[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.5]

[Page 199]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 108_EMERGENCY PERMIT CONTROL--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  108.5  Determination of the need for a permit.

    (a) Whenever the Commissioner determines after investigation that a 
manufacturer, processor, or packer of a food for which a regulation has 
been promulgated in subpart B of this part does not meet the mandatory 
conditions and requirements established in such regulation, he shall 
issue to such manufacturer, processor, or packer an order determining 
that a permit shall be required before the food may be introduced or 
delivered for introduction into interstate commerce by that person. The 
order shall specify the mandatory conditions and requirements with which 
there is a lack of compliance.
    (1) The manufacturer, processor, or packer shall have 3 working days 
after receipt of such order within which to file objections. Such 
objections may be filed by telegram, telex, or any other mode of written 
communication addressed to the Center for Food Safety and Applied 
Nutrition, Food and Drug Administration (HFS-605), 5100 Paint Branch 
Pkwy., College Park, MD 20740. If such objections are filed, the 
determination is stayed pending a hearing to be held within 5 working 
days after the filing of objections on the issues involved unless the 
Commissioner determines that the objections raise no genuine and 
substantial issue of fact to justify a hearing.
    (2) If the Commissioner finds that there is an imminent hazard to 
health, the order shall contain this finding and the reasons therefor, 
and shall state that the determination of the need for a permit is 
effective immediately pending an expedited hearing.
    (b) A hearing under this section shall be conducted by the 
Commissioner or his designee at a location agreed upon by the objector 
and the Commissioner or, if such agreement cannot be reached, at a 
location designated by the Commissioner. The manufacturer, processor, or 
packer shall have the right to cross-examine the Food and Drug 
Administration's witnesses and to present witnesses on his own behalf.
    (c) Within 5 working days after the hearing, and based on the 
evidence presented at the hearing, the Commissioner shall determine 
whether a permit is required and shall so inform the manufacturer, 
processor, or packer in writing, with the reasons for his decision.
    (d) The Commissioner's determination of the need for a permit 
constitutes final agency action from which appeal lies to the courts. 
The Commissioner will not stay a determination of the need for a permit 
pending court appeal except in unusual circumstances, but will 
participate in expediting any such appeal.

[42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12, 1989; 
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]