3.0.0 415 2023-01-11T13:46:32Z 2023-01-11T13:46:32Z Senate S 2021-02-24 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Discharged from 2021-03-10T15:25:20Z Referred to 2021-02-24T20:18:30Z 2021-04-23 Became Public Law No: 117-9. President E40000 9 Library of Congress 2021-04-23 Became Public Law No: 117-9. BecameLaw 36000 9 Library of Congress 2021-04-23 Signed by President. President E30000 9 Library of Congress 2021-04-23 Signed by President. BecameLaw 36000 9 Library of Congress 2021-04-20 Presented to President. Floor E20000 2 House floor actions 2021-04-20 Presented to President. President 28000 9 Library of Congress 2021-04-14 13:23:54 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2021-04-14 13:23:47 On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H1755) Floor H37300 2 House floor actions 2021-04-14 13:23:47 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H1755) Floor 8000 9 Library of Congress 2021-04-14 13:17:55 DEBATE - The House proceeded with forty minutes of debate on S. 415. Floor H8D000 2 House floor actions 2021-04-14 13:17:51 Considered under suspension of the rules. (consideration: CR H1755-1756) Floor H30000 2 House floor actions 2021-04-14 13:17:27 Mr. Pallone moved to suspend the rules and pass the bill. Floor H30300 2 House floor actions 2021-03-12 10:58:11 Held at the desk. Floor H15000 2 House floor actions 2021-03-12 10:37:57 Received in the House. Floor H14000 2 House floor actions 2021-03-11 Senate Message on Senate action sent to the House. Floor 2021-03-10 Senate Passed Senate without amendment by Unanimous Consent. (text: CR S1435) Floor 2021-03-10 Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(text: CR S1435) Floor 17000 9 Library of Congress 2021-03-10 sshr00 Health, Education, Labor, and Pensions Committee Senate Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. (consideration: CR S1435) Discharge 2021-03-10 Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.(consideration: CR S1435) Committee 14500 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2021-02-24 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-02-24 Introduced in Senate IntroReferral 10000 9 Library of Congress C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA N S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN 2021-02-24 True M001198 Sen. Marshall, Roger [R-KS] Roger Marshall R KS 2021-02-24 True Public Law 117-9 Health Administrative law and regulatory procedures Chemistry Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health 00 2021-02-24 Introduced in Senate 2021-05-04T19:23:22Z 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.

]]> 55 2021-03-10 Passed Senate 2021-05-04T20:59:03Z 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.

]]> 53 2021-04-14 Passed House 2021-05-04T20:59:52Z 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.

]]> 49 2021-04-23 Public Law 2021-05-04T20:59:29Z 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.

]]> A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity. Display Title A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity. Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity. Introduced in Senate IS Enrolled Bill https://www.govinfo.gov/content/pkg/BILLS-117s415enr/xml/BILLS-117s415enr.xml Engrossed in Senate 2021-03-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s415es/xml/BILLS-117s415es.xml Introduced in Senate 2021-02-24T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s415is/xml/BILLS-117s415is.xml 2021-04-24T03:59:59Z https://www.govinfo.gov/content/pkg/PLAW-117publ9/xml/PLAW-117publ9.xml Public Law 2021-04-23 Became Public Law No: 117-9. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.