#aadth ,,congress #b;d ,session ,s4 #dhc ,,an ,,act ,to improve enforcement efforts related to prescription drug diversion and abuse1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,ensuring ,patient ,access and ,effective ,drug ,enforcement ,act of #bjaf4 #b4 ,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 7j7 ,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 due to the failure of the registrant to maintain effective controls against diversion or otherwise comply with the obligations of a registrant under this title or title ,,iii1 there is a substantial likelihood of an immediate threat that death1 serious bodily harm1 or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration4 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 three 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 revocation1 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 #c4 ,report to ,congress 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 ,drugs1 the ,administrator of the ,substance ,abuse and ,mental ,health ,services ,administration1 the ,director of the ,agency for ,healthcare ,research and ,quality1 and the ,director of the ,centers for ,disease ,control and ,prevention1 in coordination with the ,administrator of the ,drug ,enforcement ,administration and in consultation with the ,secretary of ,defense and the ,secretary of ,veterans ,affairs1 shall submit a report to the ,committee 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 ,labor1 and ,pensions of the ,senate identifying-- 7#a7 obstacles to legitimate patient access to controlled substances2 7#b7 issues with diversion of controlled substances2 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 substances2 7#d7 the availability of medical education1 training opportunities1 and comprehensive clinical guidance for pain management and opioid prescribing1 and any gaps that should be addressed2 7#e7 beneficial enhancements to ,state prescription drug monitoring programs1 including enhancements to require comprehensive prescriber input and to expand access to the programs for appropriate authorized users2 and 7#f7 steps to improve reporting requirements so that the public and ,congress have more information regarding prescription opioids1 such as the volume and formulation of prescription opioids prescribed annually1 the dispensing of such prescription opioids1 and outliers and trends within large data sets4 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 7#aj7 ,veterinarians4 7#aa7 ,professional medical societies and boards4 7#ab7 ,state and local public health authorities4 7#ac7 ,health services research organizations4 ,passed the ,senate ,march #ag1 #bjaf4,secretary