,i #aacth ,,congress #b;d ,session ,h4 ,r4 #ddid ,,in ,,the ,,house ,,of ,,representatives ,april #bh1 #bjad ,ms4 ,de,gette 7for herself and ,mr4 ,paulsen7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to launch a national strategy to support regenerative medicine through funding for research and commercial development of regenerative medicine products and development of a regulatory environment that enables rapid approval of safe and effective products1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,regenerative ,medicine ,promotion ,act of #bjad4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,findings4 ,sec4 #c4 ,report on ongoing ,federal programs and activities regarding regenerative medicine4 ,sec4 #d4 ,establishment of ,regenerative ,medicine ,coordinating ,council4 ,sec4 #e4 ,grants for basic or preclinical research into regenerative medicine4 ,sec4 #f4 ,grants for development of drugs1 biological products1 medical devices1 and biomaterials for use in regenerative medicine4 ,sec4 #g4 ,supporting innovation in regenerative medicine through cures acceleration network4 ,sec4 #h4 ,funding for ,food and ,drug ,administration research4 #b4 ,findings ,congress finds the following3 7#a7 ,regenerative medicine has the potential to treat many chronic diseases1 promote economic growth1 and reduce health care spending in the ,united ,states4 7#b7 ,regenerative medicine products have already successfully treated numerous health conditions1 and have the potential to provide cures1 treatments1 and diagnostics for a range of diseases and disabilities including diabetes1 spinal cord injury1 heart disease1 stroke1 and various forms of cancer4 7#c7 ,a ,united ,states national strategy on regenerative medicine is critical to ensure that this technology fulfills its potential to cure and treat diseases and disabilities1 reduce overall health spending1 and promote economic growth4 7#d7 ,the ,department of ,defense has stated that regenerative medicine has the potential to treat many battlefield injuries such as burns1 that it has the potential to heal wounds without scarring1 and that it has the potential to be used for traumatic brain injury and other forms of trauma1 craniofacial reconstruction1 limb reconstruction1 regeneration1 and transplantation4 7#e7 ,the ,department of ,health and ,human ,services and the ,multi-,agency ,tissue ,engineering ,science ,interagency ,working ,group have endorsed a national initiative to support research and product development in regenerative medicine4 7#f7 ,the ,department of ,health and ,human ,services has said the potential benefits of regenerative medicine in improved health care and economic savings are enormous4 ,states that have invested in regenerative medicine have experienced economic growth and see future growth potential1 including an increase in biotech employment1 payroll increases1 and proportional impacts on tax receipts4 #c4 ,report on ongoing ,federal programs and activities regarding regenerative medicine ,not later than #ahj days after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall provide for the completion1 and submission to the ,congress1 of a report identifying all ongoing ,federal programs and activities regarding regenerative medicine4 #d4 ,establishment of ,regenerative ,medicine ,coordinating ,council 7a7 ,establishment ,the ,secretary of ,health and ,human ,services shall establish1 within six months of the enactment of this ,act1 in the ,office of the ,secretary1 a ,regenerative ,medicine ,coordinating ,council 7in this section referred to as the ,council74 7b7 ,composition ,the ,council shall be composed of the following3 7#a7 ,the ,secretary of ,commerce4 7#b7 ,the ,secretary of ,defense4 7#c7 ,the ,secretary of ,health and ,human ,services4 7#d7 ,the ,secretary of the ,treasury4 7#e7 ,the ,secretary of ,veterans ,affairs4 7#f7 ,the ,administrator of the ,agency for ,healthcare ,research and ,quality4 7#g7 ,the ,administrator of the ,centers for ,medicare ,medicaid ,services4 7#h7 ,the ,commissioner of ,food and ,drugs4 7#i7 ,the ,director of the ,national ,institutes of ,health4 7#aj7 ,the ,director of the ,national ,institutes of ,standards and ,technology4 7#aa7 ,the members appointed by the ,secretary under subsection 7d74 7c7 ,chair ,the ,secretary of ,health and ,human ,services shall be the ,chair of the ,council4 7d7 ,members appointed by secretary ,the ,secretary shall appoint at least #e persons to serve as members of the ,council under subsection 7b77#aa74 ,the members of the ,council appointed under the preceding sentence shall include persons with expertise in third-party payment1 regenerative medicine researchers from academic institutions1 patient advocates1 persons with expertise in drug discovery1 persons with expertise in drug development1 persons with expertise in basic research1 persons with expertise in translational research1 persons with expertise in medical device development1 persons with expertise in biomaterials1 clinicians1 and persons with expertise in clinical research4 7e7 ,functions ,the ,council shall-- 7#a7 consult with1 and provide information to1 the ,secretary of ,health and ,human ,services for purposes of implementing any recommendations in the report required by section #c2 7#b7 prepare1 and keep up-to-date1 a national strategy to support research into regenerative medicine and the development of drugs1 biological products1 medical devices1 and biomaterials for use in regenerative medicine2 7#c7 prepare a plan specifying priorities for research into regenerative medicine2 7#d7 not later than #a year after the date of the enactment of this ,act1 establish priorities for the award of grants under sections #e and #f 7relating to grants for basic or preclinical research into regenerative medicine and for development of drugs1 biological products1 medical devices1 and biomaterials for use in regenerative medicine1 respectively72 7#e7 identify sources of funding for research into regenerative medicine2 7#f7 identify areas where such funding is inadequate2 7#g7 make recommendations regarding ,federal regulatory1 reimbursement1 tax1 and other policies that will support development and marketing of regenerative medicine products2 7#h7 facilitate development of consensus standards regarding scientific issues critical to regulatory approval of regenerative medicine products2 and 7#i7 determine the need for establishing centers of excellence or consortia to further advance regenerative medicine4 7f7 ,transparency2 reporting requirements 7#a7 ,transparency ,the ,council shall adopt procedures to ensure the receipt of public input1 such as holding public stakeholder meetings or creating advisory boards4 7#b7 ,annual reports ,the ,council shall submit an annual report on its activities to the ,congress1 the ,director of the ,national ,institutes of ,health1 and the ,commissioner of ,food and ,drugs4 ,each such report shall-- 7,a7 provide details on progress in meeting goals identified by the ,council for regenerative medicine2 7,b7 make recommendations regarding funding1 regulatory1 or other policies to achieve regenerative medicine goals identified by the ,council2 7,c7 identify all regenerative medicine products currently on the market and those in development2 7,d7 identify regenerative medicine research and technological advances and discoveries that occurred in the previous year2 and 7,e7 assess the impact of regenerative medicine on the ,nation's economy1 including with respect to-- 7i7 the number of people employed in companies or research institutions working in regenerative medicine2 7ii7 the number of companies pursuing regenerative medicine products2 7iii7 increases in tax revenues2 and 7iv7 the impact on national health spending4 #e4 ,grants for basic or preclinical research into regenerative medicine 7a7 ,grants for basic or preclinical research ,the ,secretary may make grants to eligible entities for the purpose of funding basic or preclinical research into regenerative medicine4 7b7 ,conditions ,the ,secretary may make a grant under this section for research only if-- 7#a7 the research is carried out directly by the grant recipient2 7#b7 the research is partly funded by one or more private entities2 and 7#c7 the amount of the grant does not exceed the total amount provided for the research by private entities 7other than the grant recipient itself74 7c7 ,terms and conditions ,a grant under this section may be made on such terms and conditions as the ,secretary determines appropriate4 7d7 ,priority ,in awarding grants under this section1 the ,secretary shall take into consideration the priorities established by the ,regenerative ,medicine ,coordinating ,council under section #d7;e74 7e7 ,definitions ,in this section3 7#a7 ,the term eligible entity means a nonprofit entity or an institution of higher education4 7#b7 ,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 7#c7 ,the term nonprofit entity means an entity that-- 7,a7 is described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eja7;c77#c772 and 7,b7 is exempt from tax under section #eja7;a7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eja7;a774 7#d7 ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health4 #f4 ,grants for development of drugs1 biological products1 medical devices1 and biomaterials for use in regenerative medicine 7a7 ,grants for drug development ,the ,secretary may make grants to eligible entities for the purpose of funding projects that have as their aim-- 7#a7 the research and development of drugs1 biological products1 medical devices1 and biomaterials for use in regenerative medicine2 and 7#b7 the making of an investigational new drug application with respect to such drugs or biological products1 or the making of an investigational device exemption application with respect to such devices1 by not later than the end of the #d-year period beginning on the date on which such grant is made4 7b7 ,terms and conditions ,a grant under this section may be made on such terms and conditions as the ,secretary determines appropriate4 7c7 ,priority ,in awarding grants under this section1 the ,secretary shall take into consideration the priorities established by the ,regenerative ,medicine ,coordinating ,council under section #d7;e74 7d7 ,definitions ,in this section3 7#a7 ,the term biological product has the meaning given the term in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i774 7#b7 ,the terms drug and medical device have the meanings given to the terms drug and device1 respectively1 in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7#c7 ,the term eligible entity means a collaborative partnership including-- 7,a7 a qualified nonprofit entity or an institution of higher education2 and 7,b7 a for-profit entity4 7#d7 ,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 7#e7 ,the term investigational new drug application means an investigational new drug application that is made to the ,food and ,drug ,administration under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #eje7;i774 7#f7 ,the term investigational device exemption application means an application for an investigational device exemption that is made to the ,food and ,drug ,administration under section #ebj7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7g774 7#g7 ,the term qualified nonprofit entity means an entity that-- 7,a7 is described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eja7;c77#c772 and 7,b7 is exempt from tax under section #eja7;a7 of the ,internal ,revenue ,code of #aihf 7#bf ,u4,s4,c4 #eja7;a774 7#h7 ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health4 #g4 ,supporting innovation in regenerative medicine through cures acceleration network ,section #dhj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg;a7 is amended-- 7#a7 in subsection 7d71 by adding at the end the following3 7#g7 ,collaboration ,with respect to activities of the ,board relating to medical products and behavioral therapies for use in regenerative medicine1 the ,board shall collaborate with the ,regenerative ,medicine ,coordinating ,council4 2 and 7#b7 in subsection 7e77#c71 by adding at the end the following3 7,d7 ,the cures acceleration awards with respect to products and therapies for use in regenerative medicine ,the ,director of ,,nih may1 without regard to subparagraphs 7,a71 7,b71 and 7,c71 provide assistance under paragraph 7#a7 with respect to medical products and behavioral therapies for use in regenerative medicine1 including assistance-- 7i7 to perform clinical trials under a protocol approved by the ,commissioner of ,food and ,drugs or studies which use good manufacturing practice or good laboratory practice procedures and the data from which are intended for inclusion in an investigational new drug application or an investigational device exemption application2 or 7ii7 to perform basic research or preclinical studies in regenerative medicine the data from which are not intended for inclusion in an investigational new drug application or an investigational device exemption application4 4 #h4 ,funding for ,food and ,drug ,administration research 7a7 ,grants ,the ,secretary may-- 7#a7 conduct1 support1 or collaborate in regulatory research for the purpose of assisting the ,food and ,drug ,administration to perform its functions with respect to regenerative medicine2 or 7#b7 make grants to fund regulatory research for such purpose4 7b7 ,definitions ,in this section3 7#a7 ,the term regulatory research means research regarding development1 evaluation1 and availability of new or improved tools1 methods1 standards1 and applied science that support a better understanding and improved evaluation of product safety1 quality1 effectiveness1 and manufacturing throughout the product life cycle4 7#b7 ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs4