3 Certification DED & PRS Forms

Attachment 6

25 Oct 2022
Attachment 6 – Certification to Delay Submission of Results Information

ClinicalTrials.gov Results Data Element Definitions
for Interventional and Observational Studies
February 1, 2021
8. Delayed Results (Optional)
A responsible party may delay the deadline for submitting results information if one of the two
certification conditions below applies to the clinical study and the certification is submitted prior to the
date of (i.e., the day before) the standard submission deadline for results information. The standard
submission deadline for results information is no later than 1 year after the ACT's primary completion
date. Alternatively, the responsible party may request an extension of the results submission deadline for
good cause. The extension must be granted by the NIH Director.
Delay Results Type [*] : Select one
•

•

Certify Initial Approval: Trial studies an FDA-regulated drug product (including a biological
product) or device product that was not approved, licensed or cleared by FDA for any use before
the Primary Completion Date of the trial, and the sponsor intends to continue with product
development and is either seeking, or may at a future date seek, FDA approval, licensure, or
clearance of the drug product (including a biological product) or device product under study.
Certify New Use: Trial studies an FDA-regulated drug product (including a biological product) or
device product that previously has been approved, licensed, or cleared, for which the
manufacturer is the sponsor of the trial and for which an application or premarket notification
seeking approval, licensure, or clearance of the use being studied (which is not included in the
labeling of the approved, licensed, or cleared drug, product (including a biologic product) or
device product) has been filed or will be filed within one year with FDA.

Note: If a responsible party who is both the manufacturer of the drug product (including a biological
product) or device product studied in an applicable clinical trial and the sponsor of the applicable clinical
trial submits a certification under "Certify New Use," that responsible party must submit such a
certification for each applicable clinical trial that meets the following criteria: (1) the applicable clinical
trial is required to be submitted in an application or premarket notification seeking approval, licensure, or
clearance of a new use; (2) the applicable clinical trial studies the same drug product (including a
biological product) or device product for the same use as studied in the applicable clinical trial for which
the initial certification was submitted. [42 U.S.C. 282 (j)(3)(E)(v)(II) and 42 CFR 11.44(b)(3)]
Intervention Name(s)
Definition: Provide the name of one or more drugs, biological products or devices to which the
certification applies. For drugs use generic name; for other types of interventions provide a brief
descriptive name. The name(s) entered should match Intervention Name(s) provided in the protocol
section.
FDA Application Number(s)
Definition: Provide at least one FDA application number (for example, NDA, BLA, or PMA number), if
available, when Delay Results Type is "Certify Initial Approval" or "Certify New Use."

1

Attachment 6

25 Oct 2022

OMB NO: 0925-0586
EXPIRATION DATE: 02/28/2023
Burden Statement
Public reporting burden for this collection of information is estimated to vary from 2.0 to 8.0
hours per response for registration, 10.0 to 45.0 hours per response for results information
submissions, and 15 minutes to 2 hours for other submissions including certifications for delay,
extension requests, and expanded access. These estimates include the time for reviewing
instructions, searching existing data sources, gathering the data needed, and completing and
reviewing the collection of information. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it displays a currently valid OMB
control number. Send comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-0586). Do not return the completed form to this address

2

Attachment 6

25 Oct 2022

3