The final rule clarifies that expanded access (EA) use of a drug, biological, or device product is not considered an "applicable clinical trial" (ACT) under the definition in 42 CFR 11.10 (81 FR 65009-10). Thus, the submission of clinical trial registration and results information for EA use would not be required by 42 CFR 11.22 and 42 CFR 11.42.
However, for "applicable drug clinical trials" that are required to submit the registration information specified in 42 CFR 11.28, and the responsible party is both the drug manufacturer and trial sponsor, information on the availability of investigational drug products for expanded access is required to be submitted as part of the registration information under 42 CFR 11.28(a)(2)(ii)(H). In addition, an expanded access record must be submitted as required under 42 CFR 11.28(c) to provide details about how to obtain access to the investigational drug (including biological) product. The regulations at 42 CFR 11.64(a)(1)(ii)(D) and (E) requires this availability of expanded access and expanded access record information to be updated. More information about the expanded access submission requirements is available in the final rule preamble. (81 FR 65059-62)