{"data":{"id":"us/21-cfr-60.26","jurisdiction":"us","citation":"21 CFR 60.26","heading":"Final action on regulatory review period determinations.","body":"(a) FDA will consider a regulatory review period determination to be final upon expiration of the 180-day period for filing a due diligence petition under § 60.30 unless FDA receives:\n(1) New information from PTO records, FDA records, or FDA centers that affects the regulatory review period determination;\n(2) A request under § 60.24 for revision of the regulatory review period determination;\n(3) A due diligence petition filed under § 60.30; or\n(4) A request for a hearing filed under § 60.40.\n(b) FDA will notify PTO that the regulatory review period determination is final upon:\n(1) The expiration of the 180-day period for filing a due diligence petition; or\n(2) If FDA has received a request for a revision, a due diligence petition, or a request for a hearing, upon resolution of the request for a revision, the petition, or the hearing, whichever is later. FDA will send a copy of the notification to the applicant and file a copy of the notification in the docket established for the application in FDA's Dockets Management Staff (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 60—PATENT TERM RESTORATION","Subpart C—Regulatory Review Period Determinations"],"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":"52baf6d0104336f2ff3f55a25aa9cd90b9802accee283eae45fd8902f4064174","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-60.24","next":"us/21-cfr-60.28"},"notice":"GroundRules: Original legal text. Not legal advice."}