Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project, 60391-60393 [2015-25349]

Download as PDF Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60391 comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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 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 the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. decision-making on these important issues. ADDRESSES: II. Electronic Access 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’’). FOR FURTHER INFORMATION CONTACT: SUMMARY: Ashley Boam, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4192, Silver Spring, MD 20993, 301–796– 2400; 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, 240– 402–7911. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES I. Background In the Federal Register of June 1, 2015 (80 FR 31050), FDA announced the availability of a draft guidance for industry entitled ‘‘Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.’’ Interested persons were originally given until July 31, 2015, to comment on the draft guidance. The Agency believes that reopening the comment period for an additional 90 days from the date of publication of this notice will allow adequate time for interested persons to submit comments without significantly delaying Agency VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 Persons with access to the Internet may obtain the draft guidance at https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: September 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25356 Filed 10–5–15; 8:45 am] BILLING CODE 4164–01–P 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. Notice of pilot project, request for comments. ACTION: 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. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 You may submit comments as follows: 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 https://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 E:\FR\FM\06OCN1.SGM 06OCN1 60392 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 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 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: https://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 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 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: tkelley on DSK3SPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 REMS report) (https://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 (https:// 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. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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’’ (https://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 humanreadable ‘‘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 (https://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 (https:// 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. E:\FR\FM\06OCN1.SGM 06OCN1 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 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 (https:// 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 tkelley on DSK3SPTVN1PROD with NOTICES 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) (https://www.fda.gov/ForIndustry/ ElectronicSubmissionsGateway/ default.htm). The ESG is an Agencywide 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 https://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 (https:// VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 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 https://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 https:// 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 60393 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2015–M–1064, FDA– 2015–M–1065, FDA–2015–M–1177, FDA– 2015–M–1178, FDA–2015–M–1325, FDA– 2015–M–1326, FDA–2015–M–1460, FDA– 2015–M–1461, FDA–2015–M–1557, FDA– 2015–M–1708, FDA–2015–M–1709, FDA– 2015–M–1956, FDA–2015–M–1957, FDA– 2015–M–1958, FDA–2015–M–1959, FDA– 2015–M–2077, FDA–2015–M–2078, FDA– 2014–M–2247] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency’s Division of Dockets Management. SUMMARY: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Melissa Torres, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993–0002, 301–796–5576. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 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): 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 https://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 https://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: https://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 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 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) 
(https://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 (https://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'' 
(https://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 
(https://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 (https://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 (https://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) 
(https://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 https://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 (https://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 https://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 https://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
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