For applicable clinical trials that are subject to 42 CFR 11.42, the standard submission deadline for results information is no later than 1 year after the study's Primary Completion Date, as described in 42 CFR 11.44(a) of the final rule.
The regulations provide for the delayed submission of results information under certain conditions (see 42 CFR 11.44(b)) with certification if the responsible party is seeking approval, licensure, or clearance of a new use being studied for a product that previously has been approved, licensed, or cleared by the FDA. For applicable clinical trials with a Primary Completion Date on or after January 18, 2017, the final rule in 42 CFR 11.44(c) also provides for the delayed submission of results information under certain conditions with certification if the responsible party is seeking initial approval, licensure, or clearance for the studied product. The deadline for the delayed submission of results information as specified in 42 CFR 11.44(b) or 42 CFR 11.44(c) is 30 calendar days after the earliest of specific events described in each provision, with a maximum deadline for delayed results information submission of 2 years after the date of submission of the certification. Specific deadlines are also described in 42 CFR 11.44(d) of the final rule for the submission of partial results information. An extension for good cause may be requested under conditions specified in 42 CFR 11.44(e) of the final rule. The preamble explains that such requests will be granted in limited circumstances. (81 FR 65076-79)