Notice2022-28602
Format and Content of a Risk Evaluation and Mitigation Strategy Document; Guidance for Industry; Availability
Primary source
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Published
January 5, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Format and Content of a REMS Document." This final guidance describes the format for a proposed risk evaluation and mitigation strategy (REMS) document. This format was created based on extensive stakeholder feedback. This guidance finalizes the revised draft guidance of the same title issued on October 12, 2017, and announces the availability of the technical specifications document entitled "REMS Document Technical Conformance Guide."
Full Text
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<title>Federal Register, Volume 88 Issue 3 (Thursday, January 5, 2023)</title>
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[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Notices]
[Pages 871-873]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-28602]
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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; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Format and
Content of a REMS Document.'' This final guidance describes the format
for a proposed risk evaluation and mitigation strategy (REMS) document.
This format was created based on extensive stakeholder feedback. This
guidance finalizes the revised draft guidance of the same title issued
on October 12, 2017, and announces the availability of the technical
specifications document entitled ``REMS Document Technical Conformance
Guide.''
DATES: The announcement of the guidance is published in the Federal
Register on January 5, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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of comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Suzanne Robottom, Center for Drug
Evaluation and Research, Food and Drug Administration,10903 New
Hampshire Ave, Bldg. 22, Rm. 4475, Silver Spring, MD 20993-0002, 301-
796-3554, 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 guidance for industry
entitled ``Format and Content of a REMS Document.'' Section 505-1 of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1)
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 should include concise
information that describes the goals and requirements of a REMS as they
relate to the elements described under the FD&C Act.
In the Federal Register of October 12, 2017 (82 FR 47529), FDA
announced the availability of a revised draft guidance for industry
entitled ``Format and Content of a REMS Document.'' This draft guidance
communicated changes to the format of the REMS document based on
stakeholder feedback that REMS requirements are not communicated to
stakeholders in a clear and consistent manner. (For more general
information on REMS as well as a more comprehensive discussion of the
issues summarized in this paragraph, please refer to the Background
Materials <a href="http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM362078.pdf">http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM362078.pdf</a> for the July 2013 REMS
Standardization and Evaluation Public Meeting.)
This guidance finalizes the revised draft guidance entitled
``Format and Content of a REMS Document'' issued on October 12, 2017.
FDA considered comments received on the revised draft guidance as the
guidance was finalized. Changes from the revised draft guidance to the
final guidance include: revising the REMS document to add and clarify
requirements participants, including the applicants, must complete to
comply with the REMS, adding a reference to a new authority to require
certain packaging and safe disposal technologies for drugs that pose a
serious risk of abuse or overdose, adding a new section to list the
statutory elements of the REMS, adding a prompt to identify the risk
addressed by the REMS, and relocating the information contained in the
appendix of the guidance (i.e., REMS document template) to a technical
specifications document entitled ``REMS Document Technical Conformance
Guide'' available on FDA's website (<a href="https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/roles-different-participants-rems">https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/roles-different-participants-rems</a>). In addition, editorial changes were made to improve clarity and
consistency between the guidance and the standardized text in the REMS
document template.
The guidance, along with the new technical specifications document,
can be used for drafting a REMS document for a single product and
shared system REMS and includes recommendations for drafting a
Bifurcated REMS document.\1\
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\1\ A Bifurcated REMS Document is used when the approval of a
shared system REMS may coincide with tentative approval of an
abbreviated new drug application or section 505(b)(2) application
(described in section 505(b)(2) of the FD&C Act (21 U.S.C.
355(b)(2)). For more information, refer to the guidance for
industry, ``Development of a Shared System REMS'' (June 2018),
available at <a href="https://www.fda.gov/media/113869/download">https://www.fda.gov/media/113869/download</a>.
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The recommendations in this guidance and the associated technical
specifications document are intended to help ensure that REMS documents
are clear; understandable to stakeholders; and to the extent possible,
consistent in content and format, as well as support submission of a
REMS document in Structured Product Labeling format, which is required
starting December 28, 2022.\2\
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\2\ See guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Content of the Risk Evaluation and
Mitigation Strategies Document Using Structured Product Labeling
Format'' (December 2020).
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This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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.
II. The Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 pertaining to the submission of new
drug applications (NDAs), abbreviated new drug applications (ANDAs),
and supplements to NDAs and ANDAs have been approved under 0910-0001.
The collections of information in 21 CFR part 601 pertaining to
biologics license applications (BLAs) and supplements to BLAs have been
approved under OMB control number 0910-0338. The collections of
information pertaining to Medication Guides for prescription drug
products have been approved under OMB control number 0910-0393.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, https://www.fda.gov/drugs/guidance-compliance-regulatory-
information/
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guidances-drugs, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: December 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28602 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P
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