{"format":1,"id":"117-hr-4369","congress":117,"number":"H.R. 4369","kind":"bill","group":"bills","title":"National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021","title_source":"Short Title(s) as Passed House","official_title":"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.","titles":[{"type":"Official Title as Introduced","title":"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."},{"type":"Short Titles from RFS (Referred to Senate) bill text","title":"National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021"},{"type":"Display Title","title":"National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021"},{"type":"Short Title(s) as Passed House","title":"National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021"},{"type":"Short Title(s) as Introduced","title":"National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021"},{"type":"Official Titles as Amended by House","title":"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."},{"type":"Short Title(s) as Reported to House","title":"National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021"}],"outcome":"passed_house","law_number":null,"introduced":"2021-07-06","chambers":{"house":{"status":"roll_call","date":"2021-10-19","vote":{"id":"117-2021-h318","question":"On Motion to Suspend the Rules and Pass, as Amended","title":"National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act","result":"Passed","yea":368,"nay":56,"present":0,"not_voting":7,"source":"https://clerk.house.gov/evs/2021/roll318.xml"}},"senate":{"status":"na","date":null,"vote":null}},"president":{"status":"na","date":null},"vice_president_tie_breaker":null,"latest_action":{"text":"Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.","date":"2021-10-20"},"nominees":null,"amendments":[],"other_votes":[],"crs_summary":{"date":"2021-10-19","stage":"Passed House","blocks":[{"k":"h","t":"National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021"},{"k":"p","t":"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.)"}],"words":90},"summary":{"main_subject":{"text":"Replaces section 3016 of the 21st Century Cures Act so that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, designates and funds National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing at institutions of higher education.","cites":[{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text/eh#HC3CF862E5BBC49E6B63F0DB7B14088B2"}]},"core_areas":["Designation of National Centers of Excellence in advanced and continuous pharmaceutical manufacturing","Grants, contracts and cooperative agreements for center research and infrastructure","Reports to Congress on the centers and the Food and Drug Administration's role","Authorization of appropriations for fiscal years 2022 through 2026"],"what_it_does":[{"text":"Directs the Secretary to solicit requests and designate not more than 5 institutions of higher education or consortia that meet listed criteria, such as research capacity, knowledge-sharing networks and workforce training ability.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text/eh#HC3CF862E5BBC49E6B63F0DB7B14088B2"}},{"text":"Allows the Secretary to terminate a designation if a center no longer meets the criteria, with written notice and the rationale given not later than 90 days before the termination takes effect.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text/eh#HC3CF862E5BBC49E6B63F0DB7B14088B2"}},{"text":"Requires each designated center to agree to collaborate with the Food and Drug Administration on reports, share data, develop workforce and relationship roadmaps, and provide an annual report to the agency.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text/eh#HC3CF862E5BBC49E6B63F0DB7B14088B2"}},{"text":"Requires the Secretary to award funding through grants, contracts or cooperative agreements to designated centers to study and recommend improvements to advanced and continuous pharmaceutical manufacturing.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text/eh#HC3CF862E5BBC49E6B63F0DB7B14088B2"}},{"text":"Requires the Secretary to submit an annual report to Congress on the centers and, within 2 years after the first designation, a report on the long-term vision of the Food and Drug Administration's role.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text/eh#HC3CF862E5BBC49E6B63F0DB7B14088B2"}},{"text":"Authorizes $100,000,000 to be appropriated for the period of fiscal years 2022 through 2026, and limits Federal administrative expenses to not more than eight percent of the amounts made available for a fiscal year.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text/eh#HC3CF862E5BBC49E6B63F0DB7B14088B2"}}],"unexpected":[],"version":{"type":"Engrossed in House","date":"2021-10-19","rule":"passed","href":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text/eh"},"current":true,"model":"claude-sonnet-5-5","approved":"2026-10-15","approved_by":"checks"},"sources":{"congress_gov":"https://www.congress.gov/bill/117th-congress/house-bill/4369","text":"https://www.congress.gov/bill/117th-congress/house-bill/4369/text"},"card":{"image":"card/item/117-hr-4369.png","v":"284c3e05a791","alt":"Votes on Record. H.R. 4369, 117th Congress: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021. House: 368 Yea, 56 Nay. Outcome: Passed House, 19 Oct 2021."}}