Congress Finalizes FY2012 Appropriations with an NIH/NEI Increase Although a Continuing Resolution Funds the Government Through December 23

Congress Finalizes FY2012 Appropriations With an NIH/NEI Increase Although A Continuing Resolution Funds the Government through
December 23

Legislative Update
December 19, 2011

*Editor’s Note: The President signed the conference agreement into law (P.L. 112-74) on December 23, 2011

Summary of the conference agreement:

Increases NIH program funding by $299 million
Increases NEI funding by $3.2 million
Reduces NIH Institute and Center funding by 0.189 percent due to an across-the-board DHHS rescission
Approves and funds the new National Center for Advancing Translational Sciences
Directs NIH to produce a number of studies and reports by specific dates

On Friday, December 16 in the House, and Saturday, December 17 in the Senate, Congress voted to adopt the conference agreement (H.R. 2055, H. Report 112-331) for a nine-bill Fiscal Year (FY) 2012 spending package that finalizes the appropriations process. This action came after the Congress passed a fourth Continuing Resolution (CR) to fund the government through December 17 (previous CR expired December 16), than a fifth CR on December 17 to fund the government through December 23, as the conference agreement must be signed by President Obama.

Although the agreement funds the National Institutes of Health (NIH) at a $30.698 billion program level in FY2012—a $299 million increase over FY2011—it will be subject to a 0.189 percent across-the-board rescission within the Department of Health and Human Services (DHHS). Although the House also approved an accompanying bill H.R. 3672, which provides $8.1 billion in disaster relief funding, and H. Con. Res. 94, which offsets the disaster aid with a 1.83 percent across-the-board cut to all FY2012 base discretionary funding except for the Defense and Military Construction/Department of Veterans Affairs Veterans Administration bills, the latter was disagreed to in the Senate. As a result, NIH Institutes and Centers (I/Cs) increases will only experience the internal 0.189 percent DHHS rescission, retaining a positive net increase.

The National Eye Institute (NEI) will be funded at $704.043 million, an increase of 3.2 million or .46 percent over the FY2011 enacted level of $700.8 million. NEIs net of the 0.189 rescission yields FY2012 funding at $702.7 million. Since the agreement also eliminated the National Center for Research Resources (NCRR), moving most of its programs into the new National Center for Advancing Translational Sciences (NCATS) with its own dedicated funding line, the FY2011 funding levels are re-stated to reflect this reorganization. NEIs net FY2011 baseline funding was re-stated as $700.251 million, since it had contributed $577,000 to the Therapeutics for Rare and Neglected Diseases (TRND) program, which is now funded in the dedicated NCATS line item.

Other highlights of the agreement include:

The conferees strongly urge NIH to maintain extramural research at a level of at least 90 percent of the budget, as in most recent years, and to establish safeguards to ensure the percentage of funds used to support basic research across the NIH is maintained.

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 the Cures Acceleration Network (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 Clinical and Translational Science Awards (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.

The conferees direct NIH to conduct a three-year pilot study to assess the viability of third party reimbursement for clinical services that are incurred in NIH research facilities.

The conferees direct the NIH to conduct a trans-NIH review of the applicability of the recommendations made in a 2010 study by the IOM as to how the I/Cs could better design, implement, and manage clinical trials. They request this study by September 30, 2012.