### FORM CALC-1. Report on Receipt of Drug - Guide for Reporting Investigational New Animal Drug Shipments for Poikilothermic Food Animals

**[INSTRUCTIONS]{.underline}**

> 1\. Investigator must fill out Form CALC-1
> **[immediately]{.underline}** upon receipt of SE-MARK^®^.
>
> 2\. Investigator should keep the original on file, and send one copy
> to the Study Monitor for review.

3.  Within 10 days of receipt, the Study Monitor should send a copy to
    the AADAP Office.

4.  **[Note:]{.underline}** Both Investigator and Study Monitor should
    sign and date Form CALC-1.

***The sponsor, [U.S. Fish and Wildlife Service]{.underline}, submits a
notice of claimed investigational exemption for the shipment or delivery
of a new animal drug under the provisions of Section 512 of the Federal
Food, Drug, and Cosmetics Act.***

+--------------------------+----------+---------------------+----------+
| Name of Drug             | **SE-M   | INAD Number         | **       |
|                          | ARK^®^** |                     | 10-987** |
+--------------------------+----------+---------------------+----------+
| Proposed Use of Drug     | Marking  |                     |          |
|                          | of       |                     |          |
|                          | c        |                     |          |
|                          | alcified |                     |          |
|                          | st       |                     |          |
|                          | ructures |                     |          |
|                          | i        |                     |          |
|                          | ncluding |                     |          |
|                          | o        |                     |          |
|                          | toliths, |                     |          |
|                          | fin      |                     |          |
|                          | rays,    |                     |          |
|                          | and      |                     |          |
|                          | scales   |                     |          |
+--------------------------+----------+---------------------+----------+
| Date of CVM              | August   |                     |          |
| Authorization Letter     | 28, 2008 |                     |          |
+--------------------------+----------+---------------------+----------+
| **Date of Drug Receipt** |          | **Amount of Drug    |          |
|                          |          | Received**          |          |
+--------------------------+----------+---------------------+----------+
| **Drug Lot Number**      |          | **Study Worksheet   |          |
|                          |          | Number**            |          |
+--------------------------+----------+---------------------+----------+
| **Name of Investigator** |          |                     |          |
+--------------------------+----------+---------------------+----------+
| **Address of             |          |                     |          |
| Investigator**           |          |                     |          |
+--------------------------+----------+---------------------+----------+
| **Location of Trial**    |          |                     |          |
+--------------------------+----------+---------------------+----------+
| Pivotal Study (yes/no)   |          | Non-pivotal Study   |          |
|                          |          | (yes/no)            |          |
+--------------------------+----------+---------------------+----------+
| **Approximate Number of  |          | **Approximate       |          |
| Treated Animals**        |          | Number of Control   |          |
|                          |          | Animals**           |          |
+--------------------------+----------+---------------------+----------+
| **Number of Animals Used |          |                     |          |
| Previously^1^**          |          |                     |          |
+--------------------------+----------+---------------------+----------+
| Study Protocol Number    | 10-987   |                     |          |
+--------------------------+----------+---------------------+----------+
| **Approximate dates of   |          |                     |          |
| trial (start/end)**      |          |                     |          |
+--------------------------+----------+---------------------+----------+
| **Species, Size, and     |          |                     |          |
| Type of Animals**        |          |                     |          |
+--------------------------+----------+---------------------+----------+
| Maximum daily dose and   | 125-250  |                     |          |
| duration                 | mg/L for |                     |          |
|                          | 1-6 hr   |                     |          |
|                          |          |                     |          |
|                          | 2.5-5.0  |                     |          |
|                          | g/L for  |                     |          |
|                          | 1-7 min  |                     |          |
+--------------------------+----------+---------------------+----------+
| Methods(s) of            | I        |                     |          |
| Administration           | mmersion |                     |          |
|                          | (static  |                     |          |
|                          | bath)    |                     |          |
+--------------------------+----------+---------------------+----------+
| Withdrawal Period        | 21 days  |                     |          |
|                          | for all  |                     |          |
|                          | fish     |                     |          |
|                          | species  |                     |          |
+--------------------------+----------+---------------------+----------+

**^1^ To be filled out by the NIO**

  ------------- ----------------- ------------------- ---------------------------
  **Date                          **Investigator:**   
  Prepared:**                                         

  **Date                          **Study Monitor:**  
  Reviewed:**                                         

  **Date                          **Sponsor:**        
  Reviewed:**                                         
  ------------- ----------------- ------------------- ---------------------------