[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.7]
[Page 205-206]
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. 108.7 Issuance or denial of permit.
(a) After a determination and notification by the Commissioner in
accordance with the provisions of Sec. 108.5 that a manufacturer,
processor, or packer requires a permit, such manufacturer,
[[Page 206]]
processor, or packer may not thereafter introduce or deliver for
introduction into interstate commerce any such food manufactured,
processed, or packed by him unless he holds a permit issued by the
Commissioner or obtains advance written approval of the Food and Drug
Administration pursuant to Sec. 108.12(a).
(b) Any manufacturer, processor, or packer for whom the Commissioner
has made a determination that a permit is necessary may apply to the
Commissioner for the issuance of such a permit. The application shall
contain such data and information as is necessary to show that all
mandatory requirements and conditions for the manufacturer, processing
or packing of a food for which regulations are established in subpart B
of this part are met and, in particular, shall show that the deviations
specified in the Commissioner's determination of the need for a permit
have been corrected or suitable interim measures established. Within 10
working days after receipt of such application, (except that the
Commissioner may extend such time an additional 10 working days where
necessary), the Commissioner shall issue a permit, deny the permit, or
offer the applicant a hearing conducted in accordance with Sec. 108.5
(b) and (c) as to whether the permit should be issued. The Commissioner
shall issue such a permit to which shall be attached, in addition to the
mandatory requirements and conditions of subpart B of this part, any
additional requirements or conditions which may be necessary to protect
the public health if he finds that all mandatory requirements and
conditions of subpart B of this part are met or suitable interim
measures are established.
(c) Denial of a permit constitutes final agency action from which
appeal lies to the courts. The Commissioner will not stay such denial
pending court appeal except in unusual circumstances, but will
participate in expediting any such appeal.
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