To provide uniform guidance concerning supervisory charges in connection with the reconditioning of imported merchandise under an "APPLICATION FOR AUTHORIZATION TO RELABEL OR TO PERFORM OTHER ACTION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND OTHER RELATED ACTS" Form FDA-766.
The statements in this subchapter are intended only to provide operating guidance for FDA personnel and are not intended to bind FDA or to create or confer any obligations, rights, privileges, or benefits on or for any private person.
Section 801(c) of the Federal Food, Drug, and Cosmetic Act (Act) requires the owner or consigner of imported merchandise to pay for all expenses, including travel, per diem or subsistence, and salaries of officers or employees of the United States in connection with the supervision of the relabeling or other action necessary to bring the merchandise into compliance with the Act. The amount of such expenses is determined by regulation (see 21 CFR 1.99).
In 1985, CBP financial management consolidated all billing operations for FDA supervisory charges at their Accounting Services Division (ASD) in Indianapolis, Indiana. Payments of FDA's supervisory charges are deposited into the U.S. Treasury Miscellaneous Receipts account.
In submitting a Form FDA-766, (or other form of application) for authorization to relabel or perform other action to bring an article into compliance with the Act (see 21 CFR 1.95), the applicant agrees to pay for all supervisory costs in accordance with current regulations. 21 CFR 1.99 provides that such costs shall include, but not be restricted to, the following:
- Travel expenses of the FDA supervisory officer. If travel is by government vehicle, this charge includes the current mileage rate plus toll charges. If travel is by public transportation, the charge is for the actual cost of such travel.
- Per diem in lieu of subsistence of the FDA supervising officer when away from his or her home station, as provided by current regulations.
- Services of the FDA supervising officer, calculated at the current rate as given by Regulation (21 CFR 1.99). This rate includes charges for administrative support, travel, and clerical time, therefore, separate charges will not be assessed for those services.
- Services of the FDA analyst, calculated at the current rate as given by Regulation (21 CFR 1.99). This rate includes the use of the FDA laboratories and equipment.
The minimum charge for services of supervising offices and analysts shall not be less than the charge for one (1) hour. Time after the first hour shall be computed in multiples of one (1) hour, rounding down for fractional parts less than 1/2 hour. For example, if the supervisory time is one hour and 20 minutes, charges for one hour should be assessed; if the time is greater than one hour and 30 minutes, charges for two (2) hours should be made. See Exhibit 9-2 Form FDA-766.
PREPARATION AND SUBMISSION OF CHARGE SHEET
Future enhancements to OASIS may result in electronic processing of the supervisory charge-sheet (with appropriate identification and accounting information)- for districts to use when submitting their charges to the CBP Accounting Services Division. Until this OASIS enhancement is operational, districts should continue to use Form FD-790 (Exhibit 9-12).
Charges should be assessed on these forms only after reconditioning of the merchandise is completed. They should be filled out and submitted at the same time FDA issues the Notice of Release and/or the Notice of Refusal of Admission (if reconditioning is not successful, or if the reject portion of the reconditioned product is to be re-exported under CBP supervision. In addition to the information identified above for supervisory charges, the form must also include the CBP Entry Number and date of Entry, name of the Importer of Record, name of the vessel, product description, name of the consignee (if different from the importer of record, FDA sample number (if applicable), and FDA district office address.
If using form FD-790, submit the original and 2 copies along with a copy of the Notice of Release and/or Notice of Refusal for each sample covered by the bill to:
U.S. Customs and Border Protection
Revenue Division - Reimbursable Team
6650 Telecom Drive Suite 100
Indianapolis, IN 46278
Maintain a copy in the FDA district file. By including a copy of the FDA Notice of Release and/or Refusal, there should be no problem identifying the exact entry and samples being covered by the bill. DO NOT send a copy directly to the applicant. It is the responsibility of CBP to contact the applicant to obtain payment of the bill. CBP will also add on any expenses incurred by their personnel in connection with an entry.
PAYMENT OF SUPERVISORY CHARGES
CBP will instruct the applicant to send payment to the CBP, Revenue Division, not the local FDA office. If the applicant sends payment to FDA, the district office should return the payment to the organization or importer by registered mail with instructions to submit the payment to CBP at the above address.
FDA is not routinely notified by CBP when payment is received. If the applicant refuses to make payment, CBP will take appropriate action against the importer's bond or place a lien against the importer's future importations.