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Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.




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Supreme Court Affirms: High Level of Proof Needed to Invalidate A Patent

Posted by Stephanie Fischer on June 10, 2011 at 3:29pm EDT on BIOtech Now The U.S. Supreme Court issued a favorable decision yesterday in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent.   Microsoft argued for a lower “preponderance […]




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Bayer donates 8 million chloroquine tablets to the German Federal Government

Additional donations of chloroquine sent to governments in numerous other countries / Various clinical and preclinical studies investigate the efficacy and adverse effects in COVID-19 infections / Bayer plans considerable expansion of production capacities in the event that the efficacy of chloroquine is proven for COVID-19




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Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT

Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports.




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Former Florida State Corrections Officer Convicted of Federal Civil Rights Crime

A federal jury in Jacksonville, Fla., found Paul Tillis, a former Florida Department of Corrections officer, guilty on Jan. 16, 2009, of a felony federal civil rights violation for an August 2005 assault on an inmate.



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Chicago Police Officer Pleads Guilty to Violating Federal Civil Rights of a Man Beaten While Restrained in a Wheelchair

A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair.



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New York Man Pleads Guilty to Federal Hate Crime Conspiracy

Brian Carranza, 21, pleaded guilty today before U.S. District Court Judge Carol B. Amon in Brooklyn, N.Y., to conspiring to assault African-American residents in Staten Island, N.Y., in retaliation for President Barack Obama winning last year’s presidential election.



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Two Oklahoma County Corrections Officers Indicted for Federal Civil Rights Violation in Death of Oklahoma City Man

A federal grand jury indictment was unsealed today in Oklahoma City charging corrections officers Gavin Littlejohn, 25, of Oklahoma City, and Justin Isch, 21, of Edmond, Okla., with a federal civil rights violation for the fatal assault of Christopher Beckman at the Oklahoma County Detention Center in May 2007.



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U.S. Recovers $19 Million from AMEC Construction Management to Settle Litigation Regarding Fraud, False Claims, Kickbacks & Re-Procurement Costs on Federal Construction Contracts

The United States has recovered more than $19 million from AMEC Construction Management Inc. (ACMI) to resolve allegations of fraud, false claims and kickbacks on four General Services Administration (GSA) construction contracts, as well as litigation over claims by the GSA for excess re-procurement costs incurred by GSA after it terminated ACMI’s contract to build the Thomas F. Eagleton United States Courthouse in St. Louis, Missouri. ACMI was formerly known as Morse Diesel International Inc.



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Federal Court Bars Maine Resident from Preparing Tax Returns for Others

A federal court in Maine has permanently barred Robert A. Grover from preparing federal tax returns for others. The court also ordered the Maine resident to provide his customer lists to the government and to mail copies of the complaint and court order to his customers. Grover consented to the civil injunction order.



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Federal Court Bars Connecticut Woman from Preparing Tax Returns for Others

A federal district court in Connecticut has permanently barred Elda Sinani, a resident of that state, from preparing federal tax returns for others. Sinani consented to the civil injunction order.



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Two Individuals Arrested on Federal Sex Trafficking Charges

Two men have been arrested and charged in an indictment unsealed today with crimes related to sex trafficking. Tommy Handy and his nephew, Everett Cooney, were indicted by a federal grand jury in Little Rock, Ark., for conspiracy to commit sex trafficking and sex trafficking for their roles in using force, fraud and coercion to cause juvenile girls and adult women to engage in commercial sex acts.



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District of Columbia Seafood Company, Owner and Employee Plead Guilty to Federal Trafficking Charges

A fish wholesaler, its owner and an employee have all pleaded guilty in U.S. District Court for the District of Columbia for the illegal purchase and sale of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007.



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U.S. Asks Federal Court to Shut Down Iowa Tax Preparers

The United States has sued a Clive, Iowa, couple to bar them from preparing federal tax returns for others. According to the government complaint, Jill Schwartz-Musin, her husband Howard Musin, and their business, SSC Services, prepare fraudulent federal income tax returns for small business owners.



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Federal Court Bars Tennessee Resident from Preparing Tax Returns for Others

A federal district court in Tennessee has permanently barred Chattanooga resident Demita Brown-Watkins from preparing federal income tax returns for others. Brown-Watkins agreed to the civil injunction order. According to the government complaint, Brown-Watkins ran her tax-preparation business through two companies—Fastax and Rapid Tax Service—and advertised the “largest refund in town.”



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Memphis Man Pleads Guilty to Federal Sex Trafficking Charges

Leonard Fox a/k/a Anton a/k/a “Daddy” pleaded guilty today to a federal civil rights charge for sex trafficking of minors. In U.S. District Court in Memphis, Fox admitted to recruiting and obtaining underage girls and arranging for those girls to engage in commercial sex acts for his financial benefit.



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Two Oregon Men Plead Guilty to Federal Hate Crime

Gary Moss and Devan Klausegger of Medford, Ore., pleaded guilty today to conspiring to interfere with civil rights. According to facts stipulated in their plea agreements and set forth in the indictment, on May 26, 2008, Moss poured a flammable liquid on the front lawn of the victims’ residence in the shape of a cross and the letters “KKK”.



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Federal Court Permanently Bars Florida “Tax Doctor” from Preparing Tax Returns

A federal court has permanently barred Harold Mette of Bradenton, Fla., from preparing federal income tax returns for others. Mette, who has a Ph.D. degree and calls his business “The Tax Doctor,” consented to the permanent injunction order, which was entered by U.S. District Judge Richard A. Lazzara in U.S. District Court for the Middle District of Florida.



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Fairfield, Calif., Couple Indicted on Federal Civil Rights Charge for Alleged Bias-Motivated Assault

A Fairfield, Calif., couple was indicted today by a federal grand jury in Sacramento, Calif., on federal civil rights charges related to an alleged bias-motivated assault on an Indian-American couple. The two-count indictment alleges that on the evening of July 14, 2007, Joseph and Georgia Silva committed a bias-motivated assault on another couple at a public beach in South Lake Tahoe, Calif.



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Federal Court Shuts Down North Carolina Tax Preparer

A federal court has permanently barred Raymond A. Renfrow of Elm City, N.C., from preparing federal income tax returns for others. The U.S. District Court for the Eastern District of North Carolina entered the civil injunction order, which also stops Renfrow from promoting a tax fraud scheme that used sham trusts to falsely deduct customers’ non-deductible personal expenses.



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U.S. Border Patrol Agent Indicted on Federal Civil Rights Charge for Assault in Federal Detention Facility

A U.S. Border Patrol agent has been indicted by a federal grand jury in Tucson, Ariz., on federal civil rights charges related to an alleged assault on a detainee at a federal detention facility. The two-count indictment, returned on March 11, 2009, alleges that on May 10, 2006, Eduardo Moreno violated the civil rights of a federal detainee by assaulting and causing bodily injury to the individual while Moreno was on duty at the U.S. Border Patrol processing facility in Nogales, Ariz.



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Federal Judge Shuts Down Two Dallas Tax Preparers

A federal court has shut down two Dallas tax preparers during the height of tax-filing season. Chief Judge Sidney Fitzwater of the U.S. District Court for the Northern District of Texas signed a temporary restraining order barring Ethel Washington from preparing any tax returns. The court has also permanently barred Washington’s former employer, Tina Preston, and her firm, The Preston Group & Associates Inc., from preparing federal tax returns.



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Justice Department Asks Federal Court to Shut Down Iowa Tax Preparation Firm

The United States has brought suit in federal court against Gayle Lemmon of Humboldt, Iowa. The lawsuit seeks to bar her and her firm from preparing federal tax returns for others. According to the government complaint in the case, Lemmon’s firm, Gayle’s Bookkeeping and Tax Service Inc., prepares federal income tax returns for customers that unlawfully understate tax liabilities by claiming improper deductions for the business use of the home and for non-deductible personal expenses.



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Former Member of U.S. Navy Sentenced to 10 Years in Federal Prison for Disclosing Classified Information

Nora R. Dannehy, Acting U.S. Attorney for the District of Connecticut, and other federal officials announced that Hassan Abu-Jihaad, formerly known as Paul R. Hall, 33, of Phoenix, Arizona, was sentenced today by U.S. District Judge Mark R. Kravitz in New Haven to 120 months of imprisonment, followed by three years of supervised release, for disclosing previously classified information relating to the national defense.



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Statement from Department of Justice Regarding Federal Law Enforcement Response to Binghamton, N.Y., Shootings

The Department of Justice, through the FBI and Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), is providing federal law enforcement assistance to the Binghamton Police Department in response to the shootings in Binghamton.  The FBI’s Albany, N.Y., field office has sent hostage negotiators, an evidence response team and command post assistance.  ATF is providing seven special agents from the Syracuse and Albany field offices. The Department will continue to provide assistance as requested in response to this rapidly developing situation.



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Federal, State Partners Announce Multi-Agency Crackdown Targeting Foreclosure Rescue Scams, Loan Modification Fraud

As homeowners and communities throughout the country continue to face devastating consequences from the deep contraction in the economy and the housing market, the Obama Administration today announced a new coordinated effort across federal and state government and the private sector to target mortgage loan modification fraud and foreclosure rescue scams that threaten to hurt American homeowners and prevent them from getting the help they need during these challenging times.



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Former Bristol-Myers Squibb Senior Executive Pleads Guilty for Role in Dishonest Dealings with the Federal Government

A former senior executive of Bristol-Myers Squibb Company (BMS), Andrew Bodnar, pleaded guilty for his role in BMS’s dishonest dealings with the federal government relating to a patent deal involving the popular blood-thinning drug Plavix. This plea agreement follows BMS’s June 11, 2007, agreement to plead guilty and pay a $1 million criminal fine – the maximum fine permitted by statute – for misleading the government about the Plavix patent deal.



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Federal Court Bars Homewood, Illinois, Tax Preparers from Preparing Federal Tax Returns for Others

U.S. District Court Judge Robert W. Gettlemen entered an order barring tax preparers, Michael J. Singleton and his wife, Ladonna Singleton, from preparing federal tax returns for others. The court’s ruling came after the Singletons failed to defend against the government’s allegations.



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Federal Court Blocks Chicago Tax Preparation Firm from Claiming Improper Tax Credits

A federal court has barred a Chicago tax preparation firm, El Caminante, Inc. and its principal operator, Maria Colica, from preparing federal income tax returns claiming false tax credits. The company and Colica agreed to the injunction. The Government civil injunction complaint filed in the case alleged that Colica fraudulently claimed fuel tax credits for customers who were not entitled to them.



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Louisiana Tax Defier Convicted on Federal Tax Charges

Following three and a half days of trial and 19 minutes of deliberations, a Gulfport, Miss., federal jury yesterday convicted Paul Richard Arceneaux, a resident of Church Point, La., of tax crimes. Arceneaux, who owned and operated Speedy Cash Inc. in Gulfport, was convicted of all counts of the indictment charging him with corruptly interfering with the Internal Revenue laws and failing to file his income tax returns for 2003 and 2004.



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St. Louis Woman Pleads Guilty to Federal Sex Trafficking Charge

Waquita Wallace pleaded guilty to the federal civil rights charge of sex trafficking. Wallace admitted to forcing a young woman to engage in commercial sex acts through a combination of force, fraud and coercion. Defendant Wallace also benefitted financially from the sex trafficking. She faces a maximum sentence of life in prison and a fine of up to $250,000.



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Former Oklahoma Deputy Sheriff Indicted for Federal Civil Rights and Obstruction of Justice Violations

Ben Milner, a former deputy sheriff with the Choctaw County, Okla., Sheriff’s Department, has been indicted by a federal grand jury for violating the civil rights of a man during a traffic stop and the civil rights of two inmates at the Choctaw County Jail. The grand jury also indicted Milner on two counts of obstructing justice in connection with the incident involving the inmates.



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Former Gary, Indiana, Police Chief Sentenced for Federal Civil Rights Violation

WASHINGTON – Acting Assistant Attorney General Loretta King of the Civil Rights Division announced today that Thomas Houston, former Chief of the Gary, Ind., Police Department, was sentenced to 41 months in prison followed by two years of supervised release for violating the civil rights of a Gary resident in June 2007.



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Federal Court Bars Bloomfield, Connecticut Tax Preparer from Preparing Tax Returns

A federal court has permanently barred Donald Morris of Bloomfield, Conn., from preparing federal income tax returns for others. Morris consented to the permanent injunction order, which was entered by U.S. District Court Judge Jane C. Hall in the U.S. District Court for the District of Connecticut.



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West Virginia Man Pleads Guilty on Federal Civil Rights Charges

Daryl Lee Fierce, 69, of Charleston, W.Va., pleaded guilty today to a civil rights charge in federal court in the Southern District of West Virginia for using fire to intimidate and interfere with a person’s housing rights. Fierce set fire to the victim’s home because African-American and biracial individuals visited the victim in her home.



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Federal Court Shuts Down Dallas Tax Preparer

A federal court in Dallas has permanently barred a Garland, Texas, man from preparing federal tax returns for others. Lucky Ngo, who operated “Lucky’s Translation and Tax Service” and “Water Inn,” prepared over 6,100 federal tax returns for customers since 2004, according to the government complaint filed in the civil injunction case. Ngo agreed to the permanent injunction order.



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Texas Man Pleads Guilty on Federal Civil Rights Charges

Brandit Franco, 33, a former deputy with the Bexar County Sheriff’s Office, pleaded guilty to a civil rights charge today in federal court in San Antonio, Texas, for using excessive force against a prisoner while working as a detention officer at the county jail. Franco faces a maximum term of imprisonment of 10 years and a fine of $250,000. A sentencing hearing is set for July 24, 2009.



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Three South Carolina Men Indicted on Federal Civil Rights Charges

A federal grand jury in Florence, S.C., indicted three men from Marlboro County, S.C., on charges relating to their attack on an African-American man and two white men in December 2007.



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Five Donaldson, Arkansas, Men Indicted on Federal Civil Rights Charges

A federal grand jury in Fort Smith, Ark., has indicted five men from the Donaldson, Ark., area on federal civil rights charges as well as charges of making false statements to the FBI.



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MS-13 Leader Sentenced to 60 Years in Federal Prison for Racketeering Conspiracy, Armed Robbery and Gun Violation

U.S. District Judge Deborah K. Chasanow today sentenced Victor Ramirez, a/k/a “Mousey,” age 30, a native of El Salvador who resided in Hyattsville, Md., to 60 years in prison, followed by five years of supervised release.



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Federal Court Bars Individual Return Preparers and Sarasota Firms from Preparing Tax Returns

A federal court in Tampa, Fla., has permanently barred Daniel Prewett from preparing tax returns for others. The court also barred Prewett from helping customers hide income offshore to avoid taxes, and from promoting other tax-dodging schemes. The court has also enjoined Prewett’s wife, Elizabeth George; former Prewett employees Frances Carlson, Elsie Chouinard and Natalie Swaney; and Prewett’s three tax preparation businesses, listed below. The individual defendants agreed to the injunctions.



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Federal Judge Permanently Bars Texas Tax Preparers

A federal court today has permanently barred two additional former employees of Preston Tax Services, Inc., from preparing federal tax returns.



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U.S. Judge Bars Two Connecticut Residents from Preparing Federal Tax Returns for Others

A federal district court in Connecticut has permanently barred Wethersfield residents Deowraj Buddhu and his daughter, Sunita Buddhu, from preparing federal tax returns for others.



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President of Company That Illegally Imported Catfish Sentenced to More Than Five Years in Federal Prison

A Virginia man has been sentenced to 63 months in federal prison for participating in a conspiracy that led to more than 10 million pounds of frozen catfish being imported from Vietnam, but fraudulently labeled and sold in the United States as sole, grouper and other species. This sentence is one of the longest imposed by a federal judge for falsely labeling seafood.



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Tax Shelter Promoter Pleads Guilty to Conspiring to Impede and Impair the IRS

Anthony G. Merlo, a former resident of Fort Worth, Texas, and the U.S. Virgin Islands, pleaded guilty today to conspiracy to defraud the United States.



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Civil Rights Division Attorney Named “Top Prosecutor” by the Association of Women in Federal Law Enforcement

Special Litigation Counsel Kristy Parker, a senior attorney in the Civil Rights Division’s Criminal Section, has been selected to receive the 2009 Top Prosecutor Award from the Women in Federal Law Enforcement (WIFLE).



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Federal Judge Hands Downs Sentences in Holy Land Foundation Case

Today, in federal court in Dallas, U.S. District Judge Jorge A. Solis sentenced the Holy Land Foundation for Relief and Development (HLF) and five of its leaders following their convictions by a federal jury in November 2008 on charges of providing material support to Hamas, a designated foreign terrorist organization.



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Federal Court Enjoins Iowa Tax Preparation Firm

A federal judge in Sioux City, Iowa, has barred a Humboldt, Iowa, woman, Gayle Lemmon, and her tax preparation business from preparing federal tax returns. U.S. District Judge Mark W. Bennett entered the preliminary injunction against Gayle Lemmon and Gayle’s Bookkeeping and Tax Service Inc. The order, which Lemmon agreed to, remains in effect until further order of the court.



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Georgia Federal Court Permanently Bars Fulton County Man from Preparing Tax Returns

A federal court in Atlanta has permanently barred Derrick Jackson and his businesses from preparing federal tax returns for others. The court said that since 2002, Jackson "has prepared blatantly fraudulent tax returns for customers." Jackson’s businesses were called Tax Wisdom and International Tax and Accounting Services.



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Chicago Police Officer Sentenced for Violating Federal Civil Rights of a Man Beaten While Restrained in a Wheelchair

William Cozzi, a Chicago police officer, was sentenced today to 40 months in federal prison for violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair.



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