,,ii #aahth ,,congress #ast ,session ,s4 #adda ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #d1 #bjbc,mr4 ,cornyn 7for himself and ,mr4 ,kaine7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to establish a ,center for ,biomedical ,innovation and ,development in order to accelerate innovation and development of advanced medical countermeasure products4 #a4 ,short title ,this ,act may be cited as the ,accelerating ,biomedical ,innovation ,act4 #b4 ,center for biomedical innovation and development program ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by inserting after section #cai,l-#a the following3 #cai,l-#b4 ,center for biomedical innovation and development program 7a7 ,establishment of consortium ,not later than #a year after the date of enactment of this section1 the ,secretary shall establish a consortium of not fewer than #c institutions of higher education 7as defined in section #aja of the ,higher ,education ,act71 to accelerate innovation and development of advanced medical countermeasure products1 including biological products and devices1 selected by the ,biomedical ,advanced ,research and ,development ,agency 7referred to in this section as ,,barda74 ,such consortium shall be known as the ,center for ,biomedical ,innovation and ,development 7referred to in this section as the ,center74 7b7 ,selection of participating institutions ,in selecting institutions of higher education to participate in the ,center under subsection 7a71 the ,secretary shall-- 7#a7 select eligible institutions that have-- 7,a7 expertise and capabilities in current good manufacturing practices1 as defined in part #aag of title #ba ,code of ,federal ,regulations 7or successor regulations72 7,b7 experience in technology innovation1 including advanced manufacturing technologies1 that may assist in countermeasure and advanced research and development2 7,c7 facilities with flexible and adaptable advanced process development capabilities2 and 7,d7 other relevant qualifications1 as determined by the ,secretary2 7#b7 select at least one institution with the capability to handle secure and classified information1 as appropriate2 and 7#c7 prioritize institutions most likely to aid in the advancement and innovation of the medical countermeasure products1 the manufacturing processes for such products1 and the execution and design of clinical trials4 7c7 ,center activities ,the ,center established under subsection 7a7 shall assist public and private entities in accelerating nonclinical research discoveries with respect to medical countermeasures through advanced development and clinical trials4 ,the activities of the ,center may include-- 7#a7 advanced process development and pilot manufacturing to support clinical trials2 7#b7 technical assistance2 7#c7 contract award management2 7#d7 referral and coordination with potential manufacturing partners2 7#e7 regulatory assistance2 7#f7 technology transfer2 and 7#g7 program management4 7d7 ,eligible products ,a drug or device 7including a combination of one or more drugs or devices7 is eligible for consideration and referral by the ,director of ,,barda to the ,center if such drug or device incorporates a novel technology1 or uses an established technique or technology in a novel way1 that will substantially-- 7#a7 further development of a drug or device of interest2 7#b7 fulfil an unmet need2 or 7#c7 develop the manufacturing process for a drug or device4 7e7 ,international coordination ,the ,director of ,,barda1 in collaboration with the ,assistant ,secretary for ,global ,affairs and the ,center established under subsection 7a71 shall coordinate1 as appropriate1 with international partners to enhance global health security by encouraging other initiatives1 similar to the program described in subsection 7a71 under which international advanced development networks support an expanded worldwide strategy for vaccine1 drug1 device1 and other countermeasure research1 development1 and manufacturing4 4