,,ii #aafth ,,congress #b;d ,session ,s4 #cafa ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #h1 #bjbj,ms4 ,warren 7for herself1 ,mr4 ,markey1 ,ms4 ,baldwin1 ,ms4 ,hirono1 ,mr4 ,van ,hollen1 ,mr4 ,cardin1 ,mr4 ,booker1 ,mr4 ,casey1 ,mr4 ,sanders1 ,mr4 ,kaine1 ,ms4 ,harris1 ,mr4 ,whitehouse1 and ,mr4 ,murphy7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish the 8,biomedical ,innovation ,fund01 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,national ,biomedical ,research ,act4 #b4 ,definitions ,in this ,act3 7#a7 ,discretionary appropriations ,the term discretionary appropriations has the meaning given such term in section #bej of the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe 7#b ,u4,s4,c4 #ijj74 7#b7 ,fund ,the term ,fund means the ,biomedical ,innovation ,fund established under section #c7;a74 7#c7 ,minimum amount ,the term minimum amount1 with respect to the applicable entity and for an applicable fiscal year-- 7,a7 means the amount equal to the greatest amount of discretionary appropriations appropriated to such entity for a fiscal year during the period beginning with fiscal year #bjbj and ending with the fiscal year before the applicable fiscal year2 and 7,b7 does not include-- 7i7 any reduction in an appropriation under a sequestration order issued under the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe 7#b ,u4,s4,c4 #ijj et seq472 7ii7 amounts collected by the ,secretary of ,health and ,human ,services under subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq472 7iii7 amounts distributed under section #c7;c77#b72 or 7iv7 amounts appropriated under a supplemental or emergency appropriation ,act4 #c4 ,biomedical ,innovation ,fund 7a7 ,establishment ,there is established in the ,treasury of the ,united ,states a fund to be known as the ,biomedical ,innovation ,fund1 to be administered by the ,secretary of the ,treasury1 consisting of-- 7#a7 the amounts transferred to the ,fund under subsection 7b72 and 7#b7 any interest earned on the investment of such amounts under subsection 7d74 7b7 ,commitment to biomedical innovation ,not later than ,september #a1 #bjbj1 and every year thereafter through #bjbi1 the ,secretary of the ,treasury shall transfer #aj1jjj1jjj1jjj from the general fund of the ,treasury into the ,fund4 7c7 ,distribution of amounts 7#a7 ,calculation of annual fund amount ,for fiscal year #bjbj and each fiscal year thereafter1 not later than #ae days after the latter of the date of enactment of an appropriation ,act making full fiscal year appropriations for such fiscal year to the entity described in paragraph 7#b77;,a7 and the date of enactment of an appropriation ,act making full fiscal year appropriations for such fiscal year to the entity described in paragraph 7#b77;,b71 the ,secretary of the ,treasury shall calculate the total amount in the ,fund that is available to be distributed for such fiscal year in accordance with paragraph 7#b74 7#b7 ,distribution of amounts in the ,fund ,subject to the other provisions of this section1 not later than #cj days after a calculation is made under paragraph 7#a7 for a fiscal year1 the ,secretary of the ,treasury shall distribute the amount available to be distributed for such fiscal year to each of the following entities3 7,a7 ,the ,national ,institutes of ,health4 7,b7 ,the ,food and ,drug ,administration4 7#c7 ,ratio ,the amount that the ,secretary of the ,treasury distributes to an entity described in subparagraph 7,a7 or 7,b7 of paragraph 7#b7 during a fiscal year shall bear the same relation to the total amount calculated under paragraph 7#a7 for such fiscal year as the amount of discretionary appropriations appropriated to such entity for such fiscal year bears to the total amount of discretionary appropriations appropriated to the entities described in subparagraphs 7,a7 and 7,b7 of paragraph 7#b7 for such fiscal year4 7#d7 ,requirements for distribution 7,a7 ,in general ,the ,secretary of the ,treasury shall distribute amounts in the ,fund during a fiscal year in accordance with paragraph 7#b7 only if-- 7i7 the discretionary appropriations for the entity described in paragraph 7#b77;,a7 is greater than the applicable minimum amount for such entity for such fiscal year2 and 7ii7 the discretionary appropriations for the entity described in paragraph 7#b77;,b7 is greater than the applicable minimum amount for such entity for such fiscal year4 7,b7 ,subsequent law impacting distribution 7i7 ,below minimum amount ,if a law is enacted or becomes effective after amounts are appropriated to each entity described in subparagraph 7,a7 or 7,b7 of paragraph 7#b7 for a fiscal year and such law decreases the amount appropriated to either such entity for such fiscal year from an amount that is greater than the applicable minimum amount to an amount that is less than or equal to such minimum amount1 any amounts that were distributed by the ,secretary of the ,treasury under paragraph 7#b7 shall remain so distributed for such fiscal year4 7ii7 ,above minimum amount ,if a law is enacted or becomes effective after amounts are appropriated for a fiscal year to each entity described in subparagraph 7,a7 or 7,b7 of paragraph 7#b7 and such law increases the amount appropriated to either such entity for such fiscal year from an amount that is less than or equal to the minimum amount to an amount that is greater than such minimum amount1 and all other conditions for distribution under this paragraph are met for the fiscal year1 the amounts in the ,fund shall be distributed by the ,secretary of the ,treasury under paragraph 7#b7 for such fiscal year4 7,c7 ,failure to meet requirements ,if the requirements under subparagraph 7,a7 are not met during a fiscal year1 amounts in the ,fund shall-- 7i7 not be distributed under paragraph 7#b72 and 7ii7 remain in the ,fund1 earning interest in accordance with subsection 7d71 until such requirements1 or the conditions under subsection 7f71 are met during a fiscal year4 7#e7 ,allocations 7,a7 ,in general ,if amounts are distributed under paragraph 7#b7 during a fiscal year1 of the amounts so distributed-- 7i7 #bj percent shall become available for obligation during the fiscal year during which the distribution is made2 7ii7 #bj percent shall become available for obligation during the first fiscal year after the fiscal year during which the distribution is made2 7iii7 #bj percent shall become available for obligation during the second fiscal year after the fiscal year during which the distribution is made2 7iv7 #bj percent shall become available for obligation during the third fiscal year after the fiscal year during which the distribution is made2 and 7v7 #bj percent shall become available for obligation during the fourth fiscal year after the fiscal year during which the distribution is made4 7,b7 ,availability of amounts ,any amounts distributed under paragraph 7#b7 shall remain available until expended4 7#f7 ,authorized uses ,amounts distributed under paragraph 7#b7 from the ,fund shall be used to support-- 7,a7 basic research on the underlying basis for disease to better address disease prevention1 diagnosis1 and treatment2 7,b7 research that fosters disruptive innovation1 such as-- 7i7 research on diseases or conditions for which treatments exist but are inadequate1 including chronic and acute pain2 7ii7 research on diseases or conditions for which there are unmet medical needs2 7iii7 research on diseases or conditions for which treatments exist but the side effect profiles of such treatments limit therapeutic potential2 7iv7 research on new approaches to treatment of diseases using drugs1 devices1 or therapies that1 at the time of distribution under paragraph 7#b71 are not used or are underused2 or 7v7 research conducted by experienced investigators with a history of productive and innovative research1 such that funding provides long-term stability for such research and allows such investigators to take greater risks1 be more adventurous in their lines of inquiry1 or take the time to develop groundbreaking techniques2 7,c7 research related to diseases that disproportionally account for ,federal health care spending1 including spending under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 the ,state ,children's ,health ,insurance ,program under title ,,xxi of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;aa et seq471 the ,,tricare program under chapter #ee of title #aj1 ,united ,states ,code1 and hospital care and medical services furnished by the ,department of ,veterans ,affairs under chapters #ag and #ah of title #ch1 ,united ,states ,code1 such as research relating to-- 7i7 diseases that disproportionally impact older individuals2 7ii7 degenerative diseases2 or 7iii7 chronic conditions2 7,d7 early career scientists1 such as through-- 7i7 awarding research project grants that support discrete1 specified1 and circumscribed projects to be performed by the investigator in an area representing the specific interests and competencies of such investigator1 to investigators-- 7,i7 who are within #aj years of completing a terminal research degree2 or 7,,ii7 who are within #aj years of completing a medical residency2 7ii7 awarding grants that support career development experiences that lead to earlier research independence2 and 7iii7 awarding grants that support innovative training programs that1 in addition to scientific training1 provide additional training to enhance employment opportunities1 including training in management and business1 to-- 7,i7 graduate students2 7,,ii7 post-doctoral fellows2 7,,iii7 individuals within #aj years of completing a terminal research degree2 or 7,,iv7 individuals within #aj years of completing a medical residency2 7,e7 research efforts that increase the potential for breakthrough discoveries across a diverse set of investigators1 research groups1 and institutions1 which may include supporting-- 7i7 investigators that are members of traditionally underrepresented racial and ethnic groups2 7ii7 research groups that are diverse in size2 or 7iii7 institutions that increase the geographic diversity of funding provided by the ,national ,institutes of ,health2 7,f7 the development1 review1 and post-market surveillance of medical products1 as determined by the ,secretary of ,health and ,human ,services2 and 7,g7 research to carry out the goals of the strategy and implementation plan for advancing science to promote public health and advance innovation in regulatory decision making developed under section #aabd of the ,food and ,drug ,administration ,safety and ,innovation ,act 7#ba ,u4,s4,c4 #cic note71 and other such research activities to improve the predictability1 consistency1 and efficiency of science-based decision making concerning medical products1 including facilitating the timely introduction of new technologies and methodologies in a safe and effective manner as determined by the ,secretary of ,health and ,human ,services4 7#g7 ,interagency transfers ,amounts distributed from the ,fund under paragraph 7#b7 shall be available through interagency transfer to support research conducted jointly by the ,national ,institutes of ,health or the ,food and ,dug ,administration and other ,federal agencies4 7d7 ,investment of fund balances 7#a7 ,in general ,amounts in the ,fund shall be invested in interest-bearing obligations of the ,united ,states in the form of special-issue securities1 paying interest to the ,fund at rates applicable to such securities1 and such amounts shall be redeemable by the ,secretary of the ,treasury1 for purposes of distribution under subsection 7c77#b74 7#b7 ,distributed amounts ,any amounts that have been distributed during a fiscal year under subsection 7c77#b7 shall not be considered amounts in the ,fund for the purpose of this subsection4 7e7 ,prohibition ,amounts in the ,fund may not be made available for any use other than a use described in subsection 7c77#f74 7f7 ,transfer ,to reduce the deficit 7#a7 ,in general ,subject to paragraph 7#b71 if amounts in the ,fund are not distributed by the ,secretary of the ,treasury under subsection 7c77#b7 for any #c consecutive fiscal years1 the ,secretary of the ,treasury shall transfer all amounts in the ,fund to the general fund of the ,treasury for purposes of reducing the ,federal deficit4 7#b7 ,year of distribution ,for purposes of paragraph 7#a71 #c fiscal years shall not be deemed to be consecutive if during any of such years the ,secretary of the ,treasury has transferred all amounts in the ,fund into the general fund of the ,treasury in accordance with such paragraph4 7g7 ,reports 7#a7 ,secretary reports 7,a7 ,in general ,not later than ,november #cj1 #bjba1 and every year thereafter through #bjcj the ,secretary of the ,treasury shall submit to the ,committee on ,appropriations of the ,senate1 the ,committee on ,appropriations of the ,house of ,representatives1 and the authorizing committees a report on the operation of the ,fund during the fiscal year4 7,b7 ,contents ,each report shall include1 for the fiscal year covered by the report1 each of the following3 7i7 ,a statement of the amounts1 and the source of such amounts1 transferred to1 credited to1 and deposited into the ,fund4 7ii7 ,a description of any amounts distributed under subsection 7c77#b7 during the fiscal year4 7iii7 ,a statement of the balance remaining in the ,fund at the end of the fiscal year4 7iv7 ,a statement of the amounts invested in interest-bearing obligations of the ,united ,states1 and the interest earned on such investments4 7#b7 ,agency reports 7,a7 ,annual reporting ,for each fiscal year in which amounts are available for obligation under subsection 7c77#e71 the ,director of the ,national ,institutes of ,health and the ,commissioner of ,food and ,drugs shall report on the use of such amounts in the annual budget submission for such fiscal year of the ,national ,institutes of ,health and the ,food and ,drug ,administration1 respectively4 7,b7 ,,nih reports ,section #djc7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc7;a77 is amended by adding at the end the following3 7#g7 ,a summary of the use of funds distributed under section #c7;c77#b77;,a7 of the ,national ,biomedical ,research ,act to the ,national ,institutes of ,health from the ,biomedical ,innovation ,fund1 established under section #c7;a7 of such ,act1 including the amounts allocated to each national research institute and national center1 the projects funded by such amounts1 the accomplishments that have resulted from such amounts1 and the goals for future use of such amounts4 4 7,c7 ,,fda reports ,for each #c-year period beginning on the date of enactment of this ,act1 if amounts are distributed under subsection 7c77#b77;,b7 to the ,food and ,drug ,administration for any fiscal year during such #c-year period1 the ,commissioner of ,food and ,drugs shall submit1 to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 a report that describes the allocation of such amounts within the ,food and ,drug ,administration1 the projects funded by such amounts1 the accomplishments that have resulted from such amounts1 and the goals for future use of such amounts4 #d4 ,budgetary provisions 7a7 ,discretionary spending limits ,the ,office of ,management and ,budget shall not include amounts distributed under section #c7;c77#b7 during a fiscal year in determining whether there has been a breach of the discretionary spending limits under the ,balanced ,budget and ,emergency ,deficit ,control ,act of #aihe 7#b ,u4,s4,c4 #ijj et seq47 during the fiscal year4 7b7 ,budget enforcement ,if a bill or joint resolution1 or amendment thereto or conference report thereon1 if enacted1 would cause amounts to be distributed under section #c7;c77#b71 the ,chairperson of the ,committee on the ,budget of the ,house of ,representatives and ,chairperson of the ,committee on the ,budget of the ,senate shall not include the budgetary effects of such distribution for purposes of enforcement of budgetary allocations1 aggregates1 levels1 and limits in the ,house of ,representatives and the ,senate4 #e4 ,offsets ,it is the sense of the ,senate that the amounts transferred under section #c7;b7 should be offset completely4