[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.4]

[Page 21]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 601--LICENSING--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 601.4  Issuance and denial of license.

    (a) A biologics license shall be issued upon a determination by the 
Director, Center for Biologics Evaluation and Research that the 
establishment(s) and the product meet the applicable requirements 
established in this chapter. A biologics license shall be valid until 
suspended or revoked.
    (b) If the Commissioner determines that the establishment or product 
does not meet the requirements established in this chapter, the 
biologics license application shall be denied and the applicant shall be 
informed of the grounds for, and of an opportunity for a hearing on, the 
decision. If the applicant so requests, the Commissioner shall issue a 
notice of opportunity for hearing on the matter pursuant to 
Sec. 12.21(b) of this chapter.

[42 FR 4718, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977; 42 
FR 19142, Apr. 12, 1977; 64 FR 56450, Oct. 20, 1999]