October 19, 2021

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Texas Pharmacist Pleads Guilty to Adulterating Drug Used in Cataract Surgeries

16 min read
<div>A Texas man pleaded guilty Tuesday to one count of adulterating a drug that was used in cataract surgeries.</div>
A Texas man pleaded guilty Tuesday to one count of adulterating a drug that was used in cataract surgeries.

More from: October 13, 2021

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  • Lithuanian National Day
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    A Utah man and his company were charged in an indictment today with violating the Endangered Species Act and Lacey Act for their role in illegal wildlife trafficking, announced Principal Deputy Assistant Attorney General Jonathan D. Brightbill of the Justice Department’s Environment and Natural Resources Division and U.S. Attorney John W. Huber of the District of Utah.
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  • July 29, 2021, letter commenting on AICPA’s February 2021 Exposure Draft, “Proposed Statements on Quality Management Standards – Quality Management”
    In U.S GAO News
    This letter provides GAO's response to the American Institute of Certified Public Accountants (AICPA) Auditing Standards Board's (ASB) Proposed Statement on Quality Management Standards – Quality Management: A Firm's System of Quality Management (SQMS No. 1); Proposed Statement on Quality Management Standards – Engagement Quality Reviews (SQMS No. 2); and Proposed Statement on Auditing Standards, Quality Management for an Engagement Conducted in Accordance with Generally Accepted Auditing Standards (QM SAS). GAO provides standards for performing high-quality audits of government organizations, programs, activities, and functions and of government assistance to contractors, nonprofit organizations, and other nongovernment organizations with competence, integrity, objectivity, and independence. These standards, often referred to as generally accepted government auditing standards (GAGAS), are to be followed when required by law, regulation, agreement, contract, or policy. For financial audits, GAGAS incorporates by reference the AICPA's Statements on Auditing Standards (SAS). For attestation engagements, GAGAS incorporates by reference the AICPA's Statements on Standards for Attestation Engagements.
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  • DOD Procurement of Mi-17 Helicopters
    In U.S GAO News
    What GAO FoundIn summary, DOD's Office of the Secretary of Defense directed the Navy to cancel its competitive solicitation for 21 civilian Mi-17s because Russian authorities told DOD in late 2010 that, in accordance with Russian law, they would sell the helicopters only through Rosoboronexport since they were intended for military end use. Specifically, in response to letters written by the U.S. Ambassador to Russia, the Russian Ministry of Foreign Affairs confirmed to DOD that it considered the Mi-17s to be military because they were for use by the Afghan Air Force, and therefore could be sold only through Rosoboronexport, the sole entity responsible for Russian military exports.DOD did not assess alternative means for procuring Mi-17s after verifying that Russia would sell the helicopters to the United States only through Rosoboronexport. The Navy's original procurement strategy in 2010 was to purchase civilian Mi-17s and subsequently add weapons to them for use in Afghanistan. However, given the Russian government's determination, DOD officials stated that no alternative approaches to procure the helicopters were available to them as any attempt to procure a new civilian aircraft could be blocked by Rosoboronexport if DOD did not go through them, and purchasing used helicopters posed safety concerns. Although some potential vendors told us that, if awarded a contract, they could provide these aircraft to DOD at a lower cost, an Army analysis determined that the price paid to Rosoboronexport for the Mi-17s was reasonable and fell within the historical range of the unit price paid for similar aircraft.DOD determined that the Rosoboronexport contract offered the Army greater access to technical information from the original equipment manufacturer and increased assurance of safety compared to previous Mi-17 contracts. However, the risk of counterfeiting may be similar. The 2011 contract with Rosoboronexport provided Army officials with extensive access to the original equipment manufacturer's facilities and allowed for technical discussions on the aircraft's design, testing, and manufacturing processes. This level of insight enabled the Army to determine that the Russians' process was sufficient by U.S. standards to certify airworthiness. However, both Rosoboronexport and other vendors have purchased new Mi-17s that came from the original equipment manufacturer--a practice used to decrease the risk of counterfeiting. Therefore, GAO found no evidence that shows how Rosoboronexport would decrease the risk of counterfeit parts over other vendors if aircraft were purchased new from the original equipment manufacturer.Why GAO Did This StudyThis letter responds to the Senate Armed Services Committee report 112-173 accompanying the 2013 National Defense Authorization Act, which directed GAO to review the Department of Defense (DOD) procurement of Mi-17 helicopters through Rosoboronexport, a Russian state-owned arms export firm. In response, GAO reviewed: (1) the reasons for DOD's cancellation of a 2010 competitive solicitation for 21 Mi-17 helicopters; (2) the extent to which DOD evaluated the availability and feasibility of alternative procurement approaches for military or civilian variants of the Mi-17 helicopter; and (3) DOD's assessment of the impact that contracting directly with Rosoboronexport may have had on the risk of access to technical data, aircraft safety, and counterfeiting.For more information, contact Michael Courts at (202) 512-4841 or courtsm@gao.gov.
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    In U.S GAO News
    A firm requested reconsideration of its dismissed protest of the Navy's decision to perform base operations and support services in-house rather than contract for these services, contending that the Navy's proposed corrective action failed to address all of its concerns. GAO held that it would not consider these issues, since the Navy's proposed corrective action may affect key requirements in the solicitation and render the protester's concerns academic. Accordingly, the request for reconsideration was denied.
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  • Military Training: Actions Needed to Further Improve the Consistency of Combat Skills Training Provided to Army and Marine Corps Support Forces
    In U.S GAO News
    In conventional warfare, support forces such as military police, engineers, and medical personnel normally operate behind the front lines of a battlefield. But in Iraq and Afghanistan--both in U.S. Central Command's (CENTCOM) area of responsibility--there is no clear distinction between front lines and rear areas, and support forces are sometimes exposed to hostile fire without help from combat arms units. The House report to the National Defense Authorization Act for fiscal year 2010 directed GAO to report on combat skills training for support forces. GAO assessed the extent to which (1) Army and Marine Corps support forces are completing required combat skills training; (2) the services and CENTCOM have information to validate completion of required training; and (3) the services have used lessons learned to adjust combat skills training for support forces. To do so, GAO analyzed current training requirements, documentation of training completion, and lessons learned guidance; observed support force training; and interviewed headquarters officials, trainers, and trainees between August 2009 and February 2010.Army and Marine Corps support forces undergo significant combat skills training, but additional actions could help clarify CENTCOM's training requirements, ensure the services fully incorporate those requirements into their training requirements, and improve the consistency of training that is being conducted. CENTCOM has issued a list of training tasks to be completed, in addition to the services' training requirements, before deploying to its area of operations. However, there is confusion over which forces the CENTCOM requirements apply to, the conditions under which the tasks are to be trained, and the standards for successfully completing the training. As a result, interpretations of the requirements vary and some trainees receive detailed, hands-on training for a particular task while others simply observe a demonstration of the task. In addition, while the Army and Marine Corps are training their forces on most of CENTCOM's required tasks, servicemembers are not being trained on some required tasks prior to deploying. While units collect information on the completion of training tasks, additional actions would help higher level decision-makers assess the readiness of deploying units and servicemembers. Currently, both CENTCOM and the services lack complete information on the extent to which Army and Marine Corps support forces are completing required combat skills training. The Army has recently designated the Digital Training Management System as its system of record for tracking the completion of required training, but guidance concerning system implementation is unclear and the system lacks some needed capabilities. As a result, support forces are not fully utilizing the system, and are inconsistently tracking completion of individual and unit training using paper records, stand-alone spreadsheets, and other automated systems. The Marine Corps also uses inconsistent approaches to document training completion. Furthermore, as GAO reported in May 2008, CENTCOM does not have a clearly defined waiver process to provide visibility over the extent to which personnel are deploying to its area of operations without having completed its required training tasks. As a result, CENTCOM and the services have limited visibility over the extent to which servicemembers have or have not completed all required training. While trainers at Army and Marine Corps training sites have applied lessons learned information and made significant changes to the combat skills training they provide support forces, the changes to training have varied across sites. Army and Marine Corps doctrine requires the collection of after action reports, the primary formal vehicle for collecting lessons learned. Lessons are also shared informally, such as through communication between deployed forces and units training to replace them. While the services have these formal and informal means to facilitate the sharing of lessons learned information, trainers at the various training sites are not consistently sharing information about the changes they have made to their training programs. As a result, servicemembers are trained inconsistently and units that are deploying for similar missions sometimes receive different types and amounts of training.
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  • Unmanned Aircraft Systems: Improved Planning and Acquisition Strategies Can Help Address Operational Challenges
    In U.S GAO News
    The current generation of unmanned aircraft systems (UAS) has been in development for defense applications since the 1980's. As of February 2006, the Department of Defense (DOD) had more than 3,000 unmanned aircraft, about 2,000 of which are supporting ongoing operations in Iraq. DOD's 2006 Quadrennial Defense Review validates the importance of unmanned systems and establishes plans to significantly expand investment in unmanned systems and their use in military operations over the next several years. The Congress has been particularly interested in DOD's approach to determining UAS needs and managing the growing number of UAS programs. This testimony addresses GAO's prior work and preliminary observations on (1) the operational successes and challenges U.S. forces are experiencing with UAS in combat operations, and the extent to which DOD has taken steps to address challenges; (2) DOD's progress in establishing a strategic plan and oversight framework to guide joint and service-specific UAS development efforts and related investment decisions; and (3) our assessment of the Global Hawk and Predator programs' business cases and acquisition strategies and the lessons learned that can be applied to the Joint Unmanned Combat Air Systems program.DOD has experienced a high level of mission successes with UAS, but continues to face challenges in fully maximizing the use of these assets. In operations in Iraq and Afghanistan, U.S. forces have used UAS for intelligence, surveillance, reconnaissance, and offensive strike missions in support of joint and service-specific operations. As the numbers of UAS operating in the same airspace as manned aircraft grows, DOD continues to face operational challenges related to interoperability, availability of communications bandwidth, and airspace integration. While DOD and the services have taken some positive initial steps to address these challenges, such as issuing guidance and developing initiatives to improve interoperability, limited progress has been made and the effectiveness of these efforts cannot be adequately assessed until they are fully implemented. While DOD continues to request funds to support service plans for acquiring UAS, it still lacks a viable strategic plan to guide UAS development and investment decisions. Since GAO last reported, DOD established new oversight bodies and updated its UAS Roadmap, but it is too early to tell how the new entities will interrelate and whether they will be able to influence service plans. Also, the updated roadmap identifies broad goals, desired capabilities, and service acquisition plans, but lacks critical elements, such as a clear link among goals, capabilities, and plans, opportunities for joint endeavors, and funding priorities and needs. Until DOD develops a strategic plan, it will not be well positioned to validate requirements, evaluate and integrate services plans, and establish program and funding priorities, nor will Congress have all the information it needs to evaluate funding requests. Such a plan would also help DOD anticipate and minimize the types of challenges that are being experienced today. While there have been successes on the battlefield, UAS development programs have shared many of the same problems as other major weapon systems that begin an acquisition program too early, with many uncertainties about requirements, funding, and immature technology, design, and production. Unmanned systems have also experienced similar outcomes--changing requirements, cost growth, delays in delivery, performance shortfalls, and reliability and support problems. Future acquisition programscan learn from past efforts to craft better and less risky acquisition plans. Key steps conducive to success include preparing a comprehensive business case, adopting a knowledge-based and incremental acquisition strategy, and sustaining disciplined leadership and direction. Frequent changes to the Joint Unmanned Combat Air Systems technology demonstration program and recent budget actions raise some questions about the Department's priorities and future directions for UAS. Concerns have also been raised about possible duplication of systems as the services look to expand individual fleets. Ongoing Army and Air Force efforts to coordinate the Warrior and Predator programs are encouraging and could be a model for limiting duplication and fostering jointness and interoperability.
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