Montenegro Travel Advisory

Reconsider travel to Montenegro due to COVID-19.

Read the Department of State’s COVID-19 page before you plan any international travel.   

The Centers for Disease Control and Prevention (CDC) has issued a Level 3 Travel Health Notice for Montenegro due to COVID-19.  

Montenegro has resumed most transportation options (including airport operations and re-opening of borders) and business operations (including day cares).  While other improved conditions have been reported within Montenegro, local conditions are subject to change.  Visit the Embassy’s COVID-19 page for more information on COVID-19 in Montenegro.

Read the country information page.

If you decide to travel to Montenegro:

Last Update: Reissued with updates to COVID-19 information.

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    Fiscal year 2015 was the first time that the Food and Drug Administration (FDA) conducted more inspections of foreign drug manufacturers than domestic manufacturers, with the majority conducted in China and India. However, in June 2020, GAO reported that from fiscal year 2016 through fiscal year 2018, both foreign and domestic inspections decreased, in part due to staffing vacancies. While foreign inspections increased in 2019, since March 2020, FDA has largely paused foreign and domestic inspections due to the Coronavirus Disease 2019 (COVID-19) pandemic, conducting only those deemed mission critical. In January 2021, GAO reported that FDA conducted three foreign inspections in fiscal year 2020 following the pause—significantly less than in recent years. Number of FDA-Conducted Foreign Drug Manufacturing Establishment Inspections, Fiscal Years 2019–2020, by Month FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused. These tools include relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs. FDA has determined that inspections conducted by certain European regulators are equivalent to and can be substituted for an FDA inspection. Other tools provide useful information but are not equivalent. In addition, FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years. In January 2021, GAO recommended that FDA ensure that inspection plans for future fiscal years respond to the issues presented by the backlog and that FDA fully assess the agency's alternative inspection tools. FDA concurred with both recommendations. Even before the COVID-19 pandemic, FDA faced persistent challenges conducting foreign inspections. GAO found in December 2019 that there continued to be vacancies among the investigators who conduct foreign inspections. GAO further found that FDA's practice of preannouncing foreign inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection and raised questions about their equivalence to domestic inspections. In light of COVID-19, FDA is now preannouncing both foreign and domestic inspections for the safety of its staff and manufacturers. GAO also found that language barriers can create challenges during foreign inspections as FDA generally relies on the establishment for translation services. The outbreak of COVID-19 has called greater attention to the United States' reliance on foreign drug manufacturers. FDA reports that 74 percent of establishments manufacturing active ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020. FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States, regardless of where they are produced, and it conducts inspections of both foreign and domestic manufacturing establishments. GAO has had long-standing concerns about FDA's ability to oversee the increasingly global pharmaceutical supply chain, an issue highlighted in GAO's High Risk Series since 2009. This statement is largely based on GAO's Drug Manufacturing Inspections enclosure in its January 2021 CARES Act report, as well as GAO's December 2019 and June 2020 testimonies. Specifically, it discusses (1) the number of FDA's foreign inspections, (2) FDA's response to the COVID-19 pandemic pause in inspections, and (3) persistent foreign inspection challenges. For that work, GAO examined FDA data from fiscal years 2012 through 2020, interviewed FDA investigators, and reviewed documents related to drug oversight during the COVID-19 pandemic, among other things. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.
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    In U.S GAO News
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Estimated Frequency with Which Criminal Investigators Who Reported Using BSA Reports Almost Always, Frequently, or Occasionally Found Relevant Reports for Various Activities, 2015–2018 Notes: GAO conducted a generalizable survey of 5,257 personnel responsible for investigations, analysis, and prosecutions at the Drug Enforcement Administration, Federal Bureau of Investigation, Homeland Security Investigations, Internal Revenue Service-Criminal Investigation, Offices of U.S. Attorneys, and U.S. Secret Service. The margin of error for all estimates is 3 percentage points or less at the 95 percent confidence interval. As of December 2018, GAO found that the Financial Crimes Enforcement Network (FinCEN) granted the majority of federal and state law enforcement agencies and some local agencies direct access to its BSA database, allowing them to conduct searches to find relevant BSA reports. FinCEN data show that these agencies searched the BSA database for about 133,000 cases in 2018—a 31 percent increase from 2014. FinCEN created procedures to allow law enforcement agencies without direct access to request BSA database searches. But, GAO estimated that relatively few local law enforcement agencies requested such searches in 2018, even though many are responsible for investigating financial crimes. GAO found that agencies without direct access may not know about BSA reports or may face other hurdles that limit their use of BSA reports. One of FinCEN's goals is for law enforcement to use BSA reports to the greatest extent possible. However, FinCEN lacks written policies and procedures for assessing which agencies without direct access could benefit from greater use of BSA reports, reaching out to such agencies, and distributing educational materials about BSA reports. By developing such policies and procedures, FinCEN would help ensure law enforcement agencies are using BSA reports to the greatest extent possible to combat money laundering and other crimes. GAO reviewed a nongeneralizable sample of 11 banks that varied in terms of their total assets and other factors, and estimated that their total direct costs for complying with the BSA ranged from about $14,000 to about $21 million in 2018. Under the BSA, banks are required to establish BSA/anti-money laundering compliance programs, file various reports, and keep certain records of transactions. GAO found that total direct BSA compliance costs generally tended to be proportionally greater for smaller banks than for larger banks. For example, such costs comprised about 2 percent of the operating expenses for each of the three smallest banks in 2018 but less than 1 percent for each of the three largest banks in GAO's review (see figure). At the same time, costs can differ between similarly sized banks (e.g., large credit union A and B), because of differences in their compliance processes, customer bases, and other factors. In addition, requirements to verify a customer's identity and report suspicious and other activity generally were the most costly areas—accounting for 29 and 28 percent, respectively, of total compliance costs, on average, for the 11 selected banks. Estimated Total Direct Costs for Complying with the Bank Secrecy Act as a Percentage of Operating Expenses and Estimated Total Direct Compliance Costs for Selected Banks in 2018 Notes: Estimated total direct compliance costs are in parentheses for each bank. Very large banks had $50 billion or more in assets. Small community banks had total of assets of $250 million or less and met the Federal Deposit Insurance Corporation's community bank definition. Small credit unions had total assets of $50 million or less. Federal banking agencies routinely examine banks for BSA compliance. FinCEN data indicate that the agencies collectively cited about 23 percent of their supervised banks for BSA violations each year in their fiscal year 2015–2018 examinations. A small percentage of these violations involved weaknesses in a bank's BSA/anti-money laundering compliance program, which could require the agencies by statute to issue a formal enforcement action. Stakeholders had mixed views on industry proposals to increase the BSA's dollar thresholds for filing currency transaction reports (CTR) and suspicious activity reports (SAR). For example, banks must generally file a CTR when a customer deposits more than $10,000 in cash and a SAR if they identify a suspicious transaction involving $5,000 or more. If both thresholds were doubled, the changes would have resulted in banks filing 65 percent and 21 percent fewer CTRs and SARs, respectively, in 2018, according to FinCEN analysis. Law enforcement agencies told GAO that they generally are concerned that the reduction would provide them with less financial intelligence and, in turn, harm their investigations. In contrast, some industry associations told GAO that they support the changes to help reduce BSA compliance costs for banks. Money laundering and terrorist financing pose threats to national security and the U.S. financial system's integrity. The BSA requires financial institutions to file suspicious activity and other reports to help law enforcement investigate these and other crimes. FinCEN administers the BSA and maintains BSA reports in an electronic database that can be searched to identify relevant reports. Some banks cite the BSA as one of their most significant compliance costs and question whether BSA costs outweigh its benefits in light of limited public information about law enforcement's use of BSA reports. GAO was asked to review the BSA's implementation. This report examines (1) the extent to which law enforcement uses BSA reports and FinCEN facilitates their use, (2) selected banks' BSA compliance costs, (3) oversight of banks' BSA compliance, and (4) stakeholder views of proposed changes to the BSA. GAO surveyed personnel at six federal law enforcement agencies, collected data on BSA compliance costs from 11 banks, reviewed FinCEN data on banking agencies' BSA examinations, and interviewed law enforcement and industry stakeholders on the effects of proposed changes. GAO is recommending that FinCEN develop written policies and procedures to promote greater use of BSA reports by law enforcement agencies without direct database access. FinCEN concurred with GAO's recommendation. For more information, contact Michael Clements at (202) 512-8678 or clementsm@gao.gov.
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