82 FR 47529 - Format and Content of a Risk Evaluation and Mitigation Strategy Document; Revised Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 196 (October 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 196 (October 12, 2017)
| Page Range | 47529-47531 | |
| FR Document | 2017-22050 |
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)] [Notices] [Pages 47529-47531] From the Federal Register Online [www.thefederalregister.org] [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[Docket No. FDA-2009-D-0461] Format and Content of a Risk Evaluation and Mitigation Strategy Document; Revised Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Format and Content of a REMS Document.''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 This revised draft guidance describes a new recommended format for a REMS document.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 This guidance revises and supersedes the draft guidance entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,'' that was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 DATES: Submit either electronic or written comments on the draft guidance [[Page 47530]] by December 11, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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
![Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47529
and Research, Food and Drug • Data Standards Initiatives will select and notify participants by
Administration, 10903 New Hampshire Æ International Organization for March 6, 2018. All requests to make oral
Ave., Bldg. 51, Rm. 1115, Silver Spring, Standards (ISO) Identification of presentations must be received by the
MD 20993–0002, 301–796–5333, email: Medicinal Products (IDMP): ISO IDMP close of registration on February 19,
cderdatastandards@fda.hhs.gov; or standards implementation will support 2018, midnight Eastern Time. If selected
Stephen Ripley, Center for Biologics a variety of regulatory activities related for presentation, any presentation
Evaluation and Research, Food and to development, registration, and life materials must be emailed to
Drug Administration, 10903 New cycle management of medicinal cderdatastandards@fda.hhs.gov no later
Hampshire Ave., Bldg. 71, Rm. 7301, products, as well as pharmacovigilance than March 14, 2018. No commercial or
Silver Spring, MD 20993–0002, 240– and risk management. There are five promotional material will be permitted
402–7911. standards that describe the substance to be presented or distributed at the
SUPPLEMENTARY INFORMATION: (ISO 11238), dosage form and routes of public meeting.
administration (ISO 11239), units of Transcripts: Please be advised that as
I. Background measure (ISO 11240), medicinal product soon as a transcript of the public
FDA is committed to achieve the long- identifier (ISO 11615), and meeting is available, it will be accessible
term goal of improving the pharmaceutical product identifier (ISO at https://www.regulations.gov. It may
predictability and consistency of the 11616). be viewed at the Dockets Management
electronic submission process, and Æ Individual Case Safety Reports Staff (see ADDRESSES). A link to the
enhancing transparency and (ICSRs): ICSRs provide a consistent transcript will also be available on the
accountability of FDA information approach to the creation and review of internet at https://www.fda.gov/
technology related activities. FDA drug and biologics safety information forindustry/userfees/prescriptiondrug
agreed in the PDUFA VI commitment and pharmacovigilance activities. userfee/ucm446608.htm.
letter to hold annual public meetings to FDA will consider all comments made
at this workshop or received through the Dated: October 5, 2017.
seek stakeholder input related to
docket (see ADDRESSES). Leslie Kux,
electronic submissions and data
standards to inform the FDA IT Strategic Associate Commissioner for Policy.
III. Participating in the Public Meeting
Plan and published targets. The [FR Doc. 2017–21981 Filed 10–11–17; 8:45 am]
commitment letter outlines FDA’s Registration: To register to attend BILLING CODE 4164–01–P
performance goals and procedures ‘‘Prescription Drug User Fee Act VI;
under the PDUFA program for the years Electronic Submissions and Data
2018–2022. The commitment letter can Standards; Public Meeting; Request for DEPARTMENT OF HEALTH AND
be found at https://www.fda.gov/for Comments’’ please send an email to HUMAN SERVICES
industry/userfees/prescriptiondrug cderdatastandards@fda.hhs.gov by
February 19, 2018. Please provide Food and Drug Administration
userfee/ucm446608.htm.
complete contact information for each [Docket No. FDA–2009–D–0461]
II. Topics for Discussion at the Public attendee, including name, title,
Meeting affiliation, address, email, and Format and Content of a Risk
FDA strives to achieve a fully telephone. Evaluation and Mitigation Strategy
automated standards-based IT Registration is free and based on Document; Revised Draft Guidance for
environment that enhances the space availability, with priority given to Industry; Availability
regulatory review processes for human early registrants. Persons interested in
attending this public meeting must AGENCY: Food and Drug Administration,
drugs and biologics. The purpose of the
register by February 19, 2018, midnight HHS.
March 21, 2018, public meeting is to
obtain input from industry and other Eastern Time. Early registration is ACTION: Notice of availability.
interested stakeholders on enhancing recommended because seating is
limited; therefore, FDA may limit the SUMMARY: The Food and Drug
the transparency and accountability of Administration (FDA or Agency) is
the electronic submission and data number of participants from each
organization. Registrants will receive announcing the availability of a revised
standards activities. To help fulfill its draft guidance for industry entitled
commitment, FDA is particularly confirmation when they have been
accepted. ‘‘Format and Content of a REMS
interested in receiving input on the Document.’’ A Risk Evaluation and
following topics: If you need special accommodations
Mitigation Strategy (REMS) document,
• Electronic Submissions due to a disability, please contact
Æ Electronic submission process, Chenoa Conley, 301–796–0035, email which is part of a REMS that is required
including key electronic submission Chenoa.Conley@fda.hhs.gov at least 7 by FDA, establishes the goals and
milestones and associated sponsor days before the meeting. requirements of the REMS. This revised
notifications from the completion of the Request for Oral Presentations: During draft guidance describes a new
upload of the submission to the online registration you may indicate if recommended format for a REMS
Electronic Submissions Gateway (ESG) you wish to present during the public document. The new format was
through the time the submission is comment session and which topic(s) developed based on extensive
made available to the review team. you wish to address. FDA will do its stakeholder feedback. This guidance
revises and supersedes the draft
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Æ Electronic submission system past best to accommodate requests to make
performance, emerging industry needs, public comments. Individuals and guidance entitled ‘‘Format and Content
and technology initiatives. organizations with common interests are of Proposed Risk Evaluation and
Æ Published and future targets for the urged to consolidate or coordinate their Mitigation Strategies (REMS), REMS
ESG and related electronic submission presentations. Following the close of Assessments, and Proposed REMS
systems. registration, FDA will determine the Modifications,’’ that was published by
Æ Implementation of electronic amount of time allotted to each FDA on October 1, 2009.
Common Technical Document (eCTD) presenter and the approximate time DATES: Submit either electronic or
v4.0. each oral presentation is to begin, and written comments on the draft guidance
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![Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47531
pharmacists) are not clearly guidance practices regulation (21 CFR (ANDAs) that wish to pursue a request
communicated in REMS documents. 10.115). The revised draft guidance, for reconsideration within the review
Stakeholders have reported spending when finalized, will represent the discipline at the division level or
excessive time trying to locate, current thinking of FDA on the format original signatory authority. This
understand, and comply with REMS and content of a REMS document. It guidance also provides information for
requirements. does not establish any rights for any applicants to consider before pursuing a
To address the stakeholders’ feedback, person and is not binding on FDA or the request for reconsideration, procedures
FDA is revising the 2009 draft guidance public. You can use an alternative for submitting a request for
on the format and content of a REMS to approach if it satisfies the requirements reconsideration, and the Agency’s
include information to assist applicants of the applicable statutes and process for responding to those requests.
in drafting clear, informative, and regulations. This guidance is not subject DATES: Submit either electronic or
standardized REMS documents. This to Executive Order 12866. written comments on the draft guidance
revised draft guidance provides updated by December 11, 2017 to ensure that the
recommendations on the format and II. The Paperwork Reduction Act of
1995 Agency considers your comment on this
content of a REMS document and draft guidance before it begins work on
supersedes the 2009 draft guidance. This revised draft guidance contains the final version of the guidance.
Additional and more detailed information collection provisions that
information is provided in the template ADDRESSES: You may submit comments
are subject to review by the Office of
appended to this guidance. Management and Budget (OMB) under on any guidance at any time as follows:
The new format of the REMS the Paperwork Reduction Act of 1995 Electronic Submissions
document, as described in this revised (44 U.S.C. 3501–3520). The collection of
draft guidance and appended template, Submit electronic comments in the
information in the guidance was
contains substantially the same content following way:
approved under OMB control numbers
as described in the 2009 draft guidance; • Federal eRulemaking Portal:
0910–0001 and 0910–0338.
however, the information has been https://www.regulations.gov. Follow the
reorganized. In the old format, the III. Electronic Access instructions for submitting comments.
REMS requirements were organized by Persons with access to the internet Comments submitted electronically,
the elements described in the statute. In may obtain the draft guidance at either including attachments, to https://
the new format, requirements are https://www.fda.gov/Drugs/Guidance www.regulations.gov will be posted to
organized to describe who is responsible ComplianceRegulatoryInformation/ the docket unchanged. Because your
for implementing the requirement, Guidances/default.htm, https:// comment will be made public, you are
when the requirement is to be www.fda.gov/BiologicsBloodVaccines/ solely responsible for ensuring that your
implemented, what the required action GuidanceComplianceRegulatory comment does not include any
is, and with what REMS material(s). Information/Guidances/default.htm, or confidential information that you or a
Additionally, the new format supports https://www.regulations.gov. third party may not wish to be posted,
submission of REMS documents in such as medical information, your or
Dated: October 5, 2017.
Structured Product Labeling (SPL) anyone else’s Social Security number, or
Anna K. Abram, confidential business information, such
format. Deputy Commissioner for Policy, Planning,
Certain information included in the as a manufacturing process. Please note
Legislation, and Analysis. that if you include your name, contact
2009 draft guidance has been revised
[FR Doc. 2017–22050 Filed 10–11–17; 8:45 am] information, or other information that
and included in other guidances
subsequently published and therefore BILLING CODE 4164–01–P identifies you in the body of your
has been omitted from this revised draft comments, that information will be
guidance. For example: posted on https://www.regulations.gov.
DEPARTMENT OF HEALTH AND • If you want to submit a comment
• Information on how FDA
HUMAN SERVICES with confidential information that you
determines when a REMS is necessary
to ensure that the benefits of a drug Food and Drug Administration do not wish to be made available to the
outweigh its risks can be found in the public, submit the comment as a
draft guidance for industry, ‘‘FDA’s [Docket No. FDA–2017–D–5868] written/paper submission and in the
Application of Statutory Factors in manner detailed (see ‘‘Written/Paper
Requests for Reconsideration at the Submissions’’ and ‘‘Instructions’’).
Determining When a REMS Is
Division Level Under the Generic Drug
Necessary’’ (at: https://www.fda.gov/ Written/Paper Submissions
User Fee Act; Draft Guidance for
ucm/groups/fdagov-public/@fdagov-
Industry; Availability Submit written/paper submissions as
drugs-gen/documents/document/
ucm521504.pdf). AGENCY: Food and Drug Administration, follows:
• Information on REMS modifications HHS. • Mail/Hand delivery/Courier (for
can be found in the guidance for ACTION: Notice of availability. written/paper submissions): Dockets
industry, ‘‘Risk Evaluation and Management Staff (HFA–305), Food and
Mitigation Strategies: Modifications and SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
Revisions’’ (at: https://www.fda.gov/ Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
downloads/drugs/guidancecompliance announcing the availability of a draft
regulatoryinformation/guidances/ guidance for industry entitled ‘‘Requests submitted to the Dockets Management
ucm441226.pdf). for Reconsideration at the Division Staff, FDA will post your comment, as
This revised guidance and appended Level Under GDUFA.’’ This guidance well as any attachments, except for
template are being reissued in draft form provides recommendations for industry information submitted, marked and
to enable the public to review and on the procedures for resolving identified, as confidential, if submitted
comment before finalization. scientific and/or regulatory issues or as detailed in ‘‘Instructions.’’
This revised draft guidance is being matters between FDA and applicants of Instructions: All submissions received
issued consistent with FDA’s good abbreviated new drug applications must include the Docket No. FDA–
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Document Created: 2018-10-25 10:06:13
Document Modified: 2018-10-25 10:06:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 47529 |
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