Department of Health and Human Services data directive
Toolkit
A Federal Register Notice was posted Nov. 4, 2024, inviting public comment on the directive through Jan. 3, 2025, pursuant to Office of Management and Budget (OMB) review.
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.
The proposed data collection is included in a Federal Register notice of an Information Request Package (ICR) for review by the federal Office of Management and Budget (OMB). The notice invites public comment on the package for a 60-day period. The OPTN will prepare a response to the proposal, led by input from the OPTN Data Advisory Committee.
Written comments must be submitted on or before Jan. 3, 2025, via e-mail to paperwork@hrsa.gov or by mail to the HRSA Information Collection Clearance Officer, Room 14NWH04, 5600 Fishers Lane, Rockville, MD 20857. HRSA will review comments and will subsequently post another document, including any proposed revisions, for an additional 30-day public comment period. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, e-mail paperwork@hrsa.gov or call Joella Roland, the HRSA Information Collection Clearance Officer at (301) 443-3983.
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 to 60-day public comment request | Jan. 3, 2025 |
| Federal Register publication; 30-day public comment process begins with modifications to forms and proposal | Spring 2025 |
| Federal Register publication; final data forms published | Spring 2025 |
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 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 (As of February 2024)
- Pre-Waitlist Data Collection Workgroup feedback on new pre-waitlist data collection (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 (As of February 2024)
- OPO Performance Monitoring Enhancement Workgroup feedback on new ventilated referral data collection (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 that was shared with the OPTN Data Advisory Committee.
Other content to be added as available.