Monday, November 17, 2008

The Note's Must-Reads are Ready! (11/17/2008)

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Doomed British infantry officer describes siege of Charleston

Like so many first-time visitors to the Lowcountry, Charles Campbell was enchanted. In a letter to his father back home in Britain, Campbell gushed about the natural beauty of the Holy City in spring. "Charlestown is a handsome and well built town situated on the extremity of a tongue of land formed by two large & navigable rivers, Cooper and Ashley;" he wrote, "it lays open to the sea, and has the entrance of its harbor defended by a strong fort erected on Sullivan's Island."



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'New ways of doing things'

CONWAY â€" Coastal Carolina University President David DeCenzo wants his public institution to become the state's first charter university, a move he says would help compensate for dramatic state budget cuts.

Former church converted to homes

Normally, the conversion of a historic church into a dozen condo units wouldn't be something to celebrate, but the new housing at 2 Francis St. serves as an exception to that rule.

Remembering the Yorktown

BEATRICE, Neb. â€" It wasn't hard for Les Hakes, 82, of Beatrice, to reminisce about his time spent cruising the Pacific Ocean aboard the USS Yorktown during World War II.

Balancing needs of Neck Area

Life in the narrow Neck Area is becoming a squeeze. Its neighborhoods of lower income homes â€" about one-fifth of North Charleston's population in one of its densest areas â€" butt up against acres of industries and brownfield along Spruill Avenue. The neighborhoods, in fact, were built that way generations ago â€" worker villages along the railroad tracks. The fit has always been a little close for comfort.










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Clemson holds off Temple to win inaugural event

Clemson put on a dazzling display of 3-point shooting in the first half Sunday against Temple, but in the end, it was defense that enabled the Tigers to take home the Charleston Classic championship trophy after a 76-72 victory at the Carolina First Center. "I'm very pleased with winning the tournament here," said Clemson coach Oliver Purnell. "It's always nice when you can go home with the hardware. Temple is an excellent ball club. I thought our pressure and our depth kind of wore them down some and we were able to get a working margin. It was our defense and our rebounding that told the story."

Ground control keeps Lions winless

CHARLOTTE â€" Jake Delhomme was eager to make up for the worst game of his career. He settled for handing off to his two dynamic running backs.

Cowboys knock off Redskins

LANDOVER, Md. â€" Tony Romo celebrated the go-ahead touchdown pass by bouncing up and down like a little kid and patting teammates on the back with his left hand, carefully avoiding any further damage to his heavily wrapped right pinkie.

Cougars stave off late rally

All's well that ends well. The College of Charleston watched a 20-point second-half lead dwindle to five, but recovered in time to finish off Texas Christian, 86-75, Sunday night in the Charleston Classic at Carolina First Arena.

DB Holloman's commitment good sign for Gamecocks

Following his team's 50-point loss to Florida, South Carolina football coach Steve Spurrier lamented the obvious talent difference in the teams, but pointed out that with the 2009 class his staff is compiling, he believes help for his team is on the way.










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The Dumbest War President | How Shock Jocks Inspire Hate | Treat Pot Like Tobacco

AlterNet: The Mix is the Message   Headlines Newsletter
November 17th, 2008
All stories, blogs, and video »
 

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How Did We Ever Let This Guy Get Away with Being a War President?  

How Did We Ever Let This Guy Get Away with Being a War President?
By Gary Brecher, eXiled Online
Only a fool like Bush could pick an anti-American Arab country, add an invading army, and expect a nice fluffy democracy soufflé. Read more »

Former News Radio Staffer Spills the Beans on How Shock Jocks Inspire Hatred and Anger  

Former News Radio Staffer Spills the Beans on How Shock Jocks Inspire Hatred and Anger

Behind the scenes of one of the largest and most successful news/talk radio stations in America. Read more »

$2 Trillion Handed out by Paulson and Bernanke, But Who Got It, Nobody Knows  

$2 Trillion Handed out by Paulson and Bernanke, But Who Got It, Nobody Knows

We have no idea who got this money or the conditions or collateral put up in return for the loans. Read more »

We've Cut Cigarette Smoking by Half -- and We Didn't Have to Arrest 20 Million People to Do It  

We've Cut Cigarette Smoking by Half -- and We Didn't Have to Arrest 20 Million People to Do It

If lawmakers really wanted to address marijuana use, they would regulate and tax pot like they do tobacco. Read more »

Do You Want to See What War Looks Like?  

Do You Want to See What War Looks Like?

Dead bodies and blown-out humvees in Casey Porter's films reveal the brutality of the surge in Iraq. Read more »

Democrats' Soft Spot for Automakers Have Shielded Detroit from Its Own Bad Decisions  

Democrats' Soft Spot for Automakers Have Shielded Detroit from Its Own Bad Decisions

The automobile lobby is back on Capitol Hill to secure $25 billion in loans. Will the money get wasted or put to good use? Read more »

Why the Economy Grows Like Crazy Amid High Taxes  

Why the Economy Grows Like Crazy Amid High Taxes

The raw truth is that the economy has grown faster when taxes were higher, but how can we explain that phenomenon? Read more »

Afghanistan Abyss Awaits Obama  

Afghanistan Abyss Awaits Obama

Obama's got to make some really bold decisions: Talking to Iran and Russia would be a start. Read more »

Why Big Banks May Be Trying to Buy up Your Public Water System  

Why Big Banks May Be Trying to Buy up Your Public Water System

In uncertain economic and environmental times, big banks and financial groups are buying public water systems as safe investments. Read more »

  PEEK and Video: The hottest buzz and videos on the web  

Thousands Rally Nationwide for Marriage Equality  

Thousands Rally Nationwide for Marriage Equality

LGBT rights advocates, organized by Join the Impact, turned out in eight countries, 50 states, and 300 cities in support of marriage equality Read more »

Obama's Youtube Plan: Is it Really That Important?  

Obama's Youtube Plan: Is it Really That Important?

I want to inject a slight note of skepticism as to how important Obama's Youtube addresses really are. Read more »

Obama: Close Gitmo, Ban Torture to 'Regain America's Moral Stature'  

Obama: Close Gitmo, Ban Torture to 'Regain America's Moral Stature'

Obama 60 Minutes interview: talks national security, financial crisis, first dog. Read more »

McCain Adviser Admits America Is Center-Left  

McCain Adviser Admits America Is Center-Left

"This is a portrait of an electorate moving from center-right to center-left." Read more »

 

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Proposed container yard runs into opposition

A proposed container yard linking trucks to trains could allay one of the greatest complaints about Charleston's port system: that tractor-trailers fill the air with harmful emissions, while the state slips behind competitors in enhancing its rail service, viewed as the cleaner and less conspicuous alternative.

How to boot up computer faster

While the Internet age has our virtual lives up to warp speed, there remains a nagging speed bump: the time it takes to get your computer operating system up and running. It can be a couple of minutes or more, depending on the age of your computer and the applications it has. And as more p...

Lenders wage price war for bank deposits

Banks across the U.S. are engaged in a heated competition for deposits as the battered industry tries to shore up its funding sources. From giant Citigroup Inc. to tiny S&T Bancorp Inc., which is based in Indiana, Pa., and has just 55 branches, banks are responding to uncertain times b...

No easy fix for economy woes

By Susan Tompor We've witnessed a presidential election marked by history and hope. Now, one has to wonder when Wall Street might be able to ditch images of a fearful future, too. We're not going to avoid a recession. Many economists expect it to be longer than the past two, which la...

Avoid 'phishing' expeditions

Q: I hear so much about hackers attacking Web sites and stealing people's personal information. Is it safe to bank online? A: One of the scariest things about banking online is that you're forced to enter personal information, like account numbers, that you'd never type anywhere else on the...










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HIV/AIDS Update - Final Rule: Latex condom labeling

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

The Food and Drug Administration (FDA) published a final rule on November 10, 2008 amending the classification regulation for male condoms made of natural rubber latex (latex condoms) and latex condoms with spermicidal lubricant containing nonoxynol-9 (N-9), designating a guidance document containing labeling recommendations as a special control for latex condoms.

The final rule will become effective January 9, 2009.

FDA is establishing the labeling guidance as a special control because it ensures that manufacturers will address the issues identified in the guidance. Regular guidance imposes no requirements.  However, where a guidance document has been designated as a special control by a rule, manufacturers must address the issues identified in the guidance, either by following the recommendations in the guidance, or by some other means that provides equivalent assurances of safety and effectiveness.

Establishing a guidance document as a special control affords greater flexibility than a rule mandating specific labeling language, and can facilitate updating of the labeling as new scientific information becomes available because the special control permits manufacturers to use any labeling that affords equivalent assurances of safety and effectiveness for latex condoms.

In developing the rule and guidance, FDA evaluated a variety of scientific evidence and information about condoms and STIs. to assess the overall effectiveness of latex condoms in preventing transmission of STIs,

Based on review of scientific information and of existing latex condom labeling, FDA concluded that existing latex condom labeling was medically accurate in presenting the conclusion that, overall, condoms are effective in reducing the risk of sexually transmitted infections (STIs).

However, to help consumers make appropriate choices for their particular needs, and therefore to ensure the safe and effective use of condoms, FDA is establishing the labeling special control to address some additional, more nuanced information about condoms and STIs, as well as to provide information about contraception, and about appropriate directions and precautions for use of latex condoms.

The regulatory changes are intended to help ensure that latex condoms are used safely and effectively by providing labeling that conveys a concise, accurate message that neither exaggerates the degree of protection provided by latex condoms, nor undervalues overall STI-risk reduction provided by latex condom use.

The November 10, 2008 Federal Register Notice of Final Rulemaking, which contains detailed information about the rule, and FDA's findings regarding effectiveness of latex condoms for a variety of STIs, is available on the FDA web site at http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-26825.htm

Background information is also available about the earlier Proposed Guidance for Condom Labeling

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration 


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