§ 5.67 - Issuance of notices of opportunity for a hearing on proposals for denial of approval of applications for licenses, suspension of licenses, or revocation of licenses and certain notices of revocation of licenses.

The Center Director and Deputy Center Directors, Center for Biologics Evaluation and Research are authorized to issue:

(a) Notices of opportunity for a hearing on proposals to deny approval or filing of applications for biologics licenses under § 601.4(b) of this chapter.

(b) Notices of opportunity for a hearing on proposals to revoke biologics licenses under § 601.5(b) of this chapter.

(c) Notices of revocation, at the manufacturer's request, of biologics licenses under §§ 601.5(a) and 601.8 of this chapter.

(d) Notices of revocation when the manufacturer has waived the opportunity for hearing under § 601.7(a) of this chapter.

(e) Notice of license suspensions under § 601.6 of this chapter.