Format and Content of a Risk Evaluation and Mitigation Strategy Document; Revised Draft Guidance for Industry; Availability, 47529-47531 [2017-22050]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1115, Silver Spring,
MD 20993–0002, 301–796–5333, email:
cderdatastandards@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
I. Background
FDA is committed to achieve the longterm goal of improving the
predictability and consistency of the
electronic submission process, and
enhancing transparency and
accountability of FDA information
technology related activities. FDA
agreed in the PDUFA VI commitment
letter to hold annual public meetings to
seek stakeholder input related to
electronic submissions and data
standards to inform the FDA IT Strategic
Plan and published targets. The
commitment letter outlines FDA’s
performance goals and procedures
under the PDUFA program for the years
2018–2022. The commitment letter can
be found at https://www.fda.gov/for
industry/userfees/prescriptiondrug
userfee/ucm446608.htm.
II. Topics for Discussion at the Public
Meeting
FDA strives to achieve a fully
automated standards-based IT
environment that enhances the
regulatory review processes for human
drugs and biologics. The purpose of the
March 21, 2018, public meeting is to
obtain input from industry and other
interested stakeholders on enhancing
the transparency and accountability of
the electronic submission and data
standards activities. To help fulfill its
commitment, FDA is particularly
interested in receiving input on the
following topics:
• Electronic Submissions
Æ Electronic submission process,
including key electronic submission
milestones and associated sponsor
notifications from the completion of the
upload of the submission to the
Electronic Submissions Gateway (ESG)
through the time the submission is
made available to the review team.
Æ Electronic submission system past
performance, emerging industry needs,
and technology initiatives.
Æ Published and future targets for the
ESG and related electronic submission
systems.
Æ Implementation of electronic
Common Technical Document (eCTD)
v4.0.
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
• Data Standards Initiatives
Æ International Organization for
Standards (ISO) Identification of
Medicinal Products (IDMP): ISO IDMP
standards implementation will support
a variety of regulatory activities related
to development, registration, and life
cycle management of medicinal
products, as well as pharmacovigilance
and risk management. There are five
standards that describe the substance
(ISO 11238), dosage form and routes of
administration (ISO 11239), units of
measure (ISO 11240), medicinal product
identifier (ISO 11615), and
pharmaceutical product identifier (ISO
11616).
Æ Individual Case Safety Reports
(ICSRs): ICSRs provide a consistent
approach to the creation and review of
drug and biologics safety information
and pharmacovigilance activities.
FDA will consider all comments made
at this workshop or received through the
docket (see ADDRESSES).
III. Participating in the Public Meeting
Registration: To register to attend
‘‘Prescription Drug User Fee Act VI;
Electronic Submissions and Data
Standards; Public Meeting; Request for
Comments’’ please send an email to
cderdatastandards@fda.hhs.gov by
February 19, 2018. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public meeting must
register by February 19, 2018, midnight
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. Registrants will receive
confirmation when they have been
accepted.
If you need special accommodations
due to a disability, please contact
Chenoa Conley, 301–796–0035, email
Chenoa.Conley@fda.hhs.gov at least 7
days before the meeting.
Request for Oral Presentations: During
online registration you may indicate if
you wish to present during the public
comment session and which topic(s)
you wish to address. FDA will do its
best to accommodate requests to make
public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations. Following the close of
registration, FDA will determine the
amount of time allotted to each
presenter and the approximate time
each oral presentation is to begin, and
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
47529
will select and notify participants by
March 6, 2018. All requests to make oral
presentations must be received by the
close of registration on February 19,
2018, midnight Eastern Time. If selected
for presentation, any presentation
materials must be emailed to
cderdatastandards@fda.hhs.gov no later
than March 14, 2018. No commercial or
promotional material will be permitted
to be presented or distributed at the
public meeting.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/
forindustry/userfees/prescriptiondrug
userfee/ucm446608.htm.
Dated: October 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–21981 Filed 10–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0461]
Format and Content of a Risk
Evaluation and Mitigation Strategy
Document; Revised Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a revised
draft guidance for industry entitled
‘‘Format and Content of a REMS
Document.’’ A Risk Evaluation and
Mitigation Strategy (REMS) document,
which is part of a REMS that is required
by FDA, establishes the goals and
requirements of the REMS. This revised
draft guidance describes a new
recommended format for a REMS
document. The new format was
developed based on extensive
stakeholder feedback. This guidance
revises and supersedes the draft
guidance entitled ‘‘Format and Content
of Proposed Risk Evaluation and
Mitigation Strategies (REMS), REMS
Assessments, and Proposed REMS
Modifications,’’ that was published by
FDA on October 1, 2009.
DATES: Submit either electronic or
written comments on the draft guidance
SUMMARY:
E:\FR\FM\12OCN1.SGM
12OCN1
47530
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
by December 11, 2017 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2009–D–0461 for ‘‘Format and Content
of a REMS Document.’’ 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 Dockets Management Staff
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
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
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 Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov
/fdsys/pkg/FR-2015-09-18/pdf/201523389.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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance 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, or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
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 guidance document.
FOR FURTHER INFORMATION CONTACT: Gita
Toyserkani, Center for Drug Evaluation
and Research, Food and Drug
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2422, Silver Spring,
MD 20993, 301–796–1783,
Gita.Toyserkani@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Format and Content of a REMS
Document.’’ The Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85) created section
505–1 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
355–1), which authorizes FDA to
require a REMS for certain drugs if FDA
determines that a REMS is necessary to
ensure that the benefits of the drug
outweigh its risks (see section 505–1(a)
of the FD&C Act). A REMS is a required
risk management strategy that can
include one or more elements to ensure
that the benefits of a drug outweigh its
risks (see section 505–1(e) of the FD&C
Act). The REMS document includes
concise information about the goals and
requirements of the REMS as they relate
to the elements described under the
FD&C Act.
In the Federal Register of October 1,
2009 (74 FR 50801), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Format and Content
of Proposed Risk Evaluation and
Mitigation Strategies (REMS), REMS
Assessments, and Proposed REMS
Modifications.’’ The 2009 draft guidance
described the recommended format and
content for submission of proposed
REMS. It also included information and
recommendations on the content of
assessments and proposed
modifications of approved REMS.
Over the last 6 years, under the REMS
Integration Initiative, FDA’s
implementation of the REMS authorities
has evolved. The goals of the REMS
Integration Initiative included
developing guidance, improving
standardization and assessment of
REMS, and improving integration of
REMS into the health care system.
(More information on the REMS
Integration Initiative can be found at:
https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm350852.htm).
Through the REMS Integration
Initiative and other outreach, FDA has
received feedback that specific activities
and requirements for various
stakeholders (e.g., prescribers,
E:\FR\FM\12OCN1.SGM
12OCN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
pharmacists) are not clearly
communicated in REMS documents.
Stakeholders have reported spending
excessive time trying to locate,
understand, and comply with REMS
requirements.
To address the stakeholders’ feedback,
FDA is revising the 2009 draft guidance
on the format and content of a REMS to
include information to assist applicants
in drafting clear, informative, and
standardized REMS documents. This
revised draft guidance provides updated
recommendations on the format and
content of a REMS document and
supersedes the 2009 draft guidance.
Additional and more detailed
information is provided in the template
appended to this guidance.
The new format of the REMS
document, as described in this revised
draft guidance and appended template,
contains substantially the same content
as described in the 2009 draft guidance;
however, the information has been
reorganized. In the old format, the
REMS requirements were organized by
the elements described in the statute. In
the new format, requirements are
organized to describe who is responsible
for implementing the requirement,
when the requirement is to be
implemented, what the required action
is, and with what REMS material(s).
Additionally, the new format supports
submission of REMS documents in
Structured Product Labeling (SPL)
format.
Certain information included in the
2009 draft guidance has been revised
and included in other guidances
subsequently published and therefore
has been omitted from this revised draft
guidance. For example:
• Information on how FDA
determines when a REMS is necessary
to ensure that the benefits of a drug
outweigh its risks can be found in the
draft guidance for industry, ‘‘FDA’s
Application of Statutory Factors in
Determining When a REMS Is
Necessary’’ (at: https://www.fda.gov/
ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/
ucm521504.pdf).
• Information on REMS modifications
can be found in the guidance for
industry, ‘‘Risk Evaluation and
Mitigation Strategies: Modifications and
Revisions’’ (at: https://www.fda.gov/
downloads/drugs/guidancecompliance
regulatoryinformation/guidances/
ucm441226.pdf).
This revised guidance and appended
template are being reissued in draft form
to enable the public to review and
comment before finalization.
This revised draft guidance is being
issued consistent with FDA’s good
VerDate Sep<11>2014
22:35 Oct 11, 2017
Jkt 244001
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on the format
and content of a REMS document. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
II. The Paperwork Reduction Act of
1995
This revised draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in the guidance was
approved under OMB control numbers
0910–0001 and 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22050 Filed 10–11–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5868]
Requests for Reconsideration at the
Division Level Under the Generic Drug
User Fee Act; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Requests
for Reconsideration at the Division
Level Under GDUFA.’’ This guidance
provides recommendations for industry
on the procedures for resolving
scientific and/or regulatory issues or
matters between FDA and applicants of
abbreviated new drug applications
SUMMARY:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
47531
(ANDAs) that wish to pursue a request
for reconsideration within the review
discipline at the division level or
original signatory authority. This
guidance also provides information for
applicants to consider before pursuing a
request for reconsideration, procedures
for submitting a request for
reconsideration, and the Agency’s
process for responding to those requests.
DATES: Submit either electronic or
written comments on the draft guidance
by December 11, 2017 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47529-47531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22050]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0461]
Format and Content of a Risk Evaluation and Mitigation Strategy
Document; Revised Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Format and Content of a REMS Document.'' A Risk Evaluation and
Mitigation Strategy (REMS) document, which is part of a REMS that is
required by FDA, establishes the goals and requirements of the REMS.
This revised draft guidance describes a new recommended format for a
REMS document. The new format was developed based on extensive
stakeholder feedback. This guidance revises and supersedes the draft
guidance entitled ``Format and Content of Proposed Risk Evaluation and
Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS
Modifications,'' that was published by FDA on October 1, 2009.
DATES: Submit either electronic or written comments on the draft
guidance
[[Page 47530]]
by December 11, 2017 to ensure that the Agency considers your comment
on this draft guidance before it begins work on the final version of
the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2009-D-0461 for ``Format and Content of a REMS Document.'' 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 Dockets Management Staff 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 Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance 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, or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Gita Toyserkani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2422, Silver Spring, MD 20993, 301-796-
1783, Gita.Toyserkani@fda.hhs.gov; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Format and Content of a REMS Document.'' The Food
and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) created
section 505-1 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355-1), which authorizes FDA to require a REMS for
certain drugs if FDA determines that a REMS is necessary to ensure that
the benefits of the drug outweigh its risks (see section 505-1(a) of
the FD&C Act). A REMS is a required risk management strategy that can
include one or more elements to ensure that the benefits of a drug
outweigh its risks (see section 505-1(e) of the FD&C Act). The REMS
document includes concise information about the goals and requirements
of the REMS as they relate to the elements described under the FD&C
Act.
In the Federal Register of October 1, 2009 (74 FR 50801), FDA
announced the availability of a draft guidance for industry entitled
``Format and Content of Proposed Risk Evaluation and Mitigation
Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.''
The 2009 draft guidance described the recommended format and content
for submission of proposed REMS. It also included information and
recommendations on the content of assessments and proposed
modifications of approved REMS.
Over the last 6 years, under the REMS Integration Initiative, FDA's
implementation of the REMS authorities has evolved. The goals of the
REMS Integration Initiative included developing guidance, improving
standardization and assessment of REMS, and improving integration of
REMS into the health care system. (More information on the REMS
Integration Initiative can be found at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm350852.htm).
Through the REMS Integration Initiative and other outreach, FDA has
received feedback that specific activities and requirements for various
stakeholders (e.g., prescribers,
[[Page 47531]]
pharmacists) are not clearly communicated in REMS documents.
Stakeholders have reported spending excessive time trying to locate,
understand, and comply with REMS requirements.
To address the stakeholders' feedback, FDA is revising the 2009
draft guidance on the format and content of a REMS to include
information to assist applicants in drafting clear, informative, and
standardized REMS documents. This revised draft guidance provides
updated recommendations on the format and content of a REMS document
and supersedes the 2009 draft guidance. Additional and more detailed
information is provided in the template appended to this guidance.
The new format of the REMS document, as described in this revised
draft guidance and appended template, contains substantially the same
content as described in the 2009 draft guidance; however, the
information has been reorganized. In the old format, the REMS
requirements were organized by the elements described in the statute.
In the new format, requirements are organized to describe who is
responsible for implementing the requirement, when the requirement is
to be implemented, what the required action is, and with what REMS
material(s). Additionally, the new format supports submission of REMS
documents in Structured Product Labeling (SPL) format.
Certain information included in the 2009 draft guidance has been
revised and included in other guidances subsequently published and
therefore has been omitted from this revised draft guidance. For
example:
Information on how FDA determines when a REMS is necessary
to ensure that the benefits of a drug outweigh its risks can be found
in the draft guidance for industry, ``FDA's Application of Statutory
Factors in Determining When a REMS Is Necessary'' (at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm521504.pdf).
Information on REMS modifications can be found in the
guidance for industry, ``Risk Evaluation and Mitigation Strategies:
Modifications and Revisions'' (at: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm441226.pdf).
This revised guidance and appended template are being reissued in
draft form to enable the public to review and comment before
finalization.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
the format and content of a REMS document. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.
II. The Paperwork Reduction Act of 1995
This revised draft guidance contains information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in the guidance was approved under
OMB control numbers 0910-0001 and 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: October 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22050 Filed 10-11-17; 8:45 am]
BILLING CODE 4164-01-P
