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42 C.F.R. § 11.54

What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission?

§ 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission?

(a) Waiver request. (1) A responsible party for an applicable clinical trial with a primary completion date on or after January 18, 2017 may request a waiver from any applicable requirement(s) of this subpart C by submitting a waiver request in the format specified at https://prsinfo.clinicaltrials.gov/ to the Secretary or delegate prior to the deadline specified in § 11.44(a) for submitting clinical trial results information.

(2) The waiver request must contain:

(i) The NCT number, Brief Title, and Name of the Sponsor of the applicable clinical trial for which the waiver is requested;

(ii) The specific requirement(s) of this subpart C for which the waiver is requested; and

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