	Introduction

The National Institutes of Health (NIH) is the primary agency of the federal government charged with performing and supporting biomedical and behavioral research. As of FY2018, NIH was the largest single public funder of biomedical research in the world. It has the largest budget of the eight health-related agencies that make up the Public Health Service (PHS) within the Department of Health and Human Services (HHS). NIH has seen periods of both low and high funding growth. From FY1998 to FY2003, Congress doubled the NIH budget over a five-year period, from $13.7 billion to $27.1 billion. The agency then saw low funding growth or cuts from FY2004 to FY2015. Under President Trump's budget request for FY2020, NIH would be provided a program level of $34.3 billion—a 12.6% reduction from the FY2019 program level. Some members of the scientific community have cited funding variability and uncertainty as a hindrance for advancing biomedical research. Aside from funding, other potential issues of for many in Congress and the research community may include
allocating funding across disease types, areas of human health, and types of research; addressing congressional priorities and concerns, while ensuring the scientific merit and quality of NIH-funded research; helping new and early-stage investigators obtain their first independent research grants; maintaining the United States' role as a leader in biomedical research; balancing the public and private sectors' relative roles in biomedical research. The Office of the Director (OD) sets overall policy for NIH and coordinates the programs and activities of all NIH components, particularly transinstitute research initiatives and issues. Each IC plans and manages its own research programs in coordination with OD. A number of laws have addressed administration and priorities at NIH, including the NIH Reform Act of 2006 and the 21 st Century Cures Act. 109-482 ). Clinical research is conducted with human subjects. Extramural Research

NIH extramural research funding makes up more than 80% of the overall NIH budget and supports 300,000 scientists and research personnel affiliated with over 2,500 universities, academic health centers, hospitals, and independent research institutions in every state and around the world. Starting in FY2016 through FY2019, Congress provided NIH with funding increases of over 5% each year, increasing the program level from $30.3 billion in FY2015 to $39.3 billion in FY2019. In recent years, Congress has provided more direction to NIH funding in both appropriations report language and legislation. The Cures Act ( P.L. The NIH Reform Act of 2006 ( P.L. Global Research

While the United States remains the lead funder of research and development, other countries—particularly China—have increased public funding for research in recent years. It found that U.S. government research funding declined from 57% (2004) to 49% (2011) of the global total, as did that of U.S. companies (50% to 41%), with the total U.S. (public plus private) share of global research funding declining from 57% to 44%. Asian countries (China, Japan, South Korea, India and, Singapore) increased investment from $28 billion (2004) to $52.4 billion (2011). Globally, the United States continues to be the top supporter of research and development. Some Members of Congress have expressed concern over the investments being made by other countries in biomedical research.
The National Institutes of Health (NIH), under the Department of Health and Human Services (HHS), is the primary federal agency charged with performing and supporting biomedical and behavioral research. In FY2018, NIH used its over $34 billion budget to support more than 300,000 scientists and research personnel working at over 2,500 institutions across the United States and abroad, as well as to conduct biomedical and behavioral research and research training at its own facilities. The agency consists of the Office of the Director, in charge of overall policy and program coordination, and 27 institutes and centers, each of which focuses on particular diseases or research areas in human health. A broad range of research is funded through a highly competitive system of peer-reviewed grants and contracts.
The Public Health Service Act (PHSA) provides the statutory basis for NIH programs, and funding levels are mostly provided through the annual appropriations process. In December 2016, Congress introduced major reforms and programs at the NIH through the 21st Century Cures Act (P.L. 114-255). Prior to 2016, the last time Congress addressed NIH with comprehensive legislation was in December 2006, when it passed the NIH Reform Act (P.L. 109-482). Congress also gives direction to NIH through appropriations report language, but usually not through budget line items or earmarks. Historically, Congress has accepted, for the most part, the scientific and public health priorities established by the agency through its planning and grant-making activities that involve members of the scientific community and the general public.
NIH has seen periods of both low and high funding growth. From FY1998 to FY2003, Congress doubled the NIH budget from $13.7 billion to $27.1 billion. The agency then saw low funding growth or cuts from FY2004 to FY2015. Starting in FY2016, Congress provided NIH with funding increases of over 5% each year, raising the program level from $30.3 billion in FY2015 to $39.3 billion in FY2019. Under President Trump's budget request for FY2020, NIH would be provided a program level of $34.3 billion—a 12.6% reduction from the FY2019 program level.
NIH officials and scientific observers have cited funding variability and uncertainty as a challenge for the agency. Along with funding uncertainty, other challenges facing the agency and the research enterprise include
allocating funding across disease types, areas of human health, and types of research; addressing congressional priorities and concerns, while ensuring the scientific merit and quality of NIH-funded research; helping new and early-stage scientists obtain their first independent research grants; balancing the public and private sectors' relative roles in biomedical research.
NIH is the largest single public funder of biomedical research in the world, yet other countries—particularly China—have increased their funding levels for such research. Some Members of Congress have voiced concern about the position of U.S. biomedical research compared with other countries. A January 2015 study found that the total U.S. (public and private) share of global biomedical research funding declined from 57% in 2004 to 44% in 2011, while countries in Asia increased investment into biomedical research from $28 billion (2004) to $52.4 billion (2011), with especially large increases in China (analysis included Japan, China, India, Singapore and South Korea). Globally, the United States continues to be the top supporter of both public and industry medical research.