Department of Health
and Human Services (HHS)
and Human Services (HHS)
July 28, 2020
None
Office of The Director, National Institutes of Health (OD)
The purpose of this notice is to inform the extramural community that a Federal court has held that Section 801 of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) requires submission of results information for any “applicable clinical trial” (“ACT”), as defined in section 402(j)(1)(A) of the Public Health Service (“PHS”) Act, that was initiated after September 27, 2007, or that was ongoing as of December 26, 2007, if the ACT studied a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date.
Requirement
FDAAA requires submission of results information for applicable clinical trials (ACTs) that were initiated after September 27, 2007, or that were ongoing as of December 26, 2007, if the product studied in the ACT is approved, licensed, or cleared by the Food and Drug Administration (FDA) at any time, including after the ACT’s primary completion date. For ACTs subject to FDAAA’s registration and results information submission requirements that have a primary completion date before January 18, 2017 (the effective date of the Final Rule for Clinical Trials Registration and Results Information Submission, 81 FR 64982 (Sept. 21, 2016) (“Final Rule”)), results information must be submitted as follows:
If the ACT studied a drug, biological, or device product that was approved, licensed, or cleared by FDA before the ACT’s primary completion date, the responsible party generally must submit the results information specified in section 402(j)(3)(C) and section 402(j)(3)(I) of the Public Health Service (PHS) Act no later than 1 year after the study’s primary completion date; however, results information submission for these ACTs may be delayed under certain conditions as specified in section 402(j)(3)(E)(v) (seeking approval, licensing, or clearance of a new use for the drug, biological, or device product) and section 402(j)(3)(E)(vi) (requesting an extension for good cause) of the PHS Act.
Pursuant to the Federal Court decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020), if the ACT studied a drug, biological, or device product that is approved, licensed, or cleared by FDA on or after the ACT’s primary completion date, the responsible party must submit the results information specified in section 402(j)(3)(C) and section 402(j)(3)(I) of the PHS Act within 30 days after approval, licensure, or clearance of the drug, biological, or device product, in accordance with section 402(j)(3)(E)(iv) of the PHS Act.
For details on what information must be submitted, please see the ClinicalTrials.gov FAQs available here.
When results information is not submitted in a timely manner, NIH may take enforcement action against recipients as outlined in the NIH Grants Policy Statement Section 8.5 and section 402(j)(5)(A) of the Public Health Service Act.
NIH Office of Policy for Extramural Research Administration
Division of Grants Compliance and Oversight
Telephone: 301-435-0949
Email:[email protected]