{"data":{"id":"us/21-cfr-12.38","jurisdiction":"us","citation":"21 CFR 12.38","heading":"Effective date of an order.","body":"(a) If a person who is subject to a notice of opportunity for hearing under § 12.21(b) does not request a hearing, the Commissioner will—\n(1) Publish a final order denying or withdrawing approval of an NDA, NADA, device premarket approval application, or biologics license, in whole or in part, or revoking a device product development protocol or notice of completion, or declaring that such a protocol has not been completed, and stating the effective date of the order; and\n(2) If the order involves withdrawal of approval of an NADA, forthwith revoke, in whole or in part, the applicable regulation, under section 512(i) of the act.\n(b) If a person who is subject to a notice of opportunity for hearing under § 12.21(b) requests a hearing and others do not, the Commissioner may issue a final order covering all the drug or device products at once or may issue more than one final order covering different drug or device products at different times.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 12—FORMAL EVIDENTIARY PUBLIC HEARING","Subpart B—Initiation of Proceedings"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"ce367a4dfaca2f88a8638fed456ff8c29e6e569b4ed882c71b00262f012e3902","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-12.37","next":"us/21-cfr-12.40"},"notice":"GroundRules: Original legal text. Not legal advice."}