[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: 21CFR5.27]

[Page 39]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
Subpart B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.27  Patent term extensions for human drug products, medical devices, and food and color additives; and due diligence determinations.

    (a) The Director, Center for Drug Evaluation and Research (CDER) and 
the Associate Director for Policy, CDER, are authorized to perform the 
functions delegated to the Commissioner of Food and Drugs under 35 
U.S.C. 156, as amended, except for making due diligence determinations 
and holding of informal hearings under 35 U.S.C. 156(d)(2)(B).
    (b) The Chief Mediator and Ombudsman, Office of the Ombudsman, 
Office of the Senior Associate Commissioner, Office of the Commissioner, 
is authorized to perform the functions delegated to the Commissioner to 
make due diligence determinations under 35 U.S.C. 156(d)(2)(B), as 
amended, except for holding of informal hearings under 35 U.S.C. 
156(d)(2)(B)(ii).

[65 FR 34962, June 1, 2000]