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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (1)

Official Titles

Official Titles - Senate

Official Titles as Introduced

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.


Actions Overview (7)

Date Actions Overview
04/23/2021Became Public Law No: 117-9. (TXT | PDF)
04/23/2021Signed by President.
04/20/2021Presented to President.
04/14/2021Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H1755)
03/10/2021Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S1435)
03/10/2021Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S1435)
02/24/2021Introduced in Senate

All Actions (14)

Date Chamber All Actions
04/23/2021Became Public Law No: 117-9. (TXT | PDF)
04/23/2021Signed by President.
04/20/2021SenatePresented to President.
04/14/2021-1:23pmHouseMotion to reconsider laid on the table Agreed to without objection.
04/14/2021-1:23pmHouseOn motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755)
04/14/2021-1:17pmHouseDEBATE - The House proceeded with forty minutes of debate on S. 415.
04/14/2021-1:17pmHouseConsidered under suspension of the rules. (consideration: CR H1755-1756)
04/14/2021-1:17pmHouseMr. Pallone moved to suspend the rules and pass the bill.
03/12/2021-10:58amHouseHeld at the desk.
03/12/2021-10:37amHouseReceived in the House.
03/11/2021SenateMessage on Senate action sent to the House.
03/10/2021SenatePassed Senate without amendment by Unanimous Consent. (text: CR S1435)
03/10/2021SenateSenate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435)
02/24/2021SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.

Cosponsors (2)

* = Original cosponsor
CosponsorDate Cosponsored
Sen. Smith, Tina [D-MN]* 02/24/2021
Sen. Marshall, Roger W. [R-KS]* 02/24/2021

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Related Documents
Senate Health, Education, Labor, and Pensions02/24/2021 Referred to
03/10/2021 Discharged from

As of 06/15/2021 no related bill information has been received for S.415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.


Subjects (5)


Latest Summary (4)

There are 4 summaries for S.415. View summaries

Shown Here:
Public Law No: 117-9 (04/23/2021)

This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases.

Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.

The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.