21 C.F.R. § 14.7

Current through November 30, 2024
Section 14.7 - Administrative remedies

A person who alleges noncompliance by the Commissioner or an advisory committee with any provision of this part or the Federal Advisory Committee Act may pursue the following administrative remedies:

(a) If the person objects to any action, including a failure to act, other than denial of access to an advisory committee document, the person shall submit a petition in the form and in accordance with the requirements of § 10.30 . The provisions of § 10.45 relating to exhaustion of administrative remedies are applicable.
(1) If the person objects to past action, the person shall submit the petition within 30 days after the action objected to. If the Commissioner determines that there was noncompliance with any provision of this subpart or of the Federal Advisory Committee Act, the Commissioner will grant any appropriate relief and take appropriate steps to prevent its future recurrence.
(2) If the person objects to proposed future action, the Commissioner will expedite the review of the petition and make a reasonable effort to render a decision before the action concerned in the petition.
(3) If the person objects to action that is imminent or occurring and which could not reasonably have been anticipated, e.g., the closing of a portion of a meeting which is made known for the first time on the day of the meeting, the matter may be handled by an oral petition in lieu of a written petition.
(b) If the person objects to a denial of access to an advisory committee document, administrative review is in accordance with the procedures established by the Department of Health and Human Services under 45 CFR 5.61 -and 45 CFR 5.64 .

21 C.F.R. §14.7

44 FR 22351, Apr. 13, 1979, as amended at 55 FR 1404, Jan. 16, 1990; 85 FR 72906 , Nov. 16, 2020
85 FR 72906 , 12/16/2020; 85 FR 81781 , 12/17/2020