Document ID: FDA-2015-N-3402-0001
Agency: fda
Document Type: Notice
Title: Electronic Submission of Final Approved Risk Evaluation and
Mitigation Strategies and Summary Information in a Standard Structured
Product Labeling Format; Pilot Project
Posted Date: 2015-10-06T04:00Z

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60391-60393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25349]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3402]

Electronic Submission of Final Approved Risk Evaluation and 
Mitigation Strategies and Summary Information in a Standard Structured 
Product Labeling Format; Pilot Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of pilot project, request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a pilot project for the submission of final approved Risk Evaluation 
and Mitigation Strategies (REMS) and certain REMS summary information 
electronically in a standard Structured Product Labeling (SPL) format. 
Participation in the pilot is voluntary and is open to application 
holders of drugs with REMS. The pilot is intended to help application 
holders, FDA, and other interested stakeholders evaluate a potential 
approach to converting REMS into SPL format and evaluate the usefulness 
of the REMS information to be provided in SPL format. This project also 
will help provide FDA with feedback on these topics from pilot 
participants and other interested stakeholders.

DATES: Submit requests to participate in the REMS SPL pilot from 
October 6, 2015 to December 7, 2015. See the ``Participation'' section 
for instructions on how to submit a request to participate. The pilot 
will proceed for 4 months, from October 6, 2015 to February 3, 2016. 
This pilot may be extended as resources and needs allow.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-N-3402 for ``Electronic Submission of Final Approved Risk 
Evaluation and Mitigation Strategies and Summary Information in a 
Standard Structured Product Labeling Format; Pilot Project.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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

[[Page 60392]]

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 http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Adam Kroetsch at 
REMS_Standardization@fda.hhs.gov or at 301-796-3842.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a pilot project for the submission of final 
approved REMS and certain REMS summary information electronically in an 
SPL format. This pilot is being conducted as a part of the ``Pharmacy 
Systems Under REMS Project: Standardizing REMS Information for 
Inclusion Into Pharmacy Systems Using Structured Product Labeling 
(SPL).'' More information on this project--one of four predefined 
priority projects that are a part of the larger REMS Integration 
Initiative--can be found in the report ``Standardizing and Evaluating 
Risk Evaluation and Mitigation Strategies (REMS)'' (the REMS report) 
(http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM415751.pdf). FDA intends to eventually make 
REMS in SPL format accessible to the public via a free, publicly 
available Web site.
    As described in the REMS report, stakeholders have expressed 
concern that information about REMS materials, tools, and requirements 
are not communicated to stakeholders in a clear and consistent manner. 
They also have told FDA that REMS materials and requirements may be 
difficult to locate, and specific activities and requirements of 
various stakeholders (e.g., prescriber, pharmacist) are not clearly 
outlined. Furthermore, some stakeholders have difficulty integrating 
REMS materials and procedures into their existing health information 
systems and healthcare delivery processes. Because of these factors, 
stakeholders reported spending excessive time trying to locate, 
understand, and comply with different REMS requirements. (For more 
general background information on REMS, as well as a more comprehensive 
discussion of the issues mentioned 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.)
    To help address the problems described in the previous paragraph of 
this document, FDA committed to develop a standardized REMS format that 
can be included in SPL. FDA believes that this project, when completed, 
will address many of the concerns described previously regarding REMS 
because SPL information can be easily shared and made available online, 
and is readily incorporable into health information technology. 
Furthermore, FDA and application holders are both familiar with SPL and 
possess much of the institutional knowledge needed to create and 
disseminate files in this format. Ultimately, SPL can serve as a 
conduit of structured REMS information to healthcare providers and 
patients, while also providing accessible information about what 
requirements exist and who is responsible for their completion. SPL may 
also promote efficiency in the development and review of REMS 
documents.

II. About the REMS SPL Pilot

    For all REMS programs (both REMS with and without elements to 
assure safe use (ETASU)) included in the pilot, the REMS document will 
be captured using standardized section headings. More information about 
the REMS document is available in FDA's draft guidance for industry 
``Format and Content of Proposed Risk Evaluation and Mitigation 
Strategies (REMS), REMS Assessments, and Proposed REMS Modifications'' 
(http://www.fda.gov/downloads/Drugs/.../Guidances/UCM184128.pdf). For 
REMS with ETASU, the SPL will include additional information about the 
requirements these ETASU impose. This information is captured in two 
places: A human-readable ``REMS Summary'' (described in detail in ``The 
REMS Summary'' section of this document) and associated machine-
readable data elements. Both the REMS Summary and the data elements 
will capture four basic pieces of information about each requirement:
     Who is required to carry out the requirement: For example, 
a requirement may be carried out by the healthcare provider who 
prescribes the drug or dispenses it.
     What that individual is required to do: This could include 
a clinical activity, such as counseling a patient, or an administrative 
one, such as completing an enrollment form.
     When the activity must be carried out: For example, a REMS 
activity may need to be completed before a drug is prescribed or 
dispensed, or before a patient is able to receive the drug.
     References to REMS materials that may contain additional 
information about the requirement, such as forms and educational 
materials.
    For REMS approved as a shared system, the REMS information 
submitted in SPL format should be identical for each product in the 
shared system.

A. The REMS Summary

    For REMS with ETASU, the REMS Summary will be presented in a 
tabular format that facilitates coding of REMS data elements and allows 
stakeholders to quickly obtain a reader-friendly overview of what the 
REMS requires. It uses language that is similar to that found in 
existing REMS documents and the summaries found on FDA's REMS Web site 
(http://www.fda.gov/REMS). Detailed instructions for creating the REMS 
Summary are available in the Draft REMS SPL Implementation Guide 
Excerpt on FDA's SPL Web site (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm). The REMS Summary 
does not replace the approved REMS document, which will continue to be 
the enforceable document establishing the REMS requirements.

[[Page 60393]]

B. REMS Data Elements

    For REMS with ETASU, the REMS data elements describe REMS 
requirements using a standardized, machine-readable format that permits 
integration of REMS information into electronic health information 
technology, including clinical decision support, e-Prescribing systems, 
and electronic pharmacy systems. FDA has developed terminology to 
assist in the coding of REMS data elements. This terminology is 
available as part of the Draft REMS SPL Implementation Guide Excerpt on 
FDA's SPL Web site (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm). The REMS Data Elements do not 
replace the approved REMS document, which will continue to be the 
enforceable document establishing the REMS requirements.

III. How To Participate in the REMS SPL Pilot

A. Participation

    Volunteers interested in participating in the pilot should contact 
pilot staff by email at REMS_Standardization@fda.hhs.gov. The following 
information should be included in the request: Contact name, contact 
phone number, and contact email address. FDA will contact interested 
applicants to discuss the pilot. FDA is seeking a limited number of 
participants (no more than nine) to participate in this pilot. FDA is 
also seeking comment from any stakeholder on its proposed approach for 
capturing REMS information in SPL format in this pilot, as described in 
section II.

B. Procedures

    To create an SPL file and submit it to FDA, a participant will need 
the following tools: Appropriate software, knowledge of terminology and 
standards, and access to FDA's Electronic Submissions Gateway (ESG) 
(http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm). The ESG is an Agency-wide means of accepting electronic 
regulatory submissions. The FDA ESG enables the secure submission of 
regulatory submissions. Instructions and information regarding the 
creation of an SPL file and the converting of REMS information into SPL 
can be found at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. There should be no additional 
cost associated with obtaining the software. In 2010, FDA collaborated 
with Pragmatic Data, LLC (http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm), to make available free SPL 
authoring software that SPL authors may use to create new SPL documents 
or edit previous versions.
    After the SPL is created, the participant would upload the file 
through the ESG. The Internet portal can be found at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. Prior 
to uploading an SPL file, one must obtain a digital certificate. 
Instructions regarding obtaining a digital certificate used with FDA's 
ESG and uploading the SPL file for submission can be found at http://www.fda.gov/esg/default.htm. The digital certificate binds together the 
owner's name and a pair of electronic keys (a public and a private key) 
that can be used to encrypt and sign documents. A fee of up to 
approximately $20 is charged for the digital certificate. Application 
holders should have already secured a digital certificate because they 
are required to do so when they register and list.
    During the pilot, FDA staff will be available to answer any 
questions or concerns that may arise. Pilot participants will be asked 
to comment on and discuss their experiences converting their REMS into 
SPL format. Their comments are expected to assist FDA in its completion 
of the REMS SPL project.

IV. Duration of the REMS SPL Pilot

    FDA will accept requests for participation in the REMS SPL pilot 
from October 6, 2015 to December 7, 2015. The pilot will proceed for 4 
months, from October 6, 2015 to February 3, 2016. This pilot may be 
extended as resources and needs allow.

V. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in 21 CFR part 314 have been approved under 
OMB control number 0910-0001.

    Dated: September 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25349 Filed 10-5-15; 8:45 am]
 BILLING CODE 4164-01-P