What GAO Found
F-35 mission capable rates—a measure of the readiness of an aircraft fleet—have recently improved, but still fall short of warfighter requirements, as discussed in our draft report. Specifically, from fiscal year 2019 to fiscal year 2020, the U.S. F-35 fleet’s average annual (1) mission capable rate—the percentage of time during which the aircraft can fly and perform one of its tasked missions—improved from 59 to 69 percent; and (2) full mission capable rate—the percentage of time during which the aircraft can perform all of its tasked missions—improved from 32 to 39 percent. Both metrics fall below the services’ objectives. For example, in fiscal year 2020 the Air Force F-35A full mission capable rate was 54 percent, versus a 72 percent objective.
Since 2012, F-35 estimated sustainment costs over its 66-year life cycle have increased steadily, from $1.11 trillion to $1.27 trillion, despite efforts to reduce costs. The services face a substantial and growing gap between estimated sustainment costs and affordability constraints—i.e., costs per tail (aircraft) per year that the services project they can afford—totaling about $6 billion in 2036 alone (see fig.). The services will collectively be confronted with tens of billions of dollars in sustainment costs that they project as unaffordable during the program.
Gap between F-35 Affordability Constraints and Estimated Sustainment Costs in 2036
Note: Costs are in constant year 2012 dollars as that was the year when the F-35 program was most recently re-baselined.
aSteady state years for the F-35 program are defined in each respective service’s affordability analysis as: US Air Force/F-35A – 2036-2041; US Marine Corps/F-35B – 2033-2037; US Navy/F-35C – 2036-2043. Steady state refers to the program’s peak operating point.
The Air Force needs to reduce estimated costs per tail per year by $3.7 million (or 47 percent) by 2036 or it will incur $4.4 billion in costs beyond what it currently projects it could afford in that year alone. Cost reductions become increasingly difficult as the program grows and matures. However, GAO found there is no agreed upon approach to achieve the constraints. Without an assessment of cost-reduction efforts and program requirements (such as number of planned aircraft), along with a plan, the Department of Defense (DOD) may continue to invest resources in a program it ultimately cannot afford. Congress requiring DOD to report on its progress in achieving affordability constraints and making F-35 procurements contingent on DOD’s demonstrated progress would enhance DOD’s accountability for taking the necessary and appropriate actions to afford sustaining the F-35 fleet.
Why GAO Did This Study
The F-35 aircraft with its advanced capabilities represents a growing portion of DOD’s tactical aviation fleet—with the Air Force, Marine Corps, and Navy currently flying about 400 of the aircraft. It is also DOD’s most ambitious and costly weapon system in history, with estimated life-of-program costs exceeding $1.7 trillion. DOD plans to procure nearly 2,500 F-35s at an estimated total acquisition cost of just under $400 billion. The remaining $1.3 trillion in life cycle costs is associated with operating and sustaining the aircraft.
This statement, among other things, assesses the extent to which (1) the F-35 has met warfighter-required mission capable rates; and (2) DOD has reduced the F-35’s estimated life cycle sustainment costs and made progress in meeting its affordability constraints. This statement is largely based on GAO’s draft report, which was provided to DOD in March for review and comment. For that report and this statement, GAO reviewed program documentation, analyzed performance and cost data, collected data from F-35 locations, and interviewed officials.
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Vaccine Platform Technologies Supported by Operation Warp Speed, as of January 2021 As of January 30, 2021, five of the six OWS vaccine candidates have entered phase 3 clinical trials, two of which—Moderna's and Pfizer/BioNTech's vaccines—have received an emergency use authorization (EUA) from the Food and Drug Administration (FDA). For vaccines that received EUA, additional data on vaccine effectiveness will be generated from further follow-up of participants in clinical trials already underway before the EUA was issued. Technology readiness. GAO's analysis of the OWS vaccine candidates' technology readiness levels (TRL)—an indicator of technology maturity— showed that COVID-19 vaccine development under OWS generally followed traditional practices, with some adaptations. FDA issued specific guidance that identified ways that vaccine development may be accelerated during the pandemic. Vaccine companies told GAO that the primary difference from a non-pandemic environment was the compressed timelines. To meet OWS timelines, some vaccine companies relied on data from other vaccines using the same platforms, where available, or conducted certain animal studies at the same time as clinical trials. However, as is done in a non-pandemic environment, all vaccine companies gathered initial safety and antibody response data with a small number of participants before proceeding into large-scale human studies (e.g., phase 3 clinical trials). The two EUAs issued in December 2020 were based on analyses of clinical trial participants and showed about 95 percent efficacy for each vaccine. These analyses included assessments of efficacy after individuals were given two doses of vaccine and after they were monitored for about 2 months for adverse events. Manufacturing. As of January 2021, five of the six OWS vaccine companies had started commercial scale manufacturing. OWS officials reported that as of January 31, 2021, companies had released 63.7 million doses—about 32 percent of the 200 million doses that, according to OWS, companies with EUAs have been contracted to provide by March 31, 2021. Vaccine companies face a number of challenges in scaling up manufacturing to produce hundreds of millions of doses under OWS's accelerated timelines. DOD and HHS are working with vaccine companies to help mitigate manufacturing challenges, including: Limited manufacturing capacity: A shortage of facilities with capacity to handle the vaccine manufacturing needs can lead to production bottlenecks. Vaccine companies are working in partnership with OWS to expand production capacity. For example, one vaccine company told GAO that HHS's Biomedical Advanced Research and Development Authority helped them identify an additional manufacturing partner to increase production. Additionally, the U.S. Army Corps of Engineers is overseeing construction projects to expand capacity at vaccine manufacturing facilities. Disruptions to manufacturing supply chains: Vaccine manufacturing supply chains have been strained by the global demand for certain goods and workforce disruptions caused by the global pandemic. For example, representatives from one facility manufacturing COVID-19 vaccines stated that they experienced challenges obtaining materials, including reagents and certain chemicals. They also said that due to global demand, they waited 4 to 12 weeks for items that before the pandemic were typically available for shipment within one week. Vaccine companies and DOD and HHS officials told GAO they have undertaken several efforts to address possible manufacturing disruptions and mitigate supply chain challenges. These efforts include federal assistance to (1) expedite procurement and delivery of critical manufacturing equipment, (2) develop a list of critical supplies that are common across the six OWS vaccine candidates, and (3) expedite the delivery of necessary equipment and goods coming into the United States. Additionally, DOD and HHS officials said that as of December 2020 they had placed prioritized ratings on 18 supply contracts for vaccine companies under the Defense Production Act, which allows federal agencies with delegated authority to require contractors to prioritize those contracts for supplies needed for vaccine production. Gaps in the available workforce: Hiring and training personnel with the specialized skills needed to run vaccine manufacturing processes can be challenging. OWS officials stated that they have worked with the Department of State to expedite visa approval for key technical personnel, including technicians and engineers to assist with installing, testing, and certifying critical equipment manufactured overseas. OWS officials also stated that they requested that 16 DOD personnel be detailed to serve as quality control staff at two vaccine manufacturing sites until the organizations can hire the required personnel. As of February 5, 2021, the U.S. had over 26 million cumulative reported cases of COVID-19 and about 449,020 reported deaths, according to the Centers for Disease Control and Prevention. The country also continues to experience serious economic repercussions, with the unemployment rate and number of unemployed in January 2021 at nearly twice their pre-pandemic levels in February 2020. In May 2020, OWS was launched and included a goal of producing 300 million doses of safe and effective COVID-19 vaccines with initial doses available by January 2021. Although FDA has authorized two vaccines for emergency use, OWS has not yet met its production goal. Such vaccines are crucial to mitigate the public health and economic impacts of the pandemic. GAO was asked to review OWS vaccine development efforts. This report examines: (1) the characteristics and status of the OWS vaccines, (2) how developmental processes have been adapted to meet OWS timelines, and (3) the challenges that companies have faced with scaling up manufacturing and the steps they are taking to address those challenges. GAO administered a questionnaire based on HHS's medical countermeasures TRL criteria to the six OWS vaccine companies to evaluate the COVID-19 vaccine development processes. GAO also collected and reviewed supporting documentation on vaccine development and conducted interviews with representatives from each of the companies on vaccine development and manufacturing. For more information, contact Karen L. Howard and Candice N. Wright at (202) 512-6888 or email@example.com or firstname.lastname@example.org.[Read More…]
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- Combating Wildlife Trafficking: Agencies Work to Address Human Rights Abuse Allegations in Overseas Conservation ProgramsBy Sam NewsOctober 2, 2020U.S. agencies primarily use Leahy vetting as the enforcement mechanism to prevent U.S. funding for combating wildlife trafficking from supporting human rights abuses. Statutory provisions commonly referred to as "Leahy Laws" prohibit the U.S. government from using certain funds to assist units of foreign security forces where there is credible information they have committed a gross violation of human rights. The Department of State (State) and the U.S. Agency for International Development (USAID) generally consider park rangers to be foreign security forces that are authorized to search, detain, arrest, or use force against people, and thus subject to Leahy vetting, according to agency officials. State or USAID may provide funding to the Department of the Interior's Fish and Wildlife Service (FWS) that it then uses to support park ranger activities. In those instances, FWS submits the candidates' applications to State for Leahy vetting. According to a State official, Leahy approval of a security force unit is good for 1 year, and State must vet individuals again if their unit continues to receive support from State or USAID funding sources. Both U.S. agencies and implementing partners took a variety of steps in response to recent allegations of human rights abuses by overseas park rangers. For example, a State official in the Central Africa region told GAO that while the Democratic Republic of the Congo embassy's vetting program has very strict control mechanisms, the International Narcotics and Law Enforcement Affairs Bureau requested quarterly reports to facilitate a review of all assistance to park rangers to ensure that any reported activities were vetted according to Leahy Laws. USAID officials told GAO that in addition to continuing Leahy vetting, the agency's response included strengthening human rights training and conducting a site visit to a park in the DRC where human rights abuses had allegedly occurred. According to officials, the visit involved speaking with beneficiaries to further understand the allegations and efforts to assess root causes, mitigate impacts, and stop future occurrences, including making referrals to appropriate law enforcement authorities if warranted. FWS officials also stated that they take seriously allegations that U.S implementing partners have supported park rangers who have committed human rights abuses. Since June 2019, the Department of the Interior has approved no new awards to the World Wildlife Fund (WWF)—one of the implementing partners which has supported park rangers alleged to have committed human rights abuses. Moreover, the International Affairs program within FWS has put all new funding on hold since September 2019, pending a departmental review. Agencies are also implementing various changes in response to congressional directives on safeguarding human rights. For example, State officials told GAO that they have added language to all notices for countering wildlife trafficking awards that requires implementing partners to include social safeguards plans in their projects. The plans will articulate an understanding of how their work could negatively affect local communities. USAID officials stated that USAID has included provisions in new agreements with FWS that require adherence to the congressional directives. FWS officials also confirmed that they are cooperating with USAID in these efforts. Implementing partners—WWF, the Wildlife Conservation Society (WCS), and African Parks (AP)—have all conducted investigations to address allegations of human rights abuses by park rangers, according to officials from these organizations. They have also developed grievance mechanisms to report human rights abuses. For example, WWF has received 50 complaints in roughly the past year related to its project work, according to WWF representatives. WWF has responded to complaints of human rights abuses through this mechanism by reporting the allegations to relevant authorities and meeting with community representatives. U.S. agencies provide training and equipment for park rangers overseas to combat wildlife trafficking. From fiscal years 2014 through 2020, the U.S. government provided approximately $554 million to undertake a range of activities through federal agencies and in cooperation with implementing partner organizations in the field. Multiple non-governmental organization and media reports, however, have alleged that organizations that have received U.S. funds have supported park rangers engaged in combating wildfire trafficking who have committed human rights violations since the mid-2000s. GAO was asked to review human rights protection mechanisms related to U.S. efforts to combat wildlife trafficking. This report examines 1) what enforcement mechanisms agencies have to prevent U.S. funded efforts to combat wildlife trafficking from supporting human rights abuses and how they implement them, and 2) how agencies and implementing partners address allegations of human rights abuses. GAO spoke with agency officials and implementing partner representatives locally in person and overseas by phone, and collected and analyzed information related to program implementation. For more information, contact Kimberly Gianopoulos at (202) 512-8612 or email@example.com.[Read More…]
- Acting Assistant Attorney General Brian Rabbitt Delivers Remarks at the PPP Criminal Fraud Enforcement Action Press ConferenceBy Sam NewsSeptember 10, 2020Over the course of the past six months, the COVID-19 pandemic has wreaked havoc across our country and presented unprecedented challenges for ordinary Americans from all walks of life.[Read More…]
- Owner of Bitcoin Exchange Sentenced to Prison for Money LaunderingBy Sam NewsJanuary 12, 2021A Bulgarian national who was convicted by a federal jury for his role in a transnational and multimillion-dollar scheme to defraud American victims was sentenced today to 121 months in prison.[Read More…]
- Two Owners of New York Pharmacies Charged in a $30 Million COVID-19 Health Care Fraud and Money Laundering CaseBy Sam NewsDecember 21, 2020The owners of over a dozen New York-area pharmacies were charged in an indictment unsealed today for their roles in a $30 million health care fraud and money laundering scheme, in which they exploited emergency codes and edits in the Medicare system that went into effect due to the COVID-19 pandemic in order to submit fraudulent claims for expensive cancer drugs that were never provided, ordered, or authorized by medical professionals.[Read More…]
- Science & Tech Spotlight: Contact Tracing AppsBy Sam NewsJuly 30, 2020Why This Matters Contact tracing can help reduce transmission rates for infectious diseases like COVID-19 by identifying and notifying people who may have been exposed. Contact tracing apps, notably those using proximity tracing, could expedite such efforts. However, there are challenges, including accuracy, adoption rates, and privacy concerns. The Technology What is it? Contact tracing is a process in which public health officials attempt to limit disease transmission by identifying infected individuals, notifying their "contacts"—all the people they may have transmitted the disease to—and asking infected individuals and their contacts to quarantine, if appropriate (see fig. 1). For a highly contagious respiratory disease such as COVID-19, a contact could be anyone who has been nearby. Proximity tracing applications (apps) can expedite contact tracing, using smartphones to rapidly identify and notify contacts. Figure 1. A simplified depiction of disease transmission. Through contact tracing, an infected individual’s contacts are notified and may be asked to quarantine. (In reality, some contacts may not become infected, and some of those infected may not show symptoms.) How does it work? In traditional contact tracing, public health officials begin by identifying an infected individual. They then interview the individual to identify recent contacts, ask the individual and their contacts to take containment measures, if appropriate (e.g., a 14-day quarantine for COVID-19), and coordinate any needed care and testing. Proximity tracing apps may accelerate the process by replacing the time-consuming interviews needed to identify contacts. Apps may also identify more contacts than interviews, which rely on interviewees' recall and on their being acquainted with their contacts. Public health authorities provide the apps, often using systems developed by companies or research groups. Users voluntarily download the app for their country or region and opt in to contact tracing. In the U.S., state or local public health authorities would likely implement proximity tracing apps. Proximity tracing apps detect contacts using Bluetooth, GPS, or a combination of both. Bluetooth-based apps rely on anonymous codes shared between smartphones during close encounters. These codes contain no information about location or user identity, helping safeguard privacy. The apps allow public health authorities to set a minimum time and distance threshold for someone to count as a contact. Contact tracing can be centralized or decentralized. With a centralized approach, contacts identified by the app are often saved to a government server, and an official notifies contacts of possible exposure. For a decentralized approach, contact data are typically stored on the user's device at first. When a user voluntarily reports infection, the user's codes are uploaded to a database that other app users' phones search. Users who have encountered the infected person then receive notifications through the app (see fig. 2). Figure 2. Bluetooth-based proximity tracing apps exchange information, notify contacts exposed to an infected person, and provide follow-up information. How mature is it? Traditional contact tracing is well established and has been an effective infectious disease response strategy for decades. Proximity tracing apps are relatively new and not as well established. Their contact identifications could become more accurate as developers improve app technology, for example by improving Bluetooth signal interpretation or using information from other phone sensors. Opportunities Reach more people. For accurate COVID-19 contact tracing using traditional methods, public health experts have estimated that the U.S. would require hundreds of thousands of trained contact tracers because of the large number of infections. Proximity tracing apps can expedite and automate identification and notification of the contacts, reducing this need. Faster response. Proximity tracing apps could slow the spread of disease more effectively because they can identify and notify contacts as soon as a user reports they are infected. More complete identification of contacts. Proximity tracing apps, unlike traditional contact tracing, do not require users to recall or be acquainted with people they have recently encountered. Challenges Technology. Technological limitations may lead to missed contacts or false identification of contacts. For example, GPS-based apps may not identify precise locations, and Bluetooth apps may ignore barriers preventing exposure, such as walls or protective equipment. In addition, apps may overlook exposure if two people were not in close enough proximity long enough for it to count as a contact. Adoption. Lower adoption rates make the apps less effective. In the U.S., some states may choose not to use proximity tracing apps. In addition, the public may hesitate to opt in because of concerns about privacy and uncertainty as to how the data may be used. Recent scams using fake contact tracing to steal information may also erode trust in the apps. Interoperability. Divergent app designs may lead to the inability to exchange data between apps, states, and countries, which could be a problem as travel restrictions are relaxed. Access. Proximity tracing apps require regular access to smartphones and knowledge about how to install and use apps. Some vulnerable populations, including seniors, are less likely to own smartphones and use apps, possibly affecting adoption. Policy Context and Questions Although proximity tracing apps are relatively new, they have the potential to help slow disease transmission. But policymakers will need to consider how great the benefits are likely to be, given the challenges. If policymakers decide to use proximity tracing apps, they will need to integrate them into the larger public health response and consider the following questions, among others: What steps can policymakers take to build public trust and encourage communities to support and use proximity tracing apps, and mitigate lack of adoption by some populations? What legal, procedural, privacy, security, and technical safeguards could protect data collected through proximity tracing apps? What can policymakers do to improve coordination of contact tracing efforts across local, state, and international jurisdictions? What can policymakers do to expedite testing and communication of test results to maximize the benefits of proximity tracing apps? What can policymakers do to ensure that contact identification is accurate and that its criteria are based on scientific evidence? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.[Read More…]
- Wife of “El Chapo” Arrested on International Drug Trafficking ChargesBy Sam NewsFebruary 22, 2021The wife of Joaquin “El Chapo” Guzman Loera, leader of a Mexican drug trafficking organization known as the Sinaloa Cartel, was arrested today in Virginia on charges related to her alleged involvement in international drug trafficking.[Read More…]