,i #aaith ,,congress #ast ,session ,h4 ,r4 #ciee ,,in ,,the ,,house ,,of ,,representatives ,june #ab1 #bjbe ,ms4 ,craig 7for herself and ,mr4 ,van ,drew7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies4 #a4 ,short title ,this ,act may be cited as the ,rolling ,active ,pharmaceutical ,ingredient and ,drug ,reserve ,act or the ,,rapid ,reserve ,act4 #b4 ,rolling active pharmaceutical ingredient and drug reserve 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall award contracts or cooperative agreements to eligible entities with respect to drugs and active pharmaceutical ingredients of such drugs that the ,secretary determines to be critical and to have vulnerable supply chains4 ,the ,secretary shall publish the list of such drugs and active pharmaceutical ingredients of such drugs4 7b7 ,requirements 7#a7 ,in general ,an eligible entity1 pursuant to a contract or cooperative agreement under subsection 7a71 shall agree to-- 7,a7 maintain1 in a satisfactory domestic establishment registered under section #eaj7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;b77 or in a satisfactory foreign establishment registered under section #eaj7;i7 of such ,act that is located in a country that is a member of the ,organisation for ,economic ,cooperation and ,development1 which may be an establishment owned and operated by the entity1 or by a wholesaler1 distributor1 or other third party under contract with the entity1 a #f-month reserve1 or other reasonable quantity1 as determined by the ,secretary1 of-- 7i7 the active pharmaceutical ingredient of the eligible drug specified in the contract or cooperative agreement1 which reserve shall be regularly replenished with a recently manufactured supply of such ingredient2 and 7ii7 the finished eligible drug product specified in the contract or cooperative agreement1 which reserve shall be regularly replenished with a recently manufactured supply of such product2 7,b7 implement production of the eligible drug or an active pharmaceutical ingredient of the eligible drug1 at the direction of the ,secretary1 under the terms of1 and in such quantities as specified in1 the contract or cooperative agreement2 and 7,c7 enter into an arrangement with the ,secretary under which the eligible entity-- 7i7 agrees to transfer a portion1 as determined necessary1 of the reserve of active pharmaceutical ingredient maintained pursuant to subparagraph 7,a77i7 to another drug manufacturer in the event that the ,secretary determines there to be a need for additional finished eligible drug product and such eligible entity is unable to use the reserve of active pharmaceutical ingredient to manufacture a sufficient supply of such drug product2 and 7ii7 permits the ,secretary to direct allocation of the reserve of active pharmaceutical ingredient so maintained in the event of a public health emergency1 natural disaster1 or chemical1 biological1 radiological1 or nuclear threat4 7#b7 ,guidance ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary1 in coordination with the ,commissioner of ,food and ,drugs1 shall issue guidance on-- 7,a7 the factors the ,secretary will use to determine which eligible drugs1 or active pharmaceutical ingredient of such drugs1 have vulnerable supply chains and how a contract or cooperative agreement would help minimize the vulnerability or vulnerabilities identified2 7,b7 the factors the ,secretary will consider in determining eligibility of an entity to participate in the program under this section1 which shall include an entity's commitment to quality systems1 including strong manufacturing infrastructure1 reliable processes1 and trained staff1 as well as the entity's commitment to domestic manufacturing capacity and surge capacity1 as appropriate2 and 7,c7 requirements for entities receiving an award under this section1 including the extent of excess manufacturing capacity the manufacturers will be required to generate1 the amount of redundancy required1 and requirements relating to advanced quality systems4 7#c7 ,preference ,in awarding contracts and cooperative agreements under subsection 7a71 the ,secretary shall-- 7,a7 give preference to eligible entities that will-- 7i7 carry out the requirements of paragraph 7#a7 through one or more domestic establishments registered under section #eaj7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;b77 capable of manufacturing the eligible drug2 or 7ii7 source key starting materials or excipients for eligible drugs domestically or from a country that is a member of the ,organisation for ,economic ,cooperation and ,development2 and 7,b7 to the greatest extent practicable1 award such contracts and cooperative agreements in a manner that strengthens domestic manufacturing1 resiliency1 and capacity of eligible drugs and their active pharmaceutical ingredients4 7c7 ,additional contract and cooperative agreement terms 7#a7 ,in general ,each contract or cooperative agreement under subsection 7a7 shall be subject to such terms and conditions as the ,secretary may specify1 including terms and conditions with respect to procurement1 maintenance1 storage1 testing1 and delivery of drugs1 in alignment with inventory management and other applicable best practices1 under such contract or cooperative agreement1 which may consider1 as appropriate1 costs of transporting and handling such drugs4 7#b7 ,terms concerning the acquisition1 construction1 alteration1 or renovation of establishments ,notwithstanding section #fcjc of title #da1 ,united ,states ,code1 the ,secretary may award a contract or cooperative agreement under this section to support the acquisition1 construction1 alteration1 or renovation of non-federally owned establishments-- 7,a7 as determined necessary to carry out or improve preparedness and response capability at the ,state and local level2 or 7,b7 for the production of drugs1 devices1 and supplies where the ,secretary determines that such a contract or cooperative agreement is necessary to ensure sufficient amounts of such drugs1 devices1 and supplies4 7d7 ,requirements in awarding contracts ,to the greatest extent practicable1 the ,secretary shall award contracts and cooperative agreements under this section in a manner that-- 7#a7 maximizes quality1 minimizes cost1 minimizes vulnerability of the ,united ,states to severe shortages or disruptions for eligible drugs and their active pharmaceutical ingredients1 gives preference to domestic manufacturers1 and encourages competition in the marketplace2 and 7#b7 increases domestic production surge capacity and reserves of domestic-based manufacturing establishments for critical drugs and active pharmaceutical ingredients of such drugs4 7e7 ,definitions ,in this section3 7#a7 ,active pharmaceutical ingredient ,the term active pharmaceutical ingredient has the meaning given such term in section #gdd;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#da74 7#b7 ,drug ,the term drug has the meaning given such term in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g774 7#c7 ,drug shortage2 shortage ,the term drug shortage or shortage has the meaning given such term in section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c74 7#d7 ,eligible drug ,the term eligible drug means a drug1 as determined by the ,secretary1 in coordination with the ,assistant ,secretary for ,preparedness and ,response1 the ,director of the ,centers for ,disease ,control and ,prevention1 and the ,commissioner of ,food and ,drugs-- 7,a7 that is approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or licensed under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 7,b7 7i7 that is reasonably likely to be required to respond to a public health emergency or to a chemical1 biological1 radiological1 or nuclear threat2 or 7ii7 the shortage of which would pose a significant threat to the ,united ,states health care system or at-risk populations2 and 7,c7 that has a vulnerable supply chain1 such as a geographic concentration of manufacturing1 poor quality or safety issues1 complex manufacturing or chemistry1 or few manufacturers4 7#e7 ,eligible entity ,the term eligible entity means a person that-- 7,a7 7i7 is the holder of an approved application under subsection 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or subsection 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for an eligible drug2 7ii7 maintains at least one domestic establishment registered under section #eaj7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;b77 or one foreign establishment registered under section #eaj7;i7 of such ,act that is located in a country that is a member of the ,organisation for ,economic ,cooperation and ,development that is capable of manufacturing the eligible drug2 and 7iii7 has a strong record of good manufacturing practices of drugs2 7,b7 7i7 is a manufacturer of an active pharmaceutical ingredient for an eligible drug1 in partnership with an entity that meets the requirements of subparagraph 7,a72 7ii7 maintains at least one domestic establishment registered under section #eaj7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;b77 or one foreign establishment registered under section #eaj7;i7 of such ,act that is located in a country that is a member of the ,organisation for ,economic ,cooperation and ,development that is capable of manufacturing the active pharmaceutical ingredient2 and 7iii7 has a strong record of good manufacturing practices of active pharmaceutical ingredients2 or 7,c7 is a distributor or wholesaler of an eligible drug1 in partnership with an entity that meets the requirements of subparagraph 7,a74 7f7 ,reports to ,congress ,not later than #b years after the date on which the first award is made under this section1 and every #b years thereafter1 the ,secretary shall submit a report to ,congress detailing-- 7#a7 the list of drugs determined to be eligible drugs1 as described in subsection 7e77#b71 and the rationale behind selecting each such drug2 and 7#b7 an update on the effectiveness of the program under this section1 in a manner that does not compromise national security4 7g7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #ejj1jjj1jjj for fiscal year #bjbf4