that were paid before such period began for 
                registrations described in section 738(a)(3), but with 
                respect to which a remitter has not been identified.
            ``(2) Subsequently received submission or registration.--
        Notwithstanding the obligation or expenditure of a fee for the 
        process for the review of device applications pursuant to 
        paragraph (1), such fee shall be deemed to have been paid for 
        purposes of section 738(f)(1) if the Secretary subsequently 
        receives a submission or registration for such fee.
    ``(c) Effect of Enactment of Subsequent Appropriations.--Upon the 
enactment of an appropriation for fees under section 738 for a fiscal 
year, or a general appropriation bill providing appropriations for the 
Food and Drug Administration for a fiscal year without provision for 
such device fees, following a period during which a collection, 
obligation, or expenditure of fees occurs pursuant to subsection (a) or 
(b) for such fiscal year--
            ``(1) such collection, obligation, and expenditure shall be 
        charged to such appropriation (if any); and
            ``(2) amounts made available pursuant to such subsection 
        shall not be available after the date of the enactment of such 
        appropriation or general appropriation bill.''.
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