The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.
Download the Code of Federal Regulations in XML.
Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF
Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.
Purchase individual CFR titles from the U.S. Government Online Bookstore.
Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.
Electronic Code of Federal Regulations
§60.26 Final action on regulatory review period determinations.
(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:
(1) New information from PTO records, FDA records, or FDA centers that affects the regulatory review period determination;
(2) A request under §60.24 for revision of the regulatory review period determination;
(3) A due diligence petition filed under §60.30; or
(4) A request for a hearing filed under §60.40.
(b) FDA will notify PTO that the regulatory review period determination is final upon:
(1) The expiration of the 180-day period for filing a due diligence petition; or
(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 Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]