§ 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.