+----------------------+---+-----------+---+---------+---+-------------------+
| DEPARTMENT OF HEALTH | # |           |   |         |   | Form Approved:    |
| AND HUMAN SERVICES   | # |           |   |         |   | OMB No. 0910-0032 |
| FOOD AND DRUG        | # |           |   |         |   |                   |
| ADMINISTRATION       |   |           |   |         |   | Expiration Date:  |
|                      | N |           |   |         |   | December 31, 2007 |
|                      | E |           |   |         |   |                   |
|                      | W |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      | A |           |   |         |   |                   |
|                      | N |           |   |         |   |                   |
|                      | I |           |   |         |   |                   |
|                      | M |           |   |         |   |                   |
|                      | A |           |   |         |   |                   |
|                      | L |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      | D |           |   |         |   |                   |
|                      | R |           |   |         |   |                   |
|                      | U |           |   |         |   |                   |
|                      | G |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      | A |           |   |         |   |                   |
|                      | P |           |   |         |   |                   |
|                      | P |           |   |         |   |                   |
|                      | L |           |   |         |   |                   |
|                      | I |           |   |         |   |                   |
|                      | C |           |   |         |   |                   |
|                      | A |           |   |         |   |                   |
|                      | T |           |   |         |   |                   |
|                      | I |           |   |         |   |                   |
|                      | O |           |   |         |   |                   |
|                      | N |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      | ( |           |   |         |   |                   |
|                      | D |           |   |         |   |                   |
|                      | r |           |   |         |   |                   |
|                      | u |           |   |         |   |                   |
|                      | g |           |   |         |   |                   |
|                      | s |           |   |         |   |                   |
|                      | f |           |   |         |   |                   |
|                      | o |           |   |         |   |                   |
|                      | r |           |   |         |   |                   |
|                      | A |           |   |         |   |                   |
|                      | n |           |   |         |   |                   |
|                      | i |           |   |         |   |                   |
|                      | m |           |   |         |   |                   |
|                      | a |           |   |         |   |                   |
|                      | l |           |   |         |   |                   |
|                      | U |           |   |         |   |                   |
|                      | s |           |   |         |   |                   |
|                      | e |           |   |         |   |                   |
|                      | ) |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      | ( |           |   |         |   |                   |
|                      | T |           |   |         |   |                   |
|                      | i |           |   |         |   |                   |
|                      | t |           |   |         |   |                   |
|                      | l |           |   |         |   |                   |
|                      | e |           |   |         |   |                   |
|                      | 2 |           |   |         |   |                   |
|                      | 1 |           |   |         |   |                   |
|                      | , |           |   |         |   |                   |
|                      | C |           |   |         |   |                   |
|                      | F |           |   |         |   |                   |
|                      | R |           |   |         |   |                   |
|                      | 5 |           |   |         |   |                   |
|                      | 1 |           |   |         |   |                   |
|                      | 4 |           |   |         |   |                   |
|                      | ) |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
|                      |   |           |   |         |   | #### NADA         |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   | +--------------+  |
|                      |   |           |   |         |   | | ####         |  |
|                      |   |           |   |         |   | +--------------+  |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   | ####              |
+----------------------+---+-----------+---+---------+---+-------------------+
| # DRUG PRODUCT       |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| # ESTABLISHED NA     |   |           | # |         |   |                   |
| ME *(e.g. USP/USAN)* |   |           |   |         |   |                   |
|                      |   |           | P |         |   |                   |
|                      |   |           | R |         |   |                   |
|                      |   |           | O |         |   |                   |
|                      |   |           | P |         |   |                   |
|                      |   |           | R |         |   |                   |
|                      |   |           | I |         |   |                   |
|                      |   |           | E |         |   |                   |
|                      |   |           | T |         |   |                   |
|                      |   |           | A |         |   |                   |
|                      |   |           | R |         |   |                   |
|                      |   |           | Y |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           | N |         |   |                   |
|                      |   |           | A |         |   |                   |
|                      |   |           | M |         |   |                   |
|                      |   |           | E |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| # DOSAGE FORM        |   | # P       |   |         | # |                   |
|                      |   | ROPOSED I |   |         |   |                   |
|                      |   | NDICATION |   |         | S |                   |
|                      |   | S FOR USE |   |         | P |                   |
|                      |   |           |   |         | E |                   |
|                      |   |           |   |         | C |                   |
|                      |   |           |   |         | I |                   |
|                      |   |           |   |         | E |                   |
|                      |   |           |   |         | S |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| PROPOSED MARKETING   |   |           |   |         |   |                   |
| STATUS *(Check       |   |           |   |         |   |                   |
| one):* PRESCRIPTION  |   |           |   |         |   |                   |
| PRODUCT (Rx)         |   |           |   |         |   |                   |
| OVER-THE-COUNTER     |   |           |   |         |   |                   |
| PRODUCT (OTC)        |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| # NAME OF APPLICANT  |   |           | # |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           | A |         |   |                   |
|                      |   |           | D |         |   |                   |
|                      |   |           | D |         |   |                   |
|                      |   |           | R |         |   |                   |
|                      |   |           | E |         |   |                   |
|                      |   |           | S |         |   |                   |
|                      |   |           | S |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           | ( |         |   |                   |
|                      |   |           | S |         |   |                   |
|                      |   |           | t |         |   |                   |
|                      |   |           | r |         |   |                   |
|                      |   |           | e |         |   |                   |
|                      |   |           | e |         |   |                   |
|                      |   |           | t |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           | N |         |   |                   |
|                      |   |           | u |         |   |                   |
|                      |   |           | m |         |   |                   |
|                      |   |           | b |         |   |                   |
|                      |   |           | e |         |   |                   |
|                      |   |           | r |         |   |                   |
|                      |   |           | , |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           | C |         |   |                   |
|                      |   |           | i |         |   |                   |
|                      |   |           | t |         |   |                   |
|                      |   |           | y |         |   |                   |
|                      |   |           | , |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           | a |         |   |                   |
|                      |   |           | n |         |   |                   |
|                      |   |           | d |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           | Z |         |   |                   |
|                      |   |           | I |         |   |                   |
|                      |   |           | P |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           | C |         |   |                   |
|                      |   |           | o |         |   |                   |
|                      |   |           | d |         |   |                   |
|                      |   |           | e |         |   |                   |
|                      |   |           | ) |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| **NOTE:** No         |   |           |   |         |   |                   |
| application may be   |   |           |   |         |   |                   |
| filed unless a       |   |           |   |         |   |                   |
| completed            |   |           |   |         |   |                   |
| application form has |   |           |   |         |   |                   |
| been received.       |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| ORIGINAL APPLICATION |   |           |   |         |   |                   |
| (21 CFR 514.1(a))    |   |           |   |         |   |                   |
| SUPPLEMENT TO AN     |   |           |   |         |   |                   |
| APPROVED APPLICATION |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| *(21 CFR 514.8(a))*  |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| ABBREVIATED ORIGINAL |   |           |   |         |   |                   |
| APPLICATION          |   |           |   |         |   |                   |
| AMENDMENT TO AN      |   |           |   |         |   |                   |
| UNAPPROVED           |   |           |   |         |   |                   |
| SUPPLEMENT           |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| TO AN APPROVED       |   |           |   |         |   |                   |
| APPLICATION *(21 CFR |   |           |   |         |   |                   |
| 514.6)*              |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| AMENDMENT TO AN      |   |           |   |         |   |                   |
| UNAPPROVED ORIGINAL  |   |           |   |         |   |                   |
| SPECIAL SUPPLEMENT   |   |           |   |         |   |                   |
| TO AN APPROVED       |   |           |   |         |   |                   |
| APPLICATION          |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| APPLICATION *(21 CFR |   |           |   |         |   |                   |
| 514.6)* \-- CHANGES  |   |           |   |         |   |                   |
| BEING EFFECTED *(21  |   |           |   |         |   |                   |
| CFR 514.8(e))*       |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| REASON FOR           |   |           |   |         |   |                   |
| SUBMISSION:          |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
|                      |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| # Paperwork Red      |   |           |   |         |   |                   |
| uction Act Statement |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| > A federal 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        |   |           |   |         |   |                   |
| > averages 242.6     |   |           |   |         |   |                   |
| > hours per          |   |           |   |         |   |                   |
| > response,          |   |           |   |         |   |                   |
| > including time for |   |           |   |         |   |                   |
| > reviewing          |   |           |   |         |   |                   |
| > instructions,      |   |           |   |         |   |                   |
| > searching existing |   |           |   |         |   |                   |
| > data sources,      |   |           |   |         |   |                   |
| > gathering and      |   |           |   |         |   |                   |
| > maintaining the    |   |           |   |         |   |                   |
| > necessary data,    |   |           |   |         |   |                   |
| > and completing and |   |           |   |         |   |                   |
| > reviewing the      |   |           |   |         |   |                   |
| > collection of      |   |           |   |         |   |                   |
| > information. Send  |   |           |   |         |   |                   |
| > comments regarding |   |           |   |         |   |                   |
| > the burden         |   |           |   |         |   |                   |
| > estimate or any    |   |           |   |         |   |                   |
| > other aspect of    |   |           |   |         |   |                   |
| > this collection of |   |           |   |         |   |                   |
| > information to:    |   |           |   |         |   |                   |
| > Food and Drug      |   |           |   |         |   |                   |
| > Administration     |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| Center for           |   |           |   |         |   |                   |
| Veterinary Medicine  |   |           |   |         |   |                   |
| (HFV-12)             |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| Attn.: Assistant     |   |           |   |         |   |                   |
| Records Control      |   |           |   |         |   |                   |
| Officer              |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| 7500 Standish Place  |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| Rockville, MD 20855  |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| INSTRUCTIONS FOR     |   |           |   |         |   |                   |
| PREPARING AND        |   |           |   |         |   |                   |
| SUBMITTING THE NEW   |   |           |   |         |   |                   |
| ANIMAL DRUG          |   |           |   |         |   |                   |
| APPLICATION          |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
| i.  Prepare three    |   |           |   | viii\.  |   |                   |
|     identical copies |   |           |   | Prepare |   |                   |
|     of the           |   |           |   | amen    |   |                   |
|     submission.      |   |           |   | dments, |   |                   |
|                      |   |           |   | suppl   |   |                   |
| ii. Identify front   |   |           |   | ements, |   |                   |
|     cover of each    |   |           |   | reports |   |                   |
|     copy with the    |   |           |   | and     |   |                   |
|     name of the      |   |           |   | other   |   |                   |
|     applicant, the   |   |           |   | corresp |   |                   |
|     proprietary name |   |           |   | ondence |   |                   |
|     (if available),  |   |           |   | in the  |   |                   |
|     the name of the  |   |           |   | above   |   |                   |
|     new animal drug  |   |           |   | format. |   |                   |
|     and the dosage   |   |           |   | I       |   |                   |
|     form.            |   |           |   | dentify |   |                   |
|                      |   |           |   | the     |   |                   |
| iii. Use separate    |   |           |   | sub     |   |                   |
|      pages for each  |   |           |   | mission |   |                   |
|      numbered        |   |           |   | with    |   |                   |
|      heading         |   |           |   | the     |   |                   |
|      consistent with |   |           |   | a       |   |                   |
|      the             |   |           |   | ssigned |   |                   |
|      sub-paragraphs  |   |           |   | NADA    |   |                   |
|      of this         |   |           |   | number. |   |                   |
|      application     |   |           |   |         |   |                   |
|      form. (See      |   |           |   | ix\. If |   |                   |
|      reverse side of |   |           |   | the     |   |                   |
|      this page).     |   |           |   | sub     |   |                   |
|                      |   |           |   | mission |   |                   |
| iv\. Number the      |   |           |   | is a    |   |                   |
| pages of the new     |   |           |   | suppl   |   |                   |
| animal drug          |   |           |   | emental |   |                   |
| application. Each    |   |           |   | appli   |   |                   |
| copy should bear the |   |           |   | cation, |   |                   |
| same page numbering. |   |           |   | full    |   |                   |
|                      |   |           |   | info    |   |                   |
| v\. Submit separate  |   |           |   | rmation |   |                   |
| applications for     |   |           |   | shall   |   |                   |
| each different       |   |           |   | be      |   |                   |
| dosage form of the   |   |           |   | p       |   |                   |
| proposed drug.       |   |           |   | rovided |   |                   |
|                      |   |           |   | on each |   |                   |
| vi\. Basic           |   |           |   | p       |   |                   |
| information          |   |           |   | roposed |   |                   |
| pertinent to a       |   |           |   | change  |   |                   |
| dosage form should   |   |           |   | con     |   |                   |
| be made by reference |   |           |   | cerning |   |                   |
| to volume and page   |   |           |   | any     |   |                   |
| of the application   |   |           |   | st      |   |                   |
| containing such      |   |           |   | atement |   |                   |
| information. Include |   |           |   | made in |   |                   |
| in each application  |   |           |   | the     |   |                   |
| information          |   |           |   | a       |   |                   |
| applicable to the    |   |           |   | pproved |   |                   |
| specific dosage      |   |           |   | appli   |   |                   |
| form, such as,       |   |           |   | cation. |   |                   |
| labeling,            |   |           |   |         |   |                   |
| composition,         |   |           |   | x\.     |   |                   |
| stability data,      |   |           |   | Submit  |   |                   |
| efficacy data,       |   |           |   | page 1  |   |                   |
| method of            |   |           |   | and 2   |   |                   |
| manufacture and      |   |           |   | of this |   |                   |
| references to        |   |           |   | form    |   |                   |
| appropriate          |   |           |   | with    |   |                   |
| investigational new  |   |           |   | each    |   |                   |
| animal drug          |   |           |   | subm    |   |                   |
| applications and     |   |           |   | ission. |   |                   |
| master file(s).      |   |           |   |         |   |                   |
|                      |   |           |   |         |   |                   |
| vii\. Submit         |   |           |   |         |   |                   |
| applications to:     |   |           |   |         |   |                   |
| Food and Drug        |   |           |   |         |   |                   |
| Administration\      |   |           |   |         |   |                   |
| Center for           |   |           |   |         |   |                   |
| Veterinary Medicine  |   |           |   |         |   |                   |
| (HFV-199)\           |   |           |   |         |   |                   |
| 7500 Standish Place\ |   |           |   |         |   |                   |
| Rockville, MD 20855  |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
|                      |   |           |   | #       |   |                   |
|                      |   |           |   | #### FO |   |                   |
|                      |   |           |   | R FDA U |   |                   |
|                      |   |           |   | SE ONLY |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+
|                      |   |           |   |         |   |                   |
+----------------------+---+-----------+---+---------+---+-------------------+

+-----------+---+-------------------+---+--------------------+---+-----------+
| > The     |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| following |   |                   |   |                    |   |           |
| > in      |   |                   |   |                    |   |           |
| formation |   |                   |   |                    |   |           |
| > in the  |   |                   |   |                    |   |           |
| > cited   |   |                   |   |                    |   |           |
| > section |   |                   |   |                    |   |           |
| > of 21   |   |                   |   |                    |   |           |
| > CFR 514 |   |                   |   |                    |   |           |
| > shall   |   |                   |   |                    |   |           |
| > c       |   |                   |   |                    |   |           |
| onstitute |   |                   |   |                    |   |           |
| > the     |   |                   |   |                    |   |           |
| > req     |   |                   |   |                    |   |           |
| uirements |   |                   |   |                    |   |           |
| > of this |   |                   |   |                    |   |           |
| > app     |   |                   |   |                    |   |           |
| lication. |   |                   |   |                    |   |           |
| > Please  |   |                   |   |                    |   |           |
| > check   |   |                   |   |                    |   |           |
| > the     |   |                   |   |                    |   |           |
| > in      |   |                   |   |                    |   |           |
| formation |   |                   |   |                    |   |           |
| > s       |   |                   |   |                    |   |           |
| ubmitted. |   |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
|           |   | > **NOTE:** 1. An |   |                    |   |           |
|           |   | > original        |   |                    |   |           |
|           |   | > application     |   |                    |   |           |
|           |   | > shall include   |   |                    |   |           |
|           |   | > all of the      |   |                    |   |           |
|           |   | > following       |   |                    |   |           |
|           |   | > sections.       |   |                    |   |           |
|           |   | >                 |   |                    |   |           |
|           |   | > 2\. A           |   |                    |   |           |
|           |   | > supplement or   |   |                    |   |           |
|           |   | > amendment shall |   |                    |   |           |
|           |   | > include only    |   |                    |   |           |
|           |   | > those sections  |   |                    |   |           |
|           |   | > necessary.      |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
| **1.      |   |                   |   |                    |   |           |
| IDENTIF   |   |                   |   |                    |   |           |
| ICATION** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 51        |   |                   |   |                    |   |           |
| 4.1(b)(1) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **2.      |   |                   |   |                    |   |           |
| TABLE OF  |   |                   |   |                    |   |           |
| CONTENTS  |   |                   |   |                    |   |           |
| AND       |   |                   |   |                    |   |           |
| SUMMARY** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 51        |   |                   |   |                    |   |           |
| 4.1(b)(2) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| A table   |   |                   |   |                    |   |           |
| of        |   |                   |   |                    |   |           |
| contents  |   |                   |   |                    |   |           |
| and       |   |                   |   |                    |   |           |
| summary   |   |                   |   |                    |   |           |
| of        |   |                   |   |                    |   |           |
| in        |   |                   |   |                    |   |           |
| formation |   |                   |   |                    |   |           |
| to        |   |                   |   |                    |   |           |
| describe  |   |                   |   |                    |   |           |
| the       |   |                   |   |                    |   |           |
| chemistry |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| proposed  |   |                   |   |                    |   |           |
| drug and  |   |                   |   |                    |   |           |
| product,  |   |                   |   |                    |   |           |
| the       |   |                   |   |                    |   |           |
| clinical  |   |                   |   |                    |   |           |
| purpose   |   |                   |   |                    |   |           |
| and a     |   |                   |   |                    |   |           |
| summary   |   |                   |   |                    |   |           |
| of        |   |                   |   |                    |   |           |
| l         |   |                   |   |                    |   |           |
| aboratory |   |                   |   |                    |   |           |
| and       |   |                   |   |                    |   |           |
| clinical  |   |                   |   |                    |   |           |
| studies.  |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| 3.        |   |                   |   |                    |   |           |
| **L       |   |                   |   |                    |   |           |
| ABELING** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 51        |   |                   |   |                    |   |           |
| 4.1(b)(3) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| Copies of |   |                   |   |                    |   |           |
| each      |   |                   |   |                    |   |           |
| proposed  |   |                   |   |                    |   |           |
| label.    |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **4.      |   |                   |   |                    |   |           |
| C         |   |                   |   |                    |   |           |
| OMPONENTS |   |                   |   |                    |   |           |
| AND       |   |                   |   |                    |   |           |
| COMP      |   |                   |   |                    |   |           |
| OSITION** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 51        |   |                   |   |                    |   |           |
| 4.1(b)(4) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| A list of |   |                   |   |                    |   |           |
| all       |   |                   |   |                    |   |           |
| articles  |   |                   |   |                    |   |           |
| used as   |   |                   |   |                    |   |           |
| c         |   |                   |   |                    |   |           |
| omponents |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| drug      |   |                   |   |                    |   |           |
| product.  |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| A         |   |                   |   |                    |   |           |
| statement |   |                   |   |                    |   |           |
| of        |   |                   |   |                    |   |           |
| co        |   |                   |   |                    |   |           |
| mposition |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| drug      |   |                   |   |                    |   |           |
| product.  |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| A         |   |                   |   |                    |   |           |
| complete  |   |                   |   |                    |   |           |
| de        |   |                   |   |                    |   |           |
| scription |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| fer       |   |                   |   |                    |   |           |
| mentation |   |                   |   |                    |   |           |
| of        |   |                   |   |                    |   |           |
| a         |   |                   |   |                    |   |           |
| ntibiotic |   |                   |   |                    |   |           |
| drug      |   |                   |   |                    |   |           |
| su        |   |                   |   |                    |   |           |
| bstances. |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **5.      |   |                   |   |                    |   |           |
| MANU      |   |                   |   |                    |   |           |
| FACTURING |   |                   |   |                    |   |           |
| METHODS,  |   |                   |   |                    |   |           |
| FA        |   |                   |   |                    |   |           |
| CILITIES, |   |                   |   |                    |   |           |
| AND       |   |                   |   |                    |   |           |
| C         |   |                   |   |                    |   |           |
| ONTROLS** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 51        |   |                   |   |                    |   |           |
| 4.1(b)(5) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| A         |   |                   |   |                    |   |           |
| detailed  |   |                   |   |                    |   |           |
| de        |   |                   |   |                    |   |           |
| scription |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| manu      |   |                   |   |                    |   |           |
| facturer, |   |                   |   |                    |   |           |
| p         |   |                   |   |                    |   |           |
| ersonnel, |   |                   |   |                    |   |           |
| fac       |   |                   |   |                    |   |           |
| ilities/e |   |                   |   |                    |   |           |
| quipment, |   |                   |   |                    |   |           |
| new       |   |                   |   |                    |   |           |
| animal    |   |                   |   |                    |   |           |
| drug      |   |                   |   |                    |   |           |
| substance |   |                   |   |                    |   |           |
| s         |   |                   |   |                    |   |           |
| ynthesis, |   |                   |   |                    |   |           |
| raw       |   |                   |   |                    |   |           |
| material  |   |                   |   |                    |   |           |
| controls  |   |                   |   |                    |   |           |
| (specif   |   |                   |   |                    |   |           |
| ications, |   |                   |   |                    |   |           |
| tests and |   |                   |   |                    |   |           |
| methods), |   |                   |   |                    |   |           |
| manu      |   |                   |   |                    |   |           |
| facturing |   |                   |   |                    |   |           |
| inst      |   |                   |   |                    |   |           |
| ructions, |   |                   |   |                    |   |           |
| finished  |   |                   |   |                    |   |           |
| product   |   |                   |   |                    |   |           |
| a         |   |                   |   |                    |   |           |
| nalytical |   |                   |   |                    |   |           |
| controls  |   |                   |   |                    |   |           |
| (specif   |   |                   |   |                    |   |           |
| ications, |   |                   |   |                    |   |           |
| tests and |   |                   |   |                    |   |           |
| methods), |   |                   |   |                    |   |           |
| stability |   |                   |   |                    |   |           |
| program,  |   |                   |   |                    |   |           |
| co        |   |                   |   |                    |   |           |
| ntainer/p |   |                   |   |                    |   |           |
| ackaging, |   |                   |   |                    |   |           |
| and lot   |   |                   |   |                    |   |           |
| control   |   |                   |   |                    |   |           |
| number    |   |                   |   |                    |   |           |
| system.   |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **6.      |   |                   |   |                    |   |           |
| SAMPLES** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 51        |   |                   |   |                    |   |           |
| 4.1(b)(6) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| Samples   |   |                   |   |                    |   |           |
| to be     |   |                   |   |                    |   |           |
| submitted |   |                   |   |                    |   |           |
| only upon |   |                   |   |                    |   |           |
| the       |   |                   |   |                    |   |           |
| Center's  |   |                   |   |                    |   |           |
| request.  |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **7.      |   |                   |   |                    |   |           |
| A         |   |                   |   |                    |   |           |
| NALYTICAL |   |                   |   |                    |   |           |
| METHODS   |   |                   |   |                    |   |           |
| FOR       |   |                   |   |                    |   |           |
| R         |   |                   |   |                    |   |           |
| ESIDUES** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 51        |   |                   |   |                    |   |           |
| 4.1(b)(7) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| Method(s) |   |                   |   |                    |   |           |
| and data  |   |                   |   |                    |   |           |
| to enable |   |                   |   |                    |   |           |
| dete      |   |                   |   |                    |   |           |
| rmination |   |                   |   |                    |   |           |
| of        |   |                   |   |                    |   |           |
| residues  |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| drug in   |   |                   |   |                    |   |           |
| food-     |   |                   |   |                    |   |           |
| producing |   |                   |   |                    |   |           |
| animals.  |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **8.      |   |                   |   |                    |   |           |
| EVIDENCE  |   |                   |   |                    |   |           |
| TO        |   |                   |   |                    |   |           |
| ESTABLISH |   |                   |   |                    |   |           |
| SAFETY    |   |                   |   |                    |   |           |
| AND       |   |                   |   |                    |   |           |
| EFFECT    |   |                   |   |                    |   |           |
| IVENESS** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 51        |   |                   |   |                    |   |           |
| 4.1(b)(8) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| Data/in   |   |                   |   |                    |   |           |
| formation |   |                   |   |                    |   |           |
| to permit |   |                   |   |                    |   |           |
| e         |   |                   |   |                    |   |           |
| valuation |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| safety    |   |                   |   |                    |   |           |
| and       |   |                   |   |                    |   |           |
| effe      |   |                   |   |                    |   |           |
| ctiveness |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| drug      |   |                   |   |                    |   |           |
| product   |   |                   |   |                    |   |           |
| for the   |   |                   |   |                    |   |           |
| claim(s)  |   |                   |   |                    |   |           |
| proposed  |   |                   |   |                    |   |           |
| in the    |   |                   |   |                    |   |           |
| proposed  |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| species.  |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **9. GOOD |   |                   |   |                    |   |           |
| L         |   |                   |   |                    |   |           |
| ABORATORY |   |                   |   |                    |   |           |
| PRACTICE  |   |                   |   |                    |   |           |
| COM       |   |                   |   |                    |   |           |
| PLIANCE** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 514.1(b)  |   |                   |   |                    |   |           |
| (12)(iii) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| A         |   |                   |   |                    |   |           |
| statement |   |                   |   |                    |   |           |
| of        |   |                   |   |                    |   |           |
| c         |   |                   |   |                    |   |           |
| ompliance |   |                   |   |                    |   |           |
| or        |   |                   |   |                    |   |           |
| non-c     |   |                   |   |                    |   |           |
| ompliance |   |                   |   |                    |   |           |
| to good   |   |                   |   |                    |   |           |
| l         |   |                   |   |                    |   |           |
| aboratory |   |                   |   |                    |   |           |
| practices |   |                   |   |                    |   |           |
| (21 CFR   |   |                   |   |                    |   |           |
| 58) of    |   |                   |   |                    |   |           |
| each      |   |                   |   |                    |   |           |
| no        |   |                   |   |                    |   |           |
| nclinical |   |                   |   |                    |   |           |
| l         |   |                   |   |                    |   |           |
| aboratory |   |                   |   |                    |   |           |
| study.    |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **10.     |   |                   |   |                    |   |           |
| ENVI      |   |                   |   |                    |   |           |
| RONMENTAL |   |                   |   |                    |   |           |
| ASS       |   |                   |   |                    |   |           |
| ESSMENT** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 514       |   |                   |   |                    |   |           |
| .1(b)(14) |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| An        |   |                   |   |                    |   |           |
| envi      |   |                   |   |                    |   |           |
| ronmental |   |                   |   |                    |   |           |
| a         |   |                   |   |                    |   |           |
| ssessment |   |                   |   |                    |   |           |
| (21 CFR   |   |                   |   |                    |   |           |
| 25.40)    |   |                   |   |                    |   |           |
| c         |   |                   |   |                    |   |           |
| ontaining |   |                   |   |                    |   |           |
| data/in   |   |                   |   |                    |   |           |
| formaiton |   |                   |   |                    |   |           |
| to permit |   |                   |   |                    |   |           |
| e         |   |                   |   |                    |   |           |
| valuation |   |                   |   |                    |   |           |
| of the    |   |                   |   |                    |   |           |
| envi      |   |                   |   |                    |   |           |
| ronmental |   |                   |   |                    |   |           |
| safety of |   |                   |   |                    |   |           |
| the\      |   |                   |   |                    |   |           |
| drug      |   |                   |   |                    |   |           |
| product   |   |                   |   |                    |   |           |
| or a      |   |                   |   |                    |   |           |
| claim for |   |                   |   |                    |   |           |
| a         |   |                   |   |                    |   |           |
| ca        |   |                   |   |                    |   |           |
| tegorical |   |                   |   |                    |   |           |
| exclusion |   |                   |   |                    |   |           |
| from      |   |                   |   |                    |   |           |
| preparing |   |                   |   |                    |   |           |
| an        |   |                   |   |                    |   |           |
| envi      |   |                   |   |                    |   |           |
| ronmental |   |                   |   |                    |   |           |
| a         |   |                   |   |                    |   |           |
| ssessment |   |                   |   |                    |   |           |
| (21 CFR   |   |                   |   |                    |   |           |
| 25.33),   |   |                   |   |                    |   |           |
| as        |   |                   |   |                    |   |           |
| app       |   |                   |   |                    |   |           |
| ropriate. |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| **11.     |   |                   |   |                    |   |           |
| FREEDOM   |   |                   |   |                    |   |           |
| OF        |   |                   |   |                    |   |           |
| IN        |   |                   |   |                    |   |           |
| FORMATION |   |                   |   |                    |   |           |
| SUMMARY** |   |                   |   |                    |   |           |
| 21 CFR    |   |                   |   |                    |   |           |
| 514.11    |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
| A summary |   |                   |   |                    |   |           |
| prepared  |   |                   |   |                    |   |           |
| according |   |                   |   |                    |   |           |
| to Agency |   |                   |   |                    |   |           |
| gu        |   |                   |   |                    |   |           |
| idelines. |   |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
| **12.     |   |                   |   |                    |   |           |
| OTHER**   |   |                   |   |                    |   |           |
| *(        |   |                   |   |                    |   |           |
| Specify)* |   |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
| >         |   |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
| > The     |   |                   |   | > effects, and     |   |           |
| > un      |   |                   |   | > precautions      |   |           |
| dersigned |   |                   |   | > contained in the |   |           |
| >         |   |                   |   | > labeling which   |   |           |
|  official |   |                   |   | > is part of this  |   |           |
| > submits |   |                   |   | > application in   |   |           |
| > this    |   |                   |   | > accordance with  |   |           |
| > ap      |   |                   |   | > 21 CFR 201.105.  |   |           |
| plication |   |                   |   | > It is understood |   |           |
| > for a   |   |                   |   | > that all         |   |           |
| > new     |   |                   |   | > representations  |   |           |
| > animal  |   |                   |   | > in this          |   |           |
| > drug    |   |                   |   | > application      |   |           |
| >         |   |                   |   | > apply to the     |   |           |
|  pursuant |   |                   |   | > drug produced    |   |           |
| > to      |   |                   |   | > until changes    |   |           |
| > section |   |                   |   | > are made in      |   |           |
| > 512(b)  |   |                   |   | > conformity with  |   |           |
| > of the  |   |                   |   | > 21 CFR 514.8. It |   |           |
| > Federal |   |                   |   | > is further       |   |           |
| > Food,   |   |                   |   | > understood that  |   |           |
| > Drug,   |   |                   |   | > new animal drugs |   |           |
| > and     |   |                   |   | > as defined in 21 |   |           |
| >         |   |                   |   | > CFR 510.3,       |   |           |
|  Cosmetic |   |                   |   | > intended for use |   |           |
| > Act. It |   |                   |   | > in the           |   |           |
| > is      |   |                   |   | > manufacture of   |   |           |
| > u       |   |                   |   | > animal feeds in  |   |           |
| nderstood |   |                   |   | > any State will   |   |           |
| > that    |   |                   |   | > be shipped only  |   |           |
| > the     |   |                   |   | > to persons who   |   |           |
| >         |   |                   |   | > may receive such |   |           |
|  labeling |   |                   |   | > drugs in         |   |           |
| > and     |   |                   |   | > accordance with  |   |           |
| > ad      |   |                   |   | > 21 CFR 510.7.    |   |           |
| vertising |   |                   |   | > Furthermore, the |   |           |
| > for the |   |                   |   | > applicant        |   |           |
| > new     |   |                   |   | > certifies that   |   |           |
| > animal  |   |                   |   | > the services of  |   |           |
| > drug    |   |                   |   | > any person       |   |           |
| > will    |   |                   |   | > debarred under   |   |           |
| > p       |   |                   |   | > FFDCA,           |   |           |
| rescribe, |   |                   |   | > subsection       |   |           |
| > r       |   |                   |   | > 306(a) or (b),   |   |           |
| ecommend, |   |                   |   | > have not and     |   |           |
| > or      |   |                   |   | > will not be used |   |           |
| > suggest |   |                   |   | > in any capacity  |   |           |
| > its use |   |                   |   | > with this        |   |           |
| > only    |   |                   |   | > application.     |   |           |
| > under   |   |                   |   |                    |   |           |
| > the     |   |                   |   |                    |   |           |
| > c       |   |                   |   |                    |   |           |
| onditions |   |                   |   |                    |   |           |
| > stated\ |   |                   |   |                    |   |           |
| > in the  |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  labeling |   |                   |   |                    |   |           |
| > which   |   |                   |   |                    |   |           |
| > is part |   |                   |   |                    |   |           |
| > of this |   |                   |   |                    |   |           |
| > ap      |   |                   |   |                    |   |           |
| plication |   |                   |   |                    |   |           |
| > and if  |   |                   |   |                    |   |           |
| > the     |   |                   |   |                    |   |           |
| > article |   |                   |   |                    |   |           |
| > is a    |   |                   |   |                    |   |           |
| > pre     |   |                   |   |                    |   |           |
| scription |   |                   |   |                    |   |           |
| > new     |   |                   |   |                    |   |           |
| > animal  |   |                   |   |                    |   |           |
| > drug,   |   |                   |   |                    |   |           |
| > it is   |   |                   |   |                    |   |           |
| > u       |   |                   |   |                    |   |           |
| nderstood |   |                   |   |                    |   |           |
| > that    |   |                   |   |                    |   |           |
| > any     |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  labeling |   |                   |   |                    |   |           |
| > which   |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| furnishes |   |                   |   |                    |   |           |
| > or      |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  purports |   |                   |   |                    |   |           |
| > to      |   |                   |   |                    |   |           |
| > furnish |   |                   |   |                    |   |           |
| > in      |   |                   |   |                    |   |           |
| formation |   |                   |   |                    |   |           |
| > for use |   |                   |   |                    |   |           |
| > or      |   |                   |   |                    |   |           |
| > which   |   |                   |   |                    |   |           |
| > pr      |   |                   |   |                    |   |           |
| escribes, |   |                   |   |                    |   |           |
| > re      |   |                   |   |                    |   |           |
| commends, |   |                   |   |                    |   |           |
| > or      |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  suggests |   |                   |   |                    |   |           |
| > a       |   |                   |   |                    |   |           |
| > dosage  |   |                   |   |                    |   |           |
| > for use |   |                   |   |                    |   |           |
| > of the  |   |                   |   |                    |   |           |
| > new     |   |                   |   |                    |   |           |
| > animal  |   |                   |   |                    |   |           |
| > drug    |   |                   |   |                    |   |           |
| > will\   |   |                   |   |                    |   |           |
| > also    |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  contain, |   |                   |   |                    |   |           |
| > in the  |   |                   |   |                    |   |           |
| > same    |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  language |   |                   |   |                    |   |           |
| > and     |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| emphasis, |   |                   |   |                    |   |           |
| > in      |   |                   |   |                    |   |           |
| formation |   |                   |   |                    |   |           |
| > for its |   |                   |   |                    |   |           |
| > use     |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| including |   |                   |   |                    |   |           |
| > ind     |   |                   |   |                    |   |           |
| ications, |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  effects, |   |                   |   |                    |   |           |
| > dosages |   |                   |   |                    |   |           |
| > routes, |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  methods, |   |                   |   |                    |   |           |
| > f       |   |                   |   |                    |   |           |
| requency, |   |                   |   |                    |   |           |
| > and     |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  duration |   |                   |   |                    |   |           |
| > of      |   |                   |   |                    |   |           |
| > admini  |   |                   |   |                    |   |           |
| stration, |   |                   |   |                    |   |           |
| > any     |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  relevant |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  hazards, |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| contraind |   |                   |   |                    |   |           |
| ications, |   |                   |   |                    |   |           |
| > side    |   |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
| > > NOTE: |   |                   |   |                    |   |           |
| > > This  |   |                   |   |                    |   |           |
| > > ap    |   |                   |   |                    |   |           |
| plication |   |                   |   |                    |   |           |
| > > must  |   |                   |   |                    |   |           |
| > > be    |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  > signed |   |                   |   |                    |   |           |
| > > by    |   |                   |   |                    |   |           |
| > > the   |   |                   |   |                    |   |           |
| > >       |   |                   |   |                    |   |           |
| applicant |   |                   |   |                    |   |           |
| > > or by |   |                   |   |                    |   |           |
| > > an    |   |                   |   |                    |   |           |
| > > a     |   |                   |   |                    |   |           |
| uthorized |   |                   |   |                    |   |           |
| > >       |   |                   |   |                    |   |           |
| attorney, |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  > agent, |   |                   |   |                    |   |           |
| > > or    |   |                   |   |                    |   |           |
| > >       |   |                   |   |                    |   |           |
| official. |   |                   |   |                    |   |           |
| > > If    |   |                   |   |                    |   |           |
| > > the   |   |                   |   |                    |   |           |
| > >       |   |                   |   |                    |   |           |
| applicant |   |                   |   |                    |   |           |
| > > does  |   |                   |   |                    |   |           |
| > > not   |   |                   |   |                    |   |           |
| > > have  |   |                   |   |                    |   |           |
| > > a     |   |                   |   |                    |   |           |
| > > place |   |                   |   |                    |   |           |
| > > of    |   |                   |   |                    |   |           |
| > >       |   |                   |   |                    |   |           |
|  business |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  > within |   |                   |   |                    |   |           |
| > > the   |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  > United |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| > States, |   |                   |   |                    |   |           |
| > > the   |   |                   |   |                    |   |           |
| > > ap    |   |                   |   |                    |   |           |
| plication |   |                   |   |                    |   |           |
| > > must  |   |                   |   |                    |   |           |
| > > also  |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| > provide |   |                   |   |                    |   |           |
| > > the   |   |                   |   |                    |   |           |
| > > name  |   |                   |   |                    |   |           |
| > > and   |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| > address |   |                   |   |                    |   |           |
| > > of    |   |                   |   |                    |   |           |
| > > and   |   |                   |   |                    |   |           |
| > > be    |   |                   |   |                    |   |           |
| > > coun  |   |                   |   |                    |   |           |
| tersigned |   |                   |   |                    |   |           |
| > > by an |   |                   |   |                    |   |           |
| > > a     |   |                   |   |                    |   |           |
| uthorized |   |                   |   |                    |   |           |
| > > agent |   |                   |   |                    |   |           |
| > > or    |   |                   |   |                    |   |           |
| > >       |   |                   |   |                    |   |           |
|  official |   |                   |   |                    |   |           |
| > >       |   |                   |   |                    |   |           |
|  residing |   |                   |   |                    |   |           |
| > > or    |   |                   |   |                    |   |           |
| > > ma    |   |                   |   |                    |   |           |
| intaining |   |                   |   |                    |   |           |
| > > a     |   |                   |   |                    |   |           |
| > > place |   |                   |   |                    |   |           |
| > > of    |   |                   |   |                    |   |           |
| > >       |   |                   |   |                    |   |           |
|  business |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  > within |   |                   |   |                    |   |           |
| > > the   |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
|  > United |   |                   |   |                    |   |           |
| >         |   |                   |   |                    |   |           |
| > States. |   |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | * |                   |   |                    |   |           |
|           | * |                   |   |                    |   |           |
|           | ( |                   |   |                    |   |           |
|           | W |                   |   |                    |   |           |
|           | A |                   |   |                    |   |           |
|           | R |                   |   |                    |   |           |
|           | N |                   |   |                    |   |           |
|           | I |                   |   |                    |   |           |
|           | N |                   |   |                    |   |           |
|           | G |                   |   |                    |   |           |
|           | : |                   |   |                    |   |           |
|           | * |                   |   |                    |   |           |
|           | * |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | A |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | w |                   |   |                    |   |           |
|           | i |                   |   |                    |   |           |
|           | l |                   |   |                    |   |           |
|           | l |                   |   |                    |   |           |
|           | f |                   |   |                    |   |           |
|           | u |                   |   |                    |   |           |
|           | l |                   |   |                    |   |           |
|           | l |                   |   |                    |   |           |
|           | y |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | f |                   |   |                    |   |           |
|           | a |                   |   |                    |   |           |
|           | l |                   |   |                    |   |           |
|           | s |                   |   |                    |   |           |
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|           | > |                   |   |                    |   |           |
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|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | a |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
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|           | c |                   |   |                    |   |           |
|           | r |                   |   |                    |   |           |
|           | i |                   |   |                    |   |           |
|           | m |                   |   |                    |   |           |
|           | i |                   |   |                    |   |           |
|           | n |                   |   |                    |   |           |
|           | a |                   |   |                    |   |           |
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|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | o |                   |   |                    |   |           |
|           | f |                   |   |                    |   |           |
|           | f |                   |   |                    |   |           |
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|           | n |                   |   |                    |   |           |
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|           | e |                   |   |                    |   |           |
|           | . |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | U |                   |   |                    |   |           |
|           | . |                   |   |                    |   |           |
|           | S |                   |   |                    |   |           |
|           | . |                   |   |                    |   |           |
|           | C |                   |   |                    |   |           |
|           | . |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | T |                   |   |                    |   |           |
|           | i |                   |   |                    |   |           |
|           | t |                   |   |                    |   |           |
|           | l |                   |   |                    |   |           |
|           | e |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | 1 |                   |   |                    |   |           |
|           | 8 |                   |   |                    |   |           |
|           | , |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | s |                   |   |                    |   |           |
|           | e |                   |   |                    |   |           |
|           | c |                   |   |                    |   |           |
|           | . |                   |   |                    |   |           |
|           | > |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           | 1 |                   |   |                    |   |           |
|           | 0 |                   |   |                    |   |           |
|           | 0 |                   |   |                    |   |           |
|           | 1 |                   |   |                    |   |           |
|           | . |                   |   |                    |   |           |
|           | ) |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
| >         |   |                   | > |                    |   | > DATE    |
| SIGNATURE |   |                   |   |                    |   |           |
| > OF      |   |                   | T |                    |   |           |
| > RE      |   |                   | I |                    |   |           |
| SPONSIBLE |   |                   | T |                    |   |           |
| >         |   |                   | L |                    |   |           |
|  OFFICIAL |   |                   | E |                    |   |           |
| > OR      |   |                   | > |                    |   |           |
| > A       |   |                   |   |                    |   |           |
| UTHORIZED |   |                   | O |                    |   |           |
| > AGENT   |   |                   | F |                    |   |           |
|           |   |                   | > |                    |   |           |
|           |   |                   |   |                    |   |           |
|           |   |                   | A |                    |   |           |
|           |   |                   | U |                    |   |           |
|           |   |                   | T |                    |   |           |
|           |   |                   | H |                    |   |           |
|           |   |                   | O |                    |   |           |
|           |   |                   | R |                    |   |           |
|           |   |                   | I |                    |   |           |
|           |   |                   | T |                    |   |           |
|           |   |                   | Y |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
|           |   |                   | > |                    |   | >         |
|           |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
|           |   |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+
| >         |   |                   |   |                    |   |           |
| **     ** |   |                   |   |                    |   |           |
+-----------+---+-------------------+---+--------------------+---+-----------+