[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.20]

[Page 319]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 60--PATENT TERM RESTORATION--Table of Contents
 
           Subpart C--Regulatory Review Period Determinations
 
Sec. 60.20  FDA action on regulatory review period determinations.


    (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 Sec. 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.
    (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 
Branch (HFA-305), rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    (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]