United States Government Accountability Office Report to Congressional Committees ZIKA May 2018 SUPPLEMENTAL FUNDING Status of HHS Agencies’ Obligations, Disbursements, and the Activities Funded GAO-18-389 May 2018 ZIKA SUPPLEMENTAL FUNDING Status of HHS Agencies’ Obligations, Disbursements, and the Activities Funded Highlights of GAO-18-389, a report to congressional committees Why GAO Did This Study What GAO Found Zika—a virus primarily transmitted As of September 30, 2017, Department of Health and Human Services’ (HHS) through mosquito bites—can cause agencies had obligated nearly all of the $932 million of Zika supplemental symptoms that include fever, rash, and funding Congress appropriated in 2016 through the use of multiple funding joint and muscle pain. In pregnant mechanisms, including cooperative agreements, grants, and contracts. Four women, the Zika virus can be passed HHS agencies had small unobligated balances as of the September 30, 2017, to the fetus and cause severe brain obligation deadline; these balances cannot be used to incur new obligations, but defects. In response to an outbreak in may be used to adjust award amounts in future years. Disbursement of the the United States and its territories, obligated funds was ongoing, with about 21 percent of the Zika supplemental Congress appropriated $932 million in funding (approximately $195.5 million) disbursed as of December 31, 2017. The September 2016 through the Zika agencies have until September 30, 2022, to disburse the remainder. Response and Preparedness Act to HHS and its agencies to prevent, Zika Supplemental Obligations as of September 30, 2017 prepare for, and respond to the Zika In dollars (rounded) virus and its related health conditions, Total and conduct related research. supplemental Amount Unobligated HHS agency funding obligated balance The act also included a provision that Biomedical Advanced Research and Development 245,000,000 245,000,000 0 GAO study the activities supported Authority with the appropriated funds. This report Centers for Disease Control and Prevention 394,000,000 393,706,358 293,642 describes (1) the status of funds Centers for Medicare & Medicaid Services 75,000,000 74,982,493 17,508 Health Resources and Services Administration 66,000,000 65,978,442 21,558 obligated and disbursed from the Zika National Institutes of Health 152,000,000 151,998,591 1,409 supplemental funding appropriated to Total 932,000,000 931,665,883 334,117 HHS and its agencies; and (2) how Source: GAO analysis of Department of Health and Human Services (HHS) data. | GAO-18-389 selected awardees used their Zika supplemental funding, and their The 12 awardees GAO interviewed—officials from 10 states and two local experiences with applying for and entities—funded multiple activities with their Zika supplemental funding, and had managing the funding. To do this work, varying experiences applying for and managing the funds. GAO reviewed agency documents on Zika supplemental funding and • Awardees told GAO that they used their funding to support such activities as activities, and interviewed officials from collection of information about individuals affected by the Zika virus (human the HHS agencies and selected surveillance), mosquito control activities, laboratory capacity building, public awardees. To select awardees, GAO outreach, and health care services. For example, Florida used Zika identified states based on the amount supplemental funding in its state-run laboratories to purchase materials for of initial Zika supplemental funding testing Zika virus-related specimens. they received from CDC, the Centers for Medicare & Medicaid Services, and • A majority of the awardees GAO spoke with reported positive experiences the Health Resources and Services applying for and managing the Zika supplemental funding, including good Administration; and selected states communication with agency officials and awardees’ familiarity with the with the highest and lowest funding. In mechanisms used to make the awards. However, some awardees noted total, GAO selected 12 awardees: 10 challenges, such as time frames to use the funding that varied among states, as well as one county and one multiple awards and identifying the activities that could be funded. These city from 2 of the 10 states. challenges added administrative burdens to applying for and managing the GAO provided a draft of this report to Zika supplemental funding while officials were responding to the outbreak, HHS. In response, HHS provided according to the awardees. In October 2017, the Centers for Disease Control technical comments, which were and Prevention (CDC) issued a new notice of funding opportunity that incorporated as appropriate. agency officials said is intended to help minimize the administrative burden View GAO-18-389. For more information, on states and certain localities during emergencies—such as preparing contact Marcia Crosse at (202) 512-7114 or applications—by pre-approving public health departments in these crossem@gao.gov. jurisdictions to be eligible to rapidly receive future awards. United States Government Accountability Office Contents Letter 1 Background 5 HHS Agencies Have Obligated Nearly All of the Zika Supplemental Funding; Disbursements Are Ongoing 10 Selected Awardees Undertook Multiple Activities with Zika Supplemental Funding, and Had Varying Experiences Applying for and Managing Funds 18 Agency and Third-Party Comments 30 Appendix I Biomedical Advanced Research and Development Authority’s Zika Supplemental Awards 31 Appendix II Centers for Disease Control and Prevention— Epidemiology and Laboratory Capacity for Infectious Diseases Awardees 33 Appendix III Centers for Disease Control and Prevention— Birth Defects Awardees 40 Appendix IV Centers for Disease Control and Prevention— Behavioral Risk Factor Surveillance System Awardees 42 Appendix V Centers for Disease Control and Prevention— Pregnancy Risk Assessment Monitoring System Awardees 43 Appendix VI Centers for Disease Control and Prevention— Public Health Preparedness and Response Awardees 44 Page i GAO-18-389 Zika Supplemental Funding Appendix VII Centers for Disease Control and Prevention— Other Cooperative Agreements’ Awardees 45 Appendix VIII Centers for Disease Control and Prevention— Contracts and Interagency Agreements 49 Appendix IX Centers for Medicare & Medicaid Services— Zika Health Care Services Program Awards 56 Appendix X Health Resources and Services Administration’s Zika Supplemental Awards 57 Appendix XI National Institutes of Health Zika Supplemental Awards 60 Appendix XII GAO Contact and Staff Acknowledgments 68 Tables Table 1: Zika Supplemental Funding Obligations as of September 30, 2017 11 Table 2: Examples of Activities of Selected Awardees That Received Direct Zika Supplemental Funding from CDC and CMS 19 Table 3: Biomedical Advanced Research and Development Authority’s Zika Supplemental Funding Contracts 31 Table 4: Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement’s Zika Supplemental Funding for States and Territories, by Awardee and Activity Funded 33 Table 5: Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement’s Zika Supplemental Funding for Local Health Departments, by Awardee and Activity Funded 39 Page ii GAO-18-389 Zika Supplemental Funding Table 6: Birth Defects Cooperative Agreement Zika Supplemental Funding by Awardee 40 Table 7: Behavioral Risk Factor Surveillance System Cooperative Agreement’s Zika Supplemental Funding by Awardee 42 Table 8: Pregnancy Risk Assessment Monitoring System Cooperative Agreement’s Zika Supplemental Funding by Awardee 43 Table 9: Public Health Preparedness and Response Cooperative Agreement for All-Hazards Public Health Emergencies Cooperative Agreement’s Zika Supplemental Funding by Awardee 44 Table 10: Sentinel Enhanced Dengue Surveillance System Project Cooperative Agreement’s Zika Supplemental Funding by Awardee 45 Table 11: Vector-Borne Disease Regional Centers of Excellence Cooperative Agreement’s Zika Supplemental Funding by Awardee 46 Table 12: Enhancing Capacity for Vector Surveillance and Control to Prevent Zika, Dengue and Chikungunya Infection in Puerto Rico Cooperative Agreement’s Zika Supplemental Funding by Awardee 46 Table 13: Immunization Grants-CDC Partnership: Strengthening Public Health Laboratories Cooperative Agreement’s Zika Supplemental Funding by Awardee 47 Table 14: Building Capacity of the Public Health System to Improve Population Health through National, Nonprofit Organizations Cooperative Agreement’s Zika Supplemental Funding by Awardee 47 Table 15: Strengthening the Public Health System in the U.S.- Affiliated Pacific Islands Cooperative Agreement’s Zika Supplemental Funding by Awardee 48 Table 16: Pan American Health Organization: Building Capacity and Networks to Address Emerging Infectious Diseases in the Americas Cooperative Agreement’s Zika Supplemental Funding by Awardee 48 Table 17: Global Health Security Partner Engagement: Expanding Efforts and Strategies to Protect and Improve Public Health Globally Cooperative Agreement’s Zika Supplemental Funding by Awardee 48 Table 18: Centers for Disease Control and Prevention Zika Supplemental Funding Contracts by Awardee and Activity Funded 49 Page iii GAO-18-389 Zika Supplemental Funding Table 19: Centers for Disease Control and Prevention Zika Supplemental Funding Interagency Agreements by Awardee and Activity Funded 55 Table 20: Centers for Medicare & Medicaid Services’ Zika Health Care Services Program Awardees 56 Table 21: Health Resources and Services Administration Zika Supplemental Funding for Health Centers by Awardee 58 Table 22: Health Resources and Services Administration Zika Supplemental Funding for Special Projects of Regional and National Significance by Awardee 59 Table 23: National Institutes of Health’s Zika Supplemental Funding Contracts 60 Table 24: National Institutes of Health’s Zika Supplemental Funding Grants 61 Table 25: National Institutes of Health’s Zika Supplemental Funding Intramural Awards 66 Table 26: Other National Institutes of Health Zika Supplemental Funding Awards 67 Figures Figure 1: Total Zika Supplemental Funding by Agency 8 Figure 2: Examples of Vector Control Activities in Miami-Dade County, Florida 23 Figure 3: Examples of Zika Outreach Activities 26 Figure 4: Timeline of Florida’s Zika Supplemental Funding Awards 28 Page iv GAO-18-389 Zika Supplemental Funding Abbreviations BARDA Biomedical Advanced Research and Development Authority BRFSS Behavioral Risk Factor Surveillance System CDC Centers for Disease Control and Prevention CMS Centers for Medicare & Medicaid Services ELC Epidemiology and Laboratory Capacity for Infectious Diseases HHS Department of Health and Human Services HRSA Health Resources and Services Administration NIH National Institutes of Health PHPR Public Health Preparedness and Response PHSSEF Public Health and Social Services Emergency Fund PRAMS Pregnancy Risk Assessment Monitoring System This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. However, because this work may contain copyrighted images or other material, permission from the copyright holder may be necessary if you wish to reproduce this material separately. Page v GAO-18-389 Zika Supplemental Funding Letter 441 G St. N.W. Washington, DC 20548 May 14, 2018 The Honorable Roy Blunt Chairman The Honorable Patty Murray Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Committee on Appropriations United States Senate The Honorable Tom Cole Chairman The Honorable Rosa DeLauro Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies Committee on Appropriations House of Representatives The Zika virus outbreak in 2015 affected individuals infected with the virus in ways that had not been seen with other infectious disease outbreaks. Zika—a virus primarily transmitted through mosquito bites—can cause symptoms that include fever, rash, conjunctivitis (red eyes), and joint and muscle pain, though many infected individuals do not have symptoms or will only experience mild symptoms. However, in this outbreak, the Zika infection in pregnant women has been linked to adverse pregnancy and birth outcomes: the virus can be passed to the fetus and cause a birth defect of the brain called microcephaly and other severe brain defects, according to the Centers for Disease Control and Prevention (CDC). 1 CDC officials note that this is the first time in more than 50 years that an 1 Microcephaly is a rare nervous system disorder that causes a baby’s head to be smaller than expected and not fully developed, which can lead to impaired thought processes, delayed motor function, and other adverse outcomes. A study published in December 2017 found that 19 children ages 19 to 24 months born with microcephaly and with laboratory evidence of Zika virus infection experienced problems including an inability to sit independently, difficulties with sleeping and feeding, seizures, and hearing and vision problems. Ashley Satterfield-Nash et al., “Health and Development at Age 19-24 Months of 19 Children Who Were Born with Microcephaly and Laboratory Evidence of Congenital Zika Virus Infection During the 2015 Zika Virus Outbreak—Brazil, 2017,” Morbidity and Mortality Weekly Report, vol. 66, no. 49 (Dec. 15, 2017): 1347-1351. Page 1 GAO-18-389 Zika Supplemental Funding infectious pathogen has been identified as the cause of birth defects. The virus is also linked to other problems, such as miscarriage, stillbirth, and other birth defects, as well as Guillain-Barré syndrome, an uncommon sickness of the nervous system. 2 In the western hemisphere, the first cases of locally transmitted Zika virus disease were confirmed in Brazil in May 2015; in the continental United States, the first locally transmitted cases were confirmed in Florida during June to August 2016. 3 The World Health Organization declared the Zika virus a Public Health Emergency of International Concern from February to November 2016, and maintains that it is a significant, enduring public health challenge. As of January 24, 2018, about 5,600 cases involving Zika virus disease have been reported in the United States and about 37,000 cases have been reported in the U.S. territories, primarily in Puerto Rico. In response to the outbreak, Congress appropriated $932 million in September 2016 through the Zika Response and Preparedness Act to the Department of Health and Human Services (HHS) and its agencies for activities such as responding to the Zika virus, developing vaccines, and reimbursement for health care costs related to the Zika virus. 4 Specifically, the act appropriated $394 million to CDC, $152 million to the National Institutes of Health (NIH), and $387 million to HHS’s Public Health and Social Services Emergency Fund (PHSSEF), of which $386 million was allocated to additional HHS agencies—the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response, the Centers for Medicare & Medicaid Services (CMS), and the Health Resources and Services Administration (HRSA). 5 The agencies had until September 30, 2017, to obligate the funding, for example, by awarding a contract or a 2 Guillain-Barré syndrome is a rare disorder in which the body’s immune system attacks the nervous system outside the brain and spinal cord, causing muscle weakness and in some cases paralysis, although most people recover. 3 While the continental United States’ first locally transmitted case was identified in Florida, locally transmitted Zika virus was reported in December 2015 in Puerto Rico. 4 Zika Response and Preparedness Act, Pub. L. No. 114-223, div. B, tit. I, 130 Stat. 857, 901 (2016). For the purposes of this report, we refer to funding appropriated in the Zika Response and Preparedness Act as Zika supplemental funding. 5 The remaining $1 million appropriated to HHS’s PHSSEF was to be divided equally between HHS’s Office of Inspector General and GAO for oversight activities. Pub. L. No. 114-223, § 104, 130 Stat. at 904. Throughout this report we use “agency” to refer to agencies within HHS and the Office of the Secretary, except for HHS’s Office of Inspector General. Page 2 GAO-18-389 Zika Supplemental Funding grant to an entity (awardee). Agencies have until September 30, 2022, to disburse, or spend, the funding. The Zika Response and Preparedness Act included a provision that we study activities supported with funds appropriated by the act. In this report, we describe 1. the status of obligations and disbursements of Zika supplemental funding by HHS agencies; and 2. how selected awardees used their Zika supplemental funding, and their experiences with applying for and managing the funding. To describe the status of obligations and disbursements of Zika supplemental funding by HHS agencies, we analyzed BARDA, CDC, CMS, HRSA, and NIH obligation data as of September 30, 2017—the date funding had to be obligated—and disbursement data as of December 31, 2017—the first full quarter of data available at the time of our review. Each agency provided tabulated data that included information such as the award title, awardee name and location, award amount, award time frame, and the funding mechanism the agency used to award the funding. We interviewed officials from each agency to discuss the status of the agencies’ obligations and disbursements of the Zika supplemental funding, the different mechanisms used to award the funding, and the various factors that influenced the obligation and disbursement of the funding to awardees. We also reviewed documentation of the funding opportunity announcements to obtain information such as the activities allowed under each type of award. To determine the reliability of the data provided, we compared the tabulated award amounts received from CDC and HRSA to the actual notices of award provided by both agencies, and compared NIH award data to the amounts reported in NIH’s online database. We also obtained information from BARDA, CMS, and NIH officials regarding the underlying financial data systems used to compile the data and the controls in place for recording and maintaining the data. We reviewed the data from each agency for data discrepancies and obtained the information necessary to resolve the discrepancies from relevant agency officials. Furthermore, we interviewed officials from HHS’s Office of the Assistant Secretary for Financial Resources on the accuracy of the data and the steps the office takes to verify agencies’ obligation and disbursement data. On this basis, we determined that the data were sufficiently reliable for the purposes of our reporting objectives. Page 3 GAO-18-389 Zika Supplemental Funding Additionally, to describe the various factors that can affect the disbursement of funding after obligation, we interviewed officials representing selected awardees. To select awardees, we first identified states that were awarded Zika supplemental funding from HHS agencies (45 states) based on our review of the amount of initial Zika supplemental funding they received from CDC, CMS, and HRSA. From those 45 states, we judgmentally selected 10 states—5 states with the highest funding and 5 states with the lowest funding—which included the 2 states that experienced local Zika virus transmissions (Florida and Texas). Our selected states with the highest funding were Arizona, California, Florida, Louisiana, and Texas. Our selected states with the lowest funding were Alaska, Colorado, Iowa, Kansas, and Oklahoma. 6 To obtain perspectives of awardees at the local level, we judgmentally selected two local awardees within 2 of the selected states—Houston, Texas, and Los Angeles County, California. For each selected state or jurisdiction, we interviewed state, county, or city officials who could provide information about their Zika supplemental funding. The perspectives of the 12 awardees we interviewed cannot be generalized to other awardees. To describe how selected awardees used their Zika supplemental funding and gain their perspectives on applying for and managing this funding, we reviewed documentation from the 12 selected awardees to identify the activities they funded. We also interviewed officials from the selected awardees (state officials and officials from one county and one city) about their experiences with using the Zika supplemental funding and to obtain examples of awardees’ Zika activities. We conducted site visits to Florida and Texas, because at the time of our work, they alone had reported local Zika virus transmissions. 7 Additionally, we reviewed CDC and CMS documents to determine the amount of funding received and the purpose of the funding for each of the selected awardees. We also interviewed 6 In determining states’ respective funding levels under the Zika Response and Preparedness Act, we excluded funding awarded by NIH and BARDA to entities other than states. We also excluded a $44 million appropriation to CDC for the Public Health Emergency Preparedness cooperative agreement program. The Zika Response and Preparedness Act specified that this amount was to restore fiscal year 2016 funds that HHS had reprogrammed for Zika response activities prior to its enactment, which could be used for purposes other than Zika-related activities. See Pub. L. No. 114-223, 130 Stat. at 902. 7 We planned to conduct a site visit to Puerto Rico, as it was the territory with the most Zika disease cases and also had reported active Zika transmissions. However, we were not able to speak to officials in Puerto Rico due to ongoing recovery efforts following hurricanes Irma and Maria. Page 4 GAO-18-389 Zika Supplemental Funding CDC officials regarding any changes the agency has made to its plans for awarding funding in the future. We conducted this performance audit from April 2017 to May 2018 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. During a disease outbreak, including the Zika virus, HHS is the lead Background federal agency for public health and medical response, and it leverages national public health and medical resources to prepare for and respond to the outbreak. 8 Zika Virus Transmission The Zika virus is primarily transmitted to humans by infected mosquitoes, and Prevention but can also be transmitted from mother to child during pregnancy or around the time of birth, or from person-to-person through sexual contact or blood transfusion. According to CDC, once an individual has been infected with the Zika virus, they are likely to be protected from future infections. The Aedes aegypti mosquitoes are reportedly the primary mosquito spreading the Zika virus, while the Aedes albopictus mosquitoes, which share many of the same traits as Aedes aegypti, also have the ability to spread the virus. 9 Local transmission of the virus has occurred in American Samoa, Florida, Puerto Rico, Texas, and the U.S. 8 Within HHS, the Office of the Assistant Secretary for Preparedness and Response leads and coordinates national preparedness and response to outbreaks in the United States. Within that office, BARDA coordinates and supports advanced research and development, manufacturing, and initial procurement of medical countermeasures, such as vaccines, drugs, therapies, and diagnostic tools. CDC monitors and responds to outbreaks by, for example, conducting studies to learn about the link between infection and health outcomes, monitoring and reporting cases of infection, and providing guidance to travelers and health care providers. According to officials, NIH funds and carries out basic and applied research to develop diagnostics, vaccines and therapeutics, as well as epidemiological studies to better understand disease progression and long-term health effects. 9 Edward B. Hayes, “Zika Virus Outside Africa,” Emerging Infectious Diseases, vol.15, no. 9 (2009): 1347–50; and National Science and Technology Council, A Strategy for Integrating Best Practices with New Science to Prevent Disease Transmission by Aedes Mosquito Vectors (Washington, D.C.: December 2016). Page 5 GAO-18-389 Zika Supplemental Funding Virgin Islands. Travel-associated cases of Zika virus infection have been reported in every state, with the largest numbers of cases reported in California, Florida, New York, and Texas. 10 There is no vaccine to prevent the Zika virus, so CDC guidance recommends preventing the spread of the virus by protecting against mosquito bites by wearing protective clothing, using insect repellant, and staying in places with air conditioning and window and door screens to keep mosquitoes outside, among other actions. Mosquito control in the United States is implemented and overseen at the state and local levels by entities such as mosquito control districts and health agencies. Federal agencies support such control entities with funding and subject matter experts, and may regulate some control methods such as pesticides. Zika Funding Prior to In April 2016, the Office of Management and Budget and the Secretary of September 2016 Health and Human Services announced that they had identified $589 million—$510 million of it from existing Ebola virus disease resources within HHS, the Department of State, and the U.S. Agency for International Development—that could quickly be redirected and spent on immediate efforts to control and respond to the spread of the Zika virus. According to HHS, out of the $589 million, $374 million was redirected to domestic Zika virus control activities. HHS reports that almost all of this funding ($354 million) was distributed to three HHS agencies, as follows: • CDC received $222 million for various activities including field staff, state response teams, Zika virus testing, tracking of pregnant women who were infected with the Zika virus, and grants for mosquito control and other Zika prevention activities; • BARDA received $85 million for private sector development of Zika vaccines, treatments, and technologies to protect the blood supply, and other countermeasures; and • NIH received $47 million for Zika medical countermeasure development, including clinical trials on the leading Zika vaccine candidate. Additionally, according to HHS officials, in August 2016, the Secretary of Health and Human Services notified Congress of the department’s intent 10 CDC’s case counts for travel-associated cases of Zika virus infection, by state, also include cases where the Zika virus was transmitted sexually, through a laboratory, and person-to-person through an unknown route. Page 6 GAO-18-389 Zika Supplemental Funding to redirect an additional $81 million in unobligated HHS funds for Zika vaccine development activities. Of this amount, $34 million was drawn from accounts at NIH and $47 million was drawn from funds transferred from other HHS agencies and reprogrammed from within PHSSEF. 11 From these redirected funds, $34 million (i.e., the amount drawn from other NIH accounts) was to be used by NIH to continue clinical trials on its lead Zika vaccine candidate. The remaining $47 million was to be used by BARDA for continued private sector Zika vaccine development. September 2016 Zika In September 2016, Congress appropriated $932 million to HHS and its Supplemental Funding agencies in the Zika Response and Preparedness Act. Of that amount, $394 million was appropriated directly to CDC and $152 million was appropriated directly to NIH. The remainder was appropriated to HHS’s PHSSEF, from which HHS allocated $245 million to BARDA within the Office of the Assistant Secretary for Preparedness and Response, $75 million to CMS, and $66 million to HRSA. (See fig. 1.) 11 Reprogramming is the shifting of funds within an appropriation or account to use them for purposes other than those contemplated at the time of appropriation; it is the shifting of funds from one object class to another or from one program activity to another. See GAO, A Glossary of Terms Used in the Federal Budget Process, GAO-05-734SP (Washington, D.C.: Sept. 1, 2005). Page 7 GAO-18-389 Zika Supplemental Funding Figure 1: Total Zika Supplemental Funding by Agency Note: BARDA is within the Office of the Assistant Secretary for Preparedness and Response. The Zika supplemental funding remained available for obligation until September 30, 2017, for the following purposes: • CDC: to prevent, prepare for, and respond to the Zika virus, health conditions related to the virus, and other vector-borne diseases, domestically and internationally. 12 • NIH: for research on the virology, natural history, and pathogenesis of the Zika virus infection, and preclinical and clinical development of vaccines and other medical countermeasures for the Zika virus and other vector-borne diseases, domestically and internationally. 12 Additionally, CDC was directed to use $44 million of the funding appropriated by the Zika Response and Preparedness Act to restore fiscal year 2016 funds that were reprogrammed from the Public Health Emergency Preparedness cooperative agreement program for Zika virus response prior to the act’s enactment. Page 8 GAO-18-389 Zika Supplemental Funding • PHSSEF: for various activities, including to prevent, prepare for, and respond to the Zika virus, health conditions related to the virus and other vector-borne diseases, domestically and internationally; and to develop necessary countermeasures and vaccines, including the development and purchase of vaccines, therapeutics, diagnostics, necessary medical supplies, and administrative activities. • BARDA: HHS allocated funding to BARDA to support further development of Zika vaccine candidates, diagnostics, and pathogen reduction technologies initiated in fiscal year 2016 to advance these projects toward licensure or approval by the Food and Drug Administration. • CMS: HHS allocated funding to CMS for expenses to support states, territories, tribes, or tribal organizations with active or local transmission cases of the Zika virus, as confirmed by CDC. The funding was allocated to reimburse the costs of health care for health conditions related to the Zika virus, other than costs that are covered by private health insurance, of which not less than $60 million were for territories with the highest rates of Zika virus transmission. • HRSA: HHS allocated $20 million for projects of regional and national significance in Puerto Rico and other U.S. territories, $40 million to expand the delivery of primary health services in Puerto Rico and the other territories, and $6 million to be used to assign National Health Service Corps members to Puerto Rico and the other territories to provide primary health services in areas affected by the Zika virus or other vector-borne diseases through the National Health Service Corps Loan Repayment Program. 13 Agencies have until September 30, 2022, to disburse the Zika supplemental funding appropriated by the Zika Response and Preparedness Act. 13 The National Health Service Corps offers financial and other support to primary care providers and sites in underserved communities. Page 9 GAO-18-389 Zika Supplemental Funding HHS Agencies Have Obligated Nearly All of the Zika Supplemental Funding; Disbursements Are Ongoing Agencies Obligated Nearly We found that as of September 30, 2017—the end of the Zika All of Their Zika supplemental appropriation’s period of availability—nearly all Zika supplemental funding had been obligated, primarily through cooperative Supplemental Funding as agreements, grants, and contracts. 14 BARDA obligated 100 percent of its of September 30, 2017, Zika supplemental funding, while CDC, CMS, HRSA, and NIH obligated Primarily Through over 99 percent of their funding. 15 (See table 1.) Cooperative Agreements, Grants, and Contracts 14 A cooperative agreement is an alternative assistance instrument used instead of a grant whenever substantial federal involvement with the recipient during performance is anticipated. For grants, an agency’s involvement is essentially administrative, which includes standard federal stewardship responsibilities, such as reviewing performance to ensure that the objectives, terms, and conditions of the grant are accomplished. 15 These unobligated balances are not available after September 30, 2017, to incur new obligations. However, agencies can use unobligated balances to correct errors in recording obligations properly incurred during the period of availability or to cover legitimate cost adjustments in future years, such as those that may arise from contract modifications within the general scope of a prior year contract. Page 10 GAO-18-389 Zika Supplemental Funding Table 1: Zika Supplemental Funding Obligations as of September 30, 2017 In dollars (rounded) HHS agency Total supplemental Amount Unobligated funding obligated balance Biomedical Advanced Research and Development 245,000,000 245,000,000 0 Authority (BARDA) Centers for Disease Control and Prevention 394,000,000 393,706,358 293,642 Centers for Medicare & Medicaid Services 75,000,000 74,982,493 17,508 Health Resources and Services Administration 66,000,000 65,978,442 21,558 National Institutes of Health 152,000,000 151,998,591 1,409 Total 932,000,000 931,665,883 334,117 Source: GAO analysis of Department of Health and Human Services (HHS) data. | GAO-18-389 Note: BARDA is within the Office of the Assistant Secretary for Preparedness and Response. Three of the five agencies had obligated over half of their Zika supplemental funding by January 31, 2017, 4 months after enactment of the appropriation. For example, according to CDC officials, using cooperative agreements with application processes familiar to the awardees helped enable the agency to obligate its funding soon after receiving the appropriation. 16 Some agencies began obligating later in the one-year obligation time frame based on their approach to obligating the Zika supplemental funding. For example, CMS withheld a portion of its supplemental funds in the event additional awardees became eligible for funding within the obligation time frame—eligibility included having active or local transmission of the Zika virus. Agency officials told us that they used cooperative agreements, grants, and contracts to award Zika supplemental funding to existing and new awardees. The agencies also used other mechanisms to obligate the Zika supplemental funding, such as interagency agreements, intramural research awards, and funding used within the agency for travel and other 16 Although CDC generally used existing mechanisms familiar to awardees, agency officials explained that the application process still needed to be completed—from creating and publishing notices of funding opportunities to issuing notices of award—prior to the obligation of funding. Page 11 GAO-18-389 Zika Supplemental Funding expenses. 17 According to officials, agencies used these mechanisms to award Zika supplemental funding in the following ways. • BARDA executed new contracts and modified existing contracts through the agency’s typical contracting process, officials said, for research in the areas of Zika clinical diagnostics and vaccine development. BARDA did not use any Zika supplemental funding to support internal administrative or personnel costs. (See app. I for the contracts BARDA awarded with its Zika supplemental funding.) • CDC generally obligated Zika supplemental funding to current awardees through existing cooperative agreements, according to agency officials. (See app. II through VII for the cooperative agreements CDC used to award Zika supplemental funding to existing awardees.) CDC also awarded funding through contracts and interagency agreements, and obligated about $24 million for internal CDC expenses, such as salaries and benefits, travel, supplies, and equipment. (See app. VIII for the contracts and interagency agreements CDC awarded with its Zika supplemental funding.) • CMS created a new program—the Zika Health Care Services Program—to award its Zika supplemental funding through cooperative agreements, according to agency officials. The purpose of the 3-year program is to support prevention activities and treatment services for women (including pregnant women), children, and men adversely or potentially affected by the Zika virus. 18 CMS awarded funding through the Zika Health Care Services Program to those states, territories, tribes, or tribal organizations with active or local transmission of the Zika virus, as confirmed by CDC. CMS awarded funding to the health departments in American Samoa, Florida, Puerto Rico, and the U.S. Virgin Islands in January 2017. In June 2017, CMS awarded funding to the health department in Texas, the only new state or territory with 17 Intramural research entails government scientists working in their institutes’ and centers’ own laboratories and clinics. An interagency agreement occurs when one agency either places an order directly against another agency’s contract or uses the contracting services of another agency to obtain supplies or services. 18 According to CMS documentation, the Zika Health Care Services Program is intended to address four critical components of a comprehensive response to Zika: (1) increase access to contraceptive services for women and men; (2) increase access to and reduce barriers to diagnostic testing, screening, and counseling for pregnant women and newborns; (3) increase access to appropriate specialized health care services for pregnant women, children born to mothers with maternal Zika virus infection, and their families; and (4) improve provider capacity and capability. Awardee needs may vary and some awardees may not have unmet needs across each of the four areas. Page 12 GAO-18-389 Zika Supplemental Funding local transmission of the Zika virus. 19 In both CMS award rounds, only states and territories received awards, because they were the only areas with active or local transmission of the Zika virus. CMS retained about $3.6 million of the Zika supplemental funding to use for administrative support services, as well as for travel for monitoring and oversight. (See app. IX for the awards CMS made with its Zika supplemental funding.) • HRSA generally obligated Zika supplemental funding through grants to existing awardees, according to agency officials. HRSA did not retain any Zika supplemental funding for internal activities. (See app. X for the grants HRSA awarded.) • NIH used grants and contracts to award its Zika supplemental funding to new and existing awardees. NIH also used about $95 million of the Zika supplemental funding for internal activities—studies conducted by NIH researchers. According to NIH officials, the somewhat unique aspects of the Zika virus as an arbovirus infectious disease led NIH to focus on vaccines as a priority, along with development of diagnostics, therapeutics, vector control, and surveillance. 20 (See app. XI for NIH’s Zika supplemental awards.) For more information on the funding provided by CDC, CMS, and HRSA—the only agencies that provided funding for states and territories—and the number of reported Zika cases by state or territory, see an interactive graphic at https://www.gao.gov/products/GAO-18-389. Officials from all five agencies cited coordination initiatives through regular interagency or organizational teleconferences and participation in working groups. According to CMS officials, during the Zika virus response, CDC, CMS, HRSA, and other federal partners held interagency Zika coordination calls to discuss ongoing developments related to the Zika virus. Additionally, because CMS and HRSA were both awarding 19 According to officials, CMS issued supplemental awards to each of the five grantees in September 2017, using additional remaining funds. 20 Arthropod-borne viruses (arboviruses) are transmitted to humans primarily through the bites of infected mosquitoes and ticks. Surveillance is the systematic and continuous collection, analysis, and interpretation of data, closely integrated with the timely and coherent dissemination and assessment of the results by those who have the right to know so that action can be taken. For more information about Zika disease surveillance, see GAO, Emerging Infectious Diseases: Actions Needed to Address the Challenges of Responding to Zika Virus Disease Outbreaks, GAO-17-445 (Washington, D.C.: May 23, 2017). Page 13 GAO-18-389 Zika Supplemental Funding funding for perinatal health care services, officials said they collaborated to ensure that activities available through the CMS grants complemented the activities available through HRSA’s Special Projects of Regional and National Significance. In addition, HRSA officials reported conducting joint site visits with CDC and CMS, as well as streamlining reporting requirements to reduce grantee reporting burden. Furthermore, BARDA officials said that they awarded and administered a contract for CDC on the development of a vector control product. CDC provided the funding and topical subject matter expertise for the award, and BARDA provided management services for the contract, because of BARDA’s experience with these types of contracts. BARDA and NIH officials also reported collaborating on vaccine development. BARDA officials explained that while the vaccine development process requires that different agencies support multiple vaccine development candidates, the two agencies coordinated to avoid redundancy. Agencies Had Disbursed We found that as of December 31, 2017, the HHS agencies had About 21 Percent of the disbursed about 21 percent (approximately $195.5 million of $932 million) of the Zika supplemental funding. According to agency officials and Zika Supplemental selected awardees we spoke with, various factors can affect the Funding as of December disbursement of funding after obligation. These factors include time to 31, 2017 draw down funding from the federal agencies, allowing for program implementation and a planning period, and awardees’ internal administrative processes and unique characteristics, as described below. Drawdown procedures. CDC officials said that awardees draw down federal funding on their individual schedules based upon how they manage their federal funding. Some awardees draw down on a daily basis, as needed, while others draw down on a biweekly or monthly basis. Additionally, drawdowns for personnel costs coincide with payroll schedules, which could be biweekly or monthly. For example, in the case of monthly payroll, two awardees told us that the federal funding for a particular month’s expenses would be drawn down the following month. Furthermore, selected awardees we spoke with said that they draw down federal funding after they have incurred an expense, such as when they receive an invoice. For example, Los Angeles County officials reported that in order to draw down the funds for the organization that is responsible for servicing their vector control activities, they have to first receive an invoice from the organization, which the county pays with its own funds. Only then can the county draw down the federal funding. This process usually results in at least a 3-month period between receiving the invoice and drawing down the federal funding, officials said. Page 14 GAO-18-389 Zika Supplemental Funding Program implementation and planning period. According to CMS officials, the agency awarded funding to health departments in American Samoa, Florida, Puerto Rico, Texas, and the U.S. Virgin Islands from the Zika Health Care Services Program, which was a new collaboration between CMS and these specific awardees. The officials said that the steps awardees needed to take to stand-up new programs—such as budget review and approval processes, selection of key personnel to administer the grant, grant activities related to contracting, and hiring and procurement—can delay start-up and implementation of the grant programs. Additionally, CMS gave awardees in the Zika Health Care Services Program a 3-month planning period after they received their notices of award to amend their activities. 21 For example, Texas officials reported that they used the 3-month planning period to work on executing contracts with the local health departments in three counties bordering Mexico. Texas officials explained that collaborating with the local health departments entailed determining the greatest potential benefit of the use of the funds, because the award itself was not enough to cover all of the costs of direct health care services associated with the Zika virus. Awardees’ processes and characteristics. Local administrative processes for spending federal supplemental funds can result in varied disbursement time frames. For example, California received Zika supplemental funding for an award that required an amendment to an administrative contract, which state officials said takes about 7 to 8 months for internal state approval. Additionally, certain awardees’ characteristics affect disbursements. For example, Houston officials said the city was eligible for and was directly awarded a CDC cooperative agreement, but because it does not conduct vector control activities itself, the city had to negotiate a contract with the surrounding county to conduct these activities, adding additional time before it could begin disbursements. 21 CMS provided awardees with a 3-month planning period to fine tune the request for all specific activities funded under the award. CMS officials said that they provided this period because there was a limited time provided to submit an application due to the Zika virus being a public health emergency. According to CMS officials, the 3-month planning period enabled awardees to fully analyze and identify a comprehensive set of needs, to fine tune the request for all specific activities funded under the award; to begin the process for staffing, contracting, establishing reimbursement methodologies, and other procurement efforts; to ensure that CMS funding is coordinated with funding from other federal agencies; and to ensure non-duplication of funding from all sources. Page 15 GAO-18-389 Zika Supplemental Funding Officials also noted that awardees’ personnel hiring issues can affect disbursement time frames. For example, CMS officials said that some territories experienced delays in carrying out activities due to provider shortages, particularly among specialists needed to care for children with developmental delays and birth defects caused by the Zika virus. CMS officials noted that island jurisdictions, such as the U.S. territories, can find hiring more difficult due to a shortage of health care professionals available within the territory, thus requiring individuals to be recruited from outside the territory, which adds time to the process and raises costs. In addition, Florida officials in Miami-Dade County reported that the necessary staff surge during the Zika response was challenging to fill, noting that it was particularly difficult to find phlebotomists and nurses, because they were in high demand. 22 Standard vaccine development processes also influenced the rate of disbursement. Due to the long duration of the vaccine development process, BARDA officials said, disbursements to certain awardees have occurred at varying intervals. For example, some contract invoices are received on a monthly basis, or twice a month if the company is a small business. The invoices are then reviewed and if deemed acceptable, they are processed for payment. The 2017 hurricane season may have affected certain awardees’ use of their Zika supplemental funding, which prompted agencies to respond by approving various types of short-term relief for administrative, financial management, and audit requirements for awardees affected by the hurricanes. Three agencies—CDC, CMS, and HRSA—awarded Zika supplemental funding to areas affected by hurricanes Harvey, Irma, and Maria in 2017: Florida, Puerto Rico, Texas, and the U.S. Virgin Islands. CDC officials told us, for example, that because of the hurricanes they granted extensions at the request of the awardees for submitting financial and progress reports, and continuation of activities. Similarly, CMS offered hurricane-affected awardees of the Zika Health Care Services Program the option to extend the deadline for deliverables, if necessary. CMS officials told us that grant activities had been affected by the hurricanes, and all grantees had communicated the intent to fully resume activities as soon as they are able to do so. Due to the 3-year project period for grantees, CMS officials said that the affected entities can still 22 A phlebotomist is an individual trained to draw blood for tests, transfusions, research, or blood donations. Page 16 GAO-18-389 Zika Supplemental Funding accomplish programmatic responsibilities, even if there is a temporary halt in project activities. Furthermore, HRSA officials said that they provided Puerto Rico and the U.S. Virgin Islands with extensions on required program, financial, and audit reports. 23 23 On October 26, 2017, the Office of Management and Budget released a memorandum to federal agencies with guidance for administrative relief for grantees affected by hurricanes Harvey, Irma, and Maria. Under certain circumstances, agencies could provide flexibility with application deadlines, provide no-cost extensions on expiring awards, allow expenditure of award funds for salaries and other project activities, and waive prior approval requirement waivers, among other actions. Page 17 GAO-18-389 Zika Supplemental Funding Selected Awardees Undertook Multiple Activities with Zika Supplemental Funding, and Had Varying Experiences Applying for and Managing Funds Selected Awardees Used Selected awardees we spoke with used Zika supplemental funding for a Zika Supplemental variety of activities. Collectively, the activities included four primary types: medical surveillance, vector control, laboratory capacity building, and Funding for Activities providing health care services, as described below. 24 Including Surveillance, Vector Control, Laboratory • Medical surveillance activities include identifying and reporting Zika Capacity, and Health Care virus disease cases to CDC, as well as reporting Zika virus infections in pregnant women and infants to the U.S. Zika Pregnancy Registry. 25 Services • Vector control activities include detecting and monitoring Aedes aegypti and Aedes albopictus mosquito distribution and mosquito control, and monitoring of insecticide resistance and management. • Laboratory capacity building activities include developing laboratory capacity to perform Zika virus testing. • Health care service activities for those selected awardees that received funding from CMS (Florida and Texas) included increasing access to contraceptive services for men and women; increasing access to and reducing barriers to diagnostic testing, screening, and 24 The selected awardees we spoke with are Alaska; Arizona; California; Colorado; Florida; Iowa; Kansas; Louisiana; Oklahoma; and Texas; as well as Houston, Tex., and Los Angeles County, Calif. 25 CDC collaborated with state, tribal, local, and territorial health departments to establish the U.S. Zika Pregnancy Registry as an enhanced national surveillance system to monitor pregnancy and fetal/infant outcomes among pregnancies with laboratory evidence of possible recent Zika virus infection. The U.S. Zika Pregnancy Registry includes data from all 50 states, Washington, D.C., and all U.S. territories except Puerto Rico; pregnancies in Puerto Rico are monitored separately by the Zika Active Pregnancy Surveillance System. Page 18 GAO-18-389 Zika Supplemental Funding counseling for pregnant women and newborns; and increasing access to appropriate specialized health care services for pregnant women, children born to mothers with maternal Zika virus infection, and their families. Table 2 provides examples of the types of activities funded by the selected awardees we interviewed. This table does not include a comprehensive list of all of the awardees’ Zika activities—see appendixes II through VI, and appendix IX for more information on the Zika supplemental funding CDC and CMS awarded to states, territories, and local jurisdictions. Table 2: Examples of Activities of Selected Awardees That Received Direct Zika Supplemental Funding from CDC and CMS Funding received, Examples of Awardee in dollars, by award type activities Alaska ELC: 36,867 Alaska’s Zika activities include ensuring that procedures are in place to assist in the monitoring of potential Zika cases among pregnant women and their infants; and overseeing the development and dissemination of outreach materials. Arizona ELC: 5,161,956 Arizona’s activities include using a Zika Pregnancy Registry Birth defects: 200,000 coordinator to assist the local health jurisdictions with interviewing patients, contacting providers, and ensuring timely follow-up for BRFSS: 26,000 individuals at critical points in time for data collection, as well as PHPR: 388,273 transmitting the data to CDC in a timely fashion. Additionally, Arizona officials said that funding will be used for prevention efforts, including producing materials, such as posters, to hand out at events. California ELC: 12,496,481 California’s Zika activities include providing consultation, training, and Birth defects: 360,000 operational support to detect, monitor, and control Aedes aegypti and Aedes albopictus mosquitoes; providing on-site technical assistance in PHPR: 2,658,839 the event of local transmission; and conducting field-based pesticide resistance testing. According to state officials, California is also conducting education and outreach activities. Colorado ELC: 230,065 Colorado’s Zika activities include using staff to build and maintain relationships necessary for long-term follow-up of patients and consistent data transmission to the U.S. Zika Pregnancy Registry. Florida ELC: 38,298,440 Florida’s Zika activities include supporting the prevention of active Birth defects: 360,000 transmission of Zika through source reduction, communication, and control, including the application of ground adulticide treatments, BRFSS: 124,976 ground larvicide treatments, and aerial adulticide treatments. PHPR: 4,999,979 Additionally, staff will support Zika epidemiology and outreach PRAMS: 40,000 projects, including involvement with active surveillance, response to any local introductions, follow-up with potentially Zika infected infants, CMS: 2,991,000 as well as assistance with development and distribution of Zika and mosquito bite prevention outreach to targeted audiences. Page 19 GAO-18-389 Zika Supplemental Funding Funding received, Examples of Awardee in dollars, by award type activities Houston, Texas ELC: 2,475,899 Houston’s Zika activities include providing staff to improve surveillance Birth defects: 199,804 to monitor the incidence of women and infants who meet the U.S. Zika Pregnancy Registry case definition, identify and report all data to the registry in a timely manner, increase provider support and education, and gather follow-up clinical data on infants to identify developmental delays. According to city officials, Houston also will use the funding for education and outreach, to investigate all reports of suspected Zika exposure and infection, to establish and provide Zika testing for the 16 counties served by the Houston Health Department Bureau of Laboratory Services, and to partner with Harris County, Texas, for vector control activities. Iowa ELC: 372,847 According to state officials, Iowa’s Zika activities include surveillance and case follow-up. Kansas ELC: 85,658 According to state officials, Kansas’ Zika activities include staff to work on submitting data to the U.S. Zika Pregnancy Registry, and to follow- up on pregnant women and infants. Los Angeles County, ELC: 1,750,283 Los Angeles County’s Zika activities include assigning staff to conduct California Birth defects: 360,000 Zika testing and prepare testing reports, including distinguishing Zika from chikungunya and dengue infections. According to county officials, PHPR: 504,855 Los Angeles County also developed hospital protocols and conducted patient tracking and follow-up with pregnant women. Louisiana ELC: 3,559,243 Louisiana’s Zika activities include staff to provide outreach to Birth defects: 200,000 obstetricians and pediatricians in the state to disseminate information regarding the U.S. Zika Pregnancy Registry, proper diagnosis and BRFSS: 100,000 clinical management of Zika, and how to participate in the registry; and PHPR: 1,437,361 follow-up with health care providers and patients to collect clinical information at designated time intervals on pregnant women and infants meeting the registry inclusion criteria from the point of case identification through 12 months after delivery. According to state officials, Louisiana also added Zika exposure as a risk factor for hearing loss to the state’s newborn hearing screening form, and added congenital Zika virus as a maternal risk factor on the state’s birth certificate application. Oklahoma ELC: 18,121 According to state officials, Oklahoma added congenital Zika virus Birth defects: 108,262 disease (including congenital Zika syndrome) as an automatic qualifier for the Sooner Start Early Intervention program. Page 20 GAO-18-389 Zika Supplemental Funding Funding received, Examples of Awardee in dollars, by award type activities Texas ELC: 18,654,908 According to state officials, Texas’ Zika activities include awareness Birth defects: 360,000 and education of the state’s population about Zika risks and prevention; funding to local health departments for surveillance, case BRFSS: 124,854 investigation, and vector control; providing education and outreach to PHPR: 5,000,000 health care providers to improve the quality of the data within the U.S. CMS: 2,491,000 Zika Pregnancy Registry; and providing pesticide resistance training. Most of the laboratory funding is used by state-run or associated laboratories. Legend: CDC = Centers for Disease Control and Prevention CMS = Centers for Medicare & Medicaid Services ELC = Epidemiology and Laboratory Capacity for Infectious Diseases cooperative agreement Birth defects = Surveillance, Intervention, and Referral to Services Activities for Infants with Microcephaly or other Adverse Outcomes Linked with the Zika Virus cooperative agreement BRFSS = Behavioral Risk Factor Surveillance System cooperative agreement PHPR = Public Health Preparedness and Response Cooperative Agreement for All-Hazards Public Health Emergencies PRAMS = Pregnancy Risk Assessment Monitoring System cooperative agreement Source: CDC, CMS, and awardee documentation, and interviews with state, county, and city officials. | GAO-18-389 Of the awardees we spoke with, Florida and Texas were the only states that had experienced local mosquito-borne transmission of the Zika virus. Other selected awardees—which included Arizona, Los Angeles County, and Louisiana—were primarily responding to travel-related cases of Zika virus disease. The following are additional examples of activities funded using Zika supplemental funding. For more information on the types of activities authorized under each award, see appendixes II-VI and IX. Florida. Florida, which has a centralized health department with county- based offices, used Zika supplemental funding for laboratory capacity and vector control activities, among other activities. According to state officials, funding for state-run laboratories was used for purchasing materials, such as those used for testing urine for the Zika virus, and funding staff located in counties to assist with handling Zika samples and testing, data entry, and result reporting to surveillance networks. Additionally, Florida used Zika supplemental funding for local vector control activities. For example, Miami-Dade County officials said that they purchased mosquito traps and removed mosquito breeding grounds, including plants, tires, and other objects that can hold standing water. (See fig. 2 for examples of the mosquito control activities in Miami-Dade County.) Through CMS’s Zika Health Care Services Program, Florida received Page 21 GAO-18-389 Zika Supplemental Funding funding for, among other things, two part-time advanced registered nurse practitioners to provide consultation and technical assistance in family planning clinics, and assist in the prescribing and management of various birth control methods. Florida also funded a health educator for Zika prevention and response duties, which included assisting local health care organizations in the development of educational programming to ensure that health care services are provided in accordance with CDC guidelines. The health educator’s duties also included ensuring that pregnant women with the Zika virus and infants with congenital Zika infection are referred to proper care and other available programs and resources. Page 22 GAO-18-389 Zika Supplemental Funding Figure 2: Examples of Vector Control Activities in Miami-Dade County, Florida Texas. Texas officials said that the state used a CDC award to rapidly identify cases and conduct data analysis of Zika-related birth defects, to enhance surveillance of Zika virus-related birth defects by improving the Texas Birth Defects Registry database, and to facilitate remote access to electronic records. Texas also disseminated prevention materials and Page 23 GAO-18-389 Zika Supplemental Funding interviewed mothers of children with Zika-related birth defects about their experience in dealing with the health system in order to help identify developmental outcomes of the children. Texas intends to use its CMS Zika Health Care Services Program funding—awarded on June 30, 2017—to increase clients’ access to contraceptives; for care management, including counseling on Zika virus testing for pregnant women and their families; and for counseling to refer clients for services and support. State officials provided the following information on some of the activities intended for the program. 1. Increasing clients’ access to contraceptives: Community health workers and case management staff will assist clinic providers with informing women and their partners about contraceptive availability and about the potential Zika virus risks during pregnancy. They will also work with the women to determine what messages work best with their partners regarding contraceptives. 2. Care management that includes pre- and post-test counseling on Zika virus testing for pregnant women and their families: Officials said that this activity is important because the CDC testing algorithm is complex, the results from various tests can be confusing, and there can be false positives from the tests. Generally, doctors do not have the time to go through the complexities of these issues with clients, such as how to understand the laboratory tests and results. 3. Counseling to refer clients for services and supports: This can include counseling about various types of resources to support clients pre- delivery, after delivery, and during the infant’s first year of life. Arizona. According to state officials, Zika supplemental funding was used to create an action plan with counties, and increase the state’s ability to raise public awareness about the threat of the Zika virus, its transmission routes, and prevention measures. Officials stated that Arizona’s border with Mexico makes communicating about Zika more complex, because individuals frequently cross the border for a variety of reasons including work, school, and to visit family, and do not necessarily consider themselves to be travelers. Additionally, the state used funding to increase the amount of personal protective equipment for the vector surveillance staff, and set up vector control contracts that could be accessed if the Zika virus spread locally, and in the event that vector control could not be handled at the local level. However, this contracting mechanism was not used, because there was no local transmission of the Zika virus in Arizona. According to state officials, Arizona plans to ask for Page 24 GAO-18-389 Zika Supplemental Funding an extension to use the funding in the next mosquito season. The state health department also sponsored training on mosquito identification. Los Angeles County. County officials said that some funding was used to support personnel involved with Zika surveillance, testing, and case management. This included the detection of cases—individuals diagnosed with Zika infection—and also the dissemination of information to Los Angeles County’s Maternal and Child Health group, which follows pregnant women through delivery and then transfers the cases to the county’s Children’s Medical Services group. For example, according to officials, once a case is identified, information is shared with the relevant vector control district about the location of the case, and the vector control district can then conduct inspection and abatement activities to reduce the risk of a local outbreak. Los Angeles County officials found that this process takes about one week from finding out about a case to completion of inspection and abatement. This included 1 day to get information to the vector control district and 1 to 5 days for completing inspection and abatement. The funding was also used to provide funds to the vector control districts to augment Aedes mosquito detection efforts and support outreach activities, according to county officials. Louisiana. Louisiana officials said they used a CDC award, in part, to provide equipment and mileage reimbursement for nurses, who served as clinical liaisons between the birth defects surveillance program and hospitals and physicians statewide, to help enable rapid surveillance activities. Awardees also funded other activities, such as outreach campaigns. See figure 3 for examples of outreach funded with Zika supplemental funding. Page 25 GAO-18-389 Zika Supplemental Funding Figure 3: Examples of Zika Outreach Activities Selected Awardees Had While a majority of the 12 selected awardees we spoke with reported Mixed Experiences positive experiences with the process of applying for and managing the Zika supplemental funding, some awardees cited aspects of the process Applying for and Managing that were challenging. The awardees we spoke with received much of the Zika Supplemental their supplemental funding from CDC and noted that the process went Funding well: there was good communication with CDC officials; CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases cooperative agreement process to apply for Zika supplemental funds was more streamlined than the regular application process; and awardees Page 26 GAO-18-389 Zika Supplemental Funding said they were familiar with the mechanisms, which helped them navigate the process. 26 Awardees we spoke to also cited some challenges to applying for and managing the Zika supplemental funding. These awardees noted that various time frames among multiple awards and restrictions on authorized activities under the awards added administrative burdens that officials had to deal with while responding to the outbreak. Florida officials said that the state received funding from different federal agencies, from different cooperative agreement awards, with different deadlines, and different rules on what the funding could be used for. For example, CDC distributed Zika supplemental funds to states and certain localities and territories through five cooperative agreements—some of which had multiple application rounds. Florida officials said that they had to track funding separately and identify the activities that could be funded under each award—administrative requirements that were burdensome during an emergency response. Figure 4 presents the period of time Florida had to use the Zika supplemental funding from multiple awards received from CDC. 26 Awardees annually apply for and receive funding through CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases cooperative agreement. CDC provided additional awards through this cooperative agreement using its Zika supplemental funding. Page 27 GAO-18-389 Zika Supplemental Funding Figure 4: Timeline of Florida’s Zika Supplemental Funding Awards a The title of the birth defects award is the Surveillance, Intervention, and Referral to Services Activities for Infants with Microcephaly or other Adverse Outcomes Linked with the Zika Virus award. According to officials from the Centers for Disease Control and Prevention (CDC), Florida received a no-cost extension for this award, which extends the period Florida has to use the funding to July 31, 2019. b The title of this award is the Epidemiology and Laboratory Capacity for Infectious Diseases award. c For this Epidemiology and Laboratory Capacity for Infectious Diseases award, CDC officials said that Florida could not begin using the funding until August 1, 2017. Page 28 GAO-18-389 Zika Supplemental Funding d The title of this award is the Public Health Preparedness and Response Cooperative Agreement for All-Hazards Public Health Emergencies. According to CDC officials, Florida received a no-cost extension for this award, which extends the period Florida has to use the funding to June 30, 2018. In addition, awardees we spoke with cited challenges with adjusting their plans when federal funding was more or less than anticipated. For example, CDC officials said that they provided average award amount ranges as guidance for awardees as part of the application process for one of CDC’s cooperative agreements. 27 Los Angeles County officials said that they applied for an amount that was near the limit, and county officials said that they had to adjust the activities they planned to fund when they received less than what they applied for. Iowa officials said that without knowing exactly how much funding would be available it was difficult to know what to apply for and made staffing changes difficult. Iowa officials had to adjust their initial plan when they later received additional unexpected funding. In October 2017, CDC issued a new notice of funding opportunity that, according to agency officials, was intended to help minimize the administrative burden on these awardees (e.g., preparing applications and other paperwork) during significant public health emergencies by pre- approving public health departments in these jurisdictions to rapidly receive future awards. 28 This new notice of funding opportunity will be used to establish a list of awardees, with existing emergency preparedness and response capacity, that would be pre-approved for funding by CDC when a public health threat occurs, including infectious disease threats. 29 It requires that awardees have structures and plans in place to receive funding, as well as plans to respond to a public health threat. According to CDC officials, awards could potentially be provided within 2 weeks to pre-approved awardees after supplemental appropriations are enacted. According to CDC officials, as of February 2018, the agency had approved all 64 applicants for the notice of funding 27 The approximate award range provided by CDC as guidance for three activities within the cooperative agreement was (1) $0 to $10,000,000; (2) $0 to $6,000,000; and (3) $0 to $550,000. 28 According to CDC officials, they began thinking about creating the notice of funding opportunity during the 2009 H1N1 response. 29 The notice of funding opportunity is open to all of CDC’s Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) and Public Health Emergency Preparedness awardees, as well as five tribes, which CDC defines as federally or state recognized American Indian or Alaska Native tribal governments serving a population of at least 50,000 members. Page 29 GAO-18-389 Zika Supplemental Funding opportunity. 30 This means that CDC will consider these approved applicants for future funding if an emergency occurs and funding becomes available. We provided a draft of this report to HHS for review and comment. HHS Agency and Third- provided technical comments, which we incorporated as appropriate. Party Comments We also provided relevant draft portions of this report to the Zika supplemental funding awardees we interviewed. Specifically, we provided the excerpts to officials in Alaska; Arizona; California; Colorado; Florida; Houston, Texas; Iowa; Kansas; Los Angeles County, California; Louisiana; Oklahoma; and Texas. All but one awardee responded. Awardees provided technical comments, which we incorporated as appropriate. We are sending copies of this report to the appropriate congressional committees, the Secretary of Health and Human Services, and to 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 have any questions about this report, please contact me at (202) 512-7114 or crossem@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 XII. Marcia Crosse Director, Health Care 30 According to CDC officials, as of December 2017, all of the ELC and Public Health Emergency Preparedness awardees had applied, but no tribes had applied. Agency officials told us that they were contacting the tribes to ensure they were aware of the opportunity. They also said that the application process for the notice of funding opportunity will be reopened at a later date and eligible tribes that are interested in applying will have the opportunity to do so at that time. Page 30 GAO-18-389 Zika Supplemental Funding Appendix I: Biomedical Advanced Research Appendix I: Biomedical Advanced Research and Development Authority’s Zika Supplemental Awards and Development Authority’s Zika Supplemental Awards The Biomedical Advanced Research and Development Authority (BARDA), within the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, executed contracts to obligate its Zika supplemental funding for research in the areas of (1) vaccine development, (2) diagnostic development, and (3) pathogen reduction systems. Table 3 presents information for each award as it was provided to us by BARDA. Table 3: Biomedical Advanced Research and Development Authority’s Zika Supplemental Funding Contracts Award Awardee Activity description (in dollars) Battelle Battelle will develop a passive transfer murine model to 1,468,809 evaluate Zika vaccines. Battelle Battelle will conduct natural history studies for Zika infections 2,383,446 in NHPs. a Cerus Corp This project will advance the INTERCEPT Blood System for 57,421,416 pathogen reduction in donated red blood cells. It is already licensed and marketed for use platelets and plasma. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria, and parasites that may be present in donated blood. As a part of this project, a Phase 3 clinical study to evaluate safety and efficacy in acute care is being conducted in Puerto Rico. InBios International Inc. InBios is developing 2 different Zika IgM diagnostic tests 4,354,808 under this contact, a semi-automated test for use in clinical laboratories, which is available under Emergency Use Authorization (EUA), and an easy-to-use lateral flow test for use in point of care settings. Development of both tests are funded through EUA to FDA 510(K) filing. a Moderna Therapeutics Inc Moderna is presently conducting a Phase 1 trial at three 109,112,211 different clinical sites across the U.S. (first and second cohorts have been fully immunized) for an investigational mRNA Zika vaccine. Enrollment continues, and immunogenicity data (unblinded) from this study is expected later this year. Work is also ongoing at Moderna to scale up manufacturing in preparation for a large Phase 2/3 trial to initiate soon after the Phase 1 trial is completed in 2017. Orasure Technologies Inc. Orasure is developing a point of care Zika IgM diagnostic test 2,612,925 for use in informing the care of pregnant women. The test is an easy-to-use lateral flow test. Development of data to support consideration by the FDA for an Emergency Use Authorization and continued development through FDA 510(K) clearance is included in the contract. Page 31 GAO-18-389 Zika Supplemental Funding Appendix I: Biomedical Advanced Research and Development Authority’s Zika Supplemental Awards Award Awardee Activity description (in dollars) b Sanofi Pasteur Inc Sanofi will complete Zika defined preclinical vaccine 7,500,000 development activities. In addition, the Zika case definition study is being conducted in Central and South America. (As of 22 September 2017, 1,131 subjects have been enrolled). Siemens Healthcare Diagnostics Inc. Siemens is developing a laboratory Zika IgM blood test for 8,945,785 use on 3 automated platforms in their Centaur product line. These are high throughput fully automated blood analysers. When available, this test will greatly increase the Zika testing capacity in the U.S. BARDA is fund work to support consideration of an Emergency Use Authorization by the FDA and continued development to FDA 510(K) approval. a Takeda Vaccines Inc. Takeda is developing a Zika whole-virus inactivated vaccine 51,200,600 which will be adjuvanted with aluminum hydroxide. Source: Biomedical Advanced Research and Development Authority (BARDA). | GAO-18-389 a This awardee received more than one award and funding amounts for awards for the same awardee and activity were added together in this table. b Prior to September 30, 2017, Sanofi Pasteur decided to no longer develop a Zika vaccine. Non-Zika supplemental funding was de-obligated, according to BARDA officials, but the Zika supplemental funding was maintained by the agency to continue support of a Zika case definition study being conducted in Central and South America. Page 32 GAO-18-389 Zika Supplemental Funding Appendix II: Centers for Disease Control and Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) cooperative agreement. CDC awarded Zika supplemental funding for the ELC cooperative agreement for the following activities: • Zika vector surveillance and control, • Zika epidemiology and laboratory surveillance, and • U.S. Zika Pregnancy Registry. 1 The Zika supplemental funding awarded through the ELC cooperative agreement was to further support and strengthen activities to protect the public’s health, especially pregnant women, through epidemiologic surveillance and investigation, improving mosquito control and monitoring, and strengthening laboratory capacity. The funding will also support participation in the U.S. Zika Pregnancy Registry to monitor pregnant women with the Zika virus disease and their infants. For each award, we present information as it was provided to us by CDC, as well as the activities funded. Table 4 provides information on ELC Zika supplemental funding awarded to states and territories, and table 5 presents information on awards to local health departments. Table 4: Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement’s Zika Supplemental Funding for States and Territories, by Awardee and Activity Funded Award State/territory Awardee Activity funded (in dollars) Alabama Alabama Department of Public Zika vector surveillance and control 343,980 Health Zika epidemiology and laboratory surveillance 584,738 U.S. Zika Pregnancy Registry 549,996 Total 1,478,714 Alaska Alaska State Department of Zika epidemiology and laboratory surveillance 14,874 Health & Social Services U.S. Zika Pregnancy Registry 21,993 Total 36,867 American Samoa American Samoa Government Zika vector surveillance and control 180,822 Zika epidemiology and laboratory surveillance 454,563 U.S. Zika Pregnancy Registry 136,200 1 Not all awardees received funding for each activity. Page 33 GAO-18-389 Zika Supplemental Funding Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees Award State/territory Awardee Activity funded (in dollars) Total 771,585 Arizona Arizona Department of Health Zika vector surveillance and control 1,438,817 Services Zika epidemiology and laboratory surveillance 3,615,719 U.S. Zika Pregnancy Registry 107,420 Total 5,161,956 Arkansas Arkansas Department of Health Zika vector surveillance and control 493,698 Zika epidemiology and laboratory surveillance 129,539 U.S. Zika Pregnancy Registry 516,579 Total 1,139,816 California Public Health Foundation Zika vector surveillance and control 4,285,687 Enterprises (California) Zika epidemiology and laboratory surveillance 7,058,745 U.S. Zika Pregnancy Registry 1,152,049 Total 12,496,481 Colorado Colorado Department of Public Zika epidemiology and laboratory surveillance 163,688 Health and Environment U.S. Zika Pregnancy Registry 66,377 Total 230,065 Connecticut Connecticut State Department of Zika epidemiology and laboratory surveillance 175,820 Public Health U.S. Zika Pregnancy Registry 338,526 Total 514,346 Delaware Delaware Health & Social Zika epidemiology and laboratory surveillance 12,791 Services U.S. Zika Pregnancy Registry 435,759 Total 448,550 Federated States of Federated States of Micronesia - Zika vector surveillance and control 68,717 Micronesia FSM Zika epidemiology and laboratory surveillance 144,129 U.S. Zika Pregnancy Registry 120,000 Total 332,846 Florida Florida Department of Health Zika vector surveillance and control 25,590,915 Zika epidemiology and laboratory surveillance 11,411,188 U.S. Zika Pregnancy Registry 1,296,337 Total 38,298,440 Georgia Georgia Department of Public Zika vector surveillance and control 302,612 Health Zika epidemiology and laboratory surveillance 319,435 U.S. Zika Pregnancy Registry 103,913 Total 725,960 Guam Guam Department of Public Zika vector surveillance and control 146,700 Health and Social Services Zika epidemiology and laboratory surveillance 299,191 Page 34 GAO-18-389 Zika Supplemental Funding Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees Award State/territory Awardee Activity funded (in dollars) U.S. Zika Pregnancy Registry 266,201 Total 712,092 Hawaii Hawaii State Department of Zika vector surveillance and control 273,306 Health Zika epidemiology and laboratory surveillance 987,937 Total 1,261,243 Illinois Illinois Department of Public Zika epidemiology and laboratory surveillance 598,160 Health U.S. Zika Pregnancy Registry 566,770 Total 1,164,930 Indiana Indiana State Department of Zika epidemiology and laboratory surveillance 43,407 Health U.S. Zika Pregnancy Registry 83,111 Total 126,158 Iowa Iowa Department of Public Zika epidemiology and laboratory surveillance 261,681 Health U.S. Zika Pregnancy Registry 111,166 Total 372,847 Kansas Kansas Department of Health Zika epidemiology and laboratory surveillance 36,734 and Environment U.S. Zika Pregnancy Registry 48,924 Total 85,658 Kentucky Kentucky Cabinet for Health & Zika epidemiology and laboratory surveillance 249,384 Family Services U.S. Zika Pregnancy Registry 164,822 Total 414,206 Louisiana Louisiana State Office of Public Zika vector surveillance and control 1,450,246 Health Zika epidemiology and laboratory surveillance 1,872,956 U.S. Zika Pregnancy Registry 236,041 Total 3,559,243 Maine Maine Department of Health & Zika epidemiology and laboratory surveillance 274,351 Human Services U.S. Zika Pregnancy Registry 144,876 Total 419,227 Marshall Islands Republic of the Marshall Islands Zika vector surveillance and control 119,610 Ministry of Health Zika epidemiology and laboratory surveillance 91,293 U.S. Zika Pregnancy Registry 83,418 Total 294,321 Maryland Maryland Department of Health Zika vector surveillance and control 137,817 and Mental Hygiene Zika epidemiology and laboratory surveillance 604,224 U.S. Zika Pregnancy Registry 453,970 Total 1,196,011 Page 35 GAO-18-389 Zika Supplemental Funding Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees Award State/territory Awardee Activity funded (in dollars) Massachusetts Massachusetts Department of Zika epidemiology and laboratory surveillance 434,761 Public Health U.S. Zika Pregnancy Registry 546,183 Total 980,944 Michigan Michigan Department of Health Zika epidemiology and laboratory surveillance 277,714 & Human Services U.S. Zika Pregnancy Registry 218,757 Total 496,471 Minnesota Minnesota Department of Health Zika epidemiology and laboratory surveillance 344,105 U.S. Zika Pregnancy Registry 95,231 Total 439,336 Mississippi Mississippi State Department of Zika vector surveillance and control 1,311,838 Health Zika epidemiology and laboratory surveillance 447,215 U.S. Zika Pregnancy Registry 249,701 Total 2,008,754 Missouri Missouri Department of Health & Zika epidemiology and laboratory surveillance 169,373 Senior Services U.S. Zika Pregnancy Registry 124,903 Total 294,276 Montana Montana State Department of Zika epidemiology and laboratory surveillance 17,137 Public Health & Human Services Nebraska Nebraska Department of Health Zika epidemiology and laboratory surveillance 21,073 and Human Services U.S. Zika Pregnancy Registry 456,365 Total 477,438 Nevada Nevada Division of Public and Zika epidemiology and laboratory surveillance 227,645 Behavioral Health U.S. Zika Pregnancy Registry 95,409 Total 323,054 New Hampshire New Hampshire Department of Zika epidemiology and laboratory surveillance 123,684 Health and Human Services U.S. Zika Pregnancy Registry 114,811 Total 238,495 New Jersey New Jersey Department of Zika vector surveillance and control 67,500 Health Zika epidemiology and laboratory surveillance 733,627 U.S. Zika Pregnancy Registry 1,080,245 Total 1,881,372 New Mexico New Mexico Department of Zika vector surveillance and control 490,684 Health Zika epidemiology and laboratory surveillance 843,826 U.S. Zika Pregnancy Registry 513,799 Total 1,848,309 New York Health Research, Inc. (New York Zika epidemiology and laboratory surveillance 1,469,169 State) U.S. Zika Pregnancy Registry 642,324 Page 36 GAO-18-389 Zika Supplemental Funding Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees Total 2,111,493 North Carolina North Carolina Department of Zika epidemiology and laboratory surveillance 137,539 Health and Human Services U.S. Zika Pregnancy Registry 74,359 Total 211,898 North Dakota North Dakota State Department Zika epidemiology and laboratory surveillance 46,648 of Health Northern Mariana Commonwealth Healthcare Zika vector surveillance and control 16,882 Islands Corporation Zika epidemiology and laboratory surveillance 93,355 U.S. Zika Pregnancy Registry 97,780 Total 208,017 Ohio Ohio State Department of Health Zika epidemiology and laboratory surveillance 411,193 U.S. Zika Pregnancy Registry 97,757 Total 508,950 Oklahoma Oklahoma State Department of Zika epidemiology and laboratory surveillance 18,121 Health Oregon Oregon Health Authority, Public Zika epidemiology and laboratory surveillance 134,598 Health Division U.S. Zika Pregnancy Registry 159,138 Total 293,736 Palau Republic of Palau Zika vector surveillance and control 90,000 Zika epidemiology and laboratory surveillance 21,401 U.S. Zika Pregnancy Registry 35,000 Total 146,401 Pennsylvania Pennsylvania State Department Zika epidemiology and laboratory surveillance 700,766 of Health U.S. Zika Pregnancy Registry 280,035 Total 980,801 Puerto Rico Puerto Rico Department of Zika epidemiology and laboratory surveillance 2,038,276 Health U.S. Zika Pregnancy Registry 741,967 Total 2,780,243 Rhode Island Rhode Island Department of Zika epidemiology and laboratory surveillance 212,557 Health U.S. Zika Pregnancy Registry 140,879 Total 353,436 South Carolina South Carolina Department of Zika epidemiology and laboratory surveillance 136,644 Health and Environmental U.S. Zika Pregnancy Registry 283,230 Control Total 419,874 South Dakota South Dakota Department of U.S. Zika Pregnancy Registry 168,893 Health Tennessee Tennessee State Department of Zika epidemiology and laboratory surveillance 497,947 Health U.S. Zika Pregnancy Registry 550,000 Total 1,047,947 Page 37 GAO-18-389 Zika Supplemental Funding Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees Texas Texas Department of State Zika vector surveillance and control 3,662,766 Health Services Zika epidemiology and laboratory surveillance 13,978,845 U.S. Zika Pregnancy Registry 1,013,297 Total 18,654,908 Utah Utah Department of Health Zika epidemiology and laboratory surveillance 206,704 U.S. Zika Pregnancy Registry 45,242 Total 251,946 Vermont Vermont Agency of Human Zika epidemiology and laboratory surveillance 15,661 Services Virginia Virginia Department of Health Zika epidemiology and laboratory surveillance 708,799 U.S. Zika Pregnancy Registry 189,447 Total 898,246 U.S. Virgin Islands Virgin Islands Department of Zika vector surveillance and control 984,690 Health Zika epidemiology and laboratory surveillance 865,970 U.S. Zika Pregnancy Registry 1,169,735 Total 3,020,395 Washington Washington State Department of Zika epidemiology and laboratory surveillance 476,691 Health U.S. Zika Pregnancy Registry 118,618 Total 595,309 West Virginia West Virginia Department of Zika epidemiology and laboratory surveillance 168,241 Health and Human Services U.S. Zika Pregnancy Registry 108,262 Total 276,503 Wisconsin Wisconsin Department of Health Zika epidemiology and laboratory surveillance 443,218 Services U.S. Zika Pregnancy Registry 113,636 Total 556,854 Source: Centers for Disease Control and Prevention. | GAO-18-389 In addition to states and territories, six large city and county local health departments—Chicago, the District of Columbia, Houston, Los Angeles County, New York City, and Philadelphia—received ELC Zika supplemental awards. Page 38 GAO-18-389 Zika Supplemental Funding Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees Table 5: Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement’s Zika Supplemental Funding for Local Health Departments, by Awardee and Activity Funded Award City/county Awardee Activity funded (in dollars) Chicago City of Chicago Department of Zika epidemiology and laboratory surveillance 157,889 Public Health U.S. Zika Pregnancy Registry 182,496 Total 340,385 District of Columbia District of Columbia Department Zika epidemiology and laboratory surveillance 839,959 of Health U.S. Zika Pregnancy Registry 219,113 Total 1,059,072 Houston Houston Department of Health Zika vector surveillance and control 1,250,000 and Human Services Zika epidemiology and laboratory surveillance 723,104 U.S. Zika Pregnancy Registry 502,795 Total 2,475,899 Los Angeles County County of Los Angeles Zika vector surveillance and control 614,952 Department of Public Health Zika epidemiology and laboratory surveillance 585,331 U.S. Zika Pregnancy Registry 550,000 Total 1,750,283 New York City New York City Department of Zika epidemiology and laboratory surveillance 854,650 Health & Mental Hygiene U.S. Zika Pregnancy Registry 521,554 Total 1,376,204 Philadelphia Philadelphia Department of Zika epidemiology and laboratory surveillance 237,516 Public Health U.S. Zika Pregnancy Registry 215,103 Total 452,619 Source: Centers for Disease Control and Prevention. | GAO-18-389 Page 39 GAO-18-389 Zika Supplemental Funding Appendix III: Centers for Disease Control Appendix III: Centers for Disease Control and Prevention—Birth Defects Awardees and Prevention—Birth Defects Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Surveillance, Intervention, and Referral to Services Activities for Infants with Microcephaly or other Adverse Outcomes Linked with the Zika Virus (birth defects) cooperative agreement. 1 The Zika supplemental funding awarded through the birth defects cooperative agreement was to provide additional resources to better establish, enhance, and maintain rapid population-based surveillance of microcephaly and other adverse outcomes (especially central nervous system defects) possibly linked to Zika virus infection during pregnancy using an active case-finding methodology; participation in centralized pooled clinical and surveillance data projects; ensuring affected infants and families are referred to services; and assessing health and developmental outcomes of these children. Table 6 presents information for each award as it was provided to us by CDC. Table 6: Birth Defects Cooperative Agreement Zika Supplemental Funding by Awardee Award State/territory Awardee (in dollars) Alabama Alabama Department of Public Health 199,952 American Samoa American Samoa Government 200,000 Arizona Arizona Department of Health Services 200,000 Arkansas Arkansas Children’s Hospital Research 200,000 California California Department of Public Health 360,000 California County of Los Angeles Department of Public Health 360,000 Federated States of Micronesia Federated States of Micronesia - FSM 137,437 Florida Florida Department of Health 360,000 Georgia Georgia Department of Public Health 280,000 Guam Guam Department of Public Health and Social Services 163,340 Hawaii Hawaii State Department of Health 200,000 Illinois City of Chicago Department of Public Health 100,000 Illinois Illinois Department of Public Health 180,000 1 The birth defects award for cities and counties is the Surveillance, Intervention, and Referral to Services Activities for Infants with Microcephaly or other Adverse Outcomes Linked with the Zika Virus - High Risk Local Areas Cooperative Agreement. Page 40 GAO-18-389 Zika Supplemental Funding Appendix III: Centers for Disease Control and Prevention—Birth Defects Awardees Award State/territory Awardee (in dollars) Indiana Indiana State Department of Health 200,000 Iowa University of Iowa 100,000 Kentucky Kentucky Cabinet for Health & Family Services 200,000 Louisiana Louisiana State Office of Public Health 200,000 Marshall Islands Republic of the Marshall Islands Ministry of Health 200,000 Massachusetts Massachusetts Department of Public Health 100,000 Minnesota Minnesota Department of Health 100,000 Mississippi Mississippi State Department of Health 200,000 Missouri Missouri Department of Health & Senior Services 200,000 Nebraska Nebraska Department of Health and Human Services 77,427 Nevada Southern Nevada Health District 200,000 New Jersey New Jersey Department of Health 280,000 New York Health Research, Inc. (New York State) 359,999 New York New York City Department of Health & Mental Hygiene 352,287 North Carolina North Carolina Department of Health and Human Services 280,000 Northern Mariana Islands Commonwealth Healthcare Corporation 200,000 Ohio Ohio State Department of Health 280,000 Oklahoma Oklahoma State Department of Health 108,262 Pennsylvania Pennsylvania State Department of Health 280,000 Pennsylvania Philadelphia Department of Public Health 174,093 Puerto Rico Puerto Rico Department of Health 200,000 Rhode Island Rhode Island Department of Health 100,000 South Carolina South Carolina Department of Health and Environmental Control 200,000 Tennessee Tennessee State Department of Health 200,000 Texas Houston Health Department 199,804 Texas Texas Department of State Health Services 360,000 U.S. Virgin Islands Virgin Islands Department of Health 199,885 Utah Utah Department of Health 100,000 West Virginia West Virginia Department of Health and Human Services 192,150 Wisconsin Wisconsin Department of Health Services 100,000 Source: Centers for Disease Control and Prevention. | GAO-18-389 Page 41 GAO-18-389 Zika Supplemental Funding Appendix IV: Centers for Disease Control Appendix IV: Centers for Disease Control and Prevention—Behavioral Risk Factor Surveillance System Awardees and Prevention—Behavioral Risk Factor Surveillance System Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Behavioral Risk Factor Surveillance System (BRFSS) cooperative agreement. The Zika supplemental funding awarded through the BRFSS cooperative agreement was to conduct a rapid population-based assessment of women and couples using or in need of contraceptives in order to provide comprehensive contraceptive services related to Zika virus exposure. Table 7 presents information for each award as it was provided to us by CDC. Table 7: Behavioral Risk Factor Surveillance System Cooperative Agreement’s Zika Supplemental Funding by Awardee Award State/territory Awardee (in dollars) Alabama Alabama Department of Public Health 104,641 Arizona Arizona Department of Health Services 26,000 District of Columbia District of Columbia Department of Health 116,618 Florida Florida Department of Health 124,976 Georgia Georgia Department of Public Health 100,000 Guam Guam Department of Public Health and Social Services 73,111 Louisiana Louisiana State Office of Public Health 100,000 Maryland Maryland Department of Health and Mental Hygiene 65,139 Mississippi Mississippi State Department of Health 100,000 New Mexico New Mexico Department of Health 125,000 New York Health Research, Inc. (New York State) 125,000 Puerto Rico Puerto Rico Department of Health 124,294 Texas Texas Department of State Health Services 124,854 U.S. Virgin Islands Virgin Islands Department of Health 50,756 Source: Centers for Disease Control and Prevention. | GAO-18-389 Page 42 GAO-18-389 Zika Supplemental Funding Appendix V: Centers for Disease Control and Appendix V: Centers for Disease Control and Prevention—Pregnancy Risk Assessment Monitoring System Awardees Prevention—Pregnancy Risk Assessment Monitoring System Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Pregnancy Risk Assessment Monitoring System (PRAMS) cooperative agreement. The Zika supplemental funding awarded through the PRAMS cooperative agreement was to assess maternal behaviors and experiences related to Zika virus exposure among recently pregnant women who deliver a live- born infant in the United States. Table 8 presents information for each award as it was provided to us by CDC. Table 8: Pregnancy Risk Assessment Monitoring System Cooperative Agreement’s Zika Supplemental Funding by Awardee Award a State/territory Awardee (In dollars) Alabama Alabama Department of Public Health 29,993 Connecticut Connecticut State Department of Public Health 40,000 District of Columbia District of Columbia Department of Health 29,916 Florida Florida Department of Health 40,000 Georgia Georgia Department of Public Health 40,000 Illinois Illinois Department of Public Health 40,000 Indiana Indiana State Department of Health 30,000 Massachusetts Massachusetts Department of Public Health 40,000 Missouri Missouri Department of Health & Senior Services 30,000 New Jersey New Jersey State Department of Health & Senior Services 40,000 New York Health Research, Inc. (New York State) 30,000 Pennsylvania Pennsylvania State Department of Health 29,830 Puerto Rico Puerto Rico Department of Health 830,000 South Carolina South Carolina Department of Health and Environmental Control 39,975 Tennessee Tennessee State Department of Health 40,000 Virginia Virginia Department of Health 39,953 Wisconsin Wisconsin Department of Health Services 24,171 Source: Centers for Disease Control and Prevention. | GAO-18-389 a These awardees received more than one award and funding amounts for awards for the same awardee were added together in this table. Page 43 GAO-18-389 Zika Supplemental Funding Appendix VI: Centers for Disease Control Appendix VI: Centers for Disease Control and Prevention—Public Health Preparedness and Response Awardees and Prevention—Public Health Preparedness and Response Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through the Public Health Preparedness and Response (PHPR) Cooperative Agreement for All-Hazards Public Health Emergencies. According to CDC officials, the Zika supplemental funding awarded through the PHPR cooperative agreement was to enable identified state, territorial, and local jurisdictions to address Zika virus disease planning and operational response gaps. Table 9 presents information for each award as it was provided to us by CDC. Table 9: Public Health Preparedness and Response Cooperative Agreement for All-Hazards Public Health Emergencies Cooperative Agreement’s Zika Supplemental Funding by Awardee Award State/territory Awardee (in dollars) Alabama Alabama Department of Public Health 522,093 American Samoa American Samoa Government 453,009 Arizona Arizona Department of Health Services 388,273 Arkansas Arkansas Department of Health 212,707 California California Department of Public Health 2,658,839 California County of Los Angeles Department of Public Health 504,855 Federated States of Micronesia Federated States of Micronesia - FSM 289,088 Florida Florida Department of Health 4,999,979 Georgia Georgia Department of Public Health 203,738 Guam Guam Department of Public Health and Social Services 134,614 Hawaii Hawaii State Department of Health 58,603 Kentucky Kentucky Cabinet for Health & Family Services 428,132 Louisiana Louisiana State Office of Public Health 1,437,361 Marshall Islands Republic of the Marshall Islands Ministry of Health 86,300 Maryland Maryland Department of Health and Mental Hygiene 288,558 New Jersey New Jersey Department of Health 933,995 New York Health Research, Inc. (New York State) 1,086,913 New York Public Health Solutions (NYC) 1,294,244 Northern Mariana Islands Commonwealth Healthcare Corporation 86,976 Puerto Rico Puerto Rico Department of Health 3,931,723 Texas Texas Department of State Health Services 5,000,000 Source: Centers for Disease Control and Prevention. | GAO-18-389 Page 44 GAO-18-389 Zika Supplemental Funding Appendix VII: Centers for Disease Control Appendix VII: Centers for Disease Control and Prevention—Other Cooperative Agreements’ Awardees and Prevention—Other Cooperative Agreements’ Awardees This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through additional cooperative agreements. Tables 10-17 present information for each award as it was provided to us by CDC. Administrative Support for The Zika supplemental funding awarded through the Sentinel Enhanced the Zika Supplemental for Dengue Surveillance System Project cooperative agreement was to support sites working to provide new information on dengue and other Sentinel Enhanced acute febrile illnesses in Puerto Rico, which is located in the subtropics Dengue Surveillance and where dengue epidemiology is similar to dengue endemic areas System Project worldwide. The Zika supplemental funding was for two studies: (1) pregnant women with Zika infection, and (2) postnatal Zika infection by following 0-5 year old children. Table 10: Sentinel Enhanced Dengue Surveillance System Project Cooperative Agreement’s Zika Supplemental Funding by Awardee Award State/territory Awardee (in dollars) Puerto Rico Ponce School of Medicine 500,000 Source: Centers for Disease Control and Prevention. | GAO-18-389 Vector-Borne Disease The Zika supplemental funding awarded through the Vector-Borne Regional Centers of Disease Regional Centers of Excellence cooperative agreement is to establish regional centers of excellence aimed at building the capacity to Excellence address the problem of emerging and exotic vector-borne diseases in the United States, including Zika virus infection. Page 45 GAO-18-389 Zika Supplemental Funding Appendix VII: Centers for Disease Control and Prevention—Other Cooperative Agreements’ Awardees Table 11: Vector-Borne Disease Regional Centers of Excellence Cooperative Agreement’s Zika Supplemental Funding by Awardee Award State/territory Awardee (in dollars) California University of California – Davis 8,000,000 Florida University of Florida 9,999,628 New York Cornell University 9,999,936 Texas University of Texas Medical Branch, 9,995,253 Galveston Wisconsin University of Wisconsin 9,999,491 Source: Centers for Disease Control and Prevention. | GAO-18-389 Enhancing Capacity for The Zika supplemental funding awarded through the Enhancing Capacity Vector Surveillance and for Vector Surveillance and Control to Prevent Zika, Dengue and Chikungunya Infection in Puerto Rico cooperative agreement is to fund Control to Prevent Zika, activities to increase the surveillance and control of vectors, specifically Dengue and Chikungunya Aedes aegypti mosquitoes (the vector of dengue, chikungunya, and Zika). Infection in Puerto Rico The purpose of the program is to establish a vector control unit to oversee and implement comprehensive vector control activities in Puerto Rico. Table 12: Enhancing Capacity for Vector Surveillance and Control to Prevent Zika, Dengue and Chikungunya Infection in Puerto Rico Cooperative Agreement’s Zika Supplemental Funding by Awardee Award State/territory Awardee (in dollars) Puerto Rico Puerto Rico Science, Technology & Research 14,000,000 Trust Source: Centers for Disease Control and Prevention. | GAO-18-389 Immunization Grants-CDC The Zika supplemental funding awarded through the Immunization Partnership: Strengthening Grants-CDC Partnership: Strengthening Public Health Laboratories cooperative agreement is to promote quality and safe public health Public Health Laboratories laboratory practice, improve public health laboratory infrastructure, strengthen the public health laboratory system, and develop a well-trained public health laboratory workforce. Page 46 GAO-18-389 Zika Supplemental Funding Appendix VII: Centers for Disease Control and Prevention—Other Cooperative Agreements’ Awardees Table 13: Immunization Grants-CDC Partnership: Strengthening Public Health Laboratories Cooperative Agreement’s Zika Supplemental Funding by Awardee Award Awardee (in dollars) Association of Public Health Laboratories (APHL) 250,000 Source: Centers for Disease Control and Prevention. | GAO-18-389 Building Capacity of the According to CDC officials, the Zika supplemental funding awarded Public Health System to through the Building Capacity of the Public Health System to Improve Population Health through National, Nonprofit Organizations cooperative Improve Population Health agreement is to ensure national capacity for responding to the Zika through National, outbreak and meeting the needs of those affected, such as by reaching Nonprofit Organizations out to specialized constituents to ensure they were informed on epidemiology and practice guidelines. Table 14: Building Capacity of the Public Health System to Improve Population Health through National, Nonprofit Organizations Cooperative Agreement’s Zika Supplemental Funding by Awardee Award Awardee (in dollars) American Academy of Pediatrics 740,000 Association of State & Territorial Health Officials (ASTHO) 1,150,000 Council of State & Territory Epidemiologists (CSTE) 500,000 March of Dimes Birth Defects Foundation 914,757 a National Association of City & County Health Officials (NACCHO) 900,000 National Indian Health Board (NIHB) 500,000 Source: Centers for Disease Control and Prevention. | GAO-18-389 a This awardee received more than one award and funding amounts for these awards were added together in this table. Strengthening the Public The Zika supplemental funding awarded through the Strengthening the Health System in the U.S.- Public Health System in the U.S.-Affiliated Pacific Islands cooperative agreement is to provide capacity building assistance through a regional, Affiliated Pacific Islands nonprofit organization to strengthen the U.S.-Affiliated Pacific Islands’ public health leadership, workforce, and public health systems and infrastructure in response to Zika virus within the U.S. Pacific territories. Page 47 GAO-18-389 Zika Supplemental Funding Appendix VII: Centers for Disease Control and Prevention—Other Cooperative Agreements’ Awardees Table 15: Strengthening the Public Health System in the U.S.-Affiliated Pacific Islands Cooperative Agreement’s Zika Supplemental Funding by Awardee Award Awardee (in dollars) a Pacific Island Health Officers Association (PIHOA) 400,000 Source: Centers for Disease Control and Prevention. | GAO-18-389 a This awardee received more than one award and funding amounts for these awards were added together in this table. Pan American Health The Zika supplemental funding awarded through the Pan American Organization: Building Health Organization: Building Capacity and Networks to Address Emerging Infectious Diseases in the Americas cooperative agreement is Capacity and Networks to for various activities including technical assistance, such as to develop Address Emerging standard operating procedures for diagnostic and integrated surveillance Infectious Diseases in the activities, as well as to support the development, implementation, and Americas evaluation of diagnostic and surveillance guidelines. Table 16: Pan American Health Organization: Building Capacity and Networks to Address Emerging Infectious Diseases in the Americas Cooperative Agreement’s Zika Supplemental Funding by Awardee Award Awardee (in dollars) Pan American Health Organization 500,000 Source: Centers for Disease Control and Prevention. | GAO-18-389 Global Health Security According to CDC officials, the Zika supplemental funding awarded Partner Engagement: through the Global Health Security Partner Engagement: Expanding Efforts and Strategies to Protect and Improve Public Health Globally Expanding Efforts and cooperative agreement is for enhanced surveillance for pregnant women Strategies to Protect and in Colombia, including laboratory testing and case investigations. Improve Public Health Globally Table 17: Global Health Security Partner Engagement: Expanding Efforts and Strategies to Protect and Improve Public Health Globally Cooperative Agreement’s Zika Supplemental Funding by Awardee Award Awardee (in dollars) Vysnova Partners, Inc. 999,790 Source: Centers for Disease Control and Prevention. | GAO-18-389 Page 48 GAO-18-389 Zika Supplemental Funding Appendix VIII: Centers for Disease Control Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements and Prevention—Contracts and Interagency Agreements This appendix presents information on Zika supplemental funding awards made by the Centers for Disease Control and Prevention (CDC) through additional contracts and interagency agreements. Tables 18 and 19 present information for each award as it was provided to us by CDC, as well as the activity funded. Table 18: Centers for Disease Control and Prevention Zika Supplemental Funding Contracts by Awardee and Activity Funded Award Awardee Activity funded (in dollars) AB Sciex Laboratory Capacity, Acceleration, Equipment 21,403.00 a ABT Associates Public Health Outreach and Control 10,658,187.99 b ABT Associates Public Health Emergency Preparedness (1,082,005.00) Agilent Technologies Laboratory Capacity, Acceleration, Equipment 32,440.49 Air Science USA Laboratory Capacity, Acceleration, Equipment 7,355.99 Alivepromo, Inc Public Health Emergency Preparedness 728,736.08 All Business Machines, Inc Laboratory Capacity, Acceleration, Equipment 66,823.20 Altus Technical Solutions Laboratory Capacity, Acceleration, Equipment 108,000.00 Amdex Corporation Public Health Emergency Preparedness 261,424.80 American Toner & Ink Public Health Emergency Preparedness 3,827.25 AP&G Co, Inc Vector Surveillance and Control 32,505.80 Applied Medical Technologies, Inc. Laboratory Capacity, Acceleration, Equipment 7,889.16 Aprisa Technology Vector Surveillance and Control 8,671.23 Arist Medical Sciences University Laboratory Capacity, Acceleration, Equipment 52,800.00 Aspen Commercial Group Vector Surveillance and Control; 818,731.41 Surveillance, Epidemiology, and Public Health Investigations Aspen Commercial Group Laboratory Capacity, Acceleration, Equipment 71,139.96 Atlanta Biologicals Laboratory Capacity, Acceleration, Equipment 6,173.82 AUS Marketing Research Systems, Surveillance, Epidemiology, and Public Health Investigations 100,000.00 Inc. Battelle Memorial Institute Laboratory Capacity, Acceleration, Equipment 187,952.00 a Becton, Dickson & Co. Laboratory Capacity, Acceleration, Equipment 404,651.87 a BioAnalytical Instruments Laboratory Capacity, Acceleration, Equipment 450,766.67 BioAnalytical Instruments Surveillance, Epidemiology, and Public Health Investigations 25,200.00 Biocare Medical Laboratory Capacity, Acceleration, Equipment 55,366.00 Biocold Environmental, Inc Laboratory Capacity, Acceleration, Equipment 15,025.00 Bio-Nuclear Laboratory Capacity, Acceleration, Equipment 149,951.19 Bio-Rad Laboratories Laboratory Capacity, Acceleration, Equipment 24,950.00 Bio-Rad Laboratories Vector Surveillance and Control 3,741.00 Page 49 GAO-18-389 Zika Supplemental Funding Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements Award Awardee Activity funded (in dollars) a Biotek Instruments Laboratory Capacity, Acceleration, Equipment 75,486.93 a Booz Allen Hamilton Laboratory Capacity, Acceleration, Equipment 452,966.45 Booz Allen Hamilton Public Health Emergency Preparedness 1,145,449.43 Booz Allen Hamilton Vector Surveillance and Control 3,500.00 Bruker Daltonics Laboratory Capacity, Acceleration, Equipment 20,281.00 a Caduceus Healthcare Laboratory Capacity, Acceleration, Equipment 1,949,351.04 Caduceus Healthcare Vector Surveillance and Control; 374,336.60 Laboratory Capacity, Acceleration, Equipment; Public Health Outreach and Control Caduceus Healthcare, Inc Public Health Outreach and Control 249,956.60 Caduceus Healthcare, Inc Laboratory Capacity, Acceleration, Equipment 483,573.33 a Canon Public Health Emergency Preparedness 69,526.24 Carl Zeiss Microscopy, LLC Laboratory Capacity, Acceleration, Equipment 194,126.64 Carter Consulting Surveillance, Epidemiology, and Public Health Investigations 120,497.00 CDI Laboratories, Inc. Vector Surveillance and Control 16,800.00 a Certified Technical Experts Laboratory Capacity, Acceleration, Equipment 229,142.00 Chenega Government Consulting, Laboratory Capacity, Acceleration, Equipment 132,902.62 a LLC Chickasaw Health Consulting Public Health Emergency Preparedness 31,820.00 Chickasaw Management Services, Public Health Outreach and Control 193,477.20 LLC a CNI Advantage, LLC Public Health Emergency Preparedness 2,068,011.79 CNI Advantage, LLC Public Health Emergency Preparedness; 89,403.31 Surveillance, Epidemiology, and Public Health Investigations a CNI Advantage, LLC Surveillance, Epidemiology, and Public Health Investigations 7,893,052.52 Communications Professionals, Inc. Vector Surveillance and Control 15,620.00 Crimson Imaging Supplies, LLC Public Health Emergency Preparedness 11,073.34 CTG Associates Public Health Emergency Preparedness 75,699.00 Davis, James Public Health Emergency Preparedness 6,689.85 Deloitte Consulting Surveillance, Epidemiology, and Public Health Investigations 1,381,711.80 a Diagger Scientific, Inc. Laboratory Capacity, Acceleration, Equipment 21,687.00 Digital Video Group, Inc Public Health Emergency Preparedness 96,389.90 a DOC Development, Inc Laboratory Capacity, Acceleration, Equipment 12,395.72 Eagle Medical Services Public Health Emergency Preparedness; 931,963.19 Surveillance, Epidemiology, and Public Health Investigations Eagle Medical Services Surveillance, Epidemiology, and Public Health Investigations 1,999,961.12 Elsevier Limited Laboratory Capacity, Acceleration, Equipment 5,000.00 Page 50 GAO-18-389 Zika Supplemental Funding Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements Award Awardee Activity funded (in dollars) EMD Millipore Corporation Laboratory Capacity, Acceleration, Equipment 22,972.80 Entomological Society of America Vector Surveillance and Control 151,000.00 Environmental Systems Research Public Health Emergency Preparedness 49,391.00 Institute Evolution Management, Inc Public Health Outreach and Control 300,526.00 FedEx Public Health Emergency Preparedness 37,429.17 a Fisher Scientific Company Laboratory Capacity, Acceleration, Equipment 306,124.39 Fisher Scientific Company Surveillance, Epidemiology, and Public Health Investigations 16,669.48 Fisher Scientific Company Vector Surveillance and Control 10,125.85 Fitzgerald Industries International, Laboratory Capacity, Acceleration, Equipment 23,850.00 Inc G2S Corporation Public Health Emergency Preparedness 39,200.00 G2S Corporation Public Health Emergency Preparedness; 3,918,687.12 Surveillance, Epidemiology, and Public Health Investigations a G2S Corporation Surveillance, Epidemiology, and Public Health Investigations 3,391,153.86 G2S Corporation Vector Surveillance and Control 1,509,787.25 a GAP Solutions, Inc. Public Health Emergency Preparedness 626,343.67 GAP Solutions, Inc. Public Health Outreach and Control 60,408.00 Gem Laser Express, Inc. Public Health Emergency Preparedness 16,136.82 Geographic Mapping Technologies Vector Surveillance and Control 14,850.00 Corp. Georgia State University Research Laboratory Capacity, Acceleration, Equipment 1,530,000.00 Foundation, Inc a Government Scientific Source Laboratory Capacity, Acceleration, Equipment 212,643.83 Helmer Scientific Laboratory Capacity, Acceleration, Equipment 11,679.85 Hyclone Laboratories, Inc Laboratory Capacity, Acceleration, Equipment 2,716.36 a ICF Incorporated Public Health Outreach and Control 2,304,697.14 IHRC Laboratory Capacity, Acceleration, Equipment 1,356,070.32 a Illumina, Inc Laboratory Capacity, Acceleration, Equipment 101,132.07 Illumina, Inc Public Health Emergency Preparedness; 189,732.00 Vector Surveillance and Control; Public Health Outreach and Control Impres Technology Solutions Surveillance, Epidemiology, and Public Health Investigations 59,675.94 a InBios International Laboratory Capacity, Acceleration, Equipment 323,184.00 InBios International Surveillance, Epidemiology, and Public Health Investigations 6,963.00 InBios International Surveillance, Epidemiology, and Public Health Investigations; 18,731.00 Vector Surveillance and Control a JC Gonzalez, Inc. Vector Surveillance and Control 40,970.70 Page 51 GAO-18-389 Zika Supplemental Funding Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements Award Awardee Activity funded (in dollars) Johns Hopkins University Vector Surveillance and Control 500,000.00 Karna Laboratory Capacity, Acceleration, Equipment 35,668.42 Karna Public Health Emergency Preparedness 115,000.00 b Karna Surveillance, Epidemiology, and Public Health Investigations (16,568.10) Karna Surveillance, Epidemiology, and Public Health Investigations; 2,138,919.00 Public Health Outreach and Control Leica Microsystems Laboratory Capacity, Acceleration, Equipment 34,442.52 Leidos, Inc Surveillance, Epidemiology, and Public Health Investigations 621,000.00 a Life Technologies Corporation Laboratory Capacity, Acceleration, Equipment 79,918.85 Life Technologies Corporation Vector Surveillance and Control 45,776.40 Lonza Walkersville, Inc. Laboratory Capacity, Acceleration, Equipment 6,483.30 Luminex Corporation Laboratory Capacity, Acceleration, Equipment 28,086.80 Madison Cloud IT Solutions, LLC Public Health Emergency Preparedness 14,471.06 Mapbox Inc Public Health Emergency Preparedness 25,000.00 McKing Consulting Corporation Surveillance, Epidemiology, and Public Health Investigations 894,403.64 Microptics Service, Inc Laboratory Capacity, Acceleration, Equipment 6,384.35 a Molecular Devices Laboratory Capacity, Acceleration, Equipment 154,923.70 Mosquito Mate Inc Vector Surveillance and Control 999,994.02 Multisystems, Inc Laboratory Capacity, Acceleration, Equipment 10,031.80 Nexcelom Bioscience Laboratory Capacity, Acceleration, Equipment 139,400.00 Nightingale Corp Laboratory Capacity, Acceleration, Equipment 3,637.40 a Nikon Inc Laboratory Capacity, Acceleration, Equipment 150,978.71 a Northrop Grumman Public Health Outreach and Control 835,000.00 Northrop Grumman Surveillance, Epidemiology, and Public Health Investigations 175,000.00 a Northrop Grumman Vector Surveillance and Control 729,436.00 NuAire, Inc. Laboratory Capacity, Acceleration, Equipment 8,698.40 OAG Aviation Worldwide LLC Public Health Outreach and Control 147,000.00 Onset Computer Corporation Vector Surveillance and Control 4,500.00 Pacific Biosciences of California Public Health Emergency Preparedness; 168,889.71 Laboratory Capacity, Acceleration, Equipment; Vector Surveillance and Control; Surveillance, Epidemiology, and Public Health Investigations a Pacific Link International, Corp Public Health Emergency Preparedness 34,374.00 Panasonic Healthcare Corporation Laboratory Capacity, Acceleration, Equipment 9,334.00 of North America Premier & Companies Laboratory Capacity, Acceleration, Equipment 4,653.94 P3S Corporation Laboratory Capacity, Acceleration, Equipment 115,000.00 Page 52 GAO-18-389 Zika Supplemental Funding Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements Award Awardee Activity funded (in dollars) a Qiagen, Inc Laboratory Capacity, Acceleration, Equipment 175,958.27 Red River Computer Co., Inc Laboratory Capacity, Acceleration, Equipment 2,473.19 Rentokil North America, Inc Surveillance, Epidemiology, and Public Health Investigations; 1,382,575.00 Public Health Emergency Preparedness; Public Health Outreach and Control; Vector Surveillance and Control a Rentokil North America, Inc Vector Surveillance and Control 4,700,097.00 a Roche Diagnostics Corporation Laboratory Capacity, Acceleration, Equipment 602,679.70 a Roche Diagnostics Corporation Surveillance, Epidemiology, and Public Health Investigations 98,987.30 RTI International Surveillance, Epidemiology, and Public Health Investigations 67,948.00 a Rumph & Associates Laboratory Capacity, Acceleration, Equipment; 2,377,501.00 Surveillance, Epidemiology, and Public Health Investigations SBC Technology Partners, Inc Public Health Emergency Preparedness 3,748.75 a SDL Government, Inc. Public Health Outreach and Control 25,155.25 Sheknows LLC Public Health Outreach and Control 15,000.00 a Siemens Healthcare Diagnostics Laboratory Capacity, Acceleration, Equipment 357,540.66 Sigma-Aldrich Laboratory Capacity, Acceleration, Equipment 5,317.62 Smith Travel Research, Inc Public Health Outreach and Control 4,950.00 Southland Instruments, Inc. Laboratory Capacity, Acceleration, Equipment 10,909.00 a Springstar Vector Surveillance and Control 551,294.30 SRA International Public Health Emergency Preparedness; 500,000.00 Public Health Outreach and Control; Vector Surveillance and Control; Laboratory Capacity, Acceleration, Equipment; Surveillance, Epidemiology, and Public Health Investigations SRA International Public Health Outreach and Control 1,344,852.00 Steris Corporation Laboratory Capacity, Acceleration, Equipment 51,836.58 a Steris Corporation Vector Surveillance and Control 52,586.58 Strategic Communications, LLC Laboratory Capacity, Acceleration, Equipment 2,067.96 a Synergy America Public Health Emergency Preparedness 203,000.00 Synergy Group Public Health Emergency Preparedness 48,020.29 Tanaq Government Services Public Health Outreach and Control 284,990.00 Texas A&M Agrilife Research Vector Surveillance and Control 1,200,923.00 The Cresston Company, LLC Public Health Outreach and Control 40,194.00 Thermo Electron North America Public Health Outreach and Control 990,122.21 Thomson Reuters (Scientific) LLC Public Health Outreach and Control 23,588.00 Three Wire Systems, LLC Public Health Emergency Preparedness 1,970.00 Page 53 GAO-18-389 Zika Supplemental Funding Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements Award Awardee Activity funded (in dollars) Three Wire Systems, LLC Vector Surveillance and Control 19,339.77 Total Solutions Surveillance, Epidemiology, and Public Health Investigations 550,184.67 Total Solutions Surveillance, Epidemiology, and Public Health Investigations; 1,001,674.00 Laboratory Capacity, Acceleration, Equipment Triad Technology Partners, LLC Public Health Outreach and Control 3,564.00 TWD Tradewinds, Inc Laboratory Capacity, Acceleration, Equipment 145,569.00 Unicom Surveillance, Epidemiology, and Public Health Investigations 140,158.00 University of Arizona Vector Surveillance and Control 1,250,000.00 University of New Mexico Vector Surveillance and Control 1,301,000.00 University of North Carolina at Laboratory Capacity, Acceleration, Equipment 3,279,000.00 Chapel Hill Veterans4you Corporation Public Health Emergency Preparedness 3,620.00 VWR International Laboratory Capacity, Acceleration, Equipment 84,490.13 VWR International Vector Surveillance and Control 19,203.93 Vysnova Surveillance, Epidemiology, and Public Health Investigations 7,281,151.00 Westat, Inc Public Health Outreach and Control 94,026.00 Wright Line, LLC Laboratory Capacity, Acceleration, Equipment 11,072.98 3M Company Laboratory Capacity, Acceleration, Equipment 4,918.40 Source: Centers for Disease Control and Prevention (CDC). | GAO-18-389 Note: Awards that included a change in the funding amount are reflected in the table, unless the change resulted in a zero balance. For example, CDC provided funding to one company, but later rescinded the same amount. Therefore, this award does not appear in the table as the resulting award is $0. CDC officials said that these types of actions are standard, particularly in an emergency situation when the needs of the response are rapidly evolving. Changes to awards can occur because there is a change in need for services, a vendor not having the needed items in stock, a reduction in the price of the contract, changes after the contract was awarded, and administrative corrections of a funding source. a This awardee received more than one award and funding amounts for awards for the same awardee and activity were added together in this table. b This awardee had funding that was rescinded. The rescinded funding was not combined with the awardee’s other awards because it was for a different activity. Page 54 GAO-18-389 Zika Supplemental Funding Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements Table 19: Centers for Disease Control and Prevention Zika Supplemental Funding Interagency Agreements by Awardee and Activity Funded Award Awardee Activity funded (in dollars) BARDA Vector Control 9,000,000.00 a NIH Laboratory Capacity, 450,000.00 Acceleration, Equipment U.S. Department Public Health Outreach 8,574.72 of Commerce and Control U.S. Department Laboratory Capacity, 779,856.91 a of Energy Acceleration, Equipment U.S. Department Public Health Emergency 134,278.80 a of Energy Preparedness U.S. Department Surveillance, Epidemiology, 821,452.78 a of Energy and Public Health Investigations Verizon Business Public Health Emergency 112,000.00 Services Preparedness Source: Centers for Disease Control and Prevention (CDC). | GAO-18-389 Note: Awards that included a change in the funding amount are reflected in the table, unless the change resulted in a zero balance. For example, CDC provided $550,000 to the Health Resources and Services Administration, but later rescinded the same amount. Therefore, this award does not appear in the table as the resulting award is $0. CDC officials said that these types of actions are standard, particularly in an emergency situation when the needs of the response are rapidly evolving. Changes to awards can occur because there is a change in need for services, a vendor not having the needed items in stock, a reduction in the price of the contract, changes after the contract was awarded, and administrative corrections of a funding source. a This awardee received more than one award and funding amounts for awards for the same awardee and activity were added together in this table. Page 55 GAO-18-389 Zika Supplemental Funding Appendix IX: Centers for Medicare & Appendix IX: Centers for Medicare & Medicaid Services—Zika Health Care Services Program Awards Medicaid Services—Zika Health Care Services Program Awards This appendix presents information on Zika supplemental funding awards made by the Centers for Medicare & Medicaid Services (CMS) through the Zika Health Care Services Program. The Zika Health Care Services Program is aimed at supporting prevention activities and treatment services for women (including pregnant women), children, and men adversely or potentially affected by the Zika virus. According to CMS documentation, the Zika Health Care Service Program is intended to address four critical components of a comprehensive response to Zika: 1. Increase access to contraceptive services for women and men. 2. Increase access to and reduce barriers to diagnostic testing, screening, and counseling for pregnant women and newborns. 3. Increase access to appropriate specialized health care services for pregnant women, children born to mothers with maternal Zika virus infection, and their families. 4. Improve provider capacity and capability. CMS awarded funding through the Zika Health Care Services Program, in two award rounds, to states, territories, tribes, or tribal organizations with active or local transmission of the Zika virus, as confirmed by the Centers for Disease Control and Prevention. In January 2017, CMS awarded funding to American Samoa, Florida, Puerto Rico, and the U.S. Virgin Islands. In June 2017, CMS awarded funding to Texas, the only new area with local transmission of the Zika virus. Table 20 presents the awards CMS made through its Zika Health Care Services Program. Table 20: Centers for Medicare & Medicaid Services’ Zika Health Care Services Program Awardees Award State/territory Awardee Amount American Samoa American Samoa Government Department of Health 1,791,000 Florida Florida Department of Health 2,991,000 Puerto Rico Puerto Rico Department of Health 61,291,000 Texas Texas Department of State Health Services 2,491,000 U.S. Virgin Islands U.S. Virgin Islands Department of Health 2,791,000 Source: Centers for Medicare & Medicaid Services. | GAO-18-389 Page 56 GAO-18-389 Zika Supplemental Funding Appendix X: Health Resources and Services Appendix X: Health Resources and Services Administration’s Zika Supplemental Awards Administration’s Zika Supplemental Awards This appendix presents information on Zika supplemental funding awards made by the Health Resources and Services Administration (HRSA) to health centers and for Special Projects of Regional and National Significance. 1 • Health centers: HRSA provided awards to health centers through supplemental grant awards to support existing health centers in Puerto Rico and other territories in their efforts to expand the delivery of health care services, including the prevention of Zika and prevention and treatment of Zika-related illness. HRSA also provided supplemental grant awards to existing Health Center Program cooperative agreement awardees for efforts to provide training and technical assistance for Zika-related health center expansion activities. • Special Projects of Regional and National Significance: HRSA provided awards for Special Projects of Regional and National Significance to support public health departments and other entities in Puerto Rico and other territories in efforts to ensure access to recommended services for pregnant women, infants, and children infected by the Zika virus in the prenatal, perinatal, and neonatal period. Activities include early identification through developmental screening, regular assessments and monitoring, telemedicine, care coordination, enabling services, family engagement and family-to- family support; purchasing of diagnostic equipment and health information technology; and the training of health care providers, care coordinators, and other health care and public health professionals to ensure delivery of comprehensive, interdisciplinary health and social services for this population. Tables 21 and 22 present information for each award as it was provided to us by HRSA. 1 HRSA also provided student loan repayment to qualified health professionals through the National Health Services Corps. We do not present this information by awardee in this appendix, as that data contains personal information. Page 57 GAO-18-389 Zika Supplemental Funding Appendix X: Health Resources and Services Administration’s Zika Supplemental Awards Table 21: Health Resources and Services Administration Zika Supplemental Funding for Health Centers by Awardee Award State/territory Awardee (in dollars) American Samoa American Samoa Government Dept of Health 2,336,253 Hawaii Pacific Islands Primary Care Association 250,000 Puerto Rico Asociacian de Salud Primaria de Puerto Rico, Inc 750,000 Puerto Rico Municipality of San Juan (HOMIS) 1,058,362 Puerto Rico Consejo de Salud de Puerto Rico, Inc. 2,556,580 Puerto Rico Centro de Servicios Primarios de Salud Inc 1,555,327 Puerto Rico Concilio de Salud Integral de Loiza, Inc 1,577,352 Puerto Rico Centro de Salud Familiar (PALMIERI) 1,563,775 Puerto Rico Corporacion de Servicos Medicos Primarios y Prevencion de Hatillo 1,895,792 Puerto Rico Centro de Salud de Lares, Inc. 1,668,179 Puerto Rico Castaner General Hospital 1,428,258 Puerto Rico Costa Salud Community Health Centers Inc 1,517,755 Puerto Rico Corporacion de Servicios de Salud y Medicina Avanzada - COSSMA 1,938,143 Puerto Rico Morovis Community Health Center, Inc. 1,482,153 Puerto Rico Barceloneta Primary Health Services, Inc. 1,540,884 Puerto Rico Camuy Health Services, Inc. 1,542,118 Puerto Rico Salud Integral en la Montana, Inc. 2,089,258 Puerto Rico Migrant Health Center, Western Region, Inc. 1,821,303 Puerto Rico NeoMed Center Inc 2,285,262 Puerto Rico HPM Foundation, Inc. 1,590,023 Puerto Rico PryMed Medical Care, Inc. 1,532,746 Puerto Rico Patillas Community Governing Board 1,868,331 Puerto Rico Corporacion SANOS 1,266,725 U.S. Virgin Islands Frederiksted Health Care Inc. 1,459,507 U.S. Virgin Islands St. Thomas East End Medical Center Corporation 1,425,914 Source: Health Resources and Services Administration. | GAO-18-389 Note: The Zika Response and Preparedness Act required that $40 million be used to expand the delivery of primary health services in Puerto Rico and other territories. According to officials from the Health Resources and Services Administration, the Pacific Islands Primary Care Association in Hawaii was funded to support health centers within the Pacific Basin based on their Zika-related needs. Page 58 GAO-18-389 Zika Supplemental Funding Appendix X: Health Resources and Services Administration’s Zika Supplemental Awards Table 22: Health Resources and Services Administration Zika Supplemental Funding for Special Projects of Regional and National Significance by Awardee Award State/territory Awardee (in dollars) a American Samoa Dept of Health 923,142 California Children’s Hospital of Los Angeles 333,333 Florida University of Miami 333,333 Illinois American Academy of Pediatrics 250,000 Indiana Indiana University 333,333 New Mexico Family Voices, Inc 250,000 Puerto Rico Parents Training Parents 150,000 a Puerto Rico Puerto Rico Department of Health 16,202,850 U.S. Virgin Islands Virgin Islands Advocacy, Inc 150,000 a U.S. Virgin Islands Virgin Islands Department of Health Group 1,074,008 Source: Health Resources and Services Administration. | GAO-18-389 Note: The Zika Response and Preparedness Act required that $20 million be awarded for projects of regional and national significance in Puerto Rico and other territories. The projects located in California, Florida, Illinois, Indiana, and New Mexico focus on the territories. a This awardee received more than one award and funding amounts for these awards were added together in this table. Page 59 GAO-18-389 Zika Supplemental Funding Appendix XI: National Institutes of Health Appendix XI: National Institutes of Health Zika Supplemental Awards Zika Supplemental Awards The National Institutes of Health (NIH) awarded Zika supplemental funding to support research to better understand Zika and its complications, and inform the development of new interventions. The three primary activities of funding include (1) vaccine development; (2) Zika in Infants and Pregnancy study; and (3) diagnostics, therapeutics, vector control, and other interventions. 1 NIH used contracts, grants, intramural research awards, and other awards to provide funding for research on the Zika virus and its complications. Tables 23-26 present information for each award as it was provided to us by NIH. Table 23: National Institutes of Health’s Zika Supplemental Funding Contracts Award Awardee Activity description (in dollars) Advanced Bioscience Laboratories Support the production and development of a recombinant 455,190.00 subunit vaccine consisting of a portion of the Zika virus envelope protein developed by Hawaii Biotech. Advanced Bioscience Laboratories PCSs to develop a vaccine production master cell bank for 445,190.00 MVA-CHIK/Zika vaccine (Sementis). American Type Culture Collection Reagent purchases to support ZIP studies in various 1,370,000.00 countries. Battelle Support the development of virus neutralizing assay for the 880,000.00 assessment of Zika Vaccines. Baylor College of Medicine Conduct an epidemiological trial in Guatemala to study the 5,702,861.00 prevalence of microcephaly in a newborn population, viral transmission of Zika and to follow patients diagnosed with ZIKV infection for the development of neurologic manifestations of disease. Deloitte Consulting LLP Enhance the U.S. Government’s partners’ (NIH, BARDA, 64,589.70 CDC, WRAIR (DoD) and FDA) capabilities in developing vaccine candidates and advancing the most promising to licensure. The ultimate objective is to accelerate the process and reduce costs, not only for Zika but for other vaccines for emerging or reemerging vector borne infectious diseases. Emory University - Vaccine Trial To Support study of U.S. travelers infected with Zika virus 980,000.00 and Evaluation Units (VTEU) while abroad. Emory University Support T-cell assays of samples from 16-0033/34 trials to 258,122.01 assess vaccine response. 1 The Zika in Infants and Pregnancy study aims to improve understanding of the health effects of Zika virus infection in pregnant women and infants by following 10,000 pregnant women for the duration of their pregnancies and their infants at several intervals for at least one year after birth. Page 60 GAO-18-389 Zika Supplemental Funding Appendix XI: National Institutes of Health Zika Supplemental Awards Award Awardee Activity description (in dollars) Saint Louis University - Vaccine Trial Support Phase 1 ZPIV Clinical Trials. 2,479,304.00 and Evaluation Units (VTEU) Southern Research Institute Support the testing of vaccine candidates against Zika virus 1,319,631.00 infection in the Indian Rhesus macaque model. Southern Research Institute Southern Research Institute to manufacture and test 400,000.00 monoclonal antibody and synthetic compounds as therapeutics against Zika infection. St. Jude Children’s Research Hospital To continue support the Zika in Infants and Pregnancy (ZIP) 962,066.00 study in Colombia. The Emmes Corporation Data management and support for clinical studies with 3,000,000.00 NIAID developed Inactivated Zika Vaccine. University of Alabama at Birmingham Support the Zika in Infants and Pregnancy (ZIP) study in 997,527.00 Peru. Source: National Institutes of Health. | GAO-18-389 Table 24: National Institutes of Health’s Zika Supplemental Funding Grants Award Awardee Activity description (in dollars) Beth Israel Deaconess Medical Center To support the development of Biocryst drug (BCX4430) against Zika 599,666 virus. Boston University Medical Campus Study effects of pre-existing dengue virus immunity on Zika virus 246,750 infection. Boston University Medical Campus Study innate placental defense against Zika infection. 258,196 Colorado State University Study how different cells contribute to sexual and mosquito transmission 227,250 of Zika. Colorado State University Predicting genetic determinants of Zika virus emergence. 227,875 Colorado State University Support the study of Zika virus urogenital tropism, pathogenesis and 211,838 sexual transmission. Colorado State University Support the development of a rapid assay for Zika virus in biofluids and 222,546 insect vectors. Colorado State University Study virus-host interactions and mechanisms of viral pathogenesis 222,436 which will provide insights to identify novel targets for antiviral drug development or virus attenuation for vaccine production. Columbia University Health Sciences Support the development of point of care molecular diagnostics 434,850 differentiating Zika virus from other arbovirus. Duke University Support the Generation of Zika virus-specific recombinant antibodies for 198,750 the development of Zika Assays. Duke University Study Zika virus infections related birth defects in pregnant rabbit 235,406 models. Emory University Continue study of Dengue-Zika cross reactivity in vaccine development. 286,546 Page 61 GAO-18-389 Zika Supplemental Funding Appendix XI: National Institutes of Health Zika Supplemental Awards Award Awardee Activity description (in dollars) Emory University Support the repurposing of drugs to prevent and inhibit Zika virus 234,000 inflections. Fred Hutchinson Cancer Research Center Supplement to develop novel designs and methods of analysis for 99,635 upcoming Zika vaccine trials. Fundacao Oswaldo Cruz Continue support natural history study (ZIP) study in pregnant women in 1,322,941 Brazil. George Washington University Examine genes participating in innate immune response to ZIKV and 8,576 identify and characterize effector mechanisms involved in controlling ZIKV. Georgia Institute of Technology To develop Zika Virus Vaccines based on Nanoscale Constructs 250,187 Presenting the Envelope Protein. Harvard Medical School Development of small molecule inhibitors against enveloped virus entry 500,867 as potential Zika therapeutics. Harvard Medical School Manufacture a VSV vaccine for efficacy studies in mice and NHPs. 299,999 Conduct efficacy studies in mice against lethal challenge and congenital disease. Icahn School of Medicine at Mount Sinai To study the infection mechanism of Zika virus. 254,250 Icahn School of Medicine at Mount Sinai Study host determinants in resistance to Zika virus infection. 254,250 Infectious Disease Research Institute Development of an Innovative, Effective, RNA-based Vaccine for Zika 178,600 Virus. JHU To construct a protein-protein interaction (PPI) network between the Zika 245,282 virus (ZIKV) and the human proteome in order to identify host proteins that play roles in ZIKV life cycle. Johns Hopkins University Methods for Reducing Spatial Uncertainty and Bias in Zika Disease 938,706 Surveillance. Johns Hopkins University Development of novel Zika vaccine platform using virus-derived 286,125 chemokine-like molecules. Mayo Clinic Rochester Development of mucosal Single-Cycle Vaccines against Zika Virus. 198,750 Mount Sinai School of Medicine Study the enhancement of Zika virus infection caused by antibodies to 252,993 West Nile virus. Mount Sinai School of Medicine Study Zika virus envelop protein mutations. 274,277 New York State Univ Support Structure-based Design of Zika Virus Inhibitors Targeting 199,089 Envelope Glycoprotein. New York State University, Stony Brook Study of Zika virus pathogenesis in endothelial cells. 235,543 Nirmidas Biotech, Inc. Develop a Nanoscale Plasmonic-Gold diagnostic platform to differentiate 190,525 Zika virus infection from other Flavivirus infections. Ohio State University Develop plant-derived, resistance-breaking mosquitocides. 193,125 Oregon Health & Science University Determining the role of host lipids in Zika virus infection. 231,000 Pennsylvania State University-Univ Park To investigate the potential role of native and introduced mosquito taxa 235,800 in the United States to mediate Zika virus invasion and transmission. Purdue University To Study the structure of the Zika virus epitope involved in virus 373,831 neutralization, which will improve the design of Zika vaccines. Page 62 GAO-18-389 Zika Supplemental Funding Appendix XI: National Institutes of Health Zika Supplemental Awards Award Awardee Activity description (in dollars) Research Triangle Institute Continue clinical data center support for the ZIP studies. 400,000 Rockefeller University Continued development of a therapeutic mAb for Zika virus. This 699,999 supplement focuses on developing an expression cell line and evaluating mAb in NHPs. South Dakota State Develop a Zika virus capsid dimerization assay that will be the platform 179,239 to screen libraries for inhibitors of Zika virus infection. Stanford University Support Nucleotide library (Roche) screening for potential antiviral 305,080 activity against Zika. Stanford University Study the diagnostic signatures of Zika virus infection. 219,762 State University of New York at Albany Study the role of Post-transcription RNA Modifications on Zika Virus 226,813 Gene Expression. Texas A&M Agrilife Research Study social-ecological factors influencing receptivity to Zika virus and 222,750 the efficacy of interventions in communities along the Texas-Mexico border. Texas Tech University Health SCIS To study Zika virus infection in individuals previously exposed to West 191,250 Center Nile Virus. Texas Tech University Health SCIS Identify ZIKV host factors with an improved CRISPR-based genome- 191,250 Center wide knockout screen. UC Davis Develop a novel platform for rapid generation of therapeutic and 196,250 prophylactic antibody against Zika virus, by site-specific ligation of the virus-capturing ligands to clinical grade intravenous-immunoglobulins. University of Alabama at Birmingham Support the development of high throughput screening (HTS) against 157,657 ZIKV, using approach developed for screening Dengue. University of Alabama at Birmingham Support the study of Zika virus in semen, as part of ZIP study in Brazil. 457,241 University of California at Davis Imaging and study of trafficking of Neurotropic Virus in Maternal/Fetal 193,000 Nonhuman Primates. University of California San Diego To study Zika Virus Pathogenesis and Selective Autophagy Induction to 232,500 Inhibit Virus Production. University of California, Berkeley Continue operations of the Zika in Infants and Pregnancy (ZIP) study in 830,000 Nicaragua. University of California, Davis Supplement Zika natural history study in Peru, including simulation 356,436 models to systematic assess different strategies for controlling and mitigating ZIKV disease burden. University of California, Davis Develop a nonhuman primate model of fetal Zika virus infection and 308,800 disease. University of California, Davis Support the development of Zika fetal infection models in non-human 1,478,154 primate (Rhesus macaque) for therapeutic testing. University of California, Davis To study the potential of Culex quinquefasciatus as a vector of the Zika 171,750 virus. University of California, Los Angel Study the viral kinetics, immunity and transmission of Zika Virus. 201,907 University of California, San Francisco Support the identification of diagnostic and prognostic biomarkers for 198,125 Zika infection. University of California, San Francisco Study the role of Zika infection in human pregnancy. 197,523 Page 63 GAO-18-389 Zika Supplemental Funding Appendix XI: National Institutes of Health Zika Supplemental Awards Award Awardee Activity description (in dollars) University of California, San Francisco Support the study of maternal and fetal cell receptors susceptible to Zika 397,293 infection and geographical virulence. University of California, San Francisco To study antiviral immunity in the Zika virus mosquito vector. 237,750 a University of Colorado, Denver To continue support the Zika in Infants and Pregnancy (ZIP) study in 589,999 Guatemala. University of Colorado, Denver Study noncoding RNA production in Zika virus infection. 229,125 University of Connecticut Storrs To support the rapid development and testing of Zika virus vaccine 192,254 candidates. University of Hawaii at Manoa Study the modulation of the blood-testis barrier by Zika virus. 231,000 University of Kentucky Develop novel formulations of double-stranded RNA molecules as tool to 210,000 further study RNA interference (RNAi) as potential vector control. University of Maryland Baltimore Rapid Phenotyping of the ZIKV Genome. 231,750 University of Miami School of Medicine Continue support effort to develop point-of-care Zika diagnostic. 167,617 University of Michigan To elucidate the molecular mechanisms of the flaviviral nonstructural 673,901 protein 1 (NS1), a multi-functional virulence protein. University of North Carolina Chapel Hill Support the development and testing of nanoparticle planform for 529,300 vaccine and adjuvant delivery. University of North Carolina Chapel Hill Study Zika virus in the human genital tract and implications for 207,868 transmission. University of North Carolina Chapel Hill Study viral and host determinants of Zika virus tissue tropism. 228,000 University of North Carolina Chapel Hill Structure based design of recombinant Zika virus antigens for 233,250 serodiagnosis. University of North Texas Hlth Sci Ctr Prevention of Zika transmission with novel Aedes personal protective 276,530 measures. University of Oklahoma Hlth Sciences Ctr Support development of olive baboon animal model for the study of Zika 222,000 virus biology and pathogenesis. University of Pennsylvania Support the study of host factors impacting Zika infection via genetic 235,388 screening. University of Pennsylvania To study mechanisms of Zika virus infection and anti-viral innate 40,240 immunity. University of Pittsburgh at Pittsburgh Support the development of a Novel, Sensitive ZIKV-Specific Sero- 703,978 diagnostic Assay Utilizing Biologically Inspired Synthetic Molecules. University of Pittsburgh at Pittsburgh Pre-clinical evaluation of a Zika virus vaccine. 193,332 University of Puerto Rico Med Sciences To continue support the Zika in Infants and Pregnancy (ZIP) study in 830,284 Puerto Rico. University of Rochester Support the study of Single-cycle infectious Zika viruses for the 180,457 development of a live-attenuated vaccine. University of Southern California To study the role autophagy for Zika virus lifecycle. 247,500 University of Texas To understand the mechanisms that mediate Zika virus replication in 193,750 specific tissues by manipulating the host ubiquitin system, and identify host factors that can potentially be targeted for therapeutic intervention. Page 64 GAO-18-389 Zika Supplemental Funding Appendix XI: National Institutes of Health Zika Supplemental Awards Award Awardee Activity description (in dollars) University of Texas Med Br Galveston Preclinical development of candidate Zika virus vaccines using mouse 196,250 models. University of Texas Med Br Galveston To study microbial interplay between ZIKA virus and the native 235,500 microbiome in mosquitoes. University of Texas Medical Br Galveston Develop a novel system using human fetal brain neural stem cell to 228,650 model ZIKV infection. University of Texas Medical Br Galveston Develop second generation platforms to deliver zika vaccines, and 163,282 characterize newly collected zika virus strains in tissue culture, mosquito vectors and animal models for transmission and pathogenesis. University of Washington Support the development of a rapid and specific diagnostic for 188,696 immunoglobulin response to Zika Virus exposure. University of Washington Study mechanisms of sexual Zika virus transmission and early 232,063 immunopathogenesis. University of Washington Targeting Zika Virus infection with Chloroquine and related Drugs. 232,625 University of Wisconsin To support the study of Zika virus using systems biology to better 190,106 understand the host-pathogen response. University of Wisconsin To study evolution of biological transmission for ZIKV including 229,500 determining whether or not Wolbachia biocontrol is a sustainable method for ZIKV control and prevention. University of Wisconsin Examine the impact of DENV immunity on pregnancy in ZIKV infected 753,026 rhesus macaques. University of Wisconsin Define South American Zika virus susceptibility and pathogenicity in 1,569,399 adult and neonatal nonhuman primates, and testing of hyperimmune sera as potential Zika therapeutic. University of Wisconsin-Madison To perform functional analysis of Zika virus induced birth defects. 229,500 University of Wisconsin-Madison Development of nonhuman Primate Model to Assess Fetal Zika Virus 221,550 Infection Complications. UTMB Accelerate development and acquisition of reagents (cDNA clone, 499,999 serum, antibodies), small animal model development and characterization of virus and mosquito vectors for Zika research. a Vanderbilt University Support efforts to establish a stable cell line for the optimized production 1,327,897 of human monoclonal antibody-based prophylaxis. Wadsworth Center Study the efficiency of repurposed therapeutics against Flavivirus in 238,240 mouse models. Wadsworth Center Study the efficiency of repurposed therapeutics against Zika. 235,470 Wadsworth Center Develop a high throughput screen assay for the identification of 523,552 orthosteric inhibitors of the critical viral protease consisting of NS2B and NS3 proteins of flaviviruses. As the NS2B-NS3 interactive segments are conserved, an inhibitor would have a broad spectrum of antiviral activity. Wadsworth Center Identifying genetic correlates of Zika virus infection and transmission in 181,504 U.S. mosquitoes. Washington University in St. Louis Development of Zika vaccine in gorilla adenovirus platform. 190,625 Page 65 GAO-18-389 Zika Supplemental Funding Appendix XI: National Institutes of Health Zika Supplemental Awards Award Awardee Activity description (in dollars) Washington University in St. Louis Support the development of mAb that can discriminate between Zika and 530,000 Dengue virus. Weill Medical Coll of Cornell Univ Mapping the RNA modification N6-methyladenosine during Zika virus 263,750 infection. Yale University Continue studies of Aedes aegypti and Aedes albopictus as Zika virus 252,460 vector. Yale University Study mechanisms of innate host defense against sexual Zika virus 251,250 transmission. Yale University Support the Zika in Infants and Pregnancy (ZIP) study in Brazil. 891,134 Yale University Support neurological evaluation in adults in Salvador, Brazil as part of 315,063 the ZIP study. Source: National Institutes of Health. | GAO-18-389 a These awardees received more than one award and funding amounts for awards for the same awardee and activity were added together in this table. Table 25: National Institutes of Health’s Zika Supplemental Funding Intramural Awards Award Awardee Activity description (in dollars) Battelle To perform PCR testing of clinical studies to evaluate 8,135,441.00 vaccine efficacy. Bioqual Conduct preclinical studies of Zika vaccine in nonhuman 1,464,000.00 primate models. Johns Hopkins University Conduct clinical evaluation and data management of NIAID 4,099,000.00 DIR developed Dengue-Zika Chimera Vaccine studies in normal and immunocompromised adults. Leidos Biomedical Research, Inc. To conduct clinical trials for NIAID VRC developed DNA 48,635,750.00 Vaccine. Leidos Biomedical Research, Inc. Manufacturing and clinical evaluation of NIAID DIR 11,664,304.09 developed live attenuated Dengue-Zika Chimera Vaccine in Brazil. The Emmes Corporation To provide clinical data management and monitoring 11,390,893.00 support for phase 2 DNA Vaccine studies. Various Labor, material, and supplies to support the preclinical 9,593,809.09 development and testing of Zika vaccines at NIAID intramural laboratories. Source: National Institutes of Health. | GAO-18-389 Page 66 GAO-18-389 Zika Supplemental Funding Appendix XI: National Institutes of Health Zika Supplemental Awards Table 26: Other National Institutes of Health Zika Supplemental Funding Awards Award Awardee Activity description (in dollars) AI Biosciences, Inc. Support the development of rapid and low-cost point-of- 224,955 care assay for Zika virus diagnosis. Crosslife Technologies, Inc. Development of a rapid paper strip nucleic acid test for the 299,574 point-of-care detection of Zika virus. L2 Diagnostics, LLC Support the development of rapid, low-cost point of care 225,000 diagnostic for detection of Zika virus RNA. Springstar, Inc. To modify the CDC autocidal gravid ovitrap (AGO) into a 618, 531 design amenable to large-scale, low cost production for development of improved vector control strategies. United States Dept. of Agriculture Zika workshop support in collaboration with USDA- 75,000 Scientific consultation on Zika Virus Vaccine Development. United States Dept. of Agriculture Zika workshop support in collaboration with USDA- 75,000 Consultation on the Ethics of ZikV Human Challenge Trials. University of Oxford, The Printing of Zika-specific supplement in the JOURNAL OF 83,250 INFECTIOUS DISEASES to disseminate research findings. Source: National Institutes of Health. | GAO-18-389 Page 67 GAO-18-389 Zika Supplemental Funding Appendix XII: GAO Contact and Staff Appendix XII: GAO Contact and Staff Acknowledgments Acknowledgments Marcia Crosse, (202) 512-7114, crossem@gao.gov GAO Contact In addition to the contact named above, Karen Doran (Assistant Director), Staff Sarah Resavy (Analyst-in-Charge), and Hannah Grow made key Acknowledgments contributions to this report. Also contributing were Muriel Brown, Christine Davis, and Drew Long. (101928) Page 68 GAO-18-389 Zika Supplemental Funding The Government Accountability Office, the audit, evaluation, and investigative GAO’s Mission arm of Congress, exists to support Congress in meeting its constitutional responsibilities and to help improve the performance and accountability of the federal government for the American people. 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