Secretary Blinken’s Call with Salvadoran Foreign Minister Hill Tinoco

Office of the Spokesperson

The following is attributable to Spokesperson Ned Price:

Secretary of State Antony J. Blinken spoke with Salvadoran Foreign Minister Alexandra Hill Tinoco today. Secretary Blinken and Foreign Minister Hill discussed how a productive U.S.-El Salvador bilateral relationship can help us address the root causes of irregular migration. The Secretary also stressed that building economic opportunity, protecting and strengthening democratic institutions, eliminating corruption, and improving respect for human rights, including by combating impunity, are essential to ensuring the future of peace and prosperity in the region. Secretary Blinken noted the strong bonds between the governments and peoples of the United States and El Salvador and celebrated the longstanding relationship between our countries.

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    Eight federal programs addressing chemical safety or security from four departments or agencies that GAO reviewed contain requirements or guidance that generally align with at least half of the Department of Homeland Security's (DHS) 18 Chemical Facility Anti-Terrorism Standards (CFATS) program standards. At least 550 of 3,300 (16 percent) facilities subject to the CFATS program are also subject to other federal programs. Analyses of CFATS and these eight programs indicate that some overlap, duplication, and fragmentation exists, depending on the program or programs to which a facility is subject. For example, six federal programs' requirements or guidance indicate some duplication with CFATS. CFATS program officials acknowledge similarities among these programs' requirements or guidance, some of which are duplicative, and said that the CFATS program allows facilities to meet CFATS program standards by providing information they prepared for other programs. more than 1,600 public water systems or wastewater treatment facilities are excluded under the CFATS statute, leading to fragmentation. While such facilities are subject to other programs, those programs collectively do not contain requirements or guidance that align with four CFATS standards. According to DHS, public water systems and wastewater treatment facilities are frequently subject to safety regulations that may have some security value, but in most cases, these facilities are not required to implement security measures commensurate to their level of security risk, which may lead to potential security gaps. The departments and agencies responsible for all nine of these chemical safety and security programs—four of which are managed by DHS, three by the Environmental Protection Agency (EPA), and one each managed by the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) and the Department of Transportation (DOT)—have previously worked together to enhance information collection and sharing in response to Executive Order 13650, issued in 2013. This Executive Order directed these programs to take actions related to improving federal agency coordination and information sharing. However, these programs have not identified which facilities are subject to multiple programs, such that facilities may be unnecessarily developing duplicative information to comply with multiple programs. Although CFATS allows facilities to use information they prepared for other programs, CFATS program guidance does not specify what information facilities can reuse. Finally, DHS and EPA leaders acknowledged that there are differences between CFATS requirements and the security requirements for public water systems and wastewater treatment facilities, but they have not assessed the extent to which potential security gaps may exist. By leveraging collaboration established through the existing Executive Order working group, the CFATS program and chemical safety and security partners would be better positioned to minimize unnecessary duplication between CFATS and other programs and better ensure the security of facilities currently subject to fragmented requirements. Facilities with hazardous chemicals could be targeted by terrorists to inflict mass casualties or damage. Federal regulations applicable to chemical safety and security have evolved over time as authorizing statutes and regulations established programs for different purposes, such as safety versus security, and with different enforcement authorities. GAO has reported that such programs may be able to achieve greater efficiency where overlap exists by reducing duplication and better managing fragmentation. GAO was asked to review issues related to the effects that overlap, duplication, and fragmentation among the multiple federal programs may have on the security of the chemical sector. This report addresses the extent to which (1) such issues may exist between CFATS and other federal programs, and (2) the CFATS program collaborates with other federal programs. GAO analyzed the most recent available data on facilities subject to nine programs from DHS, EPA, ATF, and DOT; reviewed and analyzed statutes, regulations, and program guidance; and interviewed agency officials. GAO is making seven recommendations, including that DHS, EPA, ATF, and DOT identify facilities subject to multiple programs; DHS clarify guidance; and DHS and EPA assess security gaps. Agencies generally agreed with six; EPA did not agree with the recommendation on gaps. GAO continues to believe it is valid, as discussed in the report. For more information, contact Nathan Anderson at (206) 287-4804 or AndersonN@gao.gov.
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    In U.S GAO News
    GAO has reported on the Department of Veterans Affairs' (VA) use of research to identify and add new illnesses to its list of presumptive conditions for both Gulf War Illness and Agent Orange—a tactical herbicide used extensively during the Vietnam Era. VA entered into agreements with the National Academy of Sciences to assess the link between certain exposures and illnesses experienced by veterans, and uses the Academy's findings to inform its lists of presumptive conditions. GAO also reported in 2017 that VA did not have a single set of uniform criteria to define Gulf War Illness (a case definition) that could improve research, clinical diagnosis, and treatment of Gulf War veterans. GAO recommended that VA prepare and document a plan to develop a single case definition. In response, VA convened a group of subject matter experts from VA and the Department of Defense to create a multi-step plan to develop a case definition. According to VA, it is in the final stages of the plan and will bring together experts in 2021 to review new research and work toward delineating a definition. Further, according to VA, the department continues to support research on conditions related to Gulf War service as well as Agent Orange exposure and will use the findings to consider future presumptive conditions. In 2017, GAO reported on challenges that VA faced in processing complex, presumptive disability claims for veterans who served in the Gulf War—claims that were being denied at higher rates than other disability claims. At the time of GAO's review, VA officials stated that Gulf War Illness claims may be denied at a higher rate, in part, because they are not always well understood by VA staff, and veterans sometimes do not have medical records to adequately support their claims. The challenges we identified included: Inconsistent requests for disability medical exams. VA claims processors can request that a veteran undergo a disability medical exam to help determine whether the conditions in the claim exist and are linked to service. GAO found that claims processors were inconsistent in asking for an exam, in part, due to confusion about the guidance. VA issued training on the topic and in April 2017 completed a review of Gulf War claims to assess the effectiveness of the training and help ensure future consistency. Inconsistent disability medical exam reports. Veterans Health Administration disability medical examiners did not always complete medical exam reports properly and sometimes offered a medical opinion when one was not necessary. GAO recommended that VA require all examiners to complete Gulf War medical exam training before conducting these exams, and VA implemented this recommendation. Since our 2017 report, VA has allowed contracted medical examiners to complete these exams, and in 2018 GAO found VA was not monitoring whether all contractors completed required training. GAO recommended VA improve its oversight of training, but the department has not fully implemented this recommendation from GAO's 2018 report. VA provides disability compensation to millions of veterans with service-connected disabilities. Veterans are generally entitled to these benefits if they can prove their injuries or illnesses were incurred or aggravated by active military service. For certain claims, VA presumes a condition is due to a veteran's service. For example, VA can provide benefits to any veteran with certain symptoms, from respiratory disorders to gastrointestinal issues, who served in Southwest Asia from 1990 to the present, without the veteran needing to prove cause. GAO refers to these as Gulf War Illness claims. In 2017, GAO issued Gulf War Illness: Improvements Needed for VA to Better Understand, Process, and Communicate Decisions on Claims ( GAO-17-511 ), which identified needed improvements in VA's processing of Gulf War Illness claims. In 2018, GAO issued Agent Orange: Actions Needed to Improve Accuracy and Communication of Information on Testing and Storage Locations ( GAO-19-24 ). This statement summarizes information from these reports on how VA determined certain presumptive conditions and challenges VA faced with processing Gulf War Illness claims. In GAO's 2017 report, it recommended that VA develop a plan to establish a single case definition of Gulf War Illness and make Gulf War Illness training mandatory for medical examiners. VA implemented the recommendations. For more information, contact Elizabeth Curda at (202) 512-7215 or curdae@gao.gov.
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    In U.S GAO News
    The Centers for Disease Control and Prevention (CDC) operates the National Breast and Cervical Cancer Early Detection Program (the Early Detection Program) to provide cancer screening and diagnostic services to people who are low-income and uninsured or underinsured. For those screened under the program who require treatment, the Breast and Cervical Cancer Prevention and Treatment Act of 2000 (the Treatment Act) allows states to extend Medicaid eligibility to individuals not otherwise eligible for Medicaid. GAO analysis of CDC data show that the Early Detection Program screened 296,225 people in 2018, a decrease from 550,390 in 2011 (about 46 percent). The largest decrease occurred from 2013 to 2014 (see figure). According to a CDC-funded study, the number of people eligible for the Early Detection Program decreased from 2011 through 2017, by about 48 percent for breast cancer and about 49 percent for cervical cancer. CDC officials attributed these declines in screening and eligibility, in part, to improved access to screening under the Patient Protection and Affordable Care Act (PPACA). For example, PPACA required health plans to cover certain women's preventive health care with no cost sharing. Number of People Screened by CDC's Early Detection Program, 2011-2018 GAO analysis of Centers for Medicare & Medicaid Services' (CMS) data found that, in 2019, 43,549 people were enrolled in Medicaid under the Treatment Act to receive treatment for breast or cervical cancer, a decrease from 50,219 in 2016 (13.3 percent). Thirty-seven states experienced a decrease in Medicaid enrollment under the Treatment Act during this time period, 13 states experienced an increase, and one state had no change. CMS officials noted that Medicaid expansion to adults with incomes at or below 133 percent of the federal poverty level under PPACA (the new adult group) is a key factor that contributed to these enrollment trends. CMS officials said that, in Medicaid expansion states, there were some people who previously would have enrolled in Medicaid based on eligibility under the Treatment Act who instead became eligible for Medicaid in the new adult group. The CMS data show that total enrollment under the Treatment Act in Medicaid expansion states decreased by 25.6 percent from 2016 to 2019. In contrast, total enrollment under the Treatment Act in non-expansion states increased by about 1 percent during this time period. According to the CDC, tens of thousands of people die each year from breast or cervical cancer. Early screening and detection, followed by prompt treatment, can improve outcomes and, ultimately, save lives. Federal programs, like CDC's Early Detection Program, are intended to improve access to these services. GAO was asked to examine the implementation of the Early Detection Program and the states' use of Medicaid under the Treatment Act. This report provides information on the number of people who were 1) screened through the Early Detection Program and 2) enrolled in Medicaid under the Treatment Act. GAO analyzed CDC data on the number of people screened by the Early Detection Program from calendar years 2011 through 2018—the most recent available. GAO also analyzed CMS Medicaid enrollment data from 2016 through 2019—the most recent available. Additionally, GAO reviewed a 2020 study funded by CDC that examines the number of people eligible for the Early Detection Program from 2011 through 2017. Finally, GAO interviewed CDC and CMS officials and reviewed relevant CDC and CMS documents. For more information, contact John E. Dicken, (202) 512-7114, dickenj@gao.gov.
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    In U.S GAO News
    The Department of State (State) did not demonstrate that it used data and evidence to develop its proposal for establishing a new Bureau of Cyberspace Security and Emerging Technologies (CSET). In response to GAO requests for such data and evidence, State provided GAO with briefing slides outlining different options for the new bureau and an action memo, approved by the Secretary of State. The memo recommended that CSET focus on cyberspace security and the security aspects of emerging technologies and report to the Under Secretary for Arms Control and International Security, while the Bureau of Economic and Business Affairs (EB) would continue to have responsibility for digital economy issues. However, State did not explain how it would address any challenges associated with the decision on CSET's organizational placement. For example, the memo did not address how State would coordinate internally on the cybersecurity aspects of digital economy policy issues with cyber diplomacy functions split between CSET and EB. The memo also did not specify how State would develop consolidated positions and set priorities for State's international cyberspace efforts, given the separation of these issues. Moreover, neither the briefing nor the action memo contained analyses supporting the additional details laid out in State's 2019 notification to Congress on CSET, including support for proposed resource allocations for the new bureau. Without developing data and evidence to support its proposal for the new bureau, State lacks assurance that its proposal will effectively set priorities and allocate appropriate resources for the bureau to achieve its intended goals. State needs to develop these areas further to better ensure the success of any new organizational arrangement. The United States and its allies are facing expanding foreign cyber threats as international trade, communication, and critical infrastructure become increasingly dependent on cyberspace. State leads U.S. government international efforts to advance the full range of U.S. interests in cyberspace. The Cyber Diplomacy Act of 2019 (H.R. 739, 116th Cong.), co-sponsored by 29 members of Congress, proposed the establishment of a new office within State that would have consolidated responsibility for digital economy and internet freedom issues, together with international cybersecurity issues. While the House Foreign Affairs Committee reported out this bill in March 2019, the full House of Representatives did not consider the bill prior to expiration of the 116th Congress. State subsequently notified Congress in June 2019 of its plan to establish CSET, with a narrower focus on cyberspace security and emerging technologies. On January 7, 2021, State announced that the Secretary had approved the creation of CSET and directed the department to move forward with establishing the bureau. However, as of the date of this report, State had not created CSET. GAO was asked to review State's efforts to advance U.S. interests in cyberspace. This report examines the extent to which State used data and evidence to develop and justify its proposal to establish CSET. GAO reviewed available documentation and interviewed State officials. To determine the extent to which State used data and evidence to develop and justify its proposal to establish CSET, GAO assessed State's documentation against a relevant key practice for agency reforms compiled in GAO's June 2018 report on government reorganization. The Secretary of State should ensure that State uses data and evidence to justify its current proposal, or any new proposal, to establish the Bureau of Cyberspace Security and Emerging Technologies to enable the bureau to effectively set priorities and allocate resources to achieve its goals. While State disagreed with GAO's characterization of its use of data and evidence to develop its proposal for CSET, it agreed that reviewing such information to evaluate program effectiveness can be useful. State commented that it has provided GAO with appropriate material on its decision to establish CSET and has not experienced challenges in coordinating cyberspace security policy across the department while the CSET proposal has been in discussion. State concluded that this provides assurance that CSET will allow the new bureau to effectively set priorities and allocate resources. The documents State provided in response to GAO's requests, including a set of briefing slides and an action memo to the Secretary, did not sufficiently demonstrate that it used data and evidence in developing its proposal. In addition, State's comment that it has not experienced coordination challenges in recent years is not sufficient evidence that the potential for such challenges does not exist. Without evidence to support the creation of the new bureau, State lacks needed assurance that the bureau will effectively set priorities and allocate appropriate resources to achieve its intended goals. For more information, contact Brian M. Mazanec at (202) 512-5130 or MazanecB@gao.gov, or Nick Marinos at (202) 512-9342 or MarinosN@gao.gov.
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  • Pregnant Women in DOJ Custody: U.S. Marshals Service and Bureau of Prisons Should Better Align Policies with National Guidelines
    In U.S GAO News
    GAO analyses of available data show that from calendar year 2017 through 2019, there were at least 1,220 pregnant women in U.S. Marshals Service (USMS) custody and 524 pregnant women in Bureau of Prisons (BOP) custody. Pregnant Women in USMS and BOP Custody: Number, Age, Race, and Length of Time in Custody from 2017 through 2019 aUSMS does not track pregnancy outcomes, so length of time in custody may include time when the women were not pregnant. For BOP, the length of time represents only the period of pregnancy. GAO analyses also show that pregnant women were held at a variety of facility types from 2017 through 2019. For example, pregnant women spent 68 percent of their time in USMS custody in non-federal facilities where USMS has an intergovernmental agreement. BOP data show that pregnant women spent 21 percent of their time in BOP custody while pregnant at Carswell—BOP's only female Federal Medical Center. While USMS and BOP both have policies that address the treatment and care of pregnant women, not all policies fully align with national guidance recommendations on 16 pregnancy-related care topics. For example, national guidance recommends specialized nutrition and when needed, mental health care. USMS policies fully align on three of 16 care topics and BOP policies fully align on eight of 16. By taking steps to more closely align agency standards and policies with national guidance as feasible, USMS and BOP would be better positioned to help ensure the health of pregnant women in their custody. USMS and BOP data show that the agencies provide a variety of medical care and special accommodations to pregnant women, and both agencies track the use of restraints. For example, USMS data show that women receive prenatal care and BOP data show that women receive prenatal vitamins and lower bunk assignments, among other things. However, USMS could do more to collect data on pregnant and postpartum women in their custody who are placed in restrictive housing. While USMS requests that facilities that hold USMS prisoners submit data on a regular basis indicating which prisoners were placed in restrictive housing, facilities are not required to indicate if any of these prisoners are pregnant or postpartum. In addition, USMS does not have a requirement for facilities to immediately notify USMS when such women are placed in restrictive housing. By requiring these notifications and data collection, USMS would be better positioned to ensure that facilities are complying with its USMS Detention Standards and Department of Justice (DOJ) guidance that state pregnant and postpartum women should not be placed in restrictive housing except in rare situations. Policymakers and advocacy groups have raised questions about the treatment of incarcerated pregnant women, including the use of restrictive housing—removal from the general prisoner population with the inability to leave the cell for the majority of the day—and restraints. Within DOJ, USMS is responsible for prisoners awaiting trial or sentencing. BOP is responsible for sentenced prisoners. GAO was asked to review issues related to pregnant women in USMS and BOP custody. This report examines (1) what DOJ data indicate about pregnant women in USMS and BOP custody; (2) the extent to which USMS and BOP policies align with national guidance on pregnancy-related care; and (3) what is known about the care provided and the extent to which USMS and BOP track when pregnant women are placed in restrictive housing or restraints. GAO analyzed available agency data from calendar years 2017 through 2019, which were the most recent data available; compared agency policies to relevant national guidance; and interviewed officials and a non-generalizable sample of prisoners who had been pregnant in USMS or BOP custody. GAO is making six recommendations, including that USMS and BOP take steps to more closely align their policies with national guidance on pregnancy-related care as feasible, and that USMS require facilities to collect data on and notify USMS when pregnant or postpartum women are placed in restrictive housing. DOJ concurred with our recommendations. For more information, contact Gretta L. Goodwin at (202) 512-8777 or goodwing@gao.gov.
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    In U.S GAO News
    Since November 2020, the number of COVID-19 cases in the U.S. has rapidly increased, further straining health care systems across the country. Between December 31, 2020, and January 13, 2021, new reported COVID-19 cases averaged about 225,000 per day—over 7 and 3 times higher than the surges the nation experienced during the spring and summer of 2020, respectively. (See figure.) The country also continues to experience serious economic repercussions and turmoil as a result of the pandemic. As of December 2020, there were more than 10.7 million unemployed individuals, compared to nearly 5.8 million individuals at the beginning of the calendar year. Until the country better contains the spread of the virus, the pandemic will likely remain a significant obstacle to more robust economic activity. Reported COVID-19 Cases per Day in the U.S., Through January 13, 2021 As of January 2021, 27 of GAO’s 31 previous recommendations remained unimplemented. GAO remains deeply troubled that agencies have not acted on recommendations to more fully address critical gaps in the medical supply chain. While GAO recognizes federal agencies continue to take some steps, GAO underscores the importance of developing a well-formulated plan to address critical gaps for the remainder of the pandemic, especially in light of the recent surge in cases. In addition, implementation of GAO’s recommendation concerning the importance of clear and comprehensive vaccine distribution and communication plans remains a work in progress. Moreover, slow implementation of GAO’s recommendations relating to program integrity, in particular those made to the Small Business Administration (SBA) and Department of Labor (DOL), creates risk of considerable improper payments, including those related to fraud, and falls far short of transparency and accountability expectations. See appendix III for the status of GAO’s past recommendations. GAO is pleased that the Consolidated Appropriations Act, 2021—enacted in December of 2020—requires a number of actions that are consistent with several of GAO’s prior recommendations, including those related to the medical supply chain, vaccines and therapeutics, and COVID-19 testing. GAO will monitor the implementation of the act’s requirements. GAO’s new recommendations are discussed below. COVID-19 Testing Diagnostic testing for COVID-19 is critical to controlling the spread of the virus, according to the Centers for Disease Control and Prevention. GAO found that the Department of Health and Human Services (HHS) has not issued a comprehensive and publicly available national testing strategy. HHS’s national strategy documents are not comprehensive because they only partially address the characteristics that GAO has found to be desirable in an effective national strategy. For example, testing strategy documents do not always provide consistent definitions and benchmarks to measure progress, not all documents clearly define the problem and risks, and there is limited information on the types of resources required for future needs. Furthermore, some of the documents have not been made public. While the national testing strategy is formally outlined in a publicly available document, HHS has provided only Congress with the COVID-19 Testing Strategy Reports, which detail the implementation of the testing strategy. Stakeholders who are involved in the response efforts told GAO they were unaware of the existence of a national strategy or did not have a clear understanding of the strategy. Without a comprehensive, publicly available national strategy, HHS is at risk of key stakeholders and the public lacking crucial information to support an informed and coordinated testing response. GAO is recommending that HHS develop and make publicly available a comprehensive national COVID-19 testing strategy that incorporates all six characteristics of an effective national strategy. Such a strategy could build upon existing strategy documents that HHS has produced for the public and Congress to allow for a more coordinated pandemic testing approach. HHS partially concurred with this recommendation and agreed that it should take steps to more directly incorporate some of the elements of an effective national strategy. Vaccines and Therapeutics Multiple federal agencies, through Operation Warp Speed, continue to support the development and manufacturing of vaccines and therapeutics to prevent and treat COVID-19. As of January 8, 2021, two of the six vaccines supported by Operation Warp Speed have been authorized for emergency use, and vaccine distribution and administration have begun. (See figure below). However, distribution and administration fell short of expectations set for the end of the year. As of December 30, 2020, Operation Warp Speed had distributed (shipped) about 12.4 million doses of COVID-19 vaccine and providers reported administering about 2.8 million initial doses, according to Centers for Disease Control and Prevention data. In September 2020, GAO stressed the importance of having a plan that focused on coordination and communication and recommended that HHS, with the support of the Department of Defense, establish a time frame for documenting and sharing a national plan for distributing and administering COVID-19 vaccine, and among other things, outline an approach for how efforts would be coordinated across federal agencies and nonfederal entities.To date, this recommendationhas not been fully implemented. GAO reiterates the importance of doing so. Effective coordination and communication among federal agencies, commercial partners, jurisdictions, and providers is critical to successfully deploying COVID-19 vaccines and managing public expectations, especially because the initial supply of vaccine has been limited. Status of Development of Six Operation Warp Speed COVID-19 Vaccine Candidates, as of January 8, 2021 Medical Supply Chain The pandemic has highlighted vulnerabilities in the nation’s medical supply chain, which includes personal protective equipment and other supplies necessary to treat individuals with COVID-19. The Strategic National Stockpile (SNS) is an important piece of HHS’s recently developed strategy to improve the medical supply chain to enhance pandemic response capabilities. However, the department has yet to develop a process for engaging about the strategy with key nonfederal stakeholders that have a shared role for providing supplies during a pandemic, such as state and territorial governments and the private sector. GAO’s work has noted the importance of directly and continuously involving key stakeholders, including Congress, in the development of successful agency reforms and helping to harness ideas, expertise, and resources. To improve the nation’s response and preparedness for pandemics, GAO recommends that HHS establish a process for regularly engaging with Congress and nonfederal stakeholders—including state, local, tribal, and territorial governments and private industry—as the agency refines and implements its supply chain strategy for pandemic preparedness, to include the role of the SNS. HHS generally concurred with this recommendation and noted that the department regularly engages with Congress and nonfederal stakeholders. GAO maintains that capitalizing on existing relationships to engage these critical stakeholders as HHS refines and implements a supply chain strategy, to include the role of the SNS, will improve a whole-of-government response to, and preparedness for, pandemics. In August 2020, the President issued an Executive Order directing agencies to take steps toward the goal of strengthening domestic drug manufacturing and supply chains. Federal agencies have started implementing the Executive Order, but expressed concerns about their ability to implement some of the provisions. In particular, GAO found that federal agencies do not have complete and accessible information to identify supply chain vulnerabilities and to report the manufacturing supply chains of drugs that were procured by the agency. To help it identify and mitigate vulnerabilities in the U.S. drug supply chain, GAO recommends that the Food and Drug Administration (FDA) ensure drug manufacturing data obtained are complete and accessible, including by working with manufacturers and other federal agencies, such as the Department of Defense and the Department of Veterans Affairs and, if necessary, seek authority to obtain complete and accessible information. HHS neither agreed nor disagreed with this recommendation. COVID-19 Data for Health Care Indicators The federal government does not have a process to help systematically define and ensure the collection of standardized data across the relevant federal agencies and related stakeholders to help respond to COVID-19, communicate the status of the pandemic with citizens, or prepare for future pandemics. As a result, COVID-19 information that is collected and reported by states and other entities to the federal government is often incomplete and inconsistent. The lack of complete and consistent data limits HHS’s and others’ ability to monitor trends in the burden of the pandemic across states and regions, make informed comparisons between such areas, and assess the impact of public health actions to prevent and mitigate the spread of COVID-19. Further, incomplete and inconsistent data have limited HHS’s and others’ ability to prioritize the allocation of health resources in specific geographic areas or among certain populations most affected by the pandemic. To improve the federal government’s response to COVID-19 and preparedness for future pandemics, GAO recommends that HHS immediately establish an expert committee comprised of knowledgeable health care professionals from the public and private sectors, academia, and nonprofits or use an existing one to systematically review and inform the alignment of ongoing data collection and reporting standards for key health indicators. HHS partially concurred with this recommendation and agreed that it should establish a dedicated working group or other mechanism with a focus on addressing COVID-19 data collection shortcomings. Drug Manufacturing Inspections FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the U.S., including those manufactured overseas, and typically conducts more than 1,600 inspections of foreign and domestic drug manufacturing establishments every year. In light of the COVID-19 pandemic, since March 2020, FDA has limited domestic and foreign inspections for the safety of its employees. (See figure below.) FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused, including inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing. Although FDA has determined that inspections conducted by certain European regulators are equivalent to an FDA inspection, other tools provide useful information but are not equivalent to an FDA inspection. As a result, FDA could be faced with a backlog of inspections, threatening the agency’s goal to maximize inspections prioritized by its risk-based site selection model each year. GAO recommends that FDA (1) ensure that inspection plans for future fiscal years identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize its goal of risk-driven inspections, and (2) fully assess the agency’s alternative inspection tools and consider whether these tools or others could provide the information needed to supplement regular inspection activities or help meet the agency’s drug oversight objectives when inspections are not possible in the future. FDA concurred with both recommendations. Number of FDA-Conducted Domestic and Foreign Drug Manufacturing Establishment Inspections, Fiscal Years 2019–2020, by Month Federal Contracting Federal agencies are using other transaction agreements to respond to the pandemic, which are contracting mechanisms that can enable agencies to negotiate terms and conditions specific to a project. GAO found that HHS misreports its other transaction agreements related to COVID-19 as procurement contracts, including other transaction agreements with about $1.5 billion obligated for Operation Warp Speed and other medical countermeasures. HHS’s approach is inconsistent with federal acquisition regulations and limits the public’s insight into the agency’s contract spending. To ensure consistent tracking and transparency of federal contracting activity related to the pandemic, GAO recommends that HHS accurately report data in the federal procurement database system and provide information that would allow the public to distinguish between spending on other transaction agreements and procurement contracts. HHS concurred with this recommendation. Oversight of Worker Safety and Health GAO identified concerns about federal oversight of worker safety and health amid the COVID-19 pandemic. Specifically, the Occupational Safety and Health Administration (OSHA) has adapted its enforcement methods for COVID-19 to help protect agency employees from the virus and address resource constraints, such as by permitting remote inspections in place of on-site inspections of workplaces. However, gaps in OSHA’s oversight and tracking of its adapted enforcement methods prevent the agency from assessing the effectiveness of its enforcement methods during the pandemic, ensuring that its adapted enforcement methods do not miss violations, and ensuring that employers are addressing certain identified violations. To improve its oversight, GAO recommends that OSHA (1) develop a plan, with time frames, to implement the agency’s oversight processes for COVID-19-adapted enforcement methods, and (2) ensure that its data system includes comprehensive information on use of these enforcement methods to inform these processes. The agency neither agreed nor disagreed with these recommendations. Additionally, OSHA’s data do not include comprehensive information on workplace exposure to COVID-19. For example, OSHA does not receive employer reports of all work-related hospitalizations related to COVID-19, as disease symptoms do not appear within the required reporting time frames. Employers may also face challenges determining whether COVID-19 hospitalizations or fatalities are work-related because of COVID-19’s incubation period and the difficulties in tracking the source of exposure. GAO recommends that OSHA determine what additional datamay be neededfrom employers or other sources to better target the agency’s COVID-19 enforcement efforts. The agency neither agreed nor disagreed with this recommendation. Assistance for Fishery Participants The CARES Act appropriated $300 million in March 2020 to the Department of Commerce (Commerce) to assist eligible tribal, subsistence, commercial, and charter fishery participants affected by COVID-19, which may include direct relief payments. After administrative fees were assessed, $298 million of the $300 million appropriated was obligated for fishery participants.Widespread restaurant closures in the spring of 2020 led to a decrease in demand for seafood, adversely affecting the fisheries industry. As of December 4, 2020, all funds had been obligated and only about 18 percent ($53.9 million) of the CARES Act funding obligated for fishery participants had been disbursed, which is inconsistent with Office of Management and Budget guidance on the importance of agencies distributing CARES Act funds in an expedient manner. Commerce’s National Oceanic and Atmospheric Administration (NOAA) officials said they expect that the vast majority of funds will be disbursed to fisheries participants by early 2021. However, the agency does not have the needed information centralized to help ensure that funds are being disbursed expeditiously and efficiently. GAO recommends that NOAA develop a mechanism to track the progress of states, tribes, and territories in meeting established timelines to disburse funds in an expedited and efficient manner. NOAA concurred with this recommendation. Program Integrity GAO continues to identify areas to improve program integrity and reduce the risk of improper payments for programs funded by the COVID-19 relief laws now that federal agencies have obligated a total of $1.9 trillion and expended $1.7 trillion of the $2.7 trillion appropriated for response and recovery efforts as of November 30, 2020. Federal relief programs remain vulnerable to significant risk of fraudulent activities because of the need to quickly provide funds and other assistance to those affected by COVID-19 and its economic effects. In this report, GAO identifies concerns about overpayments and potential fraud in the unemployment insurance (UI) system, specifically in the federally funded Pandemic Unemployment Assistance (PUA) program, which provides UI benefits to individuals not otherwise eligible for these benefits, such as self-employed and certain gig economy workers. As of January 11, 2021, states that had submitted data to DOL reported more than $1.1 billion in PUA overpayments from March through December 2020. While DOL requires states to report data on PUA overpayments, as of the beginning of 2021, the agency was not tracking the amount of overpayments recovered, limiting insight into the effectiveness of states’ efforts to recoup federal funds. To better track the recovery of federal funds, GAO recommends that DOL collect data from states on the amount of PUA overpayments recovered. DOL concurred with this recommendation, and has taken the first step toward implementing it by issuing new guidance and updated instructions for states to report PUA overpayment recovery data. GAO also remains concerned about SBA’s management of internal controls and fraud risks in the Economic Injury Disaster Loans (EIDL) program. COVID-19 relief laws made qualifying small businesses and nonprofit organizations adversely affected by COVID-19 eligible for financial assistance from the EIDL program. Some approval requirements were also relaxed, such as requiring each applicant to demonstrate that it could not obtain credit elsewhere, through December 31, 2021. As of December 31, 2020, SBA officials said they had approved about 3.7 million applications for loans related to COVID-19, totaling about $200 billion. SBA rapidly processed loans and advances to millions of small businesses affected by COVID-19. GAO’s analysis of SBA data shows that the agency approved EIDL loans and advances for potentially ineligible businesses. For example, SBA approved at least 3,000 loans totaling about $156 million to potentially ineligible businesses in industries that SBA policies state were ineligible for the EIDL program, such as insurance and real estate development, as of September 30, 2020. GAO recommends that SBA develop and implement portfolio-level data analytics across EIDL loans and advances made in response to COVID-19 as a means to detect potentially ineligible and fraudulent applications. SBA neither agreed nor disagreed with this recommendation. As of January 15, 2021, the U.S. had about 23 million cumulative reported cases of COVID-19 and more than 387,000 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions. Four relief laws, including the CARES Act, were enacted as of November 2020 to provide appropriations to address the public health and economic threats posed by COVID-19. As of November 30, 2020, of the $2.7 trillion appropriated by these four laws, the federal government had obligated a total of $1.9 trillion and expended $1.7 trillion of the COVID-19 relief funds, as reported by federal agencies. In December 2020, the Consolidated Appropriations Act, 2021, provided additional federal assistance for the ongoing response and recovery. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines the federal government’s continued efforts to respond to and recover from the COVID-19 pandemic. GAO reviewed data, documents, and guidance from federal agencies about their activities and interviewed federal and state officials and stakeholders. GAO completed its audit work on January 15, 2021. GAO is making 13 new recommendations for agencies that are detailed in this Highlights and in the report. For more information, contact A. Nicole Clowers at (202) 512-7114 or clowersa@gao.gov.
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    The Department of Justice, together with the Federal Trade Commission (FTC), today announced three settlements resolving alleged violations of the Better Online Ticket Sales (BOTS) Act. These are the first enforcement actions that the department and the FTC have brought under the BOTS Act.
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