[Federal Register Volume 84, Number 144 (Friday, July 26, 2019)]
[Notices]
[Pages 36111-36112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Request for Information: Ensuring Patient Access and Effective 
Drug Enforcement

AGENCY: Office of the Assistant Secretary for Planning and Evaluation 
(ASPE), HHS.

ACTION: Request for information.

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SUMMARY: This Request for Information (RFI) seeks comment on ensuring

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legitimate access to controlled substances, including opioids, while 
also preventing diversion and abuse, as well as how federal, state, 
local, and tribal entities can collaborate to address these issues.

DATES: Comments must be received at one of the addresses provided 
below, no later than 5 p.m. on August 26, 2019.

ADDRESSES: Written comments can be provided by email, fax or U.S. mail.
    Email: [email protected].
    Fax: (202) 690-5882.
    Mail: U.S. Department of Health and Human Services, Office of the 
Assistant Secretary for Planning and Evaluation, Office of Science and 
Data Policy, Attn: EPAEDEA Report Feedback, 200 Independence Avenue SW, 
Room 434E, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Jessica White, Office of the Assistant 
Secretary for Planning and Evaluation, 202-690-7100.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 3 of the Ensuring Patient Access and Effective Drug 
Enforcement Act of 2016 (EPAEDEA), Public Law 114-145, called for the 
Department 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, and in coordination with 
the Administrator of the Drug Enforcement Administration and in 
consultation with the Secretary of Defense and the Secretary of 
Veterans Affairs, to submit a report to Congress that identifies:

 Obstacles to legitimate patient access to controlled 
substances
 issues with diversion of controlled substances
 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;
 the availability of medical education, training opportunities, 
and comprehensive clinical guidance for pain management and opioid 
prescribing, and any gaps that should be addressed
 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
 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.

II. Solicitation of Comments

    EPAEDEA requires that the report 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; and (13) health services 
research organizations.
    This RFI is seeking comment from these stakeholders on the 
aforementioned issue areas to be covered by the report.

III. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble.

    Dated: July 16, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and Evaluation (HSP).
[FR Doc. 2019-15952 Filed 7-25-19; 8:45 am]
 BILLING CODE 4150-15-P