[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.24]

[Page 325-326]
 
                        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. 60.24  Revision of regulatory review period determinations.

    (a) Any person may request a revision of the regulatory review 
period determination within 60 days after its initial publication in the 
Federal Register. The request shall be sent to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn 
Dr., Rockville, MD 20857. The request shall specify the following:
    (1) The type of action requested;
    (2) The identity of the product;
    (3) The identity of the applicant;
    (4) The FDA docket number; and
    (5) The basis for the request for revision, including any 
documentary evidence.
    (b) Unless the applicant is the person requesting the revision, the 
applicant shall respond to the request within 15 days. In responding to 
the request, the applicant may submit information which is relevant to 
the events during the regulatory review period but which was not 
included in the original patent term restoration application. A request 
for a revision is not equivalent to a due diligence petition under 
Sec. 60.30 or a request for a hearing under Sec. 60.40. If no response 
is submitted, FDA will decide the matter on the basis of the information 
in the patent term restoration application, request for revision, and 
FDA records.
    (c) FDA shall apply the provisions of Sec. 60.22 in considering the 
request for a revision of the regulatory review period determination. lf 
FDA revises its prior determination, FDA will notify PTO of the 
revision, send a copy of this

[[Page 326]]

notification to the applicant, and publish the revision in the Federal 
Register, including a statement giving the reasons for the revision.

[53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 67 
FR 9585, Mar. 4, 2002]