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Did you watch the most recent Wrestlemania? I didn't. I also haven't had a Mountain Dew in seven years. I guess this means I'm finally an real adult, which means I should do the mature thing and write a list for an audience of people who are mostly hung-over and sitting in cubicles. This week, I'll ... More >>
Trent Reznor and pals will play betwixt the monoliths in Morrison in July with grunge hero Soundgarden. Red Rocks's summer calendar continues to fill out -- Daughtry, Goo Goo Dolls and Blues Traveler also announced shows there this week. The rest of the concert calendar updates follow.
For the little bit of time I spent living in New York City, there were many times when I found myself homesick for Colorado. The only things that seemed to quell the unnecessary self-sorrow were trips to Target and McDonald's. Those places were reminders of my somewhat suburban American existence, a ... More >>
THE AVETT BROTHERS @ RED ROCKS | FRI & SAT, 7/5-7/6 The country is awash in Americana fever as scores of rock-radio favorites dabble in the sounds of yore. Though it might be cute, many of the current banjo-picking types fail to elevate their style beyond gimmick. A huge exception is the Avett Broth ... More >>
ALABAMA SHAKES @ RED ROCKS | SUN, 6/2/13 Brittany Howard of Alabama Shakes has a powerful and mesmerizing voice and she sings with an impassioned believability that sounds like she has experienced a fuller life than her young years could hope to contain. Her earthy vocals and the band's solid, vibra ... More >>
Steely Dan is making its way back to Colorado for a show at Red Rocks this August, and there's a bunch of other new shows to let you know about, including Brad Paisley at Fiddler's Green, the Geto Boys at Summit Music Hall, Ride Festival and Selena Gomez. Keep reading for the full rundown on these s ... More >>
Ever the equal opportunity rocker, Kid Rock is bringing his Best Night Ever tour to Fiddler's and every seat in the house is $20. "Everyone knows the economy is still hurting people across the country," he says, "but I didn't want that to be a reason why everyone couldn't get out and enjoy themselve ... More >>
As firefighters continue to tackle the wildfires ravaging large portions of the state, local communities are searching for ways to provide aid, even from hours away. In Denver, a handful of local live music venues and companies have already stepped up to launch shows to benefit fire relief efforts - ... More >>
BLUES TRAVELER / RUTHIE FOSTER @ BOULDER THEATER | 2.26.12 Apart from the band's annual Fourth of July show at Red Rocks, it's tough to imagine a better local setting for a Blues Traveler show than the eTown radio concert series on the Boulder Theatre stage. The intimate feel of the venue, the conv ... More >>
Big pics below.You were busy this weekend. We know, because we've been keeping track of the phone you had on our Show and Tell, Backbeat Online and Cafe Society blogs, as well as our slide show page. Look below for samples featuring Blues Traveler, Oscar winner Daniel Junge, Matt Selby and B ... More >>
John Popper seems stunned by the fact that Blues Traveler boasts a longer lifespan than a legal drinker. Popper, who helped launched the band as a quartet in a New Jersey garage in the mid '80s, has seen the outfit go through fundamental changes. The commercial success of the album Four in 1994, the ... More >>
Here's what's hot this week in music on the Front Range: On the concert front, new shows featuring the Avett Brothers, James Taylor, Blues Traveler and Gogol Bordello were announced; Gauntlet Hair, Hindershot and Fierce Bad Rabbit got spins on local radio; and recent albums from Van Halen, Dr. ... More >>
Here's what's good in the Mile High City this week. On the concert front: The Fox Theatre and Boulder Theater are hosting the first annual Boulder Blues and Roots Summit. Bad Brains is coming to the Summit Music Hall in August and Blues Traveler is coming back to Red Rocks for its annual Fo ... More >>
Thursday, March 18 Uh, hey. It's Danielle Ate the Sandwich. I've been on the road and away from home a couple of days now, and am officially one hour from Austin and ready to go. Today, I play at Bar 512 for the Spokesbuzz Showcase. I'm excited to play with a lot of great bands from Fort C ... More >>
Aaron ThackerayThe Samples.Boulder alumnus the Samples packed the area in front of the Wolf stage with their bluesy, funky jams with heavy dance hall/world influence. They played "Did You Ever Look So Nice" and the segued into "Giants," with Blues Traveler's John Popper jumping in on harmonic ... More >>
Freelance photographer Mark C. Austin is in Chicago this weekend for Lollapalooza. Here are photos from Saturday's sets. More coming Monday.Green Day
This year's Red Rocks line-up has been filling in rather nicely, and there's been a few more additions this week, including a second Sting date that's been added, Blues Traveler's annual Fourth of July show, the Barenaked Ladies, Michael Franti & Spearhead, Reggae on the Rocks, Celtic Woman and To ... More >>
This year's Lollapalooza lineup has been revealed. Bold face names this time around: Soundgarden, Green Day, Lady Gaga, Arcade Fire and Erykah Badu, alongside nearly ninety of the brightest emerging acts, including MGMT, Grizzly Bear, the National, Yeasayer, Phoenix, Frightened Rabbit and Edward S ... More >>
As if we didn't already have enough reason to find our way to Tennesee to catch the Flaming Lips playing Dark Side of the Moon in its entirety, we now have even more incentive -- namely, Chromeo with Daryl Hall and Stevie Wonder!
As previously reported, Tori Amos will stop at the Paramount Theatre on Tuesday, July 21, in support of her new album, Abnormally Attracted to Sin, which was released last week. Blues Traveler, who's made an annual tradition of playing Red Rocks on July 4, returns again this year. Tickets for both s ... More >>
Here's an index to all the great content you missed this week on Backbeat Online while you were busy gaping in sheer disbelief at the ridiculous prices Beatles memorabilia was demanding at auction...
You can plan it on your calendar. Every year on the 4th of July John Popper and his Blues Traveler mates stop by Red Rocks. Here's what the show looked like through the lens of Soren McCarty.
Head to the Denver Coliseum for the Lowrider Tour.
With over a dozen songs licensed to television, he's ready for his close-up.
Fast reviews of recent releases
The bands on the July 29 Red Rocks bill don't qualify as the newest and hottest combos on the planet. Ween, the show's headliner, actually formed way back in 1984, although its first long-player wasn't released until 1990. The Flaming Lips, which played in the second slot, are even older, springing ... More >>
Stoned Emotion (Delta 32 Music)
Tuesday, October 25, and Wednesday, October 26, Fox Theatre, Boulder, 303-443-3399.
The mountains win again at the South Park Music Fest.
A bang-up way to celebrate an earthy Fourth.
My Private Nation (Columbia)
July 3, 2003
As American As...
The hills are alive with the sound of music. Ever wonder why?
Catching up with local releases, our music writers review local albums to the letter.
Bassist Jeffrey Marshall hasn't found an obstacle yet that he couldn't overcome.


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Archive for April 2013
The Technician arrives in HAWKEN today along with a new map
HAWKEN is being updated today and the game's first ever medic/support Mech called the Technician is being added.
Vampires apparently have loads of skills. New DARK video demonstrates
Kalypso's action third person action/RPG DARK will take players into the world of vampires as Eric Bane but what skills to vampires actually have?
FIFA 14 revealed with new features. Check out the videos and shots
After a quick tease yesterday, EA has revealed more details of FIFA 14 as the top selling footy franchise gets new features.
IncGamers Podcast #111
This week, the podcast team is pleased to find Cevat Yerli vindicating the site's 6/10 Crysis 3 review with the comment that graphics are "60% of a game." At least two of us are excited by the details released so far about the PC version of Dark Souls II, and nobody is quite sure what to make of EA's new-found love for toothpaste.
Crate show Grim Dawn Focus Items
This week Crate Entertainment take a look at Focus items in the latest developer update for their ARPG Grim Dawn.
SimCity Crest DLC touches a nerve – DLC to boycott for ethical reasons
Last month Maxis released the free DLC for the Nissan Leaf which at the time received a mixed reaction from the community.
Indie 'god game' Reus reveals May release date
As a rule, I try not to get too enthusiastic about anything before its released.
Ranger danger: Metro Last Light gives you a second helping of survival tips
This three part Metro Last Light series is making it fairly clear that life both below and above ground is (to put it mildly) dangerous.
Lords of Football Review
My star striker is a fat alcoholic, I've got a kleptomaniac defensive midfielder called 'The Mummy' and in my last match I was denied a winning goal by a 'keeper called 'The Flying Viking.' Welcome to Lords of Football, where sporting matters are somewhat less serious than Football Manager.
So what is going on in Defiance? These new trailers explain
The Defiance TV show has now aired on the SyFy channel and I know not all of you will have been able to watch the show yesterday so the story may be a little confusing.
House mouse: Sega is remaking Castle of Illusion
Sega and Disney Interactive are teaming up to bring back Castle of Illusion (Starring Mickey Mouse), a title first spotted on the Sega MegaDrive/Genesis system back in 1990.
Bethesda posts cryptic looping video, says it's not about Fallout
Oh that Bethesda, always toying with us.
Their latest cryptic move, as spotted by NeoGaf, is to post a looping video on Vine (I don't even know what Vine is, am I old?) showing glimpses of barbed wire and a pair of LPs (I know what LPs are, I'm definitely old.)
One record is attributed to Bach, while the other is labelled as "The Moonbeam Trio." Bethesda's Pete Hines has already given a pretty resounding nope to suggestions that this could be a Fallout thing.
Marvel Heroes Beta Key Giveaway
IncGamers has teamed up with Gazillion for Marvel Heroes giving you the chance to take part in the beta test between Friday April 19th until Sunday April 21st.
18 frantic Minutes of Rise of the Triad gameplay
Fast paced shooters are few and far between these days but if you like super speed in your multiplayer then Rise of the Triad should get you excited.
IncGamers Plays Company of Heroes 2 – Watch the RTS action
Company of Heroes 2 from Relic and SEGA is one of the most talked about RTS titles of 2013.
No more Skyrim DLC, as Bethesda team moves to "next major project"
An update on the Bethesda blog from the development team working on Skyrim reveals that after a year and a half working on updates and DLC for the game, the studio is moving on to it's "next major project." That project has been in pre-production for a while, but is now said to require the attentions of a full team of people.
Dark Souls II launches shield design contest on Facebook
Namco Bandai is running a shield design contest for Dark Souls II over on Facebook, so if you feel like flexing your medieval-style art skills get on over there and create a stunning piece of heraldry.
Sam practises his stalking in this Splinter Cell Blacklist trailer
Watch out terrorists, Sam Fisher is up to his old stalking tricks again.
ARMA 3 gets new fog technology in patch
Bohemia Interaftive has just released a new patch for the ARMA 3 alpha which adds new features as well as ton of fixes.
EA to shut down Sims Social, Pet Society and SimCity Social
EA continue to carry out restructuring and three of their social games which include Sims Social, Pet Society and SimCity Social are getting the axe.
SimCity tops UK charts for another week
SimCity has managed to stay on top of the UK PC game charts for week ending 13 April.
Defiance content will vanish – Play before it's removed
Defiance has been out for a week, and as all players know, the big sell on this game is the tie-in with the TV show.
Black Ops 2 Personalisation Packs available for PC
Already released for the 360, PC gamers can now snag the Call of Duty: Black Ops 2 Personalisaton Packs.
Maxis update on SimCity improvements and fixes
SimCity fixes continue with a list of planned updates from Maxis, some of which have been applied to the test server already.
Dark Souls II: What we know so far about the PC version
Last year's release of Dark Souls on the PC was … let's be gentle in a way the game is not and say "a little lacking." It was still the same superb, generation-defining title (and in many ways superior to the console versions, even in its ropey ported state,) but the transition had all the signs of being handled by people who had no idea what they were doing.
Build the theme park of your dreams with Theme Park Studio
Older gamer will remember Bullfrog's excellent Theme Park, but let's face it, the game was a little on the cutesy side.
Death Inc revived with paid alpha
Ambient Studios recently failed to reach their Kickstarter goal for their strategy title Death Inc but that's not deterred them.
Twelve tasty Grim Dawn screenshots with action
It's been a while since we saw any action shots from Crate Entertainment's ARPG Grim Dawn but there's a treat today with twelve new pieces of eyecandy.
Rivals, anti-griefing and more in Grid 2's multiplayer system
A major part of any racing game is challenging your friends (and hapless strangers,) cruising past them and watching in the wing-mirror as they weep at the side of the road at the intensity of your driving skills.
Space Hulk devs Full Control will be making a Jagged Alliance game too
As if developing a new, PC-bound version of Space Hulk were not already enough excitement for one studio to bear, Danish team Full Control has also managed to get a licensing agreement in place for a new Jagged Alliance title as well.

subset: commoncrawl


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On-the-Record from Jen Psaki, Spokesperson: Department of State Formal Protest of the Decision by the Government of Bahrain to Expel Assistant Secretary Malinowski from Bahrain
The following update can be attributed on-the-record to Jen Psaki, Spokesperson:
On July 8, 2014, the Department of State summoned the Chargé d'affaires of the Embassy of the Kingdom of Bahrain in Washington, D.C. to formally protest the decision of the Government of Bahrain to expel Assistant Secretary of State for Democracy, Human Rights, and Labor Tom Malinowski from Bahrain during his recent trip to the Kingdom.
We reiterated that Assistant Secretary Malinowski's visit had been coordinated in advance with the Government of Bahrain. The purpose of his trip was to reaffirm and strengthen our bilateral ties, and to support the political reconciliation efforts at an important time. To that end, we registered our deep concern about reports that the Bahraini government called in opposition figures for questioning following their meetings with the U.S. delegation.
We also reiterated our view that the Government of Bahrain's demand to have a Foreign Ministry representative present at Assistant Secretary Malinowski's private meetings runs contrary to the longstanding partnership between the United States and Bahrain, and is inconsistent with international diplomatic protocol.
We look to the Government of Bahrain to take actions consistent with our strong bilateral relationship. We also look to all sides to recommit themselves to the reconciliation process, which remains the focus of our diplomatic engagement.
On the Decision by the Government of Bahrain to Find Assistant Secretary Malinowski Persona Non Grata and To Expel Him From Bahrain – 7/07/14


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Haydel's Dove call produces the cooing sound to locate and call Mourning Doves
We promise to never spam you, and just use your email address to identify you as a valid customer.
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A New Mexico State University research librarian has created a Google discussion group that tallies the staggering number of murders in Juarez, Mexico, since 2008. Membership includes academics, activists, and U.S. and Mexican journalists interested in the violence. View the Frontera List online.
See all the latest links and resources that supplement the current issue of Security Management magazine.


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Inspections, Compliance, Enforcement, and Criminal Investigations
Feign, Michael, D.O. 09-Oct-03
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, Maryland 20850
Via Federal Express
Michael Feign, D.O.
Front Range Orthopedic, L.L.C.
1633 Medical Center Point
Colorado Springs, Colorado 80907
Dear Dr. Feign:
The purpose of this Warning Letter is to inform you of the objectionable conditions found during a Food and Drug Administration (FDA) inspection conducted at your clinical site and to discuss your written response dated June 11, 2003, to the deviations noted, and to request a prompt reply with regard to your corrective actions. The inspection took place during the period of April 14 through 24, 2003, and was conducted by Ms. Teena Aiken, an investigator from FDA's Denver District Office. The purpose of the inspection was to determine if your activities as a clinical investigator for [redacted] investigational study of the [redacted] complied with applicable FDA regulations. These products are devices as defined in section 201 (h) of the Federal Food, Drug, and Cosmetic Act.
The inspection was conducted under a program designed to ensure that data and information contained in requests for Investigational Device Exemptions (IDE), Premarket Approval (PMA) applications, and Premarket Notification (510(k)) submissions are scientifically valid and accurate. Another objective of the program is to ensure that human subjects are protected from undue hazard or risk during the course of scientific investigations.
Our review of the inspection report submitted by the district office revealed serious violations of requirements of Title 21, Code of Federal Regulations (21 CFR), Part 812- Investigational Device Exemptions and Part 50- Protection of Human Subjects, and Section 520(g) of the Act. You received a Form FDA 483, "Inspectional Observations," at the conclusion of the inspection that listed the deviations noted and discussed with you. The deviations noted on the Form FDA 483, our subsequent review of the inspection report, and your response to the Form FDA 483 items are discussed below:
1. Failure to maintain control of the device, failure to ensure that informed consent is obtained, and failure to report use of investigational device without informed consent to the sponsor and reviewing IRB (21 CFR 812.100, 21 CFR 50.20, and 21 C.F.R. 812.150(a)(5))
On December 28, 2001, subject [redacted] was [redacted] with the investigational device. Subject [redacted] was not enrolled in the study and did not sign an informed consent form. You failed to maintain control of the investigational device, did not ensure informed consent was obtained prior to [redacted] the investigational device into subject [redacted] and did not report use of the investigational device to the reviewing IRB. In accordance with 21 CFR 812.100, investigators are responsible for: maintaining control of devices under investigation and must not supply an investigational device to any person not authorized to receive it. As required by 21 CFR 812.100 and 21 CFR 50.20, an investigator must ensure informed consent is obtained from subjects or the subject's legally authorized representative prior to his or her participation in au investigational study. If informed consent is not obtained because of emergency use, investigators are responsible for reporting use of the investigational device to the sponsor and reviewing IRB within five working days after the use occurs (21 CFR 812.150(a)(5)).
In addition, page three of the Investigator's Agreement has a statement of certification that written informed consent will be obtained from subjects or their legal representatives. You sighed this agreement and are obligated to follow it, under 21 CFR 812.100.
Your response states that you were instructed by the sponsor to [redacted] subject [redacted] on a prescription basis. Also, you are following-up with subject [redacted]. Your response is not acceptable in that it does not adequately address the reasons for not enrolling [redacted] into the study, or how to avoid future deviations. FDA regulations do not provide for the "prescription" use of an unapproved device currently under IDE. Your records contain nothing to demonstrate that the investigational device was [redacted] in subject [redacted] in accordance with 21 CFR 812.36, FDA's regulations governing treatment use of an investigational device, and our records do not indicate that FDA has approved treatment use of this device.
2. Failure to conduct the study in accordance with the approved investigational plan and protocol, the investigator agreement and any conditions of IRB approval; failure to obtain IRB approval of changes to informed consent forms (21 CFR 812.100 and 812.110(b); 21 CFR 50.27(a))
On October 23, 2001, the Memorial Hospital IRB approved the investigational plan dated May 7, 2001, and a revised informed consent form (revision dated October 1, 2001) which is part of the investigational plan and protocol. Correspondence that you received from the IRB clearly indicated that changes to the investigational plan or protocol should be reported to the IRB:
- The October 23, 2001, letter approving the initial protocol contains a statement for protocol changes to be reported to the IRB.
- The IRB's letter, dated August 27, 2002 contains a statement for your site to notify them of any changes to the protocol.
You failed to follow the protocol and IRB requirements in that:
- You did not notify the reviewing IRB of the October 5, 2001, and May 2, 2002, revisions to the informed consent forms. As a result, fifteen out of twenty-one patients signed a revised informed consent form that had not been approved by the IRB, as required by 21 CFR 50.27(a).
- You did not notify the reviewing IRB of several protocol changes with revision dates of August 29, 2001, October 5, 2001, November 12, 200l; and May 15, 2002.
- Subjects [redacted] and [redacted] did not meet the inclusion/exclusion criteria specified in the investigational plan. Your records contain evidence that they were included in the study.
On February 20,2003, the FDA approved the use of a [redacted] with the investigational device. During the inspection, you mentioned that you used the [redacted], also known as the [redacted]. During the years 2001 and 2002, the [redacted] was not approved for use, was not a part of the investigational device, and was not included in the investigational plan. Any use of the [redacted] prior to FDA approval of a revised protocol permitting its use is considered a deviation from the investigational plan. Page three of the Investigator Agreement includes a statement that "all non-emergency deviations from the FDA approved investigational plan require prior approval from FDA, the sponsor, and the appropriate IRB." The Investigator Agreement also includes a statement that any deviation from the plan be reported to the IRB, sponsor, and FDA as soon as possible but not later than five working days. You did not receive approval to use the [redacted] nor did you report your usage of this [redacted] to any of these entities, and thus you did not follow the Investigator Agreement.
Your written response indicates that [redacted] (the sponsor) made changes to the informed consent form and you were not told to send the revised forms to your IRB Your response is not acceptable, as it is your obligation to follow FDA regulations, the investigational plan, and IRB conditions of approval, regardless of whether or not the sponsor instructs you to take a particular action required by those authorities. Your response also does not adequately address the various changes to the protocol and [redacted] or how to avoid future deviations. Your clinical site received correspondence which instructed you to notify the IRB of any changes to the research study. In addition, the June 25, 2002 Continuing Review Report Form, with your signature, has a question about protocol changes. Your reply to the question is "N/A" which indicates not applicable or no changes to the research study although there were changes made. During the inspection, you acknowledged your participation in changes to the [redacted]
In addition, your records contain evidence that subjects [redacted] and [redacted] did not meet the inclusion/exclusion criteria, yet they were included in the study. In your written response you state that subject [redacted] was never enrolled into the study but was assigned a number by mistake, and that case reporting forms (CRFs) were started but that the subject was excluded from the study based on an excessive body mass index. Your response to this observation is inadequate in that you do not provide any corrective actions or details on how to avoid future deviations.
Your response for subject [redacted] states that [redacted] at the time, was regarded as "at the same surgery." On page two of the CRF #l, there is an exclusion criteria for [redacted] As noted in the operative report, Subject [redacted] had a history of [redacted] and significant degeneration, and needed [redacted] Your response to these observations is inadequate in that you do not provide any corrective actions or details on how to avoid future deviations.
In order to protect the rights, safety, and welfare of subjects under an investigator's care, clinical investigators are required to ensure that investigations are conducted according to the signed agreement, the investigational plan and applicable FDA regulations (21 CFR 812.100 and 812.110(b)).
3. Failure to adhere to informed consent requirements (21 CFR 812.100, 21 CFR 50.20, 50.25(a), 50.25(b)(2) and 50.27)
A review of the informed consent forms at your study site revealed that the informed consent forms revised June 15, 2001, and July 5, 2001; and May 15, 2002 did not contain a description of the [redacted] procedures, contact information pertaining to research and research-related injury, witness information or signatures; or a statement of anticipated circumstances of subject's possibility of termination by the investigator. A few examples follow:
- For subjects [redacted] and [redacted], contact information on the informed consent forms was blank. The IRB and investigator information was missing on subject [redacted] informed consent form.
- For Subjects [redacted] and [redacted] informed consent forms did not have any witness information or witness signature.
Further, subject signatures on several informed consent forms preceded the version date listed on that form. For example, the informed consent form signed by subject [redacted] has a version date of April 8, 2003, but the subject signed the informed consent form on March 20, 2003. Subject [redacted] signed an informed consent form on April 3, 2003 but the version date was April 8, 2003.
In accordance with 21 CFR 812.100, clinical investigators are responsible for ensuring that informed consent is obtained in accordance with the regulations. Investigators must obtain informed consent from the subject or the subject's legally authorized representative prior to his or her participation in an investigational study (21 CFR 50.20). The basic required elements for informed consent are set forth in 21 CFR 50.25(a). An investigator is responsible for providing information including: a description of the procedures to be followed, contact information for research-related injury and questions, and anticipated circumstances under which a subject's participation may be terminated by the investigator (21 CFR 50.25(a)(1), 50.25(a)(7) and 50.25(b)(2)). Also, informed consent must be documented by the use of a written consent form approved by the IRB. 21 CFR 50.27(a). The fact that subjects signed the consent forms before the forms revision dates indicates that those versions of the consent form were not approved by the IRB when they were signed. Also, that form calls for witness signatures, and hence, if that form was approved by the IRB, documentation of witness signatures was required.
In addition, paragraph four of the Memorial Hospital IRB's Certification of Review form, dated October 23, 2001, has a statement that informed consent is to be given or read to the study subject prior to the subject's participation in the study. Your signature on the Investigator's Agreement indicates your understanding of FDA's regulations, the IRB and sponsor's policies and procedures.
Your written response states that contact information was not typed into one of the revised informed consent forms and that has since been corrected, and [redacted] sent the informed consent forms. You indicate that you do not know how subjects could have signed informed consent forms on dates that precede the version date printed on the form. Your response does not address all of the problems noted above, and does not address the failure to assure that the informed consent forms that you used were approved by the IRB. Although some corrective action was taken, your response does not have details of further corrective actions and how to avoid future deviations.
4. Failure to report unanticipated adverse device effects (21 CFR 812.150(a)(1))
You failed to report to the reviewing IRB the adverse events for subjects [redacted] and [redacted] In addition, during the inspection Ms. Aiken discussed other unanticipated adverse events, as follows:
- Subject [redacted] development of pitting edema in lower extremities; and
- subject [redacted] development post-operative of right [redacted] pain, redness, and swelling.
An investigator is required to report to the sponsor and to the reviewing IRB any unanticipated device effects as soon as possible, but in no event later than ten working days after the investigators first learns of the effect (21 CFR 812.150(a)(1)).
You indicated in your written response that subject [redacted] was examined, and the complaints were felt to be physiologic and part of the new [redacted] functions which are not a problem or complication. Your response is inadequate. In your written response, you do not provide any details about the reporting of all adverse events to the sponsor or IRB, or the steps your clinical site will take or have taken to avoid future deviations.
5. Failure to maintain accurate and complete device accountability and subjects' records (21 CFR 812.140(a)(2) and 812.140(a)(3))
A review of the subject files revealed that device accountability records, CRFs and adverse event forms were incomplete or not properly maintained. Deficiencies noted include:
- Failure to properly maintain accurate, complete, and current device accountability records. There were no [redacted] usage tickets for 22 out of approximately 34 subjects.
- Failure to record inclusion/exclusion information, or to document range of motion. For example, the record for subject [redacted] contains no inclusion/exclusion documentation.
- Failure to complete operative reports. For example, for subjects [redacted] and [redacted] operative reports were blank or incomplete.
- Failure to maintain case history supporting data. For example, none of the medical records included the body mass of study subjects. A body mass greater than [redacted] is an exclusion criteria.
- Failure to maintain adverse event forms and case report forms. During the inspection, you were unable to provide the following items: adverse event form for subject [redacted], six week CRF for subject [redacted] CRF operative report and [redacted] usage ticket for subject [redacted] second [redacted] replacement; and adverse event report for subject [redacted].
FDA regulations require investigators to maintain accurate, complete, and current records of receipt, use or disposition of the investigational device, and each subject's case history and exposure to the device (21 CFR 812.140(a)(2) and 812.140(a)(3)).
Your written response has a statement that not all of your office charts are complete but the study documents are complete; the protocol is lacking in how your personal files are to be maintained or how to document information; many of the entries in different ink were completed later; and you were not aware at the time that a separate form should have been completed. Your response does not adequately address the steps you will take or have taken to correct the deviations and avoid future ones.
We do not intend the list of deviations noted above to be an all-inclusive list of deficiencies that may have existed in your clinical study.
During the close-out discussion, you acknowledged to Ms. Aiken that you did not have an adequate understanding of the regulations and you promised to notify the IRB of the changes in the protocol, informed consent form, [redacted] and [redacted] in patients not enrolled in the study. As a clinical investigator participating in an investigational device study, you are responsible for ensuring that adequate informed consent is provided to and obtained from study subjects participating in the study. Also, you are responsible for maintaining control of the investigational device and for ensuring that the investigation is conducted according to the investigational plan and applicable FDA regulations. To assist you, please refer to the complete guidance in the "FDA Information Sheets, Guidance for Institutional Review Boards and Clinical Investigators," and on the Internet at www.fda.gov/oc/ohrt/irbs/faqs.html#ClinicalInvestigations. Enclosed to assist you in better understanding of your responsibilities as a clinical investigator are copies of 21 CFR Parts 50, 56, and 812. These documents also are available electronically at www.access.gpo.gov/nara/cfr. Part 812 describes your responsibilities as a clinical investigator of an investigational device and Part 50 includes what is required to protect the welfare of study subjects. Part 56, Institutional Review Board, covers the responsibilities of IRBs and what an IRB expects from you as a clinical investigator, as well as their responsibilities to you.
Please inform us in writing within 15 working days of receipt of this letter, of the additional corrective actions you have taken or plan to take with regard to the deviations noted. Please send this information to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring, Program Enforcement Branch II (HFZ-312), 2094 Gaither Road, Rockville, Maryland 20850, Attention Linda Godfrey. Failure to respond could result in regulatory action without further notice.
A copy of this letter has been sent to FDA's Denver District Office, Building 20, Denver Federal Center, Post Office Box 25087, Sixth Avenue and Kipling Street, Denver, Colorado 80225. We request that a copy of your response also be sent to that office. If you have any questions you may contact Linda Godfrey, telephone at (301) 594-4723, ext. 134.
Sincerely yours,
David R. Kalins for
Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health


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Melting Pot Lyrics - Toxic Narcotic
Thrown inside this so called melting pot
pressed against the walls, the spoon don't hit this spot
crushed up, blackened, burned by the walls we rot
you try to mix it up but seperations what you got
the way it looks from here, youth's filled with fear
it's how it looks from here, the mounting storm front
The way it looks, who's at the helm, who steers?
no matter who's in power, oppression turns the gears
steal, rape, oppress - blame it on the next
you guess what's best - but youre always
fucking wrong again- dont try to reach me
keep on grabbin - but it aint free
brainwashed school - they try to teach me
what's to be done before we all crash
head first into the wall is all it takes to wake up
and realize who's victimized - not you or the man
the almighty dollar in demand - here's the plan
nothing but confrontation
Fueled by distrust and misinformation
keep em fighting and watch disintegration
Keep them down, no win Situation!
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Thu 27 Nov 2014
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What Up, Nerds
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Description: Your weekly podcast for all things nerdy. Games, movies, tv shows, tech... you know, nerdy stuff.
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What Up, Nerds Episode 18, back from the holiday break–with a bit of a cookie hangover–but back nonetheless. This week we talk about or favorite games, movies and television shows of 2012 and touch on what we look forward to in 2013. Music Outro: Chumbawumba – Tubthumping
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KHMR is a broadcast radio station from Lovelady, Texas, United States, providing Classic Hits and Rock music.
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Luxury Lounger
The Luxury Lounger is made of UV resistant mesh polyester with a mesh bottom for fast drainage.
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To fund her late-night vinous habits, Natalie MacLean holds down day jobs as a wine writer, speaker and judge. An accredited sommelier, she is a member of the National Capital Sommelier Guild, the Wine Writers Circle and several French wine societies with complicated and impressive names.At the World Food Media Awards in Australia, Natalie was named the World's Best Drink Writer. She is the only person to have won both the M.F.K. Fisher Distinguished Writing Award from the James Beard Found
Well maybe the one above, or perhaps the Baby Duck I had behind the high school portable. Ouch!Read more
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Domaine de Grand Pré Vintner's Reserve L'acadie Blanc 2010
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steel plate,
license data,
plate prices,
Catherine Ngai
NEW YORK Demand in the steel plate market remained flat this week, with sources anticipating continued steadiness into the fourth quarter.
"Things have been very flat, pretty much like all of 2013. Theres no reason for me to believe that were going to see a change until maybe the first of the year," one Midwest service center source said. "I dont see anything happening in the fourth quarter that will change that."
However, despite a steady outlook, mills and service centers said that a softening in steel prices in certain parts of the country this week were due to competitive imports and pressure by service centers because of stiff competition downstream.
"Were just in a malaise. The only thing thatll change it for us is if we see some confidence go back into maintaining better inventory," one mill source said. "I think most of our customers, including manufacturers, continue to be very cautious on inventory."
Midwest discrete plate prices softened to $35 per hundredweight ($700 per ton) this week, down from $35.50 per cwt ($710 per ton) last week. Some sources said deals in the $34-per-cwt range were possible with some mills in more competitive regions.
Market sources had previously speculated that the string of sheet price hikes through the summer would lift plate prices. However, while the plate market had a slight uptick for several weeks, much of that strength has dissipated, market participants said.
Some reasoned that the sheet increases were supply constraints rather than demand, which is why it has not translated to the plate market.
"Were not expecting any big changes one way or another," a Mid-Atlantic service center source said. "Things are very flat."
On the import front, foreign plate has gained little traction. Imports through the summer show volumes close to half of what arrived last year, particularly as U.S. prices were relatively low compared to world prices.
A slight uptick, however, seems likely in September, with about 70,832 tonnes arriving through Sept. 25, license data from the U.S. Commerce Departments Import Administration shows. Foreign material, including about 8,238 tonnes from Italy, about 11,087 tonnes from Turkey and about 14,060 tonnes from France, are poised to hit the United States. While volumes are lower than expected, some said, it may be enough to keep domestic prices at bay.
"Import doesnt have a big enough price advantage for people to place a lot of tons, but there are enough offerings out there that are continuing to suppress pricing so you cant raise domestic prices because demand isnt strong enough," the first mill source said.
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ScreenHunter Free 6.0.229
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Reviewed by Elena Opris, last updated on August 13th, 2014
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Book Description:The story of Etsuko, a Japanese woman now living alone in England, dwelling on the recent suicide of her daughter. In a story where past and present confuse, she relives scenes of Japan's devastation in the wake of World War II.
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Find records of Aleri Mcculley
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Aleri Eugene McCulley (born 1874) was born on September 4, 1874. Aleri was born into the Mcculley family.
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Dec. 5—The 25 states that opted not to expand Medicaid eligibility under healthcare reform added more people in the first month of marketplace enrollment than the 25 states that widened eligibility, as residents who were previously eligible for Medicaid but were not enrolled begin to sign up for coverage.
Only 25 states had formally expanded their Medicaid program's eligibility to all residents with incomes of up to 138 percent of the federal poverty level, as authorized by the Affordable Care Act (ACA). Enrollment for the newly eligible began in October. But states that chose not to expand eligibility also saw a surge in October enrollments under their tighter eligibility standards.
States found more than 1.4 million applicants for insurance through the ACA marketplaces or state agencies were eligible for Medicaid and the Children's Health Insurance Program (CHIP) in October, the Centers for Medicare & Medicaid Services (CMS) reported this week. The agency reported last month that another 183,396 applicants through the federal marketplace were found eligible for Medicaid. Taken together, non-expanding states added 880,415, or 54 percent, of newly enrolled Medicaid/CHIP beneficiaries in October, while 23 of the expanding states qualified 757,991, or 46 percent. When the later expanding states of Michigan and Ohio were added, total signups from the expanding states rose slightly to 763,348.
The total number of enrollees in October could rise further because some state figures are preliminary and might only represent the number of applications, which each could include more than one enrollee.
The surge in Medicaid and CHIP enrollment in non-expanding states appeared to confirm the beginning of the so-called woodwork effect, under which health policy experts projected many people who were unenrolled but eligible before the expansion would come forward during the federal marketplace enrollment push.
Although the rate of enrollments increased more in expanding states in October from previous months, non-expanding states garnered more enrollees because they include many of the states with the largest numbers of previously eligible but unenrolled residents.
The CMS report credited the enrollment increase to streamlined enrollment processes most states have implemented using ACA funding and to the increased publicity the ACA brought to the availability of Medicaid coverage.
"Many states that are not expanding Medicaid, but have implemented the simplifications and modernizations provided for in the law, are seeing some increase in applications among already-eligible-but-uninsured state residents," the report stated.
The woodwork enrollees could carry significant costs for states because states' share of the costs of covering those pre-ACA Medicaid enrollees, which averages 43 percent, is significantly higher than the 0 to 10 percent costs states will bear for covering ACA expansion enrollees.
The 1.6 million Medicaid approvals in October appears to put overall enrollments well along to the 8 million people the Congressional Budget Office estimated would gain Medicaid coverage in 2014, although no monthly CMS enrollment targets have been issued. Medicaid sign-ups—unlike private insurance coverage through ACA marketplaces—can continue throughout 2014.
The enrollment figures came as the Commonwealth Fund issued projections this week regarding the amount of federal funding that non-expanding states will lose—totaling billions of dollars by 2022—because they chose to forgo the 90 to 100 percent federal matching rate for those residents newly eligible for Medicaid by rejecting expansion. States that stand to lose the most for their decision not to expand Medicaid are Texas ($9.2 billion by 2022), Florida ($5 billion), Georgia ($2.9 billion), Virginia ($2.8 billion) and North Carolina ($2.6 billion), according to the Commonwealth Fund.
Publication Date: Thursday, December 05, 2013
Amy Amick, president, revenue cycle management, and William Davis, vice president, revenue cycle advisory solutions, both with MedAssets, share insights on the industry and techniques to drive sustainable performance improvement.
Eric Ward, president and CEO, Parallon Revenue Cycle Services, discusses key trends in revenue cycle management and factors providers should consider when partnering to advance their revenue cycle performance.
Doug Festermaker, managing partner and executive vice president of health care, Warbird Consulting Partners, shares strategies to leverage outsourced CFO expertise to lead special projects or fill interim roles while recruiting is underway.
Dale Hockel, senior vice president of operations, and Jim Fanelli, CFO, TriMedx, share strategies for elevating clinical engineering through innovative management programs.
Rick Heise, senior vice president, revenue cycle, at Cerner Corporation, discusses the importance of integrating clinical and financial data to excel in health care's changing payment environment.
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November 27, 2014
A new interactive smartphone and computer app featuring Iowa's trails is under development and organizations behind the development hope to launch it later this year.
Once completed, the "Iowa by Trail" app will feature an interactive map that allows users to locate their position, find the closest trail and find points of interest along the way. It also will keep track of distance, weather, news and events and communicate with friends and followers about their experience.
The Iowa Natural Heritage Foundation is working with the Greater Des Moines Partnership, the Des Moines Area Metropolitan Planning Organization, the City of West Des Moines, and other private partners to raise money to produce the app and website. The foundation needs $59,000.
The expected release date for the app is late this year.
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Oh, the drama! Why weren´t they pushing for this TWO YEARS ago?
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"What difference, at this point, does it make?"Hillary.
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Hey, Halimah Abdullah, you ARE aware that these a muslims doing these acts in the name of allah, are you not?
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"I knew the 20 women of the Senate, standing united and speaking in unison, were in a position to send a very powerful message, one that not only condemns this crime but that also helps spur action to bring these girls back home safely to their families," Collins told CNN in a statement.And they will not take "no" for an answer.Well ... that should do it!Powerful? Chatting among themselves, signing a letter, introducing meaningless legislation.
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These scientific rockets, known now as the "Congressional Sisterhood" apparently never realized that Boko Haram has been around many years, that they persecute and kill Christians, and that they are a militant Islamic terrorist group.It is a disgrace that they believe twitter is the answer to getting these girls back.
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Another Republican lawmaker in Missouri is getting national attention -- this time for a very short piece of legislation that critics say could punish poor children who get sick. House Bill 1040, introduced last week, says in its entirety: "School age children of welfare recipients must attend pub ... More >>
Republican legislator Representative Zachary Wyatt held a press conference today in Jefferson City at which he and several of his colleagues officially denounced the much-ridiculed "Don't Say Gay" bill proposed by fellow Republican Rep. Steve Cookson. Wyatt then announced to the world that he is gay ... More >>
A week after Republicans sponsors in the Missouri House referred it to committee, a bill that would severely restrict conversations about sexual orientation in public schools is under attack from a growing number of detractors including educators, doctors and fellow politicians. HB 2051 would permit ... More >>
A Missouri legislator from near the Arkansas border is pushing a bill that would severly restrict conversations about sexual orientation in Missouri schools.State Rep. Steve Cookson's HB 2051 is backed by 19 co-sponsors who helped push the legislation last week to the House Elementary and Secondary ... More >>
Legislators call for a probe of the nonprofit that governs Missouri high school sports.


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Gov. Bill Haslam speaks during the Chattanooga Area Chamber of Commerce's annual meeting Wednesday afternoon at the Chattanooga Convention Center.
Photo by Dan Henry .
published Wednesday, August 24th, 2011
Stories this photo appears in:
Saying he has talked with more than 1,000 business chiefs in his first eight months in office, Tennessee Gov. Bill Haslam told Chattanooga leaders Wednesday the state's workforce is too shallow in engineering and technical skills.


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Back from Honeymoon
Duration: 01:20
Title sequence and opening scenes from the comedy series. Gavin and Stacey, on the way home from honeymoon have a radio conversation with Bryn and Gwen and Nessa.
Available since: Tue 23 Apr 2013
This clip is from
Gavin and Stacey Series 2, Episode 1
1/7 Stacey and Gavin return from honeymoon to a big welcome from both families.
First broadcast: 16 Mar 2008


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January 8, 2009
Veolia Transportation, in conjunction with New Orleans Regional Transit Authority (RTA), took delivery of 10 Sprinter shuttle buses with optional side entry wheelchair lift from Daimler Buses North America.
Veolia Transportation is working with New Orleans RTA to offer a newly designed flex route service to the citizens of New Orleans beginning in February 2009.
The Sprinter shuttle buses will operate in areas of New Orleans that are still recovering from Hurricane Katrina in 2005, allowing them to reach other areas of New Orleans where they can then join the regular fixed routes provided by RTA.
The ADA-compliant Sprinter with optional side-entry wheelchair lift offers seating for eight passengers, plus driver, with two wheelchairs or 14 passengers, plus driver, and has successfully completed the seven-year Altoona Bus Test.
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Fort Myers Beach, Fla - A massive search off Ft. Myers Beach has been going since around 7pm Thursday.
Crews went well into the night concentrating their efforts off Lovers Key possibly due to the strong current. Rescuers are walking up and down the beach in hopes of possibly spotting that missing boater.
The Lee County Sheriffs Office tells us two men in their early to mid 20s were on 20 foot boat when they hit a sand bar about a mile out and were throw into the water.
One of the men managed to swim to shore and was rushed to the hospital the other hasn't been seen since.
The one boater's condition remains unknown tonight.
Two women walking down the beach say they heard the cries for help and immediately got in the water to help.
The Coast Guard, FWC and members of the Lee County Sheriff's Office all took part in the search for the man.


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Frederick Olson, Automotive Contributor
Tim Fuller-USA TODAY Sports/Reuters
Cleveland Browns general manager Ray Farmer said Monday that the team is investigating reports of a fight that took place at an upscale apartment in downtown Cleveland on Friday night that involved rookie quarterback Johnny Manziel.
Texas Sen. Ted Cruz is floating an unexpected option to take over for outgoing Defense Secretary Chuck Hagel: Former Sen. Joe Lieberman, a former Democrat turned Independent from Connecticut.
In the rarefied world of the wealthy, timber is the hot new commodity.
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Humidity 28%
Winds 0.0mph
Humidity 28%
Winds 0.0mph
Humidity 41%
Winds 12.7mph
Oct 31, 2011 12:15 AM by Jordan Mason
DENVER (AP) - The Colorado Rockies have declined their $11 million mutual option for next season on right-hander Aaron Cook, the franchise's career leader in wins.
Cook had a rough season in the final year of his contract, going 3-10 with a 6.03 ERA. The sinkerball specialist was bothered by shoulder stiffness in spring training and then he broke his right index finger when he slammed it in a door, forcing him to miss the first two months of the season.
The 32-year-old Cook, who's the team's career leader in wins (72), innings pitched (1,312 1-3) and starts (206), could be brought back at a reduced price.
(Copyright 2011 by The Associated Press. All Rights Reserved.)
11 hours ago


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Crab Apple Whitewater sends adventure seekers on river-bound thrill rides daily from early April through mid-October using inflatable kayaks for Class I–II rapids and larger group rafts for Class II–IV rapids. Crab Apple Whitewater charts routes through the Berkshire Mountains on rivers such as the Deerfield, making use of natural flows and daily dam releases in order to control the challenge for kayakers and rafters of all skill levels. Trips are consistent due to dam control, but vary based on interpretations of fortunes found in the guide's tea leaves the night before. All adventurers strap on provided helmets and life jackets and attend a safety lecture prior to casting off.
Those who follow Deerfield River westward from the Catamount State Forest to the Mohawk Trail State Forest travel through the hilly terrain of historic Charlemont. There, in 1989, the Berkshire Mountains and other geographical spoils caught the eyes of Bruce Lessels and Karen Blom—a medaling member of the US whitewater team and a public health nutritionist looking to make the outdoors more accessible. They built Zoar Outdoor on the river, establishing an 80-acre facility to be a base for ziplining, rock climbing, camping, and solar-powered lodging. Today, a staff of adventurers keeps that base running. They not only sell an arsenal of outdoor gear and continue those establishing activities, but also lead whitewater rafting and kayaking trips down their home river, slicing through the waves and rearranging a slew of fishes' living rooms along the way.
Established: 2000
Reservations/Appointments: Required
Staff Size: 1 person
Average Duration of Services: 1?2 hours
Brands Used: Our mini-yacht is an Aquarius 21: safe, comfortable and fun.
Pro Tip: Our boat has a big cockpit, a bow sundeck and a swim ladder. Bring sunscreen, hats and smiles.
Handicap Accessible: No
Parking: Parking lot
Most Popular Attraction/Offering: Evening sails: Twin Lakes, Salisbury CT
Recommended Age Group: Adults
From its outpost on on Lake Quinsigamond, Regatta Point Community Sailing has trained recreational sailors to hit the water for more than 50 years. Since it opened in 1960, the member-based club dedicates itself to accessible, safe, and responsible boating programs that maintain a respect for the environment—another reason why the club will never try to cut corners by trading canvas sails for a bunch of gas-powered hair dryers. The staff of instructors imparts sailing fundamentals to experienced seafarers and newcomers as well as children. Three youth tracks are offered for future captains, including a ten-week summer camp, a junior membership program, and the Deckhands after-school program in the fall and spring.
The town of Kent, about 1 mile away from Club Getaway, charms visitors with its small-town atmosphere and eclectic attractions. Pedestrians saunter alongside rustic wooden storefronts, passing a diverse collection of local cafés and shops. Kent's many galleries host frequent exhibitions with handmade pieces lining walls and shelves, a reflection of the town's longstanding appreciation for the arts. Club Getaway's foliage-filled landscape extends beyond its borders into other nearby parks. A stately string of waterfalls glide down 250 feet of limestone hills at Kent Falls State Park, about a 10-minute drive from Club Getaway. A designated trout park, Kent Falls also provides hikers with a steep, quarter-mile journey next to the tumbling water. Other parks in close proximity host campgrounds, picnic areas, and swimming sites.
Hornet Marine President David Hartmann got his taste for boat design from his father, Hal, an engineer who helped create the smooth-riding deep-vee hull now included on each Hornet 17 speedboat. Today, the 17-foot seacrafts zip through the water with help from Mercury MerCruiser engines, each carrying up to five passengers perched on custom upholstery. Hornet Marine invites landlubbers on factory tours and test drives at its headquarters in Bristol, Connecticut, where a staff of nautical experts also keep ships shipshape with oil changes, detailing, and other boat-maintenance services.


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Arcadia University program dates are set in accordance with the overseas institution's academic calendar and the Arcadia University mandatory orientation dates. Accepted students can book their travel according to the dates listed below. Students will be notified on the rare occasion of a change to the program calendar.
Fall 2014
|Depart from U.S.
|September 13, 2014
|Arrive in Palma de Mallorca
|September 14
|September 14-18
|Semester Start
|September 22
|Semester End
|December 18
|Program Concludes/Return Flight to U.S.
|December 19
Spring 2015
|Depart from U.S.
|January 24, 2015
|Arrive in Palma de Mallorca
|January 25
|Arcadia Orientation
|January 25-31
|University Orientation
|February 2
|Semester Start
|February 2
|Semester Break
|April 11-26
|Semester End
|May 16
|Program Concludes/Return Flight to U.S.
|May 17


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Thursday, October 16th, 2014
Ebola: Frequently Asked Questions
Ebola: Frequently Asked QuestionsOctober 16, 2014
Keeping you informed about Ebola.
Thursday, October 16th, 2014
Ebola: Frequently Asked QuestionsOctober 16, 2014
Keeping you informed about Ebola.
Tuesday, August 12th, 2014
America's Health Centers: Local Engines for Healthier CommunitiesAugust 12, 2014
During National Health Center Week, we're highlighting patients whose lives have been improved by the Combest Center.
Tuesday, August 5th, 2014
Giving Back: Compassion and Drive Leads to Medical SchoolAugust 5, 2014
First-Year medical students in Lubbock received their first white coats during the school's annual ceremony.
Friday, July 18th, 2014
Children have a Roarin' Good Time at Camp AlphieJuly 18, 2014
The free summer program provides fun and relaxation for families struggling with cancer.
Thursday, June 19th, 2014
Mini-Series is the New BlackJune 19, 2014
The School of Pharmacy's Office of Experiential Programs recently unveiled an innovative preceptor training program.
Thursday, May 29th, 2014
TTUHSC Celebrates its Biggest Time of the YearMay 29, 2014
Students from all disciplines were ushered into the health care profession during separate commencement ceremonies.
Thursday, May 22nd, 2014
Love from the Ranch: Pioneer Woman Supports Women's HealthMay 22, 2014
Ree Drummond tells us how she maintains her well-being on a cattle ranch in Oklahoma.
Monday, April 28th, 2014
Dreams Do Come True: Medical Students Honor DonorsApril 28, 2014
Because of donor support, more than 300 medical students are able to fulfill their dreams of becoming physicians.
Tuesday, April 1st, 2014
Medical Students Experience March Match MadnessApril 1, 2014
Held simultaneously across the country, Match Day gives medical students the opportunity to learn where they will continue their medical careers.
Friday, March 7th, 2014
They've Got Your Back: A Salute to Athletic TrainersMarch 7, 2014
In honor of National Athletic Training Month, we asked our athletic trainers to give us the scoop about what goes down on the field. They answered.


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Monmouth County birthday dinner suggestions please.
We are willing to travel for good food. We are not into fancy, but really want good food. We love Shirin,Wonderland Seafood, Ming Ying Chinese take out in Long Branch, NIkkos Taverna, As you can see my preference is ethnic cooking. I do not like Indian, or spicy foods. Suggestions much appreciated. Seafood would also be great.
re: Tapas52
Tapas - Excellent suggestion. I have to keep reminding myself to get back to this fabulous restaurant.
re: bgut1
b., If you are thinking of going to Shirin, give me a shout. It's been ages since Mr. R. and I have been there, and we'd love to go with you. :)
Btw, the o.p. mentioned that s/he loves Shirin.
re: maryanne06
maryanne06 - Fish .... really? Both mine and other Hound's reviews were less than stellar.
re: Angelina
+1 on Via 45. Not asian, but ethnically mediteranean instead. More and more if we are not going to Nicholas we find ourselves at Via 45.
re: bgut1
I find it hard to believe that there's actually an Italian restaurant in the area that's serving stellar food. But if Angelina and seal think so, I'm putting it on my pathetically short NJ "go to" list.
re: joonjoon
hey joon..I finally tried ShangHai Bun this past weekend for my daughters birthday, She loves Chinese food and we weren't disappointed...in the food anyways! At one point I truly felt like I was in a Seinfeld skit. Having said that, I would definatley reomend the food here...but most importantly an instruction sheet on what and where. First off, we went for dinner...6 persons, given 3 lunch menus and 3 forks,,,more like just dropped off casually at the table. Second,,,for any condiment or beverage it is self serve. Kinda figured this out via observation. Third, communication barrior. The food delivered...everything at once including Dim Sum and appetizers...kinda overwhelming. I will say however that each dish was amazing, Scallion pancake, right on..crisp flaky and chewy all at once. Standard Chinese dishes above par like those at NEMO in Keyport. The steamed buns were amazing, caution however that the inside had piping hot broth inside, so hot in fact I wore most of it on my shirt! lol Noodle bowl if Spicy Beef a little heavy on the five spice but definatley a great thing for a chlly December night. Would I eat there again? Sure for lunch...but for takeout definately will be back.
re: foodislove1958
It's definitely not your average restaurant, that's for sure...glad you enjoyed it! Service isn't always the friendliest though. lol
Keep in mind they have 2 menus at SHB, one has the typical American fare, and the other has the "authentic" dishes.
re: joonjoon
We found the SOP at Shanghai Bun is to grab a menu from the counter when you walk in (Making sure as Joon pointed out, to get the "good one"), take a seat at a table and circle the items you wish to order. Then hand the menu to one of the servers as they hustle by...
re: joonjoon
Re: Shanghai Bun
I've been to Shanghai Bun only once so I admit to being a neophyte. Can you make some recommendations for a newbie? I enjoy vegetarian fare, but am not averse to meat selections on occasion. Thanks for your consideration!
re: tomwocat
We ended up at Nemo where the Sushi eaters were thrilled and I enjoyed Chinese. Via would have been my choice but I got out voted. I have been there before much thanks to this board, and really liked it, but forgot about it.
Now, about Shanghai Bun! I like that but did not know there are two menus. Are they both in English? Is the good one in Chinese and English? And I loved the comment " if you don't mind dives". I am a food snob! All I care about is good food!
I would even go to a fancy place of the food were great!! Much thanks for all your help. I am enjoying discovering Monmouth County! We are new to NJ and I am finding good food thanks to reading here and I am really grateful for your suggestions.
re: joonjoon
Hi Joonjoon, thanks for your help. We are in Farmingdale. We are willing to travel for good food ! I like trying new restaurants and really appreciate the suggestions. We went to SHB once and thought it was pretty good but that was years ago. So I look forward to going again and this time knowing what to do and enjoying the improvements!
re: tomwocat
Hey tomwocat, there're lots of good recommendations in this thread:


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- Exchange: New York
- Sector: Consumer Discretionary
- Industry: Home & Office Products
- Sub-Industry: Homebuilders
Toll Brothers Inc+ Add to Watchlist
As of 20:04:06 ET on 11/21/2014.
Company Profile for Toll Brothers Inc (TOL)
Toll Brothers, Inc. builds luxury homes, serving both move-up and empty nester buyers in several regions of the United States. The Company builds customized single and attached homes, primarily on land that it develops and improves. Toll Brothers also operates its own architectural, engineering, mortgage, title, security, landscape, insurance brokerage, and manufacturing operations.
Contact Information
Toll Brothers Inc
250 Gibraltar Road
Horsham, PA 19044
United States
Phone: 1-215-938-8000
Fax: 1-215-938-8019
Key Executives for Toll Brothers Inc (TOL)
|Robert I Toll "Bob"Chairman/Co-Founder
|Douglas C Yearley Jr "Doug"Chief Executive Officer
|Richard T Hartman "Rick"President/COO
|Joseph R SicreeChief Accounting Officer
|Martin P Connor "Marty"Senior VP/CFO/Treasurer
|Michael I SnyderSecretary
Quotes delayed, except where indicated otherwise. All prices in local currency. Time is ET.
Recommended Symbols:
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Featured news
The year of living DRMishly
This year may be the year that gadget makers finally conquer the living room, replacing DVD players, VCRs and personal video recorders with all-in-one media devices that serve up HDTV, pre-recorded movies and digital music. If so, it will likely also be the year that people learn the meaning of DRM, an acronym the industry says stands for digital rights management, but critics say should stand for digital restrictions mongering.
At Wired.
[ Read more ]


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Learn how to create a lab manual for your students with iBooks Author.
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Demonstrates how to use the Apple iBooks Author application to create and publish your own iBook, without extensive design or publishing experience.
"Wow! It just keeps getting better and better. I hate the fact that I will never be able to quit—I am now a lynda.com addict." —Sharon W.
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High Tech Campus 27
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FRAME Magazine (Issue 90) covered Miriam Bäckström's installation 'See What You've Made Me Do' for the Kvadrat showroom in Paris. The article contains augmented reality, which lets you experience this special installation via your smartphone or tablet. Watch the video to see how the article comes to life via the LAYAR app. Additionally, watch this video to learn more about the installation by Miriam Bäckström.
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Robert Marcus, who's been chief executive of Time Warner Cable for less than three months, stands to receive nearly $80 million if Comcast buys the company and he leaves his job, according to a recent regulatory filing.
If Marcus receives the payout, it would be among the largest golden parachute benefits awarded since 2011, according to an analysis by executive compensation research firm Equilar.
It's been several years since the financial crisis ignited outrage over executive compensation and the ensuing Dodd-Frank reform legislation gave investors the right to vote on executive pay. But that $80 million figure makes one wonder how much executive safety nets have actually changed.
The short answer is: some, but not enough to let the air out of those parachutes.
Yes, corporate boards are under increasing pressure to not cushion chief executives' landings too much. New regulations, shareholder activism and greater public scrutiny are also constraining the figures. One recent study by the professional services firm Alvarez & Marsal found that among the largest 200 U.S. public companies, the value of golden parachute benefits has remained flat, falling slightly from $30.2 million in 2011 to $29.9 million in 2013, despite a booming stock market.
But until companies change how they treat the piles of stock options and restricted shares that executives typically become eligible to receive – for instance, $56.5 million of Marcus' potential $80 million payday would be in equities – lucrative golden parachutes will probably remain fairly common.
Unless you attack the biggest piece of it, says Paul Hodgson, an expert on executive compensation with governance research firm BHJ Partners, you're not really going to change anything.
A Comcast spokesman referred inquiries to Time Warner Cable, which declined to comment regarding Marcus.
Golden parachute has become a generic term for any big termination payment made to an executive. The arrangements first proliferated during the hostile-takeover era of the 1980s and are most associated with what's known as a change-in-control agreement, or a payout given to executives because of an acquisition. Such benefits were originally designed as a way to get executives to evaluate potential mergers that might be good for shareholders without worrying about losing their jobs – or the cushy paychecks that went with them.
But as stock grants ballooned in the 1990s and 2000s, the size of these first-class escape hatches grew enormously.
Somewhere, that got distorted, says Carol Bowie, head of Americas research for proxy adviser ISS.
Although Marcus' potential payment is hefty, particularly given the short amount of time he's held the job, it's still dwarfed by what other CEOs could potentially receive.
For instance, David Simon, the chief executive of mall developer Simon Property Group, could receive $245 million if his company changes hands, according to the company's proxy statement from last year. Meanwhile, the change in control payment for Discovery Communications chief executive David Zaslav, should that company be acquired and Zaslav lose his job, could reach $232 million.
Representatives for Simon Property Group and Discovery Communications declined to comment.
Because of the Dodd-Frank law, shareholders now have an opportunity to vote down lofty safety nets before an actual merger.
But it's rare for a majority of investors to vote against these payouts, ISS' Bowie says.
And even if they do, those advisory votes are non-binding, meaning that companies don't have to follow through on shareholders' recommendations.
Still, it does sometimes happen. Former Cooper Industries chief executive Kirk Hachigian, now chief executive of Jeld-Wen, was in line to receive a $79.3 million golden parachute as a result of his company's acquisition by Eaton in 2012, according to an analysis by Equilar for the Washington Post. Cooper's shareholders apparently weren't big fans of the compensation – 59 percent of the company's investors voted against the payment, according to a filing.


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Federal funding will help the Anoka County Job Training Center find jobs for more low-income seniors in the county.
There was a special birthday celebration at the Coon Rapids Civic Center Sept. 13.
State Rep. Jim Abeler is hosting his 14th annual Senior Fair on Wednesday, Sept. 19, 10 a.m. to noon, at the Anoka County Government Center's first-floor atrium.
The Mary Ann Young Senior Center has evolved from its bricks-and-mortar roots to a heart-and-soul institution that continues to serve a growing population.
A special celebration for seniors attending Coon Rapids Senior Dining who are 90 years or age or older will take place Thursday, Sept. 13.
Although the plans to break ground last fall fell through, First Phoenix Group's proposal to build a 72-unit senior living building in Ramsey is still moving forward.
Senior citizens at the Coon Rapids Senior Center had the opportunity to relax and focus at an introductory Raja Yoga workshop taught by Gita Kar July 12.
Seniors living at Blaine Courts are participating in the Coon Rapids VFW Auxiliary's overseas coupon program.
Anoka County Library is presenting free Understanding Medicare classes this summer for seniors and those who care for seniors.


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Here is the video of the second public lecture in this year's series on religion and freedom of expression. This one focuses on Islam, and the three speakers are Saba Mahmood, Peter Gottschalk, and Sholeh Shahrokhi. [Read more...]
The Blog of Dr. James F. McGrath, Clarence L. Goodwin Chair in New Testament Language and Literature at Butler University, Indianapolis
Here is the video of the second public lecture in this year's series on religion and freedom of expression. This one focuses on Islam, and the three speakers are Saba Mahmood, Peter Gottschalk, and Sholeh Shahrokhi. [Read more...]
The blog Friendly Atheist (sparked by an article by Sam Harris) recently discussed the Pew Forum statistic concerning the number of Muslims who say that suicide bombing is never justified. There are lots of different ways that one could take this. One thing that is noteworthy is how different the answers are depending on the location [Read More...]
I saw a news article today about the murder of Narendra Dabholkar in Pune, India. Dabholkar was an activist opposing superstition and blind faith. He was killed, not by a spell or a lightning bolt, but by human beings whose love of superstition of whatever sort did not give them supernatural power. They used technology, [Read More...]
For the Patheos Book Club centered on the book Do Jews, Christians, and Muslims Worship the Same God?, we are taking a more dialogical approach. And since I read their blogs regularly, I thought I'd interact with John Morehead and Bob Cornwall, who've both posted their thoughts on the book already, since John in turn [Read More...]
Via Access to Mideast and Islamic Resources, I learned of the Marsh Arabs Heritage Project, which looks at the cultural, religious, and social life of the marshlands of Southern Iraq, including the Mandaeans, but also Muslims, Jews, Christians, Yezidis and others. The pdf downloads appear not to have been added yet, but there is in [Read More...]
I'm hoping to read three books with students who will be participating in the trip to Israel/Palestine in May 2012. The first I've already decided on, and it is A Hitchhiker's Guide to Jesus: Reading the Gospels on the Ground by Bruce Fisk. I'm also using it as a textbook in my historical Jesus class. [Read More...]
The above infographic seemed relevant in connection with my previous post. HT Hemant Mehta. [Read more...]
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