Special Presidential Envoy for Arms Control Billingslea to Address the Conference on Disarmament 

Office of the Spokesperson

Special Presidential Envoy for Arms Control Marshall Billingslea, exercising the authorities of the Under Secretary for Arms Control and International Security, will deliver the U.S. statement to the opening plenary session of the Conference on Disarmament in Geneva, Switzerland, tomorrow, Tuesday, January 19.  The statement will be delivered virtually.

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    The four efforts within the Next Generation Combat Vehicles (NGCV) portfolio all prioritize rapid development, while using different acquisition approaches and contracting strategies. Some of the efforts use the new middle-tier acquisition approach, which enables rapid development by exempting programs from many existing DOD acquisition processes and policies. Similarly, the efforts use contracting strategies that include both traditional contract types as well as more flexible approaches to enable rapid development of technology and designs. Vehicles of the Next Generation Combat Vehicles Portfolio The two programs within the portfolio that recently initiated acquisitions—Mobile Protected Firepower and Optionally Manned Fighting Vehicle—have taken some steps to mitigate risks in cost and technology consistent with GAO's leading practices. The Army's use of the middle-tier approach for these efforts may facilitate rapid development, but the programs could benefit from additional application of GAO's leading practices. For example, the programs identified some risks in their cost estimates, but because each presented a single estimate of the total cost—referred to as a point estimate—these estimates do not fully reflect how uncertainty could affect costs. Similarly, the programs took some steps to mitigate technical risk by limiting development to 6 years or less and incrementally introducing new technologies, steps consistent with GAO's leading practices. However, by delaying key systems engineering reviews, the programs took some steps not consistent with leading practices, which could increase technical risk. While trade-offs may be necessary to facilitate rapid development, more consistent application of GAO's leading practices for providing cost estimates that reflect uncertainty and conducting timely systems engineering reviews could improve Army's ability to provide insight to decision makers and deliver capability to the warfighter on time and at or near expected costs. The Army has taken actions to enhance communication, both within the Army and with Department of Defense stakeholders, to mitigate risks. Within the Army, these actions included implementing a cross-functional team structure to collaboratively develop program requirements with input from acquisition, contracting, and technology development staff. Program officials also coordinated with other Army and Department of Defense stakeholders responsible for cost and test assessment, even where not required by policy, to mitigate risk. The Army views the NGCV portfolio as one of its most critical and urgent modernization priorities, as many current Army ground combat vehicles were developed in the 1980s or earlier. Past efforts to replace some of these systems failed at a cost of roughly $23 billion. In November 2017, the Army began new efforts to modernize this portfolio. GAO was asked to review the Army's plans for modernizing its fleet of ground combat vehicles. This report examines (1) the acquisition approaches and contracting strategies the Army is considering for the NGCV portfolio, (2) the extent to which the Army's efforts to balance schedule, cost, and technology are reducing acquisition risks for that portfolio, and (3) how the Army is communicating internally and externally to reduce acquisition risks. GAO reviewed the acquisition and contracting plans for each of the vehicles in the portfolio to determine their approaches; assessed schedule, cost, and technology information—where available—against GAO's leading practice guides on these issues as well as other leading practices for acquisition; and interviewed Army and DOD officials. GAO is making three recommendations, including that the Army follow leading practices on cost estimation and systems engineering to mitigate program risk. In its response, the Army concurred with these recommendations and plans to take action to address them. For more information, contact Jon Ludwigson at (202) 512-4841 or ludwigsonj@gao.gov.
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For example, the vaccine for rotavirus—a childhood illness that can cause severe diarrhea, dehydration, and even death—can cause intestinal blockage in one in 100,000 recipients. However, the vaccine is still administered because this very rare side effect is outweighed by the vaccine's benefits: it saves lives and prevents an estimated 40,000 to 50,000 childhood hospitalizations in the U.S. each year. The two messenger RNA (mRNA) vaccines authorized for COVID-19—a disease that contributed to more than 415,000 American deaths between January 2020 and January 2021—can cause severe allergic reactions. However, early safety reporting found that these reactions have been extremely rare, with only about five cases per 1 million recipients, according to data from January 2021 reports by the Centers for Disease Control and Prevention. In general, side effects from vaccines are less acceptable to the public than side effects from treatments given to people who already have a disease. What is known? Vaccine developers assess safety from early research, through laboratory and animal testing, and even after the vaccine is in use (fig. 2). Researchers may rely on previous studies to inform future vaccine trials. For example, safety information from preclinical trials of mRNA flu vaccine candidates in 2017 allowed for the acceleration of mRNA COVID-19 vaccine development. Vaccine candidates shown to be safe in these preclinical trials can proceed to clinical trials in humans. In the U.S., clinical trials generally proceed through three phases of testing involving increasing numbers of volunteers: dozens in phase 1 to thousands in phase 3. Although data may be collected over years, most common side effects are identified in the first 2 months after vaccination in clinical trials. After reviewing safety and other data from vaccine studies, the Food and Drug Administration (FDA) may license a vaccine to be marketed in the U.S. There are also programs to expedite—but not bypass—development and review processes, such as a priority review designation, which shortens FDA’s goal review time from 10 to 6 months. Safety monitoring continues after licensing. For example, health officials are required to report certain adverse events—such as heart problems—following vaccination, in order to help identify potential long-term or rare side effects that were not seen in clinical trials and may or may not be associated with the vaccine. Figure 2. Vaccine safety is assessed at every stage: development through post-licensure. Following a declared emergency, FDA can also issue emergency use authorizations (EUA) to allow temporary use of unlicensed vaccines if there is evidence that known and potential benefits of the vaccine outweigh known and potential risks, among other criteria. As of January 2021, two COVID-19 vaccines had received EUAs, after their efficacy and short-term safety were assessed through large clinical trials. However, developers must continue safety monitoring and meet other requirements if they intend to apply for FDA licensure to continue distribution of these vaccines after the emergency period has ended. What are the knowledge gaps? One knowledge gap that can remain after clinical trials is whether side effects or other adverse events may occur in certain groups. For example, because clinical trials usually exclude certain populations, such as people who are pregnant or have existing medical conditions, data on potential adverse events related to specific populations may not be understood until vaccines are widely administered. In addition, it can be difficult to determine the safety of new vaccines if outbreaks end suddenly. For example, vaccine safety studies were hindered during the 2014-2015 Ebola epidemic when a large increase in the number of cases was followed by a sharp decrease. This disrupted the clinical trials of Ebola vaccine candidates, because the trials require many infected and non-infected people. Furthermore, a lack of understanding and/or misinformation about the steps taken to ensure the safety of vaccines hinders accurate public knowledge about safety concerns, which may cause people to delay or refuse vaccination. This resulting hesitancy may, in turn, increase deaths, social harm, and economic damage. 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    Stakeholders GAO interviewed and studies GAO reviewed identified three factors that affect access to follow-up care for childhood cancer survivors—individuals of any age who were diagnosed with cancer from ages 0 through 19. These factors are care affordability, survivors' and health care providers' knowledge of appropriate care, and proximity to care. Childhood cancer survivors need access to follow-up care over time for serious health effects known as late effects—such as developmental problems, heart conditions, and subsequent cancers—which result from their original cancer and its treatment. Affordability: Survivors of childhood cancer may have difficulty paying for follow-up care, which can affect their access to this care. For example, one study found that survivors were significantly more likely to have difficulty paying medical bills and delay medical care due to affordability concerns when compared to individuals with no history of cancer. Knowledge: Survivors' access to appropriate follow-up care for late effects of childhood cancer can depend on both survivors' and providers' knowledge about such care, which can affect access in various ways, according to stakeholders GAO interviewed and studies GAO reviewed: Some survivors may have been treated for cancer at an early age and may have limited awareness of the need for follow- up care. Some primary or specialty care providers may not be knowledgeable about guidelines for appropriate follow-up care, which can affect whether a survivor receives recommended treatment. Follow-up care may include psychosocial care (e.g., counseling), and palliative care (e.g., pain management). Proximity: Survivors may have difficulty reaching appropriate care settings. Stakeholders GAO interviewed and studies GAO reviewed noted that childhood cancer survivors may have to travel long distances to receive follow-up care from multidisciplinary outpatient clinics—referred to as childhood cancer survivorship clinics. The lack of proximity may make it particularly difficult for survivors with limited financial resources to adhere to recommended follow-up care. The National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC)—agencies within the Department of Health and Human Services (HHS) that conduct activities specific to childhood cancer survivors, including research about access to care—have taken steps to implement three provisions in the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018 (Childhood Cancer STAR Act) relevant to access to care for survivors. For example, CDC has awarded a contract to develop software to improve the collection of information on individuals with childhood cancer, and NCI has funded three research projects focused on interventions aimed at addressing adverse outcomes among childhood cancer survivors. NCI has also funded research to study the health status and use of follow-up services of 2,000 young adult survivors. Stakeholders have raised questions about the ability of childhood cancer survivors to access needed follow-up care. According to the most recent data available, approximately 465,000 childhood cancer survivors—children, adolescents, and adults—were alive in the United States as of January 1, 2017. Although the 5-year survival rate for childhood cancer has increased from about 62 percent in the mid-1970s to about 86 percent in the mid-2010s, childhood cancer survivors may face late effects, which could require follow-up care across multiple stages of their lives. The conference report accompanying Public Law 115-245 included a provision for GAO to report on barriers to obtaining medical care for childhood cancer survivors, including psychosocial services and palliative care. This report identifies factors reported to affect access to follow-up care for this population. GAO spoke with officials from NCI and CDC and interviewed stakeholders such as providers who care for childhood cancer survivors, professional associations, and advocacy groups. Additionally, GAO reviewed peer-reviewed studies related to access to care for survivors, outcomes of treatment they may receive, and factors that may affect their access to follow-up care. To supplement this work, GAO reviewed the status of selected HHS activities to support access to care for childhood cancer survivors, including steps taken to implement selected provisions in the Childhood Cancer STAR Act. GAO provided a draft of this report to HHS for review and comment. HHS provided technical comments, which GAO incorporated as appropriate. For more information, contact Jessica Farb at (202) 512-7114 or FarbJ@gao.gov.
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  • Defense Science and Technology: Opportunities to Better Integrate Industry Independent Research and Development into DOD Planning
    In U.S GAO News
    Why This Matters Research and development (R&D) projects in high-tech areas like cybersecurity and biotechnology can help the U.S. military reassert its technological edge. Contractors decide what independent R&D projects to conduct and the Department of Defense (DOD) reimburses them about $4 billion-$5 billion annually. More information about those projects could help DOD guide its own R&D investments. Key Takeaways DOD does not know how contractors’ independent R&D projects fit into the department’s technology goals. As a result, DOD risks making decisions about its multi-billion dollar science and tech investments that could duplicate work or miss opportunities to fill in gaps that the contributions of private industry do not cover. DOD has a database of independent R&D projects, but it is not very useful for informing investment decisions because DOD does not obtain information in these and other areas: Priority. Contractors do not identify whether a project aligns with any of 10 modernization priorities. The department uses those priorities to make decisions about R&D investments. Cost. The database does not capture a project’s complete cost, which could help DOD understand cost implications of future related work. Innovation. The database does not include whether a project is a lower-risk, incremental development or a more innovative “disruptive” technology. Disruptive projects carry higher risk of failure but offer possible significant rewards in the long term. While DOD is not required to review independent R&D projects to understand how they support DOD’s priorities, GAO analysis showed 38 percent of industry projects aligned with DOD’s priorities. To help DOD better understand the scope and nature of independent projects, we recommend DOD determine whether to require additional information in the project database and review projects annually as part of its strategic planning process. DOD agreed with both recommendations. How GAO Did This Study We categorized a sample of completed projects from 2014–2018 by innovation type and analyzed projects completed in 2018 for alignment with DOD's modernization priorities. We also reviewed DOD policies on independent R&D and interviewed representatives from 10 defense contractors. For more information, contact Timothy J. DiNapoli at (202) 512-4841 or dinapolit@gao.gov.
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  • Navy and Marine Corps: Services Continue Efforts to Rebuild Readiness, but Recovery Will Take Years and Sustained Management Attention
    In U.S GAO News
    The Navy and Marine Corps continue to face significant readiness challenges that have developed over more than a decade of conflict, budget uncertainty, and reductions in force structure. These challenges prevent the services from reaping the full benefit of their existing forces and attaining the level of readiness called for by the 2018 National Defense Strategy. Both services have made encouraging progress identifying the causes of their readiness decline and have begun efforts to arrest and reverse it (see figure). However, GAO's work shows that addressing these challenges will require years of sustained management attention and resources. Recent events, such as the ongoing pandemic and the fire aboard the USS Bonhomme Richard affect both current and future readiness and are likely to compound and delay the services' readiness rebuilding efforts. Selected Navy and Marine Corps Readiness Challenges Continued progress implementing GAO's prior recommendations will bolster ongoing Navy and Marine Corps efforts to address these readiness challenges. The 2018 National Defense Strategy emphasizes that restoring and retaining readiness is critical to success in the emerging security environment. The Navy and Marine Corps are working to rebuild the readiness of their forces while also growing and modernizing their aging fleets of ships and aircraft. Readiness recovery will take years as the Navy and Marine Corps address their multiple challenges and continue to meet operational demands. This statement provides information on readiness challenges facing (1) the Navy ship and submarine fleet and (2) Navy and Marine Corps aviation. GAO also discusses its prior recommendations on Navy and Marine Corps readiness and the progress that has been made in addressing them. This statement is based on previous work published from 2016 to November 2020—on Navy and Marine Corps readiness challenges, including ship maintenance, sailor training, and aircraft sustainment. GAO also analyzed data updated as of November 2020, as appropriate, and drew from its ongoing work focused on Navy and Marine Corps readiness. GAO made more than 90 recommendations in prior work cited in this statement. The Department of Defense generally concurred with most of GAO's recommendations. Continued attention to these recommendations can assist the Navy and the Marine Corps as they seek to rebuild the readiness of their forces. For more information, contact Diana Maurer at (202) 512-9627 or maurerd@gao.gov.
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    A former subcontractor for the U.S. Marines Corps was sentenced today to 18 months in prison for destroying records in connection with a federal investigation of bribery and procurement fraud at Marine Corps Base Camp Lejeune (MCBCL), located in Jacksonville, North Carolina, announced Acting Assistant Attorney General Nicholas L. McQuaid of the Justice Department’s Criminal Division.
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  • Southwest Border: DHS and DOJ Have Implemented Expedited Credible Fear Screening Pilot Programs, but Should Ensure Timely Data Entry
    In U.S GAO News
    From October 2019 to March 2020, the Department of Homeland Security (DHS), in coordination with the Department of Justice's (DOJ) Executive Office for Immigration Review (EOIR), implemented expedited fear screening pilot programs. Under the Prompt Asylum Claim Review (for non-Mexican nationals) and Humanitarian Asylum Review Process (for Mexican nationals), DHS sought to complete the fear screening process for certain individuals within 5 to 7 days of their apprehension. To help expedite the process, these individuals remained in U.S. Customs and Border Protection (CBP) custody during the pendency of their screenings rather than being transferred to U.S. Immigration and Customs Enforcement (ICE). From October through December 2019, DHS implemented the programs in the El Paso, Texas, sector and expanded them to nearly all other southwest border sectors before pausing them in March 2020 due to COVID-19. DHS data indicate that CBP identified approximately 5,290 individuals who were eligible for screening under the pilot programs. About 20 percent of individuals were in CBP custody for 7 or fewer days; CBP held about 86 percent of individuals for 20 or fewer days. Various factors affect time in CBP custody such as ICE's ability to coordinate removal flights. U.S. Citizenship and Immigration Services (USCIS) data indicate that the majority of individuals (about 3,620) received negative fear determinations from asylum officers (see figure). About 1,220 individuals received positive credible fear determinations placing them into full removal proceedings where they may apply for various forms of protection such as asylum. However, as of October 2020, DHS and EOIR could not account for the status of such proceedings for about 630 of these individuals because EOIR's data system does not indicate that a Notice to Appear—a document indicating someone was placed into full removal proceedings before an immigration judge—has been filed and entered into the system, as required. Specifically, DHS and EOIR officials could not determine whether DHS components had filed the notices for these cases with EOIR, nor could they determine if EOIR staff had received but not yet entered some notices into EOIR's data system, per EOIR policy. Ensuring that DHS components file Notices to Appear with EOIR and that EOIR staff enter them into EOIR's data system in a timely manner, as required, would help ensure that removal proceedings move forward for these individuals. Outcomes of Screenings Under Expedited Fear Screening Pilot Programs, October 2019 through March 2020 (as of August 11, 2020) Note: Percentages do not total 100 due to rounding. Individuals apprehended by DHS and placed into expedited removal proceedings are to be removed from the U.S. without a hearing in immigration court unless they indicate a fear of persecution or torture, a fear of return to their country, or express an intent to apply for asylum. Asylum officers conduct such “fear screenings,” and EOIR immigration judges may review negative USCIS determinations. In October 2019, DHS and DOJ initiated two pilot programs to further expedite fear screenings for certain apprehended noncitizens. GAO was asked to review DHS's and DOJ's management of these pilot programs. This report examines (1) actions DHS and EOIR took to implement and expand the programs along the southwest border, and (2) what the agencies' data indicate about the outcomes of individuals' screenings and any gaps in such data. GAO analyzed CBP, USCIS, EOIR, and ICE data on all individuals processed under the programs from October 2019 to March 2020; interviewed relevant headquarters and field officials; and visited El Paso, Texas—the first pilot location. GAO is making two recommendations, including that DHS ensure components file Notices to Appear with EOIR for all those who received positive determinations under the programs, and that EOIR ensure staff enter all such notices in a timely manner, as required, into EOIR's case management system. DHS concurred and DOJ did not concur. GAO continues to believe the recommendation is warranted. For more information, contact at (202) 512-8777 or gamblerr@gao.gov.
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  • Offshore Wind Energy: Planned Projects May Lead to Construction of New Vessels in the U.S., but Industry Has Made Few Decisions amid Uncertainties
    In U.S GAO News
    Under the Jones Act, vessels carrying merchandise between two points in the U.S. must be built and registered in the United States. Developers are planning a number of offshore wind projects along the U.S. east coast, where many states have set targets for offshore wind energy production. Stakeholders described two approaches to using vessels to install offshore wind energy projects in the U.S. Either approach may lead to the construction of new vessels that comply with the Jones Act. Under one approach, a Jones Act-compliant wind turbine installation vessel (WTIV) would carry components from a U.S. port to the site and also install the turbines. WTIVs have a large deck, legs that allow the vessel to lift out of the water, and a tall crane to lift and place turbines. Stakeholders told GAO there are currently no Jones Act-compliant vessels capable of serving as a WTIV. One company, however, has announced a plan to build one. Under the second approach, a foreign-flag WTIV would install the turbines with components carried to the site from U.S. ports by Jones Act-compliant feeder vessels (see figure). While some potential feeder vessels exist, stakeholders said larger ones would probably need to be built to handle the large turbines developers would likely use. Example of an Offshore Wind Installation in U.S. Waters Using a Foreign-Flag Installation Vessel and Jones Act-Compliant Feeder Vessels Stakeholders identified multiple challenges—which some federal programs address—associated with constructing and using Jones Act-compliant vessels for offshore wind installations. For example, stakeholders said that obtaining investments in Jones Act-compliant WTIVs—which may cost up to $500 million—has been challenging, in part due to uncertainty about the timing of federal approval for projects. According to officials at the Department of the Interior, which is responsible for approving offshore wind projects, the Department plans to issue a decision on the nation's first large-scale offshore wind project in December 2020. Some stakeholders said that if this project is approved, investors may be more willing to move forward with vessel investments. While stakeholders also said port infrastructure limitations could pose challenges to using Jones Act-compliant vessels for offshore wind, offshore wind developers and state agencies have committed to make port investments. Offshore wind, a significant potential source of energy in the United States, requires a number of oceangoing vessels for installation and other tasks. Depending on the use, these vessels may need to comply with the Jones Act. Because Jones Act-compliant vessels are generally more expensive to build and operate than foreign-flag vessels, using such vessels may increase the costs of offshore wind projects. Building such vessels may also lead to some economic benefits for the maritime industry. A provision was included in statute for GAO to review offshore wind vessels. This report examines (1) approaches to use of vessels that developers are considering for offshore wind, consistent with Jones Act requirements, and the extent to which such vessels exist, and (2) the challenges industry stakeholders have identified associated with constructing and using such vessels to support U.S. offshore wind, and the actions federal agencies have taken to address these challenges. GAO analyzed information on vessels that could support offshore wind, reviewed relevant laws and studies, and interviewed officials from federal agencies and industry stakeholders selected based on their involvement in ongoing projects and recommendations from others. For more information, contact Andrew Von Ah at (202) 512-2834 or vonaha@gao.gov.
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    A Queens, New York return preparer pleaded guilty today to conspiracy to defraud the United States by filing false returns, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division.
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