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U.S. Department of Health and Human Services

For Industry

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Frequently Asked Questions - General

The Following Are General Questions About The Electronic Submissions Gateway(ESG):


Q. What is the format of the Official Center Acknowledgement (second acknowledgment)?

A. The Official Center Acknowledgement is a text file that is sent to the sender via the FDA ESG (it is not an email).  This text file contains:

  1. the original Message ID for the submission;
  2. the date/timestamp for when the submission arrived at the Center;
  3.  a unique identifier (called the CoreID) which the FDA ESG assigns to every submission and uses for reference purposes; and
  4. a description of the Center business rules for processing of submissions.

An example of the Official Center Acknowledgement is shown below.

MessageId: 666168.1122063776231.JavaMail.rmyneni@mnhu
CoreId: 1122063551533.777@appserver7
DateTime Receipt Generated: 4:25:17,7-22-2005

The date and time stamp contained in this message conveys when (Center name or Programmatic entity) received your submission from the Electronic Submission Gateway.  If your submission was received at (Center name or Programmatic entity) after 4:30 PM EST, the official receipt date for the submission is the next government business day. 


Q. How do you convert SGML ICSR to XML in to format?

A. Steps to Convert the SGML ICSR to XML are as follows:

1. Remove the EDIFACT header and footer from SGML ICSR.
2. Add the following XML header tags at the beginning of ICSR file

 

For the DTD 2.0 ICSR file use the following header tags:
<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE ichicsr SYSTEM "http://www.accessdata.fda.gov/xml/icsr-xml-v2.1.dtd">

 

For the DTD 2.1 ICSR file use the following header tags:

<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE ichicsr SYSTEM "http://www.accessdata.fda.gov/xml/icsr-xml-v2.1.dtd">

These tags are necessary to make the file XML compliant; the DOCTYPE value can contain a link to corresponding DTD.


Q. What is the required message structure (EDIFACT) for Internet transport?

 A.
Example: UNB+UNOB:1+016968919:01+FDA:ZZ+060310:0127+37'              Header
                        SGML document                                                               SGML Document
                'UNZ+1+37'                                                                                         Trailer

 

EDIFACT UNB Header Information

DescriptionCodeComments
Identification of the start of the UNB headerUNBThe code for the start of the UNB header should be UNB in upper case letters
Version of the standard of the UNB headerUNOB:1The current version code should be UNOB in upper case letters
Interchange sender identification code and sender code qualifierxxxxxxx:01 (for AS2 submissions this should match the routing ID)xxxxxxx should be the number assigned to your company by Dun and Bradstreet Information Services. (For industry sending to the FDA, the sender code qualifier is 01.)
Interchange recipientFDA:zzxxxx should be the code for the receiving center (CDER, CBER, CDRH, CVM,
CFSAN)
Date and time of preparationyymmdd:hhmmFor now, a two-digit designation should be used for the year
Interchange control referenceUp to 14 alphanumeric
characters
You should assign a unique reference number for each interchange. Otherwise the system will not recognize the transmission as new

UNZ Trailer Information


Description
CodeComments
Identification of the start of the trailerUNZThe code for the start of the trailer is UNZ in upper case letters
Interchange control countUp to 6 numerical charactersCounts either the number of messages or the number of functional groups within the interchange. Usually, this is 1
Interchange control referenceUp to 14 alphanumeric charactersThis should be the same as the interchange control reference in the UNB header

EDI headers and trailers are made up of a series of data elements separated by plus (+) signs. A colon should separate segments of the individual data elements. An apostrophe should be used to terminate the header, body of the message, and the trailer


Q. What is the DTD definition for the acknowledgment for an ICSR (Literature) PDF attachment?

A. Acknowledgement for ICSR (Literature) PDF attachment is a XML file. The URL for DTD version 2.1 is found at: http://www.accessdata.fda.gov/xml/pdfackxml.dtd

The XML acknowledgment file header information is:
<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE ichicsrack SYSTEM "http://www.accessdata.fda.gov/xml/pdfackxml.dtd">


Q. Is there any guidance for migrating existing ESTRI production clients to the FDA ESG?  Most of the information is related to clients new to electronic reporting.

A. Separate guidance for the migration of existing ESTRI production clients was not developed.  The process for existing ESTRI clients is the same as for new users.  While FDA understood that companies might encounter some difficulties in their migration to the new Gateway from the ESTRI Gateway, we took every step we could to minimize the burden on changing to the new interface.  This includes the use of an online registration system to facilitate setting up an FDA ESG account.

FDA recommends that ESTRI clients first establish themselves as transaction partners for the FDA ESG.  This can be accomplished by creating a new AS2 account with the FDA ESG.


Q. Are there any special requirements for the XML header when sending E2B files in XML format other than adhering to the XML standard of starting the file with the "?xml version=" and "!DOCTYPE" tags?

A. No, adhering to the XML standard is the main requirement.  The EDIFACT header and footer is only required for SGML submissions.  Refer to Appendix I of the FDA ESG User Guide for information on the EDIFACT header and footer.  Examples of how to use XML tags mentioned above are provided below:

For the DTD 2.0 ICSR file use the following header tags:
<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE ichicsr SYSTEM "http://www.accessdata.fda.gov/xml/icsr-xml-v2.0.dtd">

For the DTD 2.1 ICSR file use the following header tags:
<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE ichicsr SYSTEM "http://www.accessdata.fda.gov/xml/icsr-xml-v2.1.dtd">


Q. Are AERS reporting submissions "tarred" and "gzipped"?

A. No. "tarring" and "gzipping" occurs automatically only for multifile submissions sent via the FDA ESG web interface  Single file submissions, such as AERS reporting submissions, are not typically "tarred" or "gzipped".


Q. Is the use of Secure Socket Layer (SSL) mandatory or optional when using the AS2 transport protocol?

A. SSL is mandatory when using the AS2 transport protocol.


Q. Is it necessary to use the same digital certificate to sign both the individual documents within a submission and the submission package itself?

A. Different digital certificates may be used for the submission package and the documents in the package.


Q. What is the "Routing ID" referred to in the submission registration instructions?

A.  The Routing ID is a unique identifier that the FDA ESG web trader interface uses to identify an account.  It is recommended that the company's Data Universal Numbering System (DUNS) number be used for this, but any alpha-numeric text string is acceptable.


Q.  Are there plans to support current versions of the Java Runtime Edition (JRE) as they are released?

A.  At this time, the only supported version is JRE 1.6.X. 

Reference Appendix D, Java Runtime Edition (JRE) Installation in the User Guide for more information.


Q. What is the URL for online registration? 

A. The URL for online registration is: https://esg.fda.gov. When you access this site, the Login page is displayed, prompting you for a User ID and Password. To log in, use the User ID and Password that you received from FDA when you sent a request to start the registration process.


Q. What is the purpose of the second acknowledgement?

A. The second acknowledgement was designed to convey back to Industry the time when a Center took receipt of an electronic submission delivered via the FDA ESG.  The time a Center receives the submission determines when the PDUFA review time clock starts, subject to the business rules of the Center.  


Q. My computer froze up/crashed while sending a submission using the FDA ESG web interface.  How do I restart the transmission?

A: Note: this answer applies to web interface users:

If the submission had begun transmitting (i.e., signing was already completed) to the FDA ESG when the computer froze or crashed, log back into the FDA ESG web interface.  The file you were attempting to send will be on the top left hand side. Your options are to resume sending or deleting the submission. Check to make sure there is ample disk space. It is recommended that you have disc space of at least three times the size of the transmission.


Q. Do I get XML acknowledgement when I submit the ICSR as XML file?

A. Yes, the ICSR XML submissions receives XML formatted acknowledgment.

For the submission icsr-xml-v2.0.dtd
You will receive icsrack-xml--v1.0.dtd Ack file.

For the submission icsr-xml-v2.1.dtd
You will receive icsrack-xml-v1.1.dtd Ack file.


Q. Could you provide me the XML acknowledgement header information and DTD URL?

A. The following are the header and URL information:

For the DTD 2.0 ICSR file:
<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE ichicsr SYSTEM "http://www.accessdata.fda.gov/xml/icsr-xml-v2.0.dtd">

For the DTD 2.0 ICSR file
<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE ichicsrack SYSTEM "http://www.accessdata.fda.gov/xml/icsrack-xml--v1.0.dtd">


Q. Is there a deadline for conversion of ISCR SGM-based messages to XML-based messages? 

A. At present, FDA does not have a deadline for the conversion to the XML based message. FDA is encouraging migration to the XML message because FDA has the capability to process the message.


Q. Why can't I log in?

A. Make sure you are using the correct case for the User ID and Password on the Login Screen. Also you may refer to the User Guide for further instructions on how to log in to your account.


Q. What is the character limit for path names in eCTD submissions?

A. CDER has experienced situations where sponsor eCTD submissions have become corrupted because of excessively long path names in the xlink:href attribute. The maximum character limit for the FDA is 150 characters. This limit is shorter than the limit given in the eCTD specification which calls for 230 characters max.


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