> Appendix 1

+----------------+---------+------------+-----------------------------+
| Person Making  | Is the  | The        | Will the Animal Drug        |
| Submission     | Person  | submission | Sponsor Fee be Assessed?    |
|                | an      |            |                             |
|                | "Animal |            |                             |
|                |         |            |                             |
|                | Drug    |            |                             |
|                | Sp      |            |                             |
|                | onsor?" |            |                             |
+----------------+---------+------------+-----------------------------+
| 1\. The person | Yes     | A          | No. An answer regarding     |
| has approved   |         | d          | jurisdiction is an          |
| NADAs and INAD |         | escription | administrative action and   |
| files          |         | of a       | does not subject an animal  |
|                |         | product    | drug sponsor to a fee.      |
|                |         | under      |                             |
|                |         | d          |                             |
|                |         | evelopment |                             |
|                |         | and a      |                             |
|                |         | question   |                             |
|                |         | whether it |                             |
|                |         | is a new   |                             |
|                |         | animal     |                             |
|                |         | drug       |                             |
|                |         | regulated  |                             |
|                |         | by FDA     |                             |
+----------------+---------+------------+-----------------------------+
|                |         |            |                             |
+----------------+---------+------------+-----------------------------+
| 2\. The person | Yes     | A request  | No. This request for        |
| has one INAD   |         | to         | administrative action is    |
| file           |         | terminate  | not an "investigational     |
|                |         | the INAD   | animal drug submission."    |
|                |         | file that  | After CVM terminates the    |
|                |         | is         | INAD files, the person will |
|                |         | submitted  | no longer be an animal drug |
|                |         | after      | sponsor.                    |
|                |         | Sept. 1,   |                             |
|                |         | 2003       |                             |
+----------------+---------+------------+-----------------------------+
|                |         |            |                             |
+----------------+---------+------------+-----------------------------+
| 3\. The person | Yes     | A request  | No. The request for         |
| has an         |         | to         | administrative action does  |
| approved NADA  |         | terminate  | not trigger assessment of   |
| and an INAD    |         | an INAD    | the animal drug sponsor     |
| file           |         | file is    | fee.                        |
|                |         | submitted  |                             |
|                |         | after      |                             |
|                |         | Sept. 1,   |                             |
|                |         | 2003       |                             |
+----------------+---------+------------+-----------------------------+
|                |         |            |                             |
+----------------+---------+------------+-----------------------------+
| 4\. The person | Yes     | An NADA,   | Yes                         |
| has approved   |         | su         |                             |
| NADAs and/or   |         | pplemental |                             |
| INAD files     |         | NADA, or   |                             |
|                |         | an         |                             |
|                |         | inves      |                             |
|                |         | tigational |                             |
|                |         | animal     |                             |
|                |         | drug       |                             |
|                |         | submission |                             |
|                |         | submitted  |                             |
|                |         | prior to,  |                             |
|                |         | but still  |                             |
|                |         | pending    |                             |
|                |         | after,     |                             |
|                |         | Sept. 1,   |                             |
|                |         | 2003       |                             |
+----------------+---------+------------+-----------------------------+

+----------------+---------+------------+-----------------------------+
| Person Making  | Is the  | The        | Will the Animal Drug        |
| Submission     | Person  | submission | Sponsor Fee be Assessed?    |
|                | an      |            |                             |
|                | "Animal |            |                             |
|                |         |            |                             |
|                | Drug    |            |                             |
|                | Sp      |            |                             |
|                | onsor?" |            |                             |
+----------------+---------+------------+-----------------------------+
| 5\. The person | Yes     | An NADA,   | Yes                         |
| has approved   |         | su         |                             |
| NADAs and/or   |         | pplemental |                             |
| INAD files     |         | NADA, or   |                             |
|                |         | an         |                             |
|                |         | inves      |                             |
|                |         | tigational |                             |
|                |         | animal     |                             |
|                |         | drug       |                             |
|                |         | submission |                             |
|                |         | submitted  |                             |
|                |         | after      |                             |
|                |         | Sept. 1,   |                             |
|                |         | 2003       |                             |
+----------------+---------+------------+-----------------------------+
|                |         |            |                             |
+----------------+---------+------------+-----------------------------+
| 6\. The person | No      | A request  | No. The person is not an    |
| does not have  |         | for a      | animal drug sponsor and the |
| any approved   |         | meeting    | submission does not change  |
| NADAs, does    |         | solely to  | the status.                 |
| not have any   |         | discuss    |                             |
| INAD files,    |         | FDA's      |                             |
| and has not    |         | admi       |                             |
| conducted      |         | nistrative |                             |
| clinical       |         | processes  |                             |
| trials         |         | for        |                             |
|                |         | submitting |                             |
|                |         | inves      |                             |
|                |         | tigational |                             |
|                |         | in         |                             |
|                |         | formation, |                             |
|                |         | an NADA,   |                             |
|                |         | or a       |                             |
|                |         | su         |                             |
|                |         | pplemental |                             |
|                |         | NADA       |                             |
+----------------+---------+------------+-----------------------------+
|                |         |            |                             |
+----------------+---------+------------+-----------------------------+
| 7\. The person | No      | A request  | Yes, when a person requests |
| does not have  |         | for a      | a meeting to discuss        |
| any approved   |         | meeting to | investigational or          |
| NADAs, does    |         | discuss    | submission requirements,    |
| not have any   |         | inves      | they are requesting         |
| INAD files,    |         | tigational | presubmission conference    |
| and has not    |         | or         | and need to provide advance |
| conducted      |         | submission | materials. FDA will         |
| clinical       |         | re         | establish an INAD file for  |
| studies        |         | quirements | these materials and the     |
|                |         |            | person will become an       |
|                |         |            | animal drug sponsor. FDA    |
|                |         |            | reviewers will evaluate     |
|                |         |            | information submitted for   |
|                |         |            | the purpose of enabling FDA |
|                |         |            | to evaluate safety or       |
|                |         |            | effectiveness if a new      |
|                |         |            | animal drug application is  |
|                |         |            | submitted.                  |
+----------------+---------+------------+-----------------------------+

  ---------------- ----------- ----------------- -----------------------------
  Person Making    Is the      The Submission    Will the animal Drug Sponsor
  Submission       Person an                     Fee be Assessed?
                   "Animal                       
                   Drug                          
                   Sponsor?"                     

  8\. The person   No          A Notice of       Yes. When the person files a
  does not have                Claimed           claim for investigational
  any approved                 Investigational   exemption, FDA establishes an
  NADAs and does               Exemption (NCIE)  INAD file and the person
  not have any                 submitted prior   becomes an animal drug
  INAD files                   to shipping new   sponsor subject to an animal
                               animal drug for   drug sponsor fee.
                               clinical tests in 
                               animals and after 
                               Sept. 1, 2003     

                                                 

  9\. The person   Yes (see \# A request for a   No. A request only for
  submitted NCIEs  8)          meeting solely to administrative action will
  and started                  discuss FDA's     not trigger assessment of the
  clinical studies             administrative    animal drug sponsor fee.
  before September             processes for     
  1, 2003, and                 submitting        
  currently has no             investigational   
  submissions                  information, an   
  pending                      NADA; the request 
                               is made after     
                               Sept. 1, 2003     

                                                 
  ---------------- ----------- ----------------- -----------------------------

+----------------+---------+-------------+----------------------------+
| Person Making  | Is the  | The         | Will the Animal Drug       |
| Submission     | Person  | Submission  | Sponsor Fee be Assessed?   |
|                | an      |             |                            |
|                | "Animal |             |                            |
|                | Drug    |             |                            |
|                | Sp      |             |                            |
|                | onsor?" |             |                            |
+----------------+---------+-------------+----------------------------+
| 10\. The       | No      | A request   | Qualified No. If no new    |
| person does    |         | for a       | animal drug is shipped     |
| not have any   |         | meeting to  | from the U.S. to conduct   |
| approved       |         | solely to   | clinical studies, an INAD  |
| NADAs, does    |         | discuss     | has not previously been    |
| not have any   |         | FDA's       | established, and the       |
| INAD files,    |         | adm         | meeting requested is       |
| and has begun  |         | inistrative | solely to discuss          |
| foreign        |         | processes   | administrative processes,  |
| clinical       |         | for         | the person is not an       |
| studies to     |         | submitting  | animal drug sponsor and    |
| support        |         | inve        | does not become a sponsor  |
| approval in    |         | stigational | or subject to a fee by     |
| the U.S.       |         | i           | virtue of the request for  |
|                |         | nformation, | a meeting.                 |
|                |         | and NADA,   |                            |
|                |         | or a        | It is, however,            |
|                |         | s           | recommended that persons   |
|                |         | upplemental | seeking approval of a new  |
|                |         | NADA is     | animal drug in the U.S.    |
|                |         | submitted   | discuss with the FDA the   |
|                |         | after Sept. | applicability of foreign   |
|                |         | 1, 2003     | studies to support U.S.    |
|                |         |             | approval. If a             |
|                |         |             | presubmission conference   |
|                |         |             | is requested to discuss    |
|                |         |             | investigational and        |
|                |         |             | submission requirements,   |
|                |         |             | the request for the        |
|                |         |             | presubmission conference   |
|                |         |             | would trigger assessment   |
|                |         |             | of an animal drug sponsor  |
|                |         |             | fee (see #7).              |
+----------------+---------+-------------+----------------------------+
|                |         |             |                            |
+----------------+---------+-------------+----------------------------+
| 11\. The       | Yes     | An NADA,    | Yes. Because this person   |
| person has     |         | s           | has a submission pending   |
| only one       |         | upplemental | after Sept. 1, 2003, FDA   |
| approved new   |         | NADA, or    | is required to assess an   |
| animal drug    |         | inve        | animal drug sponsor fee.   |
| application    |         | stigational | The animal drug sponsor    |
| for a new      |         | animal drug | may, however, request a    |
| animal drug    |         | submission  | fee waiver or reduction    |
| intended only  |         | for a new   | (see Guidance #170.)       |
| for use in     |         | animal drug |                            |
| minor species  |         | intended    |                            |
|                |         | only for    |                            |
|                |         | use in      |                            |
|                |         | minor       |                            |
|                |         | species is  |                            |
|                |         | pending as  |                            |
|                |         | of, or      |                            |
|                |         | submitted   |                            |
|                |         | after       |                            |
|                |         | 9/1/03.     |                            |
+----------------+---------+-------------+----------------------------+