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Frequently Asked Questions (FAQs)
Click each Topic Area for a list of questions:General
Process
Errors
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:
An example of the Official Center Acknowledgement is shown below. MessageId: 666168.1122063776231.JavaMail.rmyneni@mnhu 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. For the DTD 2.0 ICSR file use the following header tags:
<?xml version="1.0" encoding="UTF-8"?> <!DOCTYPE ichicsr SYSTEM "http://www.fda.gov/cder/aerssub/icsr-xml-v2.0.dtd"> For the DTD 2.1 ICSR file use the following header tags: <?xml version="1.0" encoding="UTF-8"?> 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.
EDIFACT UNB Header Information
UNZ Trailer Information
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.fda.gov/cder/aerssub/pdfackxml.dtd The XML acknowledgment file header information is: 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: For the DTD 2.1 ICSR file use the following header tags: 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 1.5.0_11. 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? Q. Could you provide me the XML acknowledgement header information and DTD URL? 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. In the new version of the ESG, you can't hit enter after you have put in your username and password. You must actually click the Log In button. For more help with the registration and login procedures, see the User Guide. 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. Q. Our company uses a business partner to manage our Gateway-to-Gateway EDI connections. Can this vendor continue to submit on our behalf? If so, should they be credentialed as a company user or should they utilize one of their own certifications? A. A vendor / business partner can continue to submit on behalf of your company. Our paradigm will allow you to credential the vendor as a company user but we would prefer to have them utilize one of their own certifications. Q. For existing E2B AERS submitters, is a certificate and profile exchange necessary to become an AS2 transaction partner with the FDA ESG? A. Instead of a profile exchange, the online registration system will allow companies to provide all the profile information needed to setup an account with the FDA ESG. The certificate will be transferred to FDA using the online registration system. Once the account has been created, FDA will notify the responsible individual that the account has been activated and initiate testing. Q. Will submitters of ICSR messages receive three acknowledgements from the FDA ESG, instead of the two acknowledgements currently sent from the ESTRI Gateway? A. Submitters of ICSR messages will not receive three acknowledgements. Submitters of ICSR messages will continue to receive the same two acknowledgements from the FDA ESG that they currently receive from the ESTRI Gateway. Only submitters of other guidance compliant electronic submission types, such as NDAs, BLAs, or INDs, will receive three acknowledgements. Q. How do you add custom attributes to an AS2 header? A. Appendix G of the User Guide provides guidance on how to add two AS2 Header Attributes, one for Center Name, the other for Submission type. These are mandatory attributes that must be added for every submission that uses the AS2 Gateway-to-Gateway communication protocol. Typically, these attributes have to be added through custom coding. Refer to the documentation for your Gateway product to determine how to add custom attributes to an AS2 header. Cyclone Commerce has updated Cyclone Interchange (version 5.3.2) and Cyclone Activator (version 5.3.2) so that custom attributes can be added to the AS2 header using configuration parameters. Q. How do you cancel a submission using the FDA ESG web interface once a transmission has begun? A. When the upload progress window appears, press Cancel and this will cease the uploading of that submission. Q. Are there any special requirements for digital certificates? A. All digital certificates must be an X.509 version 3 certificate and all data fields in the Issuer and Subject fields must be completed. Reference Appendix C, Digital Certificates of the User Guide for more information on digital certificates. Carefully review the "Issuer" and "Subject" fields to be sure that all data fields are completed (i.e., for each data element such as "CN", there is a value that follows the equals sign). Certificates must be valid for 1 to 2 years. Certificates that do not conform to these requirements will be rejected by the FDA ESG System Administrator. Q. Our company currently uses a certificate that is valid for ten years – is this acceptable with the new FDA ESG? A. FDA policy is to accept an X509ver.3 certificate that is valid for only one to two years. It is the Transaction Partners responsibility to ensure that the validity period is acceptable and correct. Q. Where are digital certificates purchased? A. Listed below are the websites of some of the companies that sell digital certificates. Digital certificates issued by other authorities can also be used. http://www.digicert.com Q. Is there a difference between an X.509 v3 certificate and a Class 1, Class 2 and Class 3 certificate? Which Class of certificate does the FDA ESG require? A. FDA ESG requires that each account have an X.509 v3 certificate. This type of certificate can be classified as Class 1, 2 or 3. Class 1, 2, and 3 refers to the level of trust designated by the Certificate Authority (issuer of the certificate). Class 1 is the lowest level of trust and Class 3 is the highest. For a detailed description of each Class, refer to https://www.verisign.com/repository/CPS/CPSCH2.HTM#_toc361806948. The FDA ESG accepts all three certificate classes. The FDA ESG performs its own validation of the certificate owner. The FDA ESG uses the account certificate to verify that the company sending in a submission has the authority to send a submission. Digital signatures of documents in the submission may require a higher level of trust than that required by the FDA ESG. Please consult with the appropriate Center or system representatives to ensure your submissions are compliant with electronic submission requirements. Q. Can there be more than one digital certificate associated with a single account? A. Only one digital certificate can be associated with an account. The certificate can be replaced when it expires, without creating a new account. Q. When registering for another account, an error is received that says "Company name already exists". How can this error be addressed? A. The error indicates that there is already a company registered with exactly the same name. Company names cannot be identical for different registered accounts. For example, "ABCDrugs" can be used for only one account registration. The name must be changed in some way for other registrations. An example would be to use "ABCDrugsAS2" for the AS2 protocol registration and "ABCDrugsAS2" for the AS2 protocol registration. Other examples would be to use "ABCDrugs" for one account and "BBBDrugs" for another or "ABCDrugs.1" and ABCDrugs.2". Q. What is the character limit on the Company name? A. There is a character limit of 255 characters. Q. Can accounts be registered on a company, individual, and/or site basis? A. Separate accounts can be granted for the company, individual, and/or site. Conversely, one account can be utilized for the entire company. The business decision regarding the number of accounts to register will be entirely up to the transaction partner. The FDA ESG supports transactions at the company, individual, and/or site levels. Q. Is the non-repudiation letter solely for use during the testing period or is it carried forward to the production system environment? A. The non-repudiation letter is necessary to enable your corporation to submit electronic submissions to the FDA. It is mandated by 21 Code of Federal Regulations (CFR) 11 and specifically referenced in 21 CFR 11.100 (c) (2). A copy of the non-repudiation letter sent to the Office of Regional Operations (ORO) shall be provided to the FDA ESG Staff. The use of the non-repudiation letter applies to electronic submissions submitted both through the FDA ESG production system and via the mail. Q. Is it possible for a company to use both the FDA ESG web interface and the Gateway-to-Gateway exchange with the FDA ESG? For example, a company may want to send ISCR reports via the Gateway-to-Gateway exchange and other submissions via the FDA ESG web interface. A. Yes. The scenario described above is acceptable. Registration can be for any number of AS2 or FDA ESG WebTrader accounts. For example, there can be three AS2 accounts registered in addition to eight WebTrader accounts. Q. Is there a way to change a registration if a mistake is made? For example, registering for the FDA ESG web interface when the intention was to actually register for the AS2? A. There is no way for users to change and/or retract a registration. In the scenario described above, the solution would be to register for the AS2 communication protocol option as originally intended. Contact FDA ESG staff using esgprep@fda.hhs.gov to change contact information for a registration or to retract a registration. Q. Is there a recommended time of day to send submissions? A. Submissions can be transmitted at anytime via the FDA ESG. We recommend that you send large submissions via the FDA ESG after 4:30 PM EST. This should enable your submission to be received, processed and delivered to the Center overnight. Delivery and processing time is dependent upon the overall size of your submission; larger submissions will take longer to be delivered and processed. You will be sent an acknowledgement from the receiving Center with the date and time your submission arrived. The Center acknowledgement will contain the business rules used to determine the official receipt date of your submission. Errors Q. Why did I receive a disk space error when sending a submission using the FDA ESG web interface? A. Every time a submission is sent to the FDA ESG via the web
interface, a back up copy of the packaged (encrypted, tar'd &
gzipped) submission file is stored on the local PC. This
backup file is stored under: Q. Why did I receive a signing encryption error? A. Be sure to use the public key certificate that matches the certificate on file with FDA ESG. Verify the correct public key certificate was uploaded during the registration process by contacting the FDA ESG administrator and comparing the md5 fingerprints within the certificate. Q. Why did I receive a private key error? A. This error occurs when there is a mismatch between the public and private key for a certificate. Check to ensure the correct private key for the public certificate sent to the FDA ESG is in place. Obtain the correct private key and resend the document. Q. Why did I get a Federal Information Processing Standards (FIPS) error when sending a submission using the FDA ESG web interface? A. Make sure the correct JRE version or security policies are properly installed. Reinstall the JRE using instructions provided with that package. Reference Appendix D, Java Runtime Edition (JRE) Installation in the User Guide for more information. Note: FIPS are standards and guidelines that are developed by the National Institute of Standards and Technology (NIST) when there are compelling Federal government requirements such as for security and interoperability and there are no acceptable industry standards or solutions. Q. The following error was received when trying to import a digital certificate using the FDA ESG Web interface: A. 1) Check the file extension. The file extension must be
".p7b" or ".cer". Files with these extensions represent the
public key part of the certificate. Only the public key part of
the certificate can be imported. Reference Appendix C, Digital Certificates in the User Guide for more information. Q. When using the FDA ESG Web interface, an error message was received at the very end of a submission saying there was no response from the server and that the submission failed. A. When the FDA ESG has received a complete submission, a backup copy is made before the Java applet receives a reply from the server confirming the submission is complete. For large submissions (> 10 GB), this can take many minutes. Since there is no network activity for such a long time, the session timeouts and the Java applet never receives the response. The FDA ESG has received the submission successfully, but the Java applet returns an error and indicates that the submission needs to be resumed. Receipt of the first acknowledgement (MDN) confirms that the submission was successfully received by the FDA ESG and that it is okay to cancel the resume request. Since this is a large submission, it will take several hours before the first acknowledgement is received. Q. Why did I receive an "app not inited" error? A. This error usually occurs when the WebTrader Java applet does not intialize correctly. You can solve this by clearing your Java applet cache:
Q. My error was not listed here. What should I do? A. We may be able to assist you with your problem. However, it will help us to have a copy of your Java log. To obtain this:
Q. How do I reinstall Java? A. Reinstalling Java can be an effective solution to some errors. However, you must reinstall cleanly:
FDA has asked Cyclone Commerce to provide an update to the web interface that fixes this error. Last Updated: May 5, 2008 |