I don’t know a ton about the Australian band Royal Headache outside a few mp3’s and you tube vids, but I know enough to be excited to see the group Sunday night at the Triple Rock. The band, who recently released their debut LP on the awesome Memphis based garage label Goner Records, fall slightly towards the poppier side of vintage garage rock, with the melodies beating out the fuzz as the main focus. The tracks I have heard have that classic garage with a twist vibe that never seems to get old with me. The band is touring with fellow Aussies Bed Wettin’ Bad Boys, who seem to have heard of a certain 80’s Minneapolis rock group and taken a shining to their sound. Let’s just say Sorry Ma, Forgot to Take out the Trash obviously made it to Australia. A track from the band, along with a song from the self titled LP from Royal Headache, are below. Catch both bands with Juvie and Cozy for a cheap $6 Sunday night at the Triple Rock starting at 9PM.
Neil Weir of Old Blackberry Way recording studio fame recently put up a bunch of experimental/ambient recordings under the name “Devil On The Beach.” The four tracks (which you can stream on his bandcamp page) are relatively primitive dreampop orchestrations that pair heavily reverbed guitar strumming with echoing drum beats. Its a similar aesthetic to local artist Orchard Thief’s output, and it makes a great, slightly mind altering chill music. My initial favorite seems to be “Side 3″ which you can play below. Check out the rest at the bandcamp.
I have wondered recently what super fans in the future will do with all of their time. While fans of the Dead or Captain Beefheart or The Monks and dig and cross their fingers for outtakes, future musicheads are not going to be so lucky. Bands saturate the market with every last morsel of music they have, piling up EP’s and 7″‘s and tour only tapes and eight tracks and field recordings and…. One example of this trend is the uber prolific Kurt Vile, who released the solid haze-folk LP Smoke Ring From My Halo earlier this year and is following it up already with a deluxe version of the LP (it is less than a year old!) and a new EP So Outta Reach. The track below, “The Creature,” comes from the new EP and sounds like a Halo outtake (it probably is) and really doesn’t offer much beyond being more music Vile is putting out into the world. The good news is that at least Vile is good at creating large quantities of music, and if you liked Halo (and Vile’s work in general), you will like the track, but it can be a little tiring keeping up. And think about the music nerds of the future, how will they have such prized collections if there is no forgotten studio album to bootleg?
Weirdo math/noise punks Ho-Ag just dropped a new single out of the blue yesterday after a long period of non-recording (since 2008). “Seal the Room” and B side “Kuzka Mom” are both now available for free from the band’s bandcamp. The A side “Seal the Room” is a reckless piece of breakneck drumming, angular guitars, and haunted house synths. Buy comparison “Kuzka Mom” seems relatively laid back. It sounds a little like Alice and Chains if they were played backwards and at the wrong speed.
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.
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.
Vieux Farka Touré, son of Malian legend Ali Farka Touré, is gaining worldwide attention in his own right, most recently with his new LP The Secret. If you aren’t familiar with his sound, which mixes the traditional Malian music his father helped build with newer, more jammy sounds, listen to a live version of “Diarby Magni” below. You can also catch Farka Touré tonight at the Cedar Cultural Center.
“High School Lover” is a breezy little pop track from California band Oregon Bike Trails (which started as a Zach Yudin solo project and has since evolved into a full band). You can clearly hear the band’s 50’s and 60’s influence in the deceptively simple melody and reverbed vocals, all centered around a nimbly dancing bass line. Its simple but its effective and makes for a pretty little earworm. Listen to teh single here and pick up the limited editition white vinyl 7″ from Father/Daughter Records on 9/13.
Firetalk Records are best known for the spaced out pysch-kraut of Tjutjuna and Woodsmen, so the softer, more pop sounds of Night Manger come as at least a little bit of a surprise to me. “Pizza Pasta,” is a woozy, garage pop track that is based around a swooning, echo laden female vocal hook and the kind of back to the basics guitar work that has drawn so much attention to female fronted garage rock groups recently (think Dum Dum Girls, Mayfair Set, Best Coast, etc). While previous work on Firetalk has been more of a deep fried acid trip, “Pizza Pasta” is a sugary buzz of pop that will fit nicely in your fall mixtape. Grab the 7″ from Firetalk HERE.
For a reference point, new band Purity Ring are hopping on board a tour with Neon Indian and Com Truise, so people familiar with those two bands will have a good guess at their sound. For those unfamiliar with the aforementioned bands, each are heavy on 80’s nostaliga, channeled mostly through pristine pop music, vocal effects and synth tomfoolery. On the new Purity Ring 7″, the shimmering pop of “Belispeak,” the group show similar chops and clearly are up to the task of shouldering the weight of pop music of days gone by as easily as their two tour mates. Check out the track below and if you are intrigued, check them out Oct. 13th at the First Avenue Mainroom.