[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: 21CFR60.40]
[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 Division of Dockets Management 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.
[53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002]
Back to Top
© 2007 Betterchem Corp.
|
