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§ 60.26 - Final action on regulatory review period determinations.

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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:

New information from PTO records, FDA records, or FDA centers that affects the regulatory review period determination;

A request under § 60.24 for revision of the regulatory review period determination;

A due diligence petition filed under § 60.30; or

A request for a hearing filed under § 60.40.

FDA will notify PTO that the regulatory review period determination is final upon:

The expiration of the 180-day period for filing a due diligence petition; or

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.

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§ 60.24 - Revision of regulatory review period determinations.
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§ 60.28 - Time frame for determining regulatory review periods.