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). While the PHS agencies all provide and support essential public health services, 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 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 discussion of CDC in 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 2009, Congress gave FDA the 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 (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). A significant portion of the FY2013 PPHF funds that were originally allocated to CDC and SAMHSA were reallocated 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 budgeting 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 FY2016 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 specified 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. 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 the current fiscal year (i.e., 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 to many. From FY2003 through FY2014, AHRQ did not receive an annual discretionary appropriation. The agency was supported by set-aside funds and, in recent years, by amounts from other sources. In FY2015, however, AHRQ received a discretionary appropriation for the first time in more than a decade in lieu of receiving any set-aside funding. That continues to be the case in FY2016. 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 budget 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 funded three multibillion dollar trust funds to help support PHS agency programs and activities. First, the ACA provided a total of $11 billion in annual appropriations over the five-year period FY2011-FY2015 to the Community Health Center Fund (CHCF) . These funds help support the federal health centers program and the National Health Service Corps (NHSC), both of which are 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 A . Second, the Prevention and Public Health Fund (PPHF) , for which the ACA provided a permanent annual appropriation, is intended to support prevention, wellness, and other public health programs and activities. To date, CDC has received the majority of PPHF funds, while AHRQ, HRSA, and SAMHSA have received smaller amounts. The HHS Secretary transferred almost half of the FY2013 PPHF funds to CMS to support ACA implementation. A table showing the allocation of annual PPHF funding by agency since FY2010 is provided in Appendix B . Finally, the Patient-Centered Outcomes Research Trust Fund (PCORTF) 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 is allocated for AHRQ. More information on the PCORTF, including the appropriation and transfer formulas, is provided in Appendix C . 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. 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 very 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 FY2016, user fees account for 43% of the agency's funding. More discussion of user fees is provided in the FDA section of this report and in Appendix D . 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, which are briefly discussed below, have had an impact on the level of discretionary funding for several PHS agencies since FY2010. Among the five PHS agencies that are funded through the LHHS appropriations act, AHRQ has witnessed a reduction in discretionary funding over the past six years. However, that reduction has been offset by the receipt of increasing amounts 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 also 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 the Interior/Environment appropriations acts, respectively, have seen their appropriations increase since FY2010. Both agencies also 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, as part of negotiations to raise the debt ceiling, Congress and the President then 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 spending reductions equally divided between the categories of defense and nondefense spending beginning in FY2013. Within each spending category, those further reductions are allocated proportionately to discretionary spending and mandatory spending, subject to certain exemptions and special rules. All the spending summarized in this report falls within the nondefense category. 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 the mandatory spending reductions to be executed each year through 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 (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 ). While all the nonexempt PHS programs with mandatory funding were sequestered in FY2013 and FY2014, several of them avoided sequestration in FY2015 and/or FY2016 because they had no budgetary resources in place at the time the sequester was ordered by the President. The Maternal, Infant, and Early Childhood Home Visiting program, administered by HRSA, is one example of a program for which this occurred. The ACA authorized the home visiting program and funded it through FY2014 (see Table 7 ). Pursuant to the BCA, the President ordered the FY2015 sequestration on March 10, 2014. Because Congress and the President had yet to enact legislation extending funding for the home visiting program, there were no FY2015 budgetary resources to sequester. 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 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-FY2017 established by the BCA. For each of those four fiscal years, the BCA required the caps to be lowered by approximately $37 billion to achieve the necessary reduction in NDD spending. However, the Bipartisan Budget Act of 2013 (BBA13) amended the BCA by establishing new levels for the FY2014 and FY2015 NDD spending caps, and 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 FY2014 and FY2015 NDD spending caps, and eliminating the requirement for those caps to be lowered. Once again, the BBA15 caps were set at a level that is below the original BCA caps for those two fiscal years (see Table 3 ), but is higher than the BCA-lowered caps that they replace. The revised NDD caps allowed an additional $26 billion for nondefense programs in FY2016 compared to the previous fiscal year. However, there is virtually no increase in NDD appropriations allowed by the FY2017 revised cap level. (The revised cap for FY2017 is only $40 million above the revised cap for FY2016.) The President's FY2017 budget includes a total of $2.940 billion in proposed new mandatory funding for the PHS agencies: $1.825 billion for NIH; $590 million for SAMHSA; $495 million for HRSA; and $30 million for CDC. These amounts, which are discussed later in this report, would be used to supplement—and in one case replace—discretionary funding for existing programs, or provide funding for new initiatives. It will be up to Congress to decide whether to pass legislation to provide these funds. 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 do not count toward the discretionary spending caps. 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 FY2015 and FY2016 funding levels and the FY2017 budget request. The amounts in the funding tables in this report are taken from the departmental and agency budget documents submitted to the appropriations committees, as well as agency operating plans. The funding tables show the post-sequestration amounts for the accounts that were subject to sequestration in FY2015 and FY2016. The amounts shown for the FY2017 request do not reflect sequestration. 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 or, in the case of the FY2017 budget request, that no discretionary funding was requested. 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 give a somewhat distorted view of their available budgetary resources. This effect is 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 ). NIH, for example, is assessed approximately $700 million annually. While the funding table for NIH shows the transfer (i.e., receipt) of set-aside funds, which count toward the agency's overall program level funding, the amounts shown for each agency account have not been reduced to reflect the assessment. Thus, NIH appears to have about $700 million more than is in fact the case. This report is a new edition of an earlier product, which remains available: CRS Report R43304, Public Health Service Agencies: Overview and Funding (FY2010-FY2016) . 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 the Agency for Healthcare Research and Quality (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 also has received mandatory funds from the PPHF and the PCORTF (see Appendix B and Appendix C ). 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 with the agency receiving its own discretionary appropriation and no set-aside funds. Since FY2010, AHRQ's budget has increased from $403 million to $428 million (+$25 million), with transfers from PCORTF growing from $8 million in FY2011 to $94 million in FY2016. Discretionary sources of funding shifted from set-aside transfers to the agency's own discretionary appropriation in both FY2015 and FY2016, and ACA mandatory funds have been a prominent and 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, despite an increasing PCORTF transfer (see Table 4 ). CDC's mission is "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 focused on specific public health challenges (e.g., chronic disease prevention, injury prevention), and others focused on general public health capabilities (e.g., surveillance and laboratory services). In addition, the Agency for Toxic Substances and Disease Registry (ATSDR) is headed by the CDC Director and is discussed in this section. Many CDC activities are not specifically authorized but are based in broad, permanent authorities in the PHSA. Four CDC operating divisions are explicitly authorized. The National Institute for Occupational Safety and Health (NIOSH) was permanently authorized by the Occupational Safety and Health Act of 1970. The National Center on Birth Defects and Developmental Disabilities (NCBDDD) was established in PHSA Section 317C by the Children's Health Act of 2000. 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. 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. CDC provides about $5 billion per year in grants to state, local, municipal, tribal, and foreign governments, and to academic and non-profit entities. It has few regulatory responsibilities. Between FY2010 and FY2016, the total program level for CDC/ATSDR increased from $10.88 billion to $11.78 billion. During that time period, CDC/ATSDR budget authority decreased by 3% from $6.5 billion in FY2010 to $6.3 billion in FY2016. Table 5 presents funding levels for CDC programs for FY2015 through the FY2017 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 may also receive funds through the PHS set-aside, 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 FY2016, the CDC/ATSDR total operating budget, or program level, is $11.78 billion. Of this amount, $6.27 billion (53%) is composed of discretionary funds (i.e., budget authority) for CDC provided in the LHHS appropriations act; $5.42 billion (46%) is composed of mandatory funds for CDC and ATSDR programs, namely the VCF, EEOICPA, and WTCHP, and from the ACA (principally from the PPHF); $75 million (<1%) is discretionary funds for ATSDR provided in the Interior/Environment appropriations act; and $17 million (<1%) is from authorized user fees and other transfers. Many of CDC's PPHF-funded activities also receive discretionary appropriations. Exceptions include the Preventive Health and Health Services Block Grant, and the Lead Poisoning Prevention Program, which were funded solely through PPHF distributions for FY2016. For more discussion on the allocation of annual PPHF funding, see Appendix B . In December 2014 Congress provided $1.771 billion in FY2015 emergency supplemental appropriations to CDC for response to the Ebola outbreak. The funds, which are available through FY2019, are to be used for both domestic and international activities. CDC has not presented these funds within its general budget, and they are not presented in Table 5 . However, the table does include $30 million provided to CDC's Global Health Program from an earlier Ebola supplemental. FDA regulates the safety of human foods, dietary supplements, cosmetics, and animal foods; and the safety and effectiveness of human drugs, biological products (e.g., vaccines), medical devices, and animal drugs. It 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: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), the National Center for Toxicological Research (NCTR), and 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 several different user fees, which account for 43% of FDA's total FY2016 program level, 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 D presents the authorizing legislation for current FDA user fees, sorted by the dollar amount they contribute to the agency's FY2016 budget. After PDUFA, Congress added 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 apply to fees for mammography inspection, color additive certification, export certification, and priority review vouchers. Between FY2010 and FY2016, FDA's funding increased from $3.1 billion to $4.7 billion. Although discretionary appropriations increased by 16% over that time period, user fee revenue more than doubled. In FY2016, user fees account for 43% of FDA's total funding compared with 24% in FY2010. The President's FY2017 budget request was for a total program level of $4.826 billion, an increase of $81 million (+2%) from the FY2016 total program level of $4.745 billion (see Table 6 ). The FY2017 budget request includes $2.743 billion for budget authority, an increase of $15 million (+0.5%) compared to the FY2016 enacted level of $2.728 billion, and $2.084 billion for user fees, an increase of $66 million (+3%) compared to the FY2016 enacted level of $2.017 billion. In addition to the $2.084 billion in user fees from currently authorized programs, the President requested $202 million in as yet unauthorized fees to support export certification, food facility registration and inspection, food import, international courier, cosmetics, and food contact substance notification activities. With those proposed fees, the President's total user fee request was $2.286 billion, bringing the total program level request to $5.029 billion. The FY2017 request also included $75 million in new mandatory resources to support the Cancer Moonshot Initiative. 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 non-profit 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. Additionally, 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 $10.8 billion in FY2016 despite a reduction in its 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 the congressional earmark program that supported health care facility construction and renovation. The overall growth in HRSA's funding was primarily driven by increasing amounts from the CHCF, 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. With CHCF funding set to expire at the end of FY2015, Congress included two more years of CHCF funding in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA); see Table 7 and Appendix A . MACRA also extended funding for other HRSA programs that were established and initially funded by the ACA; notably, the Maternal, Infant, and Early Childhood Home Visiting Program and the Teaching Health Center Program. 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; and 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. IHS's funding, which includes discretionary appropriations and collections from third-party payers of health care, increased between FY2010 and FY2016 from $5.1 billion to $6.2 billion (see Table 8 ). This increase was driven both by increased discretionary appropriations, which rose from $4.1 billion to $4.8 billion, and by increased collections, which rose from $891 million to $1.1 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. Given the ruling that stated that these are required costs, the President's Budget includes a proposal to reclassify contract support costs as a mandatory three-year appropriation. 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 (collectively called 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 the Office of the Director. The bulk of NIH's budget, about 81%, goes out to the extramural research community through grants, contracts, and other awards. The funding supports research performed by more than 30,000 individuals who work at more than 2,500 universities, hospitals, medical schools, and other research institutions around the country and abroad. A smaller proportion of the budget, about 11%, supports the intramural research programs of the ICs, funding research performed by NIH scientists and non-employee trainees in the NIH laboratories and Clinical Center. The remaining 6% funds 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 institutes and centers. 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 the OD. NIH gets almost its entire funding (99.5%) 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 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 small increases in subsequent years. The NIH program level in FY2016 is $32.311 billion. For FY2017, the Obama Administration requests an NIH program level total of $33.136 billion, an increase of $825 million (2.6%) over FY2016. The FY2017 program level request includes $847 million in PHS set-aside funds and $1.825 billion in proposed new mandatory funding. The FY2017 request includes $755 million for the Vice President's Cancer Moonshot, of which $680 million is allocated for the National Cancer Institute, and $75 million would be transferred from NIH to FDA. SAMHSA is the lead federal agency for increasing access to behavioral health services. It 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 that fund 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 Title V of the PHSA, which organizes SAMHSA in three centers: Center for Substance Abuse Treatment (CSAT) Center for Substance Abuse Prevention (CSAP) Center for Mental Health Services (CMHS) Each center has general statutory authority, called Programs of Regional and National Significance (PRNS), under which it has established grant programs for states and communities to address their important substance abuse and mental health needs. 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. In addition to the three statutorily defined centers, SAMHSA's budget reflects a fourth category, "health surveillance and program support," for other activities such as collecting data, providing statistical and analytic support, raising public awareness, developing the behavioral health workforce, and maintaining the National Registry of Evidence-based Programs and Practices. The last comprehensive reauthorization of SAMHSA and its programs occurred in 2000 as part of the Children's Health Act, which also added "charitable choice" provisions allowing religious organizations to receive funding for substance abuse prevention and treatment services without altering their religious character. Since 2000, Congress has expanded some of SAMHSA's programs and activities without taking up comprehensive reauthorization. Although authorizations of appropriations for most of SAMHSA's grant programs expired at the end of FY2003, many of these programs continue to receive annual discretionary appropriations. Over the past 10 years (FY2007–FY2016), SAMHSA's program-level funding has increased by 12%, from $3.3 billion to $3.7 billion. It has not, however, increased every year. For example, it decreased from FY2012 ($3.6 billion) to FY2013 ($3.4 billion) due to sequestration, then rebounded in FY2014 ($3.6 billion). Relative to FY2016, SAMHSA's FY2017 request would increase program-level funding by 16% (to $4.3 billion) while decreasing discretionary budget authority by 3% (to $3.5 billion); see Table 10 . It would make up the difference with increased PHS set-aside funds, increased PPHF transfers, and new mandatory funding proposed for FY2017 and FY2018. The proposed new mandatory funding would support three programs: (1) State Targeted Response Cooperative Agreements, which would aim to increase access to opioid addiction treatment by addressing the most commonly identified barriers to treatment; (2) Evidence-based Early Interventions, which would provide formula grants to states to support early interventions for individuals with serious mental illness; and (3) Cohort Monitoring and Evaluation of Medication-Assisted Treatment, which would evaluate addiction treatment outcomes with the goal of increasing effectiveness. Appendix A. Community Health Center Fund 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 to the CHCF. For both FY2016 and FY2017, MACRA provided $3.6 billion for health center operations and $310 million for the NHSC. CHCF funding has partially supplanted discretionary funding for the health center program and entirely replaced discretionary funding for the NHSC (see Table 7 ). Table A-1 shows the amounts appropriated to the CHCF for each fiscal year as well as the post-sequestration levels for FY2013-FY2015. 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 B. Prevention and Public Health Fund (PPHF) 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. However, the Middle Class Tax Relief and Job Creation Act of 2012 amended the ACA by reducing the PPHF appropriation from FY2013 through FY2021 as part of a package of offsets to help cover the costs of the law. The PPHF annual appropriation is now $1 billion through FY2017, and thereafter will increase in increments to $2 billion for FY2022 and each subsequent fiscal year. The HHS Secretary is instructed to transfer amounts from the PPHF to 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 FY2016, provisions in appropriations acts explicitly directed the distribution of PPHF funds, prohibiting the Secretary from making further transfers. As discussed earlier in the report, the PPHF appropriation is fully sequestrable at the applicable percentage rate for nonexempt nondefense mandatory spending (see Table 2 ). Sequestration is applied to the entire appropriation by the Secretary before funds are transferred to the agencies. The distribution of PPHF funds to HHS agencies for FY2010 through the FY2017 President's budget proposal is presented in Table B-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 B-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 pre-existing programs and activities, and programs and activities newly authorized under the ACA. In directing the distribution of FY2014, FY2015, and FY2016 PPHF funds, annual appropriations acts (and accompanying report language) in most cases funded pre-existing 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 C. Patient-Centered Outcomes Research Trust Fund 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. Table C-1 shows the allocation of PCORTF funds through FY2017. Appendix D. 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 Affordable Care Act (ACA), 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 several years 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). In FY2015 and FY2016, AHRQ received its own discretionary appropriation in lieu of set-aside funds, with the FY2016 level of $428 million below the FY2015 level of $443 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's funding level has fluctuated in the past few years, with the FY2016 level of $11.8 billion above the FY2015 level of $11.2 billion. 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 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 FDA's funding level in FY2016 was $4.7 billion—above the FY2015 level of $4.5 billion—with user fees accounting for about 43% of FDA's total 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 increased from $10.6 billion in FY2015 to $10.8 billion in FY2016. 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 FY2015 and FY2016 from $5.9 billion to $6.2 billion. Appropriations and collections both increased during that period. 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 $32.3 billion in FY2016, compared to $30.3 billion in FY2015. 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 $3.6 billion in FY2015 and $3.7 billion in FY2016. This report is a new edition of an earlier product, which remains available: CRS Report R43304, Public Health Service Agencies: Overview and Funding (FY2010-FY2016). It will be updated with information on PHS agency funding for FY2017 once legislative action on appropriations for the new fiscal year is completed.