,i #aaith ,,congress #ast ,session ,h4 ,r4 #fjhi ,,in ,,the ,,house ,,of ,,representatives ,november #ah1 #bjbe,ms4 ,houlahan 7for herself1 ,mr4 ,baird1 ,ms4 ,ross1 and ,mr4 ,rouzer7 introduced the following bill2 which was referred to the ,committee on ,science1 ,space1 and ,technology ,a ,,bill ,to establish a ,biopharmaceutical ,center of ,excellence1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,biomanufacturing ,excellence ,act of #bjbe4 #b4 ,findings2 sense of ,congress 7a7 ,findings ,congress finds the following3 7#a7 ,biotechnology is the designing and engineering of biological systems4 ,biotechnology allows scientists to grow everything from medicines to crops to materials1 enabling biology by design4 7#b7 ,biotechnology holds the potential for the ,united ,states to transform its military capabilities1 strengthen food security and agricultural resilience1 and cure life-threatening diseases1 but it holds that same potential for other countries4 ,the countries that master biotechnology first will gain the ability to shape how those technologies are used for decades to come4 7#c7 ,biotechnology unlocks the capabilities of producing medicines via biological systems1 known as biopharmaceutical manufacturing4 ,biopharmaceutical manufacturing will enable better and less invasive treatments that extend and improve lives4 7#d7 ,by investing in biomanufacturing1 the ,united ,states ,government would reduce dependency on foreign supply chains4 7#e7 ,for ,united ,states manufacturers1 the biggest roadblock to commercialization is proving that their products and processes can scale and produce a return on investment4 ,biomanufacturing requires flexible and affordable infrastructure for development1 to ensure that innovative products can rapidly move from the lab to commercial-scale production4 7b7 ,sense of ,congress ,it is the sense of ,congress that-- 7#a7 to realize the potential of biotechnology1 the ,united ,states ,government should establish a biopharmaceutical manufacturing center of excellence2 7#b7 the center should facilitate and accelerate manufacturing innovation1 support good manufacturing practices1 and provide for collaboration among public1 private1 and nonprofit institutions2 and 7#c7 the center should also facilitate training for workers to operate biotechnology tools and equipment and to bolster talent throughout the biotechnology sector4 #c4 ,establishment of ,national ,biopharmaceutical ,center of ,excellence ,the ,national ,institute of ,standards and ,technology ,act 7#ae ,u4,s4,c4 #bga et seq47 is amended-- 7#a7 by redesignating section #cf as section #cg2 and 7#b7 by inserting after section #ce the following3 #cf4 ,national ,biopharmaceutical ,center of ,excellence 7a7 ,establishment of ,center of ,excellence 7#a7 ,in general ,the ,director shall award a grant to or enter into an other transaction agreement with1 on a competitive basis1 an eligible entity to establish and operate a center of excellence to be known as the ,national ,biopharmaceutical ,manufacturing ,center of ,excellence 7in this section referred to as the ,center of ,excellence74 7#b7 ,objectives ,the objectives of the ,center of ,excellence include-- 7,a7 advancing the science of biopharmaceutical manufacturing1 especially with respect to products of particular importance to the national security1 health security1 or economic security of the ,united ,states1 including by-- 7i7 developing and demonstrating flexible biopharmaceutical manufacturing technologies and systems2 7ii7 improving upstream and downstream processes for multiple biopharmaceutical manufacturing platforms or product modalities2 7iii7 improving biopharmaceutical manufacturing equipment and capabilities2 and 7iv7 reducing supply bottlenecks and strengthening supply chain self-sufficiency through demonstration of innovative technologies2 7,b7 supporting good manufacturing practices1 quality by design1 and standardization of chemistry1 manufacturing1 and controls to ensure effective and efficient manufacturing and to improve the regulation of innovative methods of manufacturing2 7,c7 advancing workforce training and development by working with educational and community partners to bolster biotechnology talent2 7,d7 developing the science of and deploying the infrastructure for innovative biopharmaceutical manufacturing by engaging with-- 7i7 institutions of higher education2 7ii7 small1 medium1 and large pharmaceutical manufacturers2 7iii7 ,federal1 ,state1 and local government agencies and institutes2 7iv7 non-profit organizations2 7v7 professional organizations2 and 7vi7 any other entity the ,director considers relevant2 7,e7 sharing with the head of any ,executive agency that oversees the planning1 management1 or coordination of ,federal activities relating to biotechnology research generated by the ,center of ,excellence1 including data regarding best practices for biopharmeceutical manufacturing2 and 7,f7 any other objective the ,director considers relevant4 7#c7 ,funding ,the ,director shall award the ,center of ,excellence funding for any of the following3 7,a7 ,to facilitate the construction of facilities necessary to accomplish the objectives described in paragraph 7#b74 7,b7 ,to conduct collaborative research on new technology for scaling biopharmaceutical manufacturing in the ,united ,states for commercial production4 7,c7 ,to facilitate workforce training programs for biopharmaceutical manufacturing4 7,d7 ,to fund relevant research and programs for the development of biopharmaceutical manufacturing4 7b7 ,application2 award 7#a7 ,in general ,not later than #ahj days after the date of the enactment of this section1 the ,director shall solicit applications from eligible entities specified in paragraph 7#b7 and award to or enter into with one such entity a grant or other transaction agreement to establish the ,center of ,excellence4 7#b7 ,eligibility ,an entity is eligible to submit an application pursuant to paragraph 7#a7 if-- 7,a7 the entity is-- 7i7 a public-private partnership2 7ii7 an institution of higher education2 or 7iii7 a consortia of entities specified in clauses 7i7 or 7ii72 and 7,b7 the entity is not a ,federal entity4 7#c7 ,content of application ,an application submitted by an entity pursuant to paragraph 7#a7 shall include-- 7,a7 examples from the entity of previous research1 development1 implementation1 and demonstration of innovative practices of biopharmaceutical manufacturing2 7,b7 a description of the manner by which the entity plans to advance the science of biopharmaceutical manufacturing1 especially with respect to products of particular importance to the national security1 health security1 or economic security of the ,united ,states2 7,c7 a description of the manner by which the entity plans to incorporate good manufacturing practices1 quality by design1 and standardization of chemistry1 manufacturing1 and controls1 and similar guidance to ensure effective and efficient manufacturing and to make innovative methods of manufacturing more understandable to ,executive agencies that are tasked with regulating such methods2 7,d7 examples of trainings facilitated by the entity that prepare workers for the biotechnology sector2 7,e7 a description of any existing partnerships with educational or community partners that help facilitate workforce training for the biotechnology sector2 7,f7 a description of any experience participating in or leading biopharmaceutical manufacturing partnerships1 including those with institutions of higher education1 pharmaceutical manufacturers1 non-profit organizations1 and governmental agencies-- 7i7 to organize and conduct research and development aimed at-- 7,i7 creating and standardizing new and more effective technology2 7,,ii7 developing best practices and sharing knowledge about such technology2 7,,iii7 creating intellectual property2 and 7,,iv7 maintaining technological leadership in the ,united ,states2 7ii7 to support the deployment of innovative practices and infrastructure of biopharmaceutical manufacturing in the ,united ,states2 and 7iii7 to support developing a skilled workforce ready to use innovations in the biopharmaceutical manufacturing sector2 and 7,g7 a description of how the entity intends to utilize any funds authorized under this section to build or expand facilities and infrastructure to achieve any of the objectives described in subsection 7a77#b74 7#d7 ,selection ,criteria ,in selecting an applicant for a grant or other transaction agreement under paragraph 7#a71 the ,director shall consider the following3 7,a7 ,the potential of the applicant to establish a ,center of ,excellence that would achieve the objectives set forth in subsection 7a77#b74 7,b7 ,the past performance of the applicant in biopharmaceutical manufacturing workforce development and the potential of the applicant to support workforce development activities in various regions throughout the ,united ,states4 7,c7 ,the extent to which the applicant proposes to leverage the activities of other biopharmaceutical manufacturing innovation1 development1 and scaling initiatives4 7,d7 ,whether the proposed location for the ,center of ,excellence is proximate to other biomanufacturing infrastructure1 training facilities1 or industrial clusters4 7,e7 ,the time the applicant estimates is needed for the ,center of ,excellence to be fully operational and to start delivering impact4 7,f7 ,the amount of co-investment committed by ,federal1 ,state1 private1 and other sources to establish the ,center of ,excellence4 7,g7 ,any additional criteria that the ,director considers relevant4 7c7 ,annual reports 7#a7 ,initial report ,not later than one year after the date on which the ,director awards to or enters into with an eligible entity a grant or other transaction agreement to establish the ,center of ,excellence under subsection 7b77#a71 the ,director shall submit to ,congress a report describing the progress on establishing the ,center of ,excellence1 including-- 7,a7 the construction of facilities2 7,b7 any activities1 partnerships1 and collaborations by the ,center of ,excellence2 and 7,c7 any other information regarding the formation of the ,center of ,excellence that the ,director considers relevant4 7#b7 ,progress report ,not later than one year after the date on which operations at the ,center of ,excellence officially begin1 the ,director shall submit to ,congress a report describing-- 7,a7 the activities1 partnerships1 collaborations1 and findings of the ,center of ,excellence2 and 7,b7 any other information regarding the ,center of ,excellence that the ,director considers relevant4 7#c7 ,final report ,not later than #e years after the date on which operations at the ,center of ,excellence officially begin1 the ,director shall submit to ,congress a report describing-- 7,a7 the activities1 partnerships1 collaborations1 and findings of the ,center of ,excellence2 and 7,b7 any other information regarding the ,center of ,excellence that the ,director considers relevant4 7#d7 ,publication ,the ,director shall make the reports required by paragraphs 7#a71 7#b71 and 7#c7 available to the public in an easily accessible electronic format on a website of the ,federal ,government that includes information on biotechnology4 7d7 ,intellectual ,property ,the ,director shall ensure that1 prior to commencing operations1 the ,center of ,excellence1 in consultation with similar existing institutions1 such as ,manufacturing ,,usa institutes 7as defined in section #cd7;d771 establishes intellectual property guidelines for research conducted within or in collaboration with the ,center of ,excellence4 7e7 ,authorization of ,appropriations ,there is authorized to be appropriated to the ,director to carry out this section #abj1jjj1jjj for fiscal year #bjbf4 7f7 ,definitions ,in this section3 7#a7 ,biomanufacturing ,the term biomanufacturing means the application of biotechnology to manufacturing4 7#b7 ,biopharmaceutical ,the term biopharmaceutical means a pharmaceutical drug product manufactured using1 extracted from1 or synthesized from living cells or biological organisms4 7#c7 ,biotechnology ,the term biotechnology means the application of science or engineering1 directly or indirectly1 to-- 7,a7 a living organism2 7,b7 a part or product of a living organism2 or 7,c7 a modified form of subparagraph 7,a7 or 7,b74 7#d7 ,executive agency ,the term ,executive agency-- 7,a7 has the meaning given that term in section #aje of title #e1 ,united ,states ,code2 and 7,b7 includes the ,executive ,office of the ,president and the ,office of the ,vice ,president4 7#e7 ,institution of higher education ,the term institution of higher education has the meaning given that term in section #aja of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajja74 4