21 CFR 1308.44
§ 1308.44 Request for hearing or appearance; waiver.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 1308.44, § 1308.44 Request for hearing or appearance; waiver, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/92000
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Full text
(a) Any interested person desiring a hearing on a proposed rulemaking, shall, within 30 days after the date of publication of notice of the proposed rulemaking in the Federal Register, file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter.
(b) Any interested person desiring to participate in a hearing pursuant to § 1308.41 shall, within 30 days after the date of publication of the notice of hearing in the Federal Register, file with the Administrator a written notice of his intention to participate in such hearing in the form prescribed in § 1316.48 of this chapter. Any person filing a request for a hearing need not also file a notice of appearance; the request for a hearing shall be deemed to be a notice of appearance.
(c) Any interested person may, within the period permitted for filing a request for a hearing, file with the Administrator a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding his position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.
(d) If any interested person fails to file a request for a hearing; or if he so files and fails to appear at the hearing, he shall be deemed to have waived his opportunity for the hearing or to participate in the hearing, unless he shows good cause for such failure.
(e) If all interested persons waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Administrator may cancel the hearing, if scheduled, and issue his final order pursuant to § 1308.45 without a hearing.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.