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Justice Department Files Lawsuit Alleging Disability-Based Discrimination by Mississippi Developer

The Justice Department filed a lawsuit today against Mississippi-based developer Dawn Properties Inc. and its affiliated companies for violating the Fair Housing Act and the Americans with Disabilities Act., alleging that the defendants violated these laws when they designed and constructed five or more residential properties with barriers that make them inaccessible to persons with disabilities



  • OPA Press Releases

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Justice Department Announces Investigation of Detention Center in Hinds County, Mississippi

The Justice Department announced today that it is opening a pattern or practice investigation of Hinds County Detention Center including both the Hinds County facility in Raymond, Mississippi, and the Jackson Detention Center, in Jackson, Mississippi.



  • OPA Press Releases

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Department of Justice and Federal Trade Commission Announce Agenda for June 23, 2014, Joint Agency Workshop on Conditional Pricing Practices

The Department of Justice and the Federal Trade Commission (FTC) have issued the agenda for their joint public workshop, which will be held on June 23, 2014, to explore the economic and legal analysis of conditional pricing practices among firms in a supply chain.



  • OPA Press Releases

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Department of Justice Reaches Landmark Agreement to Improve Missoula County Attorney’s Office’s Response to Reports of Sexual Assault

The Department of Justice announced today that it has reached a comprehensive agreement with the Missoula County Attorney’s Office, as well as Missoula County, Montana, and the Montana Attorney General’s Office, to resolve the department’s investigation of alleged gender bias in the prosecution of sexual assaults by the Missoula County Attorney’s Office (MCAO).



  • OPA Press Releases

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Justice Department Urges U.S. Sentencing Commission to Make Certain Individuals Incarcerated for Drug Offenses Retroactively Eligible for Reduced Sentences

Attorney General Eric Holder announced Tuesday that the Justice Department would formally support a proposal under consideration by the U.S. Sentencing Commission to allow certain individuals serving time in federal prison for nonviolent drug offenses to be eligible for reduced sentences.



  • OPA Press Releases

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U.S. Attorney for the District of Montana Michael Cotter Speaks at Press Conference Announcing Agreement with Missoula County Attorney’s Office

"These agreements embody a sound plan and a solid program which will improve safety of women, enhance the capacity of the County Attorney’s Office to efficiently and effectively prosecute sexual assault crimes, and increase the community’s confidence in the County Attorney’s Office response to sexual assault."




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Acting Assistant Attorney General for the Civil Rights Division Jocelyn Samuels Speaks at Press Conference Announcing Agreement with Missoula County Attorney’s Office

"Today’s groundbreaking agreement represents another important step forward in our ongoing effort to ensure that survivors of sexual assault in Missoula are treated with dignity and respect and have the full protection of the criminal justice system"




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Libyan National Charged with Federal Offenses in 2012 Attack on U.S. Special Mission and Annex in Benghazi

Ahmed Abu Khatallah, aka Ahmed Mukatalah, a Libyan national approximately 43 years of age, has been charged for his alleged participation in the Sept. 11, 2012, attack on the U.S. Special Mission and Annex in Benghazi, Libya, which resulted in the deaths of four Americans



  • OPA Press Releases

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Webb County Commissioner Pleads Guilty to Accepting Bribes in Exchange for Official Actions

Kristopher Michael Montemayor, a county commissioner for Precinct 1 of the Webb County Commissioners Court in Texas, pleaded guilty to bribery today



  • OPA Press Releases

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One Year After Supreme Court’s Historic Windsor Decision, Attorney General Holder Issues Report Outlining Obama Administration’s Work to Extend Federal Benefits to Same-sex Married Couples

Following the Supreme Court’s historic decision striking down Section 3 of the Defense of Marriage Act, Attorney General Eric Holder on Friday issued a formal report on the yearlong effort by the Justice Department and other federal agencies to implement the decision smoothly across the entire government



  • OPA Press Releases

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Court Prohibits Mississippi Tax Preparer from Preparing Tax Returns for Others

A federal court has permanently barred Kavivah Branson, aka Kavivah Bradley, of Clinton, Mississippi, and her Jackson, Mississippi, business, Branson Tax Service, from preparing federal tax returns for others, the Justice Department announced today. The civil injunction order, to which Branson consented, was signed by Judge Tom S. Lee of the U.S. District Court for the Southern District of Mississippi



  • OPA Press Releases

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U.S. Settlement with Minnesota Coal-Fired Utility to Reduce Emissions

In a settlement with the United States, Minnesota Power (MP), an ALLETE company based in Duluth, Minnesota has agreed to install pollution control technology and meet stringent emission rates to reduce harmful air pollution from the company’s three coal-fired power plants located in Cohasset, Hoyt Lakes and Schroeder, Minnesota, the Department of Justice and the U.S. Environmental Protection Agency (EPA) announced today



  • OPA Press Releases

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Four Mississippi Men and Women Indicted for Racially Motivated Hate Crimes Spree in Jackson, Mississippi

Acting Assistant Attorney General Jocelyn Samuels for the Justice Department’s Civil Rights Division and U.S. Attorney Gregory K. Davis for the Southern District of Mississippi announced today that a federal grand jury has indicted John Louis Blalack, 20, of Brandon, Mississippi, Sarah Adelia Graves, 21, of Crystal Springs, Mississippi, Robert Henry Rice, 23, of Brandon, and Shelbie Brooke Richards, 20, of Pearl, Mississippi, for their alleged roles in a conspiracy to commit federal hate crimes against African-American people in Jackson, Mississippi



  • OPA Press Releases

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Government Files Suit Against Missouri Neurosurgeon and Medical Device Supplier for Violations of the False Claims Act and Anti-Kickback Statute

The Justice Department announced today that it has filed a complaint against Midwest Neurosurgeons L.L.C. and its owner, Dr. Sanjay Fonn, M.D., and DS Medical L.L.C. and its owner, Deborah Seeger, for allegedly violating the Medicare Anti-Kickback Statute and the False Claims Act by conspiring to solicit and receive commissions from medical device manufacturers related to the purchase of spinal implants and supplies used during spinal fusion surgeries performed by Dr. Fonn



  • OPA Press Releases

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Statement by Attorney General Holder on Sentencing Commission Vote Approving Retroactivity of Sentence Reductions for Drug Offenses

Attorney General Eric Holder today released the following statement regarding the U.S. Sentencing Commission vote approving retroactivity of sentence reductions for drug offenses



  • OPA Press Releases

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Justice Department Issues Joint Statement of Principles with City of Albuquerque, New Mexico, to Reform Albuquerque Police Department

The Justice Department today announced it has signed a joint statement of principles with the city of Albuquerque, New Mexico, that reflects the good-faith intent of both sides to enter into a court-enforceable agreement to reform the Albuquerque Police Department (APD).



  • OPA Press Releases

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Department of Justice and Federal Trade Commission Extend Public Comment Period for Workshop on Conditional Pricing Practices

The Department of Justice and the Federal Trade Commission (FTC) have extended the deadline for submitting comments on their recent Conditional Pricing Practices Workshop from Aug. 22, 2014, to Sept. 22, 2014



  • OPA Press Releases

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Louisiana State Bond Commission Agrees to Settlement to Resolve Housing Discrimination Lawsuit

The Justice Department announced today that the United States District Court for the Eastern District of Louisiana has approved its settlement with the Louisiana State Bond Commission resolving the department’s housing discrimination lawsuit. The lawsuit alleged that the commission violated the Fair Housing Act and the Americans with Disabilities Act by adopting a moratorium on affordable housing financing in 2009. The moratorium blocked financing for a proposed 40-unit affordable housing project known as the “Esplanade.” Twenty of these units would provide permanent supportive housing to persons with disabilities



  • OPA Press Releases

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Statement by Attorney General Holder on Recent Shooting Incident in Ferguson, Missouri

Attorney General Eric Holder released the following statement Monday regarding the shooting incident that took place Saturday afternoon in Ferguson, Missouri



  • OPA Press Releases

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Statement by Attorney General Eric Holder on Latest Developments in Ferguson, Missouri

Attorney General Eric Holder released the following statement Thursday following his meeting earlier today with President Obama to discuss the latest developments in Ferguson, Missouri



  • OPA Press Releases

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Justice Department Asks Court to Dismiss Oakley Training School Case After Conditions for Confined Youth Improved Under Consent Decree

Today, the Justice Department asked a federal court to dismiss its case involving Oakley Training School in Raymond, Mississippi, because the state of Mississippi and the Division of Youth Services have significantly improved conditions for confined youth at Oakley. The reforms, implemented under a consent decree, resulted in increased protections to prevent harm to youth, improved suicide prevention practices, improved medical, dental and mental healthcare, increased rehabilitative services and improved special educational services



  • OPA Press Releases

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The following joint statement was released Friday by FBI Special Agent in Charge William P. Woods, U.S. Attorney for the Eastern District of Missouri Richard G. Callahan and Acting Assistant Attorney General for the Civil Rights Division Molly Moran

The former chief executive officer of Hanover Corporation was sentenced today to serve 14 years in prison, to be followed by three years of supervised release and ordered to pay $14,784,983.75 in restitution for orchestrating an $18 million Ponzi scheme



  • OPA Press Releases

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Statement by Justice Department Spokesman on Latest Developments in Federal Civil Rights Investigation in Ferguson, Missouri

The following statement was released Sunday by Justice Department spokesman Brian Fallon concerning the federal civil rights investigation into the shooting of Michael Brown in Ferguson, Missouri



  • OPA Press Releases

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Federal Court Bars Missouri Man from Preparing Federal Tax Returns

A federal court has permanently barred William Naes of St. Charles, Missouri, from preparing federal tax returns for others, the Justice Department announced today. The permanent injunction order, to which Naes consented, was entered by U.S. District Judge E. Richard Webber of the U.S. District Court for the Eastern District of Missouri



  • OPA Press Releases

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Justice Department Asks Court to Dismiss Saint Elizabeths Hospital Case After Conditions Improved Under Consent Decree

Today, the Justice Department asked a federal court to dismiss the injunction to address civil rights violations at Saint Elizabeths Hospital in Washington, D.C., because the District of Columbia and the Department of Behavioral Health have significantly improved the care and treatment of persons confined to Saint Elizabeths Hospital. Saint Elizabeths is the district’s facility for treating individuals with mental health conditions. The reforms, which were implemented following requirements under a court order, have ensured that persons at Saint Elizabeths Hospital are discharged to the community with adequate supports to live in integrated settings. Further, the reforms resulted in important improvements in integrated treatment planning, psychological and psychiatric services, nursing care and protection from assault.



  • OPA Press Releases

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United States Settles with Costco to Cut Ozone-Depleting and Greenhouse Gas Refrigerant Emissions Nationwide

Costco Wholesale Corporation, one of the nation’s largest retailers, has agreed to cut its emissions of ozone-depleting and greenhouse gases from leaking refrigeration equipment at more than half of its stores nationwide.



  • OPA Press Releases

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Two Companies to Pay $3.75 Million for Allegedly Causing Submission of Claims for Unreasonable or Unnecessary Rehabilitation Therapy at Skilled Nursing Facilities

Life Care Services LLC, a manager of skilled nursing facilities based in Des Moines, Iowa, and CoreCare V LLP, doing business as ParkVista, a skilled nursing facility in Fullerton, California, have agreed to pay a total of $3.75 million to the government for causing the submission of false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.



  • OPA Press Releases

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Justice Department Sues to Shut Down Mississippi Tax Return Preparer

The United States has requested that the U.S. District Court for the Northern District of Mississippi permanently bar Nathaniel Kimble, Greenville, Mississippi, man from preparing federal income tax returns for others, the Justice Department announced today.



  • OPA Press Releases

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Episcopal Ministries to the Aging Inc. to Pay $1.3 Million for Allegedly Causing Submission of Claims for Unreasonable or Unnecessary Rehabilitation Therapy at Skilled Nursing Facility

Episcopal Ministries to the Aging Inc., a Maryland not-for-profit corporation that owns skilled nursing facilities, has agreed to pay $1.3 million to the government for submitting false claims to Medicare for unreasonable or unnecessary rehabilitation therapy purportedly provided by RehabCare Group East Inc., a subsidiary of Kindred Healthcare Inc.



  • OPA Press Releases

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U.S. Settlement with Michigan Utility to Reduce Emissions at Its Coal-Fired Power Plants, Fund Projects to Benefit Environment and Communities

In a settlement with the United States, Consumers Energy, a subsidiary of CMS Energy Corporation, has agreed to install pollution control technology, continue operating existing pollution controls and comply with emission rates to reduce harmful air pollution from the company’s five coal-fired power plants.



  • OPA Press Releases

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Department of Justice and Federal Trade Commission Sign Cooperation Agreement with Colombian Antitrust Agency

Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division has signed an antitrust cooperation agreement with the Colombian antitrust agency on behalf of the Department of Justice. The agreement also was signed by Federal Trade Commission Chairwoman Edith Ramirez, and went into effect today with the signature of Pablo Felipe Robledo, Colombia’s Superintendent of Industry and Commerce.



  • OPA Press Releases

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Executives of Swiss and Las Vegas Companies Convicted in International Investment Fraud Scheme

A federal jury in Las Vegas convicted two men of conspiracy, wire fraud and securities fraud yesterday for their roles in an approximately $10 million international investment fraud scheme involving numerous victims



  • OPA Press Releases

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Will These Pharma Stocks Hit Or Miss Trial Goals? (ITRM, STRO, ENTA)

Let's take a look at the biotech/pharma companies that are slated to report clinical trial results this quarter.




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BPMC's VOYAGER Fails, CLSD's NDA Resubmission Faces Delay, SNDX Hits New High

Today's Daily Dose brings you news about Blueprint Medicines' disappointing results from gastrointestinal stromal tumor trial; revised timeline of Clearside Biomedical's resubmission of XIPERE NDA; encouraging trial results of INOVIO's MERS coronavirus vaccine and initial data from Syndax Pharma's acute leukemia trial.




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APEC Small and Medium Enterprises Ministers Issue Joint Statement

Ministers in charge of small and medium enterprises (SMEs) in the APEC region issued a statement following their meeting in Concepcion, Chile, on 5-6 September 2019.




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APEC Ministers in Charge of Women’s Economic Participation Issue Joint Statement

Ministers in charge of women’s economic participation in the APEC region issued a joint statement following their meeting in La Serena, Chile, on 4 October 2019.




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APEC Finance Ministers Issue Ministerial Statement

Finance Ministers from APEC member economies issued a joint statement reflecting the outcomes of the APEC Finance Ministers’ Meeting in Santiago, Chile, chaired by Chile’s Minister of Finance Felipe Larrain.




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APEC Ministers Responsible for Trade Issue Statement on COVID-19

Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community.




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RE: CDRH PREMARKET REVIEW SUBMISSION COVER SHEET

From : Communities>>Regulatory Open Forum
Hello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007.  Then for the publication date, I do put the latest version when published so would be April 2010.  Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet.  I would also rely a bit on the Recognized Standards list the FDA publishes:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  to list [More]




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RE: Medical Device Submissions - Worldwide

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Have you looked into PRA Health Sciences?




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BioMarin pens gene therapy pact with little-known Swiss biotech

BioMarin Pharmaceutical is boosting its early-stage pipeline by penning a deal with Swiss startup Dinaqor.




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Commission working on proposal to postpone MDR date of application for one year

After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]




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Commissioner Adam Silver tells NBA players that resuming the season remains fluid

Adam Silver told NBA players that a return to the court is up in the air but that games could be held in Las Vegas or Orlando, likely without fans.





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JCM Credit issuance in Indonesia

In March 2019, Yokogawa completed a demonstration project for the Optimization of the Operation Control of Oil Refining Plants in Indonesia. The New Energy and Industrial Technology Development Organization (NEDO) awarded this project to Yokogawa in 2013.




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"Yokogawa’s Approach to IT/OT Convergence," Yokogawa Technical Report (Vol.62, No.2), issued




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Achieving atmospheric verification of CO<sub>2</sub> emissions




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Achieving atmospheric verification of CO<sub>2</sub> emissions





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Digital synthesis of histological stains using micro-structured and multiplexed virtual staining of label-free tissue