OIRA Publishes Unified Agenda

The Administration has published the Spring 2023 Unified Agenda of Federal Regulatory and Deregulatory Actions. The agency rule list for the U.S. Food and Drug Administration (FDA) featured several items of note to the blood community. Proposed rules being worked on include:

• “Requirements for Determining Donor Eligibility and Donation Suitability of Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use – FDA is proposing to revise certain regulations applicable to establishments that collect blood or blood components, including blood or blood components intended solely for autologous use. The proposed rule would revise and permit limited exceptions to certain donor eligibility and donation suitability requirements. The proposed rule would provide more flexibility to accommodate advancing technology, while continuing to help ensure the safety of the nation’s blood supply and donor health.
• Medical Devices; Laboratory Developed Tests – this proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.
• Requirements for Requesting Records in Advance of or in Lieu of an Inspection, and Participation in a Remote Interactive Evaluation, of an Establishment that Manufactures Certain HCT/Ps – The proposed amendment to the regulations at 21 CFR part 1271, subpart F would establish requirements for the submission of records or other information to FDA upon request, in advance of or in lieu of an inspection of establishments that manufacture 361 HCT/Ps and require the participation in a remote interactive evaluation of such establishments, upon request by FDA.
• Biologics Regulation Modernization – FDA’s biologics regulations will be updated to clarify existing requirements and procedures related to Biologic License Applications and to promote the goals associated with FDA’s implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009.”

All dates are estimates in the Unified Agenda published by OIRA for the proposed rules to come out not definite timeframes. America’s Blood Centers (ABC) will provide updates as they become available and keep you informed of our efforts.