A former CIA officer was arrested today on charges that he illegally disclosed national defense information and obstructed justice.

Former National Security Agency (NSA) senior executive Thomas A. Drake pleaded guilty today in U.S. District Court in Baltimore to a one-count criminal information charging him with unauthorized access of an NSA computer.

Dover Chemical Corporation has agreed to pay $1.4 million in civil penalties for the unauthorized manufacture of chemical substances at facilities in Dover, Ohio, and Hammond, Ind.

The Attorney General made the following statement today on the Senate’s approval of the reauthorization of the Violence Against Women Act (VAWA).

The Justice Department announced today that it has reached a settlement with the New York City Transit Authority (NYCTA) to resolve allegations that the NYCTA is engaged in a pattern or practice of religious discrimination.

Attorney General Eric Holder issued the following statement today on the assignment of U.S. Attorneys to lead investigations of possible unauthorized disclosures of classified information.

The Justice Department announced today the filing of a lawsuit against Rose Acre Farms Inc., a major U.S. egg producer based in Seymour, Ind., alleging that Rose Acre engaged in a pattern or practice of discrimination against work-authorized non-citizens in the employment eligibility verification process.

The Justice Department announced today that it and the National Federation of the Blind have reached a settlement with the Sacramento Public Library Authority in Sacramento, Calif., to remedy alleged violations of the Americans with Disabilities Act (ADA). The agreement resolves allegations that the library violated the ADA by using inaccessible Barnes & Noble NOOK electronic reader devices in a patron lending program.

The U.S. Department of Justice and Federal Trade Commission (FTC) signed an antitrust memorandum of understanding (MOU) with the Government of India Ministry of Corporate Affairs and the Competition Commission of India (CCI) to promote increased cooperation and communication among competition agencies in both countries.

New Mexico-based Akal Security, Inc., one of the largest providers of security services at federal courthouses, agreed to pay $1,875,000 to resolve allegations that it failed to appropriately conduct firearms testing in the Northern District of California.

The Technological Research and Development Authority (TRDA) has agreed to pay $15 million to resolve allegations that it violated the False Claims Act in connection with grants from the National Aeronautics and Space Administration (NASA) and the Economic Development Administration (EDA) of the Department of Commerce, the Justice Department announced today. TRDA, which was created by the Florida legislature as a special district, owns and operates a system of incubator facilities to nurture small businesses by providing low-rent office space and business development assistance.

The United States and the Commonwealth of Pennsylvania announced today a settlement with the Scranton Sewer Authority (SSA) resolving alleged Clean Water Act violations involving sewer overflows to the Lackawanna River and its tributaries/

Attorney General Eric Holder issued the following statement today on the House passage of the reauthorization of the Violence Against Women Act.

The Justice Department announced that late yesterday a federal court in San Francisco entered an order authorizing the Internal Revenue Service to serve a John Doe summons seeking information about U.S. taxpayers who may hold offshore accounts at Canadian Imperial Bank of Commerce FirstCaribbean International Bank.

The Justice Department announced today the filing of a lawsuit against the Reading Parking Authority in the city of Reading, Pa., alleging that the Reading Parking Authority discriminated against former employee Henry Perez, as well as other current and former employees, in violation of Title VII of the Civil Rights Act of 1964 by subjecting them to harassment based upon their national origin.

The Justice Department announced that federal courts in Minnesota, Texas, Pennsylvania, Oklahoma, Virginia and California have entered orders over the past week authorizing the Internal Revenue Service (IRS) to serve John Doe summonses on certain U.S. banks and financial institutions, seeking information about persons who have used specific credit or debit cards in Norway.

The Justice Department today announced that it has filed a lawsuit alleging that the Housing Authority for the City of Ruston, La., has engaged in a pattern or practice of discrimination against African-American tenants, in violation of the federal Fair Housing Act.

Five Banks Directed to Produce Records for Accounts at Zurcher Kantonalbank, The Bank of N.T. Butterfield & Son Limited and Affiliates

The Department of Justice announced today that it has entered a consent decree with the Reading Parking Authority (RPA) in the City of Reading, Pa., which, if approved by the court, will resolve a lawsuit filed by the United States on June 27, 2013.

Under an agreement announced today by the U.S Environmental Protection Agency and the U.S. Department of Justice, the Virgin Islands Water and Power Authority (VIWAPA) will come into compliance with air pollution control requirements in the federal Clean Air Act at its Estate Richmond Generating Facility located on St. Croix, U.S. Virgin Islands.

The Justice Department announced today the filing of a lawsuit with the Executive Office for Immigration Review against Louisiana Crane Company LLC (Louisiana Crane), which is headquartered in Eunice, Louisiana.

Benjamin Pierce Bishop, 60, a former Honolulu, Hawaii, civilian defense contractor and retired lieutenant colonel in the U.S. Army, was sentenced today by U.S. District Judge Leslie E. Kobayashi to serve 87 months imprisonment and three years’ supervised release for willfully communicating classified national defense information to a person not authorized to receive it and unlawfully retaining classified national defense information at his home.

From : Communities>>Regulatory Open Forum
I disagree with Richard. I just had a conversation with the COVID-19 hotline (11:45 am, May 7) and asked about this issue after having read an update from the FDA that said UDIs for EUA devices are waived and GMPs are under limited enforcement. The person I spoke with said the update is correct and that UDIs are waived for EUA devices.  Feel free to contact me if you have any questions.  Bob Bard ------------------------------ Robert Bard JD, RAC [Managing Director] South Lyon MI United States - [More]

From : Communities>>Regulatory Open Forum
Bob, I stand corrected; if you confirmed with FDA that is good.  From what I was reading and seeing (I must have missed that update) there was nothing addressing UDI or no UDI.for EUA products.  (Personally I am a bit surprised at this since the whole concept of UDI is traceability and they waive this for emergency use products - when there is an issue this is where UDI becomes so important.  Shrugs.) ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs --- [More]

From : Communities>>Regulatory Open Forum
Hello Richard, Yesterday, I received a follow up from the Hotline (CDRH-EUA-Templates ) to my query. I was reminded that the waiver to good manufacturing practice and labeling requirements were included in the individual authorization letter. The person responding to my question concerning the UDI requirement provided the following: UDI is not specifically noted; however we are not enforcing UDI during the emergency. The specific authorization letter I was reviewing was for [More]

We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principal Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.



Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage
Without referencing any other site document, monitors can spot two types of DoA log omissions.

(1) Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.


(2) Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.  Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications
Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.

• Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
• Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
• Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures
Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review.

• Have any study tasks been conducted by staff members who have not received official delegation to do so?
• Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?

PI Oversight
The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

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A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

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