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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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9-9 - Notice of Refusal of Admission

9-9 - Notice of Refusal of Admission

  9-9 - Notice of Refusal of Admission

PURPOSE 

To provide the field with instructions for issuing the Notice of Refusal of Admission.  

BACKGROUND

Section 801(a) of the Federal Food, Drug, and Cosmetic Act directs the Secretary of the Treasury to issue a Notice of Refusal when it appears from examination of samples, or otherwise, that an imported shipment is in violation. This Section also orders the destruction of any such shipment refused admission, unless it is exported within 90 days of the date of the notice, or within such additional time as may be permitted pursuant to such regulations.

GUIDANCE

Who Should Issue the Notice of Refusal of Admission?

The language of the law places the responsibility for issuing the Notice of Refusal of Admission upon the Secretary of the Treasury who in turn has delegated this responsibility to the CBP. Traditionally, this notice is issued by the FDA district office over the facsimile signature of the Regional or District Director of CBP in accordance with local agreement. Each FDA district shall have a facsimile stamp of the signature of the Regional or District Director of CBP prepared for this purpose and supplied to the appropriate personnel, or have written delegation of authority from the District Director of CBP to issue the Notice of Refusal of Admission under FDA personnel signature. A new stamp should be prepared each time there is a change of personnel in the Regional or District Director of CBP position.

The compliance officer or designated district individual who issues the Notice of Refusal of Admission shall initial the original and each copy near the facsimile signature of the Regional or District Director of CBP. 

When Should the Notice of Refusal of Admission be Issued?

A Notice of Refusal of Admission is issued under the following circumstances:

  1. A response to a Notice of Detention and Hearing is not received within the specified ten day time frame (excluding Saturdays, Sundays, and holidays) and an extension of time for responding has not been granted. (Additional time may be noted due to circumstances affecting district operations).
  2. Efforts to relabel or recondition the detained shipment pursuant to an approved application (Form FD-766) have failed.
  3. When a detained shipment has been reconditioned pursuant to an approved application (Form FD-766), and we have agreed to the exportation of the reject material, a Notice of Refusal of Admission is issued covering the rejects.
  4. After a hearing relative to the validity of the charges for detention, the hearing officer rules that the charges are valid and a Form FD-766 has not been submitted.

NOTE: If a detention action is being appealed by the importer do not issue the Notice of Refusal of Admission until the appeal is decided. Districts should notify the CBP office of the delay to assure liquidation of the bond does not occur. 

Distribution of the Notice of Refusal of Admission

The Notice of Refusal of Admission is always issued to the importer of record (who is the same person or firm who was issued the Notice of Sampling). In accordance with local practices, copies may also be sent to the customhouse broker and the consignee when neither is the importer of record. All persons or firms who are sent copies of the Notice of Sampling and Notice of Detention and Hearing must also be sent a copy of the Notice of Refusal of Admission.

Two copies of the Notice must also be sent to CBP.  

Charges on the Notice of Refusal of Admission

The charges on a Notice of Refusal of Admission should be stated exactly as shown on the Notice of Detention and Hearing. If it becomes necessary to give additional or amended charges on a Notice of Refusal of Admission, an amended Notice of Detention and Hearing must first be issued providing another ten day period (excluding Saturdays, Sundays and holidays or additional time when appropriate) for an opportunity for hearing or the submission of a Form FD-766.

An example of the Notice of Refusal of Admission form and examples of the computer generated notice will be forwarded at a later date. 

When to close the Case

After the Issuance of the Notice of Refusal of Admission, the case should be kept in an open status until the receipt of the return copy of the Notice of Refusal from CBP showing the exportation or destruction of the shipment.

If the return copy is not received from CBP within 100 days, a letter inquiring as to the status of the shipment, or other agreed upon procedure established with your local CBP port, should be made.

It is important to monitor the final disposition of refused shipments, as FDA has encountered the distribution of such merchandise into domestic channels instead of exportation or destruction. Districts should follow the guidance for follow-up to refusals. 

Requests for Extension Beyond the Ninety Day Period

If request are received for an extension beyond the 90 day period to export or destroy a refused shipment, the requestor should be referred to the appropriate CBP office. Since the Notice of Refusal of Admission is the responsibility of CBP, FDA cannot grant such extensions. 

Reopening of a Case

Unless a Notice of Refusal of Admission was erroneously issued by FDA, consideration should not normally be given to requests to void the Notice in order to give the requestor an opportunity for a hearing or time to submit an application (Form FD-766) requesting permission to relabel or recondition. Indiscriminate voiding of this Notice tends to indicate to the importer of record that it is not necessary to respond within the prescribed period to the Notice of Detention and Hearing and, also, will generate additional paper work by both FDA and CBP. The latter result is counterproductive to our efforts to process all import matters in a timely manner.

If the compliance officer is of the opinion that the voiding of the Notice is advisable, concurrence must be obtained from the CBP office responsible for insuring the exportation or destruction of the shipment. After the receipt of CBP's concurrence, a letter voiding the Notice should be issued to the requestor with copies to CBP and all persons and firms receiving a copy of the Notice of Refusal of Admission. This letter should provide no more than a ten day period (excluding Saturdays, Sundays, and holidays) to afford the opportunity for a hearing or the submission of a Form FD-766.

Note: Because of the concern for liquidation of the Bond prior to final disposition of a detained entry, some districts have instituted procedures to issue the Notice of Refusal to CBP before a final decision on reconditioning or appeal have been made. Districts should follow their local procedures established with their CBP offices when such a practice is used.