Background In 1992, the Prescription Drug User Fee Act (PDUFA) was enacted, in part, to provide additional funds for FDA to support the process of reviewing NDAs. PDUFA authorized FDA to collect user fees from drug sponsors to supplement its annual appropriation for salaries and expenses. PDUFA has been reauthorized every 5 years since 1992; most recently PDUFA VI reauthorized the prescription drug user fee program from fiscal year 2018 through fiscal year 2022. As part of each reauthorization process, FDA identifies goals in a commitment letter to Congress. In general, these goals identify a percentage of certain types of applications that FDA is expected to review within specified time frames, including goals for the time the agency takes to complete reviews of different types of NDAs upon initial submission and resubmission. For example, in its commitment letters for PDUFA V and VI, FDA committed to completing its initial review of 90 percent of priority NDAs that involve previously marketed or approved active ingredients within 6 months of receipt. As previously noted, four key features of NDAs are linked to drug development and review processes. For initial NDA reviews, the time frames for FDA’s review that would meet its PDUFA V and VI commitments—its PDUFA goals—vary and are linked to three key features of the NDA. (See table 1.) The target time frame for the initial review of any specific NDA under these user fee commitments reflects the goals associated with all three of the key features. The fourth key feature of NDAs is whether they qualify for one of FDA’s expedited programs. Whether designated as priority or standard, FDA may determine that NDAs for drugs intended to treat serious or life- threatening conditions qualify for development and review under one or more expedited programs. These programs confer specific benefits with the potential to help reduce the development or review time needed to bring a drug to market. For example, some expedited programs provide for more intensive drug development guidance from FDA officials or allow the applicant to submit completed sections of the NDA for review before submitting the entire application. FDA’s expedited programs include accelerated approval, breakthrough therapy designation, and fast track designation. (See table 2.) NDAs must include substantial evidence of a drug’s effectiveness, which is typically drawn from clinical trials. In traditional clinical trials, patients receiving a new drug are often compared with patients receiving a placebo or a different drug. To maximize data quality, these clinical trials are usually randomized (patients are randomly assigned to either the group receiving the new drug or a comparison group) and double-blinded (neither the patients nor the investigators know who is receiving a particular treatment). According to FDA, although this type of study design is often the most powerful tool for evaluating the safety and effectiveness of new drugs, many traditional clinical trials are becoming more costly and complex to administer. Additionally, according to FDA, many new drugs are not easily evaluated using traditional approaches. For example, drugs intended for patients with rare diseases are difficult to evaluate due to the limited number of patients affected by the disease and available for study. The Cures Act was enacted on December 13, 2016, to accelerate the discovery, development and delivery of new treatments—including drugs—for patients. Among other things, the Cures Act includes provisions for FDA to evaluate and facilitate the use of evidence from sources other than traditional clinical trials to support safety and effectiveness determinations for new drugs. For example, FDA was directed to evaluate the potential use of evidence based on data that is routinely collected outside of traditional clinical trials from sources such as electronic health records, medical claims data, and disease registries; evidence from such data sources is referred to as real-world evidence. In the commitment letter associated with PDUFA VI, which was enacted on August 18, 2017, the agency agreed to certain goals relating to the use of real-world evidence in regulatory decision-making and also agreed to certain activities intended to facilitate the development and application of an additional source of evidence known as model-informed drug development. Although these nontraditional sources of evidence were included in NDAs prior to the enactment of the Cures Act and PDUFA VI, at the time this legislation was enacted, most of them were not widely used. For example, according to FDA officials, the NDAs that included real-world evidence were generally for drugs to treat oncology diseases or rare diseases. FDA Divisions Differ in Proportions of NDAs Reviewed with One or More Key Features Our analysis of the 637 original NDAs submitted from fiscal years 2014 through 2018 indicates that divisions differed in the proportions of NDAs they reviewed that had any one of three key features that are linked to time frames for initial review under FDA’s PDUFA goals. As examples: 6 percent of the NDAs reviewed by the dermatology and dental division had a priority review designation, while 56 percent of the NDAs reviewed by the anti-infective division had a priority review designation; 4 percent of the NDAs reviewed by the anesthesia, analgesia, and addiction division involved a new molecular entity, while 52 percent of the NDAs reviewed by the neurology division involved one; and None of the NDAs reviewed by the transplant and ophthalmology division involved a major amendment, while 36 percent of the applications reviewed by the gastroenterology and inborn errors division involved one. (See fig. 1. App. IV provides more detailed information about differences between divisions in the number and proportion of NDAs with these key features.) We also found differences between divisions in the proportion of NDAs that they reviewed under an expedited program—the fourth key feature of NDAs. For example, none of the NDAs reviewed by the metabolism and endocrinology division qualified for one or more expedited programs, while 52 percent of the NDAs reviewed by the antiviral division qualified for one or more expedited programs. (See fig. 2. App. V provides more detailed information about differences between divisions in the number and proportion of NDAs that qualified for one or more expedited programs.) It is not unexpected that divisions differ in the proportion of their applications with key features linked to FDA’s time frames for review or qualification for expedited programs because the divisions are responsible for different products. For example, some divisions, such as the oncology divisions, regulate products for conditions that are more likely to be serious or life-threatening, and therefore the NDAs reviewed by these divisions are more likely to qualify for priority review designation and expedited programs, compared with other divisions, such as the dermatology and dental division. FDA Divisions Vary in Their Initial Review Times for NDAs, Largely Due to PDUFA Goals Our analysis of review times for the 637 original NDAs submitted from fiscal years 2014 through 2018 shows that FDA divisions differed in the number of days they took to complete their initial reviews. For example, the median time taken to complete an initial review of an NDA by the anti- infective division was about 2 months faster than the median time taken by the gastroenterology and inborn errors division. (For more information about initial review times, see app. VI.) We found, however, that these differences in initial review times largely reflected key features of the NDAs reviewed by the divisions, particularly those features linked to FDA’s time frames for review under its PDUFA goals. We analyzed initial review times using a statistical regression with two variables reflecting key features of the NDAs—target time frame for review of the application under FDA’s PDUFA goals (in days, from FDA’s receipt of the NDA to FDA’s targeted date for completion of the initial review) and number of expedited programs (0, 1, or 2 or more)—along with division as independent variables. We found that each of these variables was a significant determinant of initial review times. Specifically, our regression analysis shows that on average The shorter the target time frame for initial review of the NDA under FDA’s PDUFA goals, the shorter the initial review, and this target time frame was responsible for the majority of variation in initial review times. The greater the number of expedited programs for which the NDA qualified, the shorter the time FDA took to complete the initial review. Controlling for the effects of these key NDA features, however, we found that most of the divisions’ average review times were similar to (within 2 weeks of) each other. In contrast, the hematology and oncology divisions reviewed applications a bit more rapidly—about 2 or 3 weeks faster—than other divisions. Figure 3 illustrates the results of our analyses. The panel on the left shows the variation in the divisions’ actual average review times. The panel on the right shows the estimated average review times, after accounting for key application features, that is, what the review times would have been if each division had reviewed equal numbers of applications with these key features. We asked FDA officials what might contribute to somewhat faster review times by the hematology and oncology divisions, and FDA officials told us that a number of variables could have contributed to these differences. For example, the officials told us that applicants differ in their level of experience, which can affect the quality of the NDA or the speed of response to FDA’s requests for information; applications differ in complexity; and the oncology and hematology divisions could differ from others in their risk/benefit considerations. As previously noted, some divisions, such as the oncology divisions, regulate products for conditions that are more likely to be serious or life-threatening compared with other divisions, such as the dermatology and dental division, and risk/benefit considerations can differ across conditions that vary in how serious or life- threatening they are. For example, the potential benefits of drugs that carry substantial risks for dangerous side effects would likely be weighed differently if the drug is intended to address a life-threatening illness for which there is no other treatment than if the drug is intended to address an illness that is not life-threatening or for which there is an alternative treatment. FDA Is Implementing Initiatives to Evaluate and Facilitate the Use of Different Evidence Sources to Support NDAs FDA has several initiatives underway to evaluate and facilitate FDA review divisions’ and drug sponsors’ use of evidence derived from sources other than traditional clinical trials to support NDAs. (See table 3 for a description of these different evidence sources and each initiative.) According to FDA officials, implementing these initiatives can help ensure that when drug sponsors utilize these sources of evidence in NDAs, the evidence is of sufficient quality to be used in regulatory decision-making and that there is consistency across FDA review divisions in their evaluation of the evidence. FDA officials also said that although complex innovative trial designs might replace traditional clinical trials as evidence in NDAs, real-world evidence is more likely to be used to supplement clinical trial data. Although the initiatives are not restricted to any particular type of disease or patient population, according to FDA officials, some initiatives may be more relevant for certain types of diseases or patient populations than others. For example, according to FDA officials: real-world evidence may be most relevant for diseases that have outcomes that are consistently collected in the health care system. clinical outcome assessments (one aspect of patient-focused drug development) may be most relevant for diseases that are chronic, symptomatic, or affect functioning and activities of daily living. complex innovative trial designs may be most relevant for situations in which the population size is small or limited, such as pediatric populations, or where there is an unmet medical need, such as rare diseases. Our review of FDA documentation and interviews with FDA officials show that FDA has taken steps to implement each of these five initiatives. These steps include conducting public workshops with key stakeholders, issuing guidance for industry and FDA staff, initiating pilot programs, and developing FDA staff capacity, including by providing training and other educational resources. (See table 4 for examples of key activities by initiative.) These and future planned activities—including issuing additional guidance and revising relevant FDA policies and procedures— are intended to address deliverables for FDA to accomplish through 2021 that are outlined in the Cures Act and the PDUFA VI commitment letter. According to FDA officials, the agency intends to meet these deliverables, though, according to these officials, some of the activities implemented under the initiatives, such as certain pilot programs, will likely extend beyond 2021. Although implementation is still in progress for all of the initiatives, FDA officials reported some outcomes. For example, since the launch of the model-informed drug development pilot program, the agency has received two NDA supplements that incorporated model-informed drug development concepts discussed during pilot program meetings. Additionally, officials told us there has been a recent increase in investigational new drug submissions utilizing complex innovative trial designs. FDA officials also reported an increase in biomarker submissions under the drug development tool qualification program, and continued growth of the clinical outcome assessment qualification program. FDA expects that fully implementing the initiatives will lead to further increases in the use of evidence from sources other than traditional clinical trials. Agency Comments We provided a draft of this report to the Department of Health and Human Services for review and comment. The department provided technical comments, which we incorporated as appropriate. As agreed with your offices, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies of this report to the appropriate congressional committees, the Secretary of the Department of Health and Human Services, and other interested parties. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or dickenj@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix VII. Appendix I: Methodology for Data Analyses To determine (1) how Food and Drug Administration (FDA) divisions differ in the proportion of new drug applications (NDA) they review with key features linked to review time goals and expedited programs and (2) how FDA review divisions differ in the time taken to complete initial reviews and the extent to which key features of NDAs contribute to those differences, we analyzed data from FDA. We also interviewed FDA officials about the data and their review processes. Data We obtained data regarding all NDAs submitted to FDA’s Center for Drug Evaluation and Research (CDER) from fiscal years 2014 through 2018. These data included information about features that distinguish NDAs from one another, including which division was responsible for the review. The data also included information through March 31, 2019, about the dates when FDA received and completed a review of each NDA, along with the target dates for completion of review under FDA’s goals in commitment letters associated with the Prescription Drug User Fee Act (PDUFA) reauthorizations for fiscal years 2013 through 2017 (PDUFA V) and fiscal years 2018 through 2022 (PDUFA VI). To ensure meaningful analysis of review times, we excluded NDAs for which FDA had not completed an initial cycle of review. Of 686 NDAs submitted in fiscal years 2014 through 2018, the applicant withdrew 10 NDAs prior to completion of FDA’s initial review and 39 NDAs were still under FDA review as of March 31, 2019, leaving 637 NDAs for which FDA had completed an initial review. To assess the reliability of these data, we conducted a series of electronic and logic tests to identify missing data or other anomalies. These analyses were informed by our review of relevant documentation and interviews with knowledgeable FDA officials. As part of our assessment of reliability, we worked with FDA to identify and correct information about certain NDAs in a small number of instances in which we identified discrepancies. Using these methods, we determined that the remaining data were sufficiently reliable for our purposes. Unless otherwise specified, the results we present are statistically significant at the 0.05 level. Proportions of NDAs with Key Features To determine how FDA divisions differ in the proportion of NDAs they review with key features linked to FDA’s time frames for initial reviews and expedited programs, we conducted a series of chi-square tests comparing the distributions of the 637 NDAs with and without specific features across divisions. These key features included: whether the NDA had a priority review designation (a designation applied by FDA if the product would provide a significant therapeutic improvement in the safety and effectiveness of the prevention, diagnosis, or treatment of a serious condition when compared to available drugs) or instead had a standard designation; whether the NDA did or did not involve a new molecular entity—an active ingredient that had not previously been marketed or approved for use as a drug in the United States, whether the NDA did or did not involve a major amendment (a submission, while a pending NDA is under FDA review, of additional information that may include a major new clinical safety or efficacy study report or major new analyses of studies, among other things); and whether the NDA did or did not qualify for an expedited program (accelerated approval, breakthrough therapy designation, or fast track designation), programs intended to help reduce the time involved in developing or reviewing certain drugs that have the potential to treat serious or life-threatening conditions. (See table 5 for relevant statistics from these chi-square tests.) Initial Review Times To determine how FDA review divisions differ in the time taken to complete initial reviews, we conducted a preliminary regression analysis of 637 NDAs with the number of days an FDA division took to complete its initial review as the dependent variable and division as a single independent variable. We defined the time to complete a review as the number of days from FDA’s receipt of the NDA to the agency’s completion of the initial review by taking regulatory action. To determine the extent to which key NDA features contributed to differences between divisions in the time taken to complete initial reviews, we conducted a multiple regression analysis of the number of days FDA took to complete its initial review with division as an independent variable, along with two other independent variables to control for the key NDA features: Target time frame for initial review of the NDA under FDA’s PDUFA goals. Three key NDA features are linked to time frames for FDA’s initial review under its PDUFA goals—whether the NDA was priority or standard, did or did not involve a new molecular entity, and did or did not involve a major amendment. To control for these three features simultaneously, we counted the number of days from FDA’s receipt of the NDA until FDA’s target date for completion of the initial review under FDA’s PDUFA goals, and used that variable—the target time frame for review under FDA’s PDUFA goals—as an independent variable. We identified five NDAs for which FDA’s review time was exceptionally long in comparison to the target time frame for review under its PDUFA goals, and we asked FDA officials about them. FDA officials stated that these reviews were substantially delayed because of complicated manufacturing site issues, complicated legal and regulatory issues, or emerging public health issues requiring last minute advisory committee meetings—conditions that we deemed sufficiently unusual to exclude these five NDAs from further statistical analyses of review times. Number of expedited programs for which the NDA qualified. Another key NDA feature is whether it qualified for one or more expedited programs, programs with the potential to help reduce the development or review time needed to bring a drug to market. We controlled for this feature by including number of expedited programs (0, 1, or 2 or more) as an independent variable in our multiple regression analysis. Thus, we tested the effect of division on initial review times for 632 NDAs while controlling for the target time frame for review under FDA’s PDUFA goals and qualification for expedited programs. (See tables 6 and 7 for relevant statistics from this multiple regression analysis.) Our multiple regression analysis allowed us to test a specific hypothesis about the effect of division on review times, namely, whether divisions differed in their review times after controlling for the key features of NDAs. This regression analysis did not test a model of review times—that is, we did not attempt to identify all variables that affect review times, nor did we seek to identify the specific set or combination of variables within our data that had maximum explanatory power. Our analyses indicated that variation remained in initial review times, even after we controlled for these variables. It is important to note that an array of factors might be expected to influence review times, including not just those factors that were captured in our analysis, but also factors such as state of the science and quality of the application. With data from 632 NDAs distributed unevenly across 15 divisions, meaningful tests of additional variables or their interactions were not possible. Nonetheless, we conducted exploratory analyses that included other potentially relevant variables in addition to the target time frame for review under FDA’s PDUFA goals, number of expedited programs, and division. In separate regression analyses, we examined (a) the fiscal year in which FDA received the NDA and (b) whether the application was a BLA, an NDA based on information from studies conducted by the applicant, or an NDA based on at least some information from studies not conducted by or for the applicant. We did not find evidence of a consistent effect of either of these additional factors on review times, but in light of the number of NDAs, we cannot exclude the possibility that one or more of these factors affects review times. In a third exploratory analysis, we examined the outcome of the initial review—(a) approval; (b) tentative approval, which FDA grants if the NDA meets requirements for approval, but cannot be approved due to a patent or exclusivity period for a listed drug; or (c) issuance of a letter to the applicant called a complete response letter, in which FDA describes the specific deficiencies the agency identified and recommends ways to make the application viable for approval. This analysis suggested that NDAs that were approved for marketing at the end of the initial cycle of review were reviewed slightly faster on average than other NDAs, but this result should be viewed with caution because a small number of NDAs with certain initial review outcomes were distributed unequally. For example, very few of the NDAs (11) reviewed through one or more expedited programs resulted in tentative approval. Appendix II: Total Times Taken by FDA Divisions to Review New Drug Applications Received in Fiscal Years 2014 through 2018 The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) divisions differed in the total number of days they took to complete reviews of 637 new drug applications (NDA) submitted from fiscal years 2014 through 2018 and completed by March 31, 2019. (See fig. 4.) Importantly, these times reflect differences associated with the number of completed review cycles, FDA’s target time frames for review under its goals in commitment letters associated with the Prescription Drug User Fee Act (PDUFA) reauthorizations for fiscal years 2013 through 2017 (PDUFA V) and fiscal years 2018 through 2022 (PDUFA VI), and number of expedited programs. Number of review cycles. The number of cycles of review to which the NDAs we examined were subject was largely dependent on factors that were not under FDA’s control, namely, the applicant’s actions and timing. When a cycle of review ends with an FDA action, that action can be (a) approval, which allows the applicant to market the drug, (b) tentative approval, which FDA grants if the NDA meets requirements for approval, but cannot be approved due to a patent or exclusivity period for a listed drug, or (c) issuance of a letter to the applicant called a complete response letter, in which FDA describes the specific deficiencies the agency identified and recommends ways to make the application viable for approval. The applicant may respond to either tentative approval or a complete response letter by resubmitting a revised application, triggering a new cycle of review; it is up to the applicant to decide whether to resubmit the application. In addition, NDAs that were submitted earlier in time would have a greater chance of being resubmitted and reviewed by March 31, 2019, than applications submitted later in time. The number of completed review cycles ranged from one to four cycles: 637 NDAs went through a completed first (initial) cycle review; 99 of those 637 NDAs went through a completed second cycle review; 20 of those 99 NDAs went through a completed third cycle review; 3 of those 20 NDAs went through a completed fourth cycle review. Target time frames for review. Review times reflect differences in time frames for review under FDA’s PDUFA goals. The target time frames for review ranged from less than 6 months to 15 months for the first cycle and from less than 2 months to 9 months for later cycles of review. Number of expedited programs. These review times also reflect differences associated with the number of FDA’s expedited programs for which NDAs qualified. In general, these expedited programs are designed to help reduce the development or review time needed for drugs intended to treat serious or life-threatening conditions. Appendix III: Requests for Breakthrough Therapy and Fast Track Designations, Fiscal Years 2013 through 2018 Two of the Food and Drug Administration’s (FDA) expedited programs for new drugs intended to treat serious or life-threatening conditions— breakthrough therapy designation and fast track designation—must be requested by the drug sponsor. These programs are intended to help reduce the development or review time needed to bring a drug to market by offering benefits such as more intensive drug development guidance from FDA officials or by allowing the applicant to submit completed sections of the NDA for review before submitting the entire application. The request is normally made while the drug sponsor is conducting clinical trials or when seeking FDA’s permission to collect clinical trial data, although the request may also be made when submitting a new drug application (NDA) or while the NDA is under review. FDA’s Center for Drug Evaluation and Research (CDER) divisions are responsible for determining whether requests qualify for these expedited programs based on evidence the drug sponsors provide in support of the requests. To qualify for breakthrough therapy designation, the drug sponsor must present preliminary clinical evidence involving one or more clinically significant endpoints that indicate that the drug may demonstrate substantial improvement over available therapies. To qualify for fast track designation, the drug sponsor must either provide evidence demonstrating the drug’s potential to address unmet need or document that the drug is designated as a qualified infectious disease product. FDA may grant or deny the request, or the drug sponsor may withdraw the request before FDA renders a decision. If FDA grants the designation, the drug sponsor may subsequently withdraw from the designation, or FDA may rescind either designation if the drug no longer meets the qualifying criteria. We obtained data regarding all requests for breakthrough therapy and fast track designations submitted to CDER from fiscal years 2013 through 2018. These data included information about which division was responsible for the review and the outcome of the request—whether it was granted or denied or whether the drug sponsor withdrew the request before FDA reached a decision. To assess the reliability of these data, we conducted a series of electronic and logic tests to identify missing data or other anomalies. These analyses were informed by our review of relevant documentation and interviews with knowledgeable FDA officials. Using these methods, we determined that the data were sufficiently reliable for our purposes. We examined these data to determine whether there were any material differences between divisions in the frequency of possible outcomes. Our analyses focused on the outcomes and did not allow us to determine whether divisions differed in their application of the stated criteria. Breakthrough therapy designation. We found few differences across divisions in the frequency of the possible outcomes of requests for breakthrough therapy designation: Of 634 requests for breakthrough therapy designation (including nine requests submitted with or after the NDA submission), 39 percent were granted, 48 percent were denied, and 13 percent were withdrawn by the drug sponsor before FDA reached a decision. Divisions differed widely in the number of requests for breakthrough therapy designation they received, from 0 for the nonprescription drug division to 102 for one of FDA’s two oncology divisions. With two exceptions, the numbers of these requests that were granted, denied, or withdrawn for each division were similar to what would be expected based on the overall frequency of the possible outcomes. Requests to the hematology division were withdrawn more frequently than requests to other divisions (32 percent) and that division denied requests less frequently (17 percent) than other divisions. The neurology division denied more (81 percent), and granted fewer (13 percent), requests for breakthrough therapy designation than other divisions. Within the time period we studied, the drug sponsor withdrew from breakthrough therapy designation after it was granted in six cases and FDA rescinded the designation in 14 cases. Fast track designation. Similarly, we found few differences across divisions in the frequency of the possible outcomes of requests for fast track designation: Of 965 requests for fast track designation (including 35 requests submitted with or after the NDA submission), 71 percent were granted, 24 percent were denied, and 5 percent were withdrawn by the drug sponsor before FDA reached a decision. Again, divisions differed widely in the number of requests for fast track designation they received, from 2 for the nonprescription drug division to 133 for the neurology division. The numbers of these requests that were granted, denied, or withdrawn for each division were generally similar to what would be expected based on the overall frequency of the possible outcomes, although the anti-infective division granted more (91 percent), and denied fewer (6 percent), requests for fast track designation than other divisions. Within the time period we studied, no drug sponsor withdrew from fast track designation after it was granted, nor did FDA rescind any such designation. Appendix IV: New Drug Applications with Key Features Linked to Time Frames for Review, Fiscal Years 2014 through 2018 Pursuant to the Prescription Drug User Fee Act (PDUFA) and its subsequent reauthorizations, the Food and Drug Administration (FDA) collects user fees from drug sponsors to supplement its annual appropriation for salaries and expenses. As part of each reauthorization process, FDA identifies goals in a commitment letter to Congress, including goals for the time the agency takes to complete reviews of different types of drug applications upon initial submission and resubmission. In general, these goals identify a percentage of certain types applications that FDA is expected to review within specified target time frames. For initial NDA reviews—reviews of the NDA as originally submitted—FDA’s target time frames for review that would meet its PDUFA goals vary and are linked to three key NDA features that reflect the drug or the applicant’s action: (1) whether or not the application receives priority review designation, which indicates that the drug could provide significant therapeutic improvements in the safety and effectiveness of the prevention, diagnosis, or treatment of a serious condition when compared to available drugs; (2) whether or not the application involves a new molecular entity—an active ingredient that has not been previously marketed or approved for use in the United States; and (3) whether or not the applicant submitted a major amendment while the NDA was pending, that is, while under FDA’s review. The target time frame for review for any specific NDA reflects all three of these features. Reviews are conducted by one of the agency’s Center for Drug Evaluation and Research (CDER) divisions, each of which specialize in a specific group of drug products, such as hematology or neurology. As shown in table 8, divisions differed in the numbers and proportions of NDAs they reviewed that had the features linked to time frames for review under FDA’s PDUFA goals. Appendix V: New Drug Applications That Qualified for Expedited Programs, Fiscal Years 2014 through 2018 The Food and Drug Administration (FDA) may determine that NDAs for drugs intended to treat serious or life-threatening conditions qualify for one or more expedited programs. These programs confer specific benefits with the potential to help reduce the development or review time needed to bring a drug to market, for example, some expedited programs provide for more intensive drug development guidance from FDA officials or allow the applicant to submit completed sections of the NDA for review before submitting the entire application. FDA’s expedited programs include accelerated approval, breakthrough therapy designation, and fast track designation. Reviews are conducted by one of the agency’s Center for Drug Evaluation and Research (CDER) divisions, each of which specialize in a specific group of drug products, such as hematology or neurology. As shown in table 9, divisions differed in the proportions of NDAs they reviewed that qualified for expedited programs. Appendix VI: Times Taken to Complete Initial Reviews of New Drug Applications Received from Fiscal Year 2014 through 2018 The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) divisions differed in the total number of days they took to complete initial reviews of new drug applications (NDA) received from fiscal years 2014 through 2018 and completed by March 31, 2019. (See fig. 5.) These review times reflect differences associated with FDA’s target time frames for initial review under its goals in commitment letters associated with the Prescription Drug User Fee Act (PDUFA) reauthorizations for fiscal years 2013 through 2017 (PDUFA V) and fiscal years 2018 through 2022 (PDUFA VI). These target time frames for review are linked to specific features of the NDA and ranged from less than 6 months to 15 months for the initial review. These review times also reflect differences associated with the number of expedited programs for which NDAs qualified. Appendix VII: GAO Contact and Staff Acknowledgments GAO Contact John E. Dicken, (202) 512-7114 or dickenj@gao.gov. Staff Acknowledgments In addition to the contact named above, William Hadley (Assistant Director), Geri Redican-Bigott (Assistant Director), Aubrey Naffis (Analyst- in-Charge), and Kristen Joan Anderson made key contributions to this report. Also contributing were Sam Amrhein, Todd D. Anderson, Leia Dickerson, Kaitlin Farquharson, Rich Lipinski, and Ethiene Salgado- Rodriguez.


Background According to FTA’s National Transit Database, about 1,500 rural transit providers, including tribal transit providers, supply vital mobility and connections to essential services for people living in rural communities. Rural transit providers generally have low budgets, few employees, and small vehicle fleets. Rural transit providers provide a variety of transit services, including: demand-response, which is scheduled in response to calls from passengers; fixed-routes, which are buses operating according to a set schedule; and deviated-fixed routes, which are fixed-routes that allow for minor route deviations in response to passenger calls. Service areas for rural providers may span dozens of square miles in remote areas—with long trips and only a few riders at any given time—or be located in smaller, more developed rural areas surrounding major cities. DOT primarily supports rural transportation through formula grants, some of which require states and rural transit providers to coordinate. Specifically, these rural transportation formula grants are apportioned to state departments of transportation based on various factors, and these state agencies then allocate funding to rural transit providers as sub- grantees. Sub-grantees can be regional or local governments, non-profit organizations, or federally recognized tribes, which provide public transit services in their communities. DOT also awards rural transit program funds directly to federally recognized Indian tribes through the Tribal Transit Program. See table 1 for a description of the DOT’s primary formula-grant programs that support rural transit. Within DOT, FTA and its 10 regional offices administer these programs; their responsibilities include: 1. grant funding, including targeted grants and contracts for coordination-related projects to enhance mobility and access nationwide; 2. oversight of state transportation agencies and tribal-transit program grantees through State Management Reviews and Tribal Transit Assessments; 3. training and technical assistance to states and rural transit providers; 4. policy interpretations and development to enhance mobility and access. DOT and FTA also lead the Coordinating Council, which is charged with improving coordination across federal programs that fund transportation services for transportation-disadvantaged persons. The Coordinating Council consists of 11 federal agency members, namely, the departments of Agriculture, Education, HHS, Housing and Urban Development, Interior, Justice, Labor, Transportation, and Veterans Affairs (VA); the National Council on Disability; and the Social Security Administration. Aside from DOT, transportation is not the primary mission of these federal agencies. However, each member agency has programs that provide funding for transportation to enable program beneficiaries to access the various health and human service programs within the agencies’ primary missions, such as job training, education, or medical care. For example, the HHS’s Medicaid program requires assurance from states that Medicaid beneficiaries have access to necessary medical services; this medical service includes arranging and providing funding for transportation to medical appointments and other health services when beneficiaries cannot transport themselves. In 2012, we found, among other things, that Coordinating Council member agencies were not effectively collaborating and recommended that the Coordinating Council strengthen its coordination efforts across federal programs. In 2014, we again identified the need to strengthen federal coordination efforts and recommended that the Coordinating Council develop both a strategic plan and a cost-sharing policy to promote and enhance federal, state, and local nonemergency medical transportation coordination activities. For a full description of our prior recommendations and their implementation status, see appendix II. State and local stakeholders—including state transportation agencies, regional planning organizations, rural and tribal transit providers—and health and human service providers, coordinate rural transportation services when they share resources and responsibilities and plan activities to achieve common goals and for the overall benefit of the community. Coordination of rural transportation services can occur across geographic jurisdictions, funding sources, and various local, state, and federal programs. Coordination of transportation services has the potential to reduce transportation program costs by clustering passengers, using fewer one-way trips, and sharing the use of personnel, equipment, and facilities; at the same time, people in need of transportation also often benefit from greater and higher quality services when transportation providers coordinate their operations. Available Resources and Alignment of Program Requirements Cited among Factors Affecting Rural Transit Coordination Various factors affect rural transit coordination, according to stakeholders we interviewed, participants from three discussion groups, and literature we reviewed. Factors that can affect coordination include availability of resources, alignment of different federal program requirements, availability of coordinating mechanisms, and the distances between transit providers. (See fig. 1.) As discussed below, we found that these factors are often interrelated and can serve as both a motivating factor and a barrier to coordination. Availability of Resources The availability of resources was the most commonly cited factor affecting rural transit coordination in our literature review and interviews. Almost two-thirds of the stakeholders we spoke with (30 of 43) and participants in three discussion groups told us that it is difficult to coordinate transit services in rural communities with limited resources, such as funding, staff and time, and technology. For example, a rural transit provider told us that while it provides public transit to a neighboring national park for its visitors during the summer season, insufficient funding from the national park combined with very limited access to FTA’s rural transit funds limits the providers’ ability to effectively coordinate services. We also reported in 2014 that smaller budgets and fewer employees can influence rural transit providers’ ability to coordinate. A 2018 survey of state and local transit and health and human services providers conducted by the National Center for Mobility Management also noted that the availability of resources can be a key barrier to transportation coordination both in rural and non-rural areas. Resources specifically affecting rural transit coordination include: Availability of Matching Funds. The availability of matching state and local funds can affect coordination, as rural transit providers tend to rely on a variety of funding sources to provide transit services. Federal programs generally require a share of state or local funding to match federal funds. Approximately one-third of selected stakeholders (13 of 43) and participants in three discussion groups said that they face challenges identifying enough state or local funding to meet FTA’s matching fund requirements. Some rural transit providers (4 of 21) told us they have access to funds from different sources, but others (4 of 21) said that they are challenged with securing state or local matching funds. For example, local, regional, or state taxes provide some funding streams for public transit, including rural transit providers, in California, Georgia, New Mexico, and Washington. Although revenues from state or local taxes may be available as a funding source, rural transit providers still told us that identifying and coordinating state and local funding sources can be challenging. We previously reported that constrained state and local budgets can make securing these funds difficult as rural transit competes for funding with other needs within a community, such as public safety. Technology and Coordination: Greater Columbia Call-Center People For People, a rural transit provider in Yakima, Washington, uses technology to coordinate and operate the Greater Columbia 2-1-1 (GC211) call center. GC211 maintains a statewide database of community resources, including transportation options. It is one of the state’s seven regional 2-1-1 call centers that directs riders to social, health, and transportation resources. Staffing and time. Some stakeholders (12 of 43) said that rural transit providers do not have enough staff and time to pursue or engage in coordination efforts. For example, three rural transit providers told us that staff sometimes take on multiple duties, such as bus driver and dispatcher in addition to grant and program manager, duties that affect their time and ability to coordinate. Representatives from a national transit planning association also told us that staffing constraints are an issue, particularly with rural transit providers because they are usually more understaffed than urban transit agencies. Technology. Access to technology can help coordinate trips and schedules across rural transit services. About half of the rural transit providers (11 of 21) we interviewed stated that they use software and other technology to schedule trips and operate call centers to facilitate coordination efforts. For example, People For People, a rural transit provider in Yakima, Washington, uses technology to coordinate and operate the Greater Columbia call-center. (See sidebar). However, a handful of stakeholders (4 of 43) mentioned that access to broadband, which is needed to enable technology and scheduling software, can be limited in certain areas, especially on tribal lands. For example, an official from EBCI Transit, a tribal transit provider in North Carolina, said EBCI experienced poor cell phone service and other communication limitations, which affected its ability to schedule and coordinate trips. Our recent work on telecommunications found that tribal lands have significantly lower levels of broadband internet access relative to the country as a whole. Availability of Formal Coordinating Mechanisms Formal Coordinating Mechanisms: State- and Regional-Coordinating Bodies As one of the regional coordinating bodies, the Southwest Georgia Regional Commission has played a central role in coordinating rural transit services through much of its region; it currently provides public transit services in 13 counties to the general public as well as to riders with specific needs to access health and human services in 14 counties. The availability of coordinating mechanisms can facilitate information sharing and coordination. About half of the stakeholders (18 of 43) told us that they participate in some statewide, regional, or local coordinating bodies as part of a process to facilitate coordination. For example, the Georgia Department of Transportation works with regional commissions to coordinate rural transit throughout Georgia. (See sidebar). In contrast, officials from the North Carolina Department of Transportation told us that the state disbanded its coordinating council, which may be contributing to challenges in providing nonemergency medical transportation services. We previously reported that state and local transportation agencies and aging network organizations used a variety of different mechanisms, such as state-, regional-, and local-planning bodies to coordinate transportation services for older adults. Half of the states we selected (4 of 8) have statewide-coordinating bodies. For example, participants from one discussion group said that state requirements can facilitate coordination when the state statute requires rural transit providers applying for or receiving federal, state, or local assistance to coordinate with other state agencies, including the state’s health and human services department, for funding and services. Rural transit providers also told us that they participate in regional- and local-coordinating bodies. For example, all transit providers in Montana are required to coordinate through local Transportation Advisory Committees that plan and prioritize local transportation needs. About one-third of the stakeholders (13 of 43) and participants in three discussion groups also mentioned knowledge-sharing forums—such as conferences and training organized by state transportation agencies, transit industry associations, and FTA—as mechanisms to facilitate coordination. For example, officials from Pullman Transit told us that these forums, such as the Washington State Transit Association’s annual conference, presented opportunities to share and learn about various federal transportation programs, coordinating efforts, and information on best practices. Alignment of Program Requirements We and others have reported that transit providers, as well as health and human service providers, may encounter substantial challenges trying to coordinate services across different programs when program requirements do not align. For our current work, about one-third of stakeholders (13 of 43) and participants in three discussion groups told us that they face a wide array of barriers coordinating across differing federal laws, regulations, and program requirements. The different federal program requirements can affect rural transit providers’ ability to coordinate transit services as some federal programs are dedicated to specific groups of riders (e.g., older adults, people with disabilities, and low-income riders) with specific needs; such specification of groups makes it difficult to coordinate trips for different riders. Three rural transit providers stated that it is sometimes difficult to coordinate transportation to medical appointments for “blended riders” (i.e., senior citizens, veterans, and the general public) in one trip. For example, VA’s Highly Rural Transportation Grants require rural transit providers to serve only veterans, while Medicaid’s nonemergency medical transportation funds require serving only Medicaid beneficiaries. Rural transit providers— which provide service to the general public within their service areas—are sometimes challenged with providing an efficient and coordinated transit service for VA or Medicaid beneficiaries to access their programs. FTA and the Coordinating Council’s 2018 Focus Group Report also identified federal program requirements, including trip purpose restrictions, as a barrier for coordination. As discussed later in the report, the Coordinating Council has been charged with addressing this barrier, among others, and is currently examining whether and how federal program requirements could be better aligned. Long Distances Coordination in rural areas can be both essential and challenging because rural transit passengers often need to travel long distances (e.g., 30-100 miles) to reach critical services, such as doctor appointments or grocery shopping. About a quarter of stakeholders (11 of 43) and participants in two of the discussion groups said that the long distance between transit providers in remote rural communities sometimes makes it difficult to find entities or other providers interested in or able to coordinate. Two rural transit providers also told us they have no neighboring transit provider to coordinate with due to the extremely remote rural locations. For example, an official from Turtle Mountain Transit in North Dakota said it is challenging to coordinate with other neighboring tribal transit providers due to the long distance to the nearest tribal transit provider in Spirit Lake, which is about 100 miles away. Turtle Mountain Transit, like a number of other tribal transit providers, often serves large and fairly remote areas. We previously reported that tribal lands can vary in size, and range from the smallest at less than one square mile to the largest, the Navajo Nation, which is more than 24,000 square miles or the size of West Virginia, and extends into the states of Utah, Arizona, and New Mexico. Selected Rural Transit Providers Coordinated Trips and Shared Resources to Improve Transit Services Coordinated Trips and Schedules Despite encountering some of the factors that can make coordination difficult, all rural transit providers we interviewed told us that they currently coordinate trips or schedules with other local or regional stakeholders. Such coordination efforts include establishing common drop-off points or common schedules (21 of 21), coordinating to provide access to health and human services (14 of 21) and using technologies, such as software, to facilitate coordination of transportation (11 of 21). Rural transit providers told us that they coordinate with others because coordinating may help them meet increasing rural-transit service demand and improve service. They mentioned that the benefits of their coordination efforts include: increased ridership or access, cost efficiency or reduced costs, and enhanced quality of services. Examples of coordination cited by our selected rural transit providers are summarized in table 2 below. Coordinated Funding and Shared Resources All of the rural transit providers we interviewed also told us they coordinated across various funding sources or shared other resources with nearby transit providers. The most commonly cited coordination and resource-sharing activities included pursuing funding from several programs and raising local revenue for transit (18 of 21); participating in opportunities to share knowledge, such as training (11 of 21); sharing vehicles and related resources, such as maintenance capabilities (8 of 21); and sharing staff to achieve a common goal (5 of 21). Four of our selected rural transit providers also stated that full consolidation of their transit services across multiple jurisdictions or providers resulted in cost savings. Specific examples of these activities cited by our selected rural transit providers are summarized in table 3 below. FTA Continues to Facilitate Coordination, but Its Efforts Have Had Mixed Results FTA and the Coordinating Council Have Ongoing Efforts, but Key Deadlines Have Been Missed and Much Work Remains As the lead agency of the Coordinating Council, FTA has taken a number of steps in recent years, including those summarized below, to work with other Coordinating Council member agencies to enhance federal interagency coordination. From January 2017 through June 2019, FTA and the Coordinating Council members were involved in more than 90 interagency- coordinating activities, according to the Coordinating Council’s summary of recent activities posted on its website. Coordinating activities included interagency meetings, trainings, and webinars to share information and coordinate interagency efforts that support rural communities and improve transportation access to health and human services. For example, in September 2018, staff from FTA and the Department of Agriculture held a webinar for federal, state, and local officials on the opioid crisis and increasing transportation in rural areas to improve access to treatment centers, the courts, and other services in rural West Virginia. In 2018, FTA and Coordinating Council members engaged in significant efforts to inform the strategic direction of the Coordinating Council. From March through June 2018, FTA and some Coordinating Council members convened a series of focus groups with state and local stakeholders, including transit and health and human services providers to be informed of the current state of transportation services and identify leading practices and barriers to transportation coordination. FTA also obtained input from state and local transit and health and human services stakeholders via a survey that the National Center for Mobility Management conducted from June through November 2018 to identify promising practices, barriers, and challenges around coordinated transportation. Working group efforts under way are addressing some of the challenges facing rural transit providers. For example, the Coordinating Council’s Program Analysis Work Group, which was convened in November 2018, is currently examining all federal programs with transportation funding available and conducting program analyses to determine whether and how federal program requirements could be better aligned. FTA officials stated that the Coordinating Council plans to submit a report to Congress with some proposed changes and recommendations for improved alignment of federal requirements by September 2020. While these coordinating activities are constructive and encouraging steps, the Coordinating Council’s progress has been slow in other key areas. In 2014, we recommended that the Coordinating Council develop a strategic plan and cost-sharing policy to promote and enhance federal, state, and local nonemergency medical transportation coordination activities. In addition, the 2015 Fixing America’s Surface Transportation Act (FAST Act) required the Council to publish a strategic plan by December 2016 that, among other things, identifies a strategy to strengthen interagency collaboration and that develops a cost-sharing policy in compliance with applicable federal laws. The FAST Act also required the Coordinating Council to submit a final report containing the Council’s final recommendations to Congress for enhancing interagency coordination. However, the Coordinating Council did not issue the required strategic plan until October 2019, about 3 years after the 2016 deadline. We are currently evaluating this plan as part of our follow-up on the implementation status of our 2014 recommendations. Regarding the final report to Congress on interagency coordination, FTA officials told us that they plan to submit the final report to Congress by September 2020. Additionally, we previously reported on the long-standing challenge of the Coordinating Council Executive Committee, which is tasked with providing top management direction for the Council, providing limited leadership and guidance that can have a broad effect on rural transportation. Specifically, we reported that the Council Executive Committee had provided limited leadership, had not met since 2007, and had not issued key guidance documents that could promote coordination. Accordingly, we recommended that the Council meet and issue guidance documents. According to FTA officials, the Executive Committee met for the first time since 2007 in October 2019 and issued the strategic plan noted above. As previously mentioned, we will continue following up on our prior recommendations (see app. II). FTA Has Facilitated Coordination of Rural Transit Services at the State and Local Level, but the Effectiveness of FTA’s Information Sharing Has Been Limited FTA also facilitates coordination of rural transit services by engaging directly with state and local stakeholders, including transit and health and human services providers. FTA has, for example, taken the following actions: It created a website that provides resources and information on planning and coordinating rural transportation services. This website includes a self-assessment toolkit for state and local transportation agencies on “Building a Coordinated Transportation System” and a link to case studies on coordination of state and regional councils. FTA staff provides ongoing training, resources, and technical support to state transportation agencies and transit and human services providers through its three technical assistance centers—the National Rural Transit Assistance Program, the National Aging and Disability Transportation Center, and the National Center for Mobility Management. FTA and its three centers have been disseminating and sharing some coordination-focused information through their websites, training, and conferences. For example, FTA officials pointed us to the National Aging and Disability Transportation Center’s webpage on “Annual Trends Report and Spotlight Series” that posted best practices information on a non-profit agency that recruits and uses volunteers to transport older adults to social outings and medical appointments. FTA also annually awards competitive grants for innovative, coordinated health and transportation programs. For example, FTA awarded approximately $9.6 million in fiscal year 2019 to 37 projects that were selected as innovative projects for the transportation of disadvantaged populations that are designed to improve the coordination of transportation services and nonemergency medical transportation services. FTA has also bi-annually recognized rural transit providers with an FTA Administrator’s Award for outstanding rural-transit programs, selected in part based on coordination efforts. FTA officials told us that recipients of this award are expected to share their successful practices at the National Rural Transit Assistance Program conference, which is attended by many rural transit providers. Although FTA has a number of efforts under way to facilitate coordination, we identified limitations with FTA’s current communication and information sharing approach. More than a third of the stakeholders we spoke with (16 of 43) stated that communication and information sharing on coordination opportunities from FTA have been limited. FTA officials told us that they disseminate and share some coordination-focused information through its three technical assistance centers, training, conferences, and regular meetings with state transportation agencies as its direct grantees and transportation industry associations. However, about a quarter of the stakeholders (11 of 43) and participants in one discussion group told us that while they have attended FTA trainings and conferences and have used FTA’s technical centers, the focus has been on grant management issues, such as compliance with drug and alcohol policy and procurement, and not on coordination opportunities. Stakeholders stated that they wanted more information on: ways to coordinate with other providers, how providers addressed coordination challenges, technologies that were used to facilitate coordination, and any quantifiable data and results on coordination. Additional information on leading coordination practices that FTA can share with stakeholders include those that we previously identified, such as defining and articulating a common outcome that agencies can engage in to sustain coordination efforts. In December 2014, we recommended that FTA and the Coordinating Council collect data to track and measure progress in achieving results, including the extent of coordination efforts under way. FTA officials told us that the Council’s recent adoption of their strategic plan includes goals and objectives that represents progress toward measuring the extent of coordination efforts at the federal level. FTA officials also told us that the Council’s final report to Congress that will be submitted in September 2020 will report on the implementation status of the objectives in the strategic plan. We have previously reported on the importance of information sharing on coordination across federal, regional, state, and local government entities. Office of Management and Budget guidance on using information as a “strategic resource” notes that making federal information “discoverable, accessible and useable” can fuel innovation. Further, according to Standards for Internal Control in the Federal Government, agencies should communicate necessary and quality information externally so that external parties can achieve their objectives and periodically evaluate methods of communication, so that the agency has the appropriate tools to communicate quality information with external parties on a timely basis. FTA, however, has not clearly communicated and conveyed information on coordination opportunities and leading practices. For example, while FTA officials told us that they rely on their website to share information with stakeholders, more than a third of the stakeholders (17 of 43) told us that information on coordination opportunities and leading coordination practices are not clearly identifiable on FTA’s website or easily accessible. Two stakeholders, for example, said that while locating program requirement information, such as on procurement, was fairly easy, it was difficult to locate coordination-related information. An official from a transit industry association also commented that “stakeholders would benefit if FTA and the technical assistance centers make coordination resources and training more visible on their websites.” This visibility could include “having coordination as a standalone topic and/or creating a page(s) dedicated to coordination on their websites.” We also determined that coordination-related information was fragmented on FTA’s website and found it difficult to navigate FTA’s website to find leading practices information on coordination. For example, FTA officials referred us to its website on FTA’s Access and Mobility Partnership Grant (also known as the Innovative Coordinated Access and Mobility Grant) for information on leading practices for transportation coordination. In our review of this website, we found a description of projects that FTA selected for the grant, the grant amount, and how the funds will be used. We could not identify any information specifically on how these projects identified opportunities to coordinate or exhibited leading coordination practices. We also examined FTA’s website that provides a self- assessment toolkit for building a coordinated transportation system, as we previously mentioned. FTA officials also mentioned that they developed the Coordination Council’s webpage to present information targeted to coordination. FTA does not have a strategy for communicating and sharing information on coordination opportunities and leading coordination practices for its wide audience of rural and tribal providers, state transportation agencies, and other stakeholders. FTA officials told us that they develop individualized communication plans when they undertake any major activities and examine an approach to communicating and sharing information when they develop annual statements of work for their three technical centers and meet with stakeholders. However, FTA could not provide us with a documented strategy that outlines how it communicates and shares coordination-focused information with state and local stakeholders. In light of the multiple means by which FTA and the Coordinating Council are attempting to communicate information about coordinating rural and tribal transit services, a comprehensive plan or strategy that assesses what information state, local, and transit providers would benefit from receiving and how that information can be effectively communicated could help FTA’s information-sharing efforts have their intended effect. Without such a strategy, stakeholders are without valuable information that could aid them in identifying potential coordination opportunities, leading practices, and data to help inform and facilitate their coordination efforts. Conclusions Coordination is important to help state transportation agencies, rural transit providers, and human health and service providers meet the increasing needs of those who rely on rural transit systems, particularly in light of limited resources. FTA has taken a number of steps to enhance and facilitate coordination, including having interagency meetings, trainings, and webinars to coordinate interagency efforts that support rural communities and improve transportation access to health and human services. Going forward, it will be critical for the Coordinating Council’s Executive Committee to implement our prior recommendations on key coordination issues. In addition, although FTA, along with its three technical centers, has developed resources to facilitate coordination, its communication efforts have fallen short. Without a communication strategy to effectively reach state and local stakeholders, FTA is missing opportunities to enhance communication and information sharing that can improve coordination among state transportation agencies and rural and tribal transit providers. Recommendation for Executive Action The Administrator of FTA should develop a communication plan that will effectively share information with state transportation agencies and rural and tribal transit providers on coordination opportunities and leading coordination practices in an accessible and informative way. (Recommendation 1) Agency Comments and Our Evaluation We provided a draft of this report to the Department of Transportation (DOT) and Department of Health and Human Services (HHS) for review and comment. DOT provided written comments, which are reproduced in appendix III and summarized below. DOT and HHS also separately provided technical comments, which we incorporated as appropriate. In written comments, DOT partially concurred with our recommendation. DOT provided examples of its communication efforts with stakeholders on coordination opportunities and practices and highlighted two recent initiatives to further support the coordination of rural transportation services. For example, in October 2019, DOT established the Rural Opportunities to Use Transportation for Economic Success (ROUTES) initiative to enable better coordination among agencies to address underserved rural areas and to collect input from stakeholders on the benefits rural transportation offers for safety and economic outcomes. In partially concurring with our recommendation, DOT wrote that it plans to direct each of its technical assistance centers to reorganize its web pages to centralize coordination information and best practices. We acknowledge FTA’s efforts and highlighted the progress FTA has made in communicating and facilitating coordination in this report. We noted that FTA has provided ongoing training, support, and resources through its technical assistance centers. While DOT’s plans to have its technical assistance centers’ web pages reorganized may help in communicating coordination opportunities with stakeholders, they fall short of a comprehensive communication plan. Such a plan would define a strategy for effectively communicating and sharing information with stakeholders and ensuring that methods of communication are reaching all intended stakeholders. Among other things, FTA’s plans to increase access to coordination information does not include reorganizing and centralizing coordination-related information on FTA’s web pages, a strategy that is different from these technical centers’ web pages and one where many stakeholders can turn to and search for communication and information. We believe that a comprehensive communication plan that includes FTA’s strategy for ongoing communication on coordination opportunities would enable FTA to ensure that coordination information is reaching intended stakeholders to inform them of opportunities to enhance rural transit services. We are sending copies of this report to the appropriate congressional committees, the Secretary of the Department of Transportation, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff members have any questions regarding this report, please contact at me (202) 512-2834 or flemings@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Key contributors to this report are listed in appendix IV. Appendix I: Rural Transit Stakeholders GAO Interviewed and Discussion Group Participants Appendix I: Rural Transit Stakeholders GAO Interviewed and Discussion Group Participants Industry groups Community Transportation Association of America National Association of Development Organizations National Association of Regional Councils National Center for Mobility Management National Rural Transit Assistance Program Small Urban, Rural and Tribal Center on Mobility Federal Transit Administration (FTA) Regional Office FTA Region IV ^ State transportation agencies Caltrans - California Department of Transportation New Mexico Department of Transportation North Carolina Department of Transportation North Dakota Department of Transportation Washington State Department of Transportation Rural transit providers (including tribes’ names, where appropriate) Carlsbad Municipal Transit System CSKT Transit (Confederated Salish and Kootenai Tribes of the Flathead Reservation) * EBCI Transit (Eastern Band of Cherokee Indians) *^ Missoula Ravalli Transportation Management Association ^ Morongo Transportation Department (Morongo Band of Mission Indians) * North Central Regional Transit District Pueblo of Santa Clara, New Mexico * Rocky Boy’s Transit (Chippewa Cree Indians of the Rocky Boy’s Reservation, Montana)* Southeast Tennessee Human Resource Agency ^ Turtle Mountain Transit (Turtle Mountain Band of Chippewa Indians of North Dakota) * Williston Council for the Aging Legend: * = Recipient of FTA’s Tribal Transit Program funding. ^ = Site visit to interview stakeholder. State transportation agencies Mississippi Department of Transportation VTrans - Vermont Agency of Transportation Rural transit providers (including tribe names, where appropriate) Big Woods Transit (Bois Forte Band (Nett Lake) component of Minnesota Chippewa Tribe, Minnesota) Center for Community the RIDE (Sitka Tribe of Alaska) * Choctaw Tribal Transit (The Choctaw Nation of Oklahoma) * Heart of Iowa Regional Transit Agency Hualapai Transit (Hualapai Indian Tribe of the Hualapai Indian Reservation, Arizona) * Oglala Sioux Transit (Oglala Sioux Tribe) * Salt River Transit (Salt River Pima-Maricopa Indian Community of the Salt River Reservation, Arizona) * Legend: * = Recipient of FTA’s Tribal Transit Program funding. Appendix II: Implementation Status of GAO’s Recommendations to the Department of Transportation Appendix III: Comments from the Department of Transportation Appendix IV: GAO Contact and Staff Acknowledgment GAO Contacts Staff Acknowledgements In addition to the individuals named above, Heather MacLeod (Assistant Director); Jennifer Kim (Analyst-in-Charge); Matthew Bond; Delwen Jones; Rosa Leung; Theresa Lo; Anna Maria Ortiz; Cheryl Peterson; Malika Rice; Kelly Rubin; Pamela Snedden; Lisa Van Arsdale; and Sarah Veale made key contributions to this report.