The Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) notified the leadership of the National Oncologic PET Registry (NOPR) that it may require the NOPR to change its procedures related to Institutional Review Board (IRB) review. At this time it is not known if IRB approval will be required. The Centers for Medicare and Medicaid Services (CMS) and OHRP are working to resolve this issue. Until this issue is resolved, the NOPR cannot accept patient registrations or finalize facility registrations.