,,ii ,calendar ,no4 #bde #aadth ,,congress #ast ,session ,s4 #dha ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #ab1 #bjae,mr4 ,hatch 7for himself1 ,mr4 ,whitehouse1 and ,mrs4 ,murray7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,october #a1 #bjae,reported by ,mr4 ,alexander1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,controlled ,substances ,act and the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to drug scheduling recommendations by the ,secretary of ,health and ,human ,services1 and with respect to registration of manufacturers and distributors seeking to conduct clinical testing1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,improving ,regulatory ,transparency for ,new ,medical ,therapies ,act4 #b4 ,scheduling of substances included in new ,,fda-approved drugs 7a7 ,effective date of approval 7#a7 ,effective date of drug approval ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7x7 ,date of approval in the case of recommended controls under the ,,csa 7#a7 ,in general ,in the case of an application under subsection 7b7 with respect to a drug for which the ,secretary provides notice to the sponsor that the ,secretary intends to recommend controls under the ,controlled ,substances ,act1 approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 7#b7 ,date of approval ,for purposes of this section1 with respect to an application described in paragraph 7#a71 the term date of approval shall mean the later of-- 7,a7 the date an application under subsection 7b7 is approved under subsection 7c72 or 7,b7 the date of issuance of the interim final rule controlling the drug4 4 7#b7 ,effective date of approval of biological products ,section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by adding at the end the following3 7n7 ,date of approval in the case of recommended controls under the ,,csa 7#a7 ,in general ,in the case of an application under subsection 7a7 with respect to a biological product for which the ,secretary provides notice to the sponsor that the ,secretary intends to recommend controls under the ,controlled ,substances ,act1 approval of such application shall not take effect until the interim final rule controlling the biological product is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 7#b7 ,date of approval ,for purposes of this section1 with respect to an application described in paragraph 7#a71 references to the date of approval of such application1 or licensure of the product subject to such application1 shall mean the later of-- 7,a7 the date an application is approved under subsection 7a72 or 7,b7 the date of issuance of the interim final rule controlling the biological product4 4 7#c7 ,effective date of approval of animal drugs 7,a7 ,in general ,section #eab of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7 is amended by adding at the end the following3 7q7 ,date of approval in the case of recommended controls under the ,,csa 7#a7 ,in general ,in the case of an application under subsection 7b7 with respect to a drug for which the ,secretary provides notice to the sponsor that the ,secretary intends to recommend controls under the ,controlled ,substances ,act1 approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 7#b7 ,date of approval ,for purposes of this section1 with respect to an application described in paragraph 7#a71 the term date of approval shall mean the later of-- 7,a7 the date an application under subsection 7b7 is approved under subsection 7c72 or 7,b7 the date of issuance of the interim final rule controlling the drug4 4 7,b7 ,conditional approval ,section #ega7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc7d77 is amended by adding at the end the following3 7#d7 7,a7 ,in the case of an application under subsection 7a7 with respect to a drug for which the ,secretary provides notice to the sponsor that the ,secretary intends to recommend controls under the ,controlled ,substances ,act1 conditional approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 7,b7 ,for purposes of this section1 with respect to an application described in subparagraph 7,a71 the term date of approval shall mean the later of-- 7i7 the date an application under subsection 7a7 is conditionally approved under subsection 7b72 or 7ii7 the date of issuance of the interim final rule controlling the drug4 4 7,c7 ,indexing of legally marketed unapproved new animal drugs ,section #egb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc-#a7 is amended by adding at the end the following3 7k7 ,in the case of a request under subsection 7d7 to add a drug to the index under subsection 7a7 with respect to a drug for which the ,secretary provides notice to the person filing the request that the ,secretary intends to recommend controls under the ,controlled ,substances ,act1 a determination to grant the request to add such drug to the index shall not take effect1 and the ,secretary shall not list the drug on such index1 until the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 4 7#d7 ,date of approval for designated new animal drugs ,section #egc7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc-#b7;c77 is amended by adding at the end the following3 7#c7 ,for purposes of determining the #g-year period of exclusivity under paragraph 7#a7 for a drug for which the ,secretary intends to recommend controls under the ,controlled ,substances ,act1 the drug shall not be considered approved or conditionally approved until the date that the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 4 7b7 ,scheduling of newly approved drugs ,section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 is amended by inserting after subsection 7i7 the following3 7j7 7#a7 ,with respect to a drug referred to in subsection 7f71 if the ,secretary of ,health and ,human ,services recommends that the ,attorney ,general add the drug to schedule ,,ii1 ,,iii1 ,,iv1 or ,v pursuant to subsections 7a7 and 7b71 the ,attorney ,general shall1 not later than #ij days after the date described in paragraph 7#b71 issue an interim final rule controlling the drug in accordance with such subsections and section #bjb7;b7 using the procedures described in paragraph 7#c74 7#b7 ,the date described in this paragraph shall be the later of-- 7,a7 the date on which the ,attorney ,general receives the scientific and medical evaluation and recommendations from the ,secretary of ,health and ,human ,services in accordance with subsection 7b72 or 7,b7 the date on which the ,attorney ,general receives notification from the ,secretary of ,health and ,human ,services that the ,secretary has approved an application under section #eje7;c71 #eab1 #ega1 or #egb of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 of the ,public ,health ,service ,act with respect to the drug described in paragraph 7#a74 7#c7 ,a rule issued by the ,attorney ,general under paragraph 7#a7 shall be in accordance with the procedures provided in subsection 7a71 except that the rule shall become immediately effective as an interim final rule without requiring the ,attorney ,general to demonstrate good cause therefor4 ,after publication of the interim final rule1 the ,attorney ,general shall issue a final rule in accordance with the procedures provided in subsection 7a74 4 7c7 ,extension of patent term ,section #aef of title #ce1 ,united ,states ,code1 is amended-- 7#a7 in subsection 7d77#a71 in the matter preceding subparagraph 7,a71 by inserting 1 or in the case of a drug product described in subsection 7i7 within the sixty-day period beginning on the covered date 7as defined in subsection 7i77 after marketing or use2 and 7#b7 by adding at the end the following3 7i7 7#a7 ,for purposes of this section1 if the ,secretary of ,health and ,human ,services provides notice to the sponsor of an application or request for approval1 conditional approval1 or indexing of a drug product for which the ,secretary intends to recommend controls under the ,controlled ,substances ,act1 beginning on the covered date1 the drug product shall be considered to-- 7,a7 have been approved2 and 7,b7 have permission for commercial marketing or use4 7#b7 ,in this subsection1 the term covered date means the later of-- 7,a7 the date an application is approved-- 7i7 under section #cea7;a77#b77;,c7 of the ,public ,health ,service ,act2 or 7ii7 under section #eje7;b7 or #eab7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,b7 the date an application is conditionally approved under section #ega7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,c7 the date a request for indexing is granted under section #egb7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7,d7 the date of issuance of the interim final rule controlling the drug under section #bja7;j7 of the ,controlled ,substances ,act4 4 #c4 ,enhancing new drug development ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7i7 7#a7 ,for purposes of registration to manufacture a controlled substance under subsection 7d7 for use only in a clinical trial1 the ,attorney ,general shall register the applicant1 or serve an order to show cause upon the applicant in accordance with section #cjd7;c71 not later than #ahj days after the date on which the application is accepted for filing4 7#b7 ,for purposes of registration to manufacture a controlled substance under subsection 7a7 for use only in a clinical trial1 the ,attorney ,general shall1 in accordance with the regulations issued by the ,attorney ,general1 issue a notice of application not later than #ij days after the application is accepted for filing4 ,not later than #ij days after the date on which the period for comment pursuant to such notice ends1 the ,attorney ,general shall register the applicant1 or serve an order to show cause upon the applicant in accordance with section #cjd7;c71 unless the ,attorney ,general has granted a hearing on the application under section #ajjh7;i7 of the ,controlled ,substances ,import and ,export ,act4 4 #a4 ,short title ,this ,act may be cited as the ,improving ,regulatory ,transparency for ,new ,medical ,therapies ,act4 #b4 ,scheduling of substances included in new ,,fda-approved drugs 7a7 ,effective date of approval 7#a7 ,effective date of drug approval ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7x7 ,date of approval in the case of recommended controls under the ,,csa 7#a7 ,in general ,in the case of an application under subsection 7b7 with respect to a drug for which the ,secretary provides notice to the sponsor that the ,secretary intends to issue a scientific and medical evaluation and recommend controls under the ,controlled ,substances ,act1 approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 7#b7 ,date of approval ,for purposes of this section1 with respect to an application described in paragraph 7#a71 the term date of approval shall mean the later of-- 7,a7 the date an application under subsection 7b7 is approved under subsection 7c72 or 7,b7 the date of issuance of the interim final rule controlling the drug4 4 7#b7 ,effective date of approval of biological products ,section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by adding at the end the following3 7n7 ,date of approval in the case of recommended controls under the ,,csa 7#a7 ,in general ,in the case of an application under subsection 7a7 with respect to a biological product for which the ,secretary provides notice to the sponsor that the ,secretary intends to issue a scientific and medical evaluation and recommend controls under the ,controlled ,substances ,act1 approval of such application shall not take effect until the interim final rule controlling the biological product is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 7#b7 ,date of approval ,for purposes of this section1 with respect to an application described in paragraph 7#a71 references to the date of approval of such application1 or licensure of the product subject to such application1 shall mean the later of-- 7,a7 the date an application is approved under subsection 7a72 or 7,b7 the date of issuance of the interim final rule controlling the biological product4 4 7#c7 ,effective date of approval of animal drugs 7,a7 ,in general ,section #eab of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;b7 is amended by adding at the end the following3 7q7 ,date of approval in the case of recommended controls under the ,,csa 7#a7 ,in general ,in the case of an application under subsection 7b7 with respect to a drug for which the ,secretary provides notice to the sponsor that the ,secretary intends to issue a scientific and medical evaluation and recommend controls under the ,controlled ,substances ,act1 approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 7#b7 ,date of approval ,for purposes of this section1 with respect to an application described in paragraph 7#a71 the term date of approval shall mean the later of-- 7,a7 the date an application under subsection 7b7 is approved under subsection 7c72 or 7,b7 the date of issuance of the interim final rule controlling the drug4 4 7,b7 ,conditional approval ,section #ega7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc7d77 is amended by adding at the end the following3 7#d7 7,a7 ,in the case of an application under subsection 7a7 with respect to a drug for which the ,secretary provides notice to the sponsor that the ,secretary intends to issue a scientific and medical evaluation and recommend controls under the ,controlled ,substances ,act1 conditional approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 7,b7 ,for purposes of this section1 with respect to an application described in subparagraph 7,a71 the term date of approval shall mean the later of-- 7i7 the date an application under subsection 7a7 is conditionally approved under subsection 7b72 or 7ii7 the date of issuance of the interim final rule controlling the drug4 4 7,c7 ,indexing of legally marketed unapproved new animal drugs ,section #egb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc-#a7 is amended by adding at the end the following3 7k7 ,in the case of a request under subsection 7d7 to add a drug to the index under subsection 7a7 with respect to a drug for which the ,secretary provides notice to the person filing the request that the ,secretary intends to issue a scientific and medical evaluation and recommend controls under the ,controlled ,substances ,act1 a determination to grant the request to add such drug to the index shall not take effect until the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 4 7#d7 ,date of approval for designated new animal drugs ,section #egc7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc-#b7;c77 is amended by adding at the end the following3 7#c7 ,for purposes of determining the #g-year period of exclusivity under paragraph 7#a7 for a drug for which the ,secretary intends to issue a scientific and medical evaluation and recommend controls under the ,controlled ,substances ,act1 the drug shall not be considered approved or conditionally approved until the date that the interim final rule controlling the drug is issued in accordance with section #bja7;j7 of the ,controlled ,substances ,act4 4 7b7 ,scheduling of newly approved drugs ,section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 is amended by inserting after subsection 7i7 the following3 7j7 7#a7 ,with respect to a drug referred to in subsection 7f71 if the ,secretary of ,health and ,human ,services recommends that the ,attorney ,general control the drug in schedule ,,ii1 ,,iii1 ,,iv1 or ,v pursuant to subsections 7a7 and 7b71 the ,attorney ,general shall1 not later than #ij days after the date described in paragraph 7#b71 issue an interim final rule controlling the drug in accordance with such subsections and section #bjb7;b7 using the procedures described in paragraph 7#c74 7#b7 ,the date described in this paragraph shall be the later of-- 7,a7 the date on which the ,attorney ,general receives the scientific and medical evaluation and the scheduling recommendation from the ,secretary of ,health and ,human ,services in accordance with subsection 7b72 or 7,b7 the date on which the ,attorney ,general receives notification from the ,secretary of ,health and ,human ,services that the ,secretary has approved an application under section #eje7;c71 #eab1 or #ega of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 of the ,public ,health ,service ,act1 or indexed a drug under section #egb of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 with respect to the drug described in paragraph 7#a74 7#c7 ,a rule issued by the ,attorney ,general under paragraph 7#a7 shall become immediately effective as an interim final rule without requiring the ,attorney ,general to demonstrate good cause therefor4 ,the interim final rule shall give interested persons the opportunity to comment and to request a hearing4 ,after the conclusion of such proceedings1 the ,attorney ,general shall issue a final rule in accordance with the scheduling criteria of subsections 7b71 7c71 and 7d7 of this section and section #bjb7;b74 4 7c7 ,extension of patent term ,section #aef of title #ce1 ,united ,states ,code1 is amended-- 7#a7 in subsection 7d77#a71 in the matter preceding subparagraph 7,a71 by inserting 1 or in the case of a drug product described in subsection 7i71 within the sixty-day period beginning on the covered date 7as defined in subsection 7i77 after marketing or use2 and 7#b7 by adding at the end the following3 7i7 7#a7 ,for purposes of this section1 if the ,secretary of ,health and ,human ,services provides notice to the sponsor of an application or request for approval1 conditional approval1 or indexing of a drug product for which the ,secretary intends to recommend controls under the ,controlled ,substances ,act1 beginning on the covered date1 the drug product shall be considered to-- 7,a7 have been approved or indexed under the relevant provision of the ,public ,health ,service ,act or ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7,b7 have permission for commercial marketing or use4 7#b7 ,in this subsection1 the term covered date means the later of-- 7,a7 the date an application is approved-- 7i7 under section #cea7;a77#b77;,c7 of the ,public ,health ,service ,act2 or 7ii7 under section #eje7;b7 or #eab7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,b7 the date an application is conditionally approved under section #ega7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,c7 the date a request for indexing is granted under section #egb7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 or 7,d7 the date of issuance of the interim final rule controlling the drug under section #bja7;j7 of the ,controlled ,substances ,act4 4 #c4 ,enhancing new drug development ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7i7 7#a7 ,for purposes of registration to manufacture a controlled substance under subsection 7d7 for use only in a clinical trial1 the ,attorney ,general shall register the applicant1 or serve an order to show cause upon the applicant in accordance with section #cjd7;c71 not later than #ahj days after the date on which the application is accepted for filing4 7#b7 ,for purposes of registration to manufacture a controlled substance under subsection 7a7 for use only in a clinical trial1 the ,attorney ,general shall1 in accordance with the regulations issued by the ,attorney ,general1 issue a notice of application not later than #ij days after the application is accepted for filing4 ,not later than #ij days after the date on which the period for comment pursuant to such notice ends1 the ,attorney ,general shall register the applicant1 or serve an order to show cause upon the applicant in accordance with section #cjd7;c71 unless the ,attorney ,general has granted a hearing on the application under section #ajjh7;i7 of the ,controlled ,substances ,import and ,export ,act4 4 #d4 ,re-,exportation ,among ,members of the ,european ,economic ,area ,section #ajjc of the ,controlled ,substances ,import and ,export ,act 7#ba ,u4,s4,c4 #iec7 is amended-- 7#a7 in subsection7f7-- 7,a7 in paragraph 7#e7-- 7i7 by striking 7#e7 and inserting 7#e77;,a72 7ii7 by inserting 1 except that the controlled substance may be exported from a second country that is a member of the ,european ,economic ,area to another country that is a member of the ,european ,economic ,area1 provided that the first country is also a member of the ,european ,economic ,area before the period at the end2 and 7iii7 by adding at the end the following3 7,b7 ,subsequent to any re-exportation described in subparagraph 7,a71 a controlled substance may continue to be exported from any country that is a member of the ,european ,economic ,area to any other such country1 if-- 7i7 the conditions applicable with respect to the first country under paragraphs 7#a71 7#b71 7#c71 7#d71 7#f71 and 7#g7 are met by each subsequent country from which the controlled substance is exported pursuant to this paragraph2 and 7ii7 the conditions applicable with respect to the second country under paragraphs 7#a71 7#b71 7#c71 7#d71 7#f71 and 7#g7 are met by each subsequent country to which the controlled substance is exported pursuant to this paragraph4 2 and 7,b7 in paragraph 7#f7-- 7i7 by striking 7#f7 and inserting 7#f77;,a72 and 7ii7 by adding at the end the following3 7,b7 ,in the case of re-exportation among members of the ,european ,economic ,area1 within #cj days after each re-exportation1 the person who exported the controlled substance from the ,united ,states delivers to the ,attorney ,general-- 7i7 documentation certifying that such re-exportation has occurred2 and 7ii7 information concerning the consignee1 country1 and product4 2 and 7#b7 by adding at the end the following3 7g7 ,limitation ,subject to paragraphs 7#e7 and 7#f7 of subsection 7f7 in the case of any controlled substance in schedule ,i or ,,ii or any narcotic drug in schedule ,,iii or ,,iv1 the ,attorney ,general shall not promulgate nor enforce any regulation1 subregulatory guidance1 or enforcement policy which impedes re-exportation of any controlled substance among ,european ,economic ,area countries1 including by promulgating or enforcing any requirement that-- 7#a7 re-exportation from the first country to the second country or re-exportation from the second country to another country occur within a specified period of time2 or 7#b7 information concerning the consignee1 country1 and product be provided prior to exportation of the controlled substance from the ,united ,states or prior to each re-exportation among members of the ,european ,economic ,area4 4 ,october #a1 #bjae,reported with an amendment