Secretary Michael R. Pompeo and Bahraini Foreign Minister Al Zayani at the U.S.-Bahrain Strategic Dialogue

Michael R. Pompeo, Secretary of State

Washington, DC

SECRETARY POMPEO:  Well, look, good morning from Washington, and good afternoon, Foreign Minister Al Zayani, and to everyone joining from Bahrain.

It’s a pleasure to kick off our first-ever bilateral strategic dialogue.

Look, our two countries have been working together for a long time.  But today is a testament to how President Trump has joined with King Hamad to make our decades-old ties even closer, for the benefit of both of our nations.

It’s been a privilege for me personally to work with His Majesty the King as well, and all the more so because he spent some time studying at the United States Army Command and General Staff College in my home state, the great state of Kansas here in America.

Together, our two teams have achieved historic outcomes for the entire Middle East.  I’m very confident that what we’re doing today, this dialogue and the sessions that will follow, will lay a foundation for more successes, and frankly an even stronger alliance.

I want to start with security – the focus of multiple working sessions.

You’ve helped us defeat ISIS, launching airstrikes against the fraudulent caliphate.

Bahrain also hosts the United States Naval Central Command and our Fifth Fleet’s headquarters.  That allows lots for us.  That allows us to collaborate across the board, from fighting terrorism to safeguarding the passage of goods in the Gulf, free from Iran’s maritime attacks.

Indeed, the regime in Tehran is the number-one threat to Gulf security, and to peace-loving people throughout the entire region.

And I want to thank you all.  I want to thank Bahrain and its people for their steadfast support of our maximum pressure campaign, which has successfully isolated Tehran and cut off tens of billions of dollars for Iranian malign influence and terror.

Bahrain and the United States share a key foreign policy insight:  We’re realists; we see the world as it is.

We recognize the violent nature of the revolutionary Iranian regime, and we understand that when it comes to countering Tehran and many other important issues, Israel is a key partner, and not a problem.

Thanks to the Abraham Accords, partnerships with Israel and the United States are now blossoming.  In fact, just what’s now last month the United States hosted our first Strategic Dialogue with the United Arab Emirates, another signatory.

Look, there’s already more trade and investment between Bahrain and Israel in areas like telecom and financial services in just a handful of weeks.

Indeed, when I was in Israel just a couple weeks back now, I greeted the first direct flight from Bahrain carrying the first cabinet-level delegation, including the foreign minister himself.  We held a trilateral meeting to build on our progress, including by opening the door for an exchange of embassies between Israel and Bahrain.

This is a sign of hope for the region as it moves past stale, outdated thinking to which no one should want to return.

And I am confident more nations will follow Bahrain’s leadership, showing the geographic size of a country does not dictate its influence on the world stage.

Together – together, we’ve proven what works.  There’s more to do; there always is.

Over the next couple weeks, five working groups from the State Department and other agencies will meet with their Bahraini counterparts.

They’ll discuss how we can make sure that our two nations coordinate more in areas like military training and on women’s empowerment.

It’s also important that our future 5G networks are safe from the Chinese Communist Party and malign operators like Huawei.

So, too, is standing up for human rights and combating human trafficking – areas in which Bahrain has made tremendous, real progress.

FOREIGN MINISTER AL ZAYANI:  Thank you, sir.

SECRETARY POMPEO:  I’m happy.  Our bilateral relationship is a powerful force for good – let’s keep together to deliver positive results.

Foreign Minister Al Zayani, thank you and the people of Bahrain for your friendship with the United States of America.  Thank you.

FOREIGN MINISTER AL ZAYANI:  Thank you, sir.  Thank you, Secretary Pompeo.  Thank you for your kind remarks.  Excellencies, distinguished participants, good morning for all those in D.C.  Good afternoon for those in Bahrain, and good afternoon for those who are joining us in Israel.  Sheikh Abdullah is there on an official visit.  Sheikh Abdullah, welcome.  I am delighted to welcome you all to this Strategic Dialogue meeting, and I want to thank you, Secretary Pompeo, and all your colleagues for joining us.

May I start by expressing appreciation for how strongly U.S.-Bahrain relations have grown over so many decades, repeatedly proving their value to both sides.  Today, they take in the full range of political, economic, security, and cultural ties, making this a truly strategic partnership.  Given this broad scope, it is also valuable to zoom out, and from this perspective, to analyze how we can most effectively move forward to maximize the benefits of our countries and the region.  So I greatly welcome these meetings as an opportunity to do just that, and I appreciate the engagement of so many agencies from both sides, corresponding to the wide scope of our agenda.

Ladies and gentlemen, I want to say a few words on the Kingdom Bahrain’s vision for the next 25 years of bilateral ties, the opportunities and challenges, and our aspirations for a broader and closer partnership across a range of issues.  I do so against the backdrop of a momentous 2020.  COVID has brought unprecedented health, social, and economic challenges across the globe.  Rebuilding from these will be among the defining issues of the next few years, and effective international cooperation will be critical.

And in the last few months, the Abraham Accords have seen a step change in the dynamics of the Middle East and a renewed optimism towards peace and prosperity.  These goals are central to our country’s shared vision, and I am convinced also that the Bahrain-U.S. partnership will be key to achieving them.  So today, I want to focus on Bahrain’s vision for bilateral relations, specifically in their security and economic assets, and how these can contribute to the wider Middle East.

Firstly, security:  For 70 or 75 years, the Bahrain-U.S. partnership has been a bedrock of Gulf security, and from Bahrain’s perspective, we see this role continuing and growing in importance.  But it will also come under renewed challenge from parties seeking to undermine Middle East stability.  Primarily, that means Iran, whose malign intent and activities are more blatant than ever.  From its nuclear program to its ballistic missiles, from its interference in other states to its increasingly overt involvement in conflicts, Iran today challenges regional security as aggressively as at any time in recent history.  It is therefore essential that the international community maintains its resolve to recognize and confront such behavior, with unrelenting pressure on Iran to become a responsible actor.  We want our partnership with the United States to be an integral part of this process in exposing the ongoing challenges of the theocratic regime and its proxies, but also in ensuring that Bahrain and other regional allies continue to have the capabilities to effectively protect their peoples against such threats.

More broadly, I am confident that the coming quarter century will also see intensified bilateral cooperation on a range of security issues.  These will build on current successful counterterrorism, counter piracy, and maritime security efforts, but they will also take in emerging challenges, where the close and effective cooperation between our respective military and civilian agencies will again prove its value.

Beyond that, the Abraham Accords hold out the possibility of a reconfigured Middle East architecture based on cooperation rather than confrontation.  Here too, Bahrain-U.S. relations will be important, both in sustaining the regional security necessary to encourage wider engagement in the process, but also by demonstrating in word and deed the benefits of doing so.  So I have no doubt that a central part of both our countries’ vision for the coming years will be to build on these agreements to advance security and prosperity across the Middle East.

Turning to the economic aspect, once again, we have solid foundations based on our 2004 FTA, but also on our shared values of transparency, open markets, fair competition, labor standards, and technology.  These are values we in Bahrain will continue to promote while ensuring that our dynamic modern economy remains an attractive trade and investment proposition for U.S. and other companies, because Bahrain’s vision for the Middle East is not just security, but prosperity, and prosperity in which all the region’s peoples ever seek.  That was one of the reasons we hosted last year’s Peace to Prosperity workshop in Manama, and why we have moved so quickly to ensure that establishing diplomatic relations with Israel leads to a genuine, warm peace and the rapid development of economic, cultural, and people-to-people ties.

We want to see more trade among the countries of the region, partly to spread prosperity, but also to build interdependence and prove the benefits of cooperation.  If we can demonstrate that working together lifts the prosperity and life chances of all our citizens, then we will have the best possible guarantor of enduring regional security.  So we see Bahrain and the United States continue to deepen their economic partnership, increasing trade and investment between them, while also drawing in other like-minded seats to create a network of Middle East prosperity.  Bilaterally, there are many opportunities for further cooperation, as will be reflected in tomorrow’s trade and investment session.  In petrochemicals, for example, U.S. expertise can be instrumental in tapping the significant reserves confirmed in 2018, while there is great scope for American partnership, with Bahrain’s vision, leading banking and fintech sector.  In 25 years, therefore, Bahrain’s vision is for closer and deeper economic partnership with the United States, one which is the centerpiece of a stable, thriving region.

Ladies and gentlemen, I want to conclude by expressing confidence that Bahrain’s ties with the United States will continue to develop strongly not just in the areas I outlined, but across the full range of our relationship.  As they do so, I hope that it will be supplemented by intensified cooperation and interconnection with other like-minded regional states who share our values and our goal of a peaceful, secure, and prosperous Middle East.

Thank you, Mr. Secretary, and thank you all.

SECRETARY POMPEO:  Thank you.

More from: Michael R. Pompeo, Secretary of State

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    For over a decade, Australia, Germany, and the United Kingdom (UK) have developed and implemented national approaches—including strategies, laws, and policies—to support family caregivers, according to experts GAO interviewed. Specifically, experts noted that these efforts could help caregivers maintain workforce attachment, supplement lost income, and save for retirement. As a result, their retirement security could improve. For example, experts said: Care leave allows employees to take time away from work for caregiving responsibilities. Australia's and Germany's policies allow for paid leave (10 days per year of work or instance of caregiving need, respectively), and all three countries allow for unpaid leave though the duration varies. Caregivers can receive income for time spent caregiving. Australia and the UK provide direct payments to those who qualify. Germany provides indirect payments, whereby the care recipient receives an allowance, which they can pass on to their caregiver. Other Countries' Policies to Support Caregivers Experts in all three countries cited some challenges with caregiver support policies. For example, paid leave is not available to all workers in Germany, such as those who work for small firms. In Australia and the UK, experts said eligibility requirements for direct payments (e.g., limits on hours worked or earnings) can make it difficult for someone to work outside their caregiving role. Experts in all three countries said caregivers may be unaware of available supports. For example, identifying caregivers is a challenge in Australia and the UK. As required under the RAISE Family Caregivers Act, the Department of Health and Human Services (HHS) convened the Family Caregiving Advisory Council (FCAC)—a stakeholder group that is to jointly develop a national family caregiving strategy. As of July 2020, HHS and the FCAC reported limited information on other countries' approaches, and neither entity had concrete plans to collect more. In September 2020, HHS officials provided sources they recently reviewed on selected policies in other countries, and they further noted that HHS staff, FCAC members, and collaborating partners have subject-matter expertise and bring perspectives about other countries' efforts into their discussions. Family caregivers play a critical role in supporting the elderly population, which is growing at a rapid rate worldwide. However, those who provide eldercare may risk their own long-term financial security. Other countries have implemented policies to support caregivers. In recognition of challenges caregivers face in the United States, Congress directed HHS, in consultation with other federal entities, to develop a national family caregiving strategy. GAO was asked to provide information about other countries' efforts that could improve the retirement security of parental and spousal caregivers. This report examines (1) other countries' approaches to support family members who provide eldercare, (2) challenges of these approaches, and (3) the status of HHS' efforts to develop a national family caregiving strategy. GAO conducted case studies of three countries—Australia, Germany, and the United Kingdom—selected based on factors including rates of informal care (i.e., help provided to older family members or friends) and the types of policies they have that could improve caregivers' retirement security. GAO interviewed government officials and experts and reviewed relevant federal laws, research, and documents. GAO's draft report recommended that HHS collect additional information about other countries' experiences. In response, in September 2020, HHS provided an update on its efforts to do so. As a result, GAO removed the recommendation and modified the report accordingly. For more information, contact Tranchau (Kris) T. Nguyen at or nguyentt@gao.gov.
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  • USDA Market Facilitation Program: Information on Payments for 2019
    In U.S GAO News
    The U.S. Department of Agriculture's (USDA) Farm Service Agency (FSA) distributed about $14.4 billion in 2019 Market Facilitation Program (MFP) payments to farming operations in all 50 states and Puerto Rico. According to USDA, these payments were intended to offset the effects of trade disruptions and tariffs targeting a variety of U.S. agricultural products. FSA distributed these payments to 643,965 farming operations. The average MFP payment per farming operation for 2019 was $22,312 but varied by county, ranging from $44 to $295,299. MFP payments for 2019 also varied by type of commodity. Three types of commodities were eligible for 2019 MFP payments: (1) nonspecialty crops (including grains and oilseeds, such as corn and soybeans); (2) specialty crops (including nuts and fruits, such as pecans and cranberries); and (3) dairy and hogs. Most of the 2019 MFP payments went to farming operations that produced nonspecialty crops. Less than 10 percent went to farming operations that produced specialty crops or dairy and hogs. USDA made approximately $519 million in additional MFP payments for 2019 compared with 2018 because of increases in payment limits—the cap on payments that members of farming operations can receive. FSA distributed these additional MFP payments to about 10,000 farming operations across 39 states. The amount of additional MFP payments that FSA distributed for 2019 varied by location. Farming operations in five states—Texas, Illinois, Iowa, Missouri, and Minnesota—received almost half of all additional payments. In May 2019, USDA announced it would distribute up to $14.5 billion in direct payments to farming operations that were affected by trade disruptions, following the approximately $8.6 billion USDA announced it had distributed for 2018. USDA referred to these 2018 and 2019 payments as the MFP. In comparison with 2018, USDA changed the 2019 payment structure for the three types of commodities that were eligible for payments. For example, USDA increased the payment limit for each of these three types. GAO was asked to review the distribution of MFP payments for 2019. This report examines, among other things, MFP payments for 2019 and how they varied by location, farming operation, and type of commodity, as well as additional MFP payments for 2019 compared with 2018 that resulted from increased payment limits. To accomplish these objectives, GAO analyzed data from USDA and interviewed agency officials knowledgeable about the data. For more information, contact Steve Morris at (202) 512-3841 or morriss@gao.gov.
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  • VA Health Care: Actions Needed to Improve Oversight of Graduate Medical Education Reimbursement
    In U.S GAO News
    The Department of Veterans Affairs' (VA) Veterans Health Administration (VHA) provides training to more than 45,000 medical and dental residents annually through its Graduate Medical Education (GME) program. VHA has established policy for its GME program that details many roles and responsibilities for overseeing VA medical facilities' reimbursements to affiliated academic institutions for residents' salaries and benefits. However, this policy does not define key roles and responsibilities for VHA's central office components, its regional networks, or its medical facilities. For example, VHA's regional networks do not have defined roles and responsibilities for overseeing GME disbursements—contributing to noninvolvement or inconsistent involvement in disbursement agreement oversight. VHA officials reported that they are in the process of updating disbursement agreement policy, but did not indicate if the updates would address all identified concerns. While VHA officials said that VHA's two disbursement agreement oversight mechanisms—facility periodic audits and the Resident Disbursement Audit Process (ReDPro) checklist—are meant to have distinct but complementary purposes, GAO found that VHA policy, guidance, and the tools distributed for these oversight mechanisms did not reflect the distinct purposes officials described. VHA officials said that periodic audits are intended to be a first level of defense and to review actual payments to affiliates, whereas the ReDPro checklist is intended to be a second level of defense, aimed at reviewing the process to see if the rules related to disbursement agreements are being followed by VA medical facilities. However, the ReDPro checklist tool and VHA's recommended periodic audit tool have numerous areas of overlap, including duplicative questions. This overlap causes inefficiencies and unnecessary burden on VA medical facility staff. GAO also found additional weaknesses in the tools, guidance, and training for the two oversight mechanisms. For example, GAO found an unclear ReDPro checklist tool, along with insufficient guidance and training related to conducting the ReDPro reviews. Officials from eight of 13 facilities in GAO's review indicated that the ReDPro checklist instructions were unclear regarding appropriate supporting documents for checklist responses. These weaknesses contributed to errors and inconsistencies in ReDPro responses. the lack of a standard audit tool, and inadequate guidance and training for periodic audit teams that contributed to problematic inconsistencies in the methodologies used by the audit teams and deficiencies in some of the audits conducted. Officials from 10 of 13 facilities in GAO's review indicated that they would benefit from more tools, guidance, or training related to conducting periodic audits. These weaknesses limit the effectiveness of VHA's oversight mechanisms, and put VHA at increased risk of both not being able to identify and correct facilities' lack of adherence to disbursement agreement policy and of possible improper payments to GME affiliates. Under VHA's GME program, VA medical facilities use disbursement agreements to reimburse affiliated academic institutions for residents' salaries and benefits. VHA developed policy related to establishing and administering disbursement agreements, but audits have found that facilities have not always adhered to VHA policy—resulting in improper payments to affiliates. GAO was asked to review VHA policies and procedures related to reimbursements to affiliates for GME. This report examines (1) oversight roles and responsibilities for GME disbursement agreements and (2) VHA's mechanisms for ensuring VA medical facilities adhere to policy. GAO reviewed relevant VHA documents and federal internal control standards and interviewed VHA officials. GAO also reviewed ReDPro checklist responses and documentation from 13 VA medical facilities—selected based on factors including geographic variation, GME program size, and number of affiliates. GAO also visited four of the 13 facilities and interviewed officials at the other nine facilities. GAO is making seven recommendations to VA to define key roles in policy, reduce overlap between the ReDPro checklist and facility periodic audits, and improve the oversight mechanisms' tools, guidance, and training. VA concurred with GAO's recommendations. For more information, contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov.
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  • Drinking Water: EPA Could Use Available Data to Better Identify Neighborhoods at Risk of Lead Exposure
    In U.S GAO News
    GAO's statistical analysis indicates that areas with older housing and vulnerable populations (e.g., families in poverty) have higher concentrations of lead service lines in the selected cities GAO examined. By using geospatial lead service line data from the selected water systems and geospatial data from the U.S. Census Bureau's American Community Survey (ACS), GAO identified characteristics of neighborhoods with higher concentrations of lead service lines. The Environmental Protection Agency's (EPA) guidance for water systems on how to identify the location of sites at high-risk of having lead service lines has not been updated since 1991 and many water systems face challenges identifying areas at risk of having lead service lines. By developing guidance for water systems that outlines methods for identifying high-risk locations using publicly available data, EPA could better ensure that public water systems test water samples from locations at greater risk of having lead service lines and identify areas with vulnerable populations to focus lead service line replacement efforts. (See figure for common sources of lead in home drinking water.) Common Sources of Lead in Drinking Water within Homes and Residences EPA has taken some actions to address the Water Infrastructure Improvements for the Nation (WIIN) Act requirement, which include developing a strategic plan regarding lead in public water systems. However, EPA's published plan did not satisfy the statutory requirement that the agency's strategic plan address targeted outreach, education, technical assistance, and risk communication undertaken by EPA, states, and public water systems. For example, the plan does not discuss public education, technical assistance or risk communication. Instead, EPA's plan focused solely on how to notify households when EPA learns of certain exceedances of lead in their drinking water. Moreover, EPA's plan is not consistent with leading practices for strategic planning. For example, EPA's plan does not set a mission statement or define long-term goals. Developing a strategic plan that meets the statutory requirement and fully reflects leading practices for strategic planning would give EPA greater assurance that it has effectively planned for how it will communicate the risks of lead in drinking water to the public. Lead in drinking water comes primarily from corrosion of service lines connecting the water main to a house or building, pipes inside a building, or plumbing fixtures. As GAO reported in September 2018, the total number of lead service lines in drinking water systems is unknown, and less than 20 of the 100 largest water systems have such data publicly available. GAO was asked to examine the actions EPA and water systems are taking to educate the public on the risks of lead in drinking water. This report examines, among other things: (1) the extent to which neighborhood data on cities served by lead service lines can be used to focus lead reduction efforts; and (2) actions EPA has taken to address WIIN Act requirements, and EPA's risk communication documents. GAO conducted a statistical analysis combining geospatial lead service line and ACS data to identify characteristics of selected communities; reviewed legal requirements and EPA documents; and interviewed EPA officials. GAO is making four recommendations, including that EPA develop (1) guidance for water systems on lead reduction efforts, and (2) a strategic plan that meets the WIIN Act requirement. EPA agreed with one recommendation and disagreed with the others. GAO continues to believe the recommendations are warranted, as discussed in the report. For more information, contact J. Alfredo Gómez at (202) 512-3841 or gomezj@gao.gov.
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  • Veterans Community Care Program: Improvements Needed to Help Ensure Timely Access to Care
    In U.S GAO News
    The Department of Veterans Affairs (VA) established an appointment scheduling process for the Veterans Community Care Program (VCCP) that allows up to 19 days to complete several steps from VA providers creating a referral to community care staff reviewing that referral. However, as the figure shows, VA has not specified the maximum amount of time veterans should have to wait to receive care through the program. GAO previously recommended in 2013 the need for an overall wait-time measure for veterans to receive care under a prior VA community care program. Subsequent to VA not implementing this recommendation, GAO again recommended in 2018 that VA establish an achievable wait-time goal as part of its new community care program (the VCCP). Potential Allowable Wait Time to Obtain Care through the Veterans Community Care Program Note: This figure illustrates potential allowable wait times in calendar days for eligible veterans who are referred to the VCCP through routine referrals (non-emergent), and have VA medical center staff—Referral Coordination Team (RCT) and community care staff (CC staff)—schedule the appointments on their behalf. VA has not yet implemented GAO's 2018 recommendation that VA establish an achievable wait-time goal. Under the VA MISSION Act, VA is assigned responsibility for ensuring that veterans' appointments are scheduled in a timely manner—an essential component of quality health care. Given VA's lack of action over the prior 7 years implementing wait-time goals for various community care programs, congressional action is warranted to help achieve timely health care for veterans. Regarding monitoring of the initial steps of the scheduling process, GAO found that VA is using metrics that are remnants from the previous community care program, which are inconsistent with the time frames established in the VCCP scheduling process. This limits VA's ability to determine the effectiveness of the VCCP and to identify areas for improvement. In June 2019, VA implemented its new community care program, the VCCP, as required by the VA MISSION Act of 2018. Under the VCCP, VAMC staff are responsible for community care appointment scheduling; their ability to execute this new responsibility has implications for veterans receiving community care in a timely manner. GAO was asked to review VCCP appointment scheduling. This report examines, among other issues, the VCCP appointment scheduling process VA established and VA's monitoring of that process. GAO reviewed documentation, such as scheduling policies, and referral data related to the VCCP and assessed VA's relevant processes. GAO conducted site visits to five VAMCs in the first region to transition to VA's new provider network, and interviewed VAMC staff and a non-generalizable sample of community providers receiving referrals from those VAMCs. GAO also interviewed VA and contractor officials. GAO recommends that Congress consider requiring VA to establish an overall wait-time measure for the VCCP. GAO is also making three recommendations to VA, including that it align its monitoring metrics with the VCCP appointment scheduling process. VA did not concur with one of GAO's recommendations related to aligning monitoring metrics to VCCP scheduling policy time frames. GAO continues to believe this recommendation is valid, as discussed in the report. For more information, contact Sharon M. Silas at (202) 512-7114 or silass@gao.gov.
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  • COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations
    In U.S GAO News
    Through Operation Warp Speed—a partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DOD)—the federal government is accelerating efforts to develop vaccines and therapeutics for COVID-19. A typical vaccine development process can take approximately 10 years or longer, but efforts under Operation Warp Speed seek to greatly accelerate this process by completing key steps simultaneously (see figure). As of October 15, 2020, Operation Warp Speed publicly announced financial support for the development or manufacturing of six COVID-19 vaccine candidates totaling more than $10 billion in obligations. It has also announced financial support for the development of therapeutics, such as a $450 million award to manufacture a monoclonal antibody treatment (a treatment that uses laboratory-made antibodies, which also may be able to serve as a prevention option). Operation Warp Speed Timeline for a Potential Vaccine Candidate Note: An Emergency Use Authorization allows for emergency use of medical products without FDA approval or licensure during a declared emergency, provided certain statutory criteria are met. The Food and Drug Administration (FDA) may temporarily allow the use of unlicensed or unapproved COVID-19 vaccines and therapeutics through emergency use authorizations (EUA), provided there is evidence that the products may be effective and that known and potential benefits outweigh known and potential risks. For vaccines, FDA issued guidance in October 2020 to provide vaccine sponsors with recommendations regarding the evidence FDA needed to support issuance of an EUA. For therapeutics, FDA has issued four EUAs as of November 9, 2020. The evidence to support FDA's COVID-19 therapeutic authorization decisions has not always been transparent, in part because FDA does not uniformly disclose its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics. Given the gravity of the pandemic, it is important that FDA identify ways to uniformly disclose this information to the public. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions. The U.S. had about 10.3 million cumulative reported cases of COVID-19 and about 224,000 reported deaths as of November 12, 2020. Given this catastrophic loss of life as well as the pandemic's effects on the U.S. economy, effective and safe vaccines and therapeutics are more important than ever. 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, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA's use of EUAs for COVID-19 therapeutics and vaccines, among other objectives. GAO reviewed federal laws and agency documents, including HHS and DOD information on vaccine and therapeutic development and EUAs as of November 2020. GAO interviewed or received written responses from HHS and DOD officials, and interviewed representatives from vaccine developers and manufacturers, as well as select public health stakeholders and provider groups covering a range of provider types. FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. HHS neither agreed nor disagreed with the recommendation, but said it shared GAO's goal of transparency and would explore approaches to achieve this goal. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov, or Alyssa M. Hundrup at (202) 512-7114 or hundrupa@gao.gov.
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  • Cybersecurity: Clarity of Leadership Urgently Needed to Fully Implement the National Strategy
    In U.S GAO News
    Federal entities have a variety of roles and responsibilities for supporting efforts to enhance the cybersecurity of the nation. Among other things, 23 federal entities have roles and responsibilities for developing policies, monitoring critical infrastructure protection efforts, sharing information to enhance cybersecurity across the nation, responding to cyber incidents, investigating cyberattacks, and conducting cybersecurity-related research. To fulfill their roles and responsibilities, federal entities identified activities undertaken in support of the nation's cybersecurity. For example, National Security Council (NSC) staff, on behalf of the President, and the National Institute of Standards and Technology, have developed policies, strategies, standards, and plans to guide cybersecurity efforts. The Department of Homeland Security has helped secure the nation's critical infrastructure through developing security policy and coordinating security initiatives, among other efforts. Other agencies have established initiatives to gather intelligence and share actual or possible cyberattack information. Multiple agencies have mechanisms in place to assist in responding to cyberattacks, and law enforcement components, including the Federal Bureau of Investigation, are responsible for investigating them. The White House's September 2018 National Cyber Strategy and the NSC's accompanying June 2019 Implementation Plan detail the executive branch's approach to managing the nation's cybersecurity. When evaluated together, these documents addressed several of the desirable characteristics of national strategies, but lacked certain key elements for addressing others. National Cyber Strategy and Implementation Plan are Missing Desirable Characteristics of a National Strategy Characteristic Cyber Strategy and Plan Coverage of Issue Purpose, scope, and methodology Addressed Organizational roles, responsibilities, and coordination Addressed Integration and implementation Addressed Problem definition and risk assessment Did not fully address Goals, subordinate objectives, activities, and performance measures Did not fully address Resources, investments, and risk management Did not fully address Source: GAO analysis of 2018 National Cyber Strategy and 2019 Implementation Plan . | GAO-20-629 For example, the Implementation Plan details 191 activities that federal entities are to undertake to execute the priority actions outlined in the National Cyber Strategy. These activities are assigned a level, or tier, based on the coordination efforts required to execute the activity and the extent to which NSC staff is expected to be involved. Thirty-five of these activities are designated as the highest level (tier 1), and are coordinated by a functional entity within the NSC . Ten entities are assigned to lead or co-lead these critical activities while also tasked to lead or co-lead lower tier activities. Leadership Roles for Federal Entities Assigned as Leads or Co-Leads for National Cyber Strategy Implementation Plan Activities Entity Tier 1 Activities Tier 2 Activities Tier 3 Activities National Security Council 15 7 3 Department of Homeland Security 14 19 15 Office of Management and Budget 7 6 5 Department of Commerce 5 9 35 Department of State 2 5 11 Department of Defense 1 6 17 Department of Justice 1 10 5 Department of Transportation 1 0 5 Executive Office of the President 1 0 0 General Services Administration 1 2 1 Source: GAO analysis of 2018 National Cyber Strategy and 2019 Implementation Plan . | GAO-20-629 Although the Implementation Plan defined the entities responsible for leading each of the activities; it did not include goals and timelines for 46 of the activities or identify the resources needed to execute 160 activities. Additionally, discussion of risk in the National Cyber Strategy and Implementation Plan was not based on an analysis of threats and vulnerabilities. Further, the documents did not specify a process for monitoring agency progress in executing Implementation Plan activities. Instead, NSC staff stated that they performed periodic check-ins with responsible entities, but did not provide an explanation or definition of specific level of NSC staff involvement for each of the three tier designations. Without a consistent approach to engaging with responsible entities and a comprehensive understanding of what is needed to implement all 191 activities, the NSC will face challenges in ensuring that the National Cyber Strategy is efficiently executed. GAO and others have reported on the urgency and necessity of clearly defining a central leadership role in order to coordinate the government's efforts to overcome the nation's cyber-related threats and challenges. The White House identified the NSC staff as responsible for coordinating the implementation of the National Cyber Strategy . However, in light of the elimination of the White House Cybersecurity Coordinator position in May 2018, it remains unclear which official ultimately maintains responsibility for not only coordinating execution of the Implementation Plan , but also holding federal agencies accountable once activities are implemented. NSC staff stated responsibility for duties previously attributed to the White House Cyber Coordinator were passed to the senior director of NSC's Cyber directorate; however, the staff did not provide a description of what those responsibilities include. NSC staff also stated that federal entities are ultimately responsible for determining the status of the activities that they lead or support and for communicating implementation status to relevant NSC staff. However, without a clear central leader to coordinate activities, as well as a process for monitoring performance of the Implementation Plan activities, the White House cannot ensure that entities are effectively executing their assigned activities intended to support the nation's cybersecurity strategy and ultimately overcome this urgent challenge. Increasingly sophisticated cyber threats have underscored the need to manage and bolster the cybersecurity of key government systems and the nation's cybersecurity. The risks to these systems are increasing as security threats evolve and become more sophisticated. GAO first designated information security as a government-wide high-risk area in 1997. This was expanded to include protecting cyber critical infrastructure in 2003 and protecting the privacy of personally identifiable information in 2015. In 2018, GAO noted that the need to establish a national cybersecurity strategy with effective oversight was a major challenge facing the federal government. GAO was requested to review efforts to protect the nation's cyber critical infrastructure. The objectives of this report were to (1) describe roles and responsibilities of federal entities tasked with supporting national cybersecurity, and (2) determine the extent to which the executive branch has developed a national strategy and a plan to manage its implementation. To do so, GAO identified 23 federal entities responsible for enhancing the nation's cybersecurity. Specifically, GAO selected 13 federal agencies based on their specialized or support functions regarding critical infrastructure security and resilience, and 10 additional entities based on analysis of its prior reviews of national cybersecurity, relevant executive policy, and national strategy documents. GAO also analyzed the National Cyber Strategy and Implementation Plan to determine if they aligned with the desirable characteristics of a national strategy. GAO is making one matter for congressional consideration, that Congress should consider legislation to designate a leadership position in the White House with the commensurate authority to implement and encourage action in support of the nation's cybersecurity. GAO is also making one recommendation to the National Security Council to work with relevant federal entities to update cybersecurity strategy documents to include goals, performance measures, and resource information, among other things. The National Security Council neither agreed nor disagreed with GAO's recommendation. For more information, contact Nick Marinos at (202) 512-9342 or marinosn@gao.gov.
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    In U.S GAO News
    Why This Matters Agile software development has the potential to save the federal government billions of dollars and significant time, allowing agencies to deliver software more efficiently and effectively for American taxpayers. However, the transition to Agile requires an investment in new tools and processes, which can be costly and time consuming. The Methodology What is it? Agile is an approach to software development that encourages collaboration across an organization and allows requirements to evolve as a program progresses. Agile software development emphasizes iterative delivery; that is, the development of software in short, incremental stages. Customers continuously provide feedback on the software's functionality and quality. By engaging customers early and iterating often, agencies that adopt Agile can also reduce the risks of funding failing programs or outdated technology. Figure 1. Cycle of Agile software development How does it work? Agile software development is well suited for programs where the end goal is known, but specific details about their implementation may be refined along the way. Agile is implemented in different ways. For example, Scrum is a framework focused on teams, Scaled Agile Framework focuses on scaling Agile to larger groups, and DevOps extends the Agile principle of collaboration and unites the development and operation teams. Scrum, one of the most common Agile frameworks, organizes teams using defined roles, such as the product owner, who represents the customer, prioritizes work, and accepts completed software. In Scrum, development is broken down into timed iterations called sprints, where teams commit to complete specific requirements within a defined time frame. During a sprint, teams meet for daily stand-up meetings. At the end of a sprint, teams present the completed work to the product owner for acceptance. At a retrospective meeting following each sprint, team members discuss lessons learned and any changes needed to improve the process. Sprints allow for distinct, consistent, and measurable progress of prioritized software features. How mature is it? Organizations have used versions of incremental software development since the 1950s, with various groups creating Agile frameworks in the 1990s, including Scrum in 1995. In 2001, a group of software developers created the Agile Manifesto, which documents the guiding principles of Agile. Following this, Agile practitioners introduced new frameworks, such as Kanban, which optimizes work output by visualizing its flow. The Federal Information Technology Acquisition Reform Act (FITARA), enacted in 2014, includes a provision for the Office of Management and Budget to require the Chief Information Officers of covered agencies to certify that IT investments are adequately implementing incremental development. This development approach delivers capabilities more rapidly by dividing an investment into smaller parts. As a result, more agencies are now adopting an incremental, Agile, approach to software development. For example, in 2016, the Department of Homeland Security announced five Agile pilot programs. In 2020, at least 22 Department of Defense major defense acquisition programs reported using Agile development methods.  As the federal government continues to adopt Agile, effective oversight of these programs will be increasingly crucial. Our GAO Agile Assessment Guide, released in 2020, takes a closer look at the following categories of best practices: Agile adoption. This area focuses on team dynamics, program operations, and organization environments. One best practice for teams is to have repeatable processes in place such as continuous integration, which automates parts of development and testing. At the program operations level, staff should be appropriately trained in Agile methods. And at an organizational level, a best practice is to create a culture that supports Agile methods. Requirements development and management. Requirements—sometimes called user stories—are important in making sure the final product will function as intended. Best practices in this area include eliciting and prioritizing requirements and ensuring work meets those requirements. Acquisition strategy. Contractors may have a role in an Agile program in government. However, long timelines to award contracts and costly changes are major hurdles to executing Agile programs. One way to clear these hurdles is for organizations to create an integrated team with personnel from contracting, the program office, and software development. Clearly identifying team roles will alleviate bottlenecks in the development process. Figure 2. Different roles come together to make an Agile software development team. Program monitoring and control. Many Agile documents may be used to generate reliable cost and schedule estimates throughout a program’s life-cycle. Metrics. It is critical that metrics align with and prioritize organization-wide goals and objectives while simultaneously meeting customer needs. Such metrics in Agile include the number of features delivered to customers, the number of defects, and overall customer satisfaction.  Opportunities Flexibility. An Agile approach provides flexibility when customers’ needs change and as technology rapidly evolves. Risk reduction. Measuring progress during frequent iterations can reduce technical and programmatic risk. For example, routine retrospectives allow the team to reflect upon and improve the development process for the next iteration. Quicker deliveries. Through incremental releases, agencies can rapidly determine if newly produced software is meeting their needs. With Agile, these deliveries are typically within months, instead of alternative development methods, which can take years. Challenges GAO has previously reported on challenges the federal government faces in applying Agile methods; for the full report see GAO-12-681. Lack of organizational commitment. For example, organizations need to create a dedicated Agile team, which is a challenge when there is an insufficient number of staff, or when staff have several simultaneous duties. Resources needed to transition to Agile. An organization transitioning to Agile may need to invest in new tools, practices, and processes, which can be expensive and time consuming. Mistrust in iterative solutions. Customers who typically see a solution as a whole may be disappointed by the delivery of a small piece of functionality. Misaligned agency practices. Some agency practices, such as procurement, compliance reviews, federal reporting, and status tracking are not designed to support Agile software development. Policy and Context Questions In what ways can Agile help the federal government improve the management of IT acquisitions and operations, an area GAO has identified as high risk for the federal government? How can policymakers implement clear guidance about the use of Agile software development, such as reporting metrics, to better support Agile methods? How might resources need to shift to accommodate the adoption of Agile in federal agencies? What risks could those shifts pose? What updates to agency practices are worth pursuing to support Agile software development? For more information, contact Tim Persons at (202) 512-6888 or personst@gao.gov.
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