[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: 21CFR60.40]

[Page 323]
 
                        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 E--Due Diligence Hearings
 
Sec. 60.40  Request for hearing.


    (a) Any person may request, not later than 60 days after the 
publication under Sec. 60.34(a) of FDA's due diligence determination, 
that FDA conduct an informal hearing on the due diligence determination.
    (b) The request for a hearing under this section shall:
    (1) Be sent by mail, personal delivery, or any other mode of written 
communication to the Dockets Management Branch and filed under the 
relevant product file;
    (2) Specify the facts and the action that are the subject of the 
hearing;
    (3) Provide the name and address of the person requesting the 
hearing; and
    (4) Certify that the requesting party has served a true and complete 
copy of the request upon the petitioner and the applicant by certified 
or registered mail (return receipt requested) or by personal delivery.
    (c) The request shall state whether the requesting party seeks a 
hearing within 30 days or 60 days of FDA's receipt of the request.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0233)