Risk Evaluation and Mitigation Strategies: Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access; Public Meeting, Request for Comments, 44135-44137 [2015-18149]
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Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On May
26, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘Petition to Request an
Exemption from 100 Percent Identity
Testing of Dietary Ingredients: CGMP in
Manufacturing, Packaging, Labeling or
Holding Operations for Dietary
Supplements’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0608. The
approval expires on July 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18140 Filed 7–23–15; 8:45 am]
BILLING CODE 4164–01–P
[FR Doc. 2015–18203 Filed 7–23–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2013–N–0502]
[Docket No. FDA–2013–N–1152]
Risk Evaluation and Mitigation
Strategies: Understanding and
Evaluating Their Impact on the Health
Care Delivery System and Patient
Access; Public Meeting, Request for
Comments
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Petition To Request an Exemption
From 100 Percent Identity Testing of
Dietary Ingredients: CGMP in
Manufacturing, Packaging, Labeling or
Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Petition to Request an Exemption from
100 Percent Identity Testing of Dietary
Ingredients: CGMP in Manufacturing,
Packaging, Labeling or Holding
Operations for Dietary Supplements’’
SUMMARY:
VerDate Sep<11>2014
19:59 Jul 23, 2015
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AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug Administration
(FDA or Agency) is announcing a public
meeting entitled ‘‘Risk Evaluation and
Mitigation Strategies (REMS):
Understanding and Evaluating Their
Impact on the Health Care Delivery
System and Patient Access’’. The
purpose of the public meeting is to
engage in constructive dialogue and
information sharing among regulators,
the scientific community, the
pharmaceutical industry, public health
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44135
agencies, patients, patient advocates,
health care system administrators,
prescribers, dispensers, hospitals,
infusion centers, health informatics
experts, third-party payers, distributors,
and the general public concerning the
impact of REMS on the health care
delivery system, including the impact
on patients and health care providers.
The discussion will focus on strategies
for characterizing and evaluating the
impact of REMS on the health care
delivery system and on patient access to
drugs subject to REMS.
The primary focus of this meeting will
be on REMS with Elements To Assure
Safe Use (ETASU); however, the
meeting will also include discussion of
issues that may apply to all REMS. The
input from this meeting and the public
docket comments will be used to inform
ongoing Agency initiatives related to
optimizing REMS design,
implementation, and assessment.
Dates and Times: The meeting will be
held on October 5, 2015, from 8 a.m. to
5 p.m. and October 6, 2015, from 8 a.m.
to 1 p.m.
Location: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Participants must enter through
Building 1 and undergo security
screening. For parking and security
information, please visit https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. Please arrive early to
ensure time for parking and security
screening.
Contact Persons for meeting
background and content: Megan
Moncur, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
REMSMeetingOct2015@fda.hhs.gov .
For registration, oral presentations,
special accommodations, and other
meeting logistics: Cherice Holloway,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
Phone 301–796–4909, FAX: 301–796–
9832, cherice.holloway@fda.hhs.gov.
Registration and Requests for Oral
Presentations: Registration is free and
available on a first-come, first-served
basis. You must register by September
21, 2015. Seating is limited, so register
early. FDA may limit the number of
participants from each organization. If
time and space permit, onsite
registration on the day of the meeting
will be available. To register for this
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44136
Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
meeting, please visit FDA’s Drugs News
& Events—Meetings, Conferences, &
Workshops calendar at https://
www.fda.gov/Drugs/NewsEvents/
ucm132703.htm and select this meeting
from the events list. If you need special
accommodations because of a disability,
please contact Cherice Holloway (see
Contact Persons) at least 7 days before
the meeting. Those without Internet
access should contact Cherice Holloway
to register.
This meeting includes public
comment sessions in which FDA is
seeking input on improved approaches
for understanding, evaluating, and
minimizing burden on the health care
delivery system to the extent practicable
and for helping to assure patient access
to drugs that are subject to REMS. If you
would like to present during a session,
please identify the topic(s) you will
address during registration (see section
II).
FDA will do its best to accommodate
requests to speak. FDA urges
individuals and organizations with
common interests to coordinate and/or
request time for a joint presentation.
Following the close of registration, FDA
will allot time for each presentation and
notify presenters by September 28,
2015. Do not present or distribute
commercial or promotional material
during the meeting. Registered
presenters should check in at the
registration desk before the meeting.
Live Webcast of the Meeting: To view
the Connect Pro Webcast of this
meeting, you must register online by 4
p.m., September 21, 2015. Webcast
connections are limited, so register
early. Organizations should register all
viewers but access the Webcast using
one connection per location.
Webcast viewers will be sent system
requirements after registration and will
be sent connection information after
September 28, 2015. Visit https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm for the
Connect Pro Connection Test. To get a
quick overview of Connect Pro, visit
https://www.adobe.com/go/connectpro_
overview. (FDA has verified the Web site
addresses in this notice but is not
responsible for any subsequent address
changes after this document publishes
in the Federal Register.)
Comments: FDA is holding this public
meeting to obtain information on
improved strategies for evaluating and
minimizing the burden of REMS on the
health care delivery system to the extent
practicable and their impact on patient
access to the drugs covered by such
programs. FDA is opening a public
docket for comments to be submitted to
the Agency on the issues and questions
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presented during the meeting.
Regardless of attendance at the public
meeting, interested persons may submit
electronic or paper comments to FDA’s
Division of Dockets Management by
November 2, 2015.
Submit electronic comments 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.
Send only one set of comments. Identify
all comments with the docket number
found in brackets in the heading of this
document. When addressing specific
topics (see section II), please identify
the topic. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. The transcript
may be viewed at the Division of
Dockets Management (see Comments). A
transcript will also be available in either
hard copy or on CD–ROM after
submission of a Freedom of Information
request. Written requests are to be sent
to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857.
SUPPLEMENTARY INFORMATION:
I. Background
This meeting builds on prior
stakeholder feedback on the design,
implementation, and assessment of
REMS, including feedback obtained
through public meetings, stakeholder
outreach, and comments to the public
docket, including the recommendations
and suggestions recently summarized in
the Agency’s report entitled
‘‘Standardizing and Evaluating Risk
Evaluation and Mitigation Strategies’’
(the Standardizing and Evaluating
REMS Report).1 The report also
describes the Agency’s findings
concerning strategies to standardize
REMS, where appropriate, with the goal
of reducing the burden of implementing
REMS on health care providers,
patients, and others in various health
care settings.
The Agency seeks to build on this
foundation by updating stakeholders
1 In the Federal Register of September 23, 2014
(79 FR 56816), FDA published a notice announcing
the availability of this draft report. The report is
available at https://www.fda.gov/downloads/
forindustry/userfees/prescriptiondruguserfee/
ucm415751.pdf.
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and obtaining their feedback on some of
our current and proposed initiatives
aimed at anticipating and minimizing
REMS’ burden on the health care
delivery system, helping to assure
access to drugs that are subject to REMS
with ETASU, and obtaining stakeholder
recommendations on additional
approaches to accomplish these goals.
The Agency recognizes that REMS can
impose burden on the health care
delivery system. The statute requires
ETASU to be commensurate with the
specific serious risks listed in a drug’s
labeling, and, considering such risks,
not be unduly burdensome on patient
access to the drug, and, to the extent
practicable, to minimize burden on the
health care delivery system. We are also
seeking input on the methods for
evaluating REMS’ burden on the health
care delivery system and their impact
on patient access to drugs.
The primary focus of this meeting will
be on REMS with ETASU see section
505(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355–1(f));
however, the meeting will also include
discussion of issues that may apply to
all REMS.
II. Who Is the Target Audience and
Who Should Attend This Public
Meeting?
This meeting is open to all interested
parties. The target audience is
comprised of regulators, the scientific
community, the pharmaceutical
industry, public health Agencies,
patients, patient advocates, health care
system administrators, prescribers,
dispensers, hospitals, infusion centers,
health informatics experts, third-party
payers, distributors, and the general
public who are interested in providing
input on approaches for both
anticipating and minimizing health care
delivery system burden and for helping
to assure patient access to drugs that are
subject to REMS, as well as those
interested in improving the approaches
used to evaluate the burden of REMS on
the health care delivery system and
their impact on patient access.
III. What Are the Topics We Intend to
Discuss at the Public Meeting?
The meeting will include panel
discussions and individual
presentations. The main questions that
will be considered are as follows: (1)
How to anticipate and minimize the
burden of REMS on the health care
delivery system and patient access; and
(2) how to improve the quality and
effectiveness of methods used to
evaluate REMS’ burden on the health
care delivery system and impact on
patient access.
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Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices
FDA will begin the meeting by
soliciting feedback regarding how
stakeholders, such as patients and
health care providers, think about
burden related to REMS. The meeting
will then focus on strategies for
anticipating and addressing REMS
burden and access issues in several
broad topic areas (including several
areas identified in the key opinions and
recommendations from stakeholders in
the Standardizing and Evaluating REMS
Report). Potential discussion topics are
described in this document. For topics
related to strategies for minimizing
burden and barriers to patient access
(topics 1–3), FDA will present ongoing
and planned Agency initiatives, solicit
feedback on these initiatives, and ask for
feedback on other opportunities for
anticipating and minimizing burden and
patient access issues.
Potential topics for discussion include
the following:
• Topic 1: Understanding the
stakeholder perspective.
Discussion will focus on gaining a
better understanding of how
stakeholders, such as patients, health
care providers, dispensers, and others,
think about burden and access issues
related to REMS—for example,
understanding the different dimensions
of burden (e.g., administrative,
logistical, workflow) and better
understanding the different types of
patient access issues that are implicated
by REMS.
• Topic 2: Improved communication
about the existence of a REMS and
about what is required of stakeholders
under that REMS.
Discussion will focus on strategies to
improve communications about REMS,
including communications about the
existence of a particular REMS or the
requirements under a particular REMS
program, and how to improve the clarity
of REMS materials.
• Topic 3: Improved integration of
activities required under a REMS.
Discussion will focus on two closely
related subtopics: (1) Strategies to
improve the integration of REMS
requirements into the health care
delivery system through process
improvement (e.g., streamlining REMS
processes that have an impact on
stakeholder workflow or the care
process, and reducing redundancies by
leveraging existing training or
certification requirements to meet REMS
requirements); and (2) strategies to
integrate REMS into electronic health
care systems (e.g., electronic health
records, decision support systems, and
pharmacy management systems).
• Topic 4: Improved methods for
measuring the burden of REMS on the
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health care delivery system and the
impact on patient access.
Discussion will focus on identifying
the most effective methods for
evaluating the burden of REMS on the
health care delivery system and the
impact on patient access, with a goal of
not only characterizing and quantifying
these effects, but also identifying
opportunities for improvements to a
REMS program and better
understanding the effect of changes to a
program. This may include discussion
of how to address methodological
challenges in the measurement of
burden and access, and how to
incorporate stakeholder input into
REMS design and assessment.
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
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the public meeting, and the
background material will be posted on
FDA’s Web site after the meeting at
https://www.fda.gov/Drugs/NewsEvents/
ucm132703.htm, and to the docket at
https://www.regulations.gov.
Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18149 Filed 7–23–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0146]
Third-Party Auditor/Certification Body
Accreditation for Food Safety Audits:
Model Accreditation Standards; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry and FDA staff entitled ‘‘ThirdParty Auditor/Certification Body
Accreditation for Food Safety Audits:
Model Accreditation Standards.’’ The
draft guidance, when finalized, will
contain FDA recommendations on thirdparty auditor/certification body
qualifications for accreditation to
conduct food safety audits and to issue
food and/or facility certifications under
an FDA program required by the FDA
Food Safety Modernization Act (FSMA).
SUMMARY:
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44137
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
your comment on this draft guidance
before we begin work on the final
version of the guidance, submit either
electronic or written comments by
October 7, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to
Charlotte A. Christin, Office of
Compliance, Center for Food Safety and
Applied Nutrition (HFS–605), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
Submit electronic comments on the
draft guidance 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:
Charlotte A. Christin, Center for Food
Safety and Applied Nutrition (HFS–
605), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, 240–402–3708.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
We are announcing the availability of
a draft guidance for industry and FDA
staff entitled ‘‘Third-Party Auditor/
Certification Body Accreditation for
Food Safety Audits: Model
Accreditation Standards’’ (draft
guidance). This draft guidance is being
made available consistent with our good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent our current
thinking on ‘‘Third-Party Auditor/
Certification Body Accreditation for
Food Safety Audits: Model
Accreditation Standards.’’ It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such an
approach satisfies the requirements of
the applicable statutes and regulations.
Section 808 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 384d) was added by FSMA and
directs FDA to establish a program for
the recognition of accreditation bodies
that accredit third-party auditors/
certification bodies to conduct food
safety audits and to issue food and/or
facility certifications that FDA may use
in certain circumstances to facilitate the
entry of foods presented for import.
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]]>Agencies
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44135-44137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0502]
Risk Evaluation and Mitigation Strategies: Understanding and
Evaluating Their Impact on the Health Care Delivery System and Patient
Access; Public Meeting, Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA or Agency) is announcing a
public meeting entitled ``Risk Evaluation and Mitigation Strategies
(REMS): Understanding and Evaluating Their Impact on the Health Care
Delivery System and Patient Access''. The purpose of the public meeting
is to engage in constructive dialogue and information sharing among
regulators, the scientific community, the pharmaceutical industry,
public health agencies, patients, patient advocates, health care system
administrators, prescribers, dispensers, hospitals, infusion centers,
health informatics experts, third-party payers, distributors, and the
general public concerning the impact of REMS on the health care
delivery system, including the impact on patients and health care
providers. The discussion will focus on strategies for characterizing
and evaluating the impact of REMS on the health care delivery system
and on patient access to drugs subject to REMS.
The primary focus of this meeting will be on REMS with Elements To
Assure Safe Use (ETASU); however, the meeting will also include
discussion of issues that may apply to all REMS. The input from this
meeting and the public docket comments will be used to inform ongoing
Agency initiatives related to optimizing REMS design, implementation,
and assessment.
Dates and Times: The meeting will be held on October 5, 2015, from
8 a.m. to 5 p.m. and October 6, 2015, from 8 a.m. to 1 p.m.
Location: The meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Participants must enter
through Building 1 and undergo security screening. For parking and
security information, please visit https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Please arrive early to ensure time for parking and
security screening.
Contact Persons for meeting background and content: Megan Moncur,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
REMSMeetingOct2015@fda.hhs.gov .
For registration, oral presentations, special accommodations, and
other meeting logistics: Cherice Holloway, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, Phone 301-796-4909, FAX: 301-796-9832,
cherice.holloway@fda.hhs.gov.
Registration and Requests for Oral Presentations: Registration is
free and available on a first-come, first-served basis. You must
register by September 21, 2015. Seating is limited, so register early.
FDA may limit the number of participants from each organization. If
time and space permit, onsite registration on the day of the meeting
will be available. To register for this
[[Page 44136]]
meeting, please visit FDA's Drugs News & Events--Meetings, Conferences,
& Workshops calendar at https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm and select this meeting from the events list. If you need
special accommodations because of a disability, please contact Cherice
Holloway (see Contact Persons) at least 7 days before the meeting.
Those without Internet access should contact Cherice Holloway to
register.
This meeting includes public comment sessions in which FDA is
seeking input on improved approaches for understanding, evaluating, and
minimizing burden on the health care delivery system to the extent
practicable and for helping to assure patient access to drugs that are
subject to REMS. If you would like to present during a session, please
identify the topic(s) you will address during registration (see section
II).
FDA will do its best to accommodate requests to speak. FDA urges
individuals and organizations with common interests to coordinate and/
or request time for a joint presentation. Following the close of
registration, FDA will allot time for each presentation and notify
presenters by September 28, 2015. Do not present or distribute
commercial or promotional material during the meeting. Registered
presenters should check in at the registration desk before the meeting.
Live Webcast of the Meeting: To view the Connect Pro Webcast of
this meeting, you must register online by 4 p.m., September 21, 2015.
Webcast connections are limited, so register early. Organizations
should register all viewers but access the Webcast using one connection
per location.
Webcast viewers will be sent system requirements after registration
and will be sent connection information after September 28, 2015. Visit
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
for the Connect Pro Connection Test. To get a quick overview of Connect
Pro, visit https://www.adobe.com/go/connectpro_overview. (FDA has
verified the Web site addresses in this notice but is not responsible
for any subsequent address changes after this document publishes in the
Federal Register.)
Comments: FDA is holding this public meeting to obtain information
on improved strategies for evaluating and minimizing the burden of REMS
on the health care delivery system to the extent practicable and their
impact on patient access to the drugs covered by such programs. FDA is
opening a public docket for comments to be submitted to the Agency on
the issues and questions presented during the meeting. Regardless of
attendance at the public meeting, interested persons may submit
electronic or paper comments to FDA's Division of Dockets Management by
November 2, 2015.
Submit electronic comments 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. Send only one set of comments. Identify all comments with the
docket number found in brackets in the heading of this document. When
addressing specific topics (see section II), please identify the topic.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. The
transcript may be viewed at the Division of Dockets Management (see
Comments). A transcript will also be available in either hard copy or
on CD-ROM after submission of a Freedom of Information request. Written
requests are to be sent to the Division of Freedom of Information
(ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element
Bldg., Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
I. Background
This meeting builds on prior stakeholder feedback on the design,
implementation, and assessment of REMS, including feedback obtained
through public meetings, stakeholder outreach, and comments to the
public docket, including the recommendations and suggestions recently
summarized in the Agency's report entitled ``Standardizing and
Evaluating Risk Evaluation and Mitigation Strategies'' (the
Standardizing and Evaluating REMS Report).\1\ The report also describes
the Agency's findings concerning strategies to standardize REMS, where
appropriate, with the goal of reducing the burden of implementing REMS
on health care providers, patients, and others in various health care
settings.
---------------------------------------------------------------------------
\1\ In the Federal Register of September 23, 2014 (79 FR 56816),
FDA published a notice announcing the availability of this draft
report. The report is available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm415751.pdf.
---------------------------------------------------------------------------
The Agency seeks to build on this foundation by updating
stakeholders and obtaining their feedback on some of our current and
proposed initiatives aimed at anticipating and minimizing REMS' burden
on the health care delivery system, helping to assure access to drugs
that are subject to REMS with ETASU, and obtaining stakeholder
recommendations on additional approaches to accomplish these goals. The
Agency recognizes that REMS can impose burden on the health care
delivery system. The statute requires ETASU to be commensurate with the
specific serious risks listed in a drug's labeling, and, considering
such risks, not be unduly burdensome on patient access to the drug,
and, to the extent practicable, to minimize burden on the health care
delivery system. We are also seeking input on the methods for
evaluating REMS' burden on the health care delivery system and their
impact on patient access to drugs.
The primary focus of this meeting will be on REMS with ETASU see
section 505(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355-1(f)); however, the meeting will also include discussion of issues
that may apply to all REMS.
II. Who Is the Target Audience and Who Should Attend This Public
Meeting?
This meeting is open to all interested parties. The target audience
is comprised of regulators, the scientific community, the
pharmaceutical industry, public health Agencies, patients, patient
advocates, health care system administrators, prescribers, dispensers,
hospitals, infusion centers, health informatics experts, third-party
payers, distributors, and the general public who are interested in
providing input on approaches for both anticipating and minimizing
health care delivery system burden and for helping to assure patient
access to drugs that are subject to REMS, as well as those interested
in improving the approaches used to evaluate the burden of REMS on the
health care delivery system and their impact on patient access.
III. What Are the Topics We Intend to Discuss at the Public Meeting?
The meeting will include panel discussions and individual
presentations. The main questions that will be considered are as
follows: (1) How to anticipate and minimize the burden of REMS on the
health care delivery system and patient access; and (2) how to improve
the quality and effectiveness of methods used to evaluate REMS' burden
on the health care delivery system and impact on patient access.
[[Page 44137]]
FDA will begin the meeting by soliciting feedback regarding how
stakeholders, such as patients and health care providers, think about
burden related to REMS. The meeting will then focus on strategies for
anticipating and addressing REMS burden and access issues in several
broad topic areas (including several areas identified in the key
opinions and recommendations from stakeholders in the Standardizing and
Evaluating REMS Report). Potential discussion topics are described in
this document. For topics related to strategies for minimizing burden
and barriers to patient access (topics 1-3), FDA will present ongoing
and planned Agency initiatives, solicit feedback on these initiatives,
and ask for feedback on other opportunities for anticipating and
minimizing burden and patient access issues.
Potential topics for discussion include the following:
Topic 1: Understanding the stakeholder perspective.
Discussion will focus on gaining a better understanding of how
stakeholders, such as patients, health care providers, dispensers, and
others, think about burden and access issues related to REMS--for
example, understanding the different dimensions of burden (e.g.,
administrative, logistical, workflow) and better understanding the
different types of patient access issues that are implicated by REMS.
Topic 2: Improved communication about the existence of a
REMS and about what is required of stakeholders under that REMS.
Discussion will focus on strategies to improve communications about
REMS, including communications about the existence of a particular REMS
or the requirements under a particular REMS program, and how to improve
the clarity of REMS materials.
Topic 3: Improved integration of activities required under
a REMS.
Discussion will focus on two closely related subtopics: (1)
Strategies to improve the integration of REMS requirements into the
health care delivery system through process improvement (e.g.,
streamlining REMS processes that have an impact on stakeholder workflow
or the care process, and reducing redundancies by leveraging existing
training or certification requirements to meet REMS requirements); and
(2) strategies to integrate REMS into electronic health care systems
(e.g., electronic health records, decision support systems, and
pharmacy management systems).
Topic 4: Improved methods for measuring the burden of REMS
on the health care delivery system and the impact on patient access.
Discussion will focus on identifying the most effective methods for
evaluating the burden of REMS on the health care delivery system and
the impact on patient access, with a goal of not only characterizing
and quantifying these effects, but also identifying opportunities for
improvements to a REMS program and better understanding the effect of
changes to a program. This may include discussion of how to address
methodological challenges in the measurement of burden and access, and
how to incorporate stakeholder input into REMS design and assessment.
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 material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the public meeting, and the background material will be posted on FDA's
Web site after the meeting at https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm, and to the docket at https://www.regulations.gov.
Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18149 Filed 7-23-15; 8:45 am]
BILLING CODE 4164-01-P
