[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: 21CFR5.27]

[Page 40]
 
                        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--General Redelegations of Authority
 
Sec. 5.27  Patent term extensions for human drug products, medical devices, and food and color additives; and authority to perform due diligence determinations 
          and informal hearings.

    (a) The Deputy Commissioner is authorized to perform the due 
diligence determinations and informal hearings functions under section 
156(d)(2)(B)(ii) of title 35 U.S.C. (35 U.S.C. 156), as amended, 
relative to patent term extensions.
    (b) The Director, Center for Drug Evaluation and Research (CDER) and 
the Associate Director for Regulatory Policy, CDER, are authorized to 
perform the functions delegated to the Commissioner under title 35 
U.S.C. 156, as amended, except for making due diligence determinations 
and holding of informal hearings under title 35 U.S.C. 156(d)(2)(B).
    (c) 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 title 35 U.S.C. 156(d)(2)(B), as 
amended, except for holding of informal hearings under title 35 U.S.C. 
156(d)(2)(B)(ii).
    (d) These officials may not further redelegate this authority.