[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.24]
[Page 321]
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 Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. 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 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]
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