United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2015-10-06 article Notices D09002ee1c7f70bba D09002ee1c7f70c2a United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 80 FR 60391 https://www.govinfo.gov/app/details/FR-2015-10-06/2015-25349 2015-25349 fr06oc15-63 4164-01-P Docket No. FDA-2015-N-3402 https://www.govinfo.gov/app/details/FR-2015-10-06/2015-25349 https://www.govinfo.gov/content/pkg/FR-2015-10-06/html/2015-25349.htm https://www.govinfo.gov/content/pkg/FR-2015-10-06/pdf/2015-25349.pdf 3 p. 60391 60393 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; Federal Register Vol. 80, Issue NOTICE 2015-25349 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-10-06 Docket No. FDA-2015-N-3402 4164-01-P 2015-25349 Notice of pilot project, request for comments.

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.

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. Adam Kroetsch at REMS_Standardization@fda.hhs.gov or at 301-796-3842. Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project , REMS_Standardization@fda.hhs.gov http://www.fda.gov/downloads/Drugs/.../Guidances/UCM184128.pdf http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM362078.pdf http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM415751.pdf http://www.fda.gov/esg/default.htm http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.fda.gov/REMS http://www.regulations.gov Vol. 80, no. 193 Office of the Federal Register, National Archives and Records Administration 2015-10-06 continuing daily deposited born digital 244 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-10-06 P0b002ee18da9c3af 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06oc15 https://www.govinfo.gov/app/details/FR-2015-10-06 https://www.govinfo.gov/content/pkg/FR-2015-10-06/pdf/FR-2015-10-06.pdf https://www.govinfo.gov/content/pkg/FR-2015-10-06/xml/FR-2015-10-06.xml fdlp 60275 60510 DGPO 2015-10-06 2024-06-02 FR-2015-10-06 machine generated eng FR FR-2015-10-06 80 193