Federal Register #0906-0110-Revision

HRSA Seeks Public Comment on OPTN Data Collection System Revisions

The Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), is seeking public comment on proposed revisions to its Organ Procurement and Transplantation Network (OPTN) data collection system. - Government Buyer: - Department of Health and Human Services (HHS) - Health Resources and Services Administration (HRSA) - Products/Services Requested: - Data collection system for OPTN, including: - New forms for Patient Safety Contact Management and Patient Transfer - Removal of Vascularized Composite Allografts (VCA) Transplant Candidate Registration forms - Updates to existing forms to improve organ matching, allocation, and compliance - Collection of time-sensitive, life-critical data on transplant candidates, organ donors, organ matching, histocompatibility results, organ labeling and packaging, and pre- and post-transplantation data - Respondent Types: - Transplant centers - Organ procurement organizations - Histocompatibility laboratories - Unique/Notable Requirements: - Focus on improving patient safety, organ matching, and regulatory compliance - No specific OEMs or commercial vendors are named; the opportunity is centered on information collection and system/process updates - Additional Note: - A separate National Cancer Institute (NCI) licensing opportunity is mentioned for a novel cancer therapeutic (hetIL-15 combinations), but this is not part of the OPTN data collection procurement.

Description

The Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for the Data System for Organ Procurement and Transplantation Network (OPTN). The data collection includes time-sensitive, life-critical data on transplant candidates, potential organ donors, organ matching, histocompatibility results, organ labeling and packaging, and pre- and post-transplantation data on recipients and donors. The information is used to develop transplant policies, monitor compliance with regulations, ensure patient safety, and support public health surveillance. HRSA seeks public comments on the burden estimate and other aspects of the ICR before submission to OMB.

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