[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Notices]
[Pages 871-873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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guidance finalizes the revised draft guidance of the same title issued 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:
     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, 240-402-7500.
     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

[[Page 872]]

of comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/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, 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 http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM362078.pdf 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 (https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/roles-different-participants-rems). 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 https://www.fda.gov/media/113869/download.
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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 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-
information/

[[Page 873]]

guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or 
https://www.regulations.gov.

    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