What GAO Found
The Department of State made key decisions for overseas posts (e.g., U.S. embassies and consulates) during the COVID-19 pandemic, as shown in the figure below, but did not communicate them to other overseas agencies before they went into effect. State created a new global evacuation policy with flexibilities that were different from the pre-existing policies for post-specific evacuations, which created confusion for staff on timelines, allowances, and conditions for returning to post. According to federal internal control standards, policies should be documented in the appropriate level of detail. However, State has not yet established an evacuation policy that could be used for future crises affecting multiple posts. In addition, State’s decisions for posts affected all U.S. government staff overseas but State did not communicate these key decisions, and related policies, to other overseas agencies before announcing them to all staff. As a result, other overseas agencies had to develop guidance for their staff to follow after State’s public announcements.
Timeline of State’s Key Decisions during the COVID-19 Pandemic
Evacuations of key personnel and public health restrictions reduced some operations at posts, but information technology improvements and other adjustments largely allowed staff to continue to work. Nevertheless, some posts reported they did not have sufficient information to help them determine which staff should remain overseas and which could be evacuated. Posts implemented a maximum telework policy and State used COVID-19 relief funds to provide equipment and better network access. Federal internal control standards state that agencies should use quality information to make decisions. However, State does not track telework at overseas posts and, as a result, does not have the information needed to inform future decisions about its use overseas.
State has identified lessons learned on telework and communication but does not have a procedure for ensuring their collection from posts. According to State’s guidance, lessons learned are required to be gathered and preserved after critical operational events. Individual posts reported lessons learned on communication, including the utility of informal communication between staff, but not all posts submitted required lessons learned. State does not have a procedure to ensure the collection of lessons learned from posts—a significant component of improving its future crisis response.
Why GAO Did This Study
The U.S. government has over 22,000 U.S. staff working in more than 290 overseas posts. State made operational adjustments in an effort to balance overseas staff’s health with the pursuit of diplomacy during the COVID-19 pandemic.
The CARES Act includes a provision for GAO to report on its ongoing oversight efforts related to COVID-19. In addition, GAO was asked to examine State’s overseas operational response to COVID-19. This report examines, among other things, actions State took to respond to COVID-19 and how it communicated them to overseas employees, posts’ operational adjustments and the effect on operations, and lessons learned identified by State.
GAO reviewed relevant State documents, including agency guidance and post-level reporting, and interviewed State and other U.S. agency officials. GAO also met with four selected overseas posts based on various factors, such as geographic location and proportion of U.S. overseas staff evacuated.
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March 4, 2021A federal jury convicted a Virginia man today for downloading images and videos depicting children as young as four years old being sexually abused and for utilizing the Darknet to solicit and promote child pornography.
- DOJ and HHS Issue Guidance on ‘Long COVID’ and Disability Rights Under the ADA, Section 504, and Section 1557
July 26, 2021Today, as we commemorate the 31st anniversary of the Americans with Disabilities Act (ADA), the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) are jointly publishing guidance on how “long COVID” can be a disability under the ADA, Section 504 of the Rehabilitation Act and Section 1557 of the Affordable Care Act. The guidance is on the DOJ website at https://www.ada.gov/long_covid_joint_guidance.pdf – PDF and on the HHS website at https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html.
- COVID-19: Significant Improvements Are Needed for Overseeing Relief Funds and Leading Responses to Public Health Emergencies
January 27, 2022What GAO Found New U.S. COVID-19 cases and virus variants continue to challenge the nation. New daily reported cases increased sharply from December 21, 2021 to January 3, 2022 due primarily to the emergence of the Omicron variant. Cases during this time generally exceeded 380,000, surpassing the daily case rate reported during the emergence of the Delta variant in summer 2021, according to Centers for Disease Control and Prevention (CDC) data. Hospitalizations of individuals with confirmed COVID-19 also increased almost twofold at the end of 2021—from an average of 50,000 daily in late November 2021 to 93,000 daily. According to CDC data, as of January 3, 2022, about 62 percent of the total U.S. population had been fully vaccinated. In late 2021, FDA expanded COVID-19 vaccine eligibility in multiple ways, including authorizing vaccines for children 5 through 11 years old, and authorizing booster shots for vaccinated individuals 12 years and older. In addition, the federal government and private businesses began requiring COVID-19 vaccination for certain employees. Reported COVID-19 Vaccinations by Age Group in U.S., as of Jan. 3, 2022 Percentage of population Percentage of fully vaccinated population Fully vaccinated Booster dose 5 years of age and older 66.1 Not applicable 12 years of age and older 71.2 Not available 18 years of age and older 72.9 37.2 65 years of age and older 87.7 58.8 Total 62.1 34.3 Source: Centers for Disease Control and Prevention (CDC). | GAO-22-105291 Note: CDC counts individuals as being fully vaccinated if they received two doses on different days of the two-dose vaccines or received one dose of the single-dose vaccine. GAO’s COVID-19 reports have provided analyses of broad federal efforts to respond to the pandemic and support U.S. businesses and residents, resulting in 246 total recommendations for improving federal operations. Agencies have fully or partially addressed 38 percent as of December 31, 2021, fully addressing 16 percent (40 recommendations) and partially addressing another 22 percent (54 recommendations). Fully addressing GAO’s recommendations will enhance the quality and accountability of federal COVID-19 pandemic response and recovery efforts. GAO also raised four matters for congressional consideration, three of which remain open. In this report, GAO makes five new recommendations in the areas of emergency rental assistance, nutrition assistance, and tax relief for businesses. GAO is also designating the Department of Health and Human Services’ (HHS) leadership and coordination of a range of public health emergencies as high risk. This designation is in keeping with long-standing efforts to identify federal programs needing transformation, and to help ensure sustained executive branch and congressional attention so the nation is prepared for future emergencies. Emergency Rental Assistance As of November 30, 2021, the Department of the Treasury had disbursed nearly $38 billion of the $46.55 billion it was appropriated for Emergency Rental Assistance (ERA) programs. These programs provide funds to grantees to administer programs to assist eligible renter households that are unable to pay rent, utilities, or other expenses due, directly or indirectly, to the COVID-19 pandemic. Treasury disburses ERA funds to grantees, such as states, local governments, and tribal governments, which make payments to landlords, households, and others eligible to receive the funds. Treasury has not yet designed processes to identify and recover overpayments made by grantees, such as post-payment reviews or recovery audits. Such reviews could verify the eligibility for and accuracy of ERA payments. Without a process for conducting effective post-payment reviews or recovery audits for the ERA programs, Treasury’s ability to consistently identify and recover overpayments made by grantees may be delayed or impossible. The Single Audit Act establishes requirements for audits of states, local governments, and other nonfederal entities that receive funding from federal awards (e.g., grants) when their expenditures meet a certain dollar threshold. The Office of Management and Budget (OMB) is responsible for developing government-wide guidance for performing audits to comply with the act. OMB guidance includes issuing an annual Compliance Supplement—a tool to help auditors identify compliance requirements that could have a direct and material effect on major programs. Auditors who conduct single audits follow guidance in the Compliance Supplement and agency guidance specific to their programs. In its 2021 Compliance Supplement, OMB listed the ERA programs as “higher risk” programs, but did not include guidance for auditing grantee compliance with ERA. Without this guidance, auditors might not consistently and effectively identify deficiencies in grantees’ compliance with the requirements of the programs, limiting Treasury’s ability to identify and mitigate risks, including risks to payment integrity. GAO recommends that Treasury design and implement processes, such as post-payment reviews or recovery audits, to help ensure timely identification and recovery of overpayments made by grantees to households, landlords, or utility providers in the ERA programs. Treasury agreed with this recommendation and stated that it is working to establish post-payment reviews and recovery audit activities. GAO also recommends that OMB, in consultation with Treasury, issue guidance now or in the near future on the ERA programs in OMB’s Compliance Supplement for single audits to help ensure that auditors consistently and timely identify deficiencies in grantees’ compliance with the programs’ requirements. OMB neither agreed nor disagreed with this recommendation. Nutrition Assistance The Food and Nutrition Service (FNS), within the Department of Agriculture, administers multiple federal nutrition assistance programs, including the Pandemic Electronic Benefits Transfer (Pandemic EBT) program—which provides food assistance for children attending schools closed due to COVID-19—and the Supplemental Nutrition Assistance Program, among others. COVID-19 Funding and Expenditures for Selected Federal Nutrition Assistance Programs as of Nov. 30, 2021 Program Description Total COVID-19 funding ($) COVID-19 expenditures as of Nov. 30, 2021 ($) SNAP Provides low-income individuals and households with benefits to purchase allowed food items and achieve a more nutritious diet. 16.8 billion 15.6 billion Indefinite appropriation 15.0 billion Pandemic EBT Provides households with children who would have received free or reduced-price school meals if not for school closures due to COVID-19, as well as eligible children in childcare, with benefits to purchase food. Indefinite appropriation 42.4 billion WIC Provides eligible low-income women, infants, and children up to age 5 who are at nutrition risk with nutritious foods to supplement diets, information on healthy eating, and referrals to health care. 1.4 billion 710.5 million TEFAP Provides low-income individuals with groceries through food banks. 1.25 billion 1.1 billion Legend: Pandemic EBT = Pandemic Electronic Benefits Transfer; SNAP = Supplemental Nutrition Assistance Program; TEFAP = the Emergency Food Assistance Program; WIC = Special Supplemental Nutrition Program for Women, Infants, and Children. Source: GAO analysis of relevant provisions of the Families First Coronavirus Response Act; the CARES Act; the Consolidated Appropriations Act, 2021; and the American Rescue Plan Act of 2021 as well as information from the Food and Nutrition Service (FNS), within the Department of Agriculture. | GAO-22-105291 Note: Amounts shown reflect amounts appropriated specifically for COVID-19 response and relief and do not include annual appropriations. SNAP received both specific amounts of funding, as well as an indefinite appropriation—an appropriation that, at the time of enactment, is for an unspecified amount—for certain purposes, including a SNAP benefit increase of 15 percent through September 2021. FNS does not have a comprehensive strategy for how its nutrition assistance programs should respond during emergencies. As part of this, FNS’s pandemic plans are outdated, and FNS efforts to identify and incorporate lessons learned from COVID-19 into its nutrition programs are incomplete. Developing a strategy for how its programs should respond to emergencies would benefit FNS’s response to both the current pandemic and future emergencies. Such a strategy could help FNS ensure that individuals and households maintain food security in times of heightened need and that FNS does not miss opportunities to coordinate with vendors across the country. FNS has also not provided sufficient assistance to state and local agencies to facilitate their efforts to obtain reliable and comprehensive eligibility data for the Pandemic EBT program. According to FNS officials, state agencies reported various challenges collecting such data, including relying on manual tracking of thousands of participants. Reliable and comprehensive data can help state Supplemental Nutrition Assistance Program agencies ensure they have issued Pandemic EBT benefits to all eligible students in the correct benefit amounts. GAO recommends that the Department of Agriculture ensure that FNS (1) develops a comprehensive strategy for the agency’s nutrition assistance programs to respond to emergencies that includes lessons learned during the COVID-19 pandemic and a mechanism to periodically review and update the strategy and (2) shares timely information with states and other stakeholders during development of the strategy to help inform their ongoing response to COVID-19. GAO also recommends that the Department of Agriculture ensure that FNS further assists state and local agencies in their efforts to obtain reliable and comprehensive eligibility data for the Pandemic EBT program in order to determine eligibility and benefits amounts accurately. The Department of Agriculture agreed with both recommendations. Tax Relief for Businesses To provide liquidity to businesses during the COVID-19 pandemic, the CARES Act and other COVID-19 relief laws included tax measures to help businesses by reducing certain tax obligations, which, in some cases, led to cash refunds. These tax measures included expanded carrybacks for net operating losses—that is, when a taxpayer’s allowable deductions exceed the gross income for a tax year—and the acceleration of alternative minimum tax (AMT) credit refunds. According to officials from the Internal Revenue Service (IRS), the CARES Act changes contributed to the agency receiving 276 percent more filings for carryback refunds—which include applications for tentative refunds for net operating loss carrybacks and AMT credit refunds—in fiscal year 2021 than in fiscal year 2020. IRS has been unable to process this backlog consistent with its statutory time frames for processing applications for tentative refunds, which businesses submit through IRS Forms 1045 and 1139. The Internal Revenue Code and the CARES Act generally require IRS to issue certain refunds within a 90-day period. IRS data show that the agency started to miss the 90-day statutory requirement for applications in September 2020 and missed it throughout 2021. As of November 2021, the average time for IRS to process all carryback refunds was 165 days (see figure). Average Monthly Processing Times for Carryback Applications and Claims Filed with the Internal Revenue Service (IRS), Apr. 2020–Nov. 2021 Note: These data include all carryback cases, including those filed as “claims” on other IRS forms and those filed as “applications” on Forms 1045 and 1139. Forms 1045 are represented in the individual line and Forms 1139 are represented in the business line. Forms 1139 may also contain refund claims for the alternative minimum tax refund. IRS officials said the reported times do not include the additional time—up to 2 weeks—it may take for IRS to finalize production and distribute the refund to the taxpayer. The figure does not represent all of the work that IRS did throughout the year, but focuses on actions specific to the processing times for carryback cases. The Consolidated Appropriations Act, 2021 and American Rescue Plan Act of 2021 were also enacted in December 2020 and March 2021 respectively, and contained provisions that also required IRS action.Note: These data include all carryback cases, including those filed as “claims” on other IRS forms and those filed as “applications” on Forms 1045 and 1139. Forms 1045 are represented in the individual line and Forms 1139 are represented in the business line. Forms 1139 may also contain refund claims for the alternative minimum tax refund. IRS officials said the reported times do not include the additional time—up to 2 weeks—it may take for IRS to finalize production and distribute the refund to the taxpayer. The figure does not represent all of the work that IRS did throughout the year, but focuses on actions specific to the processing times for carryback cases. The Consolidated Appropriations Act, 2021 and American Rescue Plan Act of 2021 were also enacted in December 2020 and March 2021 respectively, and contained provisions that also required IRS action. While IRS took some remedial actions, it did not have effective preventative control activities or mitigation plans in place to detect or address growing processing times for tentative refunds submitted on IRS Forms 1139 and 1045, such as an average processing time threshold to trigger activities to avoid missing refund deadlines. As such, IRS did not take actions to reduce the carryback backlog until April 2021—7 months after the agency began missing its statutory requirement. Until effective preventative control activities and mitigation plans are put in place, IRS remains at risk of continuing to exceed its 90-day statutory requirement to issue tentative refunds for net operating loss carrybacks and AMT credit refunds. Failure to meet processing deadlines not only causes some taxpayers to face delays in receiving their refunds, but also increases the cost to the federal government in terms of interest paid on such refunds. According to IRS data for fiscal year 2021, these interest payments amounted to approximately $61 million on all carrybacks, of which applications for tentative refund made up roughly 80 percent of all carryback interest payments for the fiscal year. GAO recommends that IRS establish mitigation plans—including indicators, such as a threshold to initiate mitigation activities—to timely address future challenges to processing times for applications for tentative refunds on Forms 1045 and 1139 within the 90-day statutory requirement. IRS neither agreed nor disagreed with this recommendation, but said that it will take the recommendation into consideration as it continues to make improvements to taxpayer services. HHS COVID-19 Funding HHS received approximately $484 billion in COVID-19 relief appropriations from the six COVID-19 relief laws. These relief funds may be used for a range of purposes, such as assistance to health care or child care providers; testing, therapeutic, or vaccine-related activities; or procurement of critical supplies. Of the $484 billion appropriated, HHS reported that it had obligated about $387 billion and expended about $226 billion—about 80 percent and 47 percent, respectively, as of November 30, 2021. GAO previously recommended that HHS provide projected time frames for its spending of the remainder of its COVID-19 relief funds in the spend plans HHS submits to Congress. HHS partially agreed with the recommendation, but stated that the department would not be able to provide specific time frames for all relief funds as it needed to remain flexible in responding to incoming requests. Providing projected time frames would not affect HHS’s ability to be flexible in its spend plans, as these plans are not binding to the agency and can be revised. GAO will continue to examine HHS’s oversight of COVID-19 relief funds. High-Risk Designation: HHS’s Leadership and Coordination of Public Health Emergencies For more than a decade, GAO has reported on HHS’s execution of its lead role in preparing for, and responding to, a range of public health emergencies and has found persistent deficiencies in its ability to perform this role. These deficiencies have hindered the nation’s response to the current COVID-19 pandemic and a variety of past threats, including other infectious diseases—such as the H1N1 influenza pandemic, Zika, and Ebola—and extreme weather events, such as hurricanes. As devastating as the COVID-19 pandemic has been, more frequent extreme weather events, new viruses, and bad actors who threaten to cause intentional harm loom, making the deficiencies GAO has identified particularly concerning. Not being sufficiently prepared for a range of public health emergencies can also negatively affect the time and resources needed to achieve full recovery. While HHS has taken some actions to address the 115 recommendations GAO has made related to its leadership and coordination of public health emergencies since fiscal year 2007, 72 remain open. For example, HHS has not addressed our September 2020 recommendation to work with the Federal Emergency Management Agency to develop plans to mitigate supply chain shortages for the remainder of the pandemic, thus contributing to the shortage of such supplies as of January 2022. Also, while HHS began to procure additional tests in the latter part of 2021 and into 2022, and the White House recently appointed a new testing coordinator, HHS had not issued a comprehensive and publicly available testing strategy, which we recommend it do in January 2021. Such a strategy is needed to ensure more timely proactive action in the future and the efficient use of billions of dollars in unobligated funds. GAO’s prior work has identified persistent deficiencies in HHS’s preparedness and response efforts in several areas, including (1) establishing clear roles and responsibilities for the wide range of key federal, state, local, tribal, territorial, and nongovernmental partners; (2) collecting and analyzing complete and consistent data to inform decision-making—including any necessary midcourse changes—as well as future preparedness; (3) providing clear and consistent communication to key partners and the public; (4) establishing transparency and accountability to help ensure program integrity and build public trust; and (5) understanding key partners’ capabilities and limitations. GAO is adding this area to the high-risk list to help ensure the executive branch and Congress pay sustained attention in order to make additional progress in implementing GAO’s open recommendations and strengthen HHS’s leadership and coordination role for future public health emergencies. Why GAO Did This Study At the beginning of January 2022, the U.S. had about 56 million reported cases of COVID-19 and over 830,000 reported deaths, according to CDC. The country also experiences lingering economic repercussions related to the pandemic, including rising inflation and ongoing supply chain disruptions. Six relief laws, including the CARES Act, have been enacted to address the public health and economic threats posed by COVID-19. As of November 30, 2021 (the most recent date for which data were available), the federal government had obligated a total of $4 trillion and expended $3.5 trillion, 88 and 77 percent, respectively, of the total COVID-19 relief funds provided by these six laws. 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, GAO’s ninth, examines the federal government’s continued efforts to respond to, and recover from, the COVID-19 pandemic. GAO reviewed federal data and documents. GAO also interviewed federal and state officials and other stakeholders.
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- Taxpayer Advocate Service: Opportunities Exist to Improve Reports to Congress
June 17, 2021What GAO Found The budget for the Internal Revenue Service’s (IRS) Taxpayer Advocate Service (TAS) declined by about 14 percent from fiscal years 2011 to 2020, when adjusted for inflation. For fiscal year 2020, TAS used most of its resources to assist individual taxpayers, known as case advocacy. TAS allocated about 76 percent of its $222 million budget and 86 percent of its almost 1,700 full-time equivalents to this purpose. The percentage of resources for case advocacy has decreased during the past decade—in fiscal year 2011 about 85 percent of the budget was devoted to it. For the same period, resources to address broader issues affecting groups of taxpayers, known as systemic advocacy, increased from 9 percent to 14 percent of the total budget. This shift is due in part to the reallocation of staff to better integrate systemic advocacy work and TAS’s overall attrition rate more than doubling to 15.9 percent between fiscal years 2011 and 2019. Since 2011, TAS has received more than 2 million taxpayer cases, of which almost half were referrals from other IRS offices. TAS closed more cases than it received each year from 2012 to 2017, but its inventory has grown since fiscal year 2018, due in part to attrition in case advocacy staff and an increase in taxpayers seeking assistance (see figure below). Number of Taxpayer Cases Received and Closed, Fiscal Years 2011 to 2020 TAS has recently modified its two mandated reports to Congress by reducing their length and separately compiling legislative recommendations. It shortened its annual reports in part because the Taxpayer First Act reduced the required number of most serious taxpayer problems from “at least 20” to “the 10” most serious problems. GAO identified the following additional actions that could further improve TAS reporting. Report outcome-oriented objectives and progress. The objectives for the upcoming fiscal year that TAS included in its most recent report are not always clearly identified and do not link to the various planned activities that are described. Further, the objectives TAS does identify do not include measurable outcomes. In addition, TAS’s reports do not include the actual results achieved against objectives so it is not possible to assess related performance and progress. Improved performance reporting could help both TAS and Congress better understand which activities are contributing toward achieving TAS’s objectives and where actions may be needed to address any unmet goals. Consult with Congress and other stakeholders. TAS briefs congressional committees each year after publishing its annual report and solicits perspectives from stakeholders. TAS officials said they incorporate the perspectives into its objectives. However, TAS does not follow leading practices to consult congressional committees about its goals and objectives prior to publication at least once every 2 years. Thus, it misses opportunities to obtain congressional input on its objectives and performance reporting. Consultations would provide TAS opportunities to confirm if its goals incorporate congressional and other stakeholder perspectives and whether its reports meet their information needs. Publish updates on recommendation implementation status. By law, TAS’s annual report must include an inventory of actions IRS has fully, partially, and not yet taken on TAS’s recommendations to address the most serious problems facing taxpayers. If those recommendations take multiple years to implement, which some have as shown in the table below, updating the inventory would be required. In its objectives reports, TAS provides only a one-time inventory of IRS responses to TAS’s recommendations made during the preceding year, including plans and preliminary actions taken for those IRS accepts for implementation. TAS does not publicly update the inventory in subsequent annual reports to reflect actions IRS takes or does not take to address TAS’s recommendations. This reporting approach does not provide complete information on the status of actions IRS has taken to address serious problems facing taxpayers and also does not provide the information in the annual report, as required. Publishing such updated status information would support congressional oversight. Taxpayer Advocate Service’s (TAS) Recommendation Reporting and Status as of the Fourth Quarter of Fiscal Year 2020 GAO also identified options for TAS to consider to improve its reporting. These options include explaining changes to the list of the most serious taxpayer problems from year to year and streamlining report sections congressional staff use less frequently. Why GAO Did This Study TAS, an independent office within IRS, helps taxpayers resolve problems with IRS and addresses broader, systemic issues that affect groups of taxpayers by recommending administrative and legislative changes to mitigate such problems. Congress mandated that TAS issue two reports every year—one known as the annual report which includes sections on, among other things, the 10 most serious problems encountered by taxpayers, and the other known as the objectives report that discusses organizational objectives. GAO was asked to review how TAS carries out its mission, focusing on resources and reporting. This report (1) describes TAS’s resources and workload, and (2) assesses TAS’s reporting to Congress and identifies opportunities for improvement. GAO reviewed documents from TAS, IRS, and other sources, including TAS’s annual and objectives reports and internal guidance; analyzed TAS’s budget, staffing, and workload data for fiscal years 2011 through 2020; and interviewed knowledgeable TAS and IRS officials. GAO assessed TAS’s reporting of its objectives and performance against statutory requirements, relevant internal control standards, and selected key practices for performance reporting developed by GAO. In addition, GAO reviewed relevant TAS web pages, analyzed the length and composition of TAS’s reports, and interviewed key congressional committee staff to identify additional options to improve TAS’s reporting.
- COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations
November 17, 2020Through 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 firstname.lastname@example.org, or Alyssa M. Hundrup at (202) 512-7114 or email@example.com.
- Intellectual Property: Additional Agency Actions Can Improve Assistance to Small Businesses and Inventors
September 28, 2020The U.S. Patent and Trademark Office (USPTO) offers multiple programs that help small businesses and inventors with acquiring intellectual property protections, which can help protect creative works or ideas. These programs, such as the Inventors Assistance Center, are aimed at assisting the public, especially small businesses and inventors, with intellectual property protections. Several stakeholders GAO interviewed said that USPTO programs have been helpful, but they were also not aware of some USPTO programs. Although these programs individually evaluate how they help small businesses and inventors, the agency does not collect and evaluate overall information on whether these programs are effectively reaching out to and meeting the needs of these groups. Under federal internal control standards, an agency should use quality information to achieve its objectives. Without an agency-wide approach to collect information to help evaluate the extent to which its programs serve small businesses and inventors, USPTO may not have the quality information needed to fully evaluate the effectiveness of its outreach and assistance for these groups and thus make improvements where necessary. Although the Small Business Administration (SBA) coordinates with USPTO through targeted efforts to provide intellectual property training to small businesses, it has not fully implemented some statutory requirements that can further enhance this coordination. While SBA and the Small Business Development Centers (SBDCs) coordinate with USPTO programs at the local level to train small businesses on intellectual property protection (see figure), this coordination is inconsistent. For example, two of the 12 SBDCs that GAO interviewed reported working primarily with USPTO to help small businesses protect their intellectual property, but the other 10 did not. The Small Business Innovation Protection Act of 2017 requires SBA and USPTO to coordinate and build on existing intellectual property training programs, and requires that SBA’s local partners, specifically the SBDCs, provide intellectual property training, in coordination with USPTO. SBA officials reported that they are in the process of implementing requirements of this act. Incorporating selected leading practices for collaboration, such as documenting the partnership agreement and clarifying roles and responsibilities, could help SBA and USPTO fully and consistently communicate their existing resources to their partners and programs, enabling them to refer these resources to small businesses and inventors. Figure: The Small Business Administration (SBA) and the U.S. Patent and Trademark Office (USPTO) Coordinate at the Local Level, but Are Inconsistent Small businesses employ about half of the U.S. private workforce and create approximately two-thirds of the nation’s jobs. For many small businesses, intellectual property aids in building market share and creating jobs. Among the federal agencies assisting small businesses with intellectual property are USPTO, which grants patents and registers trademarks, and SBA, which assists small businesses on a variety of business development issues, including intellectual property. GAO was asked to review resources available to help small businesses and inventors protect intellectual property, and their effectiveness. This report examines, among other things, (1) the extent to which USPTO evaluates the effectiveness of its efforts to assist small businesses and (2) SBA’s coordination with USPTO to assist small businesses. GAO analyzed agency documents and interviewed officials who train and assist small businesses. GAO also interviewed stakeholders, including small businesses, and, among other things, reviewed federal internal control standards and selected leading practices for enhancing interagency collaboration. GAO is making four recommendations, including that USPTO develop an agency-wide approach to evaluate the effectiveness of its efforts to help small businesses and inventors, and that SBA document its partnership agreement with USPTO and clarify roles and responsibilities for coordinating with USPTO to provide training. Both agencies agreed with GAO’s recommendations. For more information, contact John Neumann, (202) 512-6888, NeumannJ@gao.gov.
- Small Business Contracting: Better Documentation and Reporting Needed on Procurement Center Representatives
July 30, 2020The Small Business Administration (SBA) does not maintain complete documentation to support data on the activities of procurement center representatives (PCR), which is information used to oversee PCRs and assess their performance. PCRs are responsible for helping small businesses gain access to federal contracting and subcontracting opportunities—for example, by making set-aside recommendations to federal agency contracting officers. SBA area offices generate a monthly report that summarizes data on PCRs’ activities and accomplishments, and SBA procedures require PCRs to maintain these reports and the supporting documentation. GAO found that they do not consistently do either. According to SBA officials, in some cases the supporting documentation, which PCRs store on their individual computers or in their offices, either was destroyed or was not maintained after PCRs left their positions. Officials told GAO that SBA recently implemented a new database and established a policy requiring the monthly reports to be maintained in the database. However, SBA has not established a centralized means of maintaining the supporting documentation. A central repository for PCRs to store their supporting documentation would provide greater assurance that the documentation is maintained as required and help SBA verify the accuracy of the data PCRs report on their activities. SBA assigns PCRs to buying activities, divisions in federal agencies that purchase goods and services based on geographic coverage and other factors. Specifically, PCRs are assigned within one of six regional areas to ensure geographic coverage, at specific federal agencies, and at buying activities that have significant opportunities for small business contracting. However, SBA has not submitted required reports to Congress on its rationale for assigning PCRs to cover buying activities. The Small Business Act, as amended, requires that SBA submit a report (1) identifying each area for which SBA has assigned a PCR, (2) explaining why SBA selected the areas for assignment, and (3) describing the activities performed by PCRs. SBA was required to submit the first report to Congress by December 26, 2010, and subsequent reports every 3 years thereafter. SBA officials told GAO they were not aware of the reporting requirement. As a result, Congress lacks the information these reports were intended to provide, information that could be useful for its oversight of PCRs. The Small Business Act establishes tools to enhance procurement opportunities for small businesses, such as set-asides and requirements that large contractors set goals for using small business subcontractors. SBA’s PCRs advocate for the inclusion of small businesses during the procurement process. GAO was asked to examine how PCRs help small businesses gain access to federal contracting and subcontracting opportunities. This report addresses, among other objectives, (1) documentation SBA maintains on the activities of PCRs and (2) how SBA assigns PCRs to cover buying activities and its requirement to report to Congress on these assignments. GAO reviewed SBA policies and procedures, data on PCR assignments, and selected data reported by PCRs and related documentation. GAO also interviewed agency officials. GAO recommends that SBA (1) develop a central repository for PCRs to store the supporting documentation for the data they report on their activities and (2) ensure that it submits required reports to Congress on PCRs’ assignments and activities. SBA concurred with both recommendations. For more information, contact William B. Shear at (202) 512-8678 or firstname.lastname@example.org.
- Priority Open Recommendations: U.S. Agency for International Development
May 24, 2021What GAO Found In April 2020, GAO identified three priority recommendations for the U.S. Agency for International Development (USAID). Since then, USAID has implemented all three of those recommendations by taking actions to improve management and oversight of international food assistance projects, project performance data collection, and reform efforts. In May 2021, GAO identified three additional priority recommendations for USAID, bringing the total number to three. These recommendations involve the following areas: Complying with Equal Employment Opportunity requirements Improving financial information USAID’s continued attention to these issues could lead to significant improvements in government operations. Why GAO Did This Study Priority open recommendations are the GAO recommendations that warrant priority attention from heads of key departments or agencies because their implementation could save large amounts of money; improve congressional and/or executive branch decision-making on major issues; eliminate mismanagement, fraud, and abuse; or ensure that programs comply with laws and funds are legally spent, among other benefits. Since 2015 GAO has sent letters to selected agencies to highlight the importance of implementing such recommendations. For more information, contact Thomas Melito at (202) 512-9601 or email@example.com.
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