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.

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.

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.”.