3.0.0 5333 2023-01-11T13:40:11Z 2023-01-11T13:40:11Z House HR 2018-03-19 115 [Congressional Record Volume 164, Number 47 (Monday, March 19, 2018)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. LATTA:H.R. 5333.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3: Congress shall have thePower . . .'' to regulate Commerce with foreign Nations, andamong the several States, and with the Indian tribes.''[Page H1698]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2018-03-23T18:49:01Z Reported by 2018-07-16T18:33:34Z Markup by 2018-05-09T15:46:15Z Referred to 2018-03-19T16:01:45Z H. Rept. 115-827 Over-the-Counter Drug Safety, Innovation, and Reform Act 115 2315 S 2018-05-14 Placed on Senate Legislative Calendar under General Orders. Calendar No. 413. Related bill House Related bill CRS Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 115 7328 HR 2018-12-20 Received in the Senate. Related bill CRS 2018-07-17 Senate Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 518. Calendars 2018-07-16 18:24:54 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2018-07-16 18:24:53 On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6227-6235) Floor H37300 2 House floor actions 2018-07-16 18:24:53 Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H6227-6235) Floor 8000 9 Library of Congress 2018-07-16 18:06:26 DEBATE - The House proceeded with forty minutes of debate on H.R. 5333. Floor H8D000 2 House floor actions 2018-07-16 18:06:25 Considered under suspension of the rules. (consideration: CR H6227-6237) Floor H30000 2 House floor actions 2018-07-16 18:06:16 Mr. Latta moved to suspend the rules and pass the bill, as amended. Floor H30300 2 House floor actions 2018-07-16 Placed on the Union Calendar, Calendar No. 640. Calendars H12410 2 House floor actions U00640 2018-07-16 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 115-827. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2018-07-16 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 115-827. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2018-05-09 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by Voice Vote. Committee 2018-05-09 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2018-03-23 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2018-03-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2018-03-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2018-03-19 Introduced in House IntroReferral 1000 9 Library of Congress L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 N B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 2018-03-19 True G000410 Rep. Green, Gene [D-TX-29] GENE GREEN D TX 29 2018-03-19 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2018-03-19 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2018-03-19 True D000624 Rep. Dingell, Debbie [D-MI-12] Debbie Dingell D MI 12 2018-03-19 True M001163 Rep. Matsui, Doris O. [D-CA-6] Doris Matsui D CA O. 6 2018-05-15 False F000459 Rep. Fleischmann, Charles J. "Chuck" [R-TN-3] Charles Fleischmann R TN J. "Chuck" 3 2018-05-18 False S001180 Rep. Schrader, Kurt [D-OR-5] Kurt Schrader D OR 5 2018-07-10 False 2018-06-08T16:07:00Z H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 https://www.cbo.gov/publication/53985 As ordered reported by the House Committee on Energy and Commerce on May 9, 2018 Health Administrative law and regulatory procedures Drug safety, medical device, and laboratory regulation Government studies and investigations Inflation and prices Prescription drugs User charges and fees Health 00 2018-03-19 Introduced in House 2019-08-20T16:59:12Z Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018

This bill amends the Federal Food, Drug, and Cosmetic Act to substantially revise how over-the-counter (OTC)drugs are approved.

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Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 Display Title Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application, and for other purposes. Introduced in House IH Short Titles as Introduced for portions of this bill Over-the-Counter Monograph User Fee Act of 2018 Short Titles as Passed House for portions of this bill Over-the-Counter Monograph User Fee Act of 2018 H House Short Titles as Reported to House for portions of this bill Over-the-Counter Monograph User Fee Act of 2018 H House Short Titles as Passed House Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 H House Short Titles as Introduced Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 Short Titles as Reported to House Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 H House Placed on Calendar Senate 2018-07-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr5333pcs/xml/BILLS-115hr5333pcs.xml Engrossed in House 2018-07-16T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr5333eh/xml/BILLS-115hr5333eh.xml Reported in House 2018-07-16T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr5333rh/xml/BILLS-115hr5333rh.xml Introduced in House 2018-03-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr5333ih/xml/BILLS-115hr5333ih.xml 2018-07-17 Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 518. 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.