America’s Blood Centers (ABC) has submitted comments to the U.S. Food and Drug Administration (FDA) in response to the “FDA Draft Report and Plan on Best Practices for Guidance.” In the FDA Draft Report comments, ABC recommended that:
- “FDA develop draft guidance documents for implementation under emergency conditions, and provide these documents to blood centers in advance, so blood centers can reconfigure and validate their blood establishment computer systems (BECS), update their standard operating procedures (SOPs), and train their staff in preparation for immediate implementation, should the need arise; [and]
- that FDA provide additional information in the Center for Biologics Evaluation and Research’s (CBER) annual Guidance Agenda regarding the specific topics to be addressed in the Level I planned guidance documents.”
Additionally, ABC noted in the FDA Draft Report comments that, “in the event FDA decides to release draft guidance documents for immediate implementation that have not already been provided to blood centers, FDA should look to the Level I guidance documents provided during the public health emergency for immediate implementation, which provided less stringent requirements for blood centers to follow. This allowed blood centers to implement the new, less stringent guidance documents, or maintain the more stringent requirements al-ready in place, allowing blood centers flexibility until they developed the necessary SOPs, without com-promising the safety of the blood supply.”
Regarding CBER’s annual guidance agency, ABC explained in the FDA Draft Report comments that, “[w]e recognize that CBER is not bound by the list of planned guidance documents, nor would the Center be bound by any details they provide. However, this additional information would allow blood centers to begin strategizing around the implementation of potential changes to their operations.”
FDA is seeking input on “whether there are any additional circumstances, categories of guidance documents, or topics for guidance for which it may be appropriate and consistent with the FD&C Act and FDA’s GGP regulation for FDA to consider issuance as a Level I guidance document for immediate implementation without prior public comment,” and also, “whether there are additional categories or types of guidance documents that FDA should consider issuing as Level II guidance documents to streamline the guidance process and allow [FDA] to better leverage its resources for the timely development of more guidance documents.”
In the January notice published in the Federal Register, the FDA explained that the draft report, “responds to the Consolidated Appropriations Act of 2023, which directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices. It also directs FDA to publish a draft report and plan no later than one year after enactment of the Consolidated Appropriations Act and to consult with stakeholders in developing the report and implementation plan.”
An archive of all letters and comments on America’s Blood Centers’ blood advocacy initiatives is available.