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NIH Establishes NCATS, per the FY2012 Appropriations Conference Agreement

Legislative Update
December 23, 2011

Today, the National Institutes of Health (NIH) issued a press release announcing the establishment of the National Center for Advancing Translational Sciences (NCATS) as its centralized translational research authority. In its Fiscal Year (FY) 2012 Appropriations Conference Agreement (H.R. 2055, H. Report 112-331), the nine-bill spending package that finalized the appropriations process and was signed into law (P.L. 112-74) by President Obama today, Congress approved NCATS and funded it as a line item in the NIH budget, along with the other 26 Institutes and Centers (I/Cs) and the Office of the Director (O/D). For FY2012, the NCATS funding of $575 million is primarily a reallocation of funds from programs located within the O/D, National Human Genome Research Institute (NHGRI), and the National Center for Research Resources (NCRR), which has been abolished. New funding is reflected in the $10 million Congress approved for the Cures Acceleration Network (CAN), which is an NCATS program. In addition to CAN, other major NIH programs that will comprise NCATS include:

  • Bridging Interventional Development Gaps
  • Clinical and Translational Science Awards (CTSAs)
  • FDA/NIH Regulatory Science
  • Office of Rare Diseases Research
  • Components of the Molecular Libraries
  • Therapeutics for Rare and Neglected Diseases (TRND)

The agreement’s Report Language contained several requirements for reports and studies by NIH regarding NCATS implementation, including:

  • The conferees anticipate that the mission of NCATS to accelerate the therapeutics development and implementation process will complement, not compete with, the efforts of the private sector. They also encourage NCATS to study and foster private sector models that accelerate commercialization of therapies to patients.

  • The agreement funds implementation of CAN within NCATS at $10 million, primarily to support the CAN Board and related activities. The conferees request NCATS to charter an Institute of Medicine (IOM) work group to review, evaluate, and identify issues related to CAN authority and provide a report for the CAN Board to help it identify ways to accelerate and expand the number of cures.

  • The conferees address several of the specific NIH programs that will form the cornerstone of NCATS, specifically the CTSA program, the TRND program, and the Institutional Development Awards (IDeA) program. Since CTSAs now represent an investment of half a decade of innovation in translational research, the conferees urge NIH to support a study by the IOM that would evaluate the program and recommend any necessary changes. Conferees request study results by 18 months after enactment of the bill. They also request an annual report of the TRND program by July 1, 2012, as well as a report addressing concerns about IDeA program eligibility to be included in the FY2013 congressional budget justification

NIH’s Scientific Management Review Board (SMRB), the entity created by the NIH Reform Act of 2006 to make recommendations on NIH management and structure, recommended the creation of NCATS in December 2010 after discussions at several previous meetings. NAEVR had testified at the September and December 2010 SMRB meetings about NCATS, cautioning that any centralized authority should not stifle the creativity of mid-to-small sized I/Cs in pursuing translational research approaches, as the National Eye Institute (NEI) has done in partnerships within NIH, the Department of Health and Human Services (DHHS), other government agencies, and private funding foundations.