HR 9635
Getting Innovations to Patients During Shutdowns Act
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119th CONGRESS — 2d Session
H. R. 9635
IN THE HOUSE OF REPRESENTATIVES
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.
This Act may be cited as the Getting Innovations to Patients During Shutdowns Act
.
A human drug applicationand inserting the following:
by adding at the end the following:
the Secretary shall consider the application or supplement to be incomplete and deem the application or supplement not accepted; and
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.
Section 738(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(f)(1)) is amended—
A premarket applicationand inserting the following:
by adding at the end the following:
the Secretary shall deem the submission not accepted; and
in no case shall the Secretary clear, authorize, or approve the submission (or any related submission) until such fee is paid.