82_FR_21907 82 FR 21818 - Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids; Availability

82 FR 21818 - Draft Revisions to the Food and Drug Administration Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 89 (May 10, 2017)

Page Range21818-21819
FR Document2017-09442

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft revisions to the ``FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics'' (Blueprint). The Blueprint is part of the FDA-approved risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS). FDA is seeking comment on the draft revisions to the Blueprint and has added sections of draft revised Blueprint to the background materials for the public workshop scheduled for May 9-10, 2017. Although the draft revisions to the Blueprint will not be a discussion topic at the workshop, FDA expects the draft revisions to provide important context for discussions during the workshop.

Federal Register, Volume 82 Issue 89 (Wednesday, May 10, 2017)
[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Notices]
[Pages 21818-21819]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2497]


Draft Revisions to the Food and Drug Administration Blueprint for 
Prescriber Education for Extended-Release and Long-Acting Opioids; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of draft revisions to the ``FDA Blueprint for 
Prescriber Education for Extended-Release and Long-Acting Opioid 
Analgesics'' (Blueprint). The Blueprint is part of the FDA-approved 
risk evaluation and mitigation strategy (REMS) for extended release 
(ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid 
Analgesics REMS).
    FDA is seeking comment on the draft revisions to the Blueprint and 
has added sections of draft revised Blueprint to the background 
materials for the public workshop scheduled for May 9-10, 2017. 
Although the draft revisions to the Blueprint will not be a discussion 
topic at the workshop, FDA expects the draft revisions to provide 
important context for discussions during the workshop.

DATES: To ensure that FDA considers your comments on the draft 
revisions to the Blueprint, submit either electronic or written 
comments by July 10, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    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'').

Written/Paper Submissions

    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-D-2497 for ``Draft Revisions to FDA Blueprint for Prescriber 
Education for Extended-Release and Long-Acting Opioids; Request for 
Comments.'' Received comments 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

[[Page 21819]]

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.thefederalregister.org/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.
    Submit written requests for single copies of the draft revised 
Blueprint to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002. Send one self-addressed adhesive label to assist that 
office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft revised Blueprint.

FOR FURTHER INFORMATION CONTACT: Janelle Derbis, Center for Drug 
Evaluation and Research (HFD-1), Food and Drug Administration 20 North 
Michigan Ave., Suite 510, Chicago, IL 60602, 312-596-6516.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of draft 
revisions to the ``FDA Blueprint for Prescriber Education for Extended-
Release and Long-Acting Opioid Analgesics'' (draft revisions to the 
Blueprint). In addition to seeking comment on the draft revisions to 
the Blueprint, FDA expects the draft revisions to create important 
context for discussions at a public workshop 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 opioids) for health care providers. That workshop, which is 
scheduled for May 9-10, 2017, was previously announced in the Federal 
Register on April 18, 2017 (82 FR 18300).

I. Background

    On July 12, 2012, FDA approved an ER/LA Opioid Analgesics REMS, 
including an FDA-created ``Blueprint for Prescriber Education for 
Extended-Release and Long-Acting (ER/LA) Opioid Analgesics.'' The goal 
of the REMS is to reduce serious adverse outcomes resulting from 
inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics 
while maintaining patient access to pain medications.
    The ER/LA Opioid Analgesics REMS requires that training in the form 
of accredited continuing education be made available to health care 
providers who prescribe ER/LA opioid analgesics. The accredited 
continuing education must include all elements of the FDA Blueprint, 
which includes a basic outline and the core messages related to ER/LA 
opioid analgesics. FDA developed the Blueprint following extensive 
input from stakeholders and sought input on a draft version on November 
7, 2011 (76 FR 68766), before approving it in 2012 as part of the ER/LA 
Opioid Analgesics REMS.
    On May 3-4, 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 or not it is unduly burdensome to 
patient access to the drugs; and whether it (to the extent practicable) 
minimizes the burden to the health care delivery system (March 14, 
2016, 81 FR 13372). FDA also 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. Advisory 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. The majority of the members were in favor of a 
requirement for all prescribers to complete training. Many of the 
members recommended that the required training program be implemented 
through mechanisms outside the FDA REMS authority. The majority of 
members 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.

II. Potential Modifications to the FDA Blueprint

    FDA is considering modifications to the existing Blueprint in light 
of recommendations from the May 2016 Advisory Committee meeting. The 
draft revisions to the Blueprint being made available pursuant to this 
notice would broaden the Blueprint to include information on pain 
management, including the principles of acute and chronic pain 
management; non-pharmacologic treatments for pain; and pharmacologic 
treatments for pain (both non-opioid analgesic and opioid analgesic). 
FDA intends to consider public input as it considers modifications to 
the ER/LA Opioid Analgesics REMS.

III. May 2017 Public Workshop

    On April 18, 2017, FDA published a notice announcing a public 
workshop scheduled for May 9-10, 2017, to seek 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 opioids) for health care providers. Through the 
public workshop, FDA hopes to obtain additional insight from a variety 
of stakeholders on how best to ensure that health care providers 
receive training in pain management and the safe use of opioids. The 
draft revisions to the Blueprint being made available at https://www.fda.gov/Drugs/NewsEvents/ucm553931.htm are intended to provide 
important context for the public workshop's discussion. However, the 
Blueprint itself will not be a discussion topic at the workshop. FDA 
intends to consider any comments submitted to this docket as it 
considers possible modifications to the ER/LA Opioid Analgesics REMS.

    Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09442 Filed 5-9-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                  21818                        Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Notices

                                                  CMS–10225 Disclosures Required of                          Dated: May 5, 2017                                 third party may not wish to be posted,
                                                  Certain Hospitals and Critical Access                   William N. Parham, III,                               such as medical information, your or
                                                  Hospitals Regarding Physician                           Director, Paperwork Reduction Staff, Office           anyone else’s Social Security number, or
                                                  Ownership                                               of Strategic Operations and Regulatory                confidential business information, such
                                                                                                          Affairs.                                              as a manufacturing process. Please note
                                                    Under the PRA (44 U.S.C. 3501–                        [FR Doc. 2017–09478 Filed 5–9–17; 8:45 am]            that if you include your name, contact
                                                  3520), federal agencies must obtain                     BILLING CODE 4120–01–P                                information, or other information that
                                                  approval from the Office of Management                                                                        identifies you in the body of your
                                                  and Budget (OMB) for each collection of                                                                       comments, that information will be
                                                  information they conduct or sponsor.                    DEPARTMENT OF HEALTH AND                              posted on https://www.regulations.gov.
                                                  The term ‘‘collection of information’’ is               HUMAN SERVICES                                          • If you want to submit a comment
                                                  defined in 44 U.S.C. 3502(3) and 5 CFR                                                                        with confidential information that you
                                                  1320.3(c) and includes agency requests                  Food and Drug Administration                          do not wish to be made available to the
                                                  or requirements that members of the                     [Docket No. FDA–2017–D–2497]                          public, submit the comment as a
                                                  public submit reports, keep records, or                                                                       written/paper submission and in the
                                                                                                          Draft Revisions to the Food and Drug                  manner detailed (see ‘‘Written/Paper
                                                  provide information to a third party.
                                                                                                          Administration Blueprint for Prescriber               Submissions’’ and ‘‘Instructions’’).
                                                  Section 3506(c)(2)(A) of the PRA
                                                  requires federal agencies to publish a                  Education for Extended-Release and                    Written/Paper Submissions
                                                  60-day notice in the Federal Register                   Long-Acting Opioids; Availability
                                                                                                                                                                   Submit written/paper submissions as
                                                  concerning each proposed collection of                  AGENCY:    Food and Drug Administration,              follows:
                                                  information, including each proposed                    HHS.                                                     • Mail/Hand delivery/Courier (for
                                                  extension or reinstatement of an existing               ACTION:Notice of availability; request                written/paper submissions): Division of
                                                  collection of information, before                       for comments.                                         Dockets Management (HFA–305), Food
                                                  submitting the collection to OMB for                                                                          and Drug Administration, 5630 Fishers
                                                  approval. To comply with this                           SUMMARY:    The Food and Drug                         Lane, Rm. 1061, Rockville, MD 20852.
                                                  requirement, CMS is publishing this                     Administration (FDA or Agency) is                        • For written/paper comments
                                                  notice.                                                 announcing the availability of draft                  submitted to the Division of Dockets
                                                                                                          revisions to the ‘‘FDA Blueprint for                  Management, FDA will post your
                                                  Information Collection                                  Prescriber Education for Extended-                    comment, as well as any attachments,
                                                                                                          Release and Long-Acting Opioid                        except for information submitted,
                                                     1. Type of Information Collection                    Analgesics’’ (Blueprint). The Blueprint               marked and identified, as confidential,
                                                  Request: Extension of a currently                       is part of the FDA-approved risk                      if submitted as detailed in
                                                  approved collection; Title of                           evaluation and mitigation strategy                    ‘‘Instructions.’’
                                                  Information Collection: Disclosures                     (REMS) for extended release (ER) and                     Instructions: All submissions received
                                                  Required of Certain Hospitals and                       long-acting (LA) opioid analgesic                     must include the Docket No. FDA–
                                                  Critical Access Hospitals Regarding                     medications (ER/LA Opioid Analgesics                  2017–D–2497 for ‘‘Draft Revisions to
                                                  Physician Ownership; Use: This                          REMS).                                                FDA Blueprint for Prescriber Education
                                                  information collection relates to the                      FDA is seeking comment on the draft                for Extended-Release and Long-Acting
                                                  required third party disclosures by                     revisions to the Blueprint and has added              Opioids; Request for Comments.’’
                                                  certain Medicare-participating hospitals                sections of draft revised Blueprint to the            Received comments will be placed in
                                                  and Critical Access Hospitals (CAHs)                    background materials for the public                   the docket and, except for those
                                                  and physicians to their patients. The                   workshop scheduled for May 9–10,                      submitted as ‘‘Confidential
                                                  intent of the disclosure notice is to                   2017. Although the draft revisions to the             Submissions,’’ publicly viewable at
                                                  assist the patient in making an informed                Blueprint will not be a discussion topic              https://www.regulations.gov or at the
                                                  decision regarding their care. The                      at the workshop, FDA expects the draft                Division of Dockets Management
                                                  disclosure requires hospitals and CAHs                  revisions to provide important context                between 9 a.m. and 4 p.m., Monday
                                                  to disclose to its patients whether the                 for discussions during the workshop.                  through Friday.
                                                  hospitals/CAHs are physician-owned                      DATES: To ensure that FDA considers                      • Confidential Submissions—To
                                                                                                          your comments on the draft revisions to               submit a comment with confidential
                                                  and, if so, the names of the physician-
                                                                                                          the Blueprint, submit either electronic               information that you do not wish to be
                                                  owners. The second disclosure requires
                                                                                                          or written comments by July 10, 2017.                 made publicly available, submit your
                                                  all hospitals and CAHs that do not have
                                                                                                          ADDRESSES: You may submit comments                    comments only as a written/paper
                                                  a Doctor of Medicine (MD) or a Doctor                                                                         submission. You should submit two
                                                  of Osteopathic Medicine (DO) on the                     as follows:
                                                                                                                                                                copies total. One copy will include the
                                                  premises at all times to disclose this to               Electronic Submissions                                information you claim to be confidential
                                                  patients upon admission or registration                   Submit electronic comments in the                   with a heading or cover note that states
                                                  for both inpatient and specified                        following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                  outpatient services. Form Number:                         • Federal eRulemaking Portal:                       CONFIDENTIAL INFORMATION.’’ The
                                                  CMS–10225 (OMB Control Number:                          https://www.regulations.gov. Follow the               Agency will review this copy, including
                                                  0938–1034); Frequency: Occasionally;                    instructions for submitting comments.                 the claimed confidential information, in
                                                  Affected Public: Private sector—                        Comments submitted electronically,                    its consideration of comments. The
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  Business or other for-profits and Not-                  including attachments, to https://                    second copy, which will have the
                                                  for-profit institutions; Number of                      www.regulations.gov will be posted to                 claimed confidential information
                                                  Respondents: 2,556; Total Annual                        the docket unchanged. Because your                    redacted/blacked out, will be available
                                                  Responses: 162,993; Total Annual                        comment will be made public, you are                  for public viewing and posted on
                                                  Hours: 6,435. (For policy questions                     solely responsible for ensuring that your             https://www.regulations.gov. Submit
                                                  regarding this collection contact Natalie               comment does not include any                          both copies to the Division of Dockets
                                                  Clybourn at 410–786–5642).                              confidential information that you or a                Management. If you do not wish your


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                                                                               Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Notices                                                   21819

                                                  name and contact information to be                      I. Background                                         II. Potential Modifications to the FDA
                                                  made publicly available, you can                                                                              Blueprint
                                                  provide this information on the cover                      On July 12, 2012, FDA approved an
                                                                                                          ER/LA Opioid Analgesics REMS,                            FDA is considering modifications to
                                                  sheet and not in the body of your                                                                             the existing Blueprint in light of
                                                  comments and you must identify this                     including an FDA-created ‘‘Blueprint for
                                                                                                                                                                recommendations from the May 2016
                                                  information as ‘‘confidential.’’ Any                    Prescriber Education for Extended-
                                                                                                                                                                Advisory Committee meeting. The draft
                                                  information marked as ‘‘confidential’’                  Release and Long-Acting (ER/LA)
                                                                                                                                                                revisions to the Blueprint being made
                                                  will not be disclosed except in                         Opioid Analgesics.’’ The goal of the                  available pursuant to this notice would
                                                  accordance with 21 CFR 10.20 and other                  REMS is to reduce serious adverse                     broaden the Blueprint to include
                                                  applicable disclosure law. For more                     outcomes resulting from inappropriate                 information on pain management,
                                                  information about FDA’s posting of                      prescribing, misuse, and abuse of ER/LA               including the principles of acute and
                                                  comments to public dockets, see 80 FR                   opioid analgesics while maintaining                   chronic pain management; non-
                                                  56469, September 18, 2015, or access                    patient access to pain medications.                   pharmacologic treatments for pain; and
                                                  the information at: https://www.gpo.gov/                   The ER/LA Opioid Analgesics REMS                   pharmacologic treatments for pain (both
                                                  fdsys/pkg/FR-2015-09-18/pdf/2015-                       requires that training in the form of                 non-opioid analgesic and opioid
                                                  23389.pdf.                                              accredited continuing education be                    analgesic). FDA intends to consider
                                                     Docket: For access to the docket to                  made available to health care providers               public input as it considers
                                                  read background documents or the                        who prescribe ER/LA opioid analgesics.                modifications to the ER/LA Opioid
                                                  electronic and written/paper comments                   The accredited continuing education                   Analgesics REMS.
                                                  received, go to https://                                must include all elements of the FDA                  III. May 2017 Public Workshop
                                                  www.regulations.gov and insert the                      Blueprint, which includes a basic
                                                                                                                                                                   On April 18, 2017, FDA published a
                                                  docket number, found in brackets in the                 outline and the core messages related to
                                                                                                                                                                notice announcing a public workshop
                                                  heading of this document, into the                      ER/LA opioid analgesics. FDA
                                                                                                                                                                scheduled for May 9–10, 2017, to seek
                                                  ‘‘Search’’ box and follow the prompts                   developed the Blueprint following
                                                                                                                                                                input on issues and challenges
                                                  and/or go to the Division of Dockets                    extensive input from stakeholders and                 associated with Federal efforts to
                                                  Management, 5630 Fishers Lane, Rm.                      sought input on a draft version on                    support training on pain management
                                                  1061, Rockville, MD 20852.                              November 7, 2011 (76 FR 68766), before                and the safe prescribing, dispensing,
                                                     Submit written requests for single                   approving it in 2012 as part of the ER/               and patient use of opioids (safe use of
                                                  copies of the draft revised Blueprint to                LA Opioid Analgesics REMS.                            opioids) for health care providers.
                                                  the Division of Drug Information, Center                   On May 3–4, 2016, FDA convened a                   Through the public workshop, FDA
                                                  for Drug Evaluation and Research, Food                  joint meeting of the Drug Safety and                  hopes to obtain additional insight from
                                                  and Drug Administration, 10001 New                      Risk Management Advisory Committee                    a variety of stakeholders on how best to
                                                  Hampshire Ave., Hillandale Building,                    and the Anesthetic and Analgesic Drug                 ensure that health care providers receive
                                                  4th Floor, Silver Spring, MD 20993–                     Products Advisory Committee to discuss                training in pain management and the
                                                  0002. Send one self-addressed adhesive                  whether this REMS assures safe use of                 safe use of opioids. The draft revisions
                                                  label to assist that office in processing               these products; whether or not it is                  to the Blueprint being made available at
                                                  your requests. See the SUPPLEMENTARY                    unduly burdensome to patient access to                https://www.fda.gov/Drugs/NewsEvents/
                                                  INFORMATION section for electronic                      the drugs; and whether it (to the extent              ucm553931.htm are intended to provide
                                                  access to the draft revised Blueprint.                  practicable) minimizes the burden to the              important context for the public
                                                                                                          health care delivery system (March 14,                workshop’s discussion. However, the
                                                  FOR FURTHER INFORMATION CONTACT:                                                                              Blueprint itself will not be a discussion
                                                                                                          2016, 81 FR 13372). FDA also sought
                                                  Janelle Derbis, Center for Drug                         input on possible modifications to the                topic at the workshop. FDA intends to
                                                  Evaluation and Research (HFD–1), Food                   ER/LA Opioid Analgesic REMS,                          consider any comments submitted to
                                                  and Drug Administration 20 North                        including expansion of the scope and                  this docket as it considers possible
                                                  Michigan Ave., Suite 510, Chicago, IL                   content of prescriber training and                    modifications to the ER/LA Opioid
                                                  60602, 312–596–6516.                                    expansion of the REMS program to                      Analgesics REMS.
                                                  SUPPLEMENTARY INFORMATION:      FDA is                  include immediate release (IR) opioid                   Dated: May 4, 2017.
                                                  announcing the availability of draft                    analgesics. Advisory Committee                        Anna K. Abram,
                                                  revisions to the ‘‘FDA Blueprint for                    members were in favor of modifying the                Deputy Commissioner for Policy, Planning,
                                                  Prescriber Education for Extended-                      REMS program to include the IR opioid                 Legislation, and Analysis.
                                                  Release and Long-Acting Opioid                          analgesics as well as broadening the                  [FR Doc. 2017–09442 Filed 5–9–17; 8:45 am]
                                                  Analgesics’’ (draft revisions to the                    training program to include pain                      BILLING CODE 4164–01–P
                                                  Blueprint). In addition to seeking                      management. The majority of the
                                                  comment on the draft revisions to the                   members were in favor of a requirement
                                                  Blueprint, FDA expects the draft                        for all prescribers to complete training.             DEPARTMENT OF HEALTH AND
                                                  revisions to create important context for               Many of the members recommended                       HUMAN SERVICES
                                                  discussions at a public workshop on                     that the required training program be
                                                  issues and challenges associated with                   implemented through mechanisms                        Nerve Agents and Certain Insecticides
                                                  Federal efforts to support training on                  outside the FDA REMS authority. The                   (Organophosphorus and/or
                                                  pain management and the safe                            majority of members also stated that                  Carbamate) Countermeasures
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  prescribing, dispensing, and patient use                other health care providers involved in               AGENCY: Department of Health and
                                                  of opioids (safe use of opioids) for                    the management of pain should be                      Human Services, Office of the Secretary.
                                                  health care providers. That workshop,                   included as a target audience for                     ACTION: Notice.
                                                  which is scheduled for May 9–10, 2017,                  education, though they did not specify
                                                  was previously announced in the                         that the training should be mandatory                 SUMMARY:  The Secretary is issuing a
                                                  Federal Register on April 18, 2017 (82                  for non-prescribing health care                       declaration pursuant to section 319F–3
                                                  FR 18300).                                              providers.                                            of the Public Health Service Act to


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Document Created: 2017-05-10 00:00:52
Document Modified: 2017-05-10 00:00:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability; request for comments.
DatesTo ensure that FDA considers your comments on the draft revisions to the Blueprint, submit either electronic or written comments by July 10, 2017.
ContactJanelle Derbis, Center for Drug Evaluation and Research (HFD-1), Food and Drug Administration 20 North Michigan Ave., Suite 510, Chicago, IL 60602, 312-596-6516.
FR Citation82 FR 21818 

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