Oneohtrix Point Never is the ambient/electronic project for Danial Lopitan, better know these days as half of the 80’s synth duo Games. While his other project has seemingly gotten him more attention, he really has cut his teeth making amazing music under his OPN moniker, most recently with the spellbinding Returnal, which was and is a underrated gem of the last few years. He is back with his new LP Replica, which will be dropping this fall on his new Mexican Summer imprint Software. The first song we have heard from the LP is the chilly electronic track “Sleep Dealer,” which follows up and expands upon the lush, noisy pop dissonance of Returnal. Hopefully his success with his side project will help to spur more attention to his work, because the music he is creating is going places and doing things that other artists simply are not. Look for a full review of Replica in the very near future.
Electronic SPL filing process requires new steps and content than paper filing.(Validation) website duns number lookup
Validation Times December 1, 2009 | Winn, Melissa A.
WASHINGTON — Electronic SPL filing under SPL R4 is designed to make the process easier and more efficient, but the process is vastly different than the previous filing of paper forms 2656, 2657 and 2658.
Gary Saner, a senior manager at Reed Technology and Information Services, told a Dec. 8 Center for Business Intelligence workshop that the process “is not a straight line affair. It’s cyclic.” The process, he said, involves three steps: Labeler Code Request, Establishment Registration and Product Listing/Labeling. Knowing the process and what content is required for each step is critical to pass validation.
The SPL NDC Labeler Code Request (SPL-LCR) is used to obtain a new NDC labeler code and to register existing NDC labeler codes in the new FDA eList system. Saner said the Labeler Code Request should be submitted first, and in fact, it must be submitted before any listing or labeling information can be submitted. The labeler code request must be submitted via FDA’s Electronic Submissions Gateway system (ESG).
Ron Celeste, president, ThinSpring, told attendees: “You need to send this because FDA is not migrating old numbers into the new system. The only way your code gets in is if you submit a valid NDC Labeler Code Request.” “For each product listing file there must be one and only one Labeler,” Celeste said.
Once a particular Labeler Code is submitted in SPL, no future paper submissions should be made for that Labeler Code, Saner said.
When submitting a Labeler Code Request, the company will need to have contact information for the company’s designated contact and the facility’s DUNS number. The Data-Universal-Numbering-System (DUNS) number is a unique 9 digit identification number provided by Dun & Bradstreet (D&B) and is site specific. If not immediately known, the number can be retrieved from or assigned by D&B, if one is not already assigned. Retrieving a DUNS number from D&B or being assigned a new one can take up to 30 days, so all presenters advised industry to work on collecting this piece of data as soon as possible. (See Sidebar on DUNS numbers, Page 5.) Celeste said a new DUNS number may be required for foreign establishments, and the registrant should “research import activities to identify each importer used by each foreign establishment.” With a Labeler Code Request submitted, companies must then submit Establishment Registration (SPL-REG) before any listing can be submitted. Saner said a manufacturing corporation may have one SPL-REG identifying all establishments owned by the corporation or multiple SPL-REGs, one for each sub-company, identifying all establishments owned by each company.
The registrant, Celeste said, is the owner and operator of the medical product processing facility (establishment). An establishment can only be listed in one Establishment Registration file.
An Establishment Registration must be submitted annually. If content doesn’t change, Saner said, a company can submit an “SPL-No Change” by Dec 31. If content changes, a company should submit a new SPL-REG version at the time of the change or wait until the next December. If the registrant goes out of business, it must submit an “SPL-Out-of-Business.” Finally, the company can submit its labeling and listing file (SPL-LL). In order to do so, Saner said, the product Labeler and all Establishment sites identified in the product SPL must be previously listed in a SPL-LCR and SPL-REG respectively. go to web site duns number lookup
With SPL R4 in place, labeling and listing submissions must contain some new data not previously required, including marketing and manufacturing data. Saner said the new filing should include manufacturing information such as the labeler, the registrant, establishment sites, operations, etc. It should also include product listing information such as active moiety, product size, UNII, etc. and marketing information such as category, status, dates, etc.
If content doesn’t change, there’s no need to submit a duplicate SPL-LL, Saner said. If Listing or Labeling content does change, he advised, submit a new SPL-LL version at the time of the change or wait until the next June/December (Listing change) or the Annual Report anniversary (Labeling change).
SPL filing does not end with submission, Saner said, but it creates a cyclic effect. He said maintenance is required and the content manager should monitor labeler code, establishment and listing changes; should update the SPL as appropriate; and resubmit SPLs when appropriate.
By Melissa A. Winn Managing Editor Winn, Melissa A.
