Generics+--+4-07-09+Minutes

**April 7, 2009 **     1. Meeting minutes from 3/10/09 - are posted on the Wiki site - any questions, additions, etc? No.  2. Update on Two Major Technical Errors In SPL R4 Submissions (taken from an email from Mary Beth Wilusz and Patrice L. Mckoy commenting on a note from Lonnie Smith)  Below is information regarding two common errors the FDA is seeing with SPL r4 submissions. The first error impacts submissions for ER and DL. The second errors potentially impacts all submissions (ER, DL and application). Please make any necessary changes to your processes to avoid these errors. We will discuss the impact of these errors further at the next SPL Process Communication Forum on April 8th. Thanks Mary Beth
 * Minutes for Generic HL7 SPL Sub Team **

Error update from pilot eList submissions: Here are two major errors in SPL R4 documents submitted since July 2008. 1. **SPL R4 documents submitted for the purpose of electronic drug establishment registration and drug listing without a folder.** As stated in section 5 of the //Instructions for using Electronic Drug Establishment Registration and Drug Listing XForms v1.0 // <span style="font-size: 10pt; font-family: 'Arial','sans-serif';">which was published in July 2008 with the draft guidance  //<span style="font-size: 10pt; font-family: 'Arial','sans-serif';">Guidance for Industry: Providing Regulatory Submissions in Electronic Format  ////<span style="font-size: 10pt; font-family: 'Tahoma','sans-serif';">– ////<span style="font-size: 10pt; font-family: 'Arial','sans-serif';"> Drug Establishment Registration and Drug Listing " //<span style="font-size: 10pt; font-family: 'Arial','sans-serif';">SPL files including all image files are placed in a folder and sent through the FDA Gateway." **__<span style="font-size: 10pt; color: red; font-family: 'Arial','sans-serif';">If the SPL R4 file is submitted for the purpose of electronic drug establishment registration and drug listing without the folder via the OC gateway folder, the file will fail validation. __** No comments. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-fareast-font-family: Helv; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold; mso-bidi-font-family: Helv;"> 3. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">A question was raised by one of our group with regard to APIs: a)  I'd be interested to find out how people are contacting all their API suppliers/manufacturers to advise them of the requirements for SPL (that they need a DUNS # and need to register with the FDA) if they are not already. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">     b)   Who is the best point of contact, the CEO/CFO?? <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> c)  In obtaining the DUNS #s thru the D&B website I have found that many of our foreign API suppliers are not listed with the address we have on hand so I have had to ask D&B to investigate, Is anyone else experiencing this?? <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">    One firm reviewed the API supplier websites and then requested DUNS numbers from their Finance or Accounting Departments. If these departments were not accessible, then contact was made with the CEO/President. Most of the time, the information came from the Accounting Department within a couple of days.   Another approach is to contact your sales rep from the API supplier and obtain the appropriate contact person.  Some firms are not listed with D&B. In that case, utilize the API NDC number, as FDA has said is permissible. This information is provided in the Source NDC field. FDA has stated that they will manually process the SPL files with no API supplier DUNS number to avoid validation issues. But don’t forget to include the NDC numbers! Most, if not all, US companies will have a DUNS number assigned. D&B will provide DUNS number, for a fee. Some sites have been found to have multiple DUNS numbers...which one should be used? FDA has recommended that the DUNS number for the corporate office be used. To assist companies without a DUNS number, some firms has sent emails to their API suppliers with instructions/links/information on how to obtain the DUNS number. This has proven to be helpful and encourage a supplier to apply for a DUNS number. Give as much assistance as possible to make it as easy as possible for the supplier. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-fareast-font-family: Helv; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold; mso-bidi-font-family: Helv;"> 4. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">A June 10th Face-to-Face SPL R4 Training Session has been scheduled <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> For more information on new training opportunities offered by FDA, check out the Training Page on the wiki. There is still room in the June 10 meeting and the latest webinars. <span style="color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-weight: bold;"> <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-fareast-font-family: Helv; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold; mso-bidi-font-family: Helv;"> 5. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">Discussion of successful submissions through the Electronic Gateway <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> Some people are successfully submitting through the gateway; some have not yet tried. Reed Tech has submitted successfully for their clients (over 24 submissions for LC, ER and COL/DL). Note, FDA offers a Webinar on this topic. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-fareast-font-family: Helv; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold; mso-bidi-font-family: Helv;"> 6. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">D&B Update - who to contact if there are issues <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> No new information. The D&B website provides information on this topic. There are basically three ways to get the DUNS numbers: 1. Pay $15 for each number. 2. Go through your company account with D&B. 3. Wait to get the numbers off the FDA website, as they get posted. The D&B website provides contact information for the D&B representatives who can help. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-fareast-font-family: Helv; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold; mso-bidi-font-family: Helv;"> 7. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">Development of General SPL Press release. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> The press release is almost complete; it is undergoing final review. The purpose of this release is to get the information out to everyone in the community who needs to know about SPL. It is apparent that, even today, many companies/organizations are unaware of the SPLr4 initiative. This short, one-page release will first be published in trade and industry journals. If anyone knows of specific target audiences, please pass this information to Virginia or Jeffery.
 * <span style="font-size: 10pt; font-family: 'Arial','sans-serif';">2. Incorrect Gateway routing of SPL R4 electronic drug establishment registration and drug listing files and application submissions. ** <span style="font-size: 10pt; font-family: 'Arial','sans-serif';">A few companies are utilizing the CDER or CBER gateway folders to submit SPL R4 eList submissions to FDA. **__<span style="font-size: 10pt; color: red; font-family: 'Arial','sans-serif';">If any gateway folder other than the "OC" folder is used to send in eList submissions, the file will not reach the appropriate center or office and will not be processed. If an eCTD file is submitted to "OC," it will not route to the appropriate center. __**

<span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-fareast-font-family: Helv; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold; mso-bidi-font-family: Helv;"> 8. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">How can we be of assistance? We need Agenda items to keep team running. A reminder to submit agenda items was provided. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-fareast-font-family: Helv; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold; mso-bidi-font-family: Helv;"> 9. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;">AOB <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> DIA is planning an SPLr4 workshop in August, 2009 in the Philadelphia area. If anyone has suggested topics for the workshop, please provide to Virginia or Jeffery. <span style="font-size: 10pt; color: black; font-family: 'Helv','sans-serif'; mso-bidi-font-size: 12.0pt; mso-bidi-font-weight: bold;"> General Questions: Q1. If a distributor submits its LC Notification to FDA, however, the registrant (manufacturer) has not registered electronically, will the distributor’s COL/DL file be returned as invalid? A1. FDA has stated that they will allow such files to be accepted during the pilot program. To encourage as much participation in the pilot program as possible, they will not penalize a distributor for submitting electronically just because the manufacturer has not submitted the registration electronically. After June 1, 2009, all parties must submit electronically in order to pass validation. Q2. If only the API NDC number is provided initially, can a firm update the SPL file to include the API supplier DUNS number, once it is obtained? A2. Yes. Be sure to consider the subsequent file an UPDATE, following all the relevant rules for an update.