Getting Innovations to Patients During Shutdowns Act

[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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