[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR1.94]



[Page 13-14]

 

                        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



[[Page 14]]



shall specify a time limit, reasonable in the light of the 

circumstances, for filing such application.