3.0.0 4369 2023-03-08T20:26:20Z 2023-03-08T20:26:20Z House HR 2021-07-06 117 [Congressional Record Volume 167, Number 118 (Tuesday, July 6, 2021)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. PALLONE:H.R. 4369.Congress has the power to enact this legislation pursuantto the following:Under Article I, Section 8, Clause 3: [The Congress shallhave Power] To regulate Commerce with foreign Nations, andamong the several States, and with the Indian Tribes.[Page H3611]]]> sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-10-20T15:49:23Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Reported by 2021-07-15T18:32:50Z Markup by 2021-07-15T15:42:23Z Referred to 2021-07-07T18:30:02Z Reported by 2021-10-19T18:29:02Z Markup by 2021-07-21T16:08:53Z Referred to 2021-07-06T16:31:05Z H. Rept. 117-151 Securing America’s Medicine Cabinet Act of 2021 117 2589 S 2021-08-03 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2021-10-20 sshr00 Health, Education, Labor, and Pensions Committee Senate Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-10-19 19:36:22 The title of the measure was amended. Agreed to without objection. Floor H38800 2 House floor actions 2021-10-19 19:36:15 Motion to reconsider laid on the table Agreed to without objection. Floor H38310 2 House floor actions 2021-10-19 19:36:14 On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 368 - 56 (Roll no. 318). (text: CR H5645-5647) Floor H37300 2 House floor actions 318 https://clerk.house.gov/evs/2021/roll318.xml House 117 2021-10-19T23:36:14Z 1 2021-10-19 19:36:14 Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 368 - 56 (Roll no. 318).(text: CR H5645-5647) Floor 8000 9 Library of Congress 318 https://clerk.house.gov/evs/2021/roll318.xml House 117 2021-10-19T23:36:14Z 1 2021-10-19 19:19:41 Considered as unfinished business. (consideration: CR H5662-5663) Floor H30000 2 House floor actions 2021-10-19 16:08:05 At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed. Floor H37220 2 House floor actions 2021-10-19 16:01:19 DEBATE - The House proceeded with forty minutes of debate on H.R. 4369. Floor H8D000 2 House floor actions 2021-10-19 16:01:18 Considered under suspension of the rules. (consideration: CR H5645-5647) Floor H30000 2 House floor actions 2021-10-19 16:01:03 Mr. Pallone moved to suspend the rules and pass the bill, as amended. Floor H30300 2 House floor actions 2021-10-19 Placed on the Union Calendar, Calendar No. 111. Calendars H12410 2 House floor actions U00111 2021-10-19 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-151. Committee H12200 2 House floor actions hsif00 Energy and Commerce Committee 2021-10-19 Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-151. Committee 5000 9 Library of Congress hsif00 Energy and Commerce Committee 2021-07-21 hsif00 Energy and Commerce Committee 1 House committee actions Ordered to be Reported (Amended) by Voice Vote. Committee 2021-07-21 hsif00 Energy and Commerce Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2021-07-15 hsif14 Health Subcommittee 1 House committee actions Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote . Committee 2021-07-15 hsif14 Health Subcommittee 1 House committee actions Subcommittee Consideration and Mark-up Session Held. Committee 2021-07-07 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2021-07-06 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2021-07-06 Introduced in House IntroReferral Intro-H 9 Library of Congress 2021-07-06 Introduced in House IntroReferral 1000 9 Library of Congress P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 N G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2021-07-06 True 2021-10-25T20:27:00Z H.R. 4369, National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 https://www.cbo.gov/publication/57573 As passed by the House of Representatives on October 19, 2021 Health Advanced technology and technological innovations Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health programs administration and funding Health technology, devices, supplies Higher education Manufacturing Prescription drugs Product development and innovation Research administration and funding Research and development Health 00 2021-07-06 Introduced in House 2021-10-19T16:21:54Z National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021

This bill directs the Food and Drug Administration (FDA) to designate qualified institutions of higher education as National Centers of Excellence in Continuous Pharmaceutical Manufacturing and to provide grants to the centers. Each designated center must conduct research on continuous manufacturing technologies and must share information from such research with the FDA. (Currently, most drug production involves batch manufacturing, which typically takes longer than continuous manufacturing processes.)

]]> 53 2021-10-19 Passed House 2021-12-01T11:51:18Z National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021

This bill directs the Food and Drug Administration (FDA) to designate qualified institutions of higher education (or consortia of such institutions) as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing and to provide grants to the centers. Each designated center must conduct research on advanced and continuous pharmaceutical manufacturing technologies and must share information from such research with the FDA. (Currently, most drug production involves batch manufacturing, which typically takes longer than continuous manufacturing processes.)

]]> National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 Display Title National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 Short Title(s) as Passed House National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 H House Engrossed in House EH Official Title as Introduced To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes. Reported in House RH Short Title(s) as Introduced National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 Introduced in House IH Short Titles as Passed House National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 H House Official Titles as Amended by House To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous pharmaceutical manufacturing as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, and for other purposes. H House Short Title(s) as Reported to House National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021 H House Reported in House RH Referred in Senate 2021-10-20T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr4369rfs/xml/BILLS-117hr4369rfs.xml Engrossed in House 2021-10-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr4369eh/xml/BILLS-117hr4369eh.xml Reported in House 2021-10-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr4369rh/xml/BILLS-117hr4369rh.xml Introduced in House 2021-07-06T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr4369ih/xml/BILLS-117hr4369ih.xml 2021-10-20 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.