Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2 - PSS

1a. Project Name Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2 1b. Project ID 1662 1c. Is Your Project an Investigative Project (aka PSS-Lite)? No 1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU? No 1e. Today's Date 1f. Name of standard being reaffirmed HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2 1g. Project Artifact Information 1h. ISO/IEC Standard to Adopt 1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption? 1j. Unit of Measure 2a. Primary/Sponsor WG Biomedical Research & Regulation 2d. Project Facilitator Boris Brodsky 2e. Other Interested Parties (and roles) 2f. Modeling Facilitator 2g. Publishing Facilitator 2h. Vocabulary Facilitator 2i. Domain Expert Representative 2j. Business Requirements Analyst 2k. Conformance Facilitator 2l. Other Facilitators 2m. Implementers 3a. Project Scope Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2. Work Group approved to withdraw on 2020-11-24 Conference Call, https://confluence.hl7.org/display/BRR/2020-11-24+Conference+Call Attachments 3b. Project Need The HL7 Version 3 Drug Stability Reporting (eStability) standard standardizes the format and the type of information in Drug Stability Reports for drug: substances; products; and devices. The purpose of eStability is to provide a method to communicate stability data in a standard electronic format so that it may be viewed as it appears on paper or electronic paper by regulatory agencies and industry. 3c. Security Risk No 3d. External Drivers 3e. Objectives/Deliverables and Target Dates 2021 September Ballot 3f. Common Names / Keywords / Aliases: 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: HTTP://Withdraw Drug Stability Reporting (eStability), Release 2 3j. Backwards Compatibility N/A 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? N/A 3l. Reason for not using current V3 data types? 3m. External Vocabularies N/A 3n. List of Vocabularies 3o. Earliest prior release and/or version to which the compatibility applies 4a. Products 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Revise current standard 5a. White Paper Type 5a. Is the project adopting/endorsing an externally developed IG? 5a. Externally developed IG is to be (select one) 5a. Specify external organization 5a. Revising Current Standard Info HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2, published 22 Aug 2016. Material included in Pharmaceutical Quality/Chemistry Manufacturing & Controls (PQ/CMC), http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1537 5b. Project Ballot Type Withdrawal 5c. Additional Ballot Info 5d. Joint Copyright No 5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval. no 6a. External Project Collaboration 6b. Content Already Developed 6c. Content externally developed? 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? 6f. Stakeholders 6f. Other Stakeholders 6g. Vendors 6g. Other Vendors 6h. Providers 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS 7b. Sponsoring WG Approval Date Nov 24, 2020 7c. Co-Sponsor Approval Date 7c. Co-Sponsor 2 Approval Date 7c. Co-Sponsor 3 Approval Date 7c. Co-Sponsor 4 Approval Date 7c. Co-Sponsor 5 Approval Date 7c. Co-Sponsor 6 Approval Date 7c. Co-Sponsor 7 Approval Date 7c. Co-Sponsor 8 Approval Date 7c. Co-Sponsor 9 Approval Date 7c. Co-Sponsor 10 Approval Date 7e. CDA MG Approval Date 7f. FMG Approval Date 7g. V2 MG Approval Date 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date Apr 16, 2021 7j. TSC Approval Date Apr 26, 2021