Inspections, Compliance, Enforcement, and Criminal Investigations
9-8 - Response (Hearing) to Notice of Detention and Hearing
To provide guidance to FDA field offices regarding who can respond to a Notice of Detention and Hearing; time frames for responding; and conduct of the hearing.
The statements in this chapter are intended only to provide operating guidance for FDA personnel and are not intended to create or confer any rights, privileges, or benefits on or for any private person.
Section 801(a) of the Federal Food, Drug, and Cosmetic Act provides the owner or consignee of FDA regulated imported goods with an opportunity to appear before the Secretary of Health and Human Services to introduce testimony relative to the admissibility of their imported shipment.
21 CFR Section 1.94 provides that if it appears that an imported article may be subject to refusal of admission, the FDA district director shall give the owner or consignee a written notice stating the reasons therefore. This regulation further provides that this notice shall specify a place and period of time during which the owner or consignee shall have an opportunity to introduce testimony, either orally or in writing, as to the admissibility of the shipment.
In developing FDA's automated import system, known as the Operational and Administrative System for Import Support (OASIS) the specific form "Notice of Detention and Hearing" has been replaced by the issuance of a "Notice of FDA Action," which contains a description of the article(s) and action taken for a specific entry. The use of the designation "DETAINED," or other similar wording, under the heading of "Current Status," should be considered as meeting the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee" (see RPM Chapter 9-8 Notice of Detention and Hearing for an example of "Notice of FDA Action" for detention).
Section 801(a) of the Federal Food, Drug, and Cosmetic Act and FDA regulation 21 CFR 1.94 provide the owner or consignee an opportunity to introduce testimony relevant to the admissibility of the article if it appears that an imported lot may be subject to refusal of admission. However, the regulations are rather complicated as to the definition of "owner or consignee." 21 CFR 1.83(a) defines, for the purpose of the regulation, the owner or consignee as the person who has the right of a consignee under Sections 483, 484, and 485 of the Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).
For the purposes of the Tariff Act, only the declared consignee as shown on the bill of lading may be the importer, unless bill of lading endorsements by this consignee confer his rights to other persons. For the purposes of the Tariff Act, the consignee (importer) is to be regarded as the owner of the imported goods. If the consignee (importer) is not the true owner of the goods, the true owner may file with the District Director of CBP a declaration of ownership, which bestows upon the true owner all of the rights of a consignee. Thus, we are obligated by statute to recognize as eligible for the presentation of testimony, the consignee (importer) or the true owner (if the true owner is not the consignee) if there is on file with CBP a declaration of ownership.
In addition to the consignee (importer) and the true owner, we also recognize the eligibility of the importer of record to present testimony. (The importer of record is the person or firm who guarantees, by bond, proper custody and handling of the imported shipment in compliance with the laws governing such shipment. The importer of record may be the broker, consignee, true owner, or whoever owns the bond covering the shipment.) In most cases, it is the importer of record who responds to the "Notice of Detention and Hearing."
A designated representative of the consignee (importer), true owner, or importer of record may appear in the consignee's (importer's) behalf; however, unless known to be authorized representatives, the district should require proper documentation designating the individual(s) to be a bonafide representative for the purpose of the hearing. Recognition of others may open the way for claims by the consignee (importer), true owner, or importer of record that FDA has denied or abridged the importer's right to be heard, or for complaints that FDA has permitted unauthorized persons to intrude into the case.
The "Notice of Detention and Hearing" provides an opportunity for the introduction of testimony or the filing of a statement in writing within ten days (or longer if district circumstances require a longer time for response) following the date of detention shown on the notice (excluding Saturdays, Sundays, and holidays). This is indicated on the Notice by the reference to a "Respond By" date. The "introduction of testimony" may take many forms, including a telephone conversation, a FAX or mail, and does not have to be introduced in person. However, if the consignee (importer), true owner, or importer of record requests a hearing as such, it should be scheduled for the earliest possible date.
The response period may be extended at the request of the respondent if it is made within the 10-day time-frame shown in the "Notice of Detention and Hearing," and the requestor provides a reasonable basis for extension, and the requested extension is confirmed in writing. It is preferable for extension requests to be made in writing, but this is not mandatory. Such requests should be answered by the district, in writing. If the request is granted, the new time frame should be clearly stated in the response letter.
Generally speaking, requests for extension for indefinite or excessively long periods should not be granted. This also applies to requests for extensions based upon reasons other than to obtain or prepare evidence pertaining to the specific charges of the detention. However, extensions should only be granted if some type of resolution is actively being pursued.
The import hearing provided by section 801(a) of the Act is a different procedure from a hearing pursuant to Section 305 of the Act. Under section 801(a), it is the respondent's opportunity to present a defense of the importation and/or to present evidence to show how the importation may be made eligible for entry. This type of hearing may vary from a series of telephone conversations to a more formal 305 type of meeting. Formal memoranda covering import hearings are not required, although a written record should be made for the files.
The hearing officer (generally it is the district compliance officer, however, it may be any individual designated by the district to conduct such a hearing) should avoid any indication of prejudice or pre- judgment until all evidence is submitted and should assure that the respondent has been provided ample opportunity to present all relevant evidence. If the question arises, the respondent should be made aware of their rights of appeal to a higher level of review in the agency, including to the specific Center responsible for the detained article, to the Associate Commissioner for Regulatory Affairs, to the Commissioner of FDA, to the Secretary of Health and Human Services, and to file legal actions with the court.
The hearing should be confined to relevant matters, and the respondent should be required to confine their comments to the submission of relevant evidence and not be permitted merely to attempt to question, probe, or pass judgment on FDA's basis for detention.
If the facts in the case are such that a decision can be reached regarding the validity of the detention charges at the termination of the hearing, the hearing officer should so advise the respondent of the decision with confirmation by the issuance of the appropriate "Notice," (Refusal, Release, etc.). A copy of the appropriate "Notice" should be sent to the importer of record, if this person is not the respondent.
There is no need to dictate a summary of the hearing in the presence of the respondent, as is done during a "Section 305 meeting," nor is it necessary to provide the respondent with a copy of our memorandum covering the hearing.
Occasionally, a respondent at an import hearing attempts to weigh the relative desirability of appealing a refusal of admission against submitting a request for an authorization to relabel, recondition, etc. (FD Form-766), or reopen the basic question of the shipment's legality if relabeling or reconditioning is unduly burdensome. The respondent should be advised that orderly procedure requires that the respondent first present a view on the validity of the FDA charge(s), and then, if the respondent concludes that the charges are valid, a request for an authorization to relabel or recondition or refusal can be submitted. This should not be taken as preventing a discussion, at the appropriate time, of what is needed to bring the article into compliance. Once the hearing has been held and a Form FD-766 has been submitted for an authorization to relabel or recondition, the hearing should not be reopened for the purpose of determining whether the article is subject to refusal of admission.
On occasion, a respondent will request that a Notice of Refusal of Admission be issued immediately so the merchandise can be exported. These requests should also be confirmed in writing by the respondent. Requests for issuance of a Notice of Refusal of Admission should be acted upon without delay.
The response to a Notice of Detention and Hearing by mail is no different from a hearing where a verbal response is provided. The hearing officer must consider the evidence developed by FDA and that presented in the written response, and then make a decision as to whether or not the importation is violative as charged in the Notice of Detention and Hearing. All such responses should be replied to in writing, e.g., appropriate "Notice" with a clear statement of the hearing officer's decision. A copy of this Notice should be sent to the importer of record, if the person is not the respondent.
Questions regarding appropriateness of respondent, procedures for conducting the hearing, or other concerns not specifically identified in this guidance, should be referred to the Division of Import Operations (301-796-0356).