Friday, January 10, 2014

ATTORNEY GENERAL HOLDER'S STATEMENT ON SAME-SEX MARRIAGES IN UTAH

FROM:  JUSTICE DEPARTMENT 
Friday, January 10, 2014
Statement by Attorney General Eric Holder on Federal Recognition of Same-Sex Marriages in Utah
Attorney General Eric Holder issued the following statement today on the status of same-sex marriages performed in the state of Utah:

 “Last June, the Supreme Court issued a landmark decision – in United States v. Windsor – holding that Americans in same-sex marriages are entitled to equal protection and equal treatment under the law.  This ruling marked a historic step toward equality for all American families.  And since the day it was handed down, the Department of Justice has been working tirelessly to implement it in both letter and spirit—moving to extend—federal benefits to married same-sex couples as swiftly and smoothly as possible.

"Recently, an administrative step by the court has cast doubt on same-sex marriages that have been performed in the state of Utah.  And the governor has announced that the state will not recognize these marriages pending additional court action.

"In the meantime, I am confirming today that, for purposes of federal law, these marriages will be recognized as lawful and considered eligible for all relevant federal benefits on the same terms as other same-sex marriages.  These families should not be asked to endure uncertainty regarding their status as the litigation unfolds. In the days ahead, we will continue to coordinate across the federal government to ensure the timely provision of every federal benefit to which Utah couples and couples throughout the country are entitled – regardless of whether they in same-sex or opposite-sex marriages.  And we will continue to provide additional information as soon as it becomes available.”

HEALTH CARE COMPANY EXECS TO PAY OVER $1 MILLION TO RESOLVE FALSE CLAIMS ALLEGATIONS

FROM:  JUSTICE DEPARTMENT 
Friday, January 10, 2014
Former HealthEssentials Solutions Inc. Executives to Pay More Than $1 Million to Resolve Allegations of Submitting False Claims to Federal Health Care Program

Michael R. Barr, former chief executive officer of Louisville, Kentucky-based HealthEssentials Solutions Inc., has agreed to pay $1 million to resolve allegations that he knowingly caused HealthEssentials to submit false claims to Medicare between 1999 and 2004, the Justice Department announced today.  Norman J. Pfaadt, HealthEssentials’ former chief financial officer, also agreed to pay $20,000 to resolve similar allegations.  H ea lt h E s s e nt i a ls provided primary medical care to patients in nursing facilities, assisted living facilities and other settings from 1998 until it filed for bankruptcy and ceased operations in 2005.  Barr founded HealthEssentials and served as its president, chief executive and board chairman.  Pfaadt served as HealthEssentials’ senior vice president and chief financial officer.

“Healthcare executives should lead by example and create cultures of compliance within their companies, not pressure their employees to cheat the taxpayers,” said Assistant Attorney General for the Civil Division Stuart F. Delery.  “We will continue to hold health care executives personally accountable for their dealings with Medicare.”

“Pursuing health care fraud is a priority of this office and the Department of Justice,” said U.S. Attorney for the Western District of Kentucky David J. Hale.  “We will continue to work with the Department of Health and Human Services and the public to ensure that fraudulent claims are investigated and those responsible are required to pay.”
         
In March 2008, HealthEssentials pleaded guilty to submitting false statements to Medicare relating to services it provided to patients in assisted living facilities and entered into a civil settlement with the government.  In May 2011, HealthEssentials’ former director of billing, Karen Stone, pleaded guilty for her role in the company’s billing scheme.

The settlement announced today resolves Barr’s and Pfaadt’s alleged liability under the False Claims Act for their roles in HealthEssentials’ false billings.  The government alleged that, between 1999 and 2004, HealthEssentials billed for services that were inflated or not medically necessary and that Barr and Pfaadt pressured HealthEssentials employees to inflate the company’s billings, despite having been advised by attorneys and others that doing so would be improper.  The government further alleged that Barr pressured HealthEssentials employees to conduct special medical assessments on patients, without regard to whether the patients required the assessments, solely to increase the amount that HealthEssentials could bill for the visits.  As part of the settlement, Barr has agreed to a three-year period of exclusion from participating in federally funded health care programs.

“Executives cheating taxpayers and patients – as alleged in this case – should beware of exclusion from Medicare, Medicaid and all other federal health programs, as well as criminal and civil liability,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson.  “Vulnerable beneficiaries deserve protection from potentially harmful, medically unnecessary services.”

The allegations that were resolved by the settlement arose in part from a lawsuit filed by former HealthEssentials employees Michael and Leigh RoBards under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring suit on behalf of the government and to share in any recovery.  Mr. and Mrs. RoBards will receive a total of $153,000.

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $17 billion through False Claims Act cases, with more than $12.2 billion of that amount recovered in cases involving fraud against federal health care programs.

The case was handled by the Commercial Litigation Branch, Civil Division, U.S. Department of Justice and the U.S. Attorney’s Office for the Western District of Kentucky, with assistance from the Department of Health and Human Services Office of Inspector General and the Federal Bureau of Investigation.

The claims settled by this agreement are allegations only; there has been no determination of liability.  The case is captioned United States ex rel. Stydinger, et al. v. Michael R. Barr and Norman J. Pfaadt, Civil No. 3:03-cv-00380-TBR (W.D. Ky.).

FEDS SEND MORE FUNDING TO AID IN SEVERE WEATHER RECOVERY EFFORTS IN MISSISSIPPI

FROM:  LABOR DEPARTMENT 

Additional funding awarded to Mississippi to assist ongoing cleanup 
and recovery efforts from severe storms, tornadoes and flooding

WASHINGTON — The U.S. Department of Labor today announced a $833,835 National Emergency Grant incremental award to continue with the cleanup and recovery efforts resulting from the severe storms, tornadoes and flooding in Mississippi on Feb. 10, 2013. These funds are being awarded to the Mississippi Department of Employment Security to create temporary jobs for eligible individuals to assist in cleanup efforts.

"The residents of Mississippi recovering from the devastating storms last February," said Eric M. Seleznow, acting assistant secretary of labor for employment and training. "This funding will help create the jobs necessary to provide assistance to the communities impacted by this damaging weather system."
This grant was first approved on March 4, 2013, for up to $2,000,000, with $1,000,000 initially released, to assist in the aftermath of the Mississippi severe storms, tornadoes and flooding. This incremental award brings the total funds awarded for this project to $1,833,835, which is projected to create a total of 95 temporary jobs.

Following the Mississippi severe storms, tornadoes and flooding, the Federal Emergency Management Agency declared Forrest, Lamar, Marion and Wayne counties as eligible for FEMA's Public Assistance Program. The state is targeting Forrest and Lamar counties for assistance under this grant.

National Emergency Grants are part of the secretary of labor's discretionary fund and are awarded based on a state's ability to meet specific guidelines.

Editor's Note: Acting Assistant Secretary of Labor for Employment and Training Eric M. Seleznow's radio actuality on National Emergency Grants is available for public use.

FTC GOES AFTER AUTO DEALERS FOR FALSE ADVERTISING

FROM:  FEDERAL TRADE COMMISSION 
FTC Announces Sweep Against 10 Auto Dealers
‘Operation Steer Clear’ Drives Home That Auto Ads Must Be Truthful

The Federal Trade Commission announced today that nine auto dealers agreed to settle deceptive advertising charges, and the agency is taking action against a 10th dealer, in a nationwide sweep focusing on the sale, financing, and leasing of motor vehicles.

According to the complaints, the dealers made a variety of misrepresentations in print, Internet, and video advertisements that violated the FTC Act, falsely leading consumers to believe they could purchase vehicles for low prices, finance vehicles with low monthly payments, and/or make no upfront payment  to lease vehicles. One dealer even misrepresented that consumers had won prizes they could collect at the dealership.

“Buying or leasing a car is a big deal, and car ads are an important source of information for serious shoppers,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection. “Dealers’ ads need to spell out costs and other important terms customers can count on. If they don’t, dealers can count on the FTC to take action.”

‘Operation Steer Clear’ is the latest effort from the FTC to protect consumers in the auto marketplace. The dealerships that settled are charged as follows:

California

Casino Auto Sales of La Puente, Calif., and Rainbow Auto Sales, of South Gate, Calif., allegedly violated the FTC Act by deceptively advertising that consumers could purchase vehicles at specific low prices when, in fact, the price was $5,000 higher. Both dealers’ ads involved a mix of English and Spanish. Honda of Hollywood, Los Angeles, and Norm Reeves Honda of Cerritos, Calif., violated the FTC Act by deceptively advertising that consumers could pay $0 up-front to lease a vehicle when, in fact, the advertised amounts excluded substantial fees and other amounts. The ads also allegedly violated the Consumer Leasing Act (CLA) and Regulation M, by failing to disclose certain lease related terms. Norm Reeves Honda’s ads also allegedly violated the Truth in Lending Act (TILA) and Regulation Z, by failing to disclose certain credit related terms.

Georgia

Nissan of South Atlanta of Morrow, Ga., allegedly violated the FTC Act by deceptively advertising that consumers could finance a vehicle purchase with low monthly payments when, in fact, the payments were temporary “teasers” after which consumers would owe a different amount. The ads also allegedly violated TILA and Regulation Z, by failing to disclose certain credit related terms.

Illinois

Infiniti of Clarendon Hills of Clarendon Hills, Ill., allegedly violated the FTC Act by deceptively advertising that consumers could pay $0 up-front to lease a vehicle when, in fact, the advertised amounts excluded substantial fees and other amounts. The ads also allegedly violated the CLA and Regulation M, by failing to disclose certain lease related terms.

North Carolina

Paramount Kia of Hickory, N.C., allegedly violated the FTC Act by deceptively advertising that consumers could finance a purchase with low monthly payments when, in fact, the payments were temporary “teasers” after which the consumer would owe a much higher amount, by several hundred dollars. The ads also allegedly violated the TILA and Regulation Z, by failing to clearly and conspicuously disclose certain credit related terms.

Michigan

Fowlerville Ford of Fowlerville, Mich., allegedly violated the FTC Act by sending mailers that deceptively claimed consumers had won a sweepstakes prize, when, in fact, they had not. Some of their ads also allegedly violated TILA and Regulation Z, by failing to disclose certain credit related terms.

Texas

Southwest Kia companies, including New World Auto Imports, Dallas, Texas, New World Auto Imports of Rockwall, Rockwall, Texas, and Hampton Two Auto Corporations, Mesquite, Texas, allegedly violated the FTC Act by deceptively advertising that consumers could purchase a vehicle for specific low monthly payments when, in fact, consumers would owe a final balloon payment of over $10,000. The companies also allegedly deceptively advertised that consumers could drive home a vehicle for specific low up-front amounts and low monthly payments when, in fact, the deal was a lease and they would owe substantially more up-front. The ads also allegedly violated the CLA and Regulation M, by failing to disclose certain lease related terms, and the TILA and Regulation Z, by failing to disclose certain credit related terms.

The proposed consent orders settling the FTC’s charges in the nine cases are designed to prevent the dealerships from engaging in similar deceptive advertising practices in the future. The orders prohibit the dealerships from misrepresenting in any advertisement for the purchase, financing, or leasing of motor vehicles the cost of leasing a vehicle, the cost of purchasing a vehicle with financing, or any other material fact about the price, sale, financing, or leasing of a vehicle. When relevant, the proposed consent orders also address the alleged TILA and CLA violations by requiring the dealerships to clearly and conspicuously disclose terms required by these credit and lease laws. In the case where the dealerships misrepresented that consumers had won a prize, the proposed order also prohibits misrepresenting material terms of any prize, sweepstakes, giveaway, or other incentive.

The FTC would like to thank the Los Angeles Department of Consumer Affairs for its assistance with multiple investigations in California, and the Michigan Department of Attorney General for its assistance with the investigation in Michigan.

The Commission votes to accept the packages containing the nine proposed consent orders and complaints for public comment were 4-0. The agreements will be subject to public comment for 30 days, beginning today and continuing through Feb. 10, 2014, after which the Commission will decide whether to make the proposed consent orders final. Submit a comment electronically:

Casino Auto Sales
Honda of Hollywood
Fowlerville Ford
Infiniti of Clarendon Hills
Nissan of South Atlanta
Norm Reeves Honda Superstore
Paramount Kia
Rainbow Auto Sales
Southwest Kia
Comments in paper form should be mailed or delivered to: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, N.W., Washington, DC 20580.

In addition, the FTC issued an administrative complaint against Courtesy Auto Group of Attleboro, Mass. The FTC alleges the dealership violated the FTC Act by deceptively advertising that consumers can lease a vehicle for $0 down and specific monthly payments when, in fact, the advertised amounts exclude substantial fees. The ads also allegedly violate the CLA and Regulation M, by failing to disclose or clearly and conspicuously disclose certain lease related terms.

The Commission vote to issue the administrative complaint was 4-0.

QUADRENNIAL ENERGY REVIEW LAUNCHED BY WHITE HOUSE

FROM:  THE WHITE HOUSE 
Obama Administration Launches Quadrennial Energy Review
First QER Will Focus on Transmission and Distribution Infrastructure

Today, President Obama signed a Memorandum directing his Administration to conduct a Quadrennial Energy Review (QER).  This first QER will focus on the development of a comprehensive strategy for the infrastructure involved in transporting, transmitting, and delivering energy. The QER will be developed through robust interagency dialogue and engagement of external stakeholders and will help to build on the Nation’s progress toward greater energy and climate security.

Building on the foundation provided in the President’s Blueprint for a Secure Energy Future and his Climate Action Plan, this QER will study the opportunities and challenges that our energy infrastructure faces as a result of transformations in energy supply, markets, and use; issues of aging and capacity; impacts of climate change; and cyber and physical threats.  The QER will provide rigorous analysis in a focused, actionable document for policymakers across all sectors.

The development of the QER will include broad outreach, including to the private sector; state, local and tribal governments; labor and other non-governmental organizations; and the academic community.  The QER will be conducted by an interagency task force that is co-chaired by the leaders of the White House Domestic Policy Council and Office of Science and Technology Policy, and includes representation from all relevant executive departments and agencies.  The Department of Energy will play a key role in providing analytical support to the QER.

As the Presidential Memorandum outlines, the QER will provide an integrated view of, and recommendations for, Federal energy policy in the context of economic, environmental, occupational, security, and health and safety priorities; review the adequacy of existing executive and legislative activities and recommend additional executive and legislative actions as appropriate; assess and recommend priorities for research, development, and demonstration programs to support key goals; and identify analytical tools and data needed to support further policy development and implementation.

Since President Obama took office, domestic oil production has increased more than 50 percent and natural gas production is now the highest it has ever been. Today, America is not just leading the world in energy production but it is also leading the world in energy innovation: Investments in research, development, and deployment have more than doubled the renewable electricity that we generate from wind and solar, even as the prices of those technologies continue to drop, and advances in energy efficiency are making our energy system cleaner, cheaper, and more reliable.  All this change tests an aging infrastructure that must keep pace both with the transformations in energy supply, climate change and security.  In this context, the QER will help U.S. policymakers across all sectors make decisions based on unbiased data and rigorous analysis.

READOUT: PRESIDENT OBAMA'S MEETING WITH CONGRESSIONAL MEMBERS

FROM:  THE WHITE HOUSE 
Readout of the President's Meeting with Members of Congress

Today President Obama met with Members of Congress to discuss the Administration’s ongoing review of signals intelligence programs, including our study of the Review Group on Intelligence and Communications Technologies report. In August, the President committed his Administration to working with Congress to pursue reforms to our nation’s surveillance programs and the Foreign Intelligence Surveillance Court. This meeting was an opportunity for the President to hear from the Members about the work they have been doing on these issues since they last met and solicit their input as we near the end of our internal review. The President thanked the Members for their ongoing work on these challenging issues.

The following Members of Congress attended:

Senator Dianne Feinstein, D-CA, Chairman, Select Committee on Intelligence

Senator Saxby Chambliss, R-GA, Vice Chairman, Select Committee on Intelligence

Senator Patrick Leahy, D-VT, Chairman, Judiciary Committee

Senator Chuck Grassley, R-IA, Ranking Member, Judiciary Committee

Senator Dick Durbin, D-IL, Assistant Majority Leader and Chairman, Appropriations Subcommittee on Defense

Senator Thad Cochran, R-MS, Ranking Member, Appropriations Subcommittee on Defense

Senator Richard Blumenthal, D-CT

Senator Mark Udall, D-CO

Senator Ron Wyden, D-OR

Representative Mike Rogers, R-MI, Chairman, Permanent Select Committee on Intelligence

Representative Bob Goodlatte, R-VA, Chairman, Judiciary Committee

Representative John Conyers, D-MI, Ranking Member, Judiciary Committee

Representative Rodney Frelinghuysen, R-NJ, Chairman, Appropriations Subcommittee on Defense

Representative Peter Visclosky, D-IN, Ranking Member, Appropriations Subcommittee on Defense

Representative Adam Schiff, D-CA

Representative Jim Sensenbrenner, R-WI

SECRETARY OF DEFENSE HAGEL VISITS NEW MEXICO NUCLEAR FACILITIES

FROM:  DEFENSE DEPARTMENT 
Hagel Visits Troops, Defense Nuclear Facilities in New Mexico
By Cheryl Pellerin
American Forces Press Service


ALBUQUERQUE, N.M., Jan. 9, 2014 – Defense Secretary Chuck Hagel said he was impressed with what he saw here yesterday at an Air Force base on the northern edge of the Chihuahuan Desert, where two facilities represent a large and historic part of the nation’s nuclear weapons expertise.

The secretary spent the morning in San Antonio, visiting troops, wounded warriors and their families, and hospital workers and staff at Brooke Army Medical Center and its Center for the Intrepid. He then traveled here for briefings at Kirtland Air Force Base and the Air Force Materiel Command's Nuclear Weapons Center, whose responsibilities include nuclear system programs acquisition, modernization and sustainment for the Defense and Energy departments.
Also on the nearly 52,000-acre base is the main facility of Sandia National Laboratories, where scientists and engineers develop, engineer and test non-nuclear components of nuclear weapons. An initial version of the lab was established in 1945 in the early days of the Manhattan Project, a research and development program that produced the first atomic bombs during World War II.
During his visit to Sandia and Kirtland, Hagel met with experts and discussed microsystems and engineering science applications, proliferation assessment, the advanced hypersonic weapon concept, and other topics.

Afterward, while briefing reporters who are traveling with him, Hagel said he wanted especially to visit Sandia “because modernization, research and development, [and] that technical edge that we have been able to maintain, is critically important … in the world we’re in today.”

Technology in particular, he added, has increasingly driven complications, combustibility and new dimensions in the global environment.

At the lab, he said, “I was impressed not only with the technical capability but with the people.”

Because of the critical skills required in any institution, but particularly in the area of nuclear weapons, nuclear modernization and research and development, Hagel said, the United States must continue to be able to recruit and keep cutting-edge minds worldwide on its team.

The secretary said he also was impressed with the people he met at Sandia and Kirtland, including “what they’re doing, how they’re doing it, and the commitment they have made to this country and [its] future.” They understand the privilege of helping to make a better world, he added.

Today, Hagel will travel to Cheyenne, Wyo., to visit the Missile Alert Facility and Launch Control Center, where he will receive briefings and have lunch with missile combat crewmembers and security forces.

Afterward, Hagel will move to F.E. Warren Air Force Base, where the 90th Missile Wing, activated in 1963, operates 150 Minuteman III intercontinental ballistic missiles. At the base, he will hold a troop event for up to 200 service members.

“I think it’s very important that all of us who have some responsibility for the national security of this country pay attention to every aspect of that responsibility,” Hagel said, “and certainly the nuclear component of our defense capabilities -- the deterrence capabilities that nuclear gives us.”
The secretary said he firmly believes that nuclear deterrence probably is the reason there has been no World War III. “We've had wars, but not on the scale of what we saw in the first half of the 20th century,” he said.

Hagel said another reason he visited Sandia and Kirtland yesterday and will travel to Cheyenne today “is that the American people have to be assured of the safety, security and reliability of the nuclear component of our national security.”
In a fact sheet released a year ago, the State Department said the U.S. government is committed to modernizing the nuclear weapons infrastructure to support a safe, secure and effective nuclear weapons stockpile in the absence of nuclear explosive testing. In accordance with the Nuclear Posture Review, the State Department fact sheet said, the National Nuclear Security Administration identified a path forward.

The modernization focuses on recapitalizing and refurbishing existing infrastructure for plutonium, uranium, tritium, high-explosive production, non-nuclear component production, high-fidelity testing and waste disposition. It also will preserve and enhance essential science and technology tools for assessing and certifying weapons without nuclear explosive testing.

“These investments in science, technology, engineering, manufacturing and information technology infrastructure will sustain the capabilities that underpin the stockpile and other national security missions,” the document said.
During his visit here, Hagel acknowledged the high cost of modernizing the U.S. nuclear weapons infrastructure, but noted the importance of nuclear weapons continuing to stay secure and safe. In a December report, the Congressional Budget Office estimated that between 2014 and 2023, the costs of the administration’s plans for nuclear forces will total $355 billion.

“This country has always been willing to make that investment,” Hagel said, “and I think we will continue to make it.”

The secretary said he believes Congress will be a strong partner in this effort. “I’m often asked many questions by members of Congress of both parties and both houses about nuclear modernization and about our investment and our commitment, so I look forward to that continued conversation,” he said. “We’ll get into the specifics of that when I present our [defense] budget, probably within the next two months.”

FDA APPROVES FARXIGA TABLETS FOR TREATMENT OF TYPE 2 DIABETES

FROM:  FOOD AND DRUG ADMINISTRATION
FDA NEWS RELEASE
For Immediate Release: Jan. 8, 2014
FDA approves Farxiga to treat type 2 diabetes

The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects about 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

“Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar control).

Farxiga has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, pioglitazone, glimepiride, sitagliptin, and insulin. Farxiga should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or those with moderate or severe renal impairment, end stage renal disease, or patients on dialysis.

An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician before using Farxiga. Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function. The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk.

The FDA is requiring six post-marketing studies for Farxiga:

a  cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Farxiga in patients with high baseline risk of cardiovascular disease;
a double-blind, randomized, controlled assessment of bladder cancer risk in patients enrolled in the CVOT;
an animal study evaluating the role of Farxiga-induced urinary flow/rate and composition changes on bladder tumor promotion in rodents;
two clinical trials to assess the pharmacokinetics, efficacy, and safety in pediatric patients; and
an enhanced pharmacovigilance program to monitor reports of  liver abnormalities and pregnancy outcomes.
In clinical trials the most common side effects observed in patients treated with Farxiga were genital mycotic (fungal) infections and urinary tract infections.

Farxiga is marketed by Bristol-Meyers Squibb Company, Princeton, N.J. and AstraZeneca Pharmaceuticals L.P., Wilmington, Del.
For more information:

FDA Approved Drugs
FDA: Drug Innovation
FDA: Diabetes Information
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

CDC SAYS LUNG CANCER NEW CASES DECREASED FROM 2005-2009

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION 
Rates of new lung cancer cases drop in U.S. men and women
CDC report finds fastest drop in adults aged 35-44 years

Tobacco control efforts are having a major impact on Americans’ health, a new analysis of lung-cancer data suggests. The rate of new lung cancer cases decreased among men and women in the United States from 2005 to 2009, according to a report in this week’s Morbidity and Mortality Weekly Report.

The study also found that lung cancer incidence rates went down 2.6 percent per year among men, from 87 to 78 cases per 100,000 men and 1.1 percent per year among women, from 57 to 54 cases per 100,000 women.

The fastest drop was among adults aged 35-44 years, decreasing 6.5 percent per year among men and 5.8 percent per year among women. Lung cancer incidence rates decreased more rapidly among men than among women in all age groups. Among adults aged 35-44 years, men had slightly lower rates of lung cancer incidence than women.

“These dramatic declines in the number of young adults with lung cancer show that tobacco prevention and control programs work – when they are applied,” said CDC Director Tom Frieden, M.D., M.P.H.

Lung cancer is the leading cause of cancer death and the second most commonly diagnosed cancer among both men and women in the United States. Most lung cancers are attributable to cigarette smoking and secondhand smoke. Because smoking behaviors among women are now similar to those among men, women are now experiencing the same risk of lung cancer as men.

“While it is encouraging that lung cancer incidence rates are dropping in the United States, one preventable cancer is one too many,” Dr. Frieden said. “Implementation of tobacco control strategies is needed to reduce smoking prevalence and the lung cancer it causes among men and women.”

In 2010, states appropriated only 2.4 percent of their tobacco revenues for tobacco control. An earlier CDC study showed that states vary widely in their success at reducing smoking – and in reducing new lung cancers.

In the new report, CDC used data from the National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End ResultsExternal Web Site Icon program for the period 2005–2009 to assess lung cancer incidence rates and trends among men and women by age group.
Lung cancer incidence decreased among men in all U.S. Census regions and 23 states, and decreased among women in the South and West and seven states. Rates were stable in all other states. These declines reflect the successes of past tobacco prevention and control efforts.

The study indicates that continued attention to local, state, and national population-based tobacco prevention and control strategies are needed to achieve further reductions in smoking prevalence among both men and women of all ages to reduce subsequent lung cancer in the United States. Strategies proven to reduce tobacco use among youth and adults include increased tobacco prices, comprehensive smoke-free laws, restriction of tobacco advertising and promotion, and hard-hitting mass media and community engagement campaigns.

This month marks the 50th anniversary of the first Surgeon General's Report linking cigarette smoking to lung cancer. Smoking remains the leading cause of preventable death and disease in the United States. Millions of Americans are living with a smoking-related disease, and each day more than 2,100 youth and young adults become daily smokers.

Through the Affordable Care Act, more Americans will qualify to get health care coverage that fits their needs and budget, including important preventive services such as tobacco use screenings and tobacco cessation services that may be covered with no additional costs.

Thursday, January 9, 2014

1/9/13: White House Press Briefing

WHITE HOUSE STATEMENT REGARDING BIPARTISAN CONGRESSIONAL TRADE PRIORITIES ACT OF 2014

FROM:  THE WHITE HOUSE 
Statement by the Press Secretary on the Bipartisan Congressional Trade Priorities Act of 2014

Trade Promotion Authority is a key part of a comprehensive strategy to increase exports and support more American jobs at higher wages, including in a stronger manufacturing sector.  We welcome the introduction of the Bipartisan Congressional Trade Priorities Act of 2014 as an important step towards Congress updating its important role in trade negotiations.  We look forward to working with Democrats and Republicans in Congress throughout the legislative process to pass Trade Promotion Authority legislation with as broad bipartisan support as possible.

The United States has the most open markets in the world, but our products and services still face barriers abroad.  That’s why we need to use every tool we have to knock down trade barriers that prevent American goods and services from being exported.  If we don’t seize these opportunities, our competitors surely will.  And if we don’t take the leadership to set high standards around the world, we will face a race to the bottom which is not in the interest of our workers and firms.

As this process moves ahead, we stand ready to work with Congress to renew the Generalized System of Preferences Program and protect and strengthen Trade Adjustment Assistance for America’s workers.

UNEMPLOYMENT INSURANCE WEEKLY CLAIMS REPORT FOR WEEKENDING JANUARY 4, 2014

UNEMPLOYMENT INSURANCE WEEKLY CLAIMS REPORT 

          SEASONALLY ADJUSTED DATA

In the week ending January 4, the advance figure for seasonally adjusted initial claims was 330,000, a decrease of 15,000 from the previous week's revised figure of 345,000. The 4-week moving average was 349,000, a decrease of 9,750 from the previous week's revised average of 358,750.

The advance seasonally adjusted insured unemployment rate was 2.2 percent for the week ending December 28, unchanged from the prior week's unrevised rate. The advance number for seasonally adjusted insured unemployment during the week ending December 28 was 2,865,000, an increase of 50,000 from the preceding week's revised level of 2,815,000. The 4-week moving average was 2,872,250, an increase of 18,750 from the preceding week's revised average of 2,853,500.

UNADJUSTED DATA

The advance number of actual initial claims under state programs, unadjusted, totaled 486,033 in the week ending January 4, an increase of 34,384 from the previous week. There were 557,724 initial claims in the comparable week in 2013.

The advance unadjusted insured unemployment rate was 2.5 percent during the week ending December 28, an increase of 0.3 percentage point from the prior week. The advance unadjusted number for persons claiming UI benefits in state programs totaled 3,295,112, an increase of 451,828 from the preceding week. A year earlier, the rate was 2.9 percent and the volume was 3,730,220.
The total number of people claiming benefits in all programs for the week ending December 21 was 4,193,749, a decrease of 265,067 from the previous week. There were 5,356,419 persons claiming benefits in all programs in the comparable week in 2012.

No state was triggered "on" the Extended Benefits program during the week ending December 21.

Initial claims for UI benefits filed by former Federal civilian employees totaled 1,199 in the week ending December 28, a decrease of 669 from the prior week. There were 1,208 initial claims filed by newly discharged veterans, a decrease of 789 from the preceding week.

There were 20,705 former Federal civilian employees claiming UI benefits for the week ending December 21, a decrease of 2,003 from the previous week. Newly discharged veterans claiming benefits totaled 28,567, a decrease of 3,430 from the prior week.

States reported 1,287,037 persons claiming Emergency Unemployment Compensation (EUC) benefits for the week ending December 21, a decrease of 104,260 from the prior week. There were 1,991,454 persons claiming EUC in the comparable week in 2012. EUC weekly claims include first, second, third, and fourth tier activity.

The highest insured unemployment rates in the week ending December 21 were in Alaska (5.3), Pennsylvania (3.4), New Jersey (3.3), Connecticut (3.2), Illinois (3.1), Montana (3.0), Puerto Rico (2.9), Wisconsin (2.9), California (2.8), Nevada (2.8), Oregon (2.8), and Rhode Island (2.8).

The largest increases in initial claims for the week ending December 28 were in Michigan (+16,056), Pennsylvania (+10,601), New Jersey (+7,345), Ohio (+7,036), and Iowa (+5,369), while the largest decreases were in California (-14,635), Texas (-6,723), Florida (-3,738), North Carolina (-2,694), and South Carolina (-2,184).

U.S. DEFENSE DEPARTMENT CONTRACTS FOR JANUARY 9, 2014

FROM:  DEFENSE DEPARTMENT 
CONTRACTS

ARMY

Sikorsky Aircraft Corp., Stratford, Conn., was awarded a $549,905,199 modification (P00126) to contract W58RGZ-12-C-0008 to fund Navy’s eighteen MH-60S helicopters and nineteen MH-60R helicopters and associated sustaining engineering, program management, systems engineering, provisioning, technical publications, other integrated logistics support and advanced procurement funding for program years four and five.  Fiscal 2014 other program funds in the amount of $230,186,863 were obligated at the time of the award.  Estimated completion date is Dec. 31, 2015.  Work will be performed in Stratford, Conn.  Army Contracting Command, Redstone Arsenal, Ala., is the contracting activity


DEFENSE LOGISTICS AGENCY

American Water Operations & Maintenance Inc., Voorhees, N.J., has been awarded a maximum $288,021,970 fixed-price with economic-price-adjustment contract for assumption of ownership, operation, and maintenance of the water distribution system and wastewater collection system at Hill Air Force Base.  This contract is a competitive acquisition and one offer was received.  Location of performance is New Jersey and Utah with a January 2064 performance completion date.  Using military service is Air Force.  Type of appropriation is fiscal 2014 Air Force operations and maintenance funds.  The contracting activity is the Defense Logistics Agency Energy, Fort Belvoir, Va., (SP0600-14-C-8290).

US Foods International Inc.*, Gardena, Calif., has been awarded a maximum $42,226,006 modification (P00202) exercising the fourth option year on a one-year base contract (SPM300-08-D-3310) with four one-year option periods for prime vendor full line food distribution.  This is a fixed-price with economic-price-adjustment, indefinite-delivery/indefinite-quantity contract.  Locations of performance are California and South Korea with a Jan. 31, 2015 performance completion date.  Using military services are Army, Navy, Air Force, Marine Corps, federal civilian agencies, and other authorized Department of Defense customers.  Type of appropriation is fiscal 2014 defense working capital funds.  The contracting activity is the Defense Logistics Agency Troop Support, Philadelphia, Pa.

The Merchants Co., Hattiesburg, Miss., has been awarded a maximum $12,316,254 fixed-price with economic-price-adjustment, indefinite-quantity, bridge contract for prime vendor food and beverage support.  This contract is a sole-source acquisition.  Location of performance is Mississippi with a July 12, 2014 performance completion date.  Using military services are Army, Navy, Air Force, Marine Corps, Coast Guard, and Air National Guard.  Type of appropriation is fiscal 2014 defense working capital funds.  The contracting activity is the Defense Logistics Agency Troop Support, Philadelphia, Pa., (SPM300-14-D-3732).

US Foods Inc., Livermore, Calif., has been awarded a maximum $7,232,994 firm-fixed-price, indefinite-quantity contract for prime vendor full-line food distribution.  This contract is a sole-source acquisition.  Location of performance is California with a July 12, 2014 performance completion date.  Using military services are Army, Navy, Air Force, Marine Corps and Coast Guard.  Type of appropriation is fiscal 2014 defense working capital funds.  The contracting activity is the Defense Logistics Agency Troop Support, Philadelphia, Pa., (SPM300-14-D-3734).

MISSILE DEFENSE AGENCY

Raytheon Missile Systems Co., Tucson, Ariz., is being awarded a not-to-exceed $156,000,000 sole-source, undefinitized contract action, with a hybrid contract structure with firm-fixed-price and cost reimbursable contract line item numbers.  Under this contract modification, the contractor will procure 8 Standard Missile-3 Block IB missile material and all up round build up.  The work will be performed in Tucson, Ariz.  The performance period is from date of award through September 2016.  Fiscal 2014 Defense wide procurement funds will be used to fund this effort.  The Missile Defense Agency, Dahlgren, Va., is the contracting activity (HQ0276-13-C-0001).

NAVY

Electric Boat Corp., Groton, Conn., is being awarded a $15,035,596 cost-plus-fixed-fee modification to previously awarded contract (N00024-13-C-2128) for procurement of integrated tube and hull long-lead-time material in support of the Ohio Class Replacement Program.  This contract combines purchases for the U.S. Navy (50 percent) and the government of the United Kingdom (50 percent) under the Foreign Military Sales program.  Work will be performed in Groton, Conn., and is scheduled to be completed by November 2016.  Fiscal 2014 research, development, test and evaluation and FMS funding in the amount of $15,035,596 will be obligated at time of award and will not expire at the end of the current fiscal year.  Supervisor of Shipbuilding Conversion and Repair, Groton, Conn., is the contracting activity.

Huntington Ingalls Inc., Newport News Shipbuilding, Newport News, Va., is being awarded an unpriced contract action not to exceed an estimated value of $8,163,923 to previously awarded contract (N00024-08-C-2110) to perform all efforts necessary to procure, manage and deliver onboard repair parts in support of the USS Gerald R. Ford (CVN 78) construction.  Work will be performed in Newport News, Va., and is expected to complete in September 2015.  Fiscal 2014 shipbuilding and conversion, Navy funding in the amount of $500,000 will be obligated at time of award and will not expire at the end of the current fiscal year.  Supervisor of Shipbuilding Conversion and Repair, Newport News, Va., is the contracting activity.

BriarTek Inc., Alexandria, Va., is being awarded an $8,070,975 indefinite-delivery/indefinite-quantity contract for supplies and services for the procurement of the Man Overboard Indicator (MOBI) Ship Installation Support System, logistics and training services.  The overall objective of the MOBI program is to outfit each ship with a system capable of alerting the crew to a man overboard event, so that a lifesaving rescue can be affected.  Work will be conducted at various ship homeports within and outside the continental United States as required and is expected to be completed by January 2019.  Fiscal 2014 other procurement, Navy, fiscal 2014 operations and maintenance, Navy, and fiscal 2014 shipbuilding and conversion, Navy funding in the amount of $18,000 will be obligated at time of award and will not expire at the end of the current fiscal year.  This contract was not competitively procured.  The contract was awarded on a sole-source basis in accordance with the statutory authority of 10 U.S.C. 2304(c)(1) as implemented by FAR 6.302-1 - only one responsible source and no other supplies or services will satisfy agency requirements.  The Naval Surface Warfare Center, Carderock Division, Ship System Engineering Station, Philadelphia, Pa., is the contracting activity (N65540-14-D-0001).

AIR FORCE

The Boeing Co., Huntington Beach, Calif., has been awarded a $7,131,719 firm-fixed-price contract for Combat Survivor Evader Locator (CSEL) contractor logistics support 2014-2017.  The contractor will provide maintenance, sustaining engineering, new equipment training for users/operators; engineering support for the entire CSEL system on a continuous, around-the-clock basis; and analysis, tools, countermeasures, and software development and integration solutions for all Department of Defense cyber security and information assurance directives, instructions, procedures, threats and policies.  Work will be performed at Huntington Beach, Calif., and is expected to be completed on Dec. 31, 2014.  Fiscal 2014 operations and maintenance funds in the amount of $282,704 are being obligated at time of award.  Battle Management Directorate, Hanscom Air Force Base, Mass., is the contracting activity (FA8730-14-C-0013).

*Small Business

SEC CHARGES ALCOA INC., WITH VIOLATING FOREIGN CORRUPT PRACTICES ACT

FROM:  SECURITIES AND EXCHANGE COMMISSION

The Securities and Exchange Commission today charged global aluminum producer Alcoa Inc. with violating the Foreign Corrupt Practices Act (FCPA) when its subsidiaries repeatedly paid bribes to government officials in Bahrain to maintain a key source of business.

An SEC investigation found that more than $110 million in corrupt payments were made to Bahraini officials with influence over contract negotiations between Alcoa and a major government-operated aluminum plant.  Alcoa’s subsidiaries used a London-based consultant with connections to Bahrain’s royal family as an intermediary to negotiate with government officials and funnel the illicit payments to retain Alcoa’s business as a supplier to the plant.  Alcoa lacked sufficient internal controls to prevent and detect the bribes, which were improperly recorded in Alcoa’s books and records as legitimate commissions or sales to a distributor.

Alcoa agreed to settle the SEC’s charges and a parallel criminal case announced today by the U.S. Department of Justice by paying a total of $384 million.

“As the beneficiary of a long-running bribery scheme perpetrated by a closely controlled subsidiary, Alcoa is liable and must be held responsible,” said George Canellos, co-director of the SEC Enforcement Division.  “It is critical that companies assess their supply chains and determine that their business relationships have legitimate purposes.”

Kara N. Brockmeyer, chief of the SEC Enforcement Division’s FCPA Unit added, “The extractive industries have historically been exposed to a high risk of corruption, and those risks are as real today as when the FCPA was first enacted.”

According to the SEC’s order instituting settled administrative proceedings, Alcoa is a global provider of not only primary or fabricated aluminum, but also smelter grade alumina – the raw material that is supplied to plants called smelters that produce aluminum.  Alcoa refines alumina from bauxite that it extracts in its global mining operations.  From 1989 to 2009, one of the largest customers of Alcoa’s global bauxite and alumina refining business was Aluminium Bahrain B.S.C. (Alba), which is considered one of the largest aluminum smelters in the world.  Alba is controlled by Bahrain’s government, and Alcoa’s mining operations in Australia were the source of the alumina that Alcoa supplied to Alba.

According to the SEC’s order, Alcoa’s Australian subsidiary retained a consultant to assist in negotiations for long-term alumina supply agreements with Alba and Bahraini government officials.  A manager at the subsidiary described the consultant as “well versed in the normal ways of Middle East business” and one who “will keep the various stakeholders in the Alba smelter happy…”  Despite the red flags inherent in this arrangement, Alcoa’s subsidiary inserted the intermediary into the Alba sales supply chain, and the consultant generated the funds needed to pay bribes to Bahraini officials.  Money used for the bribes came from the commissions that Alcoa’s subsidiary paid to the consultant as well as price markups the consultant made between the purchase price of the product from Alcoa and the sale price to Alba.

The SEC’s order finds that Alcoa did not conduct due diligence or otherwise seek to determine whether there was a legitimate business purpose for the use of a middleman.  Recipients of the corrupt payments included senior Bahraini government officials, members of Alba’s board of directors, and Alba senior management.  For example, after Alcoa’s subsidiary retained the consultant to lobby a Bahraini government official, the consultant’s shell companies made two payments totaling $7 million in August 2003 for the benefit of the official.  Two weeks later, Alcoa and Alba signed an agreement in principle to have Alcoa participate in Alba’s plant expansion.  In October 2004, the consultant’s shell company paid $1 million to an account for the benefit of that same government official, and Alba went on to reach another supply agreement in principle with Alcoa.  Around the time that agreement was executed, the consultant’s companies made three payments totaling $41 million to benefit another Bahraini government official as well.

The SEC’s cease-and-desist order finds that Alcoa violated Sections 30A, 13(b)(2)(A), and 13(b)(2)(B) of the Securities Exchange Act of 1934.  Alcoa will pay $175 million in disgorgement of ill-gotten gains, of which $14 million will be satisfied by the company’s payment of forfeiture in the parallel criminal matter.  Alcoa also will pay a criminal fine of $209 million.

The SEC appreciates the assistance of the Fraud Section of the Criminal Division at the Department of Justice as well as the Federal Bureau of Investigation, Internal Revenue Service, Australian Federal Police, Ontario Securities Commission, Guernsey Financial Services Commission, Liechtenstein Financial Market Authority, Norwegian ØKOKRIM, United Kingdom Financial Control Authority, and Office of the Attorney General of Switzerland.

FLORIDA COUPLE SENTENCED TO PRISON FOR ROLES IN PROCUREMENT CONTRACT BRIBERY CASE

FROM:  JUSTICE DEPARTMENT 
Wednesday, January 8, 2014
Florida Couple Sentenced for Roles in Procurement Contract Bribery Scheme

A Florida man was sentenced to serve 15 months in prison, and his wife was sentenced to 24 months of probation, for their roles in a bribery and fraud scheme involving federal procurement contracts, announced Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and U.S. Attorney David B. Barlow of the District of Utah.

On Feb. 26, 2013, Sylvester Zugrav, 70, of Sarasota, Fla., pleaded guilty to conspiracy to commit bribery and procurement fraud, and his wife, Maria Zugrav, 67, also of Sarasota, pleaded guilty to misprision of a felony related to her efforts to conceal the conspiracy.

The Zugravs were charged in an October 2011 indictment along with Jose Mendez, 51, of Farr West, Utah.   Mendez, a procurement program manager for the U.S. Air Force Foreign Materials Acquisition Support Office (FMASO) at Hill Air Force Base, in Ogden, Utah, was charged in the indictment with conspiracy, bribery and procurement fraud, and has since pleaded guilty to all charges and agreed to forfeit more than $180,000 he received as part of the bribery scheme.   Sentencing for Mendez is scheduled for Jan. 29, 2014.

According to court documents, the Zugravs owned Atlas International Trading Company, a business that contracted to provide foreign military materials to the U.S. government through FMASO.

In his plea agreement, Sylvester Zugrav admitted that, from 2008 through August 2011, he gave Mendez more than $180,000 in bribe payments and offered Mendez more than $1 million in additional bribe payments contingent upon Atlas’s receipt of future contracts with FMASO.   In exchange for Sylvester Zugrav’s bribe payments and offers, Mendez ensured that Atlas and Sylvester Zugrav received favorable treatment in connection with procurement contracts by, among other things, assisting Atlas in obtaining and maintaining procurement contracts; assisting Atlas in receiving payments on such contracts; and providing Atlas with contract bid or proposal information or source selection information before the award of procurement contracts.  In her plea agreement, Maria Zugrav admitted that she was aware of Sylvester Zugrav’s bribe payments to Mendez and assisted with concealing the crime.

According to court records, Sylvester Zugrav provided bribe payments to Mendez in three ways: cash payments via Federal Express to Mendez’s residential address; in-person payments of cash and other things of value; and electronic wire transfers to a bank account in Mexico opened by and in the name of Mendez’s cousin.   Between November 2009 and August 2011, Sylvester Zugrav sent nine FedEx packages to Mendez’s home address.   Each package contained $5,000 in cash, except the last package, which contained $3,000 and was seized by law enforcement.   Maria Zugrav assisted her husband and Mendez’s bribe scheme by limiting cash withdrawals from Atlas’s bank account to not more than $5,000 to avoid scrutiny by banking officials and law enforcement.

According to the plea documents, on multiple occasions when Sylvester Zugrav and Mendez traveled to the same location, Sylvester Zugrav would give Mendez cash payments and other things of value.   From 2008 through August 2011, Sylvester Zugrav gave Mendez seven in-person cash payments ranging from $500 to $10,000 and purchased for him[?] a laptop computer and software package worth over $2,900.

During the course of the corrupt scheme, Mendez opened a foreign bank account so that Sylvester Zugrav could pay Mendez larger bribe payments.   Mendez asked his cousin in Mexico to open an account there.   After the account was opened by Mendez’s cousin, Maria Zugrav made wire transfers to the bank account located in the name of Mendez’s cousin to avoid detection of the larger bribe payments by law enforcement.   From 2008 through August 2011, Maria Zugrav sent to the Mexico account 10 wire transfers ranging from $350 to $26,700.

Court records also describe additional steps taken to conceal the bribery scheme, including creating and using covert e-mail accounts, using encrypted documents, adopting false names and using code words.   For instance, to avoid detection of their e-mail communications, Sylvester Zugrav and Mendez established e-mail accounts to be used only to communicate requests and offers for bribe payments.   Sylvester Zugrav and Mendez also created password-protected documents for e-mail communications and used code words and false names.  Within the encrypted documents, Mendez adopted the moniker “Chuco” and Sylvester Zugrav used the codename “Jugo.”   They referred to cash as “literature.”

The case was investigated by the FBI and the Air Force Office of Special Investigations.   The case is being prosecuted by Trial Attorneys Marquest J. Meeks and Edward P. Sullivan of the Criminal Division’s Public Integrity Section, Assistant U.S. Attorney Carlos A. Esqueda of the District of Utah, and Trial Attorney Deborah Curtis of the National Security Division’s Counterespionage Section.  

READOUT OF PRESIDENT OBAMA'S CALL WITH GERMAN CHANCELLOR MERKEL

FROM:  THE WHITE HOUSE 
Readout of the President’s Call with Chancellor Merkel

The President spoke to Chancellor Merkel today to wish her a speedy recovery following her injury and to congratulate her on the formation of her new cabinet.  The leaders noted the full agenda for 2014, including the Transatlantic Trade and Investment Partnership (T-TIP) negotiations and NATO Summit, and looked forward to working closely together to advance our shared interests. The President also extended an invitation to the Chancellor to visit Washington at a mutually agreeable time in the coming months.

MEN CHARGED FOR ILLEGAL CAPTURE AND MAIMING OF MOUNTAIN LIONS AND BOBCATS

FROM:  JUSTICE DEPARTMENT 
Wednesday, January 8, 2014
Colorado Big Game Outfitter and Assistant Guide Charged with Conspiracy for Illegal Capture and Maiming of Mountain Lions and Bobcats in Colorado and Utah

Christopher W. Loncarich, 55, of Mack, Colo., and Nicholaus J. Rodgers, 30, of Medford, Or., were charged yesterday in the District of Colorado with conspiracy to violate the Lacey Act, interstate felony transportation and sale of unlawfully taken wildlife, and felony creation of false records concerning wildlife that was sold in interstate commerce.   The 17-count indictment was based on the pair’s practice between 2007 and 2010 of illegally capturing and maiming mountain lions and bobcats as part of a scheme to make hunting the cats easier for their clients.

The indictment alleges Christopher Loncarich is a big game outfitter and hunting guide who operates mainly in   western Colorado on the border with Utah.  Mr. Loncarich outfits and guides hunts for mountain lions and bobcats in the Bookcliffs Mountains, which span the Colorado-Utah border.  Mountain lion and bobcat hunting are labor-intensive pursuits.  The hunting seasons for the cats stretch from November to March when snow is likely to be on the ground.   Guides commonly release highly-trained dogs on the track of the cats after the guides discover a track in the snow.  The process is for the hunting dogs to follow the cat’s scent in the snow, then tree, corner or bay the pursued cat.   At that point a hunter arrives and kills the treed cat.

The allegations include that Mr. Loncarich and his assistant guides devised a scheme whereby they would trap the cats in cages prior to hunts and release the cats when the client was nearby.   Mr. Loncarich, Mr. Rodgers and other guides would communicate by radio to ensure that they took their clients to the location where the cats had been released.   In order to keep the cats in the areas of potential hunts Mr. Loncarich, Mr. Rodgers and other guides would sometimes shoot the cats in the paws or legs or attach leghold traps to them.  Many of the clients Mr. Loncarich and Mr. Rodgers guided did not have proper tags or licenses to take mountain lions or bobcats in Utah.   Despite knowing that the clients were hunting in Utah without proper licenses or tags, the pair continued to guide the hunts.  Ultimately, Mr. Loncarich, Mr. Rodgers and other guides brought the animals taken in Utah back to Colorado.   Mr. Loncarich often took the client to “check in” the illegally taken mountain lions with the Colorado Division of Wildlife (now “Colorado Parks and Wildlife”) where Mr. Loncarich would provide false records to obtain seals for the hides.   Many of the cats were then transported back to the clients’ home states.   To date, four assistant guides have pleaded guilty to offenses arising from the conspiracy.

An indictment is merely an accusation and a defendant is presumed innocent unless and until proven guilty beyond a reasonable doubt.

The case was investigated by the U.S. Fish and Wildlife Service Office of Law Enforcement, Colorado Parks and Wildlife, and Utah Division of Wildlife Resources, and is being prosecuted by the Environmental Crimes Section of the Justice Department’s Environment and Natural Resources Division.

FDA WARNS CONSUMERS OF POTENTIAL DANGERS OF OVER-THE-COUNTER LAXITIVES

FROM:  FOOD AND DRUG ADMINISTRATION 
Constipation may not be a subject for polite conversation, but it's a condition that bothers many of us on occasion.

The Food and Drug Administration (FDA) is warning consumers that some of the over-the-counter (OTC) laxatives they may turn to for relief are potentially dangerous if dosing instructions or warnings on the Drug Facts label are not properly followed or when there are certain coexisting health conditions. In fact, there have been dozens of reports of serious side effects, including 13 deaths, associated with the use of sodium phosphate laxatives.

The label of sodium phosphate laxatives states that they should be used as a single dose taken once a day, and the products should not be used for more than three days. Equally important, consumers who do not have a bowel movement after taking an oral or rectal dose should not take another dose of the product.

In addition, labeling instructs adults and children to ask health care professionals before using these products if they have kidney disease, heart problems or dehydration.

FDA is now warning that adults older than 55 and adults and children with certain health conditions should ask a health care professional before using these products because they may be at increased risk for harmful side effects. These new warnings are not currently in the Drug Facts label and apply to both adults and children.

who are taking certain drugs that affect how the kidneys work, such as diuretics or fluid medicines; angiotensin-converting enzyme (ACE) inhibitors used to lower blood pressure; angiotensin receptor blockers (ARBs) used to treat high blood pressure, heart, or kidney failure; and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.
with inflammation of the colon.

Constipation is marked by infrequent bowel movements or difficulty in passing stools.

Laxatives—taken both orally and rectally—come in different forms, with different ingredients. The sodium phosphate used in some products is in a class of medications called saline laxatives. This class of laxatives helps promote a bowel movement by drawing water into the bowel, which softens the stool and makes it easier to pass.

Laxative products containing sodium phosphates are marketed under the brand name "Fleet" and also as store brands and generic products. All of them are potentially associated with serious side effects, such as dehydration and/or abnormal levels of electrolytes in the blood that can lead to serious complications, such as kidney damage and sometimes death.

Who is Most at Risk?

According to Mona Khurana, M.D., a medical officer in FDA's Division of Nonprescription Regulation Development and a pediatric nephrologist (a doctor who specializes in children's kidney diseases), the most serious harm in recent reports occurred after consumers overdosed by taking a single dose that was higher than recommended on the drug label or took more than one dose in a day because they had a poor laxative effect from the first dose.
"The bottom line is that these products are safe for otherwise healthy adults and older children for whom dosing instructions are provided on the Drug Facts label as long as they follow these dosing instructions and don't take the product more often, or in greater amounts, than the label instructs," Khurana says.

In recent reviews of harmful side effects reported by consumers and health care professionals, FDA has identified 54 cases of serious side effects associated with the oral or rectal use of OTC sodium phosphate products for the treatment of constipation in adults and children. Thirteen cases were fatal, including one child and 12 adults.

"It is not possible to determine the precise rate of these events as no one knows how many individuals who take these medications may experience side effects," says Khurana, adding, "Not everybody who develops problems in association with sodium phosphate use reports to the FDA."

Can these laxatives be used safely in young children?

"Caregivers should not give these products orally to children under age 5 years without first asking a health care professional. Both caregivers and health care professionals should avoid the rectal use of these drug products in children under age 2 years," Khurana cautions. "These warnings against use in young children are listed on product labeling."

Warning Signs
Consumers taking these laxatives should watch for warning signs of a bad reaction. For example, a rectal dose that is retained and does not produce a bowel movement may cause dehydration and/or serious changes in blood electrolyte levels. Symptoms of dehydration include dry mouth, thirst, reduced urine output, and lightheadedness, especially with changes in position. If the rectal dose is retained in the body longer than 30 minutes, a health care professional should be contacted right away.
The symptoms of kidney injury include drowsiness, sluggishness, a decreased amount of urine, or swelling of the ankles, feet and legs. If you experience any of these symptoms after using laxatives containing sodium phosphates, you should seek medical attention immediately.

If you have any concerns about using the products, particularly for use with young children, talk to your health care professional first, Khurana says.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Jan. 8, 2014

READOUT: VICE PRESIDENT BIDEN'S CALL WITH IRAQI PRIME MINISTER AL-MALIKI

FROM:  THE WHITE HOUSE 

Readout of Vice President Biden's Call with Iraqi Prime Minister Nouri al-Maliki
This morning, Vice President Biden spoke with Iraqi Prime Minister Nouri al-Maliki.  The Vice President encouraged the Prime Minister to continue the Iraqi government’s outreach to local, tribal, and national leaders and welcomed the Council of Ministers’ decision to extend state benefits to tribal forces killed or injured in the fight against the Islamic State of Iraq and the Levant (ISIL).  He also welcomed Prime Minister Maliki’s statement earlier today affirming that Iraqi elections will occur as scheduled, as well as the Prime Minister’s commitment to ensuring that humanitarian aid is reaching people in need.  Prime Minister Maliki updated the Vice President on the situation in Anbar province, including a series of political initiatives that are underway at the local and national level. The Vice President underscored that America will support and assist Iraq in its fight against international terrorism.

FUNERAL HOME TO PAY $32,000 TO SETTLE FTC CHARGES

FROM:  FEDERAL TRADE COMMISSION 
New York Funeral Home Will Pay $32,000 to Settle FTC Charges for Funeral Rule Violations

A New York funeral home and its funeral director/owner agreed to pay a $32,000 civil penalty to settle Federal Trade Commission charges for violating the agency’s Funeral Rule, which requires funeral providers to provide information consumers need to compare prices and buy only the funeral services and goods they want.

In May 2012, at the FTC’s request, the United States Attorney for the Southern District of New York charged Harrison Funeral Home Inc. in Harrison, N.Y., and John Balsamo with allegedly failing to provide consumers with an itemized general price list at the beginning of any in person discussion about funeral arrangements; a casket price list at the beginning of any discussion about caskets; and an outer burial container price list at the beginning of any discussion about outer burial containers, as required by the Funeral Rule. An amended complaint was filed in October 2012. The amended complaint was based on inspections by FTC staff posing as consumers seeking to make funeral arrangements.

The FTC conducts undercover inspections every year to ensure funeral homes are complying with the Funeral Rule, which gives consumers important rights when making funeral arrangements. The Rule, issued in 1984, requires funeral homes to provide consumers with itemized price lists at the start of any in-person discussions of funeral arrangements, caskets, and/or outer burial containers. The Rule also requires funeral homes to provide price information by telephone on request. It also prohibits funeral homes from requiring consumers to buy any item, such as a casket, as a condition of obtaining any other funeral good or service.

The consent decree requires the defendants to pay a $32,000 civil penalty, and permanently prohibits them from violating the Funeral Rule.

For more information about the Funeral Rule, read Shopping for Funeral Services and Complying with the Funeral Rule.

The Commission vote to approve the proposed consent judgment was 4-0. The United States Attorney for the Southern District of New York filed it on behalf of the Commission in the U.S. District Court for the Southern District of New York on November 27, 2013.  The judgment was entered by the court on January 2, 2014.

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