[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.4]

[Page 23]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, 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 or the Director, 
Center for Drug 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; 70 FR 14983, Mar. 
24, 2005]