[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: 21CFR601.7]

[Page 22]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 601--LICENSING--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 601.7  Procedure for hearings.

    (a) A notice of opportunity for hearing, notice of appearance and 
request for hearing, and grant or denial of hearing for a biological 
drug pursuant to this part, for which the exemption from the Federal 
Food, Drug, and Cosmetic Act in Sec. 310.4 of this chapter has been 
revoked, shall be subject to the provisions of Sec. 314.200 of this 
chapter except to the extent that the notice of opportunity for hearing 
on the matter issued pursuant to Sec. 12.21(b) of this chapter 
specifically provides otherwise.
    (b) Hearings pursuant to Secs. 601.4 through 601.6 shall be governed 
by part 12 of this chapter.
    (c) When a license has been suspended pursuant to Sec. 601.6 and a 
hearing request has been granted, the hearing shall proceed on an 
expedited basis.

[42 FR 4718, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977; 42 
FR 19143, Apr. 12, 1977]