80 FR 60391 - Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 193 (October 6, 2015)

Page Range		60391-60393
FR Document		2015-25349

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.

Federal Register, Volume 80 Issue 193 (Tuesday, October 6, 2015)

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60391-60393]
From the Federal Register Online [www.thefederalregister.org]
[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

Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60393

B. REMS Data Elements www.fda.gov/ForIndustry/ DEPARTMENT OF HEALTH AND
For REMS with ETASU, the REMS DataStandards/ HUMAN SERVICES
data elements describe REMS StructuredProductLabeling/
requirements using a standardized, ucm189651.htm), to make available free Food and Drug Administration
machine-readable format that permits SPL authoring software that SPL authors [Docket Nos. FDA–2015–M–1064, FDA–
integration of REMS information into may use to create new SPL documents 2015–M–1065, FDA–2015–M–1177, FDA–
electronic health information or edit previous versions. 2015–M–1178, FDA–2015–M–1325, FDA–
technology, including clinical decision After the SPL is created, the 2015–M–1326, FDA–2015–M–1460, FDA–
support, e-Prescribing systems, and 2015–M–1461, FDA–2015–M–1557, FDA–
participant would upload the file 2015–M–1708, FDA–2015–M–1709, FDA–
electronic pharmacy systems. FDA has through the ESG. The Internet portal can 2015–M–1956, FDA–2015–M–1957, FDA–
developed terminology to assist in the be found at http://www.fda.gov/ 2015–M–1958, FDA–2015–M–1959, FDA–
coding of REMS data elements. This ForIndustry/ 2015–M–2077, FDA–2015–M–2078, FDA–
terminology is available as part of the ElectronicSubmissionsGateway/ 2014–M–2247]
Draft REMS SPL Implementation Guide default.htm. Prior to uploading an SPL
Excerpt on FDA’s SPL Web site (http:// file, one must obtain a digital certificate. Medical Devices; Availability of Safety
www.fda.gov/ForIndustry/ Instructions regarding obtaining a and Effectiveness Summaries for
DataStandards/ digital certificate used with FDA’s ESG Premarket Approval Applications
StructuredProductLabeling/
and uploading the SPL file for AGENCY: Food and Drug Administration,
default.htm). The REMS Data Elements
submission can be found at http:// HHS.
do not replace the approved REMS
www.fda.gov/esg/default.htm. The ACTION: Notice.
document, which will continue to be
the enforceable document establishing digital certificate binds together the
owner’s name and a pair of electronic SUMMARY: The Food and Drug
the REMS requirements.
keys (a public and a private key) that Administration (FDA) is publishing a
III. How To Participate in the REMS can be used to encrypt and sign list of premarket approval applications
SPL Pilot documents. A fee of up to (PMAs) that have been approved. This
A. Participation approximately $20 is charged for the list is intended to inform the public of
digital certificate. Application holders the availability of safety and
Volunteers interested in participating should have already secured a digital effectiveness summaries of approved
in the pilot should contact pilot staff by certificate because they are required to PMAs through the Internet and the
email at REMS_Standardization@ Agency’s Division of Dockets
do so when they register and list.
fda.hhs.gov. The following information Management.
should be included in the request: During the pilot, FDA staff will be
Contact name, contact phone number, available to answer any questions or ADDRESSES: Submit written requests for
and contact email address. FDA will concerns that may arise. Pilot copies of summaries of safety and
contact interested applicants to discuss participants will be asked to comment effectiveness data to the Division of
the pilot. FDA is seeking a limited on and discuss their experiences Dockets Management (HFA–305), Food
number of participants (no more than converting their REMS into SPL format. and Drug Administration, 5630 Fishers
nine) to participate in this pilot. FDA is Their comments are expected to assist Lane, Rm. 1061, Rockville, MD 20852.
also seeking comment from any FDA in its completion of the REMS SPL Please cite the appropriate docket
stakeholder on its proposed approach project. number as listed in table 1 when
for capturing REMS information in SPL submitting a written request. See the
IV. Duration of the REMS SPL Pilot SUPPLEMENTARY INFORMATION section for
format in this pilot, as described in
section II. electronic access to the summaries of
FDA will accept requests for safety and effectiveness.
B. Procedures participation in the REMS SPL pilot
FOR FURTHER INFORMATION CONTACT:
from October 6, 2015 to December 7,
To create an SPL file and submit it to Melissa Torres, Center for Devices and
2015. The pilot will proceed for 4
FDA, a participant will need the Radiological Health, Food and Drug
months, from October 6, 2015 to Administration, 10903 New Hampshire
following tools: Appropriate software,
February 3, 2016. This pilot may be Ave., Bldg. 66, Rm. 1650, Silver Spring,
knowledge of terminology and
standards, and access to FDA’s extended as resources and needs allow. MD 20993–0002, 301–796–5576.
Electronic Submissions Gateway (ESG) V. Paperwork Reduction Act of 1995 SUPPLEMENTARY INFORMATION:
(http://www.fda.gov/ForIndustry/
ElectronicSubmissionsGateway/ This notice refers to previously I. Background
default.htm). The ESG is an Agency- approved collections of information In accordance with sections 515(d)(4)
wide means of accepting electronic found in FDA regulations. These and (e)(2) of the Federal Food, Drug, and
regulatory submissions. The FDA ESG collections of information are subject to Cosmetic Act (the FD&C Act) (21 U.S.C.
enables the secure submission of review by the Office of Management and 360e(d)(4) and (e)(2)), notification of an
regulatory submissions. Instructions and Budget (OMB) under the Paperwork order approving, denying, or
information regarding the creation of an Reduction Act of 1995 (44 U.S.C. 3501– withdrawing approval of a PMA will
SPL file and the converting of REMS 3520). The collections of information in continue to include a notice of
information into SPL can be found at 21 CFR part 314 have been approved opportunity to request review of the
tkelley on DSK3SPTVN1PROD with NOTICES

http://www.fda.gov/ForIndustry/ under OMB control number 0910–0001. order under section 515(g) of the FD&C
DataStandards/ Dated: September 30, 2015. Act. The 30-day period for requesting
StructuredProductLabeling/default.htm. reconsideration of an FDA action under
Leslie Kux,
There should be no additional cost § 10.33(b) (21 CFR 10.33(b)) for notices
associated with obtaining the software. Associate Commissioner for Policy. announcing approval of a PMA begins
In 2010, FDA collaborated with [FR Doc. 2015–25349 Filed 10–5–15; 8:45 am] on the day the notice is placed on the
Pragmatic Data, LLC (http:// BILLING CODE 4164–01–P Internet. Section 10.33(b) provides that

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Document Created: 2015-12-15 08:51:30
Document Modified: 2015-12-15 08:51:30

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 pilot project, request for comments.
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.
Contact		Adam Kroetsch at REMS_S[email protected] or at 301-796-3842.
FR Citation		80 FR 60391

80 FR 60391 - Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 193 (October 6, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration