***SUBMIT IN TRIPLICATE*** (Submit in QUADRUPLICATE if you desire copy
returned to you.)

+-------------------------------+---+---+---------+----+---+---+---+------------+
| **APPLICATION FOR             |   |   |         |    | * |   |   |            |
| AUTHORIZATION TO RELABEL OR   |   |   |         |    | * |   |   |            |
| TO PERFORM OTHER ACTION**     |   |   |         |    | F |   |   |            |
|                               |   |   |         |    | O |   |   |            |
| **OF THE FEDERAL FOOD, DRUG,  |   |   |         |    | R |   |   |            |
| AND COSMETIC ACT AND OTHER    |   |   |         |    | M |   |   |            |
| RELATED ACTS**                |   |   |         |    | A |   |   |            |
|                               |   |   |         |    | P |   |   |            |
|                               |   |   |         |    | P |   |   |            |
|                               |   |   |         |    | R |   |   |            |
|                               |   |   |         |    | O |   |   |            |
|                               |   |   |         |    | V |   |   |            |
|                               |   |   |         |    | E |   |   |            |
|                               |   |   |         |    | D |   |   |            |
|                               |   |   |         |    | : |   |   |            |
|                               |   |   |         |    | O |   |   |            |
|                               |   |   |         |    | M |   |   |            |
|                               |   |   |         |    | B |   |   |            |
|                               |   |   |         |    | N |   |   |            |
|                               |   |   |         |    | o |   |   |            |
|                               |   |   |         |    | . |   |   |            |
|                               |   |   |         |    | 0 |   |   |            |
|                               |   |   |         |    | 9 |   |   |            |
|                               |   |   |         |    | 1 |   |   |            |
|                               |   |   |         |    | 0 |   |   |            |
|                               |   |   |         |    | - |   |   |            |
|                               |   |   |         |    | 0 |   |   |            |
|                               |   |   |         |    | 0 |   |   |            |
|                               |   |   |         |    | 2 |   |   |            |
|                               |   |   |         |    | 5 |   |   |            |
|                               |   |   |         |    | * |   |   |            |
|                               |   |   |         |    | * |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    | * |   |   |            |
|                               |   |   |         |    | * |   |   |            |
|                               |   |   |         |    | E |   |   |            |
|                               |   |   |         |    | X |   |   |            |
|                               |   |   |         |    | P |   |   |            |
|                               |   |   |         |    | I |   |   |            |
|                               |   |   |         |    | R |   |   |            |
|                               |   |   |         |    | A |   |   |            |
|                               |   |   |         |    | T |   |   |            |
|                               |   |   |         |    | I |   |   |            |
|                               |   |   |         |    | O |   |   |            |
|                               |   |   |         |    | N |   |   |            |
|                               |   |   |         |    | D |   |   |            |
|                               |   |   |         |    | A |   |   |            |
|                               |   |   |         |    | T |   |   |            |
|                               |   |   |         |    | E |   |   |            |
|                               |   |   |         |    | : |   |   |            |
|                               |   |   |         |    | 1 |   |   |            |
|                               |   |   |         |    | 2 |   |   |            |
|                               |   |   |         |    | / |   |   |            |
|                               |   |   |         |    | 3 |   |   |            |
|                               |   |   |         |    | 1 |   |   |            |
|                               |   |   |         |    | / |   |   |            |
|                               |   |   |         |    | 0 |   |   |            |
|                               |   |   |         |    | 8 |   |   |            |
|                               |   |   |         |    | * |   |   |            |
|                               |   |   |         |    | * |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| > **Paper work Reduction Act  |   |   |         |    |   |   |   |            |
| > Statement** An agency may   |   |   |         |    |   |   |   |            |
| > not conduct or sponsor, and |   |   |         |    |   |   |   |            |
| > a person is not required to |   |   |         |    |   |   |   |            |
| > respond to, a collection of |   |   |         |    |   |   |   |            |
| > information unless it       |   |   |         |    |   |   |   |            |
| > displays a currently valid  |   |   |         |    |   |   |   |            |
| > OMB control number. Public  |   |   |         |    |   |   |   |            |
| > reporting burden for this   |   |   |         |    |   |   |   |            |
| > collection of information   |   |   |         |    |   |   |   |            |
| > is estimated to average 25  |   |   |         |    |   |   |   |            |
| > hours per response,         |   |   |         |    |   |   |   |            |
| > including time for          |   |   |         |    |   |   |   |            |
| > reviewing instructions,     |   |   |         |    |   |   |   |            |
| > searching existing data     |   |   |         |    |   |   |   |            |
| > sources, gathering and      |   |   |         |    |   |   |   |            |
| > maintaining the necessary   |   |   |         |    |   |   |   |            |
| > data, and completing of     |   |   |         |    |   |   |   |            |
| > review of the collection of |   |   |         |    |   |   |   |            |
| > information. Send comments  |   |   |         |    |   |   |   |            |
| > regarding the burden        |   |   |         |    |   |   |   |            |
| > estimate or any other       |   |   |         |    |   |   |   |            |
| > aspect of this collection   |   |   |         |    |   |   |   |            |
| > of information to:          |   |   |         |    |   |   |   |            |
| >                             |   |   |         |    |   |   |   |            |
| > Department of Health and    |   |   |         |    |   |   |   |            |
| > Human Services\             |   |   |         |    |   |   |   |            |
| > Food and Drug               |   |   |         |    |   |   |   |            |
| > Administration\             |   |   |         |    |   |   |   |            |
| > 15800CrabbsBranchParkway\   |   |   |         |    |   |   |   |            |
| > Rockville, MD 20855-2613    |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| TO: DIRECTOR                  |   |   | DATE    | SA |   |   |   |            |
|                               |   |   |         | MP |   |   |   |            |
| > [     ]{.underline}         |   |   |         | LE |   |   |   |            |
| > District                    |   |   |         | N  |   |   |   |            |
| >                             |   |   |         | O. |   |   |   |            |
| > Food and Drug               |   |   |         |    |   |   |   |            |
| > Administration              |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
| Application is hereby made    |   |   |         |    |   |   |   |            |
| for authorization to bring    |   |   |         |    |   |   |   |            |
| the merchandise Below into    |   |   |         |    |   |   |   |            |
| compliance with the Act.      |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
|                               |   |   | PRODUCT |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
|                               |   |   | ENTRY   |    |   |   | E |            |
|                               |   |   | NO.     |    |   |   | N |            |
|                               |   |   |         |    |   |   | T |            |
|                               |   |   |         |    |   |   | R |            |
|                               |   |   |         |    |   |   | Y |            |
|                               |   |   |         |    |   |   | D |            |
|                               |   |   |         |    |   |   | A |            |
|                               |   |   |         |    |   |   | T |            |
|                               |   |   |         |    |   |   | E |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| CARRIER                       | A |   |         |    |   |   |   |            |
|                               | M |   |         |    |   |   |   |            |
|                               | O |   |         |    |   |   |   |            |
|                               | U |   |         |    |   |   |   |            |
|                               | N |   |         |    |   |   |   |            |
|                               | T |   |         |    |   |   |   |            |
|                               | A |   |         |    |   |   |   |            |
|                               | N |   |         |    |   |   |   |            |
|                               | D |   |         |    |   |   |   |            |
|                               | M |   |         |    |   |   |   |            |
|                               | A |   |         |    |   |   |   |            |
|                               | R |   |         |    |   |   |   |            |
|                               | K |   |         |    |   |   |   |            |
|                               | S |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| Redelivery bond has been      |   |   |         |    |   |   |   |            |
| posted by the applicant. The  |   |   |         |    |   |   |   |            |
| merchandise will be kept      |   |   |         |    |   |   |   |            |
| apart from all other          |   |   |         |    |   |   |   |            |
| merchandise and will be       |   |   |         |    |   |   |   |            |
| available for inspection at   |   |   |         |    |   |   |   |            |
| all reasonable times. The     |   |   |         |    |   |   |   |            |
| operations, if authorized,    |   |   |         |    |   |   |   |            |
| will be carried out at:       |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
| [     ]{.underline} and will  |   |   |         |    |   |   |   |            |
| require                       |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
| about [   ]{.underline} days  |   |   |         |    |   |   |   |            |
| to complete. A detailed       |   |   |         |    |   |   |   |            |
| description of the method by  |   |   |         |    |   |   |   |            |
| which the merchandise will be |   |   |         |    |   |   |   |            |
| brought into compliance is    |   |   |         |    |   |   |   |            |
| given in the space below:     |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| We will pay all supervisory   |   |   |         |    |   |   |   |            |
| costs in accordance with      |   |   |         |    |   |   |   |            |
| current regulations.          |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| FIRM NAME                     |   | A |         |    |   |   |   |            |
|                               |   | D |         |    |   |   |   |            |
|                               |   | D |         |    |   |   |   |            |
|                               |   | R |         |    |   |   |   |            |
|                               |   | E |         |    |   |   |   |            |
|                               |   | S |         |    |   |   |   |            |
|                               |   | S |         |    |   |   |   |            |
|                               |   | O |         |    |   |   |   |            |
|                               |   | F |         |    |   |   |   |            |
|                               |   | F |         |    |   |   |   |            |
|                               |   | I |         |    |   |   |   |            |
|                               |   | R |         |    |   |   |   |            |
|                               |   | M |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| APPLICANT\'S SIGNATURE        |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| **ACTION ON APPLICATION**     |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| TO: *(Name and Address)*      |   |   |         |    |   | D |   |            |
|                               |   |   |         |    |   | A |   |            |
|                               |   |   |         |    |   | T |   |            |
|                               |   |   |         |    |   | E |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| Your application has been:    |   |   |         |    |   |   |   |            |
| Denied because:               |   |   |         |    |   |   |   |            |
| Approved with the following   |   |   |         |    |   |   |   |            |
| conditions:\                  |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| Time limit within which to    |   |   |         |    |   |   |   |            |
| complete authorized           |   |   |         |    |   |   |   |            |
| operations:                   |   |   |         |    |   |   |   |            |
| [     ]{.underline}\          |   |   |         |    |   |   |   |            |
| When the authorized           |   |   |         |    |   |   |   |            |
| operations are completed,     |   |   |         |    |   |   |   |            |
| fill in the importer\'s       |   |   |         |    |   |   |   |            |
| certificate on the reverse    |   |   |         |    |   |   |   |            |
| side and return this notice   |   |   |         |    |   |   |   |            |
| to this office.               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+
| SIGNATURE OF DISTRICT         | D |   |         |    |   |   |   | DATE       |
| DIRECTOR                      | I |   |         |    |   |   |   |            |
|                               | S |   |         |    |   |   |   |            |
|                               | T |   |         |    |   |   |   |            |
|                               | R |   |         |    |   |   |   |            |
|                               | I |   |         |    |   |   |   |            |
|                               | C |   |         |    |   |   |   |            |
|                               | T |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
|                               |   |   |         |    |   |   |   |            |
+-------------------------------+---+---+---------+----+---+---+---+------------+

**FORM FDA 766 (12/04)** *(See Back)* **FRONT**

PSC Media Arts (301)443-1090 EF

+-----------------------------+-----------------------+---------------+
| **IMPORTER\'S CERTIFICATE** |                       |               |
+-----------------------------+-----------------------+---------------+
| PLACE                       |                       | DATE          |
|                             |                       |               |
|                             |                       |               |
+-----------------------------+-----------------------+---------------+
| I certify that the work to  |                       |               |
| be performed under the      |                       |               |
| authorization has been      |                       |               |
| completed and the goods are |                       |               |
| now ready for inspection    |                       |               |
| at:                         |                       |               |
+-----------------------------+-----------------------+---------------+
| The rejected portion is     |                       |               |
| ready for destruction under |                       |               |
| Customs\' supervision and   |                       |               |
| is held at:                 |                       |               |
+-----------------------------+-----------------------+---------------+
| TYPED NAME OF APPLICANT     | SIGNATURE             |               |
|                             |                       |               |
|                             |                       |               |
+-----------------------------+-----------------------+---------------+
| **REPORT OF INVESTIGATOR /  |                       |               |
| INSPECTOR**                 |                       |               |
+-----------------------------+-----------------------+---------------+
| TO                          |                       | DATE          |
|                             |                       |               |
| > PORT DIRECTOR OR DISTRICT |                       |               |
| > DIRECTOR                  |                       |               |
+-----------------------------+-----------------------+---------------+
| I have examined the         |                       |               |
| within-described goods and  |                       |               |
| find them to be the         |                       |               |
| identical goods described   |                       |               |
| herein, and that they have  |                       |               |
| been: [     ]{.underline}   |                       |               |
| on: [     ]{.underline} ,   |                       |               |
| 20 [  ]{.underline} ,       |                       |               |
|                             |                       |               |
| as authorized, except:      |                       |               |
|                             |                       |               |
+-----------------------------+-----------------------+---------------+
| **DATA ON CLEANED GOODS**   |                       |               |
+-----------------------------+-----------------------+---------------+
| Good Portion:               |                       |               |
+-----------------------------+-----------------------+---------------+
| Rejections:                 |                       |               |
+-----------------------------+-----------------------+---------------+
| Loss (if any)               |                       |               |
+-----------------------------+-----------------------+---------------+
| Did importer clean          |                       |               |
|                             |                       |               |
| entire shipment?            |                       |               |
+-----------------------------+-----------------------+---------------+
| Time and cost of            |                       |               |
|                             |                       |               |
| supervision                 |                       |               |
+-----------------------------+-----------------------+---------------+
| INSPECTING OFFICER          |                       | DATE          |
|                             |                       |               |
|                             |                       |               |
+-----------------------------+-----------------------+---------------+
| **DIRECTOR OF DISTRICT**    |                       |               |
+-----------------------------+-----------------------+---------------+
| > Disposed of as noted      |                       |               |
| > above.                    |                       |               |
+-----------------------------+-----------------------+---------------+
| DIRECTOR OF CUSTOMS         |                       | DATE          |
|                             |                       |               |
|                             |                       |               |
+-----------------------------+-----------------------+---------------+

**FORM FDA 766 (12/04) BACK\
**