Question:
Why GAO Did This Study

The success of the decennial census depends in large part on the Bureau's ability to locate every household in the United States. To accomplish this monumental task, the Bureau must maintain accurate address and map information for every location where a person could reside. For the 2018 End-to-End Test, census workers known as listers went door-to-door to verify and update address lists and associated maps in selected areas of three test sites—Bluefield-Beckley-Oak Hill, West Virginia; Pierce County, Washington; and Providence County, Rhode Island.
GAO was asked to review in-field address canvassing during the End-to-End Test. This report determines whether key address listing activities functioned as planned during the End-to-End Test and identifies any lessons learned that could inform pending decisions for the 2020 Census. To address these objectives, GAO reviewed key documents including test plans and training manuals, as well as workload, productivity and hiring data. At the three test sites, GAO observed listers conducting address canvassing.

What GAO Found

The Census Bureau (Bureau) recently completed in-field address canvassing for the 2018 End-to-End Test. GAO found that field staff known as listers generally followed procedures when identifying and updating the address file; however, some address blocks were worked twice by different listers because the Bureau did not have procedures for reassigning work from one lister to another while listers work offline. Bureau officials told GAO that they plan to develop procedures to avoid duplication but these procedures have not been finalized. Duplicating work decreases efficiency and increases costs.
GAO also found differences between actual and projected data for workload, lister productivity, and hiring.
For the 2020 Census, the Bureau estimates it will have to verify 30 percent of addresses in the field. However, at the test sites, the actual workload ranged from 37 to 76 percent of addresses. Bureau officials told GAO the 30 percent was a nationwide average and not site specific; however, the Bureau could not provide documentation to support the 30 percent workload estimate.
At all three test sites listers were significantly more productive than expected possibly because a design change provided better quality address and map data in the field, according to the Bureau.
Hiring, however, lagged behind Bureau goals. For example, at the West Virginia site hiring was only at 60 percent of its goal. Bureau officials attributed the shortfall to a late start and low unemployment rates.
Workload and productivity affect the cost of address canvassing. The Bureau has taken some steps to evaluate factors affecting its estimates, but continuing to so would help the Bureau refine its assumptions to better manage the operation's cost and hiring.
Listers used laptops to connect to the Internet and download assignments. They worked offline and went door-to-door to update the address file, then reconnected to the Internet to transmit their completed assignments. Bureau officials told GAO that during the test 11 out of 330 laptops did not properly transmit address and map data collected for 25 blocks. Data were deleted on 7 laptops. Because the Bureau had known there was a problem with software used to transmit address data, it created an alert report to notify the Bureau staff if data were not properly transmitted. However, Bureau officials said that either responsible staff did not follow procedures to look at the alert reports or the reports were not triggered. The Bureau is working to fix the software problem and develop new alert reports, but has not yet determined and addressed why these procedures were not followed.
The Bureau's data management reporting system did not always provide accurate information because of a software issue. The system was supposed to pull data from several systems to create a set of real-time cost and progress reports for managers to use. Because the data were not accurate, Bureau staff had to rely on multiple systems to manage address canvassing. The Bureau agreed that not only is inaccurate data problematic, but that creating workarounds is inefficient. The Bureau is developing new requirements to ensure data are accurate but these requirements have not been finalized.

What GAO Recommends

GAO is making seven recommendations to the Department of Commerce and Bureau including to: (1) finalize procedures for reassigning work, (2) continue to evaluate workload and productivity data, (3) fix software problem, or determine and address why procedures were not followed, and (4) finalize report requirements to ensure data are accurate. The Department of Commerce agreed with GAO's recommendations, and the Bureau provided technical comments that were incorporated, as appropriate.


Question:
Why GAO Did This Study

The ODA provides incentives, including tax credits and exclusive marketing rights, for manufacturers to develop drugs to treat rare diseases, which are typically defined as affecting fewer than 200,000 people in the United States. Approximately 7,000 rare diseases affect an estimated 30 million people in the United States, and only 5 percent of rare diseases have FDA-approved treatments.
GAO was asked to examine FDA's orphan drug processes. In this report, GAO examines, among other things, (1) the actions FDA has taken to address the growing demand for orphan designations; (2) the extent to which FDA has used consistent criteria and complete information in reviewing orphan designation applications; and (3) the steps FDA has taken to address rare disease drug development challenges. GAO analyzed FDA documents and data, as well as all designation review templates FDA completed as of March 2018 for applications received from October to December 2017. GAO interviewed agency officials, as well as stakeholders, including drug manufacturers, industry experts, and patient advocacy groups.

What GAO Found

The Food and Drug Administration's (FDA) Office of Orphan Products Development is responsible for reviewing drug manufacturer applications for orphan designation. Drugs granted this designation treat rare diseases and may receive various incentives under the Orphan Drug Act (ODA). As the number of orphan designation applications received and granted has grown, FDA outlined several process changes in its June 2017 modernization plan to improve designation review timeliness and consistency.
In evaluating designation applications, FDA reviewers generally apply two consistent criteria—(1) the size of the rare disease population, and (2) the scientific rationale that the drug may effectively treat the disease. To inform their evaluation, reviewers must record certain background information in a standard review template, such as the drug's U.S. marketing history. Officials told us this information provides important context, such as whether FDA has experience with a little known disease, critical to ensuring a complete designation application review. However, GAO's analysis of 148 designation review templates found that FDA does not consistently record or evaluate background information when making designation decisions. For example, 48 of 148 review templates GAO analyzed were missing information on the drug's U.S. marketing history. As such, FDA cannot be sure that reviewers are conducting complete evaluations that include all critical information needed for assessing its criteria.
Stakeholders GAO interviewed and research GAO reviewed identified a number of rare disease drug development challenges, such as the difficulty in recruiting small populations for clinical trials, with differing opinions about the ODA incentives. For example, several stakeholders were critical of manufacturers obtaining multiple orphan designations—and ODA incentives—for the same drug when the drug may otherwise be profitable from treating multiple patient groups. However, many patient advocacy groups noted that granting ODA incentives in these circumstances is needed to encourage drug manufacturers to study the safety and efficacy of drugs in rare disease populations.

What GAO Recommends

FDA should ensure that all required information for reviews of orphan designation applications is consistently recorded and evaluated. The agency concurred with our recommendation.


Question:
Why GAO Did This Study

DHS has employed a variety of technology, tactical infrastructure, and personnel assets to help secure the nearly 2,000 mile long southwest border. Since 2009, GAO has issued over 35 products on the progress and challenges DHS has faced in using technology, infrastructure, and other resources to secure the border. GAO has made over 50 recommendations to help improve DHS's efforts, and DHS has implemented more than half of them.
This statement addresses (1) DHS efforts to deploy and measure the effectiveness of surveillance technologies, (2) DHS efforts to maintain and assess the effectiveness of existing tactical infrastructure and to deploy new physical barriers, and (3) staffing challenges the Border Patrol has faced. This statement is based on three GAO reports issued in 2017, selected updates conducted in 2017, and ongoing work related to DHS acquisitions and the construction of physical barriers. For ongoing work GAO analyzed DHS and CBP documents, interviewed officials within DHS, and visited border areas in California.

What GAO Found

The U.S. Border Patrol, within the Department of Homeland Security's (DHS) U.S. Customs and Border Protection (CBP), has made progress deploying surveillance technology—a mix of radars, sensors, and cameras—along the southwest U.S. border. As of October 2017, the Border Patrol had completed the planned deployment of select technologies to several states along the southwest border. The Border Patrol has also made progress toward assessing performance of surveillance technologies, but additional actions are needed to fully implement GAO's 2011 and 2014 recommendations in this area. For example, the Border Patrol has not yet used available data to determine the contribution of surveillance technologies to border security efforts.
CBP spent about $2.3 billion to deploy fencing from fiscal years 2007 through 2015 and constructed 654 miles of fencing by 2015. The Border Patrol has reported that border fencing supports agents' ability to respond to illicit cross-border activities by slowing the progress of illegal entrants. GAO reported in February 2017 that CBP was taking a number of steps in sustaining tactical infrastructure—such as fencing, roads, and lighting—along the southwest border. However, CBP has not developed metrics that systematically use data it collects to assess the contributions of border fencing to its mission, as GAO has recommended. CBP concurred with the recommendation and plans to develop metrics by January 2019. Further, CBP established the Border Wall System Program in response to a January 2017 executive order that called for the immediate construction of a southwest border wall. This program is intended to replace and add to existing barriers along the southwest border. In April 2017, DHS leadership gave CBP approval to procure barrier prototypes, which are intended to help inform new design standards for the border wall system.
Physical Barriers in San Diego, California, April 2016
The Border Patrol has faced challenges in achieving a staffing level of 21,370 agents, the statutorily-established minimum from fiscal years 2011 through 2016. As of September 2017, the Border Patrol reported it had about 19,400 agents. GAO reported in November 2017 that Border Patrol officials cited staffing shortages as a challenge for optimal deployment. As a result, officials had to make decisions about how to prioritize activities for deployment given the number of agents available.

What GAO Recommends

In recent reports, GAO made or reiterated recommendations for DHS to, among other things, assess the contributions of technology and fencing to border security. DHS generally agreed, and has actions planned or underway to address these recommendations.


Question:
Why GAO Did This Study

Since the 1970s, U.S. agencies have recognized that high-volume cigarette sales at duty-free stores near the U.S.–Mexico land border, although lawful, could be related to illicit activity. In 1988, U.S. law limited the quantity of duty-free tobacco products an individual can purchase at stores located in airports, restricting the sale of tobacco products to quantities consistent with personal use. This requirement, however, does not apply to land border duty-free stores.
GAO was asked to review information on sales of cigarettes at duty-free stores along the southwest border. CBP identified 88 such stores and warehouses. This report describes (1) requirements that govern the lawful sale and export of cigarettes from duty-free stores on the southwest border and schemes for illicit trade in such cigarettes, (2) U.S. agency observations about these exports and efforts to counter illicit trade, (3) the extent to which selected cigarette transaction data submitted by duty-free stores indicate compliance issues. GAO analyzed Census data on these exports; reviewed CBP, ICE, and Department of the Treasury documents; and interviewed agency officials in Washington, D.C., and in several ports along the southwest border, including Laredo, Texas, and the San Diego, California, area.

What GAO Found

Duty-free stores at the southwest border may sell tax-exempt cigarettes in any quantity to passengers departing the United States for Mexico; agencies have identified schemes associated with duty-free cigarette sales used to evade U.S. and Mexican taxes. U.S. Customs and Border Protection (CBP), an agency within the Department of Homeland Security (DHS), regulates duty-free stores. U.S. regulations require the stores to have procedures to provide reasonable assurance of export of cigarettes and the exporter to report export information on transactions valued at over $2,500. U.S. Census Bureau (Census) data show that about 18,500 such transactions involving cigarettes occurred from 2010 to 2015. According to information from U.S. and Mexican officials, the Mexican government limits the amount of duty-free cigarettes that can be brought into Mexico (see figure). U.S. agencies identified three schemes to evade U.S. and Mexican cigarette-related tax and other laws: (1) diversion from a duty-free store into U.S. commerce; (2) smuggling into Mexico through U.S. ports; and (3) smuggling back into the United States after export to Mexico.
U.S. agency officials said that some smuggling of duty-free cigarettes across the southwest border has links to organized crime, supplies the illicit tobacco market in Mexico, and poses oversight and enforcement challenges. U.S. Immigration and Customs Enforcement (ICE) officials said they have identified links between the smuggling of large quantities of duty-free cigarettes and transnational criminal organizations that use the smuggled cigarettes to launder money and generate revenue. Inexpensive cigarettes made in the United States are part of the trade in duty-free cigarettes along the southwest border, including brands that a Mexican official stated are prohibited for sale in Mexico. U.S. officials reported that their efforts to counter the illicit trade in duty-free cigarettes face challenges, primarily due to the ability to buy unlimited quantities of duty-free cigarettes at the land border.
According to CBP, in many cases, duty-free stores on the southwest border are filing noncompliant information that they are required to report on cigarette exports valued at more than $2,500. For example, officials had compliance concerns with filings in which stores identify themselves, and not the purchaser, as the exporter. CBP and Census have met with representatives of one of the largest operators of duty-free stores on the southwest border to clarify regulatory requirements. However, CBP officials said that this duty-free store operator continues to make incorrect filings. CBP has not issued guidance to all operators to clarify the correct procedure. Without accurate export data, agencies may lack the information they need to enhance their enforcement and intelligence efforts.

What GAO Recommends

CBP should take steps to strengthen compliance with export reporting requirements for duty-free cigarette sales on the southwest border, such as issuing guidance to all duty-free store operators. DHS agreed and noted CBP plans to address the recommendation.


Question:
Why GAO Did This Study

SNAP is the largest federally funded nutrition assistance program, providing about $64 billion in benefits to over 20 million households in fiscal year 2017. FNS oversees SNAP at the federal level and is responsible for authorizing and overseeing retailers. While most benefits are used as intended, some retailers have engaged in trafficking, which represents fraud and diverts federal funds from their intended use. GAO was asked to review FNS's efforts to address SNAP retailer trafficking since GAO's last report in 2006.
This report examines (1) what is known about the extent of SNAP retailer trafficking, and (2) the extent to which FNS has taken steps intended to improve how it prevents, detects, and responds to retailer trafficking. GAO reviewed relevant federal laws and regulations, FNS policies, and studies related to retailer trafficking; assessed FNS's use of statistical standards for federal agencies and selected leading practices in GAO's Fraud Risk Framework ; and interviewed FNS and USDA Office of Inspector General officials and key stakeholders.

What GAO Found

The U.S. Department of Agriculture (USDA) Food and Nutrition Service's (FNS) estimates of retailer trafficking—when a retailer exchanges Supplemental Nutrition Assistance Program (SNAP) benefits for cash instead of food—have limitations, though they suggest trafficking has increased in recent years, to $1 billion each year from 2012 to 2014. One key limitation of the estimates is that FNS has not evaluated the accuracy of its assumption about the percentage of SNAP benefits trafficked. FNS assumes that, among stores that trafficked, 90 percent of the benefits redeemed in small stores, and 40 percent in large stores, were trafficked. A former FNS official stated that this assumption is based on discussions with investigators in the 1990s when FNS first developed its approach to estimate trafficking, and that they have not since evaluated it for accuracy. However, there are options available for evaluating this assumption, such as reviewing SNAP transaction data from stores that are known to have trafficked. Statistical standards for federal agencies indicate that assumptions should be reviewed for accuracy and validated using available, independent information sources. By not evaluating this key assumption, FNS's commonly cited estimates of SNAP fraud are potentially inaccurate.
FNS has generally taken steps to address retailer trafficking that align with leading fraud risk management practices, but the agency has not pursued additional actions to prevent and respond to trafficking. For example:
Although FNS assigns a risk level to each store when it applies to participate in SNAP, it is not currently using this information to target its reauthorization activities to stores of greatest risk. During reauthorization, FNS reviews previously approved stores for continued compliance with program requirements. FNS currently reauthorizes all stores on the same 5-year cycle, regardless of risk, although its policy states that it will reauthorize certain high-risk stores annually. FNS officials planned to reauthorize a sample of high-risk stores each year, but said they did not follow through with those plans. Officials also stated that they did not document an analysis of the benefits and costs of this practice, which would be consistent with leading fraud risk management practices. As a result, FNS may be missing an opportunity to provide early oversight of risky stores and prevent trafficking.
The Food, Conservation, and Energy Act of 2008 gave USDA the authority to strengthen penalties for retailers found to have trafficked, but as of November 2018, FNS had not implemented this authority. FNS proposed a related rule change in 2012 and indicated the change was necessary to deter retailers from committing program violations, but the rule was not finalized. By failing to take timely action to strengthen penalties, FNS has not taken full advantage of an important tool for deterring trafficking.

What GAO Recommends

GAO is making five recommendations, including that FNS improve its trafficking estimates by, for example, evaluating the accuracy of its assumption of the percentage of benefits that are trafficked; assess the benefits and costs of reauthorizing a sample of high risk stores more frequently than others; and move forward with plans to increase penalties for trafficking. FNS generally agreed with GAO's recommendations.


Question:
Why GAO Did This Study

Since the 2007–2009 financial crisis, federal financial regulators have issued hundreds of rules to implement reforms intended to strengthen the financial services industry. Financial regulators must comply with rulemaking requirements such as RFA when drafting and implementing regulations. Congress included a provision in statute for GAO to study these financial services regulations annually.
This annual report examines the extent to which and how financial regulators performed required RFA analyses and established policies and procedures for complying with RFA requirements, among other objectives. GAO reviewed the RFA section of financial regulators' Federal Register notices of rulemaking, related internal workpapers, and policies and procedures for conducting RFA analyses. GAO also determined the extent to which regulators' analyses reflected RFA requirements, guidance issued by the Office of Advocacy, and OMB guidance on regulatory analysis. GAO's review covered certifications in 66 final rules and regulatory flexibility analyses in 39 proposed and final rules.

What GAO Found

To comply with the Regulatory Flexibility Act (RFA), agencies generally must assess the rule's potential impact on small entities and consider alternatives that may minimize any significant economic impact of the rule (regulatory flexibility analyses). Alternatively, agencies may certify that a rule would not have a significant economic impact on a substantial number of small entities. GAO found several weaknesses with the analyses of six financial regulators (Board of Governors of the Federal Reserve System, Office of the Comptroller of the Currency, Federal Deposit Insurance Corporation, Securities and Exchange Commission, Commodity Futures Trading Commission, and Consumer Financial Protection Bureau) that could undermine the goal of RFA and limit transparency and public accountability, as shown in the following examples.
Certifications. In certifications for rules that regulators determined may affect small entities, regulators conducted analyses to support their conclusions. GAO found many analyses across all regulators lacked key information the Small Business Administration's Office of Advocacy and the Office of Management and Budget (OMB) recommend. Missing information included discussions of data sources or methodologies, consideration of broader economic impacts of the rulemaking (such as cumulative economic impacts of regulations), and definitions of the criteria regulators used for “substantial number” and “significant economic impact.”
Regulatory flexibility analyses. In many of the initial and final regulatory flexibility analyses that GAO reviewed, financial regulators' evaluation of key components required by RFA—potential economic effects and alternative regulatory approaches—was limited. Most regulators (five of six) also did not disclose data sources or methodologies used for their analyses, as OMB recommends. For most rules GAO reviewed, regulators (five of six) were unable to provide documentation supporting their regulatory flexibility analyses, as OMB recommends, including analyses supporting certification decisions. However, the extent of documentation varied by regulator.
Federal internal control standards state the importance for agency management to establish policies and procedures to achieve objectives. All but one of the financial regulators have guidelines that restate RFA requirements for certification and for preparing regulatory flexibility analyses and provide some information on how to approach these analyses. However, these regulators generally have not developed specific policies and procedures to assist staff in complying with RFA, which may contribute to the weaknesses GAO identified in the analyses. For example, regulators' guidance generally did not include procedures for evaluating a rule's potential economic impact; identifying and assessing regulatory alternatives that could minimize impact on small entities; disclosing methodology and data sources; and creating and maintaining documentation that supports findings. By not developing and implementing comprehensive policies and procedures for RFA analyses, regulators' ability to consistently and effectively meet RFA objectives may be limited.

What GAO Recommends

GAO is making a total of 10 recommendations among the six financial regulators reviewed, including that regulators develop and implement specific policies and procedures for consistently complying with RFA requirements and related guidance for conducting RFA analyses. Five agencies generally agreed with the recommendations and one did not provide written comments.


Question:
Why GAO Did This Study

Since the 1980s, the Air Force has used its HH-60G Pave Hawk helicopters to conduct life-saving missions, including for personnel recovery and medical evacuations. The aging HH-60G inventory has shrunk over the years as a result of mishaps. As the inventory was declining, the Air Force began efforts to replace its fleet with the new Combat Rescue Helicopter.
The National Defense Authorization Act for fiscal year 2018 includes a provision for GAO to review HH-60G replacement programs. This report examines: (1) the maintenance condition and service life of the Air Force's HH-60G Pave Hawk helicopters; (2) the Air Force's schedule for fielding the new Combat Rescue Helicopter in the active and reserve components; and (3) any training challenges the Air Force has identified related to this schedule.
GAO analyzed flight hour and availability data and contracts and fielding schedule for new and refurbished personnel recovery helicopters for the Air Force. GAO also analyzed documentation, and interviewed officials from the Air Force Headquarters, the Air Force major commands, including the Air National Guard and Air Force Reserve, and training and test and evaluation units to discuss challenges the Air Force expects to face as it fields its new helicopters.

What GAO Found

The material condition of the Air Forces' aging HH-60G fleet has declined and maintenance challenges have increased, in part due to extensions beyond the designed service life of the helicopters. About 68 percent of the 96-helicopter fleet were mission-capable as of fiscal year 2017, below the Air Force desired mission-capable rate of 75 percent. The fleet is experiencing maintenance challenges. For example, the helicopters undergoing depot-level maintenance spent an average of 332 days undergoing such maintenance in fiscal year 2017 compared with 233 days in fiscal year 2007, more than a 40-percent increase. Air Force officials attribute these challenges to the helicopters exceeding their initially planned service life. Currently, available helicopters across the fleet average about 7,100 flight hours about 18 percent more than their initial expected service life of 6,000 hours.
According to Air Force officials, the schedule for fielding the new Combat Rescue Helicopters generally prioritizes the replacement of helicopters with the highest number of flight hours; as a result, the active component is scheduled to begin receiving its new helicopters in fiscal year 2020, 6 years before the reserve component. In May 2018, the Air Force's active component HH-60Gs averaged about 2,000 more flight hours per helicopter than the reserve component. Under the fielding schedule, the Air National Guard squadrons are to receive new Combat Rescue Helicopters beginning in 2027, at the end of the fielding period. According to officials, in the meantime, to address aging helicopters in the Air National Guard, the Guard is scheduled to receive refurbished Army helicopters beginning in 2019. According to Air Force officials, these helicopters will have 3,000 or fewer flight hours and will be upgraded to the Air Force's HH-60G configuration. The Air Force officials explained that these helicopters are expected to increase reliability rates, reduce the need for unscheduled maintenance, and bridge the gap until the Air National Guard receives the new Combat Rescue Helicopters.
Due to the Air Force fielding schedule for the Combat Rescue Helicopters, the Air Force may face a challenge in supporting formal training for reserve component squadrons in fiscal year 2025 through 2028. The training squadrons at Kirtland and Nellis Air Force Bases conduct all formal HH-60G training for both the active and reserve components. By 2025, these training squadrons are scheduled to be completely transitioned to the new Combat Rescue Helicopters. Given the fielding schedule, the training squadrons will not have any legacy HH-60Gs for formal training for the reserve component. However, some squadrons in the reserve component are scheduled to continue flying HH-60Gs until 2028 and will still need formal training. Air Force reserve component officials did not concur with the new Combat Rescue Helicopter fielding schedule. However, Air Force officials said that they plan to maintain their fielding schedule because changing it would require renegotiation of the contract, likely increase costs, and possibly delay delivery of the new helicopters. Air Force officials acknowledged this potential training issue and told GAO that the Air Force was considering options to address it; including retaining some legacy HH-60Gs at a training squadron to provide training during any gap period.

What GAO Recommends

GAO is not making any recommendations in this report. GAO requested comments from the DOD, but none were provided.


Question:
Why GAO Did This Study

Under PPACA, states could choose to expand Medicaid coverage to certain uninsured, low-income adults. As of December 2017, 31 states and the District of Columbia chose to expand Medicaid to cover these adults, and 19 states did not.
GAO was asked to provide information about the demographic characteristics of and access to health care services for low-income adults—those with household incomes less than or equal to 138 percent of the federal poverty level—in expansion and non-expansion states. This report describes 2016 national survey estimates of (1) the number and demographic characteristics for low-income adults who were uninsured in expansion and non-expansion states, (2) unmet medical needs for low-income adults in expansion and non-expansion states and by insurance status, (3) barriers to health care for low-income adults in expansion and non-expansion states and by insurance status, and (4) having a usual place of care and receiving selected health care services for low-income adults in expansion and non-expansion states and by insurance status.
GAO obtained 2016 NHIS estimates from the National Center for Health Statistics (NCHS), the federal agency within the Department of Health and Human Services that maintains these survey data.
NHIS is a household interview survey designed to be a nationally representative sample of the civilian, non-institutionalized population residing in the United States. Estimates were calculated for demographic characteristics for uninsured, low-income adults. In addition, estimates were calculated for unmet medical needs, barriers to health care, and having a usual place of care and receiving selected health services for low-income adults in expansion and non-expansion states and by insurance status The estimates were based on responses to selected survey questions. GAO selected these survey questions from the Family and Adult Access to Health Care and Utilization and another section of the 2016 NHIS.
GAO took steps to assess the reliability of the 2016 NHIS estimates, including interviewing NCHS officials and examining the data for logical errors. GAO determined that the data were sufficiently reliable for the purposes of its analyses.
The Department of Health and Human Services provided technical comments on a draft of this report, which GAO incorporated as appropriate.

What GAO Found

According to the 2016 National Health Interview Survey (NHIS), an estimated 5.6 million uninsured, low-income adults—those ages 19 through 64—had incomes at or below the income threshold for expanded Medicaid eligibility as allowed under the Patient Protection and Affordable Care Act (PPACA). Estimates from this nationally representative survey showed that about 1.9 million of the 5.6 million uninsured, low-income adults lived in states that chose to expand Medicaid under PPACA, while the remaining 3.7 million lived in non-expansion states—those that did not choose to expand Medicaid. In 2016, over half of uninsured, low-income adults were male, over half were employed, and over half had incomes less than 100 percent of the federal poverty level in both expansion and non-expansion states.
The 2016 NHIS estimates showed that low-income adults in expansion states were less likely to report having any unmet medical needs compared with those in non-expansion states, and low-income adults who were insured were less likely to report having unmet medical needs compared with those who were uninsured. Among the low-income adults who were uninsured, those in expansion states were less likely to report having any unmet medical needs compared with those in non-expansion states.
The 2016 NHIS estimates also showed that low-income adults in expansion states were less likely to report financial barriers to needed medical care and other types of health care, such as specialty care, compared with those in non-expansion states, and low-income adults who were insured were less likely to report financial barriers to needed medical care compared with those who were uninsured.
Among low-income adults who were uninsured, those in expansion states were less likely to report financial barriers to needed medical care compared with those in non-expansion states.
Finally, the 2016 NHIS estimates showed that low-income adults in expansion states were more likely to report having a usual place of care to go when sick or needing advice about their health and receiving selected health care services compared with those in non-expansion states. The estimates also showed that low-income adults who were insured were generally more likely to report having a usual place of care and receiving selected health care services compared with those who were uninsured. Among the uninsured, relatively similar percentages of low-income adults in expansion and non-expansion states reported having a usual place of care. Similarly, estimates showed that relatively similar percentages of low-income adults who were uninsured in expansion and non-expansion states reported receiving selected health care services, such as receiving a flu vaccine or a blood pressure check.


Question:
Why GAO Did This Study

Offshore seismic surveys provide federal agencies and other entities with a wide range of data, from research on fault zones to geology that may indicate the presence of oil and gas. Companies seeking to conduct such surveys to find oil and gas resources in the OCS must obtain a permit from BOEM—which oversees offshore oil and gas activities. Man-made sources of ocean noise, such as seismic surveys, may harm marine mammals. Entities whose activities may cause the taking of marine mammals, which includes harassing or injuring an animal, may obtain incidental take authorizations for seismic surveys from NMFS or FWS, depending on the potentially affected species.
GAO was asked to provide information on the seismic permitting process. This report examines (1) BOEM's review process, the number of permit applications reviewed from 2011 through 2016, and its review time frames; and (2) NMFS's and FWS's review process, the number of incidental take authorization applications reviewed from 2011 through 2016, and their review time frames, among other objectives. GAO reviewed laws and regulations and agency documents, analyzed data on applications to BOEM, NMFS, and FWS, and interviewed agency officials.

What GAO Found

The Department of the Interior's Bureau of Ocean Energy Management's (BOEM) process and time frames for reviewing seismic survey applications differ by region along the Outer Continental Shelf (OCS). From 2011 through 2016, BOEM reviewed 297 applications and issued 264 seismic survey permits, and the reviews' time frames differed by region (see table). As part of the process, BOEM may require approved “incidental take” authorizations from the Department of Commerce's National Marine Fisheries Service (NMFS) or Interior's U.S. Fish and Wildlife Service (FWS), given the possibility such surveys may disturb or injure marine mammals. BOEM does not have statutory review time frame requirements for issuing permits, and officials said the agency starts its formal review once it determines that an application is complete. In some cases, the agency issued a permit on the same day it determined an application was complete.
NMFS and FWS follow a similar general process for reviewing incidental take authorization applications related to seismic survey activities. From 2011 through 2016, NMFS and FWS reviewed 35 and approved 28 such applications across the three OCS regions, including some authorizations related to BOEM permits as well as research seismic surveys not associated with BOEM permits. NMFS was unable to provide accurate data for the dates the agency determines an application is adequate and complete—and FWS does not record this date. For example, based on GAO's review of NMFS data, in at least two cases, the date NMFS recorded the application had been determined adequate and complete was after the date when the proposed authorization was published in the Federal Register . Federal internal control standards call for agencies to use quality information. Without guidance on how to accurately record review dates, agencies and applicants will continue to have uncertainty around review time frames. Further, under the Marine Mammal Protection Act, the agencies are to review one type of incidental take authorization application—incidental harassment authorization applications—within 120 days of receiving an application for such authorizations. NMFS and FWS have not conducted an analysis of their review time frames. Not conducting such an analysis is inconsistent with federal internal control standards that call for agency management to design control activities to achieve objectives and respond to risks. Without analyzing the review time frames for incidental harassment authorization applications and comparing them to statutory review time frames, NMFS and FWS are unable to determine whether they are meeting their objectives to complete reviews in the 120-day statutory time frame.

What GAO Recommends

GAO is recommending that both NMFS and FWS develop guidance clarifying how and when staff should record review dates of incidental take authorization applications and analyze how long the reviews take. NMFS agreed and FWS partially agreed with our recommendations.


Question:
Why GAO Did This Study

This engagement was initiated in connection with the statutory requirement for GAO to audit the U.S. government's consolidated financial statements. The 2018 National Defense Authorization Act requires that the Secretary of Defense ensure that a full audit is performed on the financial statements of DOD for each fiscal year and that the results be submitted to Congress no later than March 31 of the following fiscal year. The Navy was the first military department to assert real property audit readiness related to DOD's Financial Improvement and Audit Readiness effort.
For this report, GAO's objectives were to (1) determine the extent to which the Navy had internal control deficiencies, if any, that may impair its ability to assert that its buildings, as reported in its financial statements, exist and that the information about these buildings is complete and adequately supported by property records and (2) identify the challenges, if any, that Navy faces in valuing its buildings in accordance with federal accounting standards. GAO reviewed the Navy's policies and procedures for control activities over its buildings, performed data analyses, and tested a nongeneralizable sample of buildings. GAO also discussed with Navy officials the challenges in complying with federal accounting standards for valuing its buildings.

What GAO Found

Although the United States Navy (Navy) has taken actions to become audit ready for its real property, GAO identified internal control deficiencies that impaired the Navy's ability to assert that (1) buildings recorded in the internet Navy Facility Assets Data Store (iNFADS), the Navy's real property system, and reported as assets in its financial statements existed and (2) all of the Navy's buildings were recorded in iNFADS and correctly reported as assets in the Navy's financial statements. As shown in the figure below, the effects of these internal control deficiencies contributed to the Navy (1) continuing to maintain records in iNFADS for buildings that had been demolished, sometimes many years ago, and include these buildings as assets in its financial statements; (2) excluding some of the buildings it owns from being recorded in iNFADS and reported as assets in its financial statements; (3) erroneously reporting nonfunctional buildings as assets in its financial statements; and (4) excluding certain buildings from being reported as assets in its financial statements that met or exceeded the Department of Defense's (DOD) capitalization threshold.
The Navy has various efforts under way to address challenges in valuing its buildings for financial reporting in accordance with federal accounting standards. Navy officials have acknowledged that significant delays can sometimes occur in the Navy being able to complete supporting documentation of the final costs to properly report buildings in its financial statements. Additionally, implementation of the Navy's new methodology to properly account for capital improvements will be critical for capturing accurate costs for buildings. Furthermore, the Navy has not consistently completed a physical inventory (asset evaluation) for each building every 5 years as required by DOD policy. These asset evaluations are an important control to help ensure that the information recorded for buildings in iNFADS is accurate. Finally, the Navy also faces a challenge in determining the placed in service dates for those buildings found through inventory procedures. The Navy's use of the date the building was found rather than the estimated date the building was placed in service can substantially affect the accuracy of the information in the Navy's systems and financial statements. Navy officials are aware of these challenges and have various efforts under way to address them. Effective implementation of these efforts is crucial to help address these challenges.

What GAO Recommends

GAO is making four recommendations to the Navy to improve internal controls for its buildings by implementing needed written procedures and control activities. The Navy concurred with these recommendations.


Question:
Why GAO Did This Study

In October 2017, the Department of Commerce (Commerce) announced that the projected life-cycle cost of the 2020 Census had climbed to $15.6 billion, a more than $3 billion (27 percent) increase over its 2015 estimate. A high-quality, reliable cost estimate is a key tool for budgeting, planning, and managing the 2020 Census. Without this capability, the Bureau is at risk of experiencing program cost overruns, missed deadlines, and performance shortfalls.
GAO was asked to evaluate the reliability of the Bureau's life-cycle cost estimate. This report evaluates the reliability of the Bureau's revised life-cycle cost estimate for the 2020 Census and the extent to which the Bureau is using it as a management tool, and compares the 2015 and 2017 cost estimates to describe key drivers of cost growth. GAO reviewed documentary and testimonial evidence from Bureau officials responsible for developing the 2020 Census cost estimate and used its cost assessment guide ( GAO-09-3SP ) as criteria.

What GAO Found

Since 2015, the Census Bureau (Bureau) has made significant progress in improving its ability to develop a reliable cost estimate. While improvements have been made, the Bureau's October 2017 cost estimate for the 2020 Census does not fully reflect all the characteristics of a reliable estimate. (See figure.) Specifically, for the characteristic of being well-documented, GAO found that some of the source data either did not support the information described in the cost estimate or was not in the files provided for two of its largest field operations. In GAO's assessment of the 2015 version of the 2020 Census cost estimate, GAO recommended that the Bureau take steps to ensure that each of the characteristics of a reliable cost estimate is met. The Bureau agreed and has taken steps, but has not fully implemented this recommendation.
A reliable cost estimate serves as a tool for program development and oversight, helping management make informed decisions. During this review, GAO found the Bureau used the cost estimate to inform decision making.
Factors that contributed to cost fluctuations between the 2015 and 2017 cost estimates include:
Changes in assumptions. Among other changes, a decrease in the assumed rate for self-response from 63.5 percent in 2015 to 60.5 percent in 2017 increased the cost of collecting responses from nonresponding housing units.
Improved ability to anticipate and quantify risk. In general, contingency allocations designed to address the effects of potential risks increased overall from $1.3 billion in 2015 to $2.6 billion in 2017.
An overall increase in information technology (IT) costs. IT cost increases, totaling $1.59 billion, represented almost 50 percent of the total cost increase from 2015 to 2017.

What GAO Recommends

GAO is not making any new recommendations but maintains its earlier recommendation—that the Secretary of Commerce direct the Bureau to take specific steps to ensure its cost estimate meets the characteristics of a high-quality estimate. In its response to this report, Commerce generally agreed with the findings related to cost estimation improvements, but disagreed that the cost estimate was not reliable. However, until GAO's recommendation is fully implemented the cost estimate cannot be considered reliable.


Question:
Why GAO Did This Study

Tax whistleblowers who report on the underpayment of taxes by others have helped IRS collect $3.6 billion since 2007, according to IRS. IRS pays qualifying whistleblowers between 15 and 30 percent of the proceeds it collects as a result of their information. However, until February 9, 2018, IRS did not pay whistleblowers for information that led to the collection of FBAR penalties.
GAO was asked to review how often and to what extent whistleblower claims involve cases where FBAR penalties were also assessed. Among other objectives, this report (1) describes the extent to which FBAR penalties were included in whistleblower awards prior to the statutory change in definition of proceeds; (2) examines how IRS used whistleblower information on FBAR noncompliance, and how IRS responded to the statutory change in definition of proceeds; and (3) describes the purposes for which IRS collects and uses FBAR penalty data, and assesses controls for ensuring data reliability. GAO reviewed the files of 132 claims closed between January 1, 2012, and July 24, 2017, that likely included FBAR allegations; analyzed IRS data; reviewed relevant laws and regulations, and IRS policies, procedures and publications; and interviewed IRS officials.

What GAO Found

Prior to February 9, 2018, when Congress enacted a statutory change requiring the Internal Revenue Service (IRS) to include penalties for Report of Foreign Bank and Financial Accounts (FBAR) violations in calculating whistleblower awards, IRS interpreted the whistleblower law to exclude these penalties from awards. However, GAO found that some whistleblowers provided information about FBAR noncompliance to IRS. In a sample of 132 whistleblower claims closed between January 2012 and July 2017, GAO found that IRS assessed FBAR penalties in 28 cases. It is unknown whether the whistleblower's information led IRS to take action in all of these cases. These penalties totaled approximately $10.7 million. Had they been included in whistleblower awards, total awards could have increased up to $3.2 million. Over 97 percent of the FBAR penalties collected from these 28 claims came from 10 cases with willful FBAR noncompliance, for which higher penalties apply.
IRS forwards whistleblower allegations of FBAR noncompliance to its operating divisions for further examination. However, IRS Form 11369, a key form used for making award determinations, does not require examiners to include information about the usefulness of a whistleblower's information FBAR and other non-tax issues. After Congress enacted the statutory change, IRS suspended award determinations for 1 week, but resumed the program before updating the form or its instructions, or issuing internal guidance on new information required on the Form. As of June 28, 2018, IRS had not begun updating the Form 11369 or its instructions. The lack of clear instructions on the form for examiners to include information on FBAR and other non-tax enforcement collections may result in relevant information being excluded from whistleblower award decisions.
IRS maintains FBAR penalty data in a standalone database. It uses these data for internal and external reporting and to make management decisions. Because of the change in statute, IRS will need these data for determining whistleblower awards. GAO found that IRS does not have sufficient quality controls to ensure the reliability of FBAR penalty data. For example, IRS staff enter data into the database manually but there are no secondary checks to make sure the data entered are accurate. Without additional controls for data reliability, IRS risks making decisions, including award determinations, with incomplete or inaccurate data.
This is a public version of a sensitive report issued in August 2018. Information on the FBAR Database that IRS deemed to be sensitive has been omitted.

What GAO Recommends

GAO recommends IRS update IRS Form 11369 and improve controls for the reliability of FBAR penalty data. IRS agreed with all of GAO's recommendations.


Question:
Why GAO Did This Study

Facilities that produce, use, or store hazardous chemicals could be targeted or used by terrorists to inflict mass casualties, damage, and fear. DHS established the CFATS program to assess the risk posed by these facilities and inspect them to ensure compliance with DHS standards. DHS places high-risk facilities in risk-based tiers and is to conduct inspections after it approves their security plans. Under the CFATS Act of 2014, authorization for the CFATS program expires in January 2019.
GAO assessed the extent to which DHS has (1) enhanced the process for identifying high-risk facilities and assigning them to tiers, (2) conducted facility inspections and measured facility security, and (3) ensured that information is shared with emergency responders to prepare them for incidents at high-risk facilities. GAO reviewed DHS reports and data on compliance inspections and interviewed DHS officials. GAO also obtained non-generalizable information from 11 trade associations representing chemical facilities regarding DHS outreach and from 15 emergency planning committees about their awareness of CFATS and the chemicals it covers.

What GAO Found

Since 2013, the Department of Homeland Security (DHS) has strengthened its processes for identifying high-risk chemical facilities and assigning them to tiers under its Chemical Facility Anti-Terrorism Standards (CFATS) program. Among other things, DHS implemented a quality assurance review process to verify the accuracy of facility self-reported information used to identify high-risk facilities. DHS also revised its risk assessment methodology—used to assess whether chemical facilities are high-risk and, if so, assign them to a risk-based tier—by incorporating changes to address prior GAO recommendations and most of the findings of a DHS-commissioned peer review. For example, the updated methodology incorporates revisions to the threat, vulnerability, and consequence scoring methods to better cover the full range of security issues regulated by CFATS. As of February 2018, a total of 29,195 facilities—including all 26,828 facilities previously assessed and 2,367 facilities new to the program—were assessed using DHS's revised methodology. DHS designated 3,500 of these facilities as high-risk and subject to further requirements.
DHS has also made substantial progress conducting and completing compliance inspections and has begun to take action to measure facility security but does not evaluate vulnerability reduction resulting from the CFATS compliance inspection process. In 2013, GAO found that the backlog of chemical facility security plans awaiting review affected DHS's ability to conduct compliance inspections, which are performed after security plans are approved. Since then DHS has made progress and increased the number of completed compliance inspections. As of May 2018, DHS had conducted 3,553 compliance inspections. DHS has also begun to update its performance measure for the CFATS program to evaluate security measures implemented both when a facility submits its initial security plan and again when DHS approves its final security plan. However, GAO found that DHS's new performance measure methodology does not measure reduction in vulnerability at a facility resulting from the implementation and verification of planned security measures during the compliance inspection process. Doing so would provide DHS an opportunity to begin assessing how vulnerability is reduced—and by extension, risk lowered—not only for individual high-risk facilities but for the CFATS program as a whole.
DHS shares some CFATS information, but first responders and emergency planners may not have all of the information they need to minimize the risk of injury or death when responding to incidents at high-risk facilities. Facilities are currently required to report some chemical inventory information, but GAO found that over 200 CFATS chemicals may not be covered by these requirements. To improve access to information, DHS developed a secure interface called the Infrastructure Protection (IP) Gateway that provides access to CFATS facility-specific information that may be missing from required reporting. However, GAO found that the IP Gateway is not widely used at the local level. In addition, officials from 13 of the 15 Local Emergency Planning Committees—consisting of first responders and covering 373 CFATS high-risk facilities—told GAO they did not have access to CFATS data in the IP Gateway. By encouraging wider use of the IP Gateway, DHS would have greater assurance that first responders have information about high-risk facilities and the specific chemicals they possess.

What GAO Recommends

GAO recommends that DHS take actions to (1) measure reduction in vulnerability of high-risk facilities and use that data to assess program performance; and (2) encourage access to and wider use of the IP Gateway among first responders and emergency planners. DHS concurred with both recommendations and outlined efforts underway or planned.


Question:
Why GAO Did This Study

Although the United States has one of the safest food supplies in the world, foodborne illness is a common public health problem; some of this illness can be linked to produce. For example, in 2017, a Salmonella outbreak linked to imported papayas sickened more than 200 people in 23 states and killed 1. FDA's produce rule, one of a number of rules required by the FDA Food Safety Modernization Act, established the first enforceable national food safety standards for produce. The Agricultural Act of 2014 required that the produce rule include “a plan to systematically…develop an ongoing process to evaluate and respond to business concerns” about the rule and a provision for GAO to report on FDA's efforts 1 year after the promulgation of the final rule and again the following year. In November 2016, GAO issued the first report.
In this follow-up report, GAO examined (1) steps FDA has taken since GAO's 2016 review to evaluate and respond to business concerns regarding the produce rule, (2) steps FDA has taken to assess the effectiveness of its efforts to evaluate and respond to business concerns regarding the rule, and (3) challenges FDA officials reported facing in evaluating and responding to business concerns regarding the rule. GAO examined TAN questions submitted by businesses; interviewed FDA officials and representatives from groups, such as the Produce Safety Alliance, working with FDA to implement the rule; and interviewed representatives from produce industry associations and a farming organization.
GAO is not making any recommendations.

What GAO Found

Since GAO's November 2016 report on the Food and Drug Administration's (FDA) 2015 produce rule, the agency has continued to use its Technical Assistance Network (TAN) to evaluate and respond to questions and concerns about the rule. GAO found that since the issuance of its 2016 report, which contained data as of September 3, 2016, 2,665 more questions were submitted to the TAN, 230 of which pertained to the produce rule, and of those 230 questions, 154 were submitted by businesses (see fig.).
a The TAN also receives questions about other rules pertaining to the FDA Food Safety Modernization Act, such as rules on imported food and the sanitary transportation of food.
b Others include members of academia, consumers, and federal or state regulators.
Most produce rule-related TAN questions concerned agricultural water standards, such as methods for testing water. In addition to the TAN, FDA has taken other steps to evaluate and respond to business concerns, including funding training for industry and visiting farms. FDA is also reviewing the rule's water standards and published a proposed rule in September 2017 to extend the compliance dates associated with those standards in response to concerns.
FDA has begun collecting survey results on the web page used for submitting TAN questions and continues to develop a survey to assess the timeliness and quality of TAN responses. FDA also continued to develop metrics intended to assess its overall efforts to evaluate and respond to business concerns, officials reported. Produce industry representatives told GAO that FDA is open to hearing questions and concerns, but businesses need more information to comply with the rule and are awaiting FDA's forthcoming guidance on parts of the rule.
FDA officials reported facing two challenges in evaluating and responding to business concerns: identifying businesses subject to the rule and providing consistent, region-specific information in response to concerns. Officials said that the agency's cooperative agreement with 43 states plays a key role in addressing these challenges, as does the Produce Safety Network, a network of region-based FDA food safety experts.


Question:
Why GAO Did This Study

FOIA requires federal agencies to provide the public with access to government records and information based on the principles of openness and accountability in government. Each year, individuals and entities file hundreds of thousands of FOIA requests. In the last 9 fiscal years, federal agencies subject to FOIA have received about 6 million requests.
GAO was asked to review federal agencies' compliance with FOIA requirements. Our objectives, among others, were to (1) determine the extent to which agencies have implemented selected FOIA requirements; (2) describe the methods established by agencies to reduce backlogged requests and the effectiveness of those methods; and (3) identify any statutory exemptions that have been used by agencies as the basis for withholding (redacting) information from requesters.
To do so, GAO selected 18 agencies based on their size and other factors and assessed their policies against six FOIA requirements. GAO also reviewed the agencies' backlog reduction plans and developed a catalog of statutes that agencies have used to withhold information.

What GAO Found

All 18 selected agencies had implemented three of six Freedom of Information Act (FOIA) requirements reviewed. Specifically, all agencies had updated response letters to inform requesters of the right to seek assistance from FOIA public liaisons, implemented request tracking systems, and provided training to FOIA personnel. For the three additional requirements, 15 agencies had provided online access to government information, such as frequently requested records, 12 agencies had designated chief FOIA officers, and 12 agencies had published and updated their FOIA regulations on time to inform the public of their operations. Until these agencies address all of the requirements, they increase the risk that the public will lack information that ensures transparency and accountability in government operations.
The 18 selected agencies had backlogs of varying sizes, with 4 agencies having backlogs of 1,000 or more requests during fiscal years 2012 through 2016. These 4 agencies reported using best practices identified by the Department of Justice, such as routinely reviewing metrics, as well as other methods, to help reduce their backlogs. Nevertheless, these agencies' backlogs fluctuated over the 5-year period (see figure). The 4 agencies with the largest backlogs attributed challenges in reducing their backlogs to factors such as increases in the number and complexity of FOIA requests. However, these agencies lacked plans that described how they intend to implement best practices to reduce backlogs. Until agencies develop such plans, they will likely continue to struggle to reduce backlogs to a manageable level.
Agencies used various types of statutory exemptions to withhold information when processing FOIA requests during fiscal years 2010 to 2016. The majority of these fell into the following categories: personally identifiable information, national security, law enforcement and investigations, and confidential and commercial business information.

What GAO Recommends

GAO is making recommendations to 16 agencies to post records online, designate chief FOIA officers, update regulations, and develop plans to reduce backlogs. Nine agencies agreed with the recommendations, 1 both agreed and disagreed, 2 disagreed, and 4 neither agreed nor disagreed. GAO continues to believe the recommendations are valid.


Question:
Why GAO Did This Study

Each year, the DHS invests billions of dollars in a diverse portfolio of major acquisition programs to help execute its many critical missions. DHS's acquisition activities are on GAO's High Risk List, in part, because of management and funding issues.
The Explanatory Statement accompanying the DHS Appropriations Act, 2015 included a provision for GAO to review DHS's major acquisitions. This report, GAO's fourth annual review, assesses the extent to which: (1) DHS's major acquisition programs are on track to meet their schedule and cost goals, and (2) DHS has taken actions to enhance its policies and processes to better reflect key practices for effectively managing a portfolio of investments.
GAO reviewed 28 acquisition programs, including DHS's largest programs that were in the process of obtaining new capabilities as of April 2017, and programs GAO or DHS identified as at risk of poor outcomes. GAO assessed cost and schedule progress against baselines, assessed DHS's policies and processes against GAO's key portfolio management practices, and met with relevant DHS officials.

What GAO Found

During 2017, 10 of the Department of Homeland Security (DHS) programs GAO assessed that had approved schedule and cost goals were on track to meet those goals. GAO reviewed 28 programs in total, 4 of which were new programs that GAO did not assess because they did not establish cost and schedule goals before the end of calendar year 2017 as planned. The table shows the status of the 24 programs GAO assessed. Reasons for schedule delays or cost increases included technical challenges, changes in requirements, and external factors.
Recent enhancements to DHS's acquisition management, resource allocation, and requirements policies largely reflect key portfolio management practices (see table). However, DHS is in the early stages of implementing these policies.
GAO identified two areas where DHS could strengthen its portfolio management policies and implementation efforts:
DHS's policies do not reflect the key practice to reassess a program that breaches—or exceeds—its cost, schedule, or performance goals in the context of the portfolio to ensure it is still relevant or affordable. Acquisition management officials said that, in practice, they do so based on a certification of funds memorandum—a tool GAO has found to be effective for DHS leadership to assess program affordability—submitted by the component when one of its programs re-baselines in response to a breach. Documenting this practice in policy would help ensure DHS makes strategic investment decisions within its limited budget.
DHS is not leveraging information gathered from reviews once programs complete implementation to manage its portfolio of active acquisition programs. DHS's acquisition policy requires programs to conduct post-implementation reviews after initial capabilities are deployed, which is in line with GAO's key practices. Acquisition management officials said they do not consider the results of these reviews in managing DHS's portfolio because the reviews are typically conducted after oversight for a program shifts to the components. Leveraging these results across DHS could enable DHS to address potential issues that may contribute to poor outcomes, such as schedule slips and cost growth, for other programs in its acquisition portfolio.

What GAO Recommends

GAO recommends DHS update its acquisition policy to require certification of fund memorandums when programs re-baseline as a result of a breach and assess programs' post-implementation reviews to improve performance across the acquisition portfolio. DHS concurred with GAO's recommendations.


Question:
Why GAO Did This Study

NASA obligated over $18 billion in contracts and more than $1 billion in grants in fiscal year 2016, and it relies on a significant number of contractor and grantee employees to accomplish its work. These employees are legally protected from reprisal—such as demotion or firing—for whistleblowing.
GAO was asked to review NASA's whistleblower reprisal protections for contractor and grantee employees. This report addresses, among other things, the extent to which (1) NASA's Inspector General investigated contractor and grantee whistleblower reprisal complaints; (2) NASA's Administrator reviewed reprisal complaints in a timely manner; and (3) NASA communicated the applicable whistleblower reprisal protections to contractors. GAO reviewed NASA and its Inspector General's policies and guidance; reviewed a generalizable sample of 100 contracts from all NASA centers with contracts in fiscal year 2016; and interviewed relevant officials and contractors, grantees, and advocacy groups.

What GAO Found

From 2008 through June 2017, National Aeronautics and Space Administration (NASA) contractor and grantee employees submitted 48 reprisal complaints such as alleged firing or demotion for reporting fraud, waste, or abuse within the government. NASA's Inspector General addressed all 48 complaints, completed investigations for 6 of those complaints, and forwarded investigation reports to the NASA Administrator, who is responsible for making a final determination of whether reprisal occurred. The Administrator determined that none of the complaints qualified for protection under the law.
Further, in 5 of the 6 cases forwarded by the OIG, the Administrator was required by statute to make a final determination of reprisal within 30 days. GAO found that the Administrator did not meet this required time frame for all 5 cases and had no documented response for one of them (see figure for all 5 cases). According to officials from NASA's Office of General Counsel, each case must be handled on a case by case basis to ensure due process and 30 days is insufficient time to issue an order of final determination of reprisal. However, in order to ensure that whistleblower reprisal complaints are handled within required timeframes, NASA would have to monitor and evaluate its processes for making final determinations of reprisal, but it has not yet taken this step. Consequently, NASA does not know what changes may be needed to ensure that it is meeting the statutory 30-day requirement.
NASA communicates whistleblower protections to contractors through inclusion of a required contract clause. For example, GAO found that almost all—98 percent—of contracts would be expected to include a whistleblower clause as required by statute. However, certain elements of NASA whistleblower protection guidance have contributed to a different understanding of reprisal protections among officials at headquarters, a NASA center, and the Inspector General. For example, a July 2014 procurement notice and contract clause language resulted in different interpretations about when the protections apply. Federal internal control standards require that an entity should communicate necessary quality information internally to meet the objectives of its mission. Without additional clarity in its guidance on when the protections apply, NASA centers and procurement officials will be at risk of inconsistent implementation of the law.

What GAO Recommends

GAO is making three recommendations to NASA, including evaluating the process for reviewing reprisal complaints to ensure it is meeting the required timeframe and clarifying guidance on when protections apply to contractor employees. NASA agreed with the recommendations and plans to develop a documented process to ensure it reviews reprisal complaints in a timely manner and clarify guidance as appropriate, among other things.


Question:
Why GAO Did This Study

Forty railroads including Amtrak, commuter, and freight railroads are currently required by statute to implement PTC, a communications-based system designed to slow or stop a train that is not being operated safely. PTC must be interoperable, meaning trains can operate seamlessly on the same PTC-equipped track, including “tenants” that operate on track owned by another “host” railroad. Although the deadline for PTC implementation is December 31, 2018, railroads may receive a maximum 2-year extension to December 31, 2020, if they meet certain statutory criteria.
GAO was asked to review railroads' PTC implementation progress. This statement discusses (1) railroads' implementation progress and FRA's steps to assist them and (2) how railroads and FRA plan to approach the 2018 and 2020 deadlines. GAO analyzed railroads' most recent quarterly reports covering activities through June 30, 2018; sent a brief questionnaire to all 40 railroads; and interviewed officials from FRA and 16 railroads, selected in part based on those identified as at-risk by FRA.

What GAO Found

As of June 30, 2018, many railroads remained in the early stages of positive train control (PTC) implementation—including equipment installation and early field testing. About half of the 40 railroads implementing PTC reported that they are still installing equipment, though many are nearing completion. However, with the exception of the largest freight railroads—known as Class I—and Amtrak, most railroads reported less progress in later implementation stages, especially revenue service demonstration (RSD), an advanced form of field testing that is required to fully implement PTC. Of the 28 commuter railroads required to implement PTC, 19 reported initiating field testing, but only 8 reported initiating RSD. The Federal Railroad Administration (FRA) recently clarified the criteria railroads must meet to qualify for a 2-year extension past the December 31, 2018, PTC implementation deadline. To receive an extension, railroads must meet 6 statutory criteria. For the sixth criterion, commuter and smaller freight railroads are authorized to either initiate RSD on at least one track segment or use FRA-approved substitute criteria. FRA clarified these and other requirements at three PTC symposiums hosted for railroads in summer 2018. For example, FRA officials said that for railroads eligible to use substitute criteria, initiating field testing instead of RSD was one approach that could potentially receive FRA's approval. FRA's actions are consistent with GAO's March 2018 recommendation that the agency communicate to the railroads the requirements and process for an extension.
Most railroads anticipate needing an extension, leaving substantial work for both railroads and FRA to complete before the end of 2020. Thirty-two of 40 railroads reported to GAO that they, or the railroad which owns the track on which they operate, will apply for an extension. Sixteen commuter and smaller freight railroads reported planning to apply for an extension using substitute criteria, and of these, 12 intend to apply for substitute criteria based on early testing such as field testing. Though substitute criteria are authorized in law, this approach defers time-intensive RSD testing into 2019 and beyond. In addition, railroads expressed concerns with the time and effort involved with interoperability testing—a key remaining hurdle for railroads such as Class I railroads that are further along with implementation. Further, railroads expressed concern that FRA's workload will markedly increase as railroads submit requests for extension approvals. FRA has acknowledged concerns about the pending surge of submissions and has taken recent steps to help manage the forthcoming influx of documentation, such as reallocating resources. Nonetheless, given that as of early September 2018, only 1 railroad—a Class I railroad—had applied for an extension, it remains unclear how many extension requests FRA will receive or what FRA's enforcement strategy will be for noncompliance with the statute, such as for railroads that fail to apply for an extension by the deadline. In addition, challenges related to PTC implementation and FRA's resources raise questions as to the extent FRA and the railroad industry are poised for full PTC implementation by December 31, 2020.

What GAO Recommends

In March 2018, GAO recommended FRA take steps to systematically communicate extension information to railroads and to use a risk-based approach to prioritize agency resources and workload. FRA has taken some steps to address these recommendations, such as recently communicating and clarifying extension requirements to all railroads during three symposiums, and GAO will continue to monitor FRA's progress.


Question:
Why GAO Did This Study

Determining that a new medical device is safe and effective is a substantial investment of time and resources for the sponsor and FDA, the agency that regulates medical devices. FDA relies on the device sponsor to provide supporting data at the time of its original submission, and the agency can request additional information during the review. The Federal Food, Drug, and Cosmetic Act, as amended, requires that when FDA requests additional information from sponsors, the agency consider the least burdensome means of evaluating a medical device.
GAO was asked to provide information on FDA's implementation of the least burdensome requirements in its medical device review process. This report (1) describes FDA's requests for additional information and sponsor disagreements, (2) describes its least burdensome training efforts, and (3) describes FDA actions to improve its requests for additional information and examines the extent to which it has evaluated its implementation of the least burdensome requirements. GAO reviewed FDA documents and guidance and interviewed agency officials. GAO also interviewed officials from four relevant medical device manufacturing associations.

What GAO Found

Since 1997, the Food and Drug Administration (FDA) has been required to consider the least burdensome means of evaluating certain types of medical devices for marketing, including when requesting that sponsors—generally manufacturers—seeking to market their medical devices provide information in addition to what was provided in their submissions. GAO found that, from 2001 through 2016, FDA issued letters asking sponsors to provide such information for a majority of the more than 62,000 medical device submissions that it reviewed. Sponsors may formally disagree with the request on the grounds that it is not the least burdensome method needed for FDA to review the submission. For example, sponsors appealed FDA decisions internally to agency management 63 times from 2013 through 2016, and of these, FDA identified 33 such appeals in which the sponsor raised an issue related to least burdensome requirements. FDA agreed or partially agreed with the sponsors in 11 of these appeals. Medical device industry representatives noted that these appeals may not fully represent the number of such disagreements, because applicants are generally concerned that an appeal would damage their relationship with FDA and potentially negatively affect future device applications.
FDA provided staff training that was specifically dedicated to addressing the least burdensome requirements from 1997 through 1999. Since 1999, FDA has not offered a course dedicated to the least burdensome requirements, but has incorporated related concepts into other training programs, such as in a training mandatory for most new reviewers. In response to the 21st Century Cures Act, enacted in 2016, FDA is providing new least burdensome training to all relevant employees, and said that 80 percent had received the training as of October 2, 2017. Although FDA did not specifically evaluate the effectiveness of past training on least burdensome requirements, it is implementing an evaluation of all device-related training, including the new least burdensome training. It also plans to complete a required audit of training on least burdensome requirements by June 2018.
FDA has not specifically evaluated implementation of the least burdensome requirements. However, in response to broader evaluations, such as an independent assessment of its medical device review process, the agency is in the early stages of developing processes that may improve its requests for additional information. For example, FDA plans to conduct an audit of letters requesting additional information. FDA is developing the audit's methodology and expects it will assess whether the agency's process was followed. However, due to their early stage, the extent to which these efforts will allow FDA to assess implementation of the least burdensome requirements is unclear. In 2002, FDA stated that it planned to periodically assess the implementation of the least burdensome principles, and federal internal control standards identify the importance of performance metrics for such assessments. However, the agency has yet to develop performance metrics to do so. Until such measures are developed and used, FDA will not be able to evaluate whether it effectively and consistently applies a least burdensome approach in its medical device reviews.

What GAO Recommends

GAO is making one recommendation that FDA develop and use performance metrics to evaluate the implementation of the least burdensome requirements. The Department of Health and Human Services agreed with GAO's recommendation.


Question:
Why GAO Did This Study

Colombia is the world's leading producer of cocaine, with production levels more than tripling from 2013 through 2017 (see figure). The U.S. and Colombian governments have been longstanding partners in the fight against drug trafficking. Since the launch of Plan Colombia in 1999, the U.S. government has invested over $10 billion in counternarcotics efforts in Colombia. This assistance has supported a range of eradication, interdiction, and alternative development programs.
GAO was asked to review U.S. counternarcotics assistance to Colombia. This report examines (1) to what extent the U.S. government has assessed the effectiveness of its counternarcotics efforts in Colombia and (2) what is known about the effectiveness of U.S.-supported eradication, interdiction, and alternative development programs in Colombia. GAO reviewed data and documentation from U.S. agencies, performed a literature review of relevant research on counternarcotics efforts in Colombia, conducted fieldwork in Colombia, and interviewed U.S. and Colombian officials.

What GAO Found

U.S. agencies that provide counternarcotics assistance to Colombia conduct performance monitoring of their activities, such as by tracking the hectares of coca fields eradicated and the amount of cocaine seized, but have not consistently evaluated the effectiveness of their activities in reducing the cocaine supply. The U.S. Agency for International Development (USAID) has evaluated some of its alternative development programs, but the Department of State (State), which has lead responsibility for U.S. counternarcotics efforts, has not evaluated the effectiveness of its eradication and interdiction activities, as called for by its evaluation policies. Additionally, State has not conducted a comprehensive review of the U.S. counternarcotics approach, which relies on a combination of eradication, interdiction, and alternative development. Without information about the relative benefits and limitations of these activities, the U.S. government lacks key information to determine the most effective combination of counternarcotics activities.
GAO's review of U.S. agency performance monitoring data and third-party research offers some information about the relative effectiveness of eradication, interdiction, and alternative development activities. For example, available evidence indicates that U.S.-supported eradication efforts in Colombia may not be an effective long-term approach to reduce the cocaine supply, due in part to coca growers responding to eradication by moving coca crops to national parks and other areas off limits to eradication. Agency data show that U.S.-supported interdiction efforts in Colombia seized hundreds of tons of cocaine and arrested thousands of drug traffickers, yet the net cocaine supply has increased and third-party studies have mixed findings on the long-term effectiveness of interdiction efforts. USAID evaluations indicate that alternative development programs in Colombia have provided legal economic opportunities to some rural populations previously involved in illicit crop production. However, USAID as well as third-party research suggests that alternative development requires significant and sustained investment and some programs have had design and sustainability challenges.

What GAO Recommends

GAO recommends that State, in consultation with relevant agencies, (1) evaluate the effectiveness of eradication and interdiction in reducing the cocaine supply in Colombia and (2) undertake a comprehensive review of the U.S. counternarcotics approach in Colombia that considers the relative benefits and limitations between eradication, interdiction, and alternative development efforts. State generally concurred with the recommendations.


Question:
Why GAO Did This Study

IRS faces a number of challenges that pose risks to meeting its mission if not managed effectively. Key to addressing IRS's challenges is its workforce. Cultivating a well-equipped, diverse, flexible, and engaged workforce requires strategic human capital management.
GAO was asked to review IRS's enterprise-wide strategic workforce planning efforts. GAO assessed (1) how IRS defines its workforce needs and develops strategies for shaping its workforce; (2) the extent to which IRS identified the critical skills and competencies it will require to meet its goals, and its strategy to address skills gaps in its workforce; and (3) the extent to which IRS's Human Capital Office has the capacity to hire employees in hard to fill positions.
GAO analyzed trends in staffing across IRS and in selected mission critical occupations; compared IRS strategic workforce management processes, practices, and activities with federal regulations and leading practices; analyzed IRS documents and interviewed agency officials.

What GAO Found

The Internal Revenue Service (IRS) has scaled back strategic workforce planning activities in recent years. IRS officials told GAO that resource constraints and fewer staff with strategic workforce planning skills due to attrition required IRS to largely abandon strategic workforce planning activities.
However, a number of indicators, such as increasing rates of retirement eligible employees and declining employee satisfaction, led IRS to determine that continuing to make short-term, largely nonstrategic human capital decisions was unsustainable. One way IRS sought to address these issues was to develop a strategic workforce plan and associated workforce planning initiative. Initiative implementation, however, is behind schedule and on hold. IRS attributed the delay to a combination of: 1) personnel resources redirected to implement Public Law 115-97—commonly referred to as the Tax Cuts and Jobs Act, 2) lack of workforce planning skills within its Human Capital Office, and 3) delayed deployment at the Department of the Treasury (Treasury) related to a new workforce planning system. As a result, IRS lacks information about what mission critical skills it has on board, where skills gaps exist, and what skills will be needed in the future.
IRS staffing has declined each year since 2011, and declines have been uneven across different mission areas. GAO found the reductions have been most significant among those who performed enforcement activities, where staffing declined by around 27 percent (fiscal years 2011 through 2017). IRS attributed staffing declines primarily to a policy decision to strictly limit hiring. Agency officials told GAO that declining staffing was a key contributor in decisions to scale back activities in a number of program and operational areas, particularly in enforcement, where the number of individual returns audited from fiscal years 2011 through 2017 declined by nearly 40 percent.
IRS has skills gaps in mission critical occupations, and the agency's efforts to address these skills gaps do not target the occupations in greatest need, such as tax examiners and revenue officers. However, the results of an interagency working group effort that began in 2011, and was intended to address skill gaps among IRS revenue agents and other occupations with skills gaps across the government, may hold important lessons for addressing skills gaps in other mission critical occupations at IRS.
IRS's Human Capital Office has limited staffing capacity to hire employees in hard to fill positions, which holds risks for the agency's ability to implement the Tax Cuts and Jobs Act. IRS is undertaking a variety of activities to improve its hiring capacity, but has not determined how each activity will be evaluated and will contribute to increased hiring capacity or associated outcomes. In addition, changes in the agency's hiring processes have been confusing to managers and contributed to hiring delays. Clear guidance on hiring request requirements would better position IRS to avoid the risk of hiring delays for mission critical occupations.

What GAO Recommends

GAO is making six recommendations to IRS that include implementing its delayed workforce planning initiative, evaluate actions to improve the agency's hiring capacity, and address changes in its processes that have contributed to hiring delays. IRS agreed with GAO's recommendations. GAO also recommends Treasury clarify guidance to IRS on a forthcoming workforce planning system. Treasury agreed with the recommendation.


Question:
Why GAO Did This Study

During the tax filing season, generally from January to mid-April, IRS processes over 100 million individual tax returns and provides telephone, correspondence, online, and in-person service to tens of millions of taxpayers. In 2018, IRS had to begin taking steps to implement major tax law changes passed in what is commonly referred to as the Tax Cuts and Jobs Act that affect both individuals and businesses.
GAO was asked to review IRS's performance during the 2018 filing season and its efforts to implement the Tax Cuts and Jobs Act. GAO assessed IRS's (1) performance providing service to taxpayers and processing individual tax returns and (2) early efforts to implement the Tax Cuts and Jobs Act.
GAO analyzed IRS documents and data and interviewed IRS officials.

What GAO Found

The Internal Revenue Service (IRS) generally improved its customer service during the 2018 filing season compared to prior years and managed multiple return processing challenges. For the third year in a row, IRS improved its telephone service by answering 80 percent of calls seeking live assistance and reducing wait times to about 5 minutes, as of the end of the 2018 filing season. This compares to 37.5 percent of calls answered with an average wait time of about 23 minutes during the 2015 filing season. Taxpayer use of online services also increased, including irs.gov and its online account tool for taxpayers to view their balances due. However, answering taxpayer correspondence remains a challenge—IRS was late responding to about 37 percent of correspondence as of the end of the 2018 filing season compared to about 26 percent at the same time in 2017. In 2015, GAO recommended that the Department of the Treasury (Treasury) include timeliness in handling taxpayer correspondence as part of its performance goals, but as of June 2018 Treasury had not done so. Overall, despite multiple challenges including mid-filing season changes to tax law and a computer system failure, IRS met its processing targets for individual tax returns.
In 2018, IRS began taking steps to implement significant tax law changes from Public Law 115-97—commonly referred to by the President and many administrative documents as the Tax Cuts and Jobs Act. To implement the changes, IRS established a centralized office to coordinate implementation across IRS offices and divisions. IRS officials cited the broad scope and complexity of the changes—which will require extensive changes to tax forms, publications, and computer systems—along with the 1 year time frame as key implementation challenges. Although IRS has taken steps to address these challenges, such as developing a project planning tool, GAO found that the new coordination office did not initially fully include the Human Capital Office (HCO), the division responsible for managing the agency's workforce. Based on GAO's discussions with IRS officials, representatives from HCO now attend weekly coordination meetings discussing and planning the tax law changes. Involving HCO in these discussions will better position IRS to hire new employees and train them and the existing workforce. It will also help HCO better understand training requirements and staffing needs ahead of the 2019 filing season.

What GAO Recommends

Because HCO is now attending the weekly meetings, GAO is not making a related recommendation. In addition, GAO believes that its 2015 recommendation to Treasury to include timeliness in handling correspondence as part of its performance goals, which Treasury neither agreed or disagreed with, is still valid. IRS generally concurred with GAO's findings but noted concerns with interpreting the percentage of correspondence considered “overage” (more than 45 days old). GAO clarified its report but notes that while the open inventory of overage correspondence at the end of the fiscal year is not representative of total overage items for the year, the overage rates are relatively consistent throughout the year.


Question:
Why GAO Did This Study

Entities undertaking shellfish aquaculture activities (i.e., the breeding and harvesting of oysters, clams, and mussels) may need to submit an application to the Corps in certain circumstances for authorization to conduct these activities. The Corps authorizes such activities using various permits, as long as the activities comply with various environmental and other laws.
GAO was asked to review the Corps' process for authorizing shellfish aquaculture activity in U.S. coastal waters. This report describes, for 2012 through 2017, (1) the number and outcomes of the applications the Corps received for shellfish aquaculture activities and the types of permits the Corps used to authorize such activities, and (2) the experiences of permit applicants in selected districts in seeking Corps' authorization for their shellfish aquaculture activities.
GAO reviewed laws and permitting documents and analyzed data on the number, outcomes, and types of permits the Corps used for 2012 through 2017 from the Corps' permitting database and assessed its reliability. GAO also reviewed detailed information from a non-generalizable sample of 15 permit applications and interviewed the applicants and Corps officials from four Corps districts, selected to reflect variation in geographic location and shellfish activity; the information from the four districts is not generalizable to other Corps districts.

What GAO Found

The U.S. Army Corps of Engineers (Corps) authorized most (87 percent) of the 3,751 shellfish aquaculture applications it received from 2012 through 2017, according to Corps data. Of the 19 Corps districts that have coastal waters within their geographic areas of responsibility, 17 districts received and authorized applications. The majority of those districts (13 of 17) authorized applications using Nationwide Permit 48, a type of permit intended to streamline the authorization process for shellfish aquaculture activities. Additionally, districts may add conditions to nationwide permits or develop region-specific permits to address state or regional environmental concerns. Of the four districts GAO reviewed in detail, two districts added regional conditions applicable to Nationwide Permit 48, such as prohibiting shellfish activity within submerged aquatic vegetation beds or saltmarshes.
The 15 permit applicants from the four districts GAO reviewed had mixed views on their experiences with seeking authorization for their shellfish aquaculture activities. For example, 10 applicants across the four districts described the length of time to authorize their activities—ranging from 1 day to about 4 months—as reasonable, with several applicants indicating the Corps was efficient in reviewing their applications. In contrast, five applicants from three Corps districts said that the amount of time it took for the Corps to authorize their shellfish aquaculture activities—ranging from 18 days to about 8 months—was unreasonable. Corps officials from the four districts indicated they have taken some steps to help reduce authorization review time. For example, the four districts took steps to more efficiently conduct reviews under the Endangered Species Act. This has in turn helped reduce the Corps' time frames for issuing authorizations, according to Corps officials GAO interviewed. For instance, officials from one district said their review time declined from over 30 days to 1 to 2 days as a result of the change in the review process.