81 FR 13372 - Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 49 (March 14, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 49 (March 14, 2016)
| Page Range | 13372-13373 | |
| FR Document | 2016-05573 |
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)] [Notices] [Pages 13372-13373] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05573] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0820] Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committees: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting will be held on May 3, 2016, from 8 a.m. to 5 p.m. and May 4, 2016, from 8 a.m. to 5 p.m. ADDRESSES: FDA is opening a docket for public comment on this meeting. The docket number is FDA-2016-N-0820. The docket will open for public comment on March 14, 2016. The docket will close on June 4, 2016. Interested persons may submit either electronic or written comments regarding this meeting. Submit electronic comments to http://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. All comments received will be posted without change, including any personal information provided. It is only necessary to send one set of 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. Comments received on or before April 19, 2016, will be provided to the committees before the meeting. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Contact Person: Stephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the committees will discuss results from assessments of the extended- release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will seek the committees' comments as to whether this REMS with ETASU assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. The ER/LA Opioid Analgesics REMS requires that prescriber training will be made available to healthcare providers who prescribe ER/LA opioid analgesics. Training is considered ``REMS-compliant'' if: (1) It, for training provided by continuing education providers, is offered by an accredited provider to licensed prescribers, (2) it includes all elements of the FDA Blueprint for Prescriber Education for ER/LA Opioid Analgesics (Blueprint), (3) it includes a knowledge assessment of all the sections of the Blueprint, and (4) it is subject to independent audit to confirm that conditions of the REMS training have been met. The Agency will seek the committees' input on possible modifications to the ER/LA Opioid Analgesics REMS, including expansion of the scope and content of prescriber training and expansion of the REMS program to include immediate-release opioids. Comments from the public can be submitted to the docket (see the ADDRESSES section) on a broad evaluation of the ER/LA Opioid Analgesics REMS program and whether the ER/LA opioid analgesics REMS should be modified as well as any proposed modifications. Comments may include but are not limited to: (1) Alternative methodologies for evaluating the overall impact of the program on knowledge and behavior by prescribers and patients, (2) the overall impact of the REMS on the adverse events it is intended to mitigate; (3) whether the FDA Blueprint or other tools (e.g., Medication Guide or Patient Counseling Document) should be revised and/or expanded; (4) the use of the continuing education as a component of the REMS as a mechanism for providing prescriber training; (5) whether to expand the REMS program to include immediate-release opioids; and (6) how additional REMS tools or ETASU (e.g., required prescriber or pharmacist training, required patient agreements), if recommended, may impact the healthcare delivery system and patient access to ER/LA opioid analgesics. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background [[Page 13373]] material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before April 19, 2016, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 12:30 p.m. on May 4, 2016. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 11, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 12, 2016. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Stephanie L. Begansky at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 8, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-05573 Filed 3-11-16; 8:45 am] BILLING CODE 4164-01-P
![13372 Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
Management (see DATES and ADDRESSES) electronic or written comments assessments of the extended-release and
for public review and comment for 30 regarding this meeting. Submit long-acting (ER/LA) Opioid Analgesics
days. Oxitec Ltd. prepared the draft EA. electronic comments to http:// REMS. The Agency will seek the
The preliminary FONSI is based upon www.regulations.gov. Submit written committees’ comments as to whether
Oxitec Ltd.’s draft EA. FDA is comments to the Division of Dockets this REMS with ETASU assures safe
considering the draft EA and tentatively Management (HFA–305), Food and Drug use, is not unduly burdensome to
agrees with its conclusion that conduct Administration, 5630 Fishers Lane, rm. patient access to the drugs, and to the
of this trial will result in no significant 1061, Rockville, MD 20852. All extent practicable, minimizes the
impacts on the environment. If nothing comments received will be posted burden to the healthcare delivery
changes FDA’s tentative determination, without change, including any personal system.
FDA will prepare and release its own information provided. It is only The ER/LA Opioid Analgesics REMS
revised, final EA and final FONSI. The necessary to send one set of comments. requires that prescriber training will be
Agency intends to take comments Identify comments with the docket made available to healthcare providers
received under advisement in number found in brackets in the who prescribe ER/LA opioid analgesics.
determining whether to prepare a heading of this document. Received Training is considered ‘‘REMS-
revised, final EA and FONSI. If FDA comments may be seen in the Division compliant’’ if: (1) It, for training
does not agree with the preliminary of Dockets Management between 9 a.m. provided by continuing education
conclusion that conduct of this trial will and 4 p.m., Monday through Friday. providers, is offered by an accredited
result in no significant impacts on the Comments received on or before April provider to licensed prescribers, (2) it
environment, it will prepare an 19, 2016, will be provided to the includes all elements of the FDA
environmental impact statement. committees before the meeting. Blueprint for Prescriber Education for
Location: FDA White Oak Campus, ER/LA Opioid Analgesics (Blueprint),
Dated: March 8, 2016.
10903 New Hampshire Ave., Bldg. 31 (3) it includes a knowledge assessment
Leslie Kux, Conference Center, the Great Room (Rm. of all the sections of the Blueprint, and
Associate Commissioner for Policy. 1503), Silver Spring, MD 20993–0002. (4) it is subject to independent audit to
[FR Doc. 2016–05622 Filed 3–11–16; 8:45 am] Answers to commonly asked questions confirm that conditions of the REMS
BILLING CODE 4164–01–P including information regarding special training have been met. The Agency will
accommodations due to a disability, seek the committees’ input on possible
visitor parking, and transportation may modifications to the ER/LA Opioid
DEPARTMENT OF HEALTH AND be accessed at: http://www.fda.gov/ Analgesics REMS, including expansion
HUMAN SERVICES AdvisoryCommittees/ of the scope and content of prescriber
AboutAdvisoryCommittees/ training and expansion of the REMS
Food and Drug Administration ucm408555.htm. program to include immediate-release
[Docket No. FDA–2016–N–0820] Contact Person: Stephanie L. opioids.
Begansky, Center for Drug Evaluation Comments from the public can be
Drug Safety and Risk Management and Research, Food and Drug submitted to the docket (see the
Advisory Committee and the Administration, 10903 New Hampshire ADDRESSES section) on a broad
Anesthetic and Analgesic Drug Ave., Bldg. 31, Rm. 2417, Silver Spring, evaluation of the ER/LA Opioid
Products Advisory Committee; Notice MD 20993–0002, 301–796–9001, Fax: Analgesics REMS program and whether
of Meeting 301–847–8533, email: AADPAC@ the ER/LA opioid analgesics REMS
fda.hhs.gov, or FDA Advisory should be modified as well as any
AGENCY: Food and Drug Administration, Committee Information Line, 1–800– proposed modifications. Comments may
HHS. 741–8138 (301–443–0572 in the include but are not limited to: (1)
ACTION: Notice. Washington, DC area). A notice in the Alternative methodologies for
Federal Register about last minute evaluating the overall impact of the
This notice announces a forthcoming modifications that impact a previously program on knowledge and behavior by
meeting of a public advisory committee announced advisory committee meeting prescribers and patients, (2) the overall
of the Food and Drug Administration cannot always be published quickly impact of the REMS on the adverse
(FDA). The meeting will be open to the enough to provide timely notice. events it is intended to mitigate; (3)
public. Therefore, you should always check the whether the FDA Blueprint or other
Name of Committees: Drug Safety and Agency’s Web site at http:// tools (e.g., Medication Guide or Patient
Risk Management Advisory Committee www.fda.gov/AdvisoryCommittees/ Counseling Document) should be
and the Anesthetic and Analgesic Drug default.htm and scroll down to the revised and/or expanded; (4) the use of
Products Advisory Committee. appropriate advisory committee meeting the continuing education as a
General Function of the Committees: link, or call the advisory committee component of the REMS as a
To provide advice and information line to learn about possible mechanism for providing prescriber
recommendations to the Agency on modifications before coming to the training; (5) whether to expand the
FDA’s regulatory issues. meeting. REMS program to include immediate-
Date and Time: The meeting will be Agenda: The Food and Drug release opioids; and (6) how additional
held on May 3, 2016, from 8 a.m. to 5 Administration Amendments Act of REMS tools or ETASU (e.g., required
p.m. and May 4, 2016, from 8 a.m. to 5 2007 (Pub. L. 110–85) requires FDA to prescriber or pharmacist training,
p.m. bring, at least annually, one or more
jstallworth on DSK7TPTVN1PROD with NOTICES
required patient agreements), if
ADDRESSES: FDA is opening a docket for drugs with Risk Evaluation and recommended, may impact the
public comment on this meeting. The Mitigation Strategies (REMS) with healthcare delivery system and patient
docket number is FDA–2016–N–0820. Elements to Assure Safe Use (ETASU) access to ER/LA opioid analgesics.
The docket will open for public before its Drug Safety and Risk FDA intends to make background
comment on March 14, 2016. The Management Advisory Committee material available to the public no later
docket will close on June 4, 2016. (DSaRM). On May 3 and 4, 2016, the than 2 business days before the meeting.
Interested persons may submit either committees will discuss results from If FDA is unable to post the background
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![Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices 13373
material on its Web site prior to the Dated: March 8, 2016. ADDRESSES: You may submit comments
meeting, the background material will Jill Hartzler Warner, as follows:
be made publicly available at the Associate Commissioner for Special Medical
Electronic Submissions
location of the advisory committee Programs.
meeting, and the background material [FR Doc. 2016–05573 Filed 3–11–16; 8:45 am] Submit electronic comments in the
will be posted on FDA’s Web site after BILLING CODE 4164–01–P
following way:
the meeting. Background material is • Federal eRulemaking Portal: http://
available at http://www.fda.gov/ www.regulations.gov. Follow the
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND instructions for submitting comments.
default.htm. Scroll down to the HUMAN SERVICES Comments submitted electronically,
appropriate advisory committee meeting including attachments, to http://
link. Food and Drug Administration www.regulations.gov will be posted to
the docket unchanged. Because your
Procedure: Interested persons may [Docket No. FDA–2015–D–4750] comment will be made public, you are
present data, information, or views,
solely responsible for ensuring that your
orally or in writing, on issues pending Implementation of the ‘‘Deemed To Be comment does not include any
before the committees. All electronic a License’’ Provision of the Biologics confidential information that you or a
and written submissions submitted to Price Competition and Innovation Act third party may not wish to be posted,
the Docket (see the ADDRESSES section) of 2009; Draft Guidance for Industry; such as medical information, your or
on or before April 19, 2016, will be Availability and Request for Comments anyone else’s Social Security number, or
provided to the committees. Oral
AGENCY: Food and Drug Administration, confidential business information, such
presentations from the public will be
HHS. as a manufacturing process. Please note
scheduled between approximately 10:30
that if you include your name, contact
a.m. and 12:30 p.m. on May 4, 2016. ACTION:Notice of availability; request
information, or other information that
Those individuals interested in making for comments.
identifies you in the body of your
formal oral presentations should notify
SUMMARY: The Food and Drug comments, that information will be
the contact person and submit a brief
Administration (FDA or Agency) is posted on http://www.regulations.gov.
statement of the general nature of the • If you want to submit a comment
evidence or arguments they wish to announcing the availability of a draft
guidance for industry entitled with confidential information that you
present, the names and addresses of do not wish to be made available to the
proposed participants, and an ‘‘Implementation of the ‘Deemed to be a
License’ Provision of the Biologics Price public, submit the comment as a
indication of the approximate time written/paper submission and in the
requested to make their presentation on Competition and Innovation Act of
2009.’’ This draft guidance describes manner detailed (see ‘‘Written/Paper
or before April 11, 2016. Time allotted Submissions’’ and ‘‘Instructions’’).
for each presentation may be limited. If FDA’s approach to implementation of
the number of registrants requesting to the statutory provision under which an Written/Paper Submissions
speak is greater than can be reasonably application for a biological product
Submit written/paper submissions as
accommodated during the scheduled approved under the Federal Food, Drug,
follows:
open public hearing session, FDA may and Cosmetic Act (FD&C Act) on or • Mail/Hand delivery/Courier (for
conduct a lottery to determine the before March 23, 2020, will be deemed written/paper submissions): Division of
speakers for the scheduled open public to be a license for the biological product Dockets Management (HFA–305), Food
hearing session. The contact person will under the Public Health Service Act and Drug Administration, 5630 Fishers
notify interested persons regarding their (PHS Act) on March 23, 2020. Lane, Rm. 1061, Rockville, MD 20852.
request to speak by April 12, 2016. Specifically, this draft guidance • For written/paper comments
describes FDA’s interpretation of the submitted to the Division of Dockets
Persons attending FDA’s advisory
‘‘deemed to be a license’’ provision of Management, FDA will post your
committee meetings are advised that the
the Biologics Price Competition and comment, as well as any attachments,
Agency is not responsible for providing
Innovation Act of 2009 (BPCI Act) for except for information submitted,
access to electrical outlets.
biological products that have been or marked and identified, as confidential,
FDA welcomes the attendance of the will be approved under the FD&C Act
public at its advisory committee if submitted as detailed in
on or before March 23, 2020. This draft ‘‘Instructions.’’
meetings and will make every effort to guidance also provides Instructions: All submissions received
accommodate persons with disabilities. recommendations to sponsors of must include the Docket No. FDA–
If you require accommodations due to a proposed protein products intended for 2015–D–4750 for ‘‘Implementation of
disability, please contact Stephanie L. submission in an application that may the ‘Deemed to be a License’ Provision
Begansky at least 7 days in advance of not receive final approval under the of the Biologics Price Competition and
the meeting. FD&C Act on or before March 23, 2020, Innovation Act of 2009; Draft Guidance
FDA is committed to the orderly to facilitate alignment of product for Industry; Availability and Request
conduct of its advisory committee development plans with FDA’s for Comments.’’ Received comments
meetings. Please visit our Web site at interpretation the transition provisions will be placed in the docket and, except
http://www.fda.gov/ of the BPCI Act. for those submitted as ‘‘Confidential
AdvisoryCommittees/ DATES: Although you can comment on
jstallworth on DSK7TPTVN1PROD with NOTICES
Submissions,’’ publicly viewable at
AboutAdvisoryCommittees/ any guidance at any time (see 21 CFR http://www.regulations.gov or at the
ucm111462.htm for procedures on 10.115(g)(5)), to ensure that the Agency Division of Dockets Management
public conduct during advisory considers your comment on this draft between 9 a.m. and 4 p.m., Monday
committee meetings. guidance before it begins work on the through Friday.
Notice of this meeting is given under final version of the guidance, submit • Confidential Submissions—To
the Federal Advisory Committee Act (5 either electronic or written comments submit a comment with confidential
U.S.C. app. 2). on the draft guidance by May 13, 2016. information that you do not wish to be
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Document Created: 2016-03-12 01:00:52
Document Modified: 2016-03-12 01:00:52
| 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 | Notice. | |
| FR Citation | 81 FR 13372 |
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