The Department of Health and Human Services (HHS) has designated 8 of its 11 operating divisions (agencies) as components of the U.S. Public Health Service (PHS). The PHS agencies are (1) the Agency for Healthcare Research and Quality (AHRQ), (2) the Agency for Toxic Substances and Disease Registry (ATSDR), (3) the Centers for Disease Control and Prevention (CDC), (4) the Food and Drug Administration (FDA), (5) the Health Resources and Services Administration (HRSA), (6) the Indian Health Service (IHS), (7) the National Institutes of Health (NIH), and (8) the Substance Abuse and Mental Health Services Administration (SAMHSA). The PHS agencies all provide and support essential public health services; however, their specific missions vary. With the exception of FDA, the agencies have limited regulatory responsibilities. Two of them—NIH and AHRQ—are primarily research agencies. NIH conducts and supports basic, clinical, and translational medical research. AHRQ conducts and supports research on the quality and effectiveness of health care services and systems. Three of the agencies—IHS, HRSA, and SAMHSA—provide health care services or help support systems that deliver such services. IHS supports a health care delivery system for American Indians and Alaska Natives. Health services are provided directly by the IHS, as well as through tribally contracted and operated health programs, and through services purchased from private providers. HRSA funds programs and systems to improve access to health care among low-income populations, pregnant women and children, persons living with Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), rural and frontier populations, and others who are medically underserved. SAMHSA funds community-based mental health and substance abuse prevention and treatment services. CDC is a public health agency that develops and supports community-based and population-wide programs and systems to promote quality of life and prevent the leading causes of disease, injury, disability, and death. ATSDR, which is headed by the CDC director and included in the CDC section of this report, is tasked with identifying potential public health effects from exposure to hazardous substances. Finally, FDA is primarily a regulatory agency, whose mission is to ensure the safety of foods, dietary supplements, and cosmetics, and the safety and effectiveness of drugs, vaccines, medical devices, and other health products. In addition, FDA has authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. The programs and activities of five of the PHS agencies—AHRQ, CDC, HRSA, NIH, and SAMHSA—are mostly authorized under the Public Health Service Act (PHSA). While some of FDA's regulatory activities are also authorized under the PHSA, the agency and its programs derive most of their statutory authority from the Federal Food, Drug, and Cosmetic Act (FFDCA). HRSA's maternal and child health programs are authorized by the Social Security Act (SSA), and many of the IHS programs and services are authorized by the Indian Health Care Improvement Act. ATSDR was created by the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA, the "Superfund" law). The primary source of funding for each PHS agency is the discretionary budget authority it receives through the annual appropriations process. AHRQ, CDC, HRSA, NIH, and SAMHSA are funded by the Departments of Labor, Health and Human Services, and Education, and Related Agencies (LHHS) appropriations act. Funding for ATSDR and IHS is provided by the Department of the Interior, Environment, and Related Agencies (Interior/Environment) appropriations act. FDA gets its funding through the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies (Agriculture) appropriations act. The annual LHHS appropriations act gives the HHS Secretary limited authority to transfer funds from one budget account to another within the department. The Secretary may transfer up to 1% of the funds in any given account. However, a recipient account may not be increased by more than 3%. Congressional appropriators must be notified in advance of any transfer. The HHS Secretary used this transfer authority in FY2013 and again in FY2014 as part of a broader effort to provide the Centers for Medicare & Medicaid Services (CMS) with additional funding to implement the Affordable Care Act (ACA). In FY2013, for example, NIH was the primary source of transfers both to CMS for ACA implementation and to CDC and SAMHSA to help offset a loss of funding for those two agencies from the ACA's Prevention and Public Health Fund (PPHF, discussed below). That year, a significant portion of the PPHF funds originally allocated to CDC and SAMHSA were instead redirected to CMS, also for ACA implementation. In FY2014, NIH was again the primary source of transfers to CMS to support ACA implementation. In addition to the transfer authority provided in the annual LHHS appropriations act, Section 241 of the PHSA authorizes the HHS Secretary, with the approval of congressional appropriators, to use a portion of the funds appropriated for programs authorized by the PHSA to evaluate their implementation and effectiveness. This long-standing transfer authority is known as the Public Health Service Evaluation Set-Aside (set-aside), or PHS budget "tap." Under this authority, the appropriations of numerous HHS programs are subject to an assessment. Although the PHSA limits the set-aside to no more than 1% of program appropriations, in recent years the annual LHHS appropriations act has specified a higher amount. The FY2017 LHHS appropriations act capped the set-aside at 2.5%, the same percentage that has been in place since FY2010. Following passage of the annual LHHS appropriations act, the HHS Budget Office calculates the assessment on each of the donor agencies and offices. These funds are then transferred to various recipient agencies and offices within the department for evaluation and other specified purposes, based on the amounts provided in the appropriations act. Table 1 shows the total assessments and transfers for FY2013, by HHS agency and office, and indicates whether the entity was a net donor or recipient of set-aside funds that year. These figures are broadly representative of the distribution of set-aside funds that occurred each fiscal year over a period of several years prior to FY2015, when the appropriators decided to make major changes to the allocation of such funds. NIH, whose annual discretionary appropriation exceeds that of all the other PHS agencies combined, is subject to the largest assessment of set-aside funds. NIH contributed almost $710 million (69%) of the $1.026 billion in set-aside funds in FY2013. However, the agency received $8 million in set-aside funding, making it a significant net donor of set-aside funds. Similarly, HRSA contributed more set-aside funds than it received in FY2013. On the other hand, AHRQ, CDC, and SAMHSA were net recipients of set-aside funding in FY2013. While not PHS agencies, the Administration for Children and Families (ACF) and various offices within the Office of the Secretary (OS) also received set-aside funds. Table 1 also shows the set-aside assessments and transfers for FY2016. These figures reflect the significant changes that the appropriators first made in FY2015 by returning most of the set-aside funding to NIH and eliminating any transfers to AHRQ, CDC, and HRSA. As a result, NIH has gone from being by far the largest net donor of set-aside funds to a net recipient of such funding. Meanwhile, AHRQ and CDC have experienced a significant loss of set-aside funding and are now both net donors of these funds. The situation with AHRQ is of particular interest. From FY2003 through FY2014, AHRQ did not receive a regular annual discretionary appropriation. The agency was supported by set-aside funds and, in recent years, by amounts from other sources. Since FY2015, however, AHRQ has received a discretionary appropriation in lieu of any set-aside funding. Enacted in December 2016, the 21 st Century Cures Act (Division A of P.L. 114-255 ) established three new accounts and authorizes annual transfers to the accounts to help support PHS agency programs and activities. The availability of funds each year in the accounts—described in more detail below—is controlled through the annual appropriations process. In other words, the funds in the accounts are not available until appropriated. Moreover, these appropriations are to be subtracted from any cost estimates provided for purposes of budget controls. Thus, these appropriations are not to be counted against any spending limits, such as the statutory discretionary spending limits. Amounts appropriated from the accounts are considered outside those limits. NIH Innovation Account. The 21 st Century Cures Act authorizes annual transfers to this account over the 10-year period FY2017-FY2026 totaling $4.796 billion. These funds are available for appropriation to NIH to help support the Precision Medicine Initiative, the BRAIN initiative, cancer research, and the use of adult stem cells in regenerative medicine (see line "NIH Innovation Account" in Table 9 ; individual amounts for each of the four activities are not listed in the table). FDA Innovation Account. The 21 st Century Cures Act authorizes annual transfers to this account over the nine-year period FY2017-FY2025 totaling $500 million. These funds are available for appropriation to FDA to help support the agency's new regulatory authorities under the act (see line "FDA Innovation Account" in Table 6 ). Account for the State Response to the Opioid Abuse Crisis. The 21 st Century Cures Act authorizes the transfer of $500 million to this account for each of FY2017 and FY2018. These funds are available for appropriation for state grants to address the opioid abuse crisis (see line "State Targeted Response to the Opioid Crisis" in Table 10 (SAMHSA)). HHS, and the PHS agencies in particular, have received a number of one-time supplemental appropriations in recent years to address specific circumstances. To ensure comparable presentations from year to year, the agency budget tables in this report generally do not include these amounts. Instead, they are summarized in Appendix A . Although the bulk of PHS agency funding is provided through annual discretionary appropriations, agencies also receive mandatory funding, user fees, and third-party collections. As discussed below, these additional sources of funding are a substantial component of the budgets of several PHS agencies. The ACA included numerous appropriations that together provided billions of dollars in mandatory spending to support specified grant programs and activities within HHS. A few PHS agencies continue to receive these funds, which are itemized in the funding tables in this report. The ACA also established and funds three multibillion dollar trust funds to help support PHS agency programs and activities: Community Health Center Fund (CHCF). The ACA provided the CHCF a total of $11 billion in annual appropriations over the five-year period FY2011-FY2015. These funds helped support the federal health centers program and the National Health Service Corps (NHSC), both administered by HRSA. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) appropriated two more years of funding for the CHCF—a total of $3.910 billion for each of FY2016 and FY2017. A table summarizing each fiscal year's CHCF appropriation and the allocation of funds appears in Appendix B . Prevention and Public Health Fund (PPHF) . The ACA provided the PPHF with a permanent annual appropriation. These funds are intended to support prevention, wellness, and other public health programs and activities authorized by the PHSA. For example, the HHS Secretary transferred almost half of the FY2013 PPHF funds to CMS to support ACA implementation. To date, CDC has received the majority of PPHF funds, while AHRQ, HRSA, and SAMHSA have received smaller amounts. A table showing the allocation of annual PPHF funding by agency since FY2010 is provided in Appendix C . Patient-Centered Outcomes Research Trust Fund (PCORTF) . This fund is supporting comparative effectiveness research over a 10-year period (FY2010-FY2019) with a mix of appropriations—some of which are offset by revenue from a fee imposed on health insurance policies and self-insured health plans—and transfers from the Medicare Part A and Part B trust funds. A portion of the PCORTF funding is allocated to AHRQ. More information on the PCORTF, including the appropriation and transfer formulas, is provided in Appendix D . In addition to the ACA funding, HRSA, CDC, and IHS each receive mandatory funds from other sources. HRSA's Family-to-Family Health Information Centers Program has been funded by a series of mandatory appropriations since FY2007; CDC receives Medicaid funding to support the Vaccines for Children program; and both IHS and NIH receive mandatory funds for diabetes programs. These and other mandatory appropriations are itemized in the agency funding tables in this report. The use of mandatory funding, including amounts provided by the ACA, has become an important component of PHS agency budgeting in recent years. Mandatory funds are not controlled by the annual appropriations process and generally do not count toward the discretionary spending caps, discussed below. Several PHS agencies assess user fees on third parties to help fund their programs and activities. User fees collected by CDC, HRSA, and SAMHSA represent a relatively small portion of each agency's overall budget. In comparison, the industry user fees that FDA collects help finance a broad range of the agency's regulatory activities and account for a substantial and growing share of the agency's budget. In 1992, the Prescription Drug User Fee Act (PDUFA) established the first user fee program at FDA. Since PDUFA's enactment, Congress has created several other FDA user fee programs. These programs provide FDA with additional resources that allow it to hire more personnel and expedite the process of reviewing new product applications. Some user fees also pay for information technology infrastructure and postmarket surveillance of FDA-approved products. FDA's user fee programs now support the agency's regulation of prescription drugs, animal drugs, medical devices, tobacco products, and some foods, among other activities. The amount of user fees that FDA collects under these programs has increased steadily since PDUFA was enacted, both in absolute terms and as a share of FDA's overall budget. In FY2017, user fees account for 41% of the agency's funding. More discussion of user fees is provided in the FDA section of this report and in Appendix E . IHS supplements its annual discretionary appropriation with third-party collections from public and private payers. Most of these funds come from Medicare and Medicaid, which reimburse IHS for services provided to American Indians and Alaska Natives enrolled in these programs at facilities operated by IHS and the tribes. IHS also collects reimbursements from private health insurers. IHS collections (and reimbursements) are reflected in Table 8 of this report. Congress has taken a number of recent steps through both the annual appropriations process and the enactment of deficit-reduction legislation to reduce the growth in federal spending. These actions, briefly discussed below, have had an impact on the level of discretionary funding for several PHS agencies since FY2010. Among the five PHS agencies funded through the LHHS appropriations act, AHRQ has seen a reduction in discretionary funding over the past seven years. However, that reduction for the most part was offset by the agency's receipt of mandatory funding. Discretionary funding for the other four agencies—CDC, HRSA, NIH, and SAMHSA—has fluctuated in recent years, dipping in FY2013 as a result of the sequestration of discretionary appropriations that fiscal year (see below). Both CDC and HRSA have received increasing amounts of mandatory funding since FY2010, which has raised each agency's overall funding level. FDA and IHS, which receive their discretionary funding through the Agriculture and Interior/Environment appropriations acts, respectively, have seen their appropriations increase since FY2010. In addition, both agencies have witnessed a steady increase in funding from other sources—user fees at FDA, and third-party collections at IHS. In April 2011, lawmakers agreed to cuts in discretionary spending for a broad range of agencies and programs as part of negotiations to complete the FY2011 appropriations process and avert a government shutdown. Four months later, during negotiations to raise the debt ceiling, Congress and President Obama enacted the Budget Control Act of 2011 (BCA). The BCA established enforceable discretionary spending limits, or caps, for defense and nondefense spending for each of FY2012 through FY2021, and provided for further annual reductions to the caps equally divided between the categories of defense and nondefense spending beginning in FY2013. All the spending summarized in this report falls within the nondefense category. Within each spending category, those further reductions are allocated proportionately to discretionary spending and mandatory spending, subject to certain exemptions and special rules. Under the BCA, the spending reductions are achieved through two different methods: (1) sequestration (i.e., an across-the-board cancellation of budgetary resources), and (2) lowering the BCA-imposed discretionary spending caps. The Office of Management and Budget (OMB) is responsible for calculating the percentages and amounts by which mandatory and discretionary spending are required to be reduced each year, and for applying the relevant exemptions and special rules. The BCA requires mandatory spending reductions to be executed each year through FY2021 via a sequestration of all nonexempt accounts. Generally, the ACA and other mandatory funding discussed in this report is fully sequestrable at the applicable percentage rate for nonexempt nondefense mandatory spending for PHS agencies (see Table 2 ), with the following key exceptions. First, the funds for the CDC-administered Vaccines for Children program come from Medicaid, which is exempt from sequestration. Second, CDC funding for the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) and the World Trade Center Health Program also are exempt from sequestration. Third, under the sequestration special rules, cuts in CHCF funding for community health centers and migrant health centers and the cuts in mandatory diabetes funding for IHS are capped at 2% (see Table 2 ). The OMB calculation for the upcoming fiscal year's mandatory spending sequestration order is announced at the same time that the President's budget is released each fiscal year. That amount is not recalculated for the subsequent enactment of additional mandatory spending. Thus, while all the nonexempt PHS programs with mandatory funding were sequestered in FY2013, FY2014, and FY2017, some programs avoided sequestration in FY2015 and/or FY2016 because budgetary resources had not yet been enacted at the time the sequestration was ordered. The Maternal, Infant, and Early Childhood Home Visiting program, administered by HRSA, is an example of one such program (see Table 7 ). The ACA authorized the home visiting program and funded it through FY2014. Subsequently, in two separate legislative actions, funding was extended for the home visiting program through FY2017. However, at the time the OMB calculation was announced for FY2015, and again for FY2016, that funding extension had not been enacted, so there were no budgetary resources for that program included in the sequestration order. Under the BCA, FY2013 discretionary spending was also reduced through sequestration. However, for each of the remaining fiscal years (i.e., FY2014 through FY2021), the annual reductions in discretionary spending required under the BCA are to be achieved by lowering the discretionary spending caps by the total dollar amount of the required reduction. This means that the cuts within the lowered spending cap may be apportioned through the annual appropriations decisionmaking, rather than via an across-the-board reduction through sequestration. In general, PHS agency discretionary appropriations in FY2013 were fully sequestrable at the applicable percentage rate for nonexempt nondefense discretionary spending (see Table 2 ). As a result, each agency saw a dip in its discretionary funding for FY2013. OMB determined that FDA user fees for FY2013 were fully sequestrable, but it concluded that IHS's third-party collections in FY2013 were exempt from sequestration. Table 3 shows the original nondefense discretionary (NDD) spending caps for FY2014-FY2018 established by the BCA. For each of these five fiscal years, the BCA required the caps to be lowered by approximately $37 billion to achieve the necessary reduction in NDD spending. The Bipartisan Budget Act of 2013 (BBA13) amended the BCA by establishing new levels for the FY2014 and FY2015 spending caps, and by eliminating the requirement for those caps to be reduced. While the BBA13 caps were set at a level that was lower than the original BCA caps (see Table 3 ), they were higher than the BCA-lowered caps that they replaced. The Bipartisan Budget Act of 2015 (BBA15) further amended the BCA by establishing new levels for the FY2016 and FY2017 NDD spending caps, and by eliminating the requirement for those caps to be lowered. Once again, the BBA15 caps were set at a level below the original BCA caps for those two fiscal years (see Table 3 ), but higher than the BCA-lowered caps that they replace. The revised caps allowed an additional $26 billion for nondefense programs in FY2016 compared with the previous fiscal year. However, virtually no increase in appropriations is allowed by the BBA15 revised cap level for FY2017. The revised cap for FY2017 is only $40 million above the revised cap for FY2016. For FY2018, OMB has calculated that the NDD spending cap of $553 billion will be lowered by $37.251 billion to $515.749 billion—pursuant to the BCA—which is almost $3 billion below the FY2017 revised cap level (see Table 3 ). The remainder of this report consists of seven sections, one for each PHS agency, beginning with AHRQ. Each section includes an overview of the agency's statutory authority and principal activities, and a brief summary of recent trends in the agency's funding. This material is accompanied by a detailed funding table showing the agency's FY2016 and FY2017 funding, as well as the requested amounts in the FY2018 budget. The funding amounts for FY2016 and the FY2018 request are based on the FY2018 budget documents, whereas the amounts for FY2017 are taken from the LHHS appropriations table in the joint explanatory statement to accompany the FY2017 LHHS appropriations act. Note that the FY2017 amounts may in some instances differ from the agency's final operating levels due to transfers, reprogramming, or other adjustments. The funding tables show the post-sequestration amounts for the accounts that were subject to sequestration, unless indicated otherwise. The funding tables are formatted in a similar, though not identical, manner. The formatting generally matches the way in which each agency's funding is presented in the congressional budget documents. Each table shows the funding for all the agency's budget accounts and, typically, for selected programs and activities within those accounts. These amounts are summed to give the agency's total, or program level , funding. At the bottom of the table any user fees, set-aside funds, ACA funds, and other nondiscretionary amounts are subtracted from the program level to give the agency's discretionary budget authority (i.e., annual discretionary appropriations). The tables for AHRQ, CDC, HRSA, and SAMHSA include non-add entries—italicized and in parentheses—to indicate the contribution of funding to specific accounts from sources other than the agency's discretionary appropriations. Almost all of the CDC accounts, for example, are funded with discretionary appropriations plus amounts from other sources (see Table 5 ). The use of a dash in the funding tables generally means "not applicable." Either the activity or program was not authorized or there was no mandatory funding provided for that fiscal year. In contrast, a zero usually indicates that congressional appropriators had chosen not to appropriate any discretionary funds that year. It is important to keep in mind that the PHS agency funding tables that appear in budget documents and appropriations committee reports, as well as the tables in this report, show only the amount of evaluation set-aside funds received. They do not reflect the amount of funding assessed on agency accounts. As a result, the funding tables for the PHS agencies subject to an assessment can give a somewhat distorted view of their available budgetary resources by not subtracting the assessment amounts. This effect has been particularly significant in the case of the three agencies—CDC, HRSA, and NIH—that are subject to a significant assessment under the evaluation set-aside authority (see Table 1 ). AHRQ supports research designed to improve the quality of health care, increase the efficiency of its delivery, and broaden access to health services. Specific research efforts are aimed at reducing the costs of care, promoting patient safety, measuring the quality of health care, and improving health care services, organization, and financing. AHRQ is required to disseminate its research findings to health care providers, payers, and consumers, among others. In addition, the agency collects data on health care expenditures and utilization through the Medical Expenditure Panel Survey (MEPS) and the Healthcare Cost and Utilization Project (HCUP). AHRQ has evolved from a succession of agencies concerned with fostering health services research and health care technology assessment. The Omnibus Budget Reconciliation Act of 1989 ( P.L. 101-239 ) added a new PHSA Title IX and established the Agency for Health Care Policy and Research (AHCPR), a successor agency to the former National Center for Health Services Research and Health Care Technology Assessment (NCHSR). AHCPR was reauthorized in 1992 ( P.L. 102-410 ). On December 6, 1999, President Clinton signed the Healthcare Research and Quality Act of 1999 ( P.L. 106-129 ), which renamed AHCPR as AHRQ and reauthorized appropriations for its programs and activities through FY2005. Congress has yet to reauthorize the agency's funding. Despite the expired authorization of appropriations, AHRQ continues to get annual funding. The AHRQ budget is organized according to three program areas: (1) Healthcare Costs, Quality, and Outcomes (HCQO) Research; (2) MEPS; and (3) program support. HCQO research currently focuses on four priority areas, summarized in the text box below. From FY2003 through FY2014, AHRQ did not receive its own annual discretionary appropriation. Instead, the agency largely relied on the PHS evaluation set-aside to fund its activities and programs. In recent years, AHRQ has received mandatory funds from the PPHF (see Appendix C ) and the PCORTF (see Appendix D ). In FY2015, AHRQ received its own discretionary appropriation for the first time in more than a decade in lieu of any set-aside funding. This trend continued in FY2016 and FY2017, with the agency receiving its own discretionary appropriation and no set-aside funds. President Trump's FY2018 budget proposes to consolidate AHRQ under NIH by adding a new institute within NIH, the National Institute for Research on Safety and Quality (NIRSQ). The request would provide NIRSQ with $272 million in budget authority, which would bring the total funding available to $379 million for FY2018 for AHRQ-related activities continued under the new institute (this amount includes the estimated PCORTF transfer of $107 million for FY2018). This would represent a decrease of $38 million from AHRQ's FY2017 program level. The request would eliminate funding for Health Information Technology (HIT) research and would decrease or keep level funding for Patient Safety research and Prevention/Care Management. It would increase funding for MEPS; exact amounts for Health Services Research, Data, and Dissemination and Program Support are not specified in the request. Since FY2010, AHRQ's budget has increased from $403 million to $417 million (+$14 million), with transfers from PCORTF growing from $8 million in FY2011 to an estimated $93 million in FY2017. Discretionary sources of funding shifted from set-aside transfers to the agency's own discretionary appropriation beginning in FY2015, and this trend continued through FY2017. In addition, ACA mandatory funds have been a prominent and generally increasing source of funding for the agency since FY2010. AHRQ's program level had been increasing steadily between FY2011 and FY2015, with decreases in discretionary funding being more than offset by transfers of PCORTF funds. However, in FY2016, the total program level for the agency decreased for the first time since FY2011. This decline continued in FY2017, with a decreasing PCORTF transfer estimated for the first time since the trust fund's inception (see Table 4 ). In Table 4 , the funding presented in the 2018 request column would go to the NIH/NIRSQ to carry out the functions within AHRQ designated to be continued under the President's budget. These amounts are also listed in the NIH section ( Table 9 ). CDC's mission is to "to protect America from health, safety and security threats, both foreign and in the [United States]." CDC is organized into a number of centers, institutes, and offices. Some of these focus on specific public health challenges (e.g., chronic disease prevention, injury prevention); others focus on general public health capabilities (e.g., surveillance and laboratory services). In addition, the Agency for Toxic Substances and Disease Registry (ATSDR), discussed below, is headed by the CDC Director. Many CDC activities are not specifically authorized but are based in broad, permanent statutory authorities in the PHSA. Four CDC operating divisions are explicitly authorized: (1) the National Institute for Occupational Safety and Health (NIOSH) was permanently authorized by the Occupational Safety and Health Act of 1970; (2) the National Center on Birth Defects and Developmental Disabilities (NCBDDD) was established in PHSA Section 317C by the Children's Health Act of 2000; (3) the National Center for Health Statistics (NCHS) was established in PHSA Section 306 by the Health Services Research, Health Statistics, and Medical Libraries Act of 1974; and (4) ATSDR was established by the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA, the "Superfund" law). Authorizations of appropriations for NCBDDD, NCHS, and ATSDR have expired, but the programs continue to receive annual appropriations. Most of CDC's spending is extramural. In FY2016, CDC provided $6.6 billion in grants for public health programs and research around the world. The agency has few regulatory responsibilities. Table 5 presents funding levels for CDC programs for FY2016 through the FY2018 request. In addition to annual discretionary appropriations, program level amounts for recent years include funds from the following four mandatory appropriations: (1) the Vaccines for Children (VFC) program; (2) NIOSH activities to support the Energy Employees Occupational Illness Compensation Program Act (EEOICPA); (3) the World Trade Center Health Program (WTCHP); and (4) appropriations provided under ACA, principally through the PPHF. CDC receives a small amount of funds from authorized user fees, and it may receive funds from supplemental appropriations and other transfers. When considering funding trends for CDC/ATSDR, it is useful to consider mandatory and discretionary funds separately. For example, for FY2017, the CDC/ATSDR total operating budget, or program level, is $12.1 billion. This amount comprises $6.3 billion (52%) in discretionary funds (i.e., budget authority) for CDC provided in the LHHS appropriations act; $4.4 billion (37%) in mandatory Medicaid funds for VFC (this amount is often excluded from analyses of overall CDC budget trends); $847 million (7%) in mandatory PPHF funds; $402 million (3%) in other mandatory funds, namely EEOICPA and WTCHP; $75 million (<1%) in discretionary funds for ATSDR provided in Interior/Environment appropriations; and $17 million (<1%) from authorized user fees and other transfers. The CDC/ATSDR program level has generally increased since FY2010, with the increase coming primarily from growth in mandatory spending (particularly VFC) rather than discretionary appropriations. The President's FY2018 request proposes to cut CDC budget authority by almost $1.2 billion from the enacted FY2017 level, to $5.1 billion. This includes a proposed $326 million reduction in budget authority for CDC chronic disease prevention programs, from the enacted FY2017 level of $778 million to $452 million. The budget proposes to consolidate several chronic disease programs (e.g., for diabetes and heart disease) into a new $500 million "America's Health Block Grant," to allow states and territories to tailor spending to their specific challenges. Similar consolidations were proposed by the Obama Administration but were not adopted in appropriations acts. FDA regulates the safety of human foods, dietary supplements, cosmetics, and animal foods, as well as the safety and effectiveness of human drugs, biological products (e.g., vaccines), medical devices, and animal drugs. FDA also regulates the manufacture of radiation-emitting products to protect the public from hazardous levels of radiation. In 2009, Congress gave FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Seven centers within FDA represent the broad program areas for which the agency has responsibility: (1) the Center for Biologics Evaluation and Research (CBER), (2) the Center for Devices and Radiological Health (CDRH), (3) the Center for Drug Evaluation and Research (CDER), (4) the Center for Food Safety and Applied Nutrition (CFSAN), (5) the Center for Veterinary Medicine (CVM), (6) the National Center for Toxicological Research (NCTR), and (7) the Center for Tobacco Products (CTP). Several other offices have agency-wide responsibilities. The Federal Food, Drug, and Cosmetic Act (FFDCA) is the principal source of FDA's statutory authority. FDA is also responsible for administering certain provisions in other laws, most notably the PHSA. Although the FDA's authorizing committees in Congress are the committees with jurisdiction over public health issues—the Senate Committee on Health, Education, Labor, and Pensions, and the House Committee on Energy and Commerce—FDA's assignment within the appropriations committees reflects its origin as part of the Department of Agriculture. The Senate and House appropriations subcommittees on Agriculture, Rural Development, FDA, and Related Agencies have jurisdiction over FDA's budget, even though the agency has been part of various federal health agencies (HHS and its predecessors) since 1940. FDA's budget has two funding streams: annual appropriations (i.e., discretionary budget authority, or BA) and industry user fees. In FDA's annual appropriation, Congress sets both the total amount of appropriated funds and the amount of user fees that the agency is authorized to collect and obligate for that fiscal year. Appropriated funds are largely for the Salaries and Expenses account, with a smaller amount for the Buildings and Facilities account. The appropriations of the several different user fees contribute only to the Salaries and Expenses account. The largest and oldest FDA user fee that is linked to a specific program was first authorized by the Prescription Drug User Fee Act (PDUFA, P.L. 102-571 ) in 1992. Appendix E presents the authorizing legislation for current FDA user fees, sorted by the dollar amount they contribute to the agency's FY2017 budget. After PDUFA, additional laws were enacted to provide user fee authorities regarding medical devices, animal drugs, animal generic drugs, tobacco products, priority review, food reinspection, food recall, voluntary qualified food importer, generic drugs, biosimilars, and, most recently, outsourcing facilities (related to drug compounding) and some wholesale distributors and third-party logistics providers (related to pharmaceutical supply chain security). Each of the medical product fee authorities requires reauthorization every five years. Several indefinite authorities, which do not need to be reauthorized, apply to fees for mammography inspection, color additive certification, export certification, and priority review vouchers. In the 114 th Congress, the 21 st Century Cures Act was signed into law (Division A of P.L. 114-255 ). Among other things, the Cures Act modified the drug and device development and approval pathways at FDA to support innovation. To help fund the activities and programs authorized in the Cures Act, the law created an FDA Innovation Account, to which a total of $500 million is authorized to be transferred over a nine-year period (FY2017-FY2025). The availability of funds in the Innovation Account is controlled through the annual appropriations process. Since the enactment of PDUFA in 1992, FDA revenue from user fees has generally increased, both in absolute terms and as a share of FDA's total funding, accounting for 41% of the agency's FY2017 total program level. The Trump Administration's FY2018 request includes $3.223 billion in user fees, an increase of 65% over the FY2017-enacted amount (see Table 6 ). Under the Administration's request, user fees would account for 63% of the FDA's total program level. This proposed increase in user fee revenue is accompanied by a proposed decrease in the agency's direct appropriation—about $900 million below the FY2017-enacted amount. This increase in user fee revenue and decrease in the direct appropriation would result in a total program level of $5.112 billion—an increase of $367 million over the FY2017 total program level. In addition to the amounts provided in the enacted FY2017 appropriation, FDA received $20 million from the FDA Innovation Account, provided in the Further Continuing and Security Assistance Appropriations Act, 2017 ( P.L. 114-254 ). The Administration's FY2018 request also includes $60 million from the FDA Innovation Account. HRSA is the federal agency charged with improving access to health care for those who are uninsured, isolated, or medically vulnerable. The agency currently awards funding to more than 3,000 grantees, including community-based organizations; colleges and universities; hospitals; state, local, and tribal governments; and private entities to support health services projects, such as training health care workers or providing specific health services. HRSA also administers the health centers program, which provides grants to nonprofit entities that provide primary care services to people who experience financial, geographic, cultural, or other barriers to health care. HRSA is organized into five bureaus (see text box below) and 10 offices. Some offices focus on specific populations or health care issues (e.g., Office of Women's Health, Office of Rural Health Policy), while others provide agency-wide support or technical assistance to HRSA's regional offices (e.g., Office of Planning, Analysis and Evaluation; Office of Regional Operations). As noted in the text box, the majority of HRSA's programs are authorized by the PHSA; others are authorized by the SSA. In addition, Section 427(e) of the Federal Mine Safety and Health Amendments Act ( P.L. 95-164 ) authorizes the Black Lung Program, which supports clinics that provide services to retired coal miners and others. HRSA funding increased from $8.1 billion in FY2010 to $10.7 billion in FY2017; this increase occurred despite a reduction in the agency's discretionary appropriation during that time (see Table 7 ). Specifically, discretionary appropriations declined by about 17%, falling from $7.5 billion to $6.2 billion. Much of the decline in discretionary appropriations occurred because of the loss of discretionary appropriations for the National Health Service Corps (NHSC) and the elimination of a program that supported health care facility construction and renovation through the congressional direction of funds to specific facilities. The overall growth in HRSA's funding was primarily driven by increasing amounts from the CHCF (see Table B-1 ), which more than offset the decline in discretionary funding. CHCF funding has partially supplanted (i.e., replaced) discretionary health center funding and has become the sole source of funding for the NHSC program, which has not received an annual discretionary appropriation since FY2011. The President's FY2018 budget would further reduce the agency's discretionary appropriation, but it would continue the funding of the CHCF among other mandatory HRSA funding streams. These funding streams include the Maternal, Infant, and Early Childhood Home Visiting Program and the Teaching Health Center Program, two new programs created in the ACA, and the Family-to-Family Health Information Centers, which received an extension of its mandatory funding in the ACA and subsequent legislation. IHS provides health care for approximately 2.2 million eligible American Indians/Alaska Natives through a system of programs and facilities located on or near Indian reservations, and through contractors in certain urban areas. IHS provides services to members of 566 federally recognized tribes, either directly or through facilities and programs operated by Indian Tribes or Tribal Organizations through self-determination contracts and self-governance compacts authorized in the Indian Self-Determination and Education Assistance Act (ISDEAA). The Snyder Act of 1921 provides general statutory authority for IHS. In addition, specific IHS programs are authorized by two acts: the Indian Sanitation Facilities Act of 1959 and the Indian Health Care Improvement Act (IHCIA). The Indian Sanitation Facilities Act authorizes the IHS to construct sanitation facilities for Indian communities and homes. IHCIA authorizes programs such as urban health, health professions recruitment, and substance abuse and mental health treatment, and permits IHS to receive reimbursements from Medicare, Medicaid, the State Children's Health Insurance Program (CHIP), the Department of Veterans Affairs (VA), and third-party insurers. As discussed earlier, IHS receives its appropriations through the Interior/Environment appropriations act. IHS funding is not subject to the PHS set-aside (see earlier discussion in " PHS Evaluation Set-Aside "). IHS's funding, which includes discretionary appropriations and collections from third-party payers of health care, increased between FY2010 and FY2017 from $5.1 billion to $6.3 billion (see Table 8 ). This increase was driven both by increased discretionary appropriations, which rose from $4.1 billion to $5.0 billion, and by increased collections, which rose from $891 million to $1.2 billion. Much of the funding increase was used to support clinical services. Discretionary appropriations, in particular, have increased funding for purchased/referred care, a subset of the clinical services budget line that applies to funds used to refer patients to an outside provider when the IHS cannot provide a service within its system. Funding allocated for contract support costs has also increased since FY2014. Contract support costs are funds that Indian Tribes and Tribal Organizations receive, in addition to operating funds, when they operate a facility or program under an ISDEAA contract or compact. According to the U.S. Supreme Court, these costs must be fully funded even if Congress does not appropriate sufficient funds to cover all tribes' contract support costs. According to IHS, beginning in FY2016, the amount allocated for contract support costs is sufficient for the contracts and compacts that IHS enters into. Contract support costs had previously been included in the Indian Health Service account, but in more recent years they have been delineated separately in IHS budget documents. The IHS's FY2018 budget notes that contract support costs receive a separate discretionary indefinite appropriation in FY2018. NIH is the primary agency of the federal government charged with performing and supporting biomedical and behavioral research. Its activities cover a wide range of basic, clinical, and translational research, as well as research training and health information collection and dissemination. The agency is organized into 27 research institutes and centers, headed by the NIH Director. The Office of the Director (OD) sets overall policy for NIH and coordinates the programs and activities of all NIH components, particularly in areas of research that involve multiple institutes. The institutes and centers (ICs) focus on particular diseases, areas of human health and development, or aspects of research support. Each IC plans and manages its own research programs in coordination with OD. More than 80% of NIH's budget funds extramural research through grants, contracts, and other awards. This funding supports research performed by more than 300,000 individuals who work at over 2,500 universities, hospitals, medical schools, and other research institutions around the country and abroad. About 10% of the NIH budget supports the intramural research programs of the ICs, funding research performed by the nearly 6,000 NIH scientists, most of whom are located on the NIH campus in Bethesda, MD. The remainder of the budget supports various research management, support, and facilities' needs. NIH derives its statutory authority from the PHSA. Title III, Section 301, of the PHSA grants the HHS Secretary broad permanent authority to conduct and sponsor research. In addition, Title IV, "National Research Institutes," authorizes in greater detail various activities, functions, and responsibilities of the NIH Director and the ICs. All of the ICs are covered by specific provisions in the PHSA, but they vary considerably in the amount of detail included in the statutory language. There are few time-and-dollar authorization levels specified for individual activities. Congress mandated a significant reorganization of IC responsibilities in the FY2012 Consolidated Appropriations Act ( P.L. 112-74 , Division F) by creating a new National Center for Advancing Translational Sciences (NCATS) and eliminating the National Center for Research Resources (NCRR). Activities relating to translational sciences from NCRR and many other ICs were consolidated in NCATS, and NCRR's other programs were moved to several other ICs and OD. Almost all NIH funding (99.5%) is from annual discretionary appropriations. As shown in Table 9 , the annual LHHS appropriations act provides separate appropriations to 24 of the ICs, the OD, and the Buildings and Facilities account. One of the ICs (Environmental Health Sciences) also receives funding for Superfund-related activities from the Interior/Environment appropriations act. In addition, NIH receives a mandatory annual appropriation ($150 million) for type 1 diabetes research. Between FY1994 and FY1998, funding for NIH grew from $11.0 billion to $13.7 billion in nominal terms. Over the next five years, Congress doubled the NIH budget to $27.2 billion in FY2003. In each of these years, the agency received annual funding increases of 14% to 16%. Since FY2003, however, NIH funding has increased more gradually in nominal dollars. Funding peaked in FY2010 before declining in FY2011 through FY2013, with increases in subsequent years. The NIH program level in FY2016 was $32.311 billion. The Obama Administration requested an FY2017 NIH program level total of $33.136 billion, an increase of $825 million (2.6%) over FY2016. Temporary FY2017 funding for NIH was provided until May 5, 2017, by three continuing resolutions ( P.L. 114-223 , P.L. 114-254 , and P.L. 115-30 ). Generally, these continuing resolutions (CRs) provided a formulaic extension of FY2016 funding levels with an across-the-board adjustment and limited exceptions for particular accounts and activities. One exception is that Section 194 of the second CR appropriated $352 million (available until expended) into an NIH Innovation account to carry out four NIH Innovation Projects as described in Section 1001(b)(4) of the 21 st Century Cures Act ( P.L. 114-255 ). The Cures Act created the NIH Innovation account and specified that funds in the account must be appropriated in order to be available for expenditure; the appropriation in Section 194 of the second CR was needed to fulfill this requirement. Projects authorized by the Cures Act are the Precision Medicine Initiative, the BRAIN Initiative, cancer research, and regenerative medicine using adult stem cells. The explanatory statement accompanying the FY2017 LHHS Appropriations Act (Division H of H.R. 244 ; P.L. 115-31 ) states that it provides $34.084 billion for NIH activities, a $2 billion (6.2%) increase over FY2016. This amount is calculated by including the $824 million from the evaluation tap, as well as $352 million for the NIH Innovation account that was previously appropriated to the agency for FY2017. Adding the amounts for Superfund-related activities ($77 million in Division G of H.R. 244 ; P.L. 115-31 ) and the mandatory type 1 diabetes program ($150 million) brings the FY2017-enacted NIH program level to $34.311 billion. The NIH Operating Plan for FY2017 provides current details on agency spending. The $352 million amount in the NIH Innovation account is divided between NCI ($300 million) and OD ($52 million). President Trump's FY2018 budget requests an NIH program level total of $26.92 billion, a decrease of $7.391 billion (-21.5%) compared with the FY2017-enacted amount. Under the FY2018 budget request, all NIH ICs would receive a decrease compared to FY2017, but the Fogarty International Center would be eliminated and the Office of the NIH Director would retain $25 million in international research and related activities. The Trump budget request also proposes the consolidation of the Agency for Healthcare Research and Quality (AHRQ) with NIH, forming a new Institute, the National Institute for Research on Safety and Quality (NIRSQ). The FY2018 budget proposal includes $272 million in budget authority for NIRSQ "to preserve key research activities previously carried out by AHRQ." In addition, NIRSQ is projected to receive $107 million in mandatory resources from the Patient-Centered Outcomes Research Trust Fund to continue the targeted dissemination of study results to help patients and providers make better informed health care decisions. SAMHSA is the lead federal agency for increasing access to behavioral health services. SAMHSA supports community-based mental health and substance abuse treatment and prevention services through formula grants to the states and U.S. territories and through competitive grant programs to states, territories, tribal organizations, local communities, and private entities. SAMHSA also engages in a range of other activities, such as technical assistance, data collection, and workforce development. SAMHSA and most of its programs and activities are authorized under PHSA Title V, which organizes SAMHSA in four centers: Center for Substance Abuse Treatment (CSAT) Center for Substance Abuse Prevention (CSAP) Center for Mental Health Services (CMHS) Center for Behavioral Health Statistics and Quality (CBHSQ) Each of CSAT, CSAP, and CMHS has general statutory authority, called Programs of Regional and National Significance (PRNS), under which it administers numerous grants and other programs. PHSA Title V also authorizes a number of specific grant programs, referred to as categorical grants. SAMHSA's two largest grant programs are separately authorized under PHSA Title XIX, Part B. The Community Mental Health Services block grant falls within CMHS. The full amount of the Substance Abuse Prevention and Treatment block grant falls within CSAT, although no less than 20% of each state's block grant must be used for prevention. SAMHSA's budget is organized in four categories, three of which correspond to CSAT, CSAP, and CMHS. The fourth category, "health surveillance and program support," does not correspond directly to CBHSQ; it supports data collection, analytic support, public awareness campaigns, behavioral health workforce initiatives, and the National Registry of Evidence-based Programs and Practices (among other programs and activities). In the 114 th Congress, the Helping Families in Mental Health Crisis Reform Act of 2016 (Division B of P.L. 114-255 ) made numerous changes to SAMHSA's statutory authorities—reauthorizing, modifying, or codifying existing programs and activities; authorizing new programs and activities; and repealing authorities for programs and activities that had not been funded. Also in the 114 th Congress, the Comprehensive Addiction and Recovery Act of 2016 (CARA, P.L. 114-198 ) included authorizations of appropriations for SAMHSA-administered grant programs, and Section 1003 of the 21 st Century Cures Act (Division A of P.L. 114-255 ) authorized appropriations for grants to support state responses to opioid abuse. SAMHSA's program-level funding increased by 13% from FY2016 ($3.8 billion) to FY2017 ($4.3 billion). SAMHSA's largest center, CSAT, received a 24% increase, attributable mostly to the $500 million appropriated for the newly authorized grants to support state responses to opioid abuse. Smaller increases—in terms of both dollar amounts and percentages—went to CMHS (1%) and CSAP (6%). Program-level funding decreased by 28% for health surveillance and program support. Relative to FY2017 as enacted, SAMHSA's FY2018 request would decrease program-level funding by 9% (to $3.9 billion) and discretionary budget authority by 8% (to $3.8 billion); see Table 10 . Funding for CSAT would stay within 1% of its FY2017-enacted amount. Funding for CMHS would decrease by 23%, including a 26% decrease in the mental health block grant and a 31% decrease in mental health PRNS. Funding for CSAP would decrease by 33%. Funding would decrease by 11% for health surveillance and program support. Appendix A. Supplemental Appropriations Several one-time appropriations for HHS, and PHS agencies in particular, are discussed below. Ebola and Zika Response In late 2014, Congress provided almost $2.8 billion in supplemental FY2015 appropriations to HHS agencies for response to the Ebola outbreak. In September 2016, Congress provided $933 million in supplemental FY2016 appropriations to HHS agencies for response to the Zika virus outbreak. Both appropriations were designated as emergency spending and made available for a mix of domestic and international response activities. The HHS Secretary and/or agency directors were granted specific transfer authorities in each act. Also in each act, additional funds were provided to other departments and agencies for aspects of the international response to each outbreak. In May 2017, Congress provided $10 million to FDA to "prevent, prepare for, and respond to emerging health threats, including the Ebola and Zika viruses, domestically and internationally and to develop necessary medical countermeasures and vaccines, including the review, regulation, and post market surveillance of vaccines and therapies, and for related administrative activities ... to remain available until expended." Table A-1 summarizes the amounts and purposes of HHS funds as appropriated for the Ebola and Zika outbreaks, and emerging health threats. As the Zika outbreak was unfolding, some unobligated funds for the Ebola response were reprogrammed to the Zika response mission. Details of those transfers are discussed elsewhere. Lead Poisoning Prevention In December 2016, in a continuing resolution ( P.L. 114-254 ), Congress provided $55 million in FY2017 appropriations to HHS for the response to lead exposures in water, in addition to the annual appropriations for these activities that were continued by the law. Table A-2 summarizes the amounts and purposes of these funds. Appendix B. Community Health Center Fund Affordable Care Act (ACA) Section 10503 established a Community Health Center Fund (CHCF) to provide supplemental funding for community and other health centers and the National Health Service Corps (NHSC). The law provided annual appropriations to the CHCF totaling $11 billion over the five-year period FY2011 through FY2015. Of that total, $9.5 billion was for health center operations, and the remaining $1.5 billion was for the NHSC. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) appropriated two more years of funding for the CHCF. For both FY2016 and FY2017, MACRA provided $3.6 billion for health center operations and $310 million for the NHSC. The President's FY2018 budget proposes extending CHCF funding for two more years. CHCF funding has partially supplanted discretionary funding for the health center program and entirely replaced discretionary funding for the NHSC (see Table 7 ). Table B-1 shows the amounts appropriated to the CHCF for each fiscal year, as well as the post-sequestration levels for FY2013-FY2015 and FY2017. As discussed earlier in this report, the FY2016 CHCF funding was not subject to sequestration. CHCF funds are awarded to the various types of health centers that are supported by the federal health center program. Those include community health centers and migrant health centers, as well as facilities that serve the homeless and residents of public housing. Sequestration of CHCF funding for community health centers and migrant health centers is capped at 2%, whereas CHCF funding for the other types of facilities (i.e., health centers for the homeless and for public housing residents) and for the NHSC is fully sequestrable at the applicable rate for nonexempt nondefense mandatory spending (see Table 2 ). Appendix C. Prevention and Public Health Fund (PPHF) Affordable Care Act (ACA) Section 4002 established the Prevention and Public Health Fund (PPHF), to be administered by the HHS Secretary, and provided it with a permanent annual appropriation . Under the ACA as originally enacted, PPHF's annual appropriation would increase from $500 million for FY2010 to $2 billion for FY2015 and each subsequent fiscal year. Congress has amended the provision two times, rescinding a portion of PPHF funds as an offset for the costs of other activities. The Middle Class Tax Relief and Job Creation Act of 2012 ( P.L. 112-96 ) reduced PPHF appropriations for FY2013 through FY2021. The 21 st Century Cures Act ( P.L. 114-255 ) reduced PPHF appropriations for FY2018 through FY2024. Further information, including amounts currently authorized and appropriated for each fiscal year, is provided in CRS Report R44796, The ACA Prevention and Public Health Fund: In Brief . The PPHF authority directs the HHS Secretary to transfer amounts from the PPHF to HHS agencies for prevention, wellness, and public health activities. The funds are available to the Secretary at the beginning of each fiscal year. The Administration's annual budget sets out the intended distribution and use of PPHF funds for that fiscal year. The Secretary determined the distribution of PPHF funds for FY2010 through FY2013. For FY2014 through FY2017, provisions in appropriations acts explicitly directed the distribution of PPHF funds, prohibiting the Secretary from making further transfers. As discussed earlier in this report, the PPHF appropriation is fully sequestrable at the applicable percentage rate for nonexempt nondefense mandatory spending (see Table 3 ). Sequestration is applied to the entire appropriation before funds are designated for or transferred to the agencies. The distribution of PPHF funds to HHS agencies for FY2010 through FY2017, and proposed in the FY2018 budget, is presented in Table C-1 . Further details regarding PPHF distributions to CDC and SAMHSA are provided in the respective agency budget tables in the body of this report. For FY2013, the Secretary transferred almost half of available PPHF funds to CMS for ACA implementation, as shown in Table C-1 . This transfer reduced the PPHF funds that had been initially allocated to CDC and other PHS agencies. Along with the sequestration of discretionary funding in FY2013, the loss of PPHF funds that year had a significant effect on CDC's budget. In determining the transfer of PPHF funds for FY2010 through FY2013, the Secretary funded a mix of preexisting programs and activities, and programs and activities newly authorized under the ACA. In directing the distribution PPHF funds for FY2014 through FY2017, annual appropriations acts (and accompanying report language) generally directed funds to preexisting programs and activities. In some cases the PPHF contribution for FY2016 made up more than 50% of a program's total funding. Examples include CDC immunization grants to states (54%) and tobacco prevention activities (60%). The CDC Preventive Health and Health Services Block Grant and the lead poisoning prevention program received 100% of their FY2016 funding from the PPHF. Appendix D. Patient-Centered Outcomes Research Trust Fund Affordable Care Act (ACA) Section 6301(e) established the Patient-Centered Outcomes Research Trust Fund (PCORTF) to support comparative clinical effectiveness research at both HHS and the Patient-Centered Outcomes Research Institute (PCORI). The law provided annual funding to the PCORTF over the period FY2010-FY2019 from the following three sources: (1) annual appropriations, (2) fees on health insurance and self-insured plans, and (3) transfers from the Medicare Part A and Part B trust funds. Specifically, the ACA appropriated the following amounts to the PCORTF: (1) $10 million for FY2010; (2) $50 million for FY2011; and (3) $150 million for each of FY2012 through FY2019. In addition, for each of FY2013 through FY2019, the ACA appropriated an amount equivalent to the net revenues from a new fee that the law imposes on health insurance policies and self-insured plans. For policy/plan years ending during FY2013, the fee equals $1 multiplied by the number of covered lives. For policy/plan years ending during each subsequent fiscal year through FY2019, the fee equals $2 multiplied by the number of covered lives. Finally, transfers to PCORTF from the Medicare Part A and Part B trust funds are calculated by multiplying the average number of individuals entitled to benefits under Medicare Part A, or enrolled in Medicare Part B, by $1 (for FY2013) or by $2 (for each of FY2014 through FY2019). For each of FY2011 through FY2019, the ACA requires 80% of the PCORTF funds to be made available to PCORI, and the remaining 20% of funds to be transferred to the HHS Secretary for carrying out PHSA Section 937. Of the total amount transferred to HHS, 80% is to be distributed to AHRQ. In the FY2018 budget request, the President proposes to incorporate AHRQ under NIH by creating a new institute, the National Institute for Research on Safety and Quality (NIRSQ); therefore, for FY2018, the funds that would have otherwise gone to AHRQ are shown as going to NIRSQ. Table D-1 shows the allocation of PCORTF funds through FY2018. Appendix E. FDA User Fee Authorizations

Summary: Within the Department of Health and Human Services (HHS), eight agencies are designated components of the U.S. Public Health Service (PHS). The PHS agencies are funded primarily with annual discretionary appropriations. They also receive significant amounts of funding from other sources, including mandatory funds from the Patient Protection and Affordable Care Act (ACA; P.L. 111-148, as amended), user fees, and third-party reimbursements (collections). The Agency for Healthcare Research and Quality (AHRQ) funds research on improving the quality and delivery of health care. For more than a decade prior to FY2015, AHRQ did not receive its own annual appropriation. Instead, it relied on redistributed ("set-aside") discretionary funds from other PHS agencies for most of its funding, with supplemental amounts from the ACA's mandatory Patient-Centered Outcomes Research Trust Fund (PCORTF). Since FY2015, AHRQ has received an annual appropriation in lieu of any set-aside funds. The agency's FY2017 funding level of $417 million was $11 million less than the FY2016 level of $428 million. The Centers for Disease Control and Prevention (CDC) is the federal government's lead public health agency. CDC obtains its funding from multiple sources besides discretionary appropriations. The Agency for Toxic Substances and Disease Registry (ATSDR) investigates the public health impact of exposure to hazardous substances. ATSDR is headed by the CDC director and included in the discussion of CDC in this report. The CDC/ATSDR funding level decreased from $12.2 billion in FY2016 to $12.1 billion in FY2017. The Food and Drug Administration (FDA) regulates drugs, medical devices, food, and tobacco products, among other consumer products. The agency is funded with annual discretionary appropriations and industry user fees. The agency's funding levels for FY2016 and FY2017 remained constant at about $4.7 billion, with user fees accounting for 41% of FDA's total FY2017 funding. The Health Resources and Services Administration (HRSA) funds programs and systems that provide health care services to the uninsured and medically underserved. HRSA, like CDC, relies on funding from several different sources. The agency's funding decreased from $10.8 billion in FY2016 to $10.7 billion in FY2017. The Indian Health Service (IHS) supports a health care delivery system for Native Americans. IHS's funding, which includes discretionary appropriations and collections from third-party payers of health care, increased between FY2016 and FY2017 from $6.2 billion to $6.4 billion. Appropriations increased during that period, while collections stayed the same in both fiscal years. The National Institutes of Health (NIH) funds basic, clinical, and translational biomedical and behavioral research. NIH gets more than 99% of its funding from discretionary appropriations. Recent increases in NIH's annual appropriations have boosted its funding level to a new high of $34.1 billion in FY2017, compared with $32.3 billion in FY2016. The Substance Abuse and Mental Health Services Administration (SAMHSA) funds mental health and substance abuse prevention and treatment services. SAMHSA's funding, about 95% of which comes from discretionary appropriations, was approximately $3.8 billion in FY2016 and $4.3 billion in FY2017. This report supersedes two earlier products, both of which remain available: CRS Report R43304, Public Health Service Agencies: Overview and Funding (FY2010-FY2016), and CRS Report R44505, Public Health Service Agencies: Overview and Funding (FY2015-FY2017).