,,ii #aadth ,,congress #b;d ,session ,s4 #bfhi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #af1 #bjaf ,mr4 ,kirk 7for himself1 ,mr4 ,manchin1 and ,ms4 ,collins7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to cellular therapies4 #a4 ,short title ,this ,act may be cited as the ,reliable and ,effective ,growth for ,regenerative ,health ,options that ,improve ,wellness or the ,,regrow ,act4 #b4 ,cellular therapeutics 7a7 ,current pathways ,nothing in this ,act1 or the amendments made by this ,act1 shall be applied or interpreted as restricting or otherwise modifying any pathway to market which is 7as of the day immediately before the date of enactment of this ,act7 provided under regulations promulgated by the ,food and ,drug ,administration1 including pathways under sections #cea and #cfa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb and #bfd74 7b7 ,approval for therapies ,subpart #a of part ,f of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb et seq47 is amended by adding after section #cea;,a the following3 #cea;,b4 ,approval for cellular therapies 7a7 ,conditional approval of cellular or tissue therapeutic ,not later than #a year after the date of enactment of this section1 the ,secretary shall establish a program to conditionally approve a cellular therapeutic product if the sponsor of such product demonstrates preliminary clinical evidence of safety1 and a reasonable expectation of effectiveness1 without initiation of phase ,,iii investigations4 7b7 ,additional requirements for conditional approval ,a conditionally approved product under subsection 7a7 shall1 for a #e-year conditional use period1 be manufactured1 introduced into interstate commerce1 and used consistent with the regulations in effect at the time of such use1 including good manufacturing practices1 without the approval of an application under section #cea7;a71 if all of the following apply3 7#a7 ,such cells or tissues are adult human cells or tissues4 7#b7 ,such cells or tissues have been evaluated to examine immunogenicity and do not provoke a significant unintended immune response in the recipient4 7#c7 ,such cells or tissues are-- 7,a7 minimally manipulated for a nonhomologous use2 or 7,b7 more-than-minimally manipulated for a homologous or nonhomologous use1 but are not genetically modified4 7#d7 ,such cells or tissues are produced for a specific indication4 7#e7 ,such cells or tissues are produced exclusively for a use that performs1 or helps achieve or restore1 the same1 or similar1 function in the recipient as in the donor4 7#f7 ,within #e years of the safety and effectiveness determination described in this section1 the sponsor of the conditionally approved new product prepares and submits an application for approval of a biological product under section #cea7;a71 demonstrating potency1 purity1 safety1 and efficacy of the use4 ,the ,secretary may permit continued use of such product until the ,secretary completes the review of the application and makes a determination4 ,upon a determination by the ,secretary not to approve the application1 use of the cellular therapeutic shall not be permitted4 7#g7 ,during the conditional approval period1 and before approval of an application under section #cea7;a71 the sponsor shall prepare and submit annual reports and adverse event reports to the ,secretary containing all the information required for approved biological products4 7#h7 ,the sponsor has submitted an application under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act for the treatment of the patients during the #e-year conditional use period4 7#i7 ,the sponsor has not previously received conditional approval for such product for the same indication4 7c7 ,informed use ,the individual administering a product approved under subsection 7b7 shall inform each individual who uses such product that the product has been conditionally approved based on studies in a limited population1 without proof of efficacy1 and that the ,secretary is requiring additional studies of the product4 7d7 ,stem cell banking ,to be eligible to provide cells for the uses described under subsection 7b71 public and private cord blood banks1 tissue banks1 and bone marrow repositories shall be in full compliance with good tissue practice requirements under part #abga of title #ba1 ,code of ,federal ,regulations 7or successor regulations71 as applicable4 4 #c4 ,devices used in recovery1 processing1 and delivery of cellular therapeutics 7a7 ,clearance ,section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 is amended-- 7#a7 in paragraph 7#a71 by striking 1 and and inserting 22 7#b7 in paragraph 7#b71 by striking the period and inserting 2 and2 and 7#c7 by inserting after paragraph 7#b7 the following3 7#c7 in the case of a cellular therapeutic described in section #cea;,b7a7 of the ,public ,health ,service ,act1 the general function of the device used for the recovery1 isolation1 processing1 or delivery of such cellular therapeutic4 4 7b7 ,clearance or approval of cellular therapeutics ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #eae;,a the following3 #eae;,b4 ,classification of cellular therapeutics ,clearance or approval of a device that is a cellular therapeutic described in section #cea;,b7a7 of the ,public ,health ,service ,act shall be based on in vitro performance testing and not in vivo human clinical trials1 as appropriate4 ,the ,secretary shall classify devices in accordance with section #eac used for cell therapy 7as described in section #cea;,b7a7 of the ,public ,health ,service ,act71 focusing on the general use of such devices for harvesting1 delivery1 or processing cells and sustaining the viability and functions of the cells in vivo4 ,the classification regulation shall not require that such devices be cleared under section #eaj7k7 or approved under section #eae for use with only specific types of cells or for specific uses unless unique to the intended use of the device4 ,if the ,secretary determines that no predicate exists1 or that a device classified as class ,,iii is sufficiently low risk to justify a lower classification1 the ,secretary shall apply the procedure outlined in section #eac7;f77#b7 to permit the review and marketing of the device4 4 7c7 ,combination products ,section #ejc7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77#a77 is amended-- 7#a7 in subparagraph 7,b71 by striking or2 7#b7 in subparagraph 7,c71 by striking the period and inserting 1 or2 and 7#c7 by adding at the end the following3 7,d7 cellular components1 the agency center charged with premarket review of biological products shall have primary jurisdiction4 4 #d4 ,guidance2 amended regulations 7a7 ,guidance ,within #a year of the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 may issue draft guidance on clarifying the requirements with respect to cellular therapeutics1 as set forth in section #cea;,b of the ,public ,health ,service ,act1 as added by section #b1 and devices used in processing or delivery of cellular therapeutics1 as set forth in section #eaj7k77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77#c77 and section #eae;,b of such ,act1 as added by section #c7;b74 ,the ,secretary shall issue final guidance not later than #ahj days after the close of the comment period 7including any extensions of such period7 for the draft guidance4 ,such comment period may not exceed #fj days4 7b7 ,amended regulations 7#a7 ,in general ,if the ,secretary determines that it is appropriate to amend the regulations under title #ba1 ,code of ,federal ,regulations1 in order to clarify the requirements of section #cea;,b of the ,public ,health ,service ,act1 as added by section #b1 the ,secretary shall amend such regulations not later than #a year after the date of enactment of this ,act4 7#b7 ,procedure ,in amending regulations under paragraph 7#a71 the ,secretary shall-- 7,a7 issue a notice of proposed rulemaking that includes the proposed regulations2 7,b7 provide a period of not more than #fj days for comments on the proposed regulations2 and 7,c7 publish the final regulations not less than #cj days before the effective date of such regulations4 7c7 ,public meeting ,in carrying out this ,act1 including the amendment made by section #b and the amendments made by section #c1 the ,secretary1 not later than #ij days after the date of enactment of this ,act1 shall have not less than #a public meeting on the relevant regulatory policies relating to cell and tissue products1 including any changes to such policies necessary to encourage innovation and regulatory certainty with regard to the development of regenerative medicine products4 #e4 ,regenerative medicine standards ,the ,secretary shall work with stakeholders1 including regenerative product manufacturers1 academic institutions1 standards setting organizations1 and the ,national ,institute of ,standards and ,technology1 to promote and facilitate an effort to develop1 through a transparent public process1 standards that will facilitate regulatory predictability regarding manufacturing processes and controls for regenerative medicine products4