§ 5.34 - Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment.

(a) The Director, the Deputy Director, and the Associate Director for Regulatory Policy, Center for Drug Evaluation and Research, the Director and Deputy Director, Center for Veterinary Medicine, and the Director and Deputy Directors, Center for Biologics Evaluation and Research are authorized to issue the following notices and make all findings required in relation to these notices under section 306 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 335a) which relate to the assigned functions of their organizations:

(1) Notices of opportunity for hearing on proposals for mandatory or permissive debarment.

(2) Notices ordering debarment when opportunity for a hearing has been waived.

(3) Notices ordering debarment where the person notifies the agency that the person consents to debarment under section 306(c)(2)(B) of the act (21 U.S.C. 335a(c)(2)(B)).

(4) Notices of opportunity for hearing on proposals denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)).

(5) Orders denying an application to terminate debarment under section 306(d)(3) of the act (21 U.S.C. 335u(d)(3)) when opportunity for a hearing has been waived.

(b) These officials may not further redelegate these authorities.