A Federal Register Notice was posted July 1, 2025, inviting public comment on the directive through July 31, 2025, pursuant to Office of Management and Budget (OMB) review.
View the OPTN's response (PDF - 525 KB) to the 30-day public comment period.
On this page:
Background
In February 2024, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services announced a directive for the OPTN to collect additional data on patients prior to waitlist registration and referrals of potential deceased donors to organ procurement organizations (OPOs). The OPTN Final Rule allows federal authorization of additional data collection to promote the efficiency of the OPTN.
The directive addresses two areas of new or updated data collection:
- Information from transplant centers about when individuals are first referred to them for an organ transplant, as well as the results of their transplant evaluation and selection as a transplant candidate.
- Information from organ procurement organizations on all ventilated patients referred to them from hospitals in their donation service area, regardless of whether such individuals progress to organ donation and procurement.
A Federal Register notice was posted in November 2024 of an Information Request Package (ICR) for review by the federal Office of Management and Budget (OMB). The notice invited public comment on the package for a 60-day period. The OPTN prepared a response (PDF - 1 MB) to the proposal, led by input from the OPTN Data Advisory Committee.
A subsequent Federal Register notice was posted July 1, 2025, with an updated version of the ICR. It invites public comment on the package for an additional 30-day comment period. The OPTN will again prepare a response to the revised proposal.
Written comments must be submitted on or before July 31, 2025 to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. To request a copy of the clearance requests submitted to OMB for review, e-mail paperwork@hrsa.gov or call Samantha Miller, the HRSA Information Collection Clearance Officer at (301) 443-9094.
Timeline
| Action | Timing |
|---|---|
| Initial announcement of data directive | Feb. 5, 2024 |
| Federal Register publication; 60-day public comment process begins for draft data forms and proposal | Nov. 4, 2024 |
| OPTN reply (PDF - 1 MB) to 60-day public comment request | Jan. 3, 2025 |
| Federal Register publication; 30-day public comment process begins with modifications to forms and proposal | July 1, 2025 |
| OPTN reply (PDF - 525 KB) to the 30-day public comment request | July 31, 2025 |
| OMB final approval of data collection forms | TBD |
Workgroup review and recommendations
Members of the OPTN Data Advisory Committee (DAC) and two OPTN workgroups have offered recommendations to HRSA regarding this initiative. The committee and workgroups provided summary, initial feedback (PDF - 1 MB) in January 2024 on both pre-waitlist referral and ventilated referrals.
The Information below addresses each of the two initiatives in greater detail.
Pre-waitlist referral
Workgroup members and reports
- The OPTN Data Advisory Committee (DAC) Pre-Waitlist Data Collection Workgroup (PDF - 45 KB) (As of February 2024)
- Pre-Waitlist Data Collection Workgroup feedback on new pre-waitlist data collection (XLSX - 310 KB) (As of February 2024)
- Reports from the workgroup meetings can be found on the DAC committee page
Ventilated patient referral
Workgroup members and reports
- The OPTN Membership and Professional Standards Committee (MPSC) OPO Performance Monitoring Enhancement Workgroup (PDF - 47 KB) (As of February 2024)
- OPO Performance Monitoring Enhancement Workgroup feedback on new ventilated referral data collection (XLSX - 30 KB) (As of February 2024)
- Reports from the workgroup meetings can be found on the MPSC committee page
News and resources
For more information on the OMB review and approval process, see an overview presentation (PDF - 534 KB) that was shared with the OPTN Data Advisory Committee.
Other content to be added as available.
Date Last Reviewed: