21 CFR §12.30

1. (a)A person with a right to submit objections and a request for hearing under § 12.20(d) may submit objections and waive the right to a hearing. The waiver may be either an explicit statement, or a failure to request a hearing, as provided in 12.22(a)(4).
2. (b)If a person waives the right to a hearing, the Commissioner will rule upon the person's objections under §§ 12.24 through 12.28. As a matter of discretion, the Commissioner may also order a hearing on the matter under any of the provisions of this part.
3. (c)If the Commissioner rules adversely on a person's objection, the person may petition for judicial review in a U.S. Court of Appeals under the act.
   1. (1)The record for judicial review is the record designated in § 12.28(b)(1).
   2. (2)The time for filing a petition for judicial review begins as of the date of publication of the Commissioner's ruling on the objections.