The regulations at 42 CFR 11.42 address those applicable clinical trials for which a responsible party must submit results information. The "Applicability of Requirements in 42 CFR Part 11" table may be used to evaluate whether the results information requirements in 42 CFR Part 11 or section 402(j) of the Public Health Service (PHS) Act apply to specific applicable clinical trials. (81 FR 65121)
As outlined in the table, required results information is determined by the Primary Completion Date:

• For ACTs that are required to be registered and with a Primary Completion Date before January 18, 2017:
  • If the ACT studies a drug, biological, or device product that is approved, licensed or cleared as of the Primary Completion Date, then the responsible party is required to submit the results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the PHS Act. (42 CFR 11.42(a)(1))
  • If the ACT studies a drug, biological, or device product that is not approved, licensed, or cleared as of the Primary Completion Date, then the responsible party is not required to submit results information. (42 CFR 11.42(b))
• For ACTs that are required to be registered and with a Primary Completion Date on or after January 18, 2017:
  • If the ACT studies a drug, biological, or device product that is approved, licensed or cleared as of the Primary Completion Date, then the responsible party is required to submit the results information specified in 42 CFR 11.48. (42 CFR 11.42(a)(2))
  • If the ACT studies a drug, biological, or device product that is not approved, licensed, or cleared as of the Primary Completion Date, then the responsible party is required to submit the results information specified in 42 CFR 11.48. (42 CFR 11.42(b))

The regulations at 42 CFR 11.60 also establish requirements for the voluntary submission of results information that are not otherwise required to be submitted under 42 CFR 11.42.