Request for Information: Ensuring Patient Access and Effective Drug Enforcement, 36932-36933 [2019-16145]

Download as PDF 36932 Federal Register / Vol. 84, No. 146 / Tuesday, July 30, 2019 / Notices FDA estimates the annual reporting burden for the draft guidance as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Total annual responses Average burden per response Total hours Rare pediatric disease designation request ........................ Rare pediatric disease priority review voucher request ...... Notification of intent to use a voucher ................................. Transfer notification ............................................................. Post-approval report ............................................................ 51 20 3 2 2 1 1 1 1 1 51 20 3 2 2 75 40 8 8 20 3,825 800 24 16 40 Total .............................................................................. ........................ ........................ ........................ ........................ 4,705 1 There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, or https:// www.regulations.gov. Dated: July 24, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–16262 Filed 7–29–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Request for Information: Ensuring Patient Access and Effective Drug Enforcement Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS. ACTION: Request for Information. AGENCY: This Request for Information (RFI) seeks comment on ensuring 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 29, 2019. ADDRESSES: Written comments can be provided by email, fax or U.S. mail. Email: EPAEDEAreport@hhs.gov. Fax: (202) 690–5882. Mail: U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, SUMMARY: jspears on DSK3GMQ082PROD with NOTICES Number of responses per respondent VerDate Sep<11>2014 16:42 Jul 29, 2019 Jkt 247001 Office of Science and Data Policy, Attn: EPAEDEA Report Feedback, 200 Independence Avenue SW, Room 434E, Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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. E:\FR\FM\30JYN1.SGM 30JYN1 Federal Register / Vol. 84, No. 146 / Tuesday, July 30, 2019 / Notices Dated: July 16, 2019. Brenda Destro, Deputy Assistant Secretary for Planning and Evaluation (HSP). [FR Doc. 2019–16145 Filed 7–29–19; 8:45 am] BILLING CODE 4150–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: July 24, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings [FR Doc. 2019–16066 Filed 7–29–19; 8:45 am] BILLING CODE 4140–01–P jspears on DSK3GMQ082PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Environmental Health Sciences Review Committee; Environmental Health Sciences: P30 Core Centers. Date: August 14–15, 2019. Time: 8:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton Imperial Hotel RaleighDurham Airport at Research Triangle Park, 4700 Emperor Blvd., Durham, NC 27703. Contact Person: Linda K. Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, P.O. Box 12233, MD EC–30, Research Triangle Park, NC 27709, 984–287– 3236, bass@niehs.nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Environmental Health Sciences P30 Core Centers. Date: August 15, 2019. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton Imperial Hotel RaleighDurham Airport at Research Triangle Park, 4700 Emperor Blvd., Durham, NC 27703. Contact Person: Varsha Shukla, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, Keystone Building, Room 3094, Research Triangle Park, NC 27709, 984–287– 3288, Varsha.shukla@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from VerDate Sep<11>2014 16:42 Jul 29, 2019 Jkt 247001 Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) DEPARTMENT OF HOMELAND SECURITY [Docket No. CISA–2019–0010] Notice of the President’s National Infrastructure Advisory Council Meeting Cybersecurity and Infrastructure Security Agency, DHS. ACTION: Announcement of meeting; request for comments. AGENCY: The Cybersecurity and Infrastructure Security Agency (CISA) announces a public meeting of the President’s National Infrastructure Advisory Council (NIAC). To facilitate public participation, CISA invites public comments on the agenda items and any associated briefing materials to be considered by the council at the meeting. SUMMARY: DATES: Meeting Registration: Individual registration to attend the meeting in person is required and must be received no later than 5:00 p.m. EST on August 7, 2019. Speaker Registration: Individuals may register to speak during the meeting’s public comment period must be received no later than 5:00 p.m. EST on August 7, 2019. Written Comments: Written comments must be received no later than 12:00 p.m. EST on August 14, 2019. NIAC Meeting: The meeting will be held on Thursday, August 15, 2019 from 2:00 p.m.–4:00 p.m. EST. ADDRESSES: The NIAC meeting will be held at The United States Naval Academy, Laboon Center, 566 Brownson Rd., Annapolis, MD 21402. Comments: Written comments may be submitted on the issues to be considered by the NIAC as described in the SUPPLEMENTARY INFORMATION section below and any briefing materials for the meeting. Any briefing materials that will PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 36933 be presented at the meeting will be made publicly available on Friday, August 2, 2019 at the following website: https://www.dhs.gov/nationalinfrastructure-advisory-council. Comments identified by docket number ‘‘CISA–2019–0010’’ may be submitted by any of the following methods: • Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting written comments. • Email: NIAC@hq.dhs.gov. Include docket number CISA–2019–0010 in the subject line of the message. Instructions: All submissions received must include the agency name and docket number for this notice. All written comments received will be posted without alteration at www.regulations.gov, including any personal information provided. For detailed instructions on sending comments and additional information on participating in the upcoming NIAC/ NSTAC meeting, see the ‘‘Public Participation’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket and comments received by the NIAC, go to www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Ginger K. Norris, 202–441–5885, ginger.norris@hq.dhs.gov. SUPPLEMENTARY INFORMATION: The NIAC is established under Section 10 of E.O. 13231 issued on October 16, 2001. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix (Pub. L. 92– 463). The NIAC shall provide the President, through the Secretary of Homeland Security, with advice on the security and resilience of the Nation’s critical infrastructure sectors. The NIAC will meet in an open meeting on August 15, 2019 to discuss the following agenda items with DHS leadership. Agenda I. Call to Order and Opening Remarks II. Panel Discussion With Critical Infrastructure Experts on Cross Sector Interdependencies III. New Business IV. Public Comment V. Closing Remarks VI. Adjournment Public Participation Meeting Registration Information Due to additional access requirements and limited seating, requests to attend in person will be accepted and processed in the order in which they are received. Individuals may register to E:\FR\FM\30JYN1.SGM 30JYN1

Agencies

[Federal Register Volume 84, Number 146 (Tuesday, July 30, 2019)]
[Notices]
[Pages 36932-36933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16145]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: This Request for Information (RFI) seeks comment on ensuring 
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 29, 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: 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.


[[Page 36933]]


    Dated: July 16, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and Evaluation (HSP).
[FR Doc. 2019-16145 Filed 7-29-19; 8:45 am]
 BILLING CODE 4150-15-P

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