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Senate Bill 1463
117th Congress(2021-2022)
Modernizing Therapeutic Equivalence Rating Determination Act
Introduced
Introduced
Introduced in Senate on Apr 29, 2021
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Text
Introduced in Senate 
Apr 29, 2021
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Introduced in Senate(Apr 29, 2021)
Apr 29, 2021
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Bill Sponsor regularly scans bill texts to find sections that are contained in other bill texts. When a matching section is found, the bills containing that section can be viewed by clicking "View Bills" within the bill text section.
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S. 1463 (Introduced-in-Senate)


117th CONGRESS
1st Session
S. 1463


To amend the Federal Food, Drug, and Cosmetic Act to modernize therapeutic equivalence rating determinations.

IN THE SENATE OF THE UNITED STATES

April 29, 2021

Mr. Cassidy (for himself and Ms. Smith) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to modernize therapeutic equivalence rating determinations.

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 “Modernizing Therapeutic Equivalence Rating Determination Act”.

SEC. 2. Therapeutic equivalence determinations.

Section 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)(A)) is amended by adding at the end the following:

“(v) (I) The Secretary shall make a determination under clause (i)(III)—

“(aa) with respect to an application submitted under this subsection, at the time of approval of such application or not later than 30 days after the date of such approval; or

“(bb) with respect to an application submitted under subsection (b)(2), at the time of approval of such application or not later than 30 days after the date of such approval, provided that the sponsor requests such a determination in the original application, in a form prescribed by the Secretary.

“(II) When the Secretary makes a determination under clause (i)(III), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug.

“(III) When the Secretary makes a determination under clause (i)(III) with respect to a drug, the Secretary shall, at the same time, make such a determination with respect to any other drug—

“(aa) whose application under subsection (b)(2) was approved;

“(bb) which references the same listed drug as the application for the first drug for which such determination is made; and

“(cc) for which there is a citizen petition pending requesting that the Secretary make a determination under clause (i)(III).”.