Department of Justice Statement on Solarwinds Update

The Department of Justice Spokesman Marc Raimondi issued the following statement:

More from: January 6, 2021

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    The Food and Drug Administration (FDA) has taken steps intended to improve safety at its laboratories, including those that work with hazardous biological agents. Specifically, FDA created the Office of Laboratory Safety (OLS) in 2017 as a safety oversight body for all FDA laboratories. Establishment of FDA's Office of Laboratory Safety (OLS) Note: Prior to March 2019, OLS was referred to as the Office of Laboratory Science and Safety. In coordination with FDA's operating divisions—known as centers—OLS has standardized safety policies, incident reporting, inspections, and safety training. However in creating OLS, FDA did not implement key reform practices that could have helped ensure OLS's effectiveness. For example, FDA's centers and OLS did not reach a shared understanding of OLS's roles and responsibilities—a key practice for effective agency reforms. Although senior agency leaders were involved in developing OLS's strategic plan, disagreements about OLS's role raised by center directors at that time still remain. For example, center directors told GAO that OLS's mission should not include science, laboratory quality management, or inspections. Conversely, the director of OLS said OLS remains committed to its mission as envisioned in the strategic plan, which includes these areas of responsibility. FDA officials said they plan to update the plan in 2021, which presents an opportunity for FDA to address areas of disagreement. In its current form, FDA's laboratory safety program also does not meet the key elements of effective oversight identified in GAO's prior work. For example, The oversight organization should have clear authority to ensure compliance with requirements. However, as part of a 2019 reorganization, FDA placed the OLS director at a lower level than the center directors. Also, OLS does not directly manage the center safety staff responsible for ensuring the implementation of safety policies that OLS develops. As a result, OLS has limited ability to access centers' laboratories—in part because they cannot inspect them unannounced—or to ensure compliance with safety policies. The oversight organization should also be independent from program offices to avoid conflict between program objectives and safety. However, OLS depends on the centers for much of its funding and has had to negotiate with the centers annually for those funds, which can allow center directors to influence OLS priorities through the funding amounts they approve. FDA has not assessed potential independence risks from using center funds for OLS. Without taking steps to do so, FDA's laboratory safety program will continue to compete with the centers' mission objectives and priorities. In 2014, FDA discovered improperly stored boxes of smallpox virus, posing a risk to individuals who might have been exposed. This raised concerns about the oversight of FDA's laboratories that conduct research on hazardous biological agents. In 2016, GAO made five recommendations to improve FDA's laboratory safety, four of which the Department of Health and Human Services (HHS) had not fully implemented as of July 2020. GAO was asked to examine FDA's efforts to strengthen laboratory safety. This report examines FDA's efforts since GAO's 2016 report to improve safety in its laboratories that work with hazardous biological agents. To conduct this work, GAO reviewed FDA documents; assessed FDA's safety oversight practices against key reform practices and oversight elements GAO identified in prior work; and interviewed FDA officials, including staff and senior leaders at OLS and the three centers that work with hazardous biological agents. GAO is making five recommendations to FDA, including to resolve disagreements over roles and responsibilities, to provide OLS with the authority and access to facilities necessary to oversee laboratory safety, and to take steps to assess and mitigate any independence risks posed by how OLS is funded. HHS agreed with all five recommendations. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.
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    Technical assistance refers to programs, activities, and services provided by federal agencies to strengthen the capacity of grant recipients and to improve their performance of grant functions. Technical assistance can improve the performance or management of grant program recipients. Technical assistance includes the improvement of grant outcomes, grant management, grantee compliance, project monitoring and evaluation, and interactions with stakeholders. The technical assistance provided by the selected agencies—the Department of Education (Education), the Department of Health and Human Services' Administration for Children and Families (ACF), and the Department of Labor's Employment and Training Administration (ETA)—is designed to align with the requirements of each agency's grant programs and the individual grantee's needs. The types of technical assistance provided by agencies varied and included a range of delivery methods shown below. Types of Technical Assistance Provided by Selected Agencies Education tailors its approach to provide technical assistance to grantees based on recipients' needs and their efforts to obtain technical assistance. According to ACF, some grant programs have extensive, dedicated technical assistance that is grant specific, while other grant programs share technical assistance resources provided by multiple technical assistance centers. ACF's technical assistance can be based on program office oversight of the grantees that includes financial and internal control reviews and site visits. For ETA, state and local grantees administer ETA-funded programs throughout the country and technical assistance plays a role in ensuring these programs' successful implementation. According to ETA officials, technical assistance activities are based on grant program objectives. The 10 grant programs GAO reviewed evaluated technical assistance, collected feedback from recipients of the technical assistance, and incorporated feedback into technical assistance. For example, a School Safety National Activities evaluation of one of its national centers included targets for multiple performance measures and the actual performance for each measure. These measures included the percentage of milestones achieved and the percentage of technical assistance and dissemination products and services deemed to be high quality by an independent review panel. The overall goal of technical assistance is to enhance the delivery of agency programs and help ensure grantee compliance. GAO was asked to review issues related to technical assistance for grants at Education, ACF, and ETA. This report (1) describes how Education, ACF, and ETA provide technical assistance to grantees; and (2) examines to what extent these agencies evaluate the technical assistance. For this review, GAO selected 10 grant programs from the three agencies based on fiscal year 2018 funding information and the purpose of the grant. GAO reviewed documents and interviewed agency officials about the technical assistance provided, the provider and recipient of technical assistance, and the amount obligated in fiscal year 2018 for the 10 grant programs reviewed. GAO also reviewed documents and interviewed agencies about the extent to which they evaluated technical assistance, whether they gathered feedback from the recipients of technical assistance, and whether feedback was included in the evaluations for the 10 grant programs reviewed. For more information, contact Michelle Sager at (202) 512-6806 or SagerM@gao.gov.
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    Why 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.
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    In U.S GAO News
    Almost all states have a network of health care volunteers—the Medical Reserve Corps—who can augment federal, state, and local capabilities in response to public health emergencies, such as those arising from wildfires and hurricanes, and infectious disease outbreaks. Having sufficient, trained personnel, such as these volunteers, is critical to a state's capability to respond and recover from public health emergencies. According to federal data, 48 states and the District of Columbia reported 102,767 health care volunteers in 838 Medical Reserve Corps units as of September 2019, with nurses making up 43 percent. Number of Medical Reserve Corps Volunteers by Type, as of September 2019 Note: These data illustrate 90 percent of total health care volunteers. The remaining five types volunteers each make up less than 5 percent of the total. Other Public Health Medical volunteers may include cardiovascular technicians, sonographers, and phlebotomists. Medical Reserve Corps volunteers in states included in GAO's review—Alabama, California, North Carolina, and New Mexico—were deployed in response to natural disasters in 2018 and 2019, migrants at the southern border in 2019, and COVID-19 in 2020. Department of Health and Human Services (HHS) documentation shows these volunteers performed a variety of health care activities, such as providing medical services, setting up and providing support at shelters, and distributing medical supplies. Volunteers from these four states and others also participated in the response to COVID-19 by supporting testing sites, collecting specimens, and performing administrative tasks, such as data entry. For example, one unit deployed four volunteers a day for 3 days to work alongside nurses at a drive-through testing site. In addition to responding to public health emergencies, volunteers participated in preparedness activities, such as an initiative to train the public on how to respond to emergencies. HHS oversees the Medical Reserve Corps program and has assisted units in developing their volunteer capabilities. For example, HHS funded the development of a checklist of activities that should occur during volunteer deployment such as re-verifying medical credentials; provided training to new unit leaders on developing, managing, and sustaining Medical Reserve Corps units; and issued generally accepted practices, such as periodically re-evaluating volunteer recruitment procedures. The Medical Reserve Corps consists of health care volunteers—medical and public health professionals—who donate their time to help strengthen a response to public health emergencies and build community resilience. These volunteers prepare for and respond to public health emergencies, which may include natural disasters—such as hurricanes and wildfires—as well as disease outbreaks, whether intentional or natural. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 included a provision for GAO to review states' use of health care volunteers during public health emergencies. This report describes (1) the number and type of Medical Reserve Corps volunteers; (2) the types of public health emergencies volunteers have participated in; and (3) how HHS has assisted in developing volunteer capabilities. To conduct this work, GAO analyzed data reported to HHS as of September 2019; reviewed HHS documentation on four states' use of volunteers, which GAO selected based on population, number of volunteers, and event; and interviewed officials from HHS who oversee the Medical Reserve Corps program. GAO plans to further examine how states have used health care volunteers to respond to public health emergencies, including COVID-19, and any associated challenges to doing so in a future report. GAO provided a draft of this report to HHS. In response, HHS provided technical comments, which were incorporated as appropriate. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov.
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    In U.S Courts
    A federal Judiciary committee has issued a new set of model jury instructions that federal judges may use to deter jurors from using social media to research or communicate about cases.
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  • Assistant Attorney General Beth A. Williams Delivers Remarks at Columbia Law School Virtual Event on Combating the Online Exploitation of Children
    In Crime News
    Good afternoon, everyone, and thank you for joining us today for a conversation on one of the most pressing challenges we face – the continuing fight against the online exploitation of children.  I want to thank Berit Berger and Columbia Law School for hosting us virtually, and for putting together this event on such an important subject.
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    In Crime Control and Security News
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  • Disaster Housing: Improved Cost Data and Guidance Would Aid FEMA Activation Decisions
    In U.S GAO News
    The Federal Emergency Management Agency (FEMA) relied primarily on rental assistance payments to assist 2017 and 2018 hurricane survivors but also used direct housing programs to address housing needs, as shown in the table below. GAO found that FEMA provided rental assistance to about 746,000 households and direct housing assistance to about 5,400 households. FEMA did not use the Disaster Housing Assistance Program (DHAP)—a pilot grant program managed jointly with the Department of Housing and Urban Development (HUD)—because FEMA viewed its direct housing programs to be more efficient and cost-effective and did not consider DHAP to be a standard post-disaster housing assistance program. Number of Households Affected by the 2017 and 2018 Hurricanes That Received Rental and Direct Temporary Housing Assistance, by State or Territory State or territory Rental assistance Direct housing assistance Florida 422,230 1,241 North Carolina 20,198 656 Puerto Rico 147,620 414 Texas 143,465 2,988 U.S. Virgin Islands 12,147 69 Total number of households 745,660 5,368 Source: Federal Emergency Management Agency (FEMA). | GAO-21-116 Notes: FEMA provided the vast majority of its direct housing assistance through transportable temporary housing units such as manufactured housing. Rental assistance data are as of February 13, 2020, and direct housing assistance data are as of July 15, 2020. FEMA's analyses of the cost-effectiveness of housing assistance programs were limited because program cost data were incomplete or not readily useable. The Robert T. Stafford Disaster Relief and Emergency Assistance Act requires FEMA to consider factors including cost-effectiveness when determining which types of housing assistance to provide. Although FEMA has stated its direct housing programs were relatively more cost-effective than DHAP, FEMA generally could not support these statements with cost data. Specifically, FEMA does not collect key program data in its system, such as monthly subsidy and administrative costs, in a manner that would allow it to analyze the full costs of providing the assistance. Without such information, the agency's program activation decisions will not be well informed, particularly with regard to cost-effectiveness. FEMA policy guidance also says that FEMA is to compare the projected costs of the direct housing programs it is considering activating, but does not consistently specify what cost information to consider, such as whether to use both programmatic and administrative costs. Without such guidance, FEMA cannot reasonably assure that its assessments and their results incorporate consistent and comparable data. The 2017 and 2018 hurricanes (Harvey, Irma, Maria, Florence, and Michael) caused $325 billion in damage. FEMA provided post-disaster assistance, including rental and direct housing assistance. DHAP was a pilot grant program that provided temporary rental assistance and was used to respond to several hurricanes before 2017. GAO was asked to review issues related to major disasters in 2018 and housing assistance provided after the 2017 and 2018 hurricanes. This report (1) describes the assistance FEMA provided in response to those hurricanes, and (2) evaluates the extent to which FEMA considered cost-effectiveness in activating programs. GAO reviewed FEMA and HUD policies, communications, and other documentation; analyzed FEMA data; and interviewed officials at FEMA headquarters and regional offices, HUD, and Texas state and local government offices. GAO makes two recommendations to FEMA for its temporary housing programs: (1) identify and make changes to its data systems to allow for capture and analysis of programs' full costs, and (2) specify the information needed to compare projected program costs in its guidance on activating programs. DHS agreed with both recommendations, and said it planned to implement them in 2021–2022. For more information, contact John Pendleton at (202) 512-8678 or pendletonj@gao.gov.
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    In Crime News
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