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The 21st Century Cures Act
The Cures Act, or the 21st Century Cures Act, passed overwhelmingly in both the U.S. House of Representatives and Senate with strong bipartisan support, and was signed into law on December 13, 2016. The legislation provides NIH with critical tools and resources to advance biomedical research across the spectrum, from foundational basic research studies to advanced clinical trials of promising new therapies.
Accelerating Research
Importantly, the Cures Act provides NIH with the flexibility and resources needed to accomplish its mission to improve the health of Americans. Most notably, the Cures Act implements measures to:
- alleviate administrative burdens that can prolong the start of clinical trials
- allow researchers to more easily attend scientific conferences where in-person collaboration can often lead to scientific breakthroughs
- enhance data sharing among NIH-supported researchers
- improve privacy protections for research volunteers
- encourage inclusion of diverse populations represented in clinical research
- open up new NIH funding opportunities for young investigators
The Innovation Fund
Additionally, the Cures Act provides multiyear funding to four highly innovative scientific initiatives:
- The All of Us Research Program, formerly known as the PMI Cohort Program,
- The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative seeks to better understand how the brain encodes, stores, and retrieves information, which will transform the ability to diagnose and treat neurological/mental disorders.
- The Cancer Moonshot℠
- The Regenerative Medicine Innovation Project will support clinical research in coordination with the FDA using adult stem cells to further the field of regenerative medicine.
The Cures Act allocates funding to NIH over each of the next 10 years, for a total of $4.8 billion. However, funding must be appropriated each year.
The Act also required the NIH Director to submit an Innovation Fund work plan to Congress. In order to develop the work plan, the Cures Act requires the NIH Director to solicit recommendations from the Advisory Committee to the Director on the allocation of funds, the contents of the work plan, and whether the proposed projects link appropriately to the NIH-Wide Strategic Plan.
| Funding for NIH Innovation Projects under the Cures Act | ||||
|---|---|---|---|---|
| Fiscal Year | Precision Medicine Initiative | BRAIN | Cancer Moonshot | Regenerative Medicine |
| 2017 | $40,000,000 | $10,000,000 | $300,000,000 | $2,000,000 |
| 2018 | $100,000,000 | $86,000,000 | $300,000,000 | $10,000,000 |
| 2019 | $186,000,000 | $115,000,000 | $400,000,000 | $10,000,000 |
| 2020 | $149,000,000 | $140,000,000 | $195,000,000 | $8,000,000 |
| 2021 | $109,000,000 | $100,000,000 | $195,000,000 | |
| 2022 | $150,000,000 | $152,000,000 | $194,000,000 | |
| 2023 | $419,000,000 | $450,000,000 | $216,000,000 | |
| 2024 | $235,000,000 | $172,000,000 | ||
| 2025 | $36,000,000 | $91,000,000 | ||
| 2026 | $31,000,000 | $195,000,000 | ||
| TOTAL | $1,455,000,000 | $1,511,000,000 | $1,800,000,000 | $30,000,000 |