[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]


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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Document; Revised Draft Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled 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This revised draft guidance describes a new recommended format for a 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 This guidance revises and supersedes the draft 
guidance entitled ``Format and Content of Proposed Risk Evaluation and 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DATES: Submit either electronic or written comments on the draft 
guidance

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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on this draft guidance before it begins work on the final version of 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, [email protected]; 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