[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9635 Introduced in House (IH)]

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119th CONGRESS
  2d Session
                                H. R. 9635

To amend the Federal Food, Drug, and Cosmetic Act to establish special 
    rules to provide for continued review of human drug and device 
 submissions during a lapse of appropriations, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              July 9, 2026

  Mr. Mullin 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 establish special 
    rules to provide for continued review of human drug and device 
 submissions during a lapse of appropriations, 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 ``Getting Innovations to Patients 
During Shutdowns Act''.

SEC. 2. SPECIAL RULES TO PROVIDE FOR CONTINUED REVIEW OF HUMAN DRUG AND 
              DEVICE SUBMISSIONS DURING A LAPSE OF APPROPRIATIONS.

    (a) Human Drug Submissions.--Section 736(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended--
            (1) by striking ``A human drug application'' and inserting 
        the following:
            ``(1) In general.--A human drug application''; and
            (2) by adding at the end the following:
            ``(2) Special rule for lapse of appropriations.--
                    ``(A) In general.--Notwithstanding paragraph (1), 
                during any period for which there is a lapse of 
                appropriations for the programs and activities of the 
                Food and Drug Administration, or for the collection of 
                fees used to support the process for the review of drug 
                applications, the Secretary--
                            ``(i) may accept for filing an application 
                        or supplement described in paragraph (1) if the 
                        application or supplement is complete except 
                        for the payment of a fee required under 
                        subsection (a); and
                            ``(ii) shall extend the deadline for the 
                        payment of such fee to the date that is 7 days 
                        after the last day of such period.
                    ``(B) Effect of failure to pay fees on or before 
                extended deadline date.--If the Secretary accepts an 
                application or supplement subject to an extended 
                deadline for the payment of a fee under subparagraph 
                (A), and the person subject to the fee does not pay the 
                fee on or before the date of the extended deadline--
                            ``(i) the Secretary shall consider the 
                        application or supplement to be incomplete and 
                        deem the application or supplement not 
                        accepted; and
                            ``(ii) in no case shall the Secretary 
                        clear, authorize, or approve the application or 
                        supplement (or any related application or 
                        supplement) until such fee is paid.''.
    (b) Device Submissions.--Section 738(f)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j(f)(1)) is amended--
            (1) by striking ``A premarket application'' and inserting 
        the following:
                    ``(A) In general.--A premarket application''; and
            (2) by adding at the end the following:
                    ``(B) Special rule for lapse of appropriations.--
                            ``(i) In general.--Notwithstanding 
                        subparagraph (A), during any period for which 
                        there is a lapse of appropriations for the 
                        programs and activities of the Food and Drug 
                        Administration, or for the collection of fees 
                        used to support the process for the review of 
                        device applications, the Secretary--
                                    ``(I) may accept a submission 
                                described in subparagraph (A) if the 
                                submission is complete except for the 
                                payment of a fee required under 
                                subsection (a)(2) or (a)(3) relating to 
                                the submission; and
                                    ``(II) shall extend the deadline 
                                for the payment of such fee to the date 
                                that is 7 days after the last day of 
                                such period.
                            ``(ii) Effect of failure to pay fees on or 
                        before extended deadline date.--If the 
                        Secretary accepts a submission subject to an 
                        extended deadline for the payment of a fee 
                        under clause (i), and the person subject to the 
                        fee does not pay the fee on or before the date 
                        of the extended deadline--
                                    ``(I) the Secretary shall deem the 
                                submission not accepted; and
                                    ``(II) in no case shall the 
                                Secretary clear, authorize, or approve 
                                the submission (or any related 
                                submission) until such fee is paid.''.
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