This PDF is the current document as it appeared on Public Inspection on 04/17/2017 at 08:45 am.
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
As part of the work by the Federal Government to address the epidemic of prescription and illicit opioid abuse, the Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of Start Printed Page 18301opioids) for health care providers. As discussed in this document, the workshop has three main goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. Finally, participants will be asked about the issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.
Participants are expected to include individuals from a broad set of Federal, State, and private stakeholder groups that are working on the challenges of improving pain management while addressing the opioid abuse epidemic. The Federal Agencies participating include FDA, the Drug Enforcement Administration, the Department of Veterans Affairs, the Centers for Disease Control and Prevention, the Department of Defense, the Centers for Medicare & Medicaid Services, the National Institute on Drug Abuse, and the Substance Abuse and Mental Health Services Administration, and the Indian Health Service. Public participation and comment are encouraged.
The public workshop will be held on May 9 and 10, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by July 10, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 10, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 10, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. See the SUPPLEMENTARY INFORMATION section for registration date and information.
The public workshop will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910, 877-298-2066.
You may submit comments as follows:
Submit electronic comments in the following way:
- Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
- Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2017-N-1094 for “Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics —Exploring the Path Forward; Public Workshop; Request for Comments.” Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
- Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Mary Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6178, Silver Spring, MD 20993-0002, 301-796-3519, email: Mary.Gross@fda.hhs.gov; or Doris Auth, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2480, Silver Spring, MD 20993-0002; 301-796-0487, email: Doris.Auth@fda.hhs.gov.End Further Info End Preamble Start Supplemental Information
On July 12, 2012, FDA approved a risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS). The goal of such REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Start Printed Page 18302Adverse outcomes of concern include addiction, unintentional overdose, and death. The ER/LA Opioid Analgesics REMS requires that prescriber training in the form of accredited continuing education be made available to health care providers who prescribe ER/LA opioid analgesics.
On May 3 and 4, 2016, FDA convened a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee to discuss whether this REMS assures safe use of these products, whether it is not unduly burdensome to patient access to the drugs, and whether it (to the extent practicable) minimizes the burden to the health care delivery system (https://www.gpo.gov/fdsys/pkg/FR-2016-03-14/pdf/2016-05573.pdf). FDA sought input on possible modifications to the ER/LA Opioid Analgesic REMS, including expansion of the scope and content of prescriber training and expansion of the REMS program to include immediate release (IR) opioid analgesics. The majority of committee members were in favor of modifying the REMS program to include the IR opioid analgesics as well as broadening the training program to include pain management. Though the majority of the committee members were in favor of a requirement for all prescribers to complete training, they recommended that the required training program be implemented through mechanisms outside of the FDA REMS authority. The committees also stated that other health care providers involved in the management of pain should be included as a target audience for education, though they did not specify that the training should be mandatory for non-prescribing health care providers.
In addition to the joint Advisory Committee advice on prescriber education, a Request for Information (RFI) was posted by the Department of Health and Human Services (HHS) Assistant Secretary of Planning and Education on July 8, 2016 (81 FR 44640), seeking comment on the most promising approaches in prescriber education and training programs and effective ways to leverage HHS programs to implement/expand them. The 2017 public workshop on May 9 and 10 seeks to build on one of the requests outlined in that RFI, specifically, the request for suggestions of additional activities HHS and its federal partners could implement to support universal prescriber education on appropriate pain management and opioid analgesic prescribing.
II. Topics for Discussion at the Public Workshop
On May 9 and 10, 2017, FDA on its own behalf and in conjunction with the other participating federal agencies will hold a public workshop and convene government experts, representatives from State licensing boards, professional associations, health care systems, patient groups, and other relevant stakeholder groups. The workshop has three major goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. As a part of this discussion, current training efforts by States, hospitals and health care systems, Federal Agencies, professional associations and other groups will be considered in order to strategize how best to facilitate training for these health care providers. Finally, participants will also be asked about issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids.
Participants include individuals from a broad set of Federal, State, and private stakeholders that are working on the challenges of improving pain management while addressing the opioid abuse epidemic. The Federal Agencies participating include FDA, the Drug Enforcement Administration, the Department of Veterans Affairs, the Centers for Disease Control and Prevention, the Department of Defense, the Centers for Medicare & Medicaid Services, the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration, and the Indian Health Service. Public participation and comment is encouraged.
Panels will be drawn from Federal and State agencies, as well as other private and public groups working to address pain management and/or opioid abuse. During the panel discussions, panelists will be asked to address the following:
(1) The relative role of Federal training/education efforts in the larger landscape of activities aimed at improving pain management, including the use of opioid analgesics. This includes a discussion of ongoing efforts being led by States, hospitals and health care systems, other Federal Agencies, and medical societies that focus on other aspects of the issue, such as Prescription Drug Monitoring Programs.
(2) The merits and challenges of utilizing Federal mechanisms to provide education on pain management and the safe use of opioid analgesics. This includes a discussion of the role, if any, of mandatory Federal education efforts.
(3) The merits and challenges of utilizing non-Federal mechanisms to provide education on pain management and the safe use of opioid analgesics. This includes a discussion of current State and other efforts and the role they are playing in training/education on pain management and the safe use of opioid analgesics.
(4) The merits and challenges of utilizing partnerships between Federal Agencies and other groups to provide education on pain management and the safe use of opioid analgesics. This includes a discussion of the role of the Federal Government in formal public-private partnerships or other combined approaches to training/education on pain management and the safe use of opioid analgesics for all prescribers. It also includes a discussion of the appropriate organizations (e.g., Federal Agency, State medical board, other) to include in such efforts.
(5) The aspects of the opioid epidemic that can be most impacted by the training of health care providers and how outcomes of these training programs can be measured.
III. Participating in the Public Workshop
Registration: Persons interested in attending this public workshop must register online by sending an email to https://nakamotoevents.wufoo.com/forms/p1gsrzm80gd7lkd/ before May 1, 2017. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by May 1, 2017. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when their registration has been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m.
If you need special accommodations due to a disability, please contact Mary Gross or Doris Auth (see FOR FURTHER INFORMATION CONTACT) no later than May 1, 2017.Start Printed Page 18303
Requests for Oral Comments: During online registration you may indicate if you wish to provide a statement during the Open Public Comment Period. We will do our best to accommodate requests to make public comments based on time allocated for public comment. Individuals and organizations with common interests are urged to consolidate or coordinate their comments, and request time for a joint presentation. Following the close of registration date, we will determine the amount of time allotted to each commenter and the approximate time each oral comment is scheduled to begin; commenters should arrive ahead of their scheduled time in case the agenda moves ahead of schedule so as to be sure not to forfeit their speaking time. All requests to make oral comments must be received by the close of registration on May 1, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Additional information will be made available regarding accessing the Webcast 2 days prior to the public workshop at http://www.fda.gov/Drugs/NewsEvents/ucm538047.htm.
Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A link to the transcript will also be available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm538047.htm.Start Signature
Dated: April 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-07821 Filed 4-17-17; 8:45 am]
BILLING CODE 4164-01-P