January 25, 2022

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Acting AG and Five Country Statement on the Temporary Derogation to the ePrivacy Directive to Combat Child Sexual Exploitation and Abuse

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<div>Acting Attorney General Jeffrey A. Rosen joined the Home Affairs, Interior, and Security Ministers of Australia, Canada, New Zealand, and the United Kingdom in issuing the following statement:</div>
Acting Attorney General Jeffrey A. Rosen joined the Home Affairs, Interior, and Security Ministers of Australia, Canada, New Zealand, and the United Kingdom in issuing the following statement:

More from: January 12, 2021

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    Operation Warp Speed (OWS)—a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD)—aimed to help accelerate the development of a COVID-19 vaccine. GAO found that OWS and vaccine companies adopted several strategies to accelerate vaccine development and mitigate risk. For example, OWS selected vaccine candidates that use different mechanisms to stimulate an immune response (i.e., platform technologies; see figure). Vaccine companies also took steps, such as starting large-scale manufacturing during clinical trials and combining clinical trial phases or running them concurrently. Clinical trials gather data on safety and efficacy, with more participants in each successive phase (e.g., phase 3 has more participants than phase 2). 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 howardk@gao.gov or wrightc@gao.gov.
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    Fifth-generation (5G) wireless networks promise to provide significantly greater speeds and higher capacity to accommodate more devices. In addition, 5G networks are expected to be more flexible, reliable, and secure than existing cellular networks. The figure compares 4G and 5G performance goals along three of several performance measures. Note: Megabits per second (Mbps) is a measure of the rate at which data is transmitted, milliseconds (ms) is a measure of time equal to one thousandth of a second, and square kilometer (km²) is a measure of area. As with previous generations of mobile wireless technology, the full performance of 5G will be achieved gradually as networks evolve over the next decade. Deployment of 5G network technologies in the U.S. began in late 2018, and these initial 5G networks focus on enhancing mobile broadband. These deployments are dependent on the existing 4G core network and, in many areas, produced only modest performance improvements. To reach the full potential of 5G, new technologies will need to be developed. International bodies that have been involved in defining 5G network specifications will need to develop additional 5G specifications and companies will need to develop, test, and deploy these technologies. GAO identified the following challenges that can hinder the performance or usage of 5G technologies in the U.S. GAO developed six policy options in response to these challenges, including the status quo. They are presented with associated opportunities and considerations in the following table. The policy options are directed toward the challenges detailed in this report: spectrum sharing, cybersecurity, privacy, and concern over possible health effects of 5G technology. Policy options to address challenges to the performance or usage of U.S. 5G wireless networks Policy Option Opportunities Considerations Spectrum-sharing technologies (report p. 47) Policymakers could support research and development of spectrum sharing technologies. Could allow for more efficient use of the limited spectrum available for 5G and future generations of wireless networks. It may be possible to leverage existing 5G testbeds for testing the spectrum sharing technologies developed through applied research. Research and development is costly, must be coordinated and administered, and its potential benefits are uncertain. Identifying a funding source, setting up the funding mechanism, or determining which existing funding streams to reallocate will require detailed analysis. Coordinated cybersecurity monitoring (report p. 48) Policymakers could support nationwide, coordinated cybersecurity monitoring of 5G networks. A coordinated monitoring program would help ensure the entire wireless ecosystem stays knowledgeable about evolving threats, in close to real time; identify cybersecurity risks; and allow stakeholders to act rapidly in response to emerging threats or actual network attacks. Carriers may not be comfortable reporting incidents or vulnerabilities, and determinations would need to be made about what information is disclosed and how the information will be used and reported. Cybersecurity requirements (report p. 49) Policymakers could adopt cybersecurity requirements for 5G networks. Taking these steps could produce a more secure network. Without a baseline set of security requirements the implementation of network security practices is likely to be piecemeal and inconsistent. Using existing protocols or best practices may decrease the time and cost of developing and implementing requirements. Adopting network security requirements would be challenging, in part because defining and implementing the requirements would have to be done on an application-specific basis rather than as a one-size-fits-all approach. Designing a system to certify network components would be costly and would require a centralized entity, be it industry-led or government-led. Privacy practices (report p. 50) Policymakers could adopt uniform practices for 5G user data. Development and adoption of uniform privacy practices would benefit from existing privacy practices that have been implemented by states, other countries, or that have been developed by federal agencies or other organizations. Privacy practices come with costs, and policymakers would need to balance the need for privacy with the direct and indirect costs of implementing privacy requirements. Imposing requirements can be burdensome, especially for smaller entities. High-band research (report p. 51) Policymakers could promote R&D for high-band technology. Could result in improved statistical modeling of antenna characteristics and more accurately representing propagation characteristics. Could result in improved understanding of any possible health effects from long-term radio frequency exposure to high-band emissions. Research and development is costly and must be coordinated and administered, and its potential benefits are uncertain. Policymakers will need to identify a funding source or determine which existing funding streams to reallocate. Status quo (report p. 52) Some challenges described in this report may be addressed through current efforts. Some challenges described in this report may remain unresolved, be exacerbated, or take longer to resolve than with intervention. GAO was asked to assess the technologies associated with 5G and their implications. This report discusses (1) how the performance goals and expected uses are to be realized in U.S. 5G wireless networks, (2) the challenges that could affect the performance or usage of 5G wireless networks in the U.S., and (3) policy options to address these challenges. To address these objectives, GAO interviewed government officials, industry representatives, and researchers about the performance and usage of 5G wireless networks. This included officials from seven federal agencies; the four largest U.S. wireless carriers; an industry trade organization; two standards bodies; two policy organizations; nine other companies; four university research programs; the World Health Organization; the National Council on Radiation Protection and Measurements; and the chairman of the Defense Science Board's 5G task force. GAO reviewed technical studies, industry white papers, and policy papers identified through a literature review. GAO discussed the challenges to the performance or usage of 5G in the U.S. during its interviews and convened a one-and-a-half day meeting of 17 experts from academia, industry, and consumer groups with assistance from the National Academies of Sciences, Engineering, and Medicine. GAO received technical comments on a draft of this report from six federal agencies and nine participants at its expert meeting, which it incorporated as appropriate. For more information, contact Hai Tran at (202) 512-6888, tranh@gao.gov or Vijay A. D’Souza at (202) 512-6240, dsouzav@gao.gov.
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  • Micro, Small, and Medium-Sized Enterprise Development: USAID Needs to Develop a Targeting Process and Improve the Reliability of Its Monitoring
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