81 FR 44640 - Request for Information: Opioid Analgesic Prescriber Education and Training Opportunities To Prevent Opioid Overdose and Opioid Use Disorder
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 81, Issue 131 (July 8, 2016)
Office of the Secretary
Federal Register Volume 81, Issue 131 (July 8, 2016)
| Page Range | 44640-44642 | |
| FR Document | 2016-16067 |
[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)] [Notices] [Pages 44640-44642] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-16067] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Request for Information: Opioid Analgesic Prescriber Education and Training Opportunities To Prevent Opioid Overdose and Opioid Use Disorder AGENCY: Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS. ACTION: Request for information. ----------------------------------------------------------------------- SUMMARY: Deaths from drug overdose have risen steadily over the past two decades and have become the leading cause of injury death in the United States. Prescription drugs, especially opioid analgesics--a class of prescription drugs such as hydrocodone, oxycodone, morphine, and methadone used to treat both acute and chronic pain--have been increasingly implicated in drug overdose deaths over the last decade. Alarmingly, deaths related to opioid analgesic overdose have quadrupled since 1999, and this increase in deaths has been linked to parallel increases in opioid prescribing. As part of its comprehensive response to the opioid epidemic, HHS is actively working to stem overprescribing of opioids in a number of ways, including by providing clinicians with the tools and education they need to make informed prescribing decisions. In particular, HHS has developed a number of activities that support opioid analgesic prescriber education. This Request for Information (RFI) seeks comment on the most promising approaches in prescriber education and training programs and effective ways to leverage HHS programs to implement/expand them. DATES: Comments must be received at one of the addresses provided below, no later than 5 p.m. on September 6, 2016. ADDRESSES: Written comments may be submitted through any of the methods specified below. Please do not submit duplicate comments.Federal eRulemaking Portal: You may submit electronic comments at http://www.regulations.gov. Follow the [[Page 44641]] instructions for submitting electronic comments. Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word. Regular, Express, or Overnight Mail: You may mail written comments (one original and two copies) to the following address only: U.S. Department of Health and Human Services, Office for Civil Rights, Attention: 1557 RFI (RIN 0945-AA02), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue SW., Washington, DC 20201. Mailed comments may be subject to delivery delays due to security procedures. Please allow sufficient time for mailed comments to be timely received in the event of delivery delays. Hand Delivery or Courier: If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) to the following address only: Office for Civil Rights, Attention: 1557 RFI (RIN 0945-AA02), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.) Inspection of Public Comments: All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment. We will post all comments received before the close of the comment period at http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Office of the Assistant Secretary for Planning and Evaluation, 202-690-7858. SUPPLEMENTARY INFORMATION: I. Background Education and training in pain management and appropriate opioid analgesic prescribing, including how to identify patients who may be at risk for opioid misuse and ensuring patients treated with opioids receive the appropriate dose and quantity of medication for their condition, are key elements of the response to the opioid epidemic. Surveys of healthcare providers indicate that they receive inadequate training on pain management, and many feel uncomfortable managing patients with pain. In addition, research has identified significant gaps and fragmentation in pain education in health professional schools, and the National Pain Strategy indicates that health professional education is a central component of advancing a system of care in which all people receive high quality and evidence-based pain care. To improve education and training on pain management and appropriate opioid prescribing, HHS has developed programs that engage prescribers throughout their training and professional career. For example, in an effort to educate health professional students, the National Institutes on Drug Abuse (NIDA) coordinates the National Institutes of Health Pain Consortium's Centers of Excellence in Pain Education that develop and distribute pain management curriculum resources for medical, dental, nursing, and pharmacy schools. Many HHS training initiatives target practicing clinicians throughout their learning and practice lifecycles. Some programs, such as NIDA's NIDAMED program, offer opioid and pain management training as continuing education credit opportunities. Additionally, the Food and Drug Administration (FDA) has put in place a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications. The ER/LA Opioid Analgesic REMS requires manufacturers to make prescriber training available through accredited continuing education (CE) programs funded by the ER/LA sponsors. To assure that the training is balanced and to protect from industry influence, the training is based upon the FDA blueprint for Prescriber Education for ER/LA opioids and is made available through third-party CE providers. Other programs utilize a peer-to-peer mentoring model. The Substance Abuse and Mental Health Services Administration's Providers' Clinical Support System for Opioid Therapies (PCSS-O) is one such model that offers colleague support and mentoring as well as evidence-based educational resources on how to effectively utilize opioid analgesics for patients with pain and patients with opioid use disorders. And, other resources are intended to support decision making during an active patient encounter. The Centers for Disease Control and Prevention's Guideline for Prescribing Opioids for Chronic Pain facilitates providers' decision-making regarding appropriate pain treatment for patients 18 years and older in the primary care setting. II. Solicitation of Comments This RFI is seeking comment on the range of approaches to educating and training providers on pain management and appropriate opioid analgesic prescribing, including identifying patients at risk for abuse and prescribing the appropriate dose and quantity of medication for their condition. As noted above HHS has undertaken several programs to engage providers on these topics, and this RFI is meant to solicit input not only on those but also on other approaches. For example, HHS seeks comment on the impact of non-federal prescriber training policies or programs on opioid analgesic prescriber competency: How states have developed, promoted, and made pain management and opioid analgesic prescriber education available, whether state requirements for mandatory pain management and opioid prescribing training have led to any changes in prescriber behavior and/or other outcomes as a result of these programs, the challenges opioid education providers have faced in implementing opioid prescriber education initiatives, which measures education providers use to evaluate the success of their interventions, or how health information technology has been implemented to assist the prescriber in appropriate opioid prescribing and pain management. HHS also is soliciting suggestions for additional activities the Department could implement to ensure universal prescriber education on appropriate pain management and opioid prescribing. For example, additional HHS activities could include: Adding new opioid prescriber education to Medicare Conditions of Participation and/or to Medicare enrollment requirements, adding quality measures around safe opioid use to the specialty core measures that clinicians may choose to report under the Merit-based Incentive Payment System (MIPS), or revising the ER/LA Opioid Analgesic REMS to require that prescribers of opioids receive appropriate training on pain management and safe opioid use before being able to prescribe specific opioids. Finally, HHS seeks feedback through this RFI on the ability of existing HHS education and training programs to educate all opioid analgesic prescribers on appropriate pain management and opioid prescribing including comments on the development and delivery of the content and on efforts to assess the impact of the training initiatives. [[Page 44642]] 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: June 29, 2016. Kathryn E. Martin, Acting Assistant Secretary for Planning and Evaluation. [FR Doc. 2016-16067 Filed 7-6-16; 8:45 am] BILLING CODE 4150-15-P
![44640 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices
individual or entity used Federal awarded with the opportunity to present deems to violate these Official Rules,
facilities or consulted with Federal their White Paper at a two-day Terms & Conditions.
employees during a Challenge if the Blockchain & Healthcare Workshop. In Authority: 15 U.S.C. 3719.
facilities and employees are made lieu of a monetary prize, finalists will be
available to all individuals and entities provided with full expenses for travel to Karen DeSalvo,
participating in the Challenge on an the Workshop, which will be held at the National Coordinator for Health Information
equitable basis. NIST Headquarters in Gaithersburg, MD. Technology.
At the end of the submission period, [FR Doc. 2016–16133 Filed 7–6–16; 8:45 am]
General Submission Requirements Submissions will be posted on the BILLING CODE 4150–45–P
In order for a Submission to be challenge Web site and will be
eligible to win this Challenge, it must reviewed, graded, and voted on by a
meet the following requirements: steering committee. DEPARTMENT OF HEALTH AND
1. No HHS or ONC logo—The HUMAN SERVICES
Solution must not use HHS’ or ONC’s Additional Information
logos or official seals and must not General Conditions: ONC reserves the Office of the Secretary
claim endorsement. right to cancel, suspend, and/or modify
2. Functionality/Accuracy—A the Challenge, or any part of it, for any Request for Information: Opioid
Solution may be disqualified if it fails reason, at ONC’s sole discretion. Analgesic Prescriber Education and
to function as expressed in the Intellectual Property: Each participant Training Opportunities To Prevent
description provided by the participant, retains title and full ownership in and Opioid Overdose and Opioid Use
or if it provides inaccurate or to their Submission. Participants Disorder
incomplete information. expressly reserve all intellectual AGENCY: Office of the Assistant
property rights not expressly granted Secretary for Planning and Evaluation
Registration Process for Participants under the challenge agreement. By (ASPE), HHS.
To register for this Challenge, participating in the Challenge, each
ACTION: Request for information.
participants can access http:// entrant hereby irrevocably grants to the
www.challenge.gov and search for Government a limited, non-exclusive, SUMMARY: Deaths from drug overdose
‘‘Blockchain and Its Emerging Role in royalty-free, perpetual, worldwide have risen steadily over the past two
Healthcare and Health-related license and right to reproduce, decades and have become the leading
Research.’’ publically perform, publically display, cause of injury death in the United
and use the Submission to the extent States. Prescription drugs, especially
Prize
necessary to administer the challenge, opioid analgesics—a class of
Winners will be provided the and to publically perform and prescription drugs such as
following: publically display the Submission, hydrocodone, oxycodone, morphine,
• Opportunity to present their paper including, without limitation, for and methadone used to treat both acute
at a Blockchain & Healthcare Workshop advertising and promotional purposes and chronic pain—have been
Hosted at NIST relating to the Challenge. This may also increasingly implicated in drug
• Paid travel to the Workshop; include displaying the results of the overdose deaths over the last decade.
• Paid room and board for the Challenge on a public Web site or Alarmingly, deaths related to opioid
Workshop; and during a public presentation. analgesic overdose have quadrupled
• Paid Per Diem. since 1999, and this increase in deaths
Representation, Warranties and
Payment of the Prize Indemnification has been linked to parallel increases in
opioid prescribing. As part of its
Prize will be paid by contractor. By entering the Challenge, each comprehensive response to the opioid
Basis Upon Which Winner Will Be applicant represents, warrants and epidemic, HHS is actively working to
Selected covenants as follows: stem overprescribing of opioids in a
(a) Participant is the sole author,
The evaluation process will begin by number of ways, including by providing
creator, and owner of the Submission;
removing those that are not responsive clinicians with the tools and education
(b) The Submission is not the subject
to this Challenge or not in compliance they need to make informed prescribing
of any actual or threatened litigation or
with all rules for eligibility. Judges will decisions. In particular, HHS has
claim;
examine all responsive and compliant (c) The Submission does not and will developed a number of activities that
submissions, and rate the entries. Judges not violate or infringe upon the support opioid analgesic prescriber
will determine the most meritorious intellectual property rights, privacy education. This Request for Information
submissions, based on these ratings and rights, publicity rights, or other legal (RFI) seeks comment on the most
select up to eight (8) finalists. Honorable rights of any third party; promising approaches in prescriber
Mentions may be included and Participants must indemnify, defend, education and training programs and
announced, along with the winners on and hold harmless the Federal effective ways to leverage HHS
Challenge.gov. Government from and against all third programs to implement/expand them.
The judging panel will rate each party claims, actions, or proceedings of DATES: Comments must be received at
submission based upon the effectiveness any kind and from any and all damages, one of the addresses provided below, no
asabaliauskas on DSK3SPTVN1PROD with NOTICES
of the overall concept to help foster liabilities, costs, and expenses relating later than 5 p.m. on September 6, 2016.
transformative change in the HealthIT to or arising from participant’s ADDRESSES: Written comments may be
culture, the viability of the proposed Submission or any breach or alleged submitted through any of the methods
recommendations, the innovativeness of breach of any of the representations, specified below. Please do not submit
the approach, and its potential for warranties, and covenants of participant duplicate comments.
achieving the objectives of ONC. hereunder. The Federal Agency • Federal eRulemaking Portal: You
Up to eight (8) submissions will be sponsors reserve the right to disqualify may submit electronic comments at
selected as winners. Winners will be any Submission that, in their discretion, http://www.regulations.gov. Follow the
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![44642 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices
III. Response to Comments Room 3B01, Bethesda, MD 20892–7523, Comment Due Date: Comments
Email: rooneyc@mail.nih.gov. regarding this information collection are
Because of the large number of public
SUPPLEMENTARY INFORMATION: The best assured of having their full effect if
comments we normally receive on
conference is sponsored by the NIH received within 30 days of the date of
Federal Register documents, we are not
Office of Dietary Supplements along this publication.
able to acknowledge or respond to them
individually. We will consider all with co-sponsors from other federal FOR FURTHER INFORMATION CONTACT: To
comments we receive by the date and agencies. Information about the obtain a copy of the data collection
time specified in the DATES section of conference agenda, registration plans and instruments or request more
this preamble. procedures, and videocast arrangements information on the proposed project
can be found at: https://events- contact: Steve Boehlert, Director of
Dated: June 29, 2016.
suport.com/events/NIH_Iron_Workshop. Operations, Division of Loan
Kathryn E. Martin, Repayment, National Institutes of
Through its Iron Initiative, the
Acting Assistant Secretary for Planning and National Institutes of Health (NIH) Health, 6011 Executive Blvd., Room 206
Evaluation. (MSC 7650), Bethesda, Maryland
Office of Dietary Supplements leads
[FR Doc. 2016–16067 Filed 7–6–16; 8:45 am] 20892–7650. Mr. Boehlert may be
efforts to advance scientific
BILLING CODE 4150–15–P understanding of iron and health: contacted via email at BoehlerS@
https://ods.od.nih.gov/Research/ od.nih.gov or by calling 301–451–4465.
Iron.aspx. Formal requests for additional plans and
DEPARTMENT OF HEALTH AND instruments must be requested in
HUMAN SERVICES Dated: July 1, 2016.
writing.
Lawrence A. Tabak,
Proposed Collection: National
National Institutes of Health Deputy Director, National Institutes of Health. Institutes of Health (NIH) Loan
[FR Doc. 2016–16254 Filed 7–7–16; 8:45 am] Repayment Programs (LRP). Type of
Public Workshop—Iron Screening and
Supplementation of Iron-Replete
BILLING CODE 4140–01–P Information Collection Request:
Pregnant Women and Young Children Revision of a currently approved
collection (OMB No. 0925–0361,
SUMMARY: The Office of Dietary DEPARTMENT OF HEALTH AND expiration date 06/30/17). Form
Supplements at the National Institutes HUMAN SERVICES Numbers: NIH 2674–1, NIH 2674–2,
of Health (NIH) is sponsoring an open NIH 2674–3, NIH 2674–4, NIH 2674–5,
National Institutes of Health
public workshop titled, ‘‘Iron Screening NIH 2674–6, NIH 2674–7, NIH 2674–8,
and Supplementation of Iron-replete Submission for OMB Review; 30-Day NIH 2674–9, NIH 2674–10, NIH 2674–
Pregnant Women and Young Children,’’ Comment Request National Institutes 11, NIH 2674–12, NIH 2674–13, NIH
September 28–29, 2016, on the NIH of Health (NIH) Loan Repayment 2674–14, NIH 2674–15, NIH 2674–16,
main campus in Bethesda, Maryland. It Programs; Office of the Director (OD) NIH 2674–17, NIH 2674–18, NIH 2674–
will also be available to be viewed live 19, and NIH 2674–20 (new).
or later on-demand as a videocast. The SUMMARY: Under the provisions of Need and Use of Information
workshop discussions will focus on the section 3507(a)(1)(D) of the Paperwork Collection: The NIH makes available
U.S. and developed countries and will Reduction Act of 1995, the Division of financial assistance, in the form of
serve to specify data gaps and research Loan Repayment (DLR), the National educational loan repayment, to M.D.,
needs by (1) exploring current Institutes of Health (NIH), has submitted Ph.D., Pharm.D., Psy.D., D.O., D.D.S.,
understanding of iron homeostasis in to the Office of Management and Budget D.M.D., D.P.M., D.C., N.D., O.D., D.V.M.,
pregnant women and in young children (OMB) a request to review and approve or equivalent degree holders who
(6-24 months); (2) identifying the the information collection listed below. perform biomedical or behavioral
challenges associated with measuring This proposed information collection research in NIH intramural laboratories
iron status and with screening practices; was previously published in the Federal or as extramural grantees or scientists
and (3) considering emerging issues Register on February 19, 2016, and page funded by domestic non-profit
associated with routine numbers 8514–8516, and allowed 60 organizations for a minimum of two
supplementation of iron-replete days for public comment. No public years (three years for the General
individuals. All persons are invited to comments were received. The purpose Research LRP) in research areas
attend, especially clinical educators, of this notice is to allow an additional supporting the mission and priorities of
those who develop clinical 30 days for public comment. The NIH the NIH.
recommendations, health care providers may not conduct or sponsor, and the The AIDS Research Loan Repayment
and researchers. Persons wishing to respondent is not required to respond Program (AIDS–LRP) is authorized by
attend are required to register in to, an information collection that has section 487A of the Public Health
advance of the conference. been extended, revised, or implemented Service Act (42 U.S.C. 288–1); the
DATES: September 28–29, 2016; 8:30 to on or after October 1, 1995, unless it Clinical Research Loan Repayment
5:15 p.m. (Eastern Time) on the first day displays a currently valid OMB control Program for Individuals from
and 8:00 to 12:30 p.m. on the second number. Disadvantaged Backgrounds (CR–LRP)
day. Direct Comments to OMB: Written is authorized by section 487E (42 U.S.C.
comments and/or suggestions regarding 288–5); the General Research Loan
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ADDRESSES: National Institutes of the item(s) contained in this notice, Repayment Program (GR–LRP) is
Health, William H. Natcher Building; especially regarding the estimated authorized by section 487C of the Public
Natcher Conference Center, Building 45, public burden and associated response Health Service Act (42 U.S.C. 288–3);
Bethesda, Maryland, 20892. time, should be directed to the: Office the Clinical Research Loan Repayment
FOR FURTHER INFORMATION CONTACT: Ms. of Management and Budget, Office of Program (LRP–CR) is authorized by
Cindy Rooney, Office of Dietary Regulatory Affairs, OIRA_submission@ section 487F (42 U.S.C. 288–5a); the
Supplements, National Institutes of omb.eop.gov or by fax to 202–395–6974, Pediatric Research Loan Repayment
Health, 6100 Executive Boulevard, Attention: NIH Desk Officer. Program (PR–LRP) is authorized by
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Document Created: 2016-07-08 00:18:07
Document Modified: 2016-07-08 00:18:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for information. | |
| Contact | Office of the Assistant Secretary for Planning and Evaluation, 202-690-7858. | |
| FR Citation | 81 FR 44640 |
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