Filing Period For Round Two of Broadband Applications Opens This Week

WASHINGTON, February 17, 2010 - Agriculture Secretary Tom Vilsack today announced the selection of eleven Broadband Infrastructure projects to enable rural residents in nine states to have access to improved economic and educational opportunities. Funding for the projects is being provided through the American Recovery and Reinvestment Act, which was signed into law by President Obama a year ago today.  Additionally, USDA and The Department of Commerce's National Telecommunications and Information Administration (NTIA) have announced that a second filing window for broadband applications opened this week.

"The broadband projects we're announcing today will create construction jobs now to build high speed Internet networks in unserved and under-served communities. Deployment of broadband will support job creation and rural economic development," Vilsack said. "The Obama Administration and USDA are bringing broadband to rural America so that Americans can compete in a global 21st Century economy.  We are opening new opportunities not only for homes and businesses, but for community institutions such as health facilities, libraries, public buildings and community centers."

In rural Kentucky, for example, the Mountain Rural Telephone Cooperative Corporation (MRTCC) has been selected to receive a $39.8 million loan and a $38.3 million grant to deploy a fiber cable-based broadband network in the counties of Morgan, Menifee, Wolfe, and Elliott.  All four counties are considered "distressed" by the Appalachian Regional Commission, and are challenged by mountainous terrain and limited highway and rail infrastructure.  MRTCC will bring broadband access to these counties to enhance economic and educational opportunities for residents and employers.

In rural Minnesota, the Southwest Minnesota Broadband Group (SWMBG) has been selected to receive an almost $6.4 million loan and a $6.4 million grant to extend fiber to the Jackson, Lakefield, Windom, Round Lake, Bingham Lake, Brewster, Wilder, Heron Lake, and Okabena communities.  This funding, along with an $88,000 private investment, will provide high-speed Internet, voice, and cable television to the participating communities.  This will improve the quality of life by increasing the availability of health, education, and public safety services across the region.

In all, over $277 million will be invested in the 11 projects through funding made available by the American Recovery and Reinvestment Act.  An additional $1.6 million in private investment will be provided in matching funds.  Congress provided USDA $2.5 billion in Recovery Act funding to help bring broadband services to rural un-served and underserved communities.

Funding of individual recipients is contingent upon their meeting the terms of the loan,   grant or loan/grant agreement. Below is a complete list of recent Recovery Act Broadband award recipients by state:

Indiana

  • Smithville Telephone Company, Inc.: $37,729,143 loan.  The funding will provide 3,815 households, 209 businesses, and 12 community anchor institutions with access to broadband service.

Iowa

  • Southeast Iowa Rural Wireless Broadband: $3,836,926 loan.  The funding will provide Internet services to 80 rural communities using proven wireless technology.

Kentucky

  • Mountain Rural Telephone Cooperative Corporation (MRTCC) ILEC Broadband: $39,843,535 loan and $38,281,044 grant.  The funding will provide fiber to Morgan, Menifee, Wolfe, and Elliott counties that will result in 20 Mbps bandwidth to end users.

Louisiana

  • Allen's Cable - Fiber-to-the-Premises (FTTP) Broadband Network Extension: $3,584,680 loan and $3,513,697 grant.  The funding will extend fiber into rural areas of three South Louisiana Parishes.
  • LBH, LLC, - Rural Broadband Powered by Fiber: $16,693,439 loan and $16,691,939 grant.  The funding will expand existing broadband into rural areas around Moss Bluff, Oakdale, and Vinton.

Minnesota

  • Southwest Minnesota Broadband Group (SWMBG): $6,350,000 loan and $6,350,250 grant.  The funding will provide service to eight rural communities throughout Southwest Minnesota.

Missouri

  • Unionville, Missouri FTTP Project: $5,140,458 loan and $5,140,458 grant.  The funding will provide broadband services to households, businesses, and key community organizations that are currently underserved in the Unionville area.

New Mexico

  • Western New Mexico Telephone Company, Broadband Infrastructure Project: $11,516,679 grant.  The funding will provide last mile broadband services to remote and unserved locations and critical community facilities throughout Western New Mexico.
  • Baca Valley Telephone Company, Inc.: $1,651,000 loan and $1,586,000 grant.  The funding will expand fiber optics to Digital Subscriber Line (DSL) nodes in rural Northeastern New Mexico, replacing outdated deteriorating copper wire and low bandwidth microwave transport systems in some areas, while providing new connectivity in others, and enabling advanced, high-speed DSL service throughout the area.

Oregon

  • Sandy Broadband Infrastructure Project: $374,548 loan and $374,537 grant.  The funding will provide broadband service to the underserved rural area of Sandy by improving and expanding wireless Internet service.

Texas

  • Southern Texas Broadband Infrastructure Development and Adoption Project: $40,093,153 loan and $38,520,868 grant.  The funding will develop a broadband infrastructure in eleven unserved and underserved rural communities of the South Texas Plains.

USDA is continuing to review broadband applications currently on file and expects to make additional announcements concerning awards throughout the current fiscal year.  Additionally, The Department of Commerce's National Telecommunications and Information Administration (NTIA) and the Department of Agriculture's Rural Utilities Service (RUS) on Tuesday began accepting applications for a second round of broadband grants.  Applications will be accepted until March 15, 2010 at 5 p.m. ET.

The application packages for electronic submissions is available at http://www.broadbandusa.gov.  Electronic submissions of applications will allow for the expeditious review of an Applicant's proposal, consistent with the goals of the Recovery Act. The government electronic application system will provide a date and time stamped confirmation number that will serve as proof of submission. The Recovery Act provided a total of $7.2 billion to the Department of Commerce and to USDA to accelerate broadband deployment in areas of the country that have been without the high-speed infrastructure.

You may obtain additional information regarding applications via the Internet at http://www.broadbandusa.gov.

President Obama signed The American Recovery and Reinvestment Act of 2009 into law on Feb. 17, 2009.  It is designed to jumpstart the nation's economy, create or save millions of jobs, and put a down payment on addressing long-neglected challenges so our country can thrive in the 21st century.  The Act includes measures to modernize our nation's infrastructure, enhance energy independence, expand educational opportunities, preserve and improve affordable health care, provide tax relief, and protect those in greatest need.

More information about USDA's Recovery Act efforts is available at www.usda.gov/recovery. More information about the Federal government's efforts on the Recovery Act is available at www.recovery.gov.

WASHINGTON --- Senator Chuck Grassley is asking the Food and Drug Administration for an update on the implementation of new guidelines for medical device makers on when they need to file new information with the agency and seek clearance for the marketing and use of modified devices under the 510(k) system, the agency's less stringent process for reviewing most medical devices.

Grassley said that his inquiry today follows up on questions he asked more than a year ago, after a ring used in heart-valve repair was being implanted in patients even though the device hadn't been cleared for this purpose by the FDA.  The FDA subsequently told Grassley that its current policy was inadequate and that an update was underway.  Grassley also asked a number of questions today about the FDA's requirements for manufacturers to report changes made to FDA-approved devices.

"My questions are aimed at establishing greater transparency and accountability for doctors and their patients," Grassley said.  "People have a right to know exactly what the FDA has approved, or not, in making decisions about their health care.  For this to happen, the FDA's policies need to be effective in establishing an accurate public record about the FDA-approval status of any particular product."

The text of the letter sent today from Grassley to the FDA Commissioner follows here.

 

February 16, 2010

The Honorable Margaret A. Hamburg

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Ave.

Silver Spring, MD 20993

Dear Commissioner Hamburg:

The United States Senate Committee on Finance (Committee) has jurisdiction over, among other things, the Medicare and Medicaid programs.  As Ranking Member of the Committee, I have a responsibility to the more than 100 million Americans who receive health care coverage under these programs to oversee their proper administration and ensure that taxpayer dollars are appropriately spent on safe and effective drugs and devices.

I appreciate your response of September 30, 2009, to my questions regarding the Food and Drug Administration's (FDA or Agency) guidance to manufacturers on when a modification to a device requires the filing of a new 510(k).  Over a year ago, I wrote to the FDA regarding serious allegations that an annuloplasty ring used in heart valve repair was being implanted in patients even though the device was allegedly not cleared for marketing by the FDA.  The FDA concluded that the company had made the wrong decision when it marketed the product without first seeking clearance from the Agency.  That device, the Myxo dETlogix Annuloplasty Ring (dETlogix ring), has since been cleared by the FDA, but as I stated in my letter to the FDA last April, the fact remains that for more than two years, patients at Northwestern Memorial Hospital were being implanted with the device before a 510(k) was submitted to the Agency.

I also wrote to Northwestern Memorial Healthcare and Northwestern University in September regarding the same allegations and asked them whether or not they obtain assurances or confirmation from a device manufacturer that a device is FDA-approved before it is used in their facilities. Attached are their responses for your consideration.  Northwestern Memorial Healthcare stated in its response that Edwards Lifesciences assured Dr. McCarthy that it was taking the steps necessary for FDA approval.  It also stated that, "the health care provider relies on the manufacturer to provide timely and accurate information regarding the regulatory status of the device."  However, in this case, the manufacturer followed FDA's guidance and made the wrong decision regarding its device.

In your September response, you stated that FDA believes its current policy on when a modification to a device requires a new 510(k) submission is not sufficiently clear and is revising the guidance document.  I agree that the guidance document needs to be revised so that we can prevent similar events from occurring in the future.  However, it has been more than four months since I received your response and the new guidance has yet to be released.  Accordingly, I would appreciate you advising me immediately on the status of FDA's revisions to the Agency's guidance entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device."

In addition, it is my understanding that device manufacturers registered with the FDA must also list the devices that they make with the Agency.  According to FDA's website, registration information must be submitted each year between October 1 and December 31 even if no changes have occurred, and at that time listing information should be reviewed as well.  The website also states that a manufacturer can access the FDA Unified Registration and Listing System at any time to update changes to their registration and listing information as the changes occur.  Examples provided by the FDA include a change to a previously listed device or the introduction of another device into commercial distribution.  In light of the statements made on FDA's website please respond to the following questions:

1)         Would a manufacturer be required to update its device listings even if it changed only the name of an existing device?

2)         Would the manufacturer also be required to update its listings if it made a modification to a device that did not require submission of a new 510(k) but marketed that device under a different name?

3)         If the answer to either question is no, please explain why not.  Please also explain how patients and their doctors would obtain information about the status of a device other than from the manufacturer itself.

4)         FDA concluded that Edwards Lifesciences' dETlogix ring did require a new 510(k).  However, even if a new 510(k) had not been required, was the company required to list that device with the FDA?

Thank you for your attention to this important matter.  I would appreciate a response to the requests set forth in this letter by no later than March 2, 2010.

Sincerely,

Chuck Grassley

United States Senator

Ranking Member of the Committee on Finance

$100 Million for CREATE Program; Investment to Create 1,087 Jobs
CHICAGO- February 17, 2010. Governor Pat Quinn announced today that the Illinois Department of Transportation (IDOT) along with the Chicago Region Environmental and Transportation Efficiency (CREATE) Program partners has received a $100 million TIGER (Transportation Investment Generating Economic Recovery) grant under the American Recovery and Reinvestment Act (ARRA). This federal investment is expected to create 1,087 jobs.
"Illinois has received the most TIGER funding in the Midwest. This investment will create 1,087 jobs and bring economic growth to our communities," said Governor Quinn. "With this grant and dedicated partnerships like CREATE, Illinois continues to work to ensure our rail industry is moving forward and our state remains one of the nation's major rail hubs."
Across the nation, 1,400 applications were submitted for TIGER Grant funding and 50 projects were awarded. Here in Illinois, three applications were awarded totaling $128 million. The funds include $100 million for CREATE, $6 million for Tri-City Port District in Granite City and $22 million for the Normal Multi-modal transportation facility.
"Throughout the country, we have huge bottlenecks that restrict the flow of freight and passengers at a cost to the United States of an estimated $200 billion a year," said U.S. Senator Dick Durbin (D-IL). "The TIGER grant program is a coordinated, comprehensive effort to identify and fund nationally significant transportation projects that will improve safety, spur economic development, reduce congestion and create thousands of good paying jobs across the country. I thank Secretary LaHood and Governor Quinn for their leadership on this issue and commend local leaders throughout Illinois for their efforts."
"These federal funds will have a tremendous impact on Illinois' economy by creating more jobs," said Illinois Transportation Secretary Gary Hannig. "This is another major step in the right direction to improve livability, sustainability and safety across the state."
The grant funding will be targeted to six projects benefiting 13 Illinois communities. The projects will range in scope from rail line and viaduct improvements to a highway-rail grade separation. The completion of these projects by 2012 will support an estimated 1,087 jobs.
CREATE is a first-of-its-kind partnership, bringing together IDOT, the Chicago Department of Transportation and the Association of American Railroads (AAR). It is comprised of 71 critically needed rail and highway infrastructure improvements in Northeastern Illinois, aimed at improving the quality of life of Illinois residents, and increasing the efficiency of freight and passenger rail service throughout the region.
For more information, log onto www.recovery.illinois.gov or www.createprogram.org.
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First Year Analysis Show Recovery Act's Successes

WASHINGTON, Feb. 17, 2010 - Today, the U.S. Department of Agriculture highlighted the successes of the American Recovery and Reinvestment Act (ARRA). One year after the passage of ARRA, evidence is clear - and growing by the day - that the Recovery Act is working to cushion the greatest economic crisis since the Great Depression and lay a new foundation for economic growth.

"President Obama's Recovery Act has helped create jobs and lay a new foundation for economic growth during the greatest economic crisis since the Great Depression," said Agriculture Secretary Tom Vilsack.  "USDA has used Recovery Act funding create badly-needed jobs and stimulate local economies, help farmers and rural businesses make it through tough times, ensure that struggling families can put food on the table, and build and revitalize critical infrastructure in rural communities across America."

Since the Recovery Act was signed into law a year ago, USDA has moved quickly to get dollars out the door.  Aside from funding for the Supplemental Nutrition Assistance Program, which is allocated on a mandatory basis each month, USDA has announced the vast majority of its remaining $7.9 billion to support more than 90,000 grants, loans, and other job-creating projects. In the first year implementing the Recovery Act, USDA has:

·         Provided over $100 billion in tax relief for American businesses and families, including tax cuts for 95 percent of working families through the Making Work Pay tax Credit.  And tax relief is expected to nearly double in the coming months.

  • Helped over 38 million Americans who need food assistance by providing an average increase in benefits of $80 per month to low-income households of four.  This funding is a fast-acting economic stimulus as every $1 in food benefits generates up to $1.84 in total economic activity, supporting jobs at all levels of the food chain.
  • Helped 85,420 rural Americans purchase or repair their homes with affordable loans while simultaneously stimulating the economy, and creating jobs in the construction and real estate sectors.
  • Helped create private sector jobs protecting rural communities from large wildfires, while improving the health of our forests, water and air resources.  We provided $500 million to treat over 134,000 acres of forest to reduce the risk of wildfire.
  • Provided 2,636 loans to farmers and ranchers help them purchase the farm equipment, feed, seed, and fuel they needed to keep their farms operating and support jobs in the rural economy.  Approximately half of these loans went to beginning farmers and 25% to socially disadvantaged farmers.
  • Created green jobs at plants that use of wood from forest restoration activities to generate renewable energy.  Grants worth $50 million went to projects that will power 223,000 homes.
  • Helped more than 5,000 schools purchase equipment to improve the safe and healthy meals they serve to children.

In the coming months, USDA will be implementing additional programs and projects as weather begins to thaw, and construction projects are expected to break ground across the country.  In 2010, USDA will continue to invest in projects to help get Americans and the economy back to work:

  • By bringing broadband internet to an estimated 1.2 million households, 230,000 businesses, and 7,800 anchor institutions like hospitals and schools across rural America, in one largest job generating efforts to date.  This $3.4 billion investment will give businesses access to global markets and spur rural economic development.
  • By helping 300 rural businesses grow, innovate and create jobs, providing $900 million on top of $570 million already at work helping 160 businesses across the country.
  • With the construction and improvement of hundreds of community facilities, such as police and fire stations, and libraries in rural America.  We will improve access to health care for 3 million rural residents, and educational services for 2.5 million residents. We will provide nearly $750 million on top of $470 million already announced for more than 850 projects.
  • By constructing and rebuilding water and waste water systems in more than 200 communities affecting 1 million rural Americans.  We will provide nearly $1 billion on top of more than $2 billion already announced for projects in 530 communities.

CHICAGO -  A group led by attorneys, labor leaders and social justice advocates that has gathered annually for more than 50 years to honor the memory of attorney Clarence Darrow will meet at the Darrow Bridge in Jackson Park Saturday,  March 13 at 10 a.m. for its traditional wreath-tossing into the Jackson Park Lagoon. Darrow's ashes were strewn in the Lagoon after his death on March 13, 1938 in Chicago.    

The annual event is convened by the Clarence Darrow Commemorative Committee. This year's program will feature a special tribute to the late Leon "Len" Depress, who co-founded the committee in 1958 and remained a leader of the group. Despres (1908-2009) attended last year's event, one of his last public appearances. More than 100 Darrow devotees, civil libertarians, and First Amendment buffs are expected to attend the outdoor wreath-throwing ceremonies behind the Museum of Science and Industry and indoor symposium that follows in the Columbian Room of the adjacent Museum of Science & Industry.

This year's symposium will feature a performance by Gary L. Anderson, a renowned and lauded portrayer of Darrow. Anderson tours year-round as America's only full-time Darrow portrayer.  This performance, "Search for Justice," portrays Darrow as legal warrior, engaging the justice system in a presentation that trembles with inescapable timeliness. Anderson is the CEO of The Clarence Darrow Foundation. See: www.clarencedarrowfoundation.org.

Judy Besser, great granddaugher of Clarence Darrow, will read a letter from Darrow to his daughter, Judy's grandmother, in 1929. This letter illustrates Darrow's great wit and sense of humor little known by the general public.

Loyola Law Professor Anita Weinberg, daughter of Arthur and Lila Weinberg, authors of three books on Darrow and founders of the annual Darrow event, will preside over the indoor program.  Tracy Baim, publisher of The Windy City Times and daughter of Joy Darrow, will preside at the bridge.

Darrow, characterized as the "attorney for the damned," who was born in 1857 in Farmdale, Ohio, practiced in Chicago and represented the underdog and vigorously opposed capital punishment. None of his many clients was sentenced to death.

Darrow's death on March 13, 1938, was memorialized throughout the world. His ashes, and later the ashes of his wife Ruby and his son Paul, were scattered from the Darrow Bridge, which was dedicated to his memory by the Chicago Park District in 1957.


Clarence Darrow                         Gary L. Anderson

MILWAUKEE, WI - Just in time for National Sleep Awareness Week, March 8-14, TOPS Club, Inc. (Take Off Pounds Sensibly), the nonprofit weight-loss support organization, explains the connection between obesity and sleep habits. According to TOPS, studies show a link between too few hours of sleep and increased body weight in both adults and children.

"Our society is an insomniac, underslept society, perhaps because of economic stress, chaotic lifestyles, or sedentary time spent with modern media, such as the Internet or cable TV," says Nicholas "Dr. Nick" Yphantides, M.D., M.P.H., medical spokesperson for TOPS. "Sleep is an afterthought to many of us."

Dr. Nick points out that insomnia often leads to late-night eating binges, which are proven to be disruptive to the digestive cycle and result in weight gain. "Falling asleep with a full stomach means you are less likely to eat breakfast, which is an essential part of maintaining a healthy lifestyle," he says. "Every study of successful long-term weight loss shows that the eating plan includes a healthy breakfast."

While it's not easy to break old habits, Dr. Nick notes that the more resistant people are to saying "lights out" the more they have to deal with the consequences the next day. For example, when fatigue sets in from late-night activity, there is less desire to engage in exercise the next day, an essential element of weight control.

Lack of sleep also affects the way the body processes and store food and alters hormones which affect the appetite. "Physiologically, when a body is not rested, it kicks into survival mode," he says. "Stress hormones are generated, resulting in less production of appetite-suppressing leptin. Instead, more ghrelin, which stimulates appetite, is generated." In addition, Dr. Nick notes, there is a suspected association with insulin, which has an impact on food going into storage in the body.

The importance of sleep cannot be overestimated. More than just resulting in fatigue and affecting daily activities, lack of sleep can impact the immune system, memory recall, hypertension, and other serious problems.

"I don't believe everyone needs seven hours or another specific number, but I do believe in adequate sleep. It fits into the larger category of being responsive to what the body needs," Dr. Nick says. "Part of the evidence of the restorative nature of sleep points out that when we are ill, we need more of it, and not less or the same."

To improve your success for a restful night, consider the following:

  • Aim to exercise at least twenty to thirty minutes each day and no later than three hours before bedtime.
  • When tired enough to seek coffee and energy drinks, take a short, half-hour nap instead.
  • Go to bed and get up at about the same time every day, even on weekends.
  • Keep bedrooms cool, dark, quiet, and comfortable.  Consider a sound machine or small fan for white noise and an eye mask to block out light.
  • Follow a relaxing bedtime routine, such as reading a book, engaging in light stretching, or taking a bath.

TOPS Club Inc. (Take Off Pounds Sensibly), the original, nonprofit weight-loss education and support organization, was established more than 62 years ago to champion weight-loss support and success. Founded and headquartered in Milwaukee, Wis., TOPS promotes successful weight management with a philosophy that combines healthy eating, regular exercise, wellness education, and support from others at weekly chapter meetings. TOPS has about 170,000 members in nearly 10,000 chapters throughout the United States and Canada, and several chapters in Europe.

Visitors are welcome to attend their first TOPS meeting free of charge. To find a local chapter, view www.tops.org or call (800) 932-8677.

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"Immigrant Rights & American Values:

Seeing with New Eyes ~ Postville: an Interpreter's Experience"

Presented by Dr. Erik Camayd-Freixas

Dr. Erik Camayd-Freixas, a federally certified interpreter who translated at federal hearings in Waterloo, Iowa, after the 2008 immigration raid at Agri-Processors, Inc., a meatpacking plant in Postville, Iowa, will speak to audiences throughout eastern Iowa in March.   "Immigrant Rights and American Values," the theme of his presentations, reflects his reaction to the hearings and the opinions he has expressed before Congress and in numerous essays published in the ensuing months.

Dr. Camayd-Freixas recounts his courtroom experiences after the raid as the saddest procession he has ever witnessed. He has lectured around the world and will share his experience and insight with audiences in five Iowa cities including presentations on the campuses of the University of Northern Iowa, Mount Mercy College and Clarke College, thanks to the organizing efforts of six congregations of Catholic Sisters based in the region.  Aside from the Iowa City luncheon in March, the presentations are free, open to the public and pre-registration is not required.

Dr. Camayd-Freixas will speak at a public event in Clinton at The Canticle, 841 13th Ave. North, on Monday, March 8, at 7 p.m.

On Tuesday, March 9, he will be in Cedar Falls visiting the University of Northern Iowa and participating in two public events.  At 2:00 p.m. in the UNI Center for Multicultural Education (109 Maucker Union) Dr. Camayd-Freixas will take part in an informal discussion about some of his recent articles.  He will speak at 7:00 p.m. at St. Stephen the Witness Catholic Student Center (1019 W. 23rd St.).  His evening presentation in Cedar Falls will be filmed for inclusion in "The Postville Project: Documenting a Community in Transition" (a collaboration of the UNI Rod Library and the Luther College Archives) and for future use by the sponsoring organizations.

On Wednesday, March 10, Dr. Camayd-Freixas will address the noon meeting of the Iowa City Foreign Relations Council at the Congregational Church, 30 N. Clinton St., Iowa City ($8/$9 - reservation required), and then travel to Cedar Rapids and give a public program at Mount Mercy College at Basile Hall, Flaherty Community Room, 1330 Elmhurst Drive, at 7 p.m.

On Thursday, March 11, Clarke College will host Dr. Camayd-Freixas' public presentation in the Jansen Music Hall in the Atrium, 1550 Clarke Drive, Dubuque, also at 7 p.m.

Dr. Camayd-Freixas, a Harvard-trained communications analyst, was one of 26 interpreters who started the court hearings at Waterloo on May 13, 2008, and one of approximately 16 interpreters who stayed the whole two weeks. Shortly after his experience, he composed an essay entitled Interpreting after the Largest ICE Raid in US History, which has been read by thousands and made its way to Congress. In his essay, he recalled his courtroom experience: "Driven single-file in groups of 10, shackled at the wrists, waist and ankles, chains dragging as they shuffled through, the slaughterhouse workers were brought in for arraignment, sat and listened through headsets to the interpreted initial appearance, before being marched out again to be bused to different county jails, only to make room for the next row of 10."

In his statement at the U.S. District Court for the Northern District of Iowa, Dr. Camayd-Freixas identified 13 problems in the judicial process that he observed, including inadequate access to legal counsel and no meaningful presumption of innocence at initial appearance.

Dr. Camayd-Freixas is Professor of Latin American Literature, Director of Translation Studies, and Founder of the Research Initiative on Immigration Reform at Florida International University, Miami. He has published and lectured worldwide on language, literature, and cultural studies. A literary critic, social theorist, and expert in forensic linguistics for federal and state courts, he has trained more than 3,000 interpreters in professional ethics and standards of practice, and regularly works on Spanish television broadcasts of presidential speeches, debates, and special events. He has interpreted internationally for eight different heads of state, including President Barack Obama and Pope Benedict XVI.

Dr. Camayd-Freixas' presentations are sponsored by a Peace & Justice Coordination Committee whose members include leaders from local religious congregations: Congregation of the Humility of Mary, Sisters of St. Francis, Clinton, Ia.; Davenport, Ia.; the Sisters of St. Francis of the Holy Family, Sisters of the Presentation of the Blessed Virgin Mary and Sisters of Charity of the Blessed Virgin Mary, Dubuque, Ia.; and, Dominican Sisters of the Most Holy Rosary, Sinsinawa, Wis.  Co-sponsors include Mount Mercy College, Cedar Rapids, Ia.; Sisters of Mercy West Midwest; Clarke College, Dubuque; First Presbyterian Church, Cedar Falls, Ia.; Iowa Center for Immigrant Leadership and Integration, Cedar Falls; Sisters United News of the Upper Mississippi Valley; Peace & Justice Center of the Cedar Valley-a ministry of Cedar Falls Mennonite Church; St. Stephen the Witness Catholic Student Center, Cedar Falls; UNI American Democracy Project, Cedar Falls..

The Iowa Law Review article "Patentable Subject Matter" authored by Charlie Damschen, an associate with Davenport's Hamilton IP Law, focused on how courts should judge whether certain software qualified for patent protection. This article has recently been cited by the Franklin Pierce Law Center in its Petition for a Writ of Certiorari amicus brief to the U.S. Supreme Court. Later, Damschen's paper was also cited by William M. Schuster in his article in the Columbia Science and Technology Law Review.

This article focuses on the merits of a patent case similar to Bilski v. Kappos, which is now before the U.S. Supreme Court.  Oral arguments for this case were heard in November and it looks like a decision will come down this spring.  "It's a thrill that my thoughts on this issue are being considered at a national level," cited Damschen.

In the Bilski v. Kappos case, Bilski filed a patent covering a method of hedging risk in the field of commodities trading. Because software is a method performed by a computer, courts treat it as a method when determining patentability. The Court of Appeals for the Federal Circuit ruled the method in Bilski as non-patentable subject matter and decided a method must transform a particular article into a different state for the method to be eligible for patenting. The software and related services sector employ 1.7 million people earning an average of $85,000 annually. The outcome of this case will undoubtedly affect this industry's growth.

Hamilton IP Law aids entrepreneurs in securing protection for all forms of intellectual property.  The firm serves a variety of specializations, including software, agricultural equipment, electrical components and industrial processes.  Hamilton IP Law provides counsel ranging from individual inventors to medium-sized businesses.  Its founder, Jay Hamilton, is a member of the Scott County Bar Association, a board member of the Quad City I-Club and a frequent guest lecturer at various small business and inventor forums.

FOR MORE INFORMATION

Contact: Charlie Damschen

331 West 3rd Street, Davenport, IA

Phone: (563) 441-0207

###

Guaranteed Loans Provided Through Recovery Act Funds Help Local Businesses and Supports the Nation's Renewable Energy Strategy

WASHINGTON, February 16, 2010 - Agriculture Secretary Tom Vilsack today announced $144 million in loan guarantees to assist 54 rural businesses through funding made available through the American Recovery and Reinvestment Act.  The funding is authorized through USDA Rural Development's Business and Industry Guaranteed Loan Program. The program received $1.57 billion through the Act to help rural businesses stimulate economic development.

"A number of the Recovery Act projects announced today support the President's comprehensive energy strategy announced earlier this month," said Vilsack. "Advancing biomass and biofuel production holds the potential to create green jobs, which is one of the many ways the Obama Administration and USDA are working to rebuild and revitalize rural America."

For example, in Hilo, Hawaii, Big Island Biodiesel, LLC, has been selected to receive a $5,000,000 loan guarantee through First Hawaiian Bank in Kahului to construct a $10 million, 2.64 million gallon per year biodiesel production plant in Keaau.  The feedstock for this biodiesel plant will primarily be used cooking oil, and potentially jatropha and algae.  More than one million gallons of used cooking oil and grease-trap oil will be diverted from Maui, Oahu, and Hawaii County landfills to produce the biodiesel. Hawaii has established an Alternative Fuel Standard (AFS) with the goal of providing 10 percent of highway fuel demand from alternate fuels by 2010, 15 percent by 2015, and 20 percent by 2020.

In Athol Massachusetts, Organic Renaissance, LLC, has been selected to receive a $450,000 loan guarantee to facilitate the provision of fresh, locally grown farm products to restaurants, retailers and other buyers.  The company intends to lease a building that is centrally located between Boston and farmers located in Mass., southern N.H., southern Vt., and northern Conn. The intent is to reduce shipping costs and enable cost-effective distribution of farm fresh produce by local rural businesses. The guaranteed loan will help to reduce costs and create opportunities for employment in a rural area as well as support the production of agricultural food products.

Eligible applicants for USDA Rural Development's Business and Industry Guaranteed Loan Program include private businesses, cooperative organizations, corporations, partnerships, non-profit groups, Federally recognized Indian tribes, public bodies and individuals. The funds are targeted to create and retain quality jobs and serve difficult-to-reach populations and areas hardest hit by the current economic downturn.

More information about USDA's Recovery Act efforts is available at www.usda.gov/recovery. More information about the Federal Government's efforts on the Recovery Act is available at www.recovery.gov.

A list of borrowers receiving loan awards is below.  Funding is contingent upon borrowers meeting conditions in the loan agreement.

Alabama
Conversion Technologies, LLC: $3,730,000

Arizona
SpeedSmart 112, Inc.: $6,399,393

California
Kenneth & Sharon Foster, Roger & Vicki Webb, Eel River Fuels, Inc.: $2,239,600

Florida
Blooming Acres: $1,500,000
Dreamland Limited: $1,500,000

Georgia
Alexander Printing Company, Inc.: $583,000
JVH&J International, LLC: $2,123,000
Moultrie Healthcare Properties, LLC: $10,000,000
Southside Plaza Developers, Inc., Dixie Discount, Curbert, Inc., and Barry T. Buchholz: $1,675,000

Guam
Quick Service Foods, Inc.: $500,000

Hawaii
Big Island Biodiesel, LLC: $5,000,000

Iowa
Northern IA Die Casting: $1,452,379
Schoon Construction, Inc., and Leroy & Judith Schoon: $3,325,000

Idaho
Valley Air Photos LLC: $1,415,536
Bosski, Inc., Thunder Mountain Properties LLC, and John and Collette Boguslawski: $450,000
True Value Hardware: $735,000

Illinois
Carri Scharf Materials: $5,000,000

Indiana
Montgomery-Besaw Leasing, LLC: $2,584,000

Louisiana
New Century Fabricators, Inc.: $3,525,000

Maine
A&J Industries, Inc.: $1,300,000

Massachusetts
Organic Renaissance, LLA: $450,000

Michigan
Vista Grand Villa: $3,000,000
CRB Real Estate: $1,356,328
PMU-LADD: $360,000

Minnesota
Kay's Processing: $700,000
Anderson Seed Co. Inc: $975,000

Missouri
Good Time Rentals, LLC: $205,000
Missouri Forge Inc.: $5,928,000
Cycle Connection, Inc.: $817,000

New Hampshire
Monadnock Economic Development Corporation: $6,377,920

Nevada
A.C.E., LLC: $350,000
T & N Properties, LLC and Leading Technology Development, LLC: $518,000

New York
Bestway NY/HDK/Builder's Best: $3,100,000
Bestway PA/Bestway South/ Bestway NE: $9,900,000

North Carolina
Orange Charter School: $700,000
Bendel Group LLC: $672,000

North Dakota
Minot Hospitality Partners, LLC: $5,000,000
Medora Environmental, Inc.: $3,000,000
RediFlame Inc.: $850,000

Oklahoma
Gallium Compounds, LLC: $2,650,000

Oregon
Oregon, Select Onion Company, LLC; et al.: $4,500,000
Oregon, RAM Trucking, Inc.; et al.: $450,000
Fiesta Foods of Oregon, Inc.: $6,900,000
Thatchers Hardware, Inc. and SDDZ, LLC: $712,683

Pennsylvania
Adonai Holdings, Inc.: $2,700,000

South Carolina
Ashlan Properties, LLC (Arby's Restaurant): $1,278,812
Industrial Management Services, Inc.: $2,600,000

Tennessee
Tennessee Materials Corporation, Inc.: $5,530,500
SomerOak Senior Living, LLC:  $3,300,000
Van Ayers Long Term Facility: $3,718,900

Texas
Frazier & Frazier Industries, Inc.: $7,242,400

Virginia
James River Car Wash, LLC: $285,000
Montgomery Restaurant Corp. and El Laurel, LLC: $1,360,000

Washington
Peninsula Plywood Group, LLC: $ 1,899,270

USDA Rural Development's mission is to increase economic opportunity and improve the quality of life for rural residents. Rural Development fosters growth in homeownership, finances business development, and supports the creation of critical community and technology infrastructure. Further information on rural programs is available at a local USDA Rural Development office or by visiting USDA Rural Development's web site at http://www.rurdev.usda.gov.

###

WASHINGTON --- Senator Chuck Grassley has asked the Food and Drug Administration about progress made to improve foreign drug inspection, following commitments made by the agency when Baxter International temporarily suspended production of its blood thinner heparin in 2008 because of adverse reactions.

"My letter today follows up on oversight I did at that time because requirements the FDA already had in place then were not met by the FDA, and the drug company itself didn't have a system to check the quality of upstream providers of the drug components.  In fact, pharmaceutical companies aren't required to have those checks in place," Grassley said.  "I will continue asking the FDA for information and working to hold the federal agency accountable in its work to protect the safety of the drugs in our medicine cabinets."

Since 2007, Grassley also has twice filed legislation to dramatically beef up the FDA's foreign inspection operation, including enhanced enforcement for quality and safety violations.  The legislation, which Grassley had introduced with the late Senator Kennedy, hasn't been passed by Congress.  China is one of the largest exporters of pharmaceutical products to the United States.  Following questions raised by Grassley and others in 2007 and 2008 about the inadequate foreign inspections, the FDA has opened an office in China to facilitate inspections.

Below is the text of the letter Grassley sent today to the FDA Commissioner.

February 16, 2010

The Honorable Margaret A. Hamburg

Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Ave.
Silver Spring, MD 20993

Dear Commissioner Hamburg:

As Ranking Member of the United States Senate Committee on Finance (Committee), I have a special responsibility to the more than 100 million Americans who receive health care coverage under those programs to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices.

In 2007 and 2008, I wrote a series of letters to the Food and Drug Administration (FDA/Agency) inquiring about the Agency's oversight of foreign-made drugs and active pharmaceutical ingredients (API).  I appreciate FDA's responses to my letters and look forward to the Agency's continued cooperation.

Almost two years ago, in February 2008, Baxter International (Baxter) had announced that it had temporarily suspended production of its blood thinner heparin because of increased reports of serious adverse events, in particular allergic reactions, associated with the use of its drug.  The company recalled its heparin sodium injection single-dose vials, the remainder of its multiple-dose vials, and the heparin flush products from the market.  Prior to the recall of its products, Baxter manufactured about 50 percent of the heparin used in the United States.  Thus, there were serious concerns about whether or not this country would have enough heparin to meet patient needs.

After several months of investigation, the FDA and the Centers for Disease Control and Prevention concluded that the adverse events were caused by heparin contaminated with oversulfated chondroitin sulfate.  According to the FDA, this contaminant was found in heparin API produced by Baxter's API supplier in China, Changzhou Scientific Protein Laboratories (SPL), as well as more than 10 other Chinese facilities in the heparin supply chain.  In addition, the Agency revealed that due to human error, the FDA had failed to conduct a pre-approval inspection of Changzhou SPL in accordance with its pre-approval inspections program to ensure compliance with current good manufacturing practices (CGMP).

Despite its own audits and inspections of the API supplier, Baxter did not discover that its heparin API supply was contaminated because the company did not have mechanisms in place to ensure that the upstream providers, such as the crude heparin processors and slaughterhouses, were providing quality product to Changzhou SPL.  Baxter and other heparin manufacturers, however, are not required to have such mechanisms in place.  FDA has stated that API and drug manufacturers "frequently audit suppliers of critical materials" but the audits are not a requirement of the CGMP regulations for finished pharmaceuticals.  Nonetheless, there was one heparin manufacturer, APP Pharmaceuticals, which had a traceable distribution system that did allow it to trace crude heparin from the API supplier to the workshops and pig farms.  That company was able to increase its heparin production capacity and take over as the major supplier for the U.S. market after Baxter's product recalls.

Investigation of the contamination of the U.S. heparin supply in 2008 highlighted the need to improve FDA's protection of the safety of products made in this country and abroad.  In fact, the FDA acknowledged at a press conference on April 21, 2008 that the heparin problem "illustrated the need for [the FDA] to focus on enhanced regulation and scrutiny of the whole supply chain for drugs, including all sources of materials, including the natural sources."  In the Agency's response to me, dated June 5, 2009, the FDA also stated that "Aside from a traceable distribution system, it is imperative that both the API and drug product manufacturer establish and implement procedures and controls to secure and assure the integrity of the supply and distribution chain."

In response to the heparin contamination, the FDA announced a number of efforts it was implementing to prevent similar incidents from occurring in the future, including the establishment of an FDA presence abroad by opening field offices in China, India and Latin America, as well as the pursuit of international agreements to augment its foreign inspection program.  The FDA also stated that the FDA and international regulators had agreed to hold an inspection summit in 2009 to apply the lessons learned from the heparin contamination.  In addition, the FDA stated in its letter to me that it is collaborating with several pharmaceutical associations "to establish more robust systems and procedures to qualify suppliers of pharmaceutical ingredients and assure the identity and purity of batches of incoming ingredients."

I am writing today to follow up on the status of FDA's initiatives to improve its foreign drug inspection program, in particular any efforts to prevent tainted final dosage forms and API from entering this country.  I would also appreciate a response to the following requests:

· A reporting of FDA's plans to ensure the safety and quality of drug products that are imported into this country, including efforts to improve surveillance, technology and testing capabilities, to harmonize regulatory standards and procedures, and to enhance the Agency's regulation of the whole supply chain of drugs.

· If FDA conducted its own assessment of how the Agency handled the heparin contamination, a copy of any report or memorandum generated from that assessment, including any recommendations and lessons learned.

· A status report on FDA's review of reports of adverse events occurring after heparin administration and the number of deaths and adverse events that have been determined to be epidemiologically associated with use of the contaminated product.  During the April 21, 2008 FDA press conference, the Agency stated that there were 81 deaths linked to the allergic reactions that may have been caused by contaminated heparin.  A month earlier, on March 5, 2008, the Agency stated that it had received 785 reports of adverse events.  FDA's webpage on adverse event reports and heparin, last updated July 1, 2009, shows that between January 1, 2007 through May 31, 2008 there were 146 reported deaths that included one or more allergic symptoms that is associated with use of the contaminated heparin.  The webpage, however, does not identify the total number of other adverse events reported to the FDA.

Thank you for your assistance on this important matter.  I would appreciate a response to the requests set forth in this letter by no later than March 2, 2010.

Sincerely,

Chuck Grassley

United States Senator

Ranking Member of the Committee on Finance

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