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.
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.)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-151.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-151.
Placed on the Union Calendar, Calendar No. 111.
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H5645-5647)
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DEBATE - The House proceeded with forty minutes of debate on H.R. 4369.
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.
Considered as unfinished business. (consideration: CR H5662-5663)
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)
Roll Call #318 (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)
Roll Call #318 (House)Motion to reconsider laid on the table Agreed to without objection.
The title of the measure was amended. Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.