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Electronic Code of Federal Regulations

e-CFR Data is current as of September 18, 2014

Title 21Chapter ISubchapter APart 60Subpart C → §60.26


Title 21: Food and Drugs
PART 60—PATENT TERM RESTORATION
Subpart C—Regulatory Review Period Determinations


§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]



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