This report provides a historical overview of federal funding provided to the National Institutes of Health (NIH) between FY1995 and FY2021. It also provides a brief explanation of the discretionary spending funding sources for NIH associated with the annual appropriations process (via the Labor, HHS, and Education and Interior/Environment Appropriations Acts) and the mandatory funding for special program on type 1 diabetes research. NIH is the primary federal agency for medical, health, and behavioral research. It is the largest of the eight health-related agencies that make up the Public Health Service (PHS) within the Department of Health and Human Services (HHS). NIH consists of the Office of the Director (OD) and 27 Institutes and Centers (ICs) that focus on aspects of health, human development, and biomedical science. The 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. NIH activities cover a wide range of basic, clinical, and translational research, focused on particular diseases, areas of human health and development, or more fundamental aspects of biology and behavior. Its mission also includes research training and health information collection and dissemination. More than 80% of the NIH budget funds extramural research (i.e., external) through grants, contracts, and other awards. This funding supports research performed by more than 300,000 individuals who work at over 2,500 hospitals, medical schools, universities, and other research institutions around the country. About 10% of the agency's budget supports intramural research (i.e., internal) conducted by nearly 6,000 NIH physicians and scientists, most of whom are located on the NIH campus in Bethesda, Maryland. Funding for NIH comes primarily from annual Labor, HHS, and Education (LHHS) Appropriations Acts, with an additional smaller amount for the Superfund Research Program from the Interior/Environment Appropriations Act. Those two bills provide NIH discretionary budget authority. Through LHHS appropriations, some funding is also transferred to NIH pursuant to the PHS Evaluation Set-Aside or the "PHS Evaluation Tap" transfer authority. Authorized by Section 241 of the Public Health Service Act, the evaluation tap allows the Secretary of HHS, with the approval of appropriators, to redistribute a portion of eligible PHS agency appropriations across HHS for program evaluation and implementation purposes. The PHSA section limits the set-aside to not less than 0.2% and not more than 1% of eligible program appropriations. However, LHHS Appropriations Acts have commonly established a higher maximum percentage for the set-aside and have distributed specific amounts of "tap" funding to selected HHS programs. Since FY2010, and including in FY2020, this higher maximum set-aside level has been 2.5% of eligible appropriations. Readers should note that totals in this report and NIH source documents include amounts "transferred in" pursuant to PHS tap but do not include any amounts "transferred out" under this same authority. NIH also receives funding through LHHS appropriations, subject to different budget enforcement rules than the rest of the NIH funding in the actâappropriations to the NIH Innovation Account created by The 21 st Century Cures Act ("the Cures Act," P.L. 114-255 ) to fund programs authorized by the act. For appropriated amounts to the accountâup the limit authorized for each fiscal yearâthe amounts are subtracted from any cost estimate for enforcing discretionary spending limits (i.e., the budget caps). In effect, appropriations to the NIH Innovation Account as authorized by the Cures Act are not subject to discretionary spending limits. The NIH Director may transfer these amounts from the NIH Innovation Account to other NIH accounts, but only for the purposes specified in the Cures Act. If the NIH Director determines that the funds for any of the four Innovation Projects are not necessary, the amounts may be transferred back to the NIH Innovation Account. All amounts authorized by the Cures Act have been fully appropriated to the Innovation Account from FY2017 to FY2020, including $492 million for FY2020. For FY2021, $404 million is authorized to be appropriated. In addition, NIH has received mandatory funding of $150 million annually that is provided in Public Health Service Act (PHSA) Section 330B, for a special program on type 1 diabetes research, most recently extended through FY2020 by the CARES Act ( P.L. 116-136 ), with additional partial-year FY2021 funding of $25,068,493 for October 1, 2020, through November 30, 2020. The total funding available for NIH activities, taking account of add-ons and PHS tap transfers, is referred to as the NIH "program level." The enacted FY2020 NIH program level is made up of the following: $40.228 billion in discretionary LHHS appropriations, including the $492 million authorized for the Cures Act Innovation Account; $1.231 billion pursuant to the PHS program evaluation transfer and a $225 million transfer from the HHS non-recurring expenses fund (NEF); $81 million for the Superfund research program in Interior/Environment appropriations; and $150 million in annual funding for the mandatory type 1 diabetes research program. Accounting for transfers and other adjustments, cited FY2021 budget documents from the Administration show the NIH FY2020 program level as $41.685 billion. NIH has also received emergency supplemental appropriations to several IC accounts as provided by the first and third, coronavirus supplemental appropriations acts, shown in Table 1 , totaling $1.8 billion. In addition to these appropriations, the fourth coronavirus supplemental required that a total of not less than $1.8 billion of $25 billion appropriated to the Public Health and Social Services Emergency Fund be transferred to two NIH institutes and the Office of the Director. When accounting for these transfers, total funding directed to the NIH would come to not less than $3.6 billion across the three actsâan 8.6% funding increase over regular enacted FY2020 appropriations. These acts also include various other transfer authorities that would allow for additional transfers to and from NIH accounts (explained in the table notes). By convention, CRS does not add amounts provided as an emergency requirement to the NIH program levels in the remainder of this report. The FY2020 regular and emergency appropriations amounts are presented separately. President Trump's FY2021 initial budget request (February 10, 2020) proposed that NIH be provided with a total program level of $38.694 billion, a decrease of $2.99 billion (-7.2%) from FY2020-enacted levels. The proposed FY2020 program level would have been made up of $37.630 billion in LHHS appropriations, including the $404 million for the Cures Act Innovation Account (the full amount authorized for FY2021); $741 million in transfers to NIH pursuant to the PHS Evaluation Tap authority; $74 million for the Superfund Research Program in Interior/Environment appropriations; and $150 million in proposed annual funding for the mandatory type 1 diabetes program. Under the request, all existing IC accounts would receive a decrease compared to FY2020-enacted levels (see Appendix A ). The Building and Facilities account would receive an increase in LHHS budget authority, from $200 million in FY2020 to $300 million in FY2021. Subsequently, on March 17, 2020, the Office of Management and Budget submitted an amendment to President Trump's original request that would increase funding for the National Institute of Allergy and Infectious Disease (NIAID) by $440 million relative to the original request. The purpose of this additional requested funding was "to ensure [NIAID] has the resources beginning October 1, 2020, to continue critical basic and applied research on coronaviruses and other infectious diseases." This amendment to the original proposal, if enacted, would result in NIAID receiving an increase of $9.3 million above the FY2020 level. Taking into account this amendment, as of the date of this report, the FY2021 budget request would provide NIH with a total program level of $39.133 billion, a decrease of $2.55 billion (-6.1%) from FY2020-enacted levels, with a total of $38.811 billion by provided by LHHS appropriations. In addition, the FY2021 budget request proposes consolidating the Agency for Healthcare Research and Quality (AHRQ) into NIH, forming a 28 th ICâthe National Institute for Research on Safety and Quality (NIRSQ). The creation of a new NIH institute would require amendments to the PHSA, especially Section 401(d), which specifies that "[i]n the National Institutes of Health, the number of national research institutes and national centers may not exceed a total of 27." Under the FY2021 request, NISRQ would receive a total appropriation of $355.112 million, including $256.66 million in discretionary LHHS budget authority and $98.452 million in mandatory appropriations from the Patient-Centered Outcomes Research Trust Fund (PCORTF) in Social Security Act Section 1181. Congress did not adopt the Administration's similar proposals to consolidate AHRQ into NIH as NIRSQ in FY2018 through FY2020. The budget request proposes select specified FY2021 funding levels for programs and activities within and across the NIH accounts based on the Administration's research priorities, as summarized in Table A-3 . If adopted, these funding levels would likely be specified in report and/or explanatory statement language accompanying LHHS appropriations bills. For the most part, Congress does not specify NIH funding for particular diseases or areas of research, instead allowing the ICs to award funding within their mission areas. Funding awards are generally made on a competitive basis through various funding mechanisms intended to balance scientific opportunity with health priorities. Table 2 outlines NIH program level funding over the previous 25 years; Figure 1 illustrates funding trends in both current (also called nominal dollars) and projected constant (i.e., inflation-adjusted) FY2021 dollars (funding shown is total budget authority). NIH has seen periods of high and low funding growth. Between FY1994 and FY1998, funding for NIH grew from $11.0 billion to $13.7 billion (nominal dollars). Over the next five years, Congress and the President doubled the NIH budget to $27.2 billion in FY2003. In each of FY1999 through FY2003, NIH received annual funding increases of 14% to 16%. From FY2003 to FY2015, NIH funding increased more gradually in nominal dollars. In some years, (FY2006, FY2011, and FY2013) funding for the agency decreased in nominal dollars. From FY2016 through FY2020, NIH has seen funding increases of over 5% each year. The largest increase was from FY2017 to FY2018, where the program level increased by $3.0 billion (+8.7%), making this the largest single-year nominal dollar increase since FY2003. The lower half of Figure 1 shows NIH funding adjusted for inflation (in projected constant FY2021 dollars) using the Biomedical Research and Development Price Index (BRDPI). It shows that the purchasing power of NIH funding peaked in FY2003 (the last year of the five-year doubling period) and then declined fairly steadily for more than a decade until back-to-back funding increases were provided in each of FY2016 through FY2020. The FY2021 budget request would provide a program level that is 13.0% below the peak FY2003 program level. Appendix A. NIH Funding Details Program-Specific Funding In recent years, Congress and the President have increasingly specified funding levels for programs or research areas within NIH accounts throughout the budget and appropriations process. Congress uses language in reports and explanatory statements accompanying appropriations bills to designate funding for specified purposes. The Administration requests NIH program-specific funding, as outlined in the HHS and NIH budget request documents. For the most part, Congress does not specify NIH funding for particular diseases or areas of research, instead allowing the ICs to award funding within their mission areas. Funding is generally awarded on a competitive basis through various funding mechanisms intended to balance scientific opportunity with health priorities. In FY2020, Congress used explanatory statement language to specify a certain amount of IC funding for designated purposes, as summarized in Table A-2 . Sometimes the language specifies that "no less than" a certain amount can be designated for a certain purpose; in other cases, language "provides" or "recommends" that an amount be spent on a certain purpose. For FY2020, while the House report ( H.Rept. 116-62 ) also included funding levels for some of the below programs, the amounts in the explanatory statement supersede those. Both the explanatory statement and the House report include many additional statements directing the agency to prioritize certain programs or areas of research, as well as expressing the opinion or concerns of Congress regarding NIH; these broad statements are not summarized here. Appendix B. Acronyms and Abbreviations

Summary: This report details the National Institutes of Health (NIH) budget and appropriations process with a focus on FY2020 and FY2021, and on coronavirus supplemental funding for NIH. The report also provides an overview of funding trends in regular appropriations to the agency from FY1995 to FY2021. Appendix A includes funding tables by account and program-specific funding levels for FY2020 and FY2021. The NIH is the primary federal agency charged with conducting and supporting medical, health, and behavioral research, and it is made up of 27 Institutes and Centers and the Office of the Director (OD). About 80% of the NIH budget funds extramural research through grants, contracts, and other awards. About 10% of NIH funding goes to intramural researchers at NIH-operated facilities. Almost all of NIH's funding is provided in the annual Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act. NIH also receives smaller amounts of funding from Interior/Environmental appropriations and a mandatory budget authority for type 1 diabetes research. NIH has an FY2020 program level of $41.685 billion and has received emergency supplemental appropriations in three coronavirus supplemental appropriations acts, totaling over $3.59 billionâan 8.6% funding increase over regular enacted FY2020 appropriations. The administration's FY2021 budget request, as amended by a March 2020 letter, proposes an FY2021 program level of $39.133 billionâa 6.1% decrease from the FY2020 program level (regular appropriations). NIH has seen periods of high and low funding growth during the period covered by this report, as illustrated in Figure 1 . Between FY1994 and FY1998, funding for NIH grew from $11.0 billion to $13.7 billion (nominal dollars). Over the next five years, Congress and the President doubled the NIH budget to $27.2 billion in FY2003. In each of FY1999 through FY2003, NIH received annual funding increases of 14% to 16%. From FY2003 to FY2015, NIH funding increased more gradually in nominal dollars. In some years (FY2006, FY2011, and FY2013), funding for the agency decreased in nominal dollars. From FY2016 through FY2020, NIH has seen funding increases of over 5% each year. The largest increase was from FY2017 to FY2018, where the program level increased by $3.0 billion (+8.7%), making this the largest single-year nominal dollar increase since FY2003. When looking at NIH funding adjusted for inflation (in projected constant FY2021 dollars using the Biomedical Research and Development Price Index; BRDPI), the purchasing power of NIH funding peaked in FY2003âthe last year of the five-year doubling periodâand then declined fairly steadily for more than a decade until back-to-back funding increases were provided in each of FY2016 through FY2020. The FY2021 budget request would provide a program level that is 13.0% below the peak FY2003 program level.