,i #aafth ,,congress #b;d ,session ,h4 ,r4 #fhhe ,,in ,,the ,,house ,,of ,,representatives ,may #ae1 #bjbj,mr4 ,flores introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to prohibit the importation of a drug or device that was manufactured at a banned foreign facility1 to create incentives for pharmaceutical or device companies to increase manufacturing capacity in the ,united ,states1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,safe and ,secure ,medicine ,supply for ,hardworking ,americans ,act of #bjbj4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,table of contents4,sec4 #c4 ,safe drug and device importation4,sec4 #d4 ,imposition of additional duties on drugs from ,china1 ,india1 and other countries4,sec4 #e4 ,secure ,medicines ,supply ,fund4,sec4 #f4 ,registry of drugs manufactured outside the ,united ,states4,sec4 #g4 ,country-of-origin labeling4 #c4 ,safe drug and device importation 7a7 ,prohibited act ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7fff7 ,the importation of a drug or device that was manufactured or processed at a banned foreign facility for which an order is in effect under section #haj4 4 7b7 ,issuance of order ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #hji of such ,act 7#ba ,u4,s4,c4 #chd;e7 the following new section3 #haj4 ,banned foreign facilities 7a7 ,determination ,the ,secretary shall issue an order determining a facility to be a banned foreign facility if-- 7#a7 the facility manufactures or processes any drug or device that is imported into the ,united ,states2 and 7#b7 a ,class ,i or ,class ,,ii recall is issued by the ,food and ,drug ,administration for any drug or device that is manufactured or processed at such facility4 7b7 ,duration 7#a7 ,banned facilities with ,class ,i recall ,for a banned facility for which a ,class ,i recall is issued as described in subsection 7a77#b73 7,a7 ,the designation of the banned facility pursuant to an order under subsection 7a71 based on an initial ,class ,i recall of a drug or device manufactured or processed at the facility1 shall be in effect for the #aj-year period beginning on the date that is one year after the issuance of the order4 7,b7 ,the designation of the banned facility pursuant to an order under subsection 7a71 based on a subsequent ,class ,i recall of a drug or device manufactured or processed at the facility1 shall be in effect permanently beginning on the date that is one year after the issuance of such order4 7#b7 ,banned facilities with ,class ,,ii recall ,for a banned facility for which a class ,,ii recall is issued as described in subsection 7a77#b73 7,a7 ,the designation of the banned facility pursuant to an order under subsection 7a71 based on an initial ,class ,,ii recall of a drug or device manufactured or processed at the facility1 shall be in effect for the #e-year period beginning on the date that is one year after the issuance of the order4 7,b7 ,the designation of the banned facility pursuant to an order under subsection 7a71 based on a first subsequent ,class ,,ii recall of a drug or device manufactured or processed at the facility1 may be renewed to be in effect for a period of #e years beginning-- 7i7 if the initial #e-year period under subparagraph 7,a7 has concluded1 one year from the date of the first subsequent recall2 or 7ii7 if the initial #e-year period under subparagraph 7,a7 has not concluded1 at the conclusion of such initial #e-year period4 7,c7 ,the designation of the banned facility pursuant to an order under subsection 7a71 based on a second subsequent ,class ,,ii recall of a drug or device manufactured or processed at the facility1 shall be in effect permanently beginning-- 7i7 if the first subsequent #e-year period under subparagraph 7,b7 has concluded1 one year after the issuance of the order2 or 7ii7 if the first subsequent #e-year period under subparagraph 7,b7 has not concluded1 immediately4 7c7 ,definition ,in this section3 7#a7 ,the term banned facility means a banned foreign facility for which an order is in effect under subsection 7a74 7#b7 ,the terms ,class ,i and ,class ,,ii1 in connection with a recall1 mean classified as ,class ,i or ,class ,,ii1 respectively1 by the ,food and ,drug ,administration pursuant to section #g4da of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 4 7c7 ,applicability ,section #haj of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7b71 applies only with respect to recalls issued or reissued on or after the date of enactment of this ,act4 7d7 ,civil monetary penalties ,subsection 7f7 of section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended by adding at the end the following new paragraph3 7#aj7 ,any person who violates section #cja7;fff7 shall be subject to a civil money penalty not to exceed-- 7,a7 if the violation involves a ,class ,i recall1 as described in section #haj7;a77#b7-- 7i7 #be1jjj1jjj if the violation is the first violation of section #cja7;fff7 by such person2 and 7ii7 #ajj1jjj1jjj if the violation is a subsequent violation of section #cja7;fff7 by such person2 and 7,b7 if the violation involves a ,class ,,ii recall1 as described in section #haj7;a77#b7-- 7i7 #aj1jjj1jjj if the violation is the first violation of section #cja7;fff7 by such person2 and 7ii7 #ej1jjj1jjj if the violation is a subsequent violation of section #cja7;fff7 by such person4 4 #d4 ,imposition of additional duties on drugs from ,china1 ,india1 and other countries 7a7 ,drugs from ,china 7#a7 ,in general ,in addition to any other duty1 there is imposed a duty on drugs which are being imported or offered for import into the ,united ,states 7within the meaning of section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a777 from the ,people's ,republic of ,china4 7#b7 ,rate of duty ,the rate of duty imposed by paragraph 7#a7 shall be #be percent ad valorem4 7b7 ,drugs from ,india 7#a7 ,in general ,in addition to any other duty1 there is imposed a duty on drugs which are being imported or offered for import into the ,united ,states 7within the meaning of section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a777 from the ,republic of ,india4 7#b7 ,rate of duty ,the rate of duty imposed by paragraph 7#a7 shall be #bj percent ad valorem4 7c7 ,drugs from other countries 7#a7 ,in general ,in addition to any other duty1 there is imposed a duty on drugs which are being imported or offered for import into the ,united ,states 7within the meaning of section #hja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;a777 from any foreign country other than the ,people's ,republic of ,china or the ,republic of ,india4 7#b7 ,rate of duty 7,a7 ,in general ,except as provided in subparagraph 7,b71 the rate of duty imposed by paragraph 7#a7 shall be #aj percent ad valorem4 7,b7 ,exception ,in the case of a drug that includes one or more active pharmaceutical ingredients originating from the ,people's ,republic of ,china or the ,republic of ,india1 the rate of duty imposed by paragraph 7#a7 shall be-- 7i7 #be percent ad valorem for those containing an active pharmaceutical ingredient from ,china2 and 7ii7 #bj percent ad valorem for those containing an active pharmaceutical ingredient from ,india4 7d7 ,effective date ,the provisions of this section shall apply to articles described in subsections 7a71 7b71 and 7c7 entered1 or withdrawn from warehouse for consumption1 on or after the date that is #ae days after the date of the enactment of this ,act4 #e4 ,secure ,medicines ,supply ,fund 7a7 ,establishment ,there is established in the ,treasury of the ,united ,states a fund1 to be known as the ,secure ,medicines ,supply ,fund 7in this section referred to as the ,fund71 consisting of such amounts as may be deposited to the ,fund pursuant to subsection 7b7 to be used1 in accordance with subsection 7c71 for the purpose of supporting and incentivizing pharmaceutical or device companies to invest in new pharmaceutical or device manufacturing capacity in the #ej ,states1 the ,district of ,columbia1 ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 and the ,commonwealth of the ,northern ,mariana ,islands4 7b7 ,requirements ,to be eligible for investment under subsection 7a71 new pharmaceutical or device manufacturing capacity shall meet each of the following3 7#a7 ,the products supported by the new pharmaceutical or device manufacturing capacity do not use active pharmaceutical ingredients or parts manufactured in ,china or ,india4 7#b7 ,at least #ej percent of the active pharmaceutical ingredients or parts for the total product line of the respective company is manufactured in any of the #ej ,states1 the ,district of ,columbia1 ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 or the ,commonwealth of the ,northern ,mariana ,islands4 7c7 ,funding 7#a7 ,duties ,amounts collected from duties imposed pursuant to section #d shall be deposited in the ,fund1 to remain available until expended4 7#b7 ,fines ,amounts collected from civil monetary penalties imposed pursuant to paragraph 7#aj7 of section #cjc7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;f771 as added by section #c7;d71 shall be deposited in the ,fund1 to remain available until expended4 7d7 ,distribution of funds 7#a7 ,grants ,the ,secretary of ,health and ,human ,services shall establish a grant program to support and incentivize pharmaceutical or device companies to manufacture prescription drugs1 active pharmaceutical ingredients1 or devices in any of the #ej ,states1 the ,district of ,columbia1 ,puerto ,rico1 the ,virgin ,islands1 ,guam1 ,american ,samoa1 and the ,commonwealth of the ,northern ,mariana ,islands4 7#b7 ,limitations on use of funds ,as a condition on receipt of a grant under this section1 the recipient of the grant shall agree to use-- 7,a7 not more than #aj percent of the grant for new or expanded manufacturing capacity2 7,b7 not more than #ej percent of the grant for training manufacturing workers2 and 7,c7 not more than #be percent of the grant for developing one or more new prescription drugs1 new active pharmaceutical ingredients1 or new antibiotics4 7#c7 ,source of funding ,all amounts used to carry out this section shall be derived from the ,fund4 7e7 ,report ,not later than one year after the date of enactment of this ,act1 and annually thereafter1 the ,secretary of ,health and ,human ,services shall submit to the ,congress a report on the ,fund4 ,each such report shall address the following3 7#a7 ,the amounts deposited into the ,fund in the most recent three fiscal years4 7#b7 ,the distribution of such amounts pursuant to grants under this section during the last three fiscal years1 including the allocation of such amounts for-- 7,a7 new or expanded manufacturing capacity2 7,b7 training workers2 and 7,c7 developing new prescription drugs1 new active pharmaceutical ingredients1 or new antibiotics4 7f7 ,device ,in this section1 the term device has the meaning given to such term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74 7g7 ,sunset ,this section 7other than subsection 7e77 shall cease to have effect beginning on the date that is #aj years after the date of the enactment of this ,act4 7h7 ,unused funds returned to the general fund of the treasury ,if any amounts remain in the ,fund after the date described in subsection 7f71 the ,secretary of the ,treasury shall transfer such amounts to the general fund of the ,treasury4 #f4 ,registry of drugs manufactured outside the ,united ,states ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #ebd;,a of such ,act 7#ba ,u4,s4,c4 #cfjn-#a7 the following new section3 #ebd;,b4 ,registry of drugs manufactured outside the ,united ,states 7a7 ,in general ,the ,secretary shall compile and maintain a registry of all drugs approved under subsection 7c7 or 7j7 of section #eje of this ,act or licensed under sub-section 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act1 and any active pharmaceutical ingredients in such drugs1 that are manufactured outside of the ,united ,states4 ,the ,secretary shall update such registry at least biannually4 7b7 ,additional list 7#a7 ,in general ,in conjunction with the registry under subsection 7a71 the ,secretary shall compile and maintain a list of those drugs included in the registry for which #ej percent or more of their active pharmaceutical ingredients are manufactured in locations within a single country outside the ,united ,states4 7#b7 ,contents ,the list of drugs under paragraph 7#a7 shall-- 7,a7 identify both the drugs and the associated sole-source country2 7,b7 be updated at least bi-annually2 and 7,c7 be publicly available4 7c7 ,requirement ,the registry under subsection 7a7 shall1 with respect to each drug included on the registry1 provide information about the drug's supply chain1 including each step in the supply chain that occurs prior to the drug's importation into the ,united ,states4 4 #g4 ,country-of-origin labeling ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7ee7 ,if it is a drug and its labeling does not specify the country of origin of each active pharmaceutical ingredient contained in the drug4 4