Ensuring Patient Access and Effective Drug Enforcement Act of 2016

Bill: 114-s-483
Sponsor: full_name: Sen. Hatch, Orrin G. [R-UT]
Introduced: 2015-02-12
Policy area: Crime and Law Enforcement
Subjects: Administrative remedies

Congressional oversight

Crime prevention

Criminal investigation, prosecution, interrogation

Department of Justice

Drug trafficking and controlled substances

Government information and archives

Government studies and investigations

Health care coverage and access

Licensing and registrations

Medical education

Prescription drugs

Retail and wholesale trades
Latest action: action_date: 2016-04-19
text: Became Public Law No: 114-145.

Summaries:
action_date: 2015-02-12
action_desc: Introduced in Senate
text: <p><b>Ensuring Patient Access and Effective Drug Enforcement Act of 2015</b></p> <p> Amends the Controlled Substances Act to define: (1) "factors as may be relevant to and consistent with the public health and safety," for purposes of the Attorney General's determination of whether registering an applicant to manufacture or distribute a controlled substance in schedule I or II is in the public interest, as factors that are relevant to and consistent with the findings of such Act; and (2) "imminent danger to the public health or safety," for purposes of the suspension of such a registration, to mean that in the absence of an immediate suspension order, 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 such Act, that the dispensing is outside the usual course of professional practice, that 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 substances, or that the controlled substances will continue to be diverted outside of legitimate distribution channels.</p> <p>Requires an order to show cause as to why such a registration should not be denied, revoked, or suspended to: (1) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated; (2) direct the applicant or registrant to appear before the Attorney General at a specific place and time within 30 days after receipt of the order; and (3) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before such appearance. Requires the Attorney General, upon review of any such plan, to determine whether denial, revocation, or suspension proceedings should be discontinued or deferred for purposes of modifications to such plan. Makes such requirements inapplicable to the issuance of an immediate suspension order.</p> <p>Directs the Department of Health and Human Services, acting through the Food and Drug Administration and the Centers for Disease Control and Prevention, to submit a report identifying: (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between federal, state, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.</p>

action_date: 2016-02-11
action_desc: Reported to Senate with amendment(s)
text: <p><b>Ensuring Patient Access and Effective Drug Enforcement Act of 2016</b></p> <p>(Sec. 2) This bill amends the Controlled Substances Act to define phrases related to the Drug Enforcement Administration's (DEA's) authority to register manufacturers, distributors, and dispensers of controlled substances.</p> <p>Currently, the DEA registers a controlled substances manufacturer, distributor, or dispenser if it is in the public interest after considering certain factors, including factors relevant to and consistent with the public health and safety. This bill defines "factors as may be relevant to and consistent with the public health and safety" to mean factors relevant to and consistent with the specified purposes of the Controlled Substances Act.</p> <p>Additionally, current law allows the DEA to immediately suspend a registration to prevent imminent danger to the public health and safety. This bill defines "imminent danger to the public health and safety" to mean an immediate threat of death, serious bodily harm, or abuse of a controlled substance due to a registrant's failure to maintain effective controls against diversion.</p> <p>The bill revises and expands the required elements of an order to show cause issued by the DEA before it denies, revokes, or suspends a registration for a Controlled Substances Act violation. An order to show cause must specifically state the legal basis for the action and notify the registrant of the opportunity to submit a corrective action plan. </p> <p>(Sec. 3) The Food and Drug Administration, the Substance Abuse and Mental Health Services Administration, the Agency for Research and Quality, and the Centers for Disease Control and Prevention, in coordination with the DEA, must report to Congress on:</p> <ul> <li>obstacles to legitimate patient access to controlled substances; </li> <li>diversion of controlled substances; </li> <li>how collaboration between law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances; </li> <li>the availability of and gaps in medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing; </li> <li>enhancements to prescription drug monitoring programs; and </li> <li>improvements to prescription opioid reporting requirements.</li> </ul>

action_date: 2016-04-19
action_desc: Public Law
text: <p>(This measure has not been amended since it was reported to the Senate on February 11, 2016. The summary of that version is repeated here.)</p> <p><b>Ensuring Patient Access and Effective Drug Enforcement Act of 2016</b></p> <p>(Sec. 2) This bill amends the Controlled Substances Act to define phrases related to the Drug Enforcement Administration's (DEA's) authority to register manufacturers, distributors, and dispensers of controlled substances.</p> <p>Currently, the DEA registers a controlled substances manufacturer, distributor, or dispenser if it is in the public interest after considering certain factors, including factors relevant to and consistent with the public health and safety. This bill defines "factors as may be relevant to and consistent with the public health and safety" to mean factors relevant to and consistent with the specified purposes of the Controlled Substances Act.</p> <p>Additionally, current law allows the DEA to immediately suspend a registration to prevent imminent danger to the public health and safety. This bill defines "imminent danger to the public health and safety" to mean an immediate threat of death, serious bodily harm, or abuse of a controlled substance due to a registrant's failure to maintain effective controls against diversion.</p> <p>The bill revises and expands the required elements of an order to show cause issued by the DEA before it denies, revokes, or suspends a registration for a Controlled Substances Act violation. An order to show cause must specifically state the legal basis for the action and notify the registrant of the opportunity to submit a corrective action plan. </p> <p>(Sec. 3) The Food and Drug Administration, the Substance Abuse and Mental Health Services Administration, the Agency for Research and Quality, and the Centers for Disease Control and Prevention, in coordination with the DEA, must report to Congress on:</p> <ul> <li>obstacles to legitimate patient access to controlled substances; </li> <li>diversion of controlled substances; </li> <li>how collaboration between law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances; </li> <li>the availability of and gaps in medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing; </li> <li>enhancements to prescription drug monitoring programs; and </li> <li>improvements to prescription opioid reporting requirements.</li> </ul>

tv_txt: II 114th CONGRESS 1st Session S. 483 IN THE SENATE OF THE UNITED STATES February 12, 2015 Mr. Hatch (for himself and Mr. Whitehouse ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary A BILL To improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 . 2. Registration process under Controlled Substances Act (a) Definitions (1) Factors as may be relevant to and consistent with the public health and safety Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (i) In this section, 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 101. . (2) Imminent danger to the public health or safety Section 304(d) of the Controlled Substances Act ( 21 U.S.C. 824(d) ) is amended— (A) by striking (d) The Attorney General and inserting (d)(1) The Attorney General ; and (B) by adding at the end the following: (2) In this subsection, the phrase imminent danger to the public health or safety means that, in the absence of an immediate suspension order, 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 Act— (A) the dispensing is outside the usual course of professional practice; (B) 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 substances; or (C) the controlled substances will continue to be diverted outside of legitimate distribution channels. . (b) Opportunity To submit corrective action plan prior to revocation or suspension Subsection (c) of section 304 of the Controlled Substances Act ( 21 U.S.C. 824 ) is amended— (1) by striking the last two sentences; (2) by striking (c) Before and inserting (c)(1) Before ; and (3) by adding at the end the following: (2) An order to show cause under paragraph (1) shall— (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant; (B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. (3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan. (4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5, United States Code. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this title or any other law of the United States. (5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d). . 3. Report to Congress on effects of law enforcement activities on patient access to medications (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention, in coordination with the Administrator of the Drug Enforcement Administration and in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, shall submit a report to the Committee on the Judiciary of the House of Representatives, the Committee on Energy and Commerce of the House of Representatives, the Committee on the Judiciary of the Senate, and the Committee on Health, Education, Labor, and Pensions of the Senate identifying— (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between Federal, State, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances. (b) Consultation The report under subsection (a) shall incorporate feedback and recommendations from the following: (1) Patient groups. (2) Pharmacies. (3) Drug manufacturers. (4) Common or contract carriers and warehousemen. (5) Hospitals, physicians, and other health care providers. (6) State attorneys general. (7) Federal, State, local, and tribal law enforcement agencies. (8) Health insurance providers and entities that provide pharmacy benefit management services on behalf of a health insurance provider. (9) Wholesale drug distributors. (10) Veterinarians.

tv_txt: II Calendar No. 368 114th CONGRESS 2d Session S. 483 IN THE SENATE OF THE UNITED STATES February 12, 2015 Mr. Hatch (for himself, Mr. Whitehouse , Mr. Rubio , Mr. Vitter , and Mr. Cassidy ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary February 11, 2016 Reported by Mr. Grassley , with an amendment Strike out all after the enacting clause and insert the part printed in italic A BILL To improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 . 2. Registration process under Controlled Substances Act (a) Definitions (1) Factors as may be relevant to and consistent with the public health and safety Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (i) In this section, 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 101. . (2) Imminent danger to the public health or safety Section 304(d) of the Controlled Substances Act ( 21 U.S.C. 824(d) ) is amended— (A) by striking (d) The Attorney General and inserting (d)(1) The Attorney General ; and (B) by adding at the end the following: (2) In this subsection, the phrase imminent danger to the public health or safety means that, in the absence of an immediate suspension order, 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 Act— (A) the dispensing is outside the usual course of professional practice; (B) 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 substances; or (C) the controlled substances will continue to be diverted outside of legitimate distribution channels. . (b) Opportunity To submit corrective action plan prior to revocation or suspension Subsection (c) of section 304 of the Controlled Substances Act ( 21 U.S.C. 824 ) is amended— (1) by striking the last two sentences; (2) by striking (c) Before and inserting (c)(1) Before ; and (3) by adding at the end the following: (2) An order to show cause under paragraph (1) shall— (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant; (B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. (3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan. (4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5, United States Code. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this title or any other law of the United States. (5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d). . 3. Report to Congress on effects of law enforcement activities on patient access to medications (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention, in coordination with the Administrator of the Drug Enforcement Administration and in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, shall submit a report to the Committee on the Judiciary of the House of Representatives, the Committee on Energy and Commerce of the House of Representatives, the Committee on the Judiciary of the Senate, and the Committee on Health, Education, Labor, and Pensions of the Senate identifying— (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; and (3) how collaboration between Federal, State, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances. (b) Consultation The report under subsection (a) shall incorporate feedback and recommendations from the following: (1) Patient groups. (2) Pharmacies. (3) Drug manufacturers. (4) Common or contract carriers and warehousemen. (5) Hospitals, physicians, and other health care providers. (6) State attorneys general. (7) Federal, State, local, and tribal law enforcement agencies. (8) Health insurance providers and entities that provide pharmacy benefit management services on behalf of a health insurance provider. (9) Wholesale drug distributors. (10) Veterinarians.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 . 2. Registration process under Controlled Substances Act (a) Definitions (1) Factors as may be relevant to and consistent with the public health and safety Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (j) In this section, 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 101. . (2) Imminent danger to the public health or safety Section 304(d) of the Controlled Substances Act ( 21 U.S.C. 824(d) ) is amended— (A) by striking (d) The Attorney General and inserting (d)(1) The Attorney General ; and (B) by adding at the end the following: (2) In this subsection, the phrase imminent danger to the public health or safety means that, 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 III, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration. . (b) Opportunity To submit corrective action plan prior to revocation or suspension Subsection (c) of section 304 of the Controlled Substances Act ( 21 U.S.C. 824 ) is amended— (1) by striking the last three sentences; (2) by striking (c) Before and inserting (c)(1) Before ; and (3) by adding at the end the following: (2) An order to show cause under paragraph (1) shall— (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant; (B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. (3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan. (4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5, United States Code. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this title or any other law of the United States. (5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d). . 3. Report to Congress (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Agency for Healthcare Research and Quality, and the Director of the Centers for Disease Control and Prevention, in coordination with the Administrator of the Drug Enforcement Administration and in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, shall submit a report to the Committee on the Judiciary of the House of Representatives, the Committee on Energy and Commerce of the House of Representatives, the Committee on the Judiciary of the Senate, and the Committee on Health, Education, Labor, and Pensions of the Senate identifying— (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; (3) how collaboration between Federal, State, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances; (4) the availability of medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing, and any gaps that should be addressed; (5) beneficial enhancements to State prescription drug monitoring programs, including enhancements to require comprehensive prescriber input and to expand access to the programs for appropriate authorized users; and (6) steps to improve reporting requirements so that the public and Congress have more information regarding prescription opioids, such as the volume and formulation of prescription opioids prescribed annually, the dispensing of such prescription opioids, and outliers and trends within large data sets. (b) Consultation The report under subsection (a) shall incorporate feedback and recommendations from the following: (1) Patient groups. (2) Pharmacies. (3) Drug manufacturers. (4) Common or contract carriers and warehousemen. (5) Hospitals, physicians, and other health care providers. (6) State attorneys general. (7) Federal, State, local, and tribal law enforcement agencies. (8) Health insurance providers and entities that provide pharmacy benefit management services on behalf of a health insurance provider. (9) Wholesale drug distributors. (10) Veterinarians. (11) Professional medical societies and boards. (12) State and local public health authorities. (13) Health services research organizations.

February 11, 2016 Reported with an amendment

tv_txt: 114th CONGRESS 2d Session S. 483 IN THE SENATE OF THE UNITED STATES AN ACT To improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 . 2. Registration process under Controlled Substances Act (a) Definitions (1) Factors as may be relevant to and consistent with the public health and safety Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (j) In this section, 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 101. . (2) Imminent danger to the public health or safety Section 304(d) of the Controlled Substances Act ( 21 U.S.C. 824(d) ) is amended— (A) by striking (d) The Attorney General and inserting (d)(1) The Attorney General ; and (B) by adding at the end the following: (2) In this subsection, the phrase imminent danger to the public health or safety means that, 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 III, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration. . (b) Opportunity To submit corrective action plan prior to revocation or suspension Subsection (c) of section 304 of the Controlled Substances Act ( 21 U.S.C. 824 ) is amended— (1) by striking the last three sentences; (2) by striking (c) Before and inserting (c)(1) Before ; and (3) by adding at the end the following: (2) An order to show cause under paragraph (1) shall— (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant; (B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. (3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan. (4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5, United States Code. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this title or any other law of the United States. (5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d). . 3. Report to Congress (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Agency for Healthcare Research and Quality, and the Director of the Centers for Disease Control and Prevention, in coordination with the Administrator of the Drug Enforcement Administration and in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, shall submit a report to the Committee on the Judiciary of the House of Representatives, the Committee on Energy and Commerce of the House of Representatives, the Committee on the Judiciary of the Senate, and the Committee on Health, Education, Labor, and Pensions of the Senate identifying— (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; (3) how collaboration between Federal, State, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances; (4) the availability of medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing, and any gaps that should be addressed; (5) beneficial enhancements to State prescription drug monitoring programs, including enhancements to require comprehensive prescriber input and to expand access to the programs for appropriate authorized users; and (6) steps to improve reporting requirements so that the public and Congress have more information regarding prescription opioids, such as the volume and formulation of prescription opioids prescribed annually, the dispensing of such prescription opioids, and outliers and trends within large data sets. (b) Consultation The report under subsection (a) shall incorporate feedback and recommendations from the following: (1) Patient groups. (2) Pharmacies. (3) Drug manufacturers. (4) Common or contract carriers and warehousemen. (5) Hospitals, physicians, and other health care providers. (6) State attorneys general. (7) Federal, State, local, and tribal law enforcement agencies. (8) Health insurance providers and entities that provide pharmacy benefit management services on behalf of a health insurance provider. (9) Wholesale drug distributors. (10) Veterinarians. (11) Professional medical societies and boards. (12) State and local public health authorities. (13) Health services research organizations.

Passed the Senate March 17, 2016. Secretary

tv_txt: One Hundred Fourteenth Congress of the United States of America 2d Session Begun and held at the City of Washington on Monday, the fourth day of January, two thousand and sixteen S. 483 IN THE SENATE OF THE UNITED STATES AN ACT To improve enforcement efforts related to prescription drug diversion and abuse, and for other purposes.

1. Short title This Act may be cited as the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 . 2. Registration process under Controlled Substances Act (a) Definitions (1) Factors as may be relevant to and consistent with the public health and safety Section 303 of the Controlled Substances Act ( 21 U.S.C. 823 ) is amended by adding at the end the following: (j) In this section, 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 101. . (2) Imminent danger to the public health or safety Section 304(d) of the Controlled Substances Act ( 21 U.S.C. 824(d) ) is amended— (A) by striking (d) The Attorney General and inserting (d)(1) The Attorney General ; and (B) by adding at the end the following: (2) In this subsection, the phrase imminent danger to the public health or safety means that, 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 III, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance will occur in the absence of an immediate suspension of the registration. . (b) Opportunity To submit corrective action plan prior to revocation or suspension Subsection (c) of section 304 of the Controlled Substances Act ( 21 U.S.C. 824 ) is amended— (1) by striking the last three sentences; (2) by striking (c) Before and inserting (c)(1) Before ; and (3) by adding at the end the following: (2) An order to show cause under paragraph (1) shall— (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant; (B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. (3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to paragraph (2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan. (4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of chapter 5 of title 5, United States Code. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this title or any other law of the United States. (5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under subsection (d). . 3. Report to Congress (a) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Agency for Healthcare Research and Quality, and the Director of the Centers for Disease Control and Prevention, in coordination with the Administrator of the Drug Enforcement Administration and in consultation with the Secretary of Defense and the Secretary of Veterans Affairs, shall submit a report to the Committee on the Judiciary of the House of Representatives, the Committee on Energy and Commerce of the House of Representatives, the Committee on the Judiciary of the Senate, and the Committee on Health, Education, Labor, and Pensions of the Senate identifying— (1) obstacles to legitimate patient access to controlled substances; (2) issues with diversion of controlled substances; (3) how collaboration between Federal, State, local, and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances; (4) the availability of medical education, training opportunities, and comprehensive clinical guidance for pain management and opioid prescribing, and any gaps that should be addressed; (5) beneficial enhancements to State prescription drug monitoring programs, including enhancements to require comprehensive prescriber input and to expand access to the programs for appropriate authorized users; and (6) steps to improve reporting requirements so that the public and Congress have more information regarding prescription opioids, such as the volume and formulation of prescription opioids prescribed annually, the dispensing of such prescription opioids, and outliers and trends within large data sets. (b) Consultation The report under subsection (a) shall incorporate feedback and recommendations from the following: (1) Patient groups. (2) Pharmacies. (3) Drug manufacturers. (4) Common or contract carriers and warehousemen. (5) Hospitals, physicians, and other health care providers. (6) State attorneys general. (7) Federal, State, local, and tribal law enforcement agencies. (8) Health insurance providers and entities that provide pharmacy benefit management services on behalf of a health insurance provider. (9) Wholesale drug distributors. (10) Veterinarians. (11) Professional medical societies and boards. (12) State and local public health authorities. (13) Health services research organizations.

Speaker of the House of Representatives Vice President of the United States and President of the Senate