NOTE: this standard has been withdrawn. The requirements of this message have been subsumed by the FDA PQ/CMC Project - Pharmaceutical Quality (PQ) - Regulatory Use Case
HL7 Specification Withdrawal Template
Use this form to request withdrawal of an Informative, STU, or Normative balloted or published protocol specification (i.e. an HL7 Standard, Implementation Guide, etc).
Date:
| Official Document / Standard Name: Drug Stability Reporting (eStability), Release 2 (revision of ANSI/HL7 V3 DSR, R1-2005) | ||
| Current Status: Stable | Selection | Status: Retired | Action to be taken (See Appendix A for guidance) |
| Balloted but not published | Withdraw ballot record (applies to comment-only) | ||
| X | Published | Withdraw publication – requires "de-affirmation"[1] ballot at same level | |
| Neither | Close project | ||
| Justification: | Material included in Pharmaceutical Quality/Chemistry Manufacturing & Controls (PQ/CMC) | ||
Sponsoring Work Group | Biomedical Research and Regulation |
Co-Sponsoring Work Group(s) | N/A |
Project Insight Project ID | 1662 |
Form Submitter Contact Info(Name, Email, Phone) | Boris Brodsky boris.brodsky@fda.hhs.gov 301-796-5179 |
Ballot Cycle Date the document last balloted and Ballot Level |
Normative |
Product Brief Modifications | N/A |
For Joint Standards, joint organization name and contact info | |
HL7 Product Management Group | |
Work Group Approval Date and Link to Minutes | |
Comments | PSS to withdraw Drug Stability Reporting (eStability), Release 2 |
Upon receiving Work Group approval, e-mail the completed form to the TSC Project Manager (TSCPM@HL7.org) and HL7 CTO.
De-affirmation Process and Checklist
[1] "De-affirmation" ballot is a limited scope ballot to request voters to approve the withdrawal of the published artifact, following regular HL7 NIB and ballot processes
- Work Group approves and submits PSS indicating published artifact/standard to be withdrawn
- Project Management Office (PMO) of HQ enters project into Project Insight and generates PI ID
- Work Group routes PSS to co-sponsor, product management, US Realm, and Steering Division group(s) for approval
- Work Group submits NIB for a withdrawal ballot at the same level the artifact was originally balloted before being published
- Director of Technical Publications (DTP) of HQ generates ballot document to resemble a reaffirmation ballot where the subject matter of the ballot document contains a question similar to:
- For the purposes of this ballot the question being asked is as follows:
- Should the standard be reaffirmed as an American National Standard, withdrawn as an ANS, or subject to revision and brought to ballot as a new version?
- Accordingly, voters should lodge their votes as follows:
- Affirmative – Indicates support of reaffirmation withdrawal of the ANS
- Negative – Indicates support of either withdrawing retaining or revising the ANS. If you do not support withdrawal, indicate your reasons in the comments accompanying your negative vote.
- At the conclusion of the ballot, conduct reconciliation of any negative votes.
Appendix A: Withdrawal Guidance chart
Ballot Level: | Published? | Date to Expire | Post-withdrawal status: | Available in standards grid after withdrawal? | Post-withdrawal Download source: | Action notes: (In addition to submitting the completed form to TSCPM@hl7.org, also do the following) |
Comment | no | n/a | Withdrawn | n/a | n/a | |
STU | yes | Withdrawn | no | expired STU page | WG submit PSS. De-affirmation ballot process. | |
STU | yes | Retired | yes | standards grid | WG submit PSS. De-affirmation ballot process. FHIR, CIMI, CDS-Hooks separate web sites | |
STU | no | Withdrawn | no | n/a | ||
Informative | yes | n/a | Withdrawn | no | n/a | WG submit PSS. De-affirmation ballot process. |
Informative | yes | n/a | Retired | yes | standards grid | WG submit PSS. De-affirmation ballot process. |
Informative | no | n/a | Withdrawn | no | n/a | |
Normative | yes | Withdrawn | no | n/a | WG submit PSS. De-affirmation ballot process. HQ to remove publication as HL7 or ANSI standard. | |
Normative | yes | Retired | yes | standards grid | WG submit PSS. De-affirmation ballot process. HQ to remove publication as ANSI standard and re-publish as HL7 standard without ANSI recognition | |
Normative | yes | Reaffirmed | yes | standards grid | HQ will generate PSS for reaffirmation for TSC approval | |
Normative | no | n/a | Withdrawn | no | n/a |