[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.94]

[Page 12]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 1--GENERAL ENFORCEMENT REGULATIONS--Table of Contents
 
                     Subpart E--Imports and Exports
 
Sec. 1.94  Hearing on refusal of admission.

    (a) If it appears that the article may be subject to refusal of 
admission, the district director shall give the owner or consignee a 
written notice to that effect, stating the reasons therefor. The notice 
shall specify a place and a period of time during which the owner or 
consignee shall have an opportunity to introduce testimony. Upon timely 
request giving reasonable grounds therefor, such time and place may be 
changed. Such testimony shall be confined to matters relevant to the 
admissibility of the article, and may be introduced orally or in 
writing.
    (b) If such owner or consignee submits or indicates his intention to 
submit an application for authorization to relabel or perform other 
action to bring the article into compliance with the act or to render it 
other than a food, drug, device, or cosmetic, such testimony shall 
include evidence in support of such application. If such application is 
not submitted at or prior to the hearing, the district director shall 
specify a time limit, reasonable in the light of the circumstances, for 
filing such application.