§ 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

(iii) A description of the extraordinary circumstances that the responsible party believes justify the waiver and an explanation of why granting the request would be consistent with the protection of public health or in the interest of national security.

(3) The responsible party will not be required to comply with the specified requirements of this subpart for which a waiver is granted.

(4) The responsible party must comply with any requirements of this subpart for which a waiver is not granted or must submit an appeal as set forth in paragraph (b) of this section. The deadline for submitting any required clinical trial results information will be the later of the original submission deadline or 30 calendar days after the notification of the denial is sent to the responsible party.

(b) Appealing a denied waiver request.

(1) A responsible party for an applicable clinical trial with a primary completion date on or after January 18, 2017 may appeal a denied waiver request by submitting an appeal to the Secretary or delegate in the format specified at https://prsinfo.clinicaltrials.gov/ not later than 30 calendar days after the date on which the electronic notification of the denial in paragraph (a)(4) of this section denying the request is sent to the responsible party.

(2) The responsible party is not required to comply with any requirements of this subpart for which a waiver is granted upon appeal.

(3) The responsible party must submit clinical trial results information to comply with any requirements of this subpart that are not waived upon appeal by the later of the original submission deadline or 30 calendar days after the notice of the denial upon appeal is sent to the responsible party.

(c) If a waiver is granted under paragraph (a) or (b) of this section:

(1) The Director will include a notation in the clinical trial record that specified elements of the requirements of this part have been waived.

(2) The Secretary will notify, in writing, the appropriate committees of Congress and provide an explanation for why the waiver was granted, not later than 30 calendar days after any waiver is granted.

(d) A responsible party for an applicable clinical trial with a primary completion date before January 18, 2017 may request a waiver from any applicable requirement(s) for clinical trial results information submission by submitting a waiver request, as specified in section 402(j)(3)(H) of the Public Health Service Act (42 U.S.C. 282(j)(3)(H)).