US Environmental Protection Agency
Office of Pesticide Programs
e-Submission XML Guidance Document
Version 1.1

July 09,2008

-------
e-Submission XML Guidance Document                                           vl.l


e-Submission Help Desk Support

In preparation for the upcoming release of our e-Submission Project, EPA's Office of
Pesticide Programs (OPP) is offering help desk support that will assist registrants with
the creation of the e-Submission XML package. Please utilize the resources we have
provided to support your technical needs.  Customers may contact the EPA PRISM e-
Submission Help Desk by phone or e-mail to request help.

      Support Hours:
          o   8:00 AM - 5:00 PM Eastern Time
          o   Monday through Friday

      Phone Number:
          o   Toll Free: 1-866-612-8664
          o   Local: 703-326-0673
             Note: A voice-mail can be left at any time.

      E-mail Address:
          o   OPP_e-Submission_Help_Desk @epa.gov
                                      11

-------
e-Submission XML Guidance Document                                           vl.l

                            Table of Contents

1   Introduction	1
2   Xml File Creation & Submission Instructions	2
  2.1     Option #1 - PMRA e-Index Builder	2
  2.2     Option #2 - XML File Creation Application	3
Appendix A: Metadata Field Description & Data Type	5
  US_MD 12 Content Categories	15
Appendix B: Detailed Sample XML File	17
                                     in

-------
e-Submission XML Guidance Document                                            vl.l


1    Introduction

The purpose of this guidance document is to provide registrants the instructions for
constructing a XML file and submitting the e-Submission documents to the Environment
Protection Agency (EPA) Office of Pesticide Programs (OPP).

e-Submission allows users to upload zip files containing digitized versions of their
submission documents (i.e., studies, labels, and forms). The zip file will also contain
extensible Markup Language (XML) files that describe the submissions document using
the prescribed schema adopted from Canada's Pest Management Regulatory Agency
(PMRA). Once EPA receives the files from the registrant, the e-Submission system will
unzip the files, parse the XML, perform several validation checks, and store the package
and document in the database records.

-------
e-Submission XML Guidance Document                                            vl.l
2    XML File Creation & Submission Instructions
There are two (2) options available for creating and submitting e-Submission XML files.
Registrants can create the files using Canada's PMRA e-Index Builder or by using a
XML file creation application (i.e., Notepad, Microsoft Word, etc.) Each option is
described below.

2.1    Option #1 - PMRA e-lndex Builder
Follow the steps listed below to create and submit the XML file using the PMRA e-Index
Builder.

   1.  Download the e-Index Builder from the PMRA website (http://www.pmra-
       arla.gc.ca/english/appregis/e-indexbuilder-e.html) by clicking the Click here
       to download the latest version of the e-Index Builder link and saving the e-
       indexbuilder.zip file to the local computer.

   2.  Create the e-Index file by describing each document being submitted to EPA.
       Documents can be submitted with the e-Index by attaching them electronically
       using the e-Index Builder. Include all pertinent forms, studies, labels, payment
       receipts, etc associated to one Pesticide submission.

       Use a file compression application (i.e., WinZip) to extract the forms, studies, etc,
       make necessary changes, and compress the file before submitting to EPA.

       For example, if you are applying for a New Registration and an Amendment to an
       existing registration, create two separate zip files, one for New Registration and
       one for Amendment.

   3.  Once all the documents are described, the e-Index Builder will automatically
       package your submission into a PMRA Regulatory Zip (PRZ) file. Change the
       .prz file extension to .zip.

   4.  Open the zip file and modify the XML file, which is required  so it can be used by
       EPA. Alter the XML with the required EPA specific metadata fields and data
       types, which are provided in Appendix A. Additionally, a detailed sample XML
       file containing all the required fields is provided in Appendix  B.

   5.  Use the file naming convention to save the  file. The XML file name should
       contain the prefix "e-PRISM." Examples of the file naming convention are
       provided below.

          e-PRISMXXXX.xml
          e-PRISM.xml
          e-PRISMXXsampleXX.xml

-------
e-Submission XML Guidance Document                                           vl.l

   6.  Save the file to DVD/CD.

   7.  Place a label on the DVD/CD.  The label should provide the following
       information:

          EPA company number
          Contact Information
          Name of chemical
          Date when the DVD/CD is mailed
          Brief description of the contents provided on the DVD/CD

   8.  Deliver the DVD/CD to EPA. United States Postal Service (USPS) delivery is not
       recommended at this time due to delays caused by the sterilization of all incoming
       mails.  The package should be labeled as the following:

       Document Processing Desk (E-Sub)
       U.S. EPA - Office of Pesticide Programs
       S-4900
       2777 S. Crystal Drive
       Arlington, VA 22202

2.2    Option #2 - XML File Creation Application
Follow the steps listed below to create and submit the XML file using a XML file
creation application (i.e., Notepad, Microsoft Word, etc.).

   1.  Create the XML file using one of the following applications:

          Notepad
          Microsoft Word
          Text Editor
          XML Editor (i.e., XMLSpy, XML Notepad).

   2.  Use the file naming convention to  save the XML file. The XML file name should
       contain the prefix "e-PRISM." Examples of for the file naming convention are
       provided below.

          e-PRISMXXXX.xml
          e-PRISM.xml
          e-PRISMXXsampleXX.xml

   3.  Alter the XML with the required EPA specific metadata fields and data types,
       which are provided in Appendix A. Additionally, a detailed sample XML file
       containing all the required fields is provided in Appendix B.

-------
e-Submission XML Guidance Document                                            vl.l

   4.  Group all pertinent forms, studies, labels and payment receipts etc associated to
       one pesticide submission. Use a file compression application (example WinZip)
       for combining all the relevant documents for the pesticide submission.

   5.  Use a separate zip file for each submission.  For example, if you are applying for
       a New Registration and an Amendment to an existing registration, create two
       separate zip files.

   6.  Save the file to DVD/CD

   7.  Place a label on the DVD/CD. The label should provide the following
       information:

          EPA company number
          Contact Information
          Name of chemical
          Date when the DVD/CD is mailed
          Brief description of the contents provided on the DVD/CD

   8.  Deliver the DVD/CD to EPA. United States Postal Service (USPS) delivery is
       not recommended at this time due to delays caused by the sterilization of all
       incoming mails. The package should be labeled as the following:

       Document Processing Desk (E-Sub)
       U.S. EPA - Office of Pesticide Programs
       S-4900
       2777 S. Crystal Drive
       Arlington, VA 22202

-------
e-Submission XML Guidance Document
vl.O
Appendix A: Metadata Field  Description & Data Type

The "Data Type/Enumeration/Format" provided in the table below is the standard used by OP PIN. Please ensure the necessary changes
are made when converting the file from PMRA e-index format to the format accepted by EPA e-Submissions.
e-PRISM
XML Tag
META
COMPANY

Description

Company
Name/Number
Details About Field



Data Type / Enumeration / Format

Varchar2(50) /
Number (6,0)- ( if numeric value)
Required for
Document
Type

All Document
types
Min

1

Max

1


-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag
BUILD
CREATE_DATE
RECORD_COUNT
FIELDS
DM_REPORT_NO
DM_TITLE
Description
Build
Create Date
Record Count

Company
Report No.
Title
Details About Field
Refer to the e-PRISM
Builder build number
that was used to
generate this file.
Date in YYYY-MM-DD
format. Refers to the
date that the XML file
was generated.
It refers to the number
of documents
referenced in the XML
file and included in the
submission. The field
accepts only numbers.

Refers to the internal
identification number
for a study provided by
the submitting
company.
Indicates the title of a
study provided by the
Data Type / Enumeration / Format
Varchar2(10)
Date in YYYY-MM-DD format
Number(10)

Varchar2(256)
Varchar2(240)
Required for
Document
Type
All Document
types
To be provided
for all
document
types
To be provided
for all
document
types

Provided only
for studies and
not for other
document
types.
Provided only
for studies and
Min
0
1
1

0
0
Max
1
1
1

1
1

-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag



DM_AUTHOR
















DM REPORT DAT
E




Description



Author(s)
















Document Date




Details About Field
submitting company or
its lab.

Refers to the author of
a study provided by the
submitting company or
its lab.
Format :
last name, first
name/initial.
All authors should be
separated using semi
colon (;)
Example :
1)BirkJ.
2) Robbin, Williams
P.
Peter,Russel ;
Johnson, Woods;
Mark, Jones.
It refers to the date of
a study provided by a
Lab. It will also be
used by EPA to
represent the date of
any document that is
Data Type / Enumeration / Format



Varchar2(2000)
















Format : YYYY-MM-DD




Required for
Document
Type
not for other
document
types
Provided only
for studies and
not for other
document
types












To be provided
for all
document
types


Min



0
















1




Max



1
















1





-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag

DM_NO_PAGES

DM_EPA_MRID_NO

DM LAB REPORT
NUMBER



Description

Page Count

EPAMRIDNo.

Lab Report
No(s)



Details About Field
submitted (for
example, the date on a
standard EPA form).
Refers to the number of
pages in a study
including appendices
provided by the
submitting company or
its lab. The value
supplied should be
numeric value.
It refers to the MRID of
the study being
submitted by the
company or its lab, in
the event that
information was
provided to the
company ahead of
time.
It refers to the internal
identification number
for a study used by the
lab that produced a
study. It is
differentiated from the
"DM_Report_No",
which refers to the
internal tracking
number for the study
used by the submitting
company.
Data Type / Enumeration / Format

Number(4)

Varchar2(8)

Varchar2(20)



Required for
Document
Type

Provided only
for studies and
not for other
document
types

Provided only
for studies and
not for other
document
types

Provided only
for studies and
not for other
document
types



Min

0

0

0



Max

1

Unbounded

Unbounded




-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag
DM_PUBLISHED
DOCUMENT GROU
P


DM_COMMENTS


DM_EFILE_NAME

Description
Key Type
(applicable only
for studies)
Document
Group


Comments


e-File Name

Details About Field
This field is called "Key
Type". It indicates
whether a study has
been published, and
therefore made publicly
available.
It allows the submitting
company to relate
different documents in
the same submission
package to each other
using a customized
string. This field is not
required. The
submitting company
may enter any value
they wish into this field.
It allows the submitting
company to
communicate
questions, notes, or
other remarks to the
agency. The
submitting company
many enter any value
they wish into this field.
It references the name
of the file associated
with the XML document
Data Type / Enumeration / Format
Y
N
Varchar2(40)


Varchar2(2000)


Varchar2(260)

Required for
Document
Type
Provided only
for studies and
not for other
document
types








Min
0
0


0


1

Max
1
1


1


1


-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag


US_MD1














US_MD2












Description


Company
Contact Info













Document
Type











Details About Field

record.
The "US_MD1" field
represents the
"Company Contact
Information" for the file.
Companies are
required to provide a
POC that can talk
specifically about the e-
Submission file sent to
EPA and his/her
contact information. It
is expected that the
value in this field will be
the same for all
documents.
The "US_MD2" field
represents the
"Document Type" of a
document to EPA. An
acceptable list of
Document Types will
be provided. Codes
will be used to
represent each
Document Type.





Data Type / Enumeration / Format


Varchar2(500)














 8570-1 (Form 8570-1 Application for
Pesticide Registration)
 ST (Study)
w  ywiuujr/
 STP (Study Profile / Study Summary)
 LB (Label)
 CSF (Confidential Statement of Formula)
 8570-5 (Form 8570-5 Notice of
Supplemental Distribution of a
Registered Pesticide Product)
 8570-35 (Form 8570-35 Data Matrix)
 8570-17 (Form 8570-17 Application for
an Experimental Use Permit)
 8570-27 (Form 8570-27 Formulator's
Exemption Statement)
Required for
Document
Type

For To be
provided for all
document
types











For all
respective
document
types









Min


1














1












Max


1














1












                                                                10

-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag




US_MD3











US_MD4
Description




PRIA Action











Regulatory
Type
Details About Field




The "US_MD3" field
represents the "PRIA
Action" for the
submission. This does
not refer to the PRIA
Code, but instead
whether the
submission was sent
in support of a PRIA-
related action. It is
expected that the
value in this field will
be the same for all
documents in the
submission.
The "US_MD4" field
indicates that the
document is being
submitted to EPA in
support of a particular
"Regulatory Type". It
is expected that the
Data Type / Enumeration / Format
 8570-28 (Form 8570-28 Certification of
Compliance with Data Gap Procedures)
 8570-32 (Form 8570-32 Certification of
Attempt to Enter into an Agreement with
other Registrants for Development of
Data)
 8570-34 (Form 8570-34 Certification with
Respect to Citations of Data)
 OTH (Other)
 Y
 N










 R (Product Registration - Section 3)
 X (Experimental Use Permit - Section 5)
 D (Distributor Product)
Required for
Document
Type




For documents
sent in support
of PRIA action










Provided only
for documents
which are
1. Registered
under section 3
2. Registered
Min




1











1
Max




1











Unbounded
                                                                11

-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag




US_MD5







US_MD6












US_MD7






Description




Application
Type






Admin Number
Type











Admin Number






Details About Field

value in this field will
be the same for all
documents.
The "US_MD5" field
indicates the
"Application Type"
(type of submission)
associated with the
document.


The "US_MD6" field
contains the "Admin
Number Type"
represented by a value
in "US_MD7", such as
"Registration Number"
or"SLN". There
should be one Admin
Number Type for each
Admin Number. The
system will match
them up based on the
order in which they
appeared in the XML.
The "US_MD7" field
contains the "Admin
Number" associated
with the Admin Number
Type in "US_MD6".
The Admin Number is
the actual identifier
Data Type / Enumeration / Format




 A (New Registration)
 C (Amendment)
 P (Pending Product Amendment)
 W (FFS Waiver Request)
 2 (Conditional Registration Follow-up)
 3 (Registrant Response)
 6 (6A2 Data)
 9 (Agency Initiated Action)
 RN (Registration Number)
 EUPN (EUP Number)
 DIST (Distributor Number)










Varchar2(20)






Required for
Document
Type
under section 5
3. Distributor
Product
For To be
provided for all
document
types




To be provided
for all
document
types










To be provided
for all
document
types



Min




1







0












0






Max




Unbounded







Unbounded












Unbounded






                                                                12

-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag





US_MD8




US_MD9



US MD10



Description





Parent Section
3




Product Name



CBI Status
(EPA)


Details About Field
(e.g. 100-234), while
the Admin Number
Type indicates what
that value represents
(e.g. a Registration
Number). There should
be one Admin Number
for each Admin Number
Type. The system will
match them up based
on the order in which
they appeared in the
XML.
The "US_MD8" field
contains the "Parent
Section 3" Registration
Number associated
with a Me-Too, SLN,
Distributor Product, or
other type of
registration.
The "US MD9" field
contains the "Product
Name" associated with
the product.
The "US MD10" field
indicates whether the
document contains
CBI-protected
information. The value
supplied should be
numeric.
Data Type / Enumeration / Format





Varchar2(20)




Varchar2(100)



Number(8)
 0 (No CBI)
 1 (Confidential attachments)
 2 (Supplemental claim)
 3 (Confidential attachments and
Required for
Document
Type


















Min





0




0







Max





1




1



1



                                                                13

-------
e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag


US_MD1 1













US_MD12










Description


Guideline
Number












Content
Category









Details About Field


The "US_MD11" field
contains the "Guideline
Number" associated
with a study. EPA only
accepts Guideline
Numbers, whereas
PMRA accepts EPA
Guideline Numbers, its
own DACO codes, or
OECD numbers in the
DACOJD.





The"US_MD12"field
indicates the "Content
Category" of a study.
A detailed description
for each code is
provided below.





Data Type / Enumeration / Format

supplemental claim)














 01 (Complete primary report ~ experimental
research)
 02 (Incomplete or summarized ~
experimental research)
 03 (Complete primary report ~ survey or
monitoring research)
 04 (Incomplete or summarized ~ survey or
monitoring research)
 05 (Complete report - case study)
 06 (Analytical method)
 11 (Secondary report attributed to others)
 12 (Unattributed secondary report)
Required for
Document
Type

Provided only
for Study
documents

* EPA accepts
only Guideline
ni imhprc
MUM IL/d o

** PMRA
accepts EPA
guideline
numbers and
DACO codes or
OECD
numbers
Provided only
for study
related
documents








Min


0













0










Max


Unbounded













1










                                                                14

-------
 e-Submission XML Guidance Document
vl.O
e-PRISM
XML Tag











US_MD13
Description











Me-Too
Indicator
Details About Field











The"US_MD13"field
indicates whether the
document is related to
a "Me-Too"
registration.
Data Type / Enumeration / Format
 21 (News reports from scientific press)
 22 (News reports from popular or trade
media)
 23 (Opinion or commentary from interested
groups)
 24 (Opinion or commentary from
individuals)
 31 (Patents, either U.S. or foreign)
 32 (Legal and regulatory documents)
 41 (Bibliographies ~ free standing)
 42 (General reference works)
 43 (Data Waiver Rationale)
 90 (Unknown)
 99 (Transmittal documents)
Varchar2(1)
 Y
 N
Required for
Document
Type











Provided for
documents
registered
under 'Me-Too'
registration
Min











1
Max











1
US_MD12 Content Categories
Code
01
02
03
Nature of Document
Complete primary reports of the author's experimental research, including discussions of materials and , methods, results and conclusions
Incomplete or summarized primary reports of the author's experimental research, missing one or more of the elements listed for code 01
Complete primary reports of the author's survey or monitoring research including discussions of methods, results, and conclusions. This
category is for non-experimental research, and will usually be associated with such fields as economics, use practices , epidemiology,
                                                  15

-------
e-Submission XML Guidance Document                                                                                        vl.O
Code
                                                     Nature of Document
       environmental monitoring, etc.
04
Incomplete or summarized primary reports of the author's survey or monitoring research, missing one or more of the elements listed for
code 03
05
Complete reports of case studies performed by the author. This category is distinguished from 03/04 survey research; case studies are
reactive investigations of incidents. This category will be associated with such data as medical investigations of accidental or intentional
poisonings, investigations of wildlife kills, of spills etc. There is no corresponding category for uninvestigated reports; these will be treated
as news reports.	
06
Complete reports of experimental, survey, or analytical methods, where the emphasis is on the method itself rather than on the results of its
application. If a method is discussed in the same document as result of it use, use codes 01-05	
11
Secondary reports of research attributed to others. When the reported research is not that of the author, either code 11 or 12 is appropriate.
When data reported or conclusions drawn are supported by cited primary references, use code 11. These reports may be broad pr narrow in
scope, and may review experimental or non experimental research.	
12
Unattributed secondary reports or summaries of research data or conclusions, not supported by cited primary references. These may take
such form as " fact sheets" or technical specifications, or assertions of scientific facts or conclusions by reputable companies or scientists
21
News reports from the scientific press. These are distinguishable from code 12 by emphasis on events rather than research results.
22
News reports from popular or trade media
23
Opinion or commentary from interested groups or their representatives. In this context interested groups would include registrant firms,
associations in the regulated community, government agencies, environmental groups, etc	
24
Opinion or commentary from individuals. This may be either favorable or adverse comment about a pesticide, and includes comments
received in response to proposed regulatory actions. If affiliation of author with an interested group is mentioned but the comment is not
made on behalf of the group, use code 24 rather than 23	
31
Patents, either U.S. or foreign
32
Legal and regulatory documents including laws, judicial opinions or orders, briefs , hearing records, official notices, regulations, etc
whether U.S. or foreign	
41
Bibliographies, when free-standing and not a part of a document falling into another category
42
General reference works, or portions thereof
                                                              16

-------
e-Submission XML Guidance Document                                     vl.O
Appendix B:  Detailed Sample XML File

- 
- 
- 
 ABCXY
 
- 
 6
 
- 
 en
 
- 
 2007-05-15
 
- 
 
 
- 
 19
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 ABC 452 44 H Cover Letter
 
- 
 ABC 452 44 H Cover Letter
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
                                 17

-------
e-Submission XML Guidance Document                                      vl.O
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
 N
 
- 
 ABC 452 44 H Cover Letter.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 OTH
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
- 
                                  18

-------
e-Submission XML Guidance Document                                       vl.O
 0
 
-
 
 
-
 
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 ABC 452 44 H Application
 
- 
 ABC 452 44 H Application
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
                                  19

-------
e-Submission XML Guidance Document                                       vl.O
 N
 
- 
 ABC 452 44 H Application.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 8570-1 
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 
 
-
 
 
-
 N
 
 
- 
                                  20

-------
e-Submission XML Guidance Document                                       vl.O
- 
 N
 
- 
 N
 
- 
 N
 
- 
 ABC 452 44 H Data Citation
 
- 
 ABC 452 44 H Data Citation
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
 N
 
- 
 ABC 452 44 H Data Citation.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 8570-56
 
- 
                                 21

-------
e-Submission XML Guidance Document                                        vl.O
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 
 
-
 
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 lmazapyr Data Matrix - lnternal
 
- 
                                  22

-------
e-Submission XML Guidance Document                                      vl.O
 lmazapyr Data Matrix - lnternal
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
 N
 
- 
 lmazapyr Data Matrix - Internal.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 8570-35
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
                                  23

-------
e-Submission XML Guidance Document                                       vl.O
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 1
 
-
 
 
-
 
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 lmazapyr Data Matrix - Public
 
- 
 lmazapyr Data Matrix - Public
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
- 
 
 
- 
 N/A
                                  24

-------
e-Submission XML Guidance Document                                       vl.O
 
- 
 
 
- 
 
 
- 
 N
 
- 
 lmazapyr Data Matrix - Public.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 8570-35
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 
 
                                  25

-------
e-Submission XML Guidance Document                                       vl.O
-
 
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 ABC 452 44 H Data Matrix - lnternal
 
- 
 ABC 452 44 H Data Matrix - lnternal
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
 N
 
- 
 ABC 452 44 H Data Matrix - Internal.pdf
 
                                 26

-------
e-Submission XML Guidance Document                                       vl.O
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 8570-35
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H  Forestry Herbicide
 
-
 1
 
-
 
 
-
 
 
-
 N
 
 
- 
- 
 N
 
- 
 N
                                  27

-------
e-Submission XML Guidance Document                                       vl.O
 
- 
 N
 
- 
 ABC 452 44 H Data Matrix - Public
 
- 
 ABC 452 44 H Data Matrix - Public
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
 N
 
- 
 ABC 452 44 H Data Matrix - Public.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 8570-35
 
- 
 Y
 
- 
 R
 
                                 28

-------
e-Submission XML Guidance Document                                       vl.O
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H  Forestry Herbicide
 
-
 0
 
-
 
 
-
 
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 ABC 452 44 H  Self-Certification
 
- 
 ABC 452 44 H  Self-Certification Statement
 
- 
 Ribbon, Knoll.
 
                                  29

-------
e-Submission XML Guidance Document                                      vl.O
- 
 2006-09-08
 
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
 N
 
- 
 ABC 452 44 H Self-Certification.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 8570-37
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
                                  30

-------
e-Submission XML Guidance Document                                       vl.O
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 
 
-
 
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 ABC 452 44 H Label
 
- 
 ABC 452 44 H Label
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
- 
 
 
- 
 N/A
 
- 
 
 
- 

-------
e-Submission XML Guidance Document                                       vl.O
 
 
- 
 N
 
- 
 ABC 452 44 H Label.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 LB
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 
 
-
 
 
-
 N
                                  32

-------
e-Submission XML Guidance Document                                       vl.O
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 ABC 452 44 HCDI
 
- 
 ABC 452 44 H Cetification of Data lntegrity
 
- 
 Ribbon, Knoll. 
 
- 
 2006-11 -06
 
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
 N
 
- 
 ABC 452 44 HCDI.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
                                 33

-------
e-Submission XML Guidance Document                                       vl.O
 OTH
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 
 
-
 
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
                                  34

-------
e-Submission XML Guidance Document                                      vl.O
 ABC 452 44 H Transmittal Document
 
- 
 ABC 452 44 H Transmittal Document
 
- 
 Ribbon, Knoll.
 
- 
 2006-09-08
 
- 
 
 
- 
 N/A
 
- 
 
 
- 
 
 
- 
 N
 
- 
 ABC 452 44 H Transmittal Document.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 OTH
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
                                 35

-------
e-Submission XML Guidance Document                                       vl.O
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 
 
-
 99
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 2006/7009415 ocr (for electronic submission only)
 
- 
 ABC 452 44 H Herbicide Group A - Product identity, composition,
and analysis
 
- 
 Byrne, Tom.
 
- 
 2006-08-28
 
- 
                                  36

-------
e-Submission XML Guidance Document                                      vl.O
 6
 
- 
 N/A
 
- 
 12548944 
 
- 
 SubNo-200609-02-01, US-FR0415
 
- 
 N
 
- 
 20060004545 ocr (for electronic submission only).pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 ST
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
                                  37

-------
e-Submission XML Guidance Document                                       vl.O
 
-
 830.1552
 830.1603
 830.1624
 830.1655
 830.1674
 830.1706
 830.1756
 830.1806
 
-
 01
 
-
 N
 
 
-
- 
 N
 
- 
 N
 
- 
 N
 
- 
 2006/0004585 ocr
 
- 
 ABC 457 55 P: Determination of oxidizing/reducing action
 
- 
 Jacoub, Rob.
 
- 
 2006-02-10
 
- 
 13
 
- 
 N/A
 
- 
                                  38

-------
e-Submission XML Guidance Document                                       vl.O
 12548944
 
- 
 SubNo-200602-08-01, US-137423
 
- 
 N
 
- 
 20067001214ocr.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 ST
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 830.6314
 
-
 01
                                  39

-------
e-Submission XML Guidance Document                                       vl.O
 
-
 N
 
 
-
- 
 N
 
- 
 N
 
- 
 N
 
- 
 2006/1014132 US ocr
 
- 
 ABC 457 55 P - Acute oral toxicity study in rats
 
- 
 Lindsay, Rob.; Grammer, Andy.
 
- 
 2006-07-07
 
- 
 21
 
- 
 N/A
 
- 
 12548944
 
- 
 EU-1 OA0603/041007
 
- 
 N
 
- 
 20061014132 US ocr.pdf
 
- 
                                 40

-------
e-Submission XML Guidance Document                                       vl.O
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 ST
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 870.1100
 
-
 01
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
                                  41

-------
e-Submission XML Guidance Document                                       vl.O
- 
 N
 
- 
 2006/1014133 US ocr
 
- 
 ABC 457 55 P - Acute dermal toxicity study in rats
 
- 
 Lindsay, Rob; Grammer, Andy.
 
- 
 2006-07-07
 
- 
 26
 
- 
 N/A
 
- 
 12548944
 
- 
 EU-11A0603/041099
 
- 
 N
 
- 
 20061014145 US ocr.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 ST
 
- 
 Y
 
- 
 R
 
- 
                                 42

-------
e-Submission XML Guidance Document                                       vl.O
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H  Forestry Herbicide
 
-
 0
 
-
 870.2500
 
-
 01
 
-
 N
 
 
- 
- 
 N
 
- 
 N
 
- 
 N
 
- 
 2006/1008224 US ocr
 
- 
 ABC 457 55 P - Acute inhalation toxicity study in Wistar rats - 4-
hour liquid aerosol exposure
 
- 
 Hancock, Jack.; Jessica, Lisa.
 
                                  43

-------
e-Submission XML Guidance Document                                      vl.O
- 
 2006-03-23
 
- 
 38
 
- 
 N/A
 
- 
 12548944
 
- 
 EU-13!0603/040007
 
- 
 N
 
- 
 20061008224 US ocr.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 ST
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
                                  44

-------
e-Submission XML Guidance Document                                       vl.O
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 870.1300
 
-
 01
 
-
 N
 
 
-
- 
 N
 
- 
 N
 
- 
 N
 
- 
 2006/1018447 US ocr
 
- 
 ABC 452 44 H- Acute eye irritation in rabbits
 
- 
 Lindsay, Rob.; Raymond, Matt.
 
- 
 2006-06-13
 
- 
 24
 
- 
 N/A
 
- 
 12548944
 
- 
                                 45

-------
e-Submission XML Guidance Document                                       vl.O
 EU-11H0598/042312
 
- 
 N
 
- 
 20061018447 US ocr.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 ST
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 870.2400
 
-
 01
 
-
 N
                                  46

-------
e-Submission XML Guidance Document                                      vl.O
 
 
-
- 
 N
 
- 
 N
 
- 
 N
 
- 
 2006/1014134 US ocr
 
- 
 ABC 457 55 P - Acute dermal irritation / corrosion in
rabbits
 
- 
 Lindsay, Rob.; Raymond, Matt.
 
- 
 2006-07-03
 
- 
 22
 
- 
 N/A
 
- 
 12548944
 
- 
 EU-18H0603/04224
 
- 
 N
 
- 
 20061014134 US ocr.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
                                 47

-------
e-Submission XML Guidance Document                                        vl.O
- 
 ST
 
- 
 Y
 
- 
 R
 
- 
 A
 
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 870.2500
 
-
 01
 
-
 N
 
 
-
- 
 N
 
- 
 N
 
- 
 N
 
                                  48

-------
e-Submission XML Guidance Document                                      vl.O
- 
 2006/1014155 US ocr
 
- 
 ABC 457 55 P - Modified BUEPTER test (9 inductions) in guinea
pigs
 
- 
 Lindsay Rob.; Grammer, Andy.
 
- 
 2006-08-03
 
- 
 32
 
- 
 N/A
 
- 
 12548944
 
- 
 EU-33H0603/042234
 
- 
 N
 
- 
 20061014136 US ocr.pdf
 
-
 ABCXYCorporation - Robert Sullivan; w: (703)985-4547; m:
(703)654-6247; robert.sullivan@ABCXY.com
 
- 
 ST
 
- 
 Y
 
- 
 R
 
- 
 A
 
                                 49

-------
e-Submission XML Guidance Document                                        vl.O
- 
 
 
- 
 
 
- 
 
 
- 
 ABC 452 44 H Forestry Herbicide
 
-
 0
 
-
 870.2600
 
-
 01
 
-
 N
 
 
 
                                   50

-------