(a) FDA will consult its records and experts to verify the dates contained in the application and to determine the length of the product’s regulatory review period under § 60.22. The application shall contain information relevant to the determination of the regulatory review period as stated in the “Guidelines for Extension of Patent Term Under 35 U.S.C. § 156” published on October 9, 1984, in PTO’s Official Gazette and as required by 37 CFR chapter I.

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(b) After determining the length of the regulatory review period, FDA will notify PTO in writing of its determination, send a copy of this determination to the applicant, and file a copy of the determination in the docket established for the application in FDA’s Dockets Management Staff (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

(c) FDA will also publish the regulatory review period determination in the Federal Register. The notice will include the following:

(1) The name of the applicant;

(2) The trade name and generic name (if applicable) of the product;

(3) The number of the patent for which an extension of the term is sought;

(4) The approved indications or uses for the product;

(5) An explanation of any discrepancies between the dates in the application and FDA records;

(6) Where appropriate, an explanation that FDA has no record in which to review the date(s) contained in the application; and

(7) The regulatory review period determination, including a statement of the length of the testing and approval phases and the dates used in calculating each phase.

[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994]