The Senate appropriations bill for the National Institutes of Health would raise the agency’s $34.1 billion budget by 6 percent, while the House bill would raise it by a more modest 3 percent. In addition to their stark rejection of President Trump’s requested 22 percent budget cut, both bills explicitly reject the administration’s proposal to cap research overhead costs at 10 percent.
The House and Senate Appropriations Committees’ fiscal year 2018 spending bills for the National Institutes of Health would increase the agency’s $34.1 billion budget, flatly rejecting the Trump Administration’s request for a deep, 22 percent cut. The Senate bill proposes a 6 percent increase, while the House bill proposes a more modest increase of 3 percent.
The chart below depicts the proposed changes in funding for five institutes that fund a significant amount of physical sciences research. Detailed tables containing funding figures for these accounts are available in FYI’s Federal Science Budget Tracker.
Appropriators continue to prioritize biomedical research
The House and Senate committees continue to prioritize biomedical research, building on the momentum from the $2 billion increases for NIH in each of the 2016 and 2017 final spending agreements. Both committees propose to reverse the administration’s request to slash the agency’s budget by $7.5 billion or 22 percent, instead opting for increases for all NIH institutes. The Senate bill proposes a $2 billion, 6 percent increase, the third year in a row that the committee has advanced this amount. Meanwhile, the House proposes a $1.1 billion, 3 percent increase.
Both committees appropriate funds for several high-priority NIH initiatives supported in part by the $496 million provided through the 21st Century Cures Act in fiscal year 2018. The Senate report recommends $400 million for the BRAIN Initiative, a $140 million increase over fiscal year 2017 levels, while the House report recommends $336 million. For “All of Us,” previously known as the Precision Medicine Initiative, which is funded in the current year at $300 million, the House and Senate reports propose increases of $80 million and $70 million, respectively. Both reports include $300 million for the Beau Biden Cancer Moonshot Initiative.
In their reports, the committees emphasize the importance of funding basic biomedical research. The House report stresses that basic research “must remain a key component” of all NIH research, and encourages the agency to ensure that it maintains its extramural basic research program at a minimum of 55 percent of the agency’s budget.
The Senate report highlights molecular science as an area that needs further basic research funding. The committee notes its concern with the recent decline in funding for basic funding research, and therefore requests that NIH provide data “on the percentage of spending of basic science for the past 10 years and specific efforts to promote basic research that supports molecular medicine and regenerative medicine using induced pluripotent stem cells.”
Appropriators reject indirect cost caps, call them ‘misguided’
In its budget request, the administration proposed a cap on reimbursements for facilities and administrative costs, also known as indirect costs, on grants at 10 percent of their total cost. The administration justified the proposal as a method to increase efficiency in NIH spending. Both committee reports explicitly state that the administration is prohibited from implementing caps, citing concerns over the impact the proposal would have to the biomedical research enterprise.
During the bill markup, Senate Labor-Health and Human Services-Education Appropriations Subcommittee Chairman Roy Blunt (R-MO) noted the subcommittee’s opposition to the caps, saying that “these costs are not optional for the research community; they are a fundamental component of doing research.” The Senate report warns that the proposed caps would have a significant negative impact on the research landscape and notes that the committee has yet to see evidence that the caps could be implemented without severe consequences:
The Administration’s proposal would radically change the nature of the Federal Government’s relationship with the research community, abandoning the Government’s long-established responsibility for underwriting much of the Nation’s research infrastructure, and jeopardizing biomedical research nationwide. The Committee has not seen any details of the proposal that might explain how it could be accomplished without throwing research programs across the country into disarray.
The House report also emphasizes that the proposal is “misguided and would have a devastating impact on biomedical research across the country,” and instead directs NIH to continue following the existing rules and guidelines for indirect cost reimbursement. The House bill also includes a provision that would explicitly prohibit NIH from implementing the cap or otherwise changing its procedures for indirect rate cost reimbursements.
While the House bill prohibits the administration from implementing additional caps, the report states that there are other ways to cut administrative burden so that “NIH can support more researchers who can in turn spend more time on science and less time on paperwork.” The House report directs NIH to develop a plan to reduce administrative and regulatory burden based on the recommendations provided in a recent National Academies report on the issue.
Committee report comparison
Below are a set of expandable tables which contain excerpts from the NIH sections of the explanatory reports that accompany the House and Senate appropriations bills.
Facilities and Administrative Costs
House: “While the Committee appreciates the Secretary’s efforts to find efficiencies in NIH research spending, the Administration’s proposal to drastically reduce and cap reimbursement of facilities and administrative (F&A) costs to research institutions is misguided and would have a devastating impact on biomedical research across the country. To ensure that NIH can continue supporting both direct and F&A costs as is their current practice, the bill includes a new general provision directing NIH to continue reimbursing institutions for F&A costs according to the rules and procedures described in 45 CFR 75 (with the exception of existing waivers for training grants). This provision also prohibits funds in this Act from being used to implement any further caps on F&A cost reimbursements.
The Committee recognizes that there are opportunities to reduce the administrative burden on research institutions through legislative, regulatory, and administrative means, so that NIH can support more researchers who can in turn spend more time on science and less time on paperwork. The National Academies of Sciences, Engineering, and Medicine 2016 publication "Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century" put forth several recommendations for reducing burden on institutions and investigators. The Committee directs NIH to identify the most appropriate and potentially impactful recommendations and submit a plan to the Committees on Appropriations of the House of Representatives and the Senate within 90 days of enactment of this Act outlining concrete steps to achieving these goals. NIH should consult with academic and independent research institutions, investigators who receive NIH grants, the HHS Office of Cost Allocation, the Office of Management and Budget, and other relevant stakeholders in developing this plan.”
Senate: “Central to the Administration's proposal to reduce Federal investments in biomedical research is its proposal to cap the F&A costs of grants, so-called "indirect costs," at 10 percent. The F&A cost of a grant is intended to cover the indirect costs of biomedical research, ranging from administration and facilities to the cost of equipment shared across multiple researchers. For example, at research facilities focused on making the next breakthrough in cancer treatment, indirect costs supply the air handlers that provide the precise conditions needed to generate therapeutic T cells for immunotherapy trials, complex data systems to analyze and protect patients' genomic data, and support for the next generation of scientific leaders. The methodology for negotiating indirect costs has been in place since 1965, and rates have remained largely stable across NIH grantees for decades. The Administration's proposal would radically change the nature of the Federal Government's relationship with the research community, abandoning the Government's long-established responsibility for underwriting much of the Nation's research infrastructure, and jeopardizing biomedical research nationwide. The Committee has not seen any details of the proposal that might explain how it could be accomplished without throwing research programs across the country into disarray. To avoid this possibility, the Committee has included bill language to prohibit HHS from developing or implementing a modified approach to funding F&A costs.”
House: “The purpose of basic research is to discover the nature and mechanics of disease and identify potential therapeutic avenues likely to lead to the prevention and treatment of human disease. Without this early scientific investigation, future development of treatments and cures would be impossible. Basic biomedical research must remain a key component of both the intramural and extramural research portfolio at the NIH. The Committee encourages NIH to take actions to ensure the percentage of funding in the extramural research program on basic research does not fall below 55 percent of NIH resources.”
Senate: "The Committee understands basic science is the foundation of the research pyramid that support biomedical and translational research efforts. The Committee is concerned with the recent decrease in the proportion of basic research. The Committee encourages NIH to expand its basic science efforts, with a specific focus on basic molecular research to increase scientific understanding at the molecular level in an effort to support translational molecular medicine research of tomorrow. The Committee requests an update in the fiscal year 2019 CJ on the percentage of spending on basic science for the past 10 years and specific efforts to promote basic research that supports molecular medicine and regenerative medicine using induced pluripotent stem cells.”
Research Project Grants
House: “The Committee expects the 3.2 percent increase of funds over the fiscal year 2017 enacted level to support an increase in the number of new and competing Research Project Grants (RPGs), with a focus on early-stage investigators and investigators seeking first-time renewals. The Committee encourages NIH to restore extramural support to at least 90 percent of all NIH funding and to continue to focus on basic research.”
House: “The Committee recommendation directs NIH to transfer $300,000,000 from the NIH Innovation Account to NCI to support the Cancer Moonshot initiative. These funds were authorized in the 21st Century Cures Act.”
Senate: “The Cancer Moonshot Initiative has helped to raise awareness of this often neglected form of cancer, and the Committee urges NCI to continue working with stakeholder organizations to advance research into improving brain imaging technologies and developing treatments to increase survivorship.”
“The Committee recognizes that the NIH's Cancer Moonshot initiative aims to accelerate the discovery of new ways to cure cancers, including through an understanding and application of cancer genetic information to the prevention and treatment of cancer. The Committee urges the NIH, through the NIMHD and NCI, to continue to support research on the cause, prevention, and treatment of cancer in populations with diverse cultural, racial, and ethnic composition. To further support such collaborations, the NCI is encouraged to consider research expertise in ethnic and racial diversity and its impact on cancer development and outcomes in evaluating applications for NCI-designated cancer centers.”
House: “The Committee also includes an increase of $400,000,000 to help find a cure for Alzheimer’s disease and an increase of $76,000,000 for the BRAIN initiative to help better understand how the brain functions and learns.”
“The Committee recommendation includes bill language transferring $43,000,000 from the NIH Innovation Account to [the National Institute of Neurological Disorders and Stroke] to support the BRAIN Initiative. These funds were authorized in the 21st Century Cures Act.”
“The Committee recommendation includes bill language transferring $43,000,000 from the NIH Innovation Account to [the National Institute of Mental Health] to support the BRAIN Initiative. These funds were authorized in the 21st Century Cures Act.”
Senate: “The Committee continues its strong support for the BRAIN Initiative and provides $400,000,000 in fiscal year 2018. The Committee commends the NIH for its leadership to date on the BRAIN Initiative and the progress made in several areas. The BRAIN Initiative is developing a more complete understanding of brain function and has the possibility of helping millions of people who suffer from a wide variety of neurological and psychiatric disorders such as Parkinson's disease, schizophrenia, Alzheimer's disease, depression, and traumatic brain injury. Powerful new technologies and tools are allowing for the study of anatomical and functional abnormalities in neuro-psychiatric diseases, which is the key to understanding these diseases and developing therapies and cures.”
“The Committee continues to strongly support the BRAIN initiative. The bill provides $400,000,000 an increase of $140,000,000 above fiscal year 2017, to expand the initiative consistent with the BRAIN 2025 report issued in 2014.”
Precision Medicine/All of Us
House: “Within the total increase, the Committee provides an increase of $80,000,000 to the Precision Medicine Initiative, which holds the promise of designing personalized, targeted cures and treatment.”
“The recommendation provides an increase of $400,000,000 for Alzheimer’s disease research; an increase of $30,000,000 for combating antibiotic-resistant bacteria; an increase of $80,000,000 for the ‘‘All of Us’’ research program (formerly called the Precision Medicine Initiative); an increase of $76,000,000 for the Brain Research through Application of Innovative Neurotechnologies (BRAIN) Initiative; an increase of $8,000,000 for regenerative medicine; and increases to every Institute and Center (IC) to support innovative research to advance fundamental knowledge and speed the development of new therapies and diagnostics to improve the health of all Americans.”
“The Committee is encouraged by the enormous potential of precision medicine for all populations, including children, since much of adult health is rooted in the earliest years. The Committee is aware that, at an All of Us Research Program stakeholder briefing, NIH announced plans to develop a working group to address inclusion of the pediatric population and has also indicated plans to host a pediatric stakeholder convening. The Committee requests an update within 30 days of enactment of this Act on the status and timeline for the working group to release recommendations regarding pediatric enrollment in the All of Us Research Program and the expected timeline for beginning enrollment of children in the program. The Committee expects NIH to ensure that the research cohort includes a sufficient number of children to make meaningful studies possible.”
Senate: “The Committee continues its strong support of NCI PMI and provides no less than $80,000,000 to continue its efforts to develop individualized treatments for cancer patients. The Committee recognizes the potential for significant advancements in cancer treatments from the NCI MATCH trial. It remains the central pillar of the precision medicine research focused on oncology for cancers that are unresponsive to standard interventions. The Committee urges NCI to continue to expand precision oncology trials. NCI should also continue to focus on launching the important pediatric MATCH trial as pediatric oncology mechanisms are very different from mutations seen in adults. Further, the Committee continues to believe in the necessity of NCI-funded clinical trials in the area of immuno-oncology, where a patient's engineered T-cells are used in combination with the immune system to fight late stage disease and commends NCI for its continued leadership in this area. Of particular interest is the use of precision medicine to develop therapies for late stage cancers and for those forms of the disease for which meaningful conventional treatments have proved largely ineffective for long term survival of the patients. NCI shall provide an update on these activities in the fiscal year 2019 CJ.”
“The Committee recommendation supports the All of Us Precision Medicine Initiative and has provided $290,000,000 in support of this Initiative. The Committee is encouraged by the enormous potential of precision medicine for all populations, including children, since much of adult health is rooted in the earliest years. The Committee is aware that at an All of Us Research Program stakeholder briefing, NIH announced plans to develop working groups to address inclusion of the pediatric population and has also indicated plans to host a pediatric stakeholder convening. The Committee requests an update within 90 days after enactment of this act on the status and timeline for the working groups to release findings regarding pediatric enrollment in the All of Us Research Program and the expected timeline for beginning enrollment of children from diverse backgrounds in the program. The Committee expects NIH to ensure that the research cohort includes a sufficient number of children to make meaningful studies possible.”
House: “…an increase of $8,000,000 for regenerative medicine.”
Senate: “$10,000,000. The Committee report reflects distribution of the remainder of funding from the NIH Innovation Account to NCI, NINOS, and NIMH and expects NIH to transfer funding shortly after enactment of this act.”
Senate: “The Committee notes that imaging research occurs in multiple Institutes throughout the NIH and is an integral component of the Cancer Moon Shot, the Precision Medicine Initiative, and the BRAIN Initiative. The Committee requests that the Director produce an overview of imaging research across the NIH, including in the focused research fields mentioned above, and assess the quality of interactions in imaging research within NIH, and report the results in the fiscal year 2019 CJ.”
House: “NIH is encouraged enter into collaborative research programs, as appropriate, with DOE, the National Laboratories, and others determined to be appropriate, to utilize the broader scientific and technological capabilities of DOE and the National Laboratories relevant to the successful implementation of the 21st Century Cures Act (P.L. 114– 255).”
Senate: “NIH is encouraged to enter into collaborative research programs with the Secretary of Energy, National Laboratories, and others determined to be appropriate by the Director, to utilize the broader scientific and technological capabilities of the Department of Energy [DOE] and National Laboratories. In particular, DOE and NIH should work together to support access for biomedical researchers to cutting-edge technology resources.”
House: “The Committee expects NIH to report on actions it has taken to lower the median age at which investigators receive their first R01 awards annually in the fiscal year 2019 Congressional Justification. In addition, the NIH shall provide an update on the concrete steps it is taking to lower the median age at which individuals receive their first R01 award within 60 days of enactment of this Act.”
Senate: “The Committee supports robust implementation of the Next Generation Researchers Initiative within the Office, as established in the 21st Century Cures Act, and is encouraged by NIH's continued work in this space. The Committee directs NIH to prioritize improving opportunities for our next generation of researchers by working through the Initiative to coordinate all current and new NIH policies to promote opportunities for new scientists and earlier research independence, including enhancing training and mentorship programs for researchers, and enhancing workforce diversity. As required by the 21st Century Cures Act, the Committee directs NIH to consider the recommendations made by the National Academies of Science study under Public Law 114-113 in carrying out the activities of the Initiative.”
House: “The Committee notes NIH has a significant backlog of maintenance and repairs. The Committee requests NIH and HHS develop a coordinated plan to address the backlog with the Office of Management and Budget in the fiscal year 2019 Congressional Justification.”
Senate: “Much of the Nation's biomedical research infrastructure, including laboratories and research facilities at academic institutions and nonprofit research organizations, is outdated or insufficient. For taxpayers to receive full value from their considerable investments in biomedical research, scientists must have access to appropriate research facilities. Therefore, $25,000,000 is provided for grants or contracts to public, nonprofit, and not-for-profit entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities as authorized under 42 U.S.C. section 283k. The Committee urges NIH to consider recommendations made by the NIH Working Group on Construction of Research Facilities, including making awards that are large enough to underwrite the cost of a significant portion of newly constructed or renovated facilities.”
Academic Research Enhancement Award (AREA) Program
Senate: “The Committee believes that biomedical discoveries can occur anywhere, and continues to support programs that foster biomedical research and opportunities for students at institutions who may not receive significant NIH funding. In particular, the Committee continues its long-standing support of the IDeA program. However, the Committee notes that many institutions that may benefit from the IDeA program are ineligible because they reside in States that are not IDeA States. The Committee encourages NIH to enhance support for the AREA program and is urged to develop ways to improve ties between institutions that receive significant NIH funding and AREA-eligible institutions.”
Big Data Infrastructure
Senate: “Biomedical research has become increasingly reliant on growing amounts of digital data, a development with tremendous and potentially disruptive promise if this data can be used effectively to enable major scientific breakthroughs. Figuring out how to make this possible is one of the biggest obstacles facing NIH. In 2012, NIH began an extramural program to provide a framework of pilot programs, centers of excellence, and grant opportunities to advance thinking in how to organize, share, and use big data. NIH is using the results from these programs to inform the next phase of development of big data infrastructure, including the ongoing Data Commons Pilot. The second phase is expected to also build off of several other major initiatives including those in cancer, Alzheimer's disease, the human brain, and the All of Us research program. The Committee wants to ensure that these efforts are coordinated and overseen to ensure all of NIH benefits from them.
In its fiscal year 2017 report, the Committee directed NIH to work with its external partners and stakeholders to provide the Committees on Appropriations of the House of Representatives and the Senate a detailed strategic plan by May 5, 2018, spelling out it how intends to make big data sustainable, interoperable, accessible, and usable. The plan is to include a roadmap to achieve these objectives, as well as milestones and estimates of the resources that will be necessary. The Committee expects to receive the strategic plan, which was first identified in the Senate report dated June 9, 2016, by the May deadline. The unanticipated delay in completing the fiscal year 2017 appropriations process means NIH will have had almost 2 years to prepare its plan, extra time that should make it possible to draft a comprehensive blueprint to help guide future investments in data science.
In the interim, the Committee directs NIH to provide a status report in the fiscal year 2019 CJ describing the current status of the strategic plan and its progress in finding a suitable candidate to fill the Associate Director for Data Science [ADDS] vacancy. The Committee recognizes the importance of the ADDS to provide strategic vision and coordinate as an honest broker across NIH on data science issues, and encourages NIH to locate this position within the Office of the Director.”
National Cancer Institute
Heavy Ion Therapy and Research
House: “The Committee supports NIH’s continued exploration of advanced therapeutic cancer research, specifically heavy ion irradiation technology. Heavy ion technology will introduce a novel treatment option to cancer patients that is currently not available in the U.S. The Committee notes that the U.S. stands to be a world leader in this advanced research. The Committee encourages NIH to explore further the development of a state of the art heavy ion research facility in the U.S. Furthermore, the Committee encourages NIH to work with the Departments of Defense and Energy, and other applicable Federal agencies to equip the first U.S. heavy ion research center. The Committee urges NIH to capitalize on the expertise and potential of recently awarded heavy ion facility planning grant recipients in order to foster a multidisciplinary approach and advance heavy ion research that would produce novel, cutting edge treatments for cancer patients.”
National Institute of General Medical Sciences
Institutional Development Awards (IDeA)
House: “The Committee has provided $373,641,000 for the IDeA program, $40,000,000 above the fiscal year 2017 enacted level. IDeA supports high-quality research and investigators throughout the country in States in which the success rate for NIH grants has been historically low.”
Senate: “The Committee provides $344,313,000 for the IDeA program, an increase of $10,952,000. The Committee believes the IDeA program has made significant contributions to biomedical research and has led to the creation of a skilled workforce and made the program an essential component of NIH's research portfolio. The Committee supports this important investment, which extends NIH's reach nationwide. Further, the Committee recognizes the importance of the Centers of Biomedical Research Excellence and the IDeA Networks of Biomedical Research Excellence programs and expects funding to be maintained for both. These programs are essential to the overall success of the program.”
“The Committee recognizes that NCI supports clinical trials across the country through its National Clinical Trials Network [NCTNJ and the NCI Community Oncology Research Program [NCORPJ. The Committee understands that there are more than 270 NCORP component sites and 14 NCORP awardees across the country located in IDeA States, and that NCI supports several NCI-designated cancer centers in IDeA States. At the same time, the Committee recognizes that there are still opportunities for academic medical centers in IDeA States to become more engaged in these networks. Therefore, the Committee encourages NCI to coordinate with NIGMS in helping Clinical and Translational Research award sites in IDeA States that do not currently have NCORP or NCTN awards build capacity in these regions to conduct cancer clinical trials. The Committee also encourages NCI to continue to support NCORP in its mission to increase diversity among patients participating in NCI clinical trials, especially with regard to rural and minority populations. Finally, the Committee urges NCI, in consultation with NIGMS, to encourage collaboration between IDeA awardees and existing NCI designated cancer centers, NCTN lead sites, and NCORP sites.”
Science Education Partnership Awards (SEPA)
Senate: “SEPA fosters important connections between biomedical researchers and K-12 teachers and their students. These connections establish an education pipeline to careers in biomedical sciences, which is one of the most important areas of workforce development for the U.S. economy. SEPA has been level funded for a number of years and the Committee encourages NIGMS to provide additional resources for the program within their general increase for fiscal year 2018. Additional funding should be used to award additional innovative K- 12 science, technology, engineering and mathematics educational projects.”
National Eye Institute
Audacious Goals Initiative
Senate: “The Committee commends NEI's leadership through its [Audacious Goals Initiative], which aims to restore vision within the next decade through regeneration of the retina by replacing cells that have been damaged by disease and injury and restoring their visual connections to the brain. The Committee is pleased that NEI has proceeded with two rounds of grants to date that relate to novel imaging technologies to help clinicians observe the function of individual neurons in human patients and follow them over time as they test new therapies, as well as identifying new factors that control regeneration and comparing the regenerative process among model organisms, rodents, and non-human primates.”
3-D Retina Organoid Challenge
House: “The Committee directs NIH to provide an update on the 3-D Retina Organoid Challenge authorized in the Consolidated Appropriations Act, 2016.”