,,ii #aacth ,,congress #b;d ,session ,s4 #bhfb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #ah1 #bjad,mr4 ,hatch 7for himself and ,mr4 ,whitehouse7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,controlled ,substances ,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 ,regulatory ,transparency1 ,patient ,access1 and ,effective ,drug ,enforcement ,act of #bjad4 #b4 ,scheduling of substances included in new ,,fda-approved drugs ,section #bja of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #haa7 is amended by inserting after subsection 7h7 the following3 7i7 ,within #de days of receiving a recommendation from the ,secretary to add a drug or substance that has never been marketed in the ,united ,states to a schedule under this title1 the ,attorney ,general shall1 without regard to the findings required by subsection 7a7 of this section or section #bjb7;b71 issue an interim final rule1 under the exception for good cause described in subparagraph 7,b7 of section #eec7;b7 of title #e1 ,united ,states ,code1 placing the drug or substance into the schedule recommended by the ,secretary4 ,the interim final rule shall be made immediately effective under section #eec7;d77#c7 of title #e1 ,united ,states ,code4 4 #c4 ,enhancing new drug development ,section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7 is amended by inserting after subsection 7g7 the following3 7h7 7#a7 ,a person who submits an application for registration to manufacture or distribute a controlled substance in accordance with this section may indicate on the registration application that the substance will be used only in connection with clinical trials of a drug in accordance with section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7#b7 ,when an application for registration to manufacture or distribute a controlled substance includes an indication that the controlled substance will be used only in connection with clinical trials of a drug in accordance with section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 the ,attorney ,general shall-- 7,a7 make a final decision on the application for registration within #ahj days2 or 7,b7 provide notice to the applicant in writing of-- 7i7 the outstanding issues that must be resolved in order to reach a final decision on the application2 and 7ii7 the estimated date on which a final decision on the application will be made4 4 #d4 ,registration process under ,controlled ,substances ,act 7a7 ,definitions 7#a7 ,factors as may be relevant to and consistent with the public health and safety ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7i7 ,in this section1 the phrase factors as may be relevant to and consistent with the public health and safety means factors that are relevant to and consistent with the findings contained in section #aja4 4 7#b7 ,imminent danger to the public health or safety ,section #cjd7;d7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbd7;d77 is amended-- 7,a7 by striking 7d7 ,the ,attorney ,general and inserting 7d77#a7 ,the ,attorney ,general2 and 7,b7 by adding at the end the following3 7#b7 ,in this subsection1 the phrase imminent danger to the public health or safety means that1 in the absence of an immediate suspension order1 controlled substances will continue to be distributed or dispensed by a registrant who knows or should know through fulfilling the obligations of the registrant under this ,act1 or has reason to believe that-- 7,a7 the dispensing is outside the usual course of professional practice2 7,b7 the distribution or dispensing poses a present or foreseeable risk of adverse health consequences or death due to the abuse or misuse of the controlled substances2 or 7,c7 the controlled substances will continue to be diverted outside of legitimate distribution channels4 4 7b7 ,opportunity ,to submit corrective action plan prior to revocation or suspension ,subsection 7c7 of section #cjd of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbd7 is amended-- 7#a7 by striking the last two sentences2 7#b7 by striking 7c7 ,before and inserting 7c77#a7 ,before2 and 7#c7 by adding at the end the following3 7#b7 ,an order to show cause under paragraph 7#a7 shall-- 7,a7 contain a statement of the basis for the denial1 revocation1 or suspension1 including specific citations to any laws or regulations alleged to be violated by the applicant or registrant2 7,b7 direct the applicant or registrant to appear before the ,attorney ,general at a time and place stated in the order1 but not less than #cj days after the date of receipt of the order2 and 7,c7 notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance4 7#c7 ,upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph 7#b71 the ,attorney ,general shall determine whether denial1 revocation or suspension proceedings should be discontinued1 or deferred for the purposes of modification1 amendment1 or clarification to such plan4 7#d7 ,proceedings to deny1 revoke1 or suspend shall be conducted pursuant to this section in accordance with subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 ,such proceedings shall be independent of1 and not in lieu of1 criminal prosecutions or other proceedings under this title or any other law of the ,united ,states4 7#e7 ,the requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection 7d74 4 #e4 ,report to ,congress on effects of law enforcement activities on patient access to medications 7a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs and the ,director of the ,centers for ,disease ,control and ,prevention1 and in consultation with the ,administrator of the ,drug ,enforcement ,administration and the ,director of ,national ,drug ,control ,policy1 shall submit a report to the ,committees on the ,judiciary of the ,house of ,representatives1 the ,committee on ,energy and ,commerce of the ,house of ,representatives1 the ,committee on the ,judiciary of the ,senate1 and the ,committee on ,health1 ,education1 ,labor and ,pensions of the ,senate identifying-- 7#a7 obstacles to legitimate patient access to controlled substances2 7#b7 issues with diversion of controlled substances2 and 7#c7 how collaboration between ,federal1 ,state1 local1 and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances4 7b7 ,consultation ,the report under subsection 7a7 shall incorporate feedback and recommendations from the following3 7#a7 ,patient groups4 7#b7 ,pharmacies4 7#c7 ,drug manufacturers4 7#d7 ,common or contract carriers and warehousemen4 7#e7 ,hospitals1 physicians1 and other health care providers4 7#f7 ,state attorneys general4 7#g7 ,federal1 ,state1 local1 and tribal law enforcement agencies4 7#h7 ,health insurance providers and entities that provide pharmacy benefit management services on behalf of a health insurance provider4 7#i7 ,wholesale drug distributors4