Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy; Availability; Request for Comments, 68766-68767 [2011-28669]

Download as PDF 68766 Federal Register / Vol. 76, No. 215 / Monday, November 7, 2011 / Notices administers ACF’s system for review, approval and documentation of delegations of authority. The Office provides technical assistance and guidance to ACF offices on intracomponent organizational proposals and is responsible for development and/ or review of inter-component organizational proposals. The Office develops policies and procedures for implementing organizational development activities and provides leadership of assigned ACF special initiatives arising from Departmental, Federal and non-Federal directives to improve service delivery to customers and to enhance employee work environment. The Office manages and coordinates designated incentive awards programs. The Office develops training policies and plans for ACF. It provides leadership in directing and managing Agency-wide staff development and training activities for ACF. OWPD is responsible for the functional management of all information technology and software training, common needs training, and management training in the Agency, including policy development, guidance, technical assistance, and evaluation of all aspects of career employee, supervisory, management and executive training. The Office provides leadership in managing/ overseeing and monitoring the ACF Training Resource Center and the Computer Training and Information Centers. The Office develops and manages the consolidated training budget for the Agency. Dated: October 25, 2011. George H. Sheldon, Acting Assistant Secretary for Children and Families. [FR Doc. 2011–28675 Filed 11–4–11; 8:45 am] BILLING CODE 4184–40–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0771] mstockstill on DSK4VPTVN1PROD with NOTICES Draft Blueprint for Prescriber Education for Long-Acting/ExtendedRelease Opioid Class-Wide Risk Evaluation and Mitigation Strategy; Availability; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Blueprint for Prescriber Education for SUMMARY: VerDate Mar<15>2010 17:50 Nov 04, 2011 Jkt 226001 the Long-Acting/Extended-Release Opioid Class-Wide REMS’’ (Blueprint). The draft Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extendedrelease opioids under the required risk evaluation and mitigation strategy (REMS) for these products (Opioid REMS). FDA seeks stakeholder input on the document. After comments are received, FDA will revise the Blueprint as appropriate, incorporate it into the Opioid REMS when it is approved, and post it on FDA’s Web site for use by CE providers. DATES: Submit either electronic or written comments on the draft Blueprint by December 7, 2011. ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic access to the draft Blueprint. Submit electronic comments on the draft Blueprint to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Michie I. Hunt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6153, Silver Spring, MD 20993–0002, (301) 796–3504. SUPPLEMENTARY INFORMATION: I. Background The Food and Drug Administration Amendments Act of 2007 (FDAAA) gave FDA the authority to require manufacturers to develop and implement a REMS when necessary to ensure the benefits of a drug or biological product outweigh its risks. A. REMS for Long-Acting and ExtendedRelease Opioids On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products indicating that these drugs will be required to have a REMS to ensure that the benefits of the drugs continue to outweigh the risks.1 The affected opioid drugs include long-acting and extended-release brand name and generic products and are formulated with the active ingredients buprenorphine, fentanyl, hydromorphone, methadone, morphine, 1 See the Opioid REMS Meeting Invitation Template at https://www.fda.gov/downloads/Drugs/ DrugSafety/InformationbyDrugClass/ UCM163652.pdf and the Opioids Products Chart at https://www.fda.gov/Drugs/DrugSafety/ InformationbyDrugClass/ucm163654.htm. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 oxycodone, oxymorphone, and tapentadol. After sending the letters, FDA held a series of meetings with stakeholders and convened an advisory committee to obtain input on the appropriate elements of the Opioid REMS. On April 19, 2011, in conjunction with the Office of National Drug Control Policy (ONDCP) release of the Obama Administration’s Epidemic: Responding to America’s Prescription Drug Abuse Crisis—a comprehensive action plan to address the national prescription drug abuse epidemic, FDA issued letters to application holders directing them to submit a REMS within 120 days and describing the elements that needed to be included in the REMS (REMS notification letters). The central component of the Opioid REMS program is an education program for prescribers (e.g., physicians, nurse practitioners, physician assistants) and patients. B. REMS Prescriber Education In the REMS notification letters, FDA provided an outline of the required prescriber education. The outline specified that the education must include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, the education must include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction. The REMS notification letters stated that although there is no mandatory requirement that prescribers take the course as a precondition to dispensing the medication to patients, application holders will be required to establish goals for the number of prescribers trained, collect the information about the number of prescribers who took the courses, and report the information to FDA as part of periodic required assessments. C. CE Providers Will Conduct Prescriber Education The REMS notification letter expressed FDA’s expectation that the training would be conducted by accredited, independent continuing education providers. FDA later elaborated on its vision for prescriber education stating that we expect the CE training to be provided without cost to the healthcare professionals and that sponsors would offer unrestricted grants to accredited CE providers to develop CE for the appropriate prescriber E:\FR\FM\07NON1.SGM 07NON1 Federal Register / Vol. 76, No. 215 / Monday, November 7, 2011 / Notices UCM277916.pdf. FDA will consider any comments submitted and make appropriate revisions before approving the Blueprint as a part of the Opioid REMS. D. The Blueprint Will Provide the Basic Outline and Core Messages for CE In response to the April REMS notification letter, application holders, through an industry working group, submitted an expanded outline of the potential topics to be covered in the CE, noting that education incorporating all of the topics in the outline could require 30 or more hours of education. FDA’s expectation is that the initial or basic REMS related CE that should be offered to all prescribers of long-acting and extended-release opioids should consist of a ‘‘core’’ content of about 2 to 3 hours. FDA has reviewed the industry submission and developed a basic outline and the core messages that FDA believes should be conveyed to prescribers in this basic educational module. After it is completed and approved as part of the REMS, the Blueprint will be posted on FDA’s Web site for use by CE providers in developing CE courses. Although FDA recognizes that additional training modules could be helpful, FDA’s goal is to require basic education for all prescribers of long-acting and extendedrelease opioids, and at this time, FDA does not intend to develop or approve messages as part of the REMS beyond those approved in the basic core module. Using the Blueprint on FDA’s Web site, CE providers can develop accredited CE in the manner they choose.3 With this document, FDA is announcing the availability of the Agency’s draft Blueprint for prescriber education and soliciting public comment. The draft Blueprint is available on the Internet at www.fda.gov/downloads/Drugs/ DrugSafety/InformationbyDrugClass/ mstockstill on DSK4VPTVN1PROD with NOTICES groups.2 We believe having the training provided by CE organizations will be an incentive and will not create new burdens on prescribers because most healthcare professionals are routinely engaged in CE activity. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments on the draft Blueprint. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. 2 See FDA Opioid REMS Meeting with Industry (May 16, 2011), at https://www.fda.gov/Drugs/ DrugSafety/InformationbyDrugClass/ ucm258184.htm and Preliminary Responses to Industry Questions About Opioid REMS at https:// www.fda.gov/Drugs/DrugSafety/ InformationbyDrugClass/ucm258113.htm. 3 Since early May 2011, FDA has held teleconferences and met with representatives from the CE accreditor and provider communities. We have expressed our interest in understanding the challenges of the CE providers, including the need to be in compliance with the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support and the need to ensure that the content of CE remains beyond the control of industry. We are confident that the ACCME standards will be met and ACCME will be satisfied that FDA will control the content of REMS CE. VerDate Mar<15>2010 17:50 Nov 04, 2011 Jkt 226001 II. Comments Dated: November 1, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–28669 Filed 11–4–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0689] Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. The Food and Drug Administration (FDA) is extending to January 3, 2012, the comment period for the notice entitled ‘‘Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability,’’ that appeared in the Federal Register of October 3, 2011 (76 FR 61103). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action due to a discrepancy in the comment period in the notice as compared to the comment period listed in the guidance document. DATES: Submit either electronic or written comments by January 3, 2012. ADDRESSES: Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit SUMMARY: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 68767 written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1646, Silver Spring, MD 20993–0002, (301) 796–5616; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville, Pike, Suite 200N, Rockville, MD 20852, (301) 827–6210. I. Background In the Federal Register of October 3, 2011 (76 FR 61103), FDA published a notice with a 60-day comment period to request comments on the draft guidance for industry and FDA staff entitled ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation).’’ Comments on the draft guidance will assist FDA in the development of a final guidance for industry and FDA staff on the de novo classification process. The Agency received a comment that the 60-day comment period in the notice was inconsistent with the 90-day comment period in the draft guidance document. FDA is extending the comment period for the notice until January 3, 2012. The Agency believes that this extension allows adequate time for interested persons to submit comments without significantly delaying action by the Agency. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all Center for Devices and Radiological Health (CDRH) guidance documents is available at https://www.fda.gov/Medical Devices/DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 68766-68767]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28669]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0771]

Draft Blueprint for Prescriber Education for Long-Acting/
Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation
Strategy; Availability; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Blueprint for Prescriber
Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS''
(Blueprint). The draft Blueprint contains core messages intended for
use by continuing education (CE) providers to develop educational
materials to train prescribers of long-acting and extended-release
opioids under the required risk evaluation and mitigation strategy
(REMS) for these products (Opioid REMS). FDA seeks stakeholder input on
the document. After comments are received, FDA will revise the
Blueprint as appropriate, incorporate it into the Opioid REMS when it
is approved, and post it on FDA's Web site for use by CE providers.

DATES: Submit either electronic or written comments on the draft
Blueprint by December 7, 2011.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft Blueprint. Submit electronic comments on the draft
Blueprint to https://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michie I. Hunt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6153, Silver Spring, MD 20993-0002, (301)
796-3504.

SUPPLEMENTARY INFORMATION:

I. Background

The Food and Drug Administration Amendments Act of 2007 (FDAAA)
gave FDA the authority to require manufacturers to develop and
implement a REMS when necessary to ensure the benefits of a drug or
biological product outweigh its risks.

A. REMS for Long-Acting and Extended-Release Opioids

On February 6, 2009, FDA sent letters to manufacturers of certain
opioid drug products indicating that these drugs will be required to
have a REMS to ensure that the benefits of the drugs continue to
outweigh the risks.\1\ The affected opioid drugs include long-acting
and extended-release brand name and generic products and are formulated
with the active ingredients buprenorphine, fentanyl, hydromorphone,
methadone, morphine, oxycodone, oxymorphone, and tapentadol. After
sending the letters, FDA held a series of meetings with stakeholders
and convened an advisory committee to obtain input on the appropriate
elements of the Opioid REMS.
---------------------------------------------------------------------------

\1\ See the Opioid REMS Meeting Invitation Template at https://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM163652.pdf and the Opioids Products Chart at https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163654.htm.
---------------------------------------------------------------------------

On April 19, 2011, in conjunction with the Office of National Drug
Control Policy (ONDCP) release of the Obama Administration's Epidemic:
Responding to America's Prescription Drug Abuse Crisis--a comprehensive
action plan to address the national prescription drug abuse epidemic,
FDA issued letters to application holders directing them to submit a
REMS within 120 days and describing the elements that needed to be
included in the REMS (REMS notification letters). The central component
of the Opioid REMS program is an education program for prescribers
(e.g., physicians, nurse practitioners, physician assistants) and
patients.

B. REMS Prescriber Education

In the REMS notification letters, FDA provided an outline of the
required prescriber education. The outline specified that the education
must include information on weighing the risks and benefits of opioid
therapy, choosing patients appropriately, managing and monitoring
patients, and counseling patients on the safe use of these drugs. In
addition, the education must include information on how to recognize
evidence of, and the potential for, opioid misuse, abuse, and
addiction. The REMS notification letters stated that although there is
no mandatory requirement that prescribers take the course as a
precondition to dispensing the medication to patients, application
holders will be required to establish goals for the number of
prescribers trained, collect the information about the number of
prescribers who took the courses, and report the information to FDA as
part of periodic required assessments.

C. CE Providers Will Conduct Prescriber Education

The REMS notification letter expressed FDA's expectation that the
training would be conducted by accredited, independent continuing
education providers. FDA later elaborated on its vision for prescriber
education stating that we expect the CE training to be provided without
cost to the healthcare professionals and that sponsors would offer
unrestricted grants to accredited CE providers to develop CE for the
appropriate prescriber

[[Page 68767]]

groups.\2\ We believe having the training provided by CE organizations
will be an incentive and will not create new burdens on prescribers
because most healthcare professionals are routinely engaged in CE
activity.
---------------------------------------------------------------------------

\2\ See FDA Opioid REMS Meeting with Industry (May 16, 2011), at
https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258184.htm and Preliminary Responses to Industry Questions About
Opioid REMS at https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258113.htm.
---------------------------------------------------------------------------

D. The Blueprint Will Provide the Basic Outline and Core Messages for
CE

In response to the April REMS notification letter, application
holders, through an industry working group, submitted an expanded
outline of the potential topics to be covered in the CE, noting that
education incorporating all of the topics in the outline could require
30 or more hours of education. FDA's expectation is that the initial or
basic REMS related CE that should be offered to all prescribers of
long-acting and extended-release opioids should consist of a ``core''
content of about 2 to 3 hours. FDA has reviewed the industry submission
and developed a basic outline and the core messages that FDA believes
should be conveyed to prescribers in this basic educational module.
After it is completed and approved as part of the REMS, the Blueprint
will be posted on FDA's Web site for use by CE providers in developing
CE courses. Although FDA recognizes that additional training modules
could be helpful, FDA's goal is to require basic education for all
prescribers of long-acting and extended-release opioids, and at this
time, FDA does not intend to develop or approve messages as part of the
REMS beyond those approved in the basic core module. Using the
Blueprint on FDA's Web site, CE providers can develop accredited CE in
the manner they choose.\3\
---------------------------------------------------------------------------

\3\ Since early May 2011, FDA has held teleconferences and met
with representatives from the CE accreditor and provider
communities. We have expressed our interest in understanding the
challenges of the CE providers, including the need to be in
compliance with the Accreditation Council for Continuing Medical
Education (ACCME) Standards for Commercial Support and the need to
ensure that the content of CE remains beyond the control of
industry. We are confident that the ACCME standards will be met and
ACCME will be satisfied that FDA will control the content of REMS
CE.
---------------------------------------------------------------------------

With this document, FDA is announcing the availability of the
Agency's draft Blueprint for prescriber education and soliciting public
comment. The draft Blueprint is available on the Internet at
www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf. FDA will consider any comments submitted and make
appropriate revisions before approving the Blueprint as a part of the
Opioid REMS.

II. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments on the draft
Blueprint. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28669 Filed 11-4-11; 8:45 am]
BILLING CODE 4160-01-P

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