FY12 appropriations bill passed and NCATS is officially established

While many of us were getting a jump on the holiday weekend, President Obama signed the FY12 omnibus appropriations bill on Friday, Dec. 23. The bill set the FY12 funding levels for government agencies covered by the remaining nine appropriations bills, which included the National Institutes of Health. The bill also establishes a new NIH center, the National Center for Advancing Translational Sciences with a budget of $575 million for FY12.

Even now that NCATS has its official seal of approval, many in the research community are still wary of how the reorganization process will proceed. Specifically, there is concern over the future of those programs that were housed in the National Center for Research Resources, which was eliminated with the establishment of NCATS.

In a memo sent out to the NIH staff, NIH director, Francis Collins, outlined the NCATS temporary leaders: the acting director will be Thomas Insel, director of the National Institute of Mental Health and the acting deputy director will be Kathy Hudson, NIH deputy director for science, outreach, and policy. NIH began soliciting for the first NCATS director in the fall.

The ASBMB Office of Public Affairs will continue to monitor the NCATS reorganization process and keep you informed with the latest information.

Several changes to NIH animal research policies

On Dec. 1, the Office of Laboratory Animal Welfare announced that the National Institutes of Health would be adopting the eighth edition of the “Guide for the Care and Use of Laboratory Animals” effective Jan. 1. The Guide establishes the agency’s policies for the humane use of animals at institutions that receive NIH funding.

Many in the research community questioned the implementation of the Guide, including the Federation of American Societies for Experimental Biology. ASBMB co-signed a letter from FASEB that addressed the cost and scientific merit of the proposed changes and urged their delayed implementation. In response to these concerns, the NIH is giving institutions more time to implement the new changes. While institutions are required to conduct one semiannual review and inspection using the new Guide standards within the year, all changes are not required to be enacted by that time. Based on the inspection, institutions will need to generate an implementation plan by Dec. 31, 2012.

To aid in the implementation process, the OLAW has developed several position statements that describe the ways in which NIH expects institutions to implement the guidelines. The position statements address:

• cost of implementing the new guidelines
• animal housing specifications
• use of non-pharmaceutical grade compounds
• food and fluid restrictions
• multiple surgical procedures
• application of the guidelines to agricultural animals used in biomedical research

The public is encouraged to comment about their understanding of the position statements here by Jan. 29.

In addition to the changes in animal care regulations, a recent study by the Institute of Medicine will have profound effects on federally-funded chimpanzee research. On Dec. 15, the IOM released its report titled “Chimpanzees in Biomedical Research: Assessing the Necessity” which found that most current uses of chimpanzees for biomedical research are “unnecessary.”

The IOM report recommended that the NIH limit funding to only studies

• for which there is no other suitable model available
• that cannot be performed ethically in humans
• that, without which, important advancements will be significantly slowed or prevented

Soon after IOM the report was issued, NIH Director Francis Collins, announced he accepted the recommendations and would move to implement them as soon as possible. The NIH already is developing a plan to implement the recommendations, which will include a more rigorous review of NIH-funded chimpanzee research. Also, no new grant applications involving research on chimpanzees will be considered until further notice. While the changes apply to only NIH-funded chimpanzee research, many feel private research likely will adopt similar standards.

Read additional reports on the changes to chimpanzee research at the NIH by The Washington Post and ScienceInsider.

FY12 Appropriations bill introduced in the House

Late Wednesday evening, U.S. House of Representatives Appropriations Chairman Hal Rogers (R-Ky.) announced the final nine FY12 appropriations bills had been combined into a large omnibus bill and introduced in the House. In addition to the nine appropriations bills, the legislation package includes a bill providing funding for disaster emergencies and a bill containing offsets for the disaster funding.

Of particular interest to the research community, is the FY12 funding level for the National Institutes of Health. The bill provides the NIH with $30.6 billion in funding, $239 million above the FY11 level, but $758 million below the President’s request. The bill also contains the establishment of the National Center for Advancing Translational Sciences and the dissolution of the National Center for Research Resources. The bill includes the following specifics:

• $576 million for the National Center for Advancing Translational Sciences
• $10 million for the Cures Acceleration Network (No funds were provided for CAN in FY11)
• $487 million for the Clinical and Translational Sciences Awards program
• $1.46 billion for the Office of the Director (FY11 comparable funding was $1.177 billion)
• $125 million for Buildings and Facilities (FY11 comparable funding was $50 million)

A summary of the bill can be found here and the complete text of the legislation that deals with NIH funding can be found here. The ASBMB Office of Public Affairs will continue to analyze the specifics of the bill to identify any policy riders that may affect the research community.

The 2012 fiscal year began on Oct. 1 and the government has been running under continuing resolutions since that time. The current CR expires on Dec. 16, so one final short-term CR may be necessary to give both the House and the Senate more time for a final vote on the bill.

The ASBMB Office of Public Affairs will continue to monitor the appropriations process and keep you updated on its progress.

Science funding agencies will have to increase funding for small businesses grants

On Tuesday, Dec. 13, the House of Representatives agreed to provisions provided earlier this month by the Senate to end five years of debate and pass a long-term extension of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.  For almost five years, Congress has been trying to pass a reauthorization bill for the SBIR/STTR programs, which have been operating under a series of temporary extensions since 2008. The most recent extension expires on Dec. 16.

Currently the SBIR program requires all federal agencies with a budget over $100 million to reserve 2.5 percent of their total extramural research budgets for grants to small businesses, as defined by Congress. The STTR program uses a similar approach as SBIR (but mandates collaboration between small businesses and research institutions), however the set-aside is 0.3 percent of the agency’s extramural research budget. The new SBIR/STTR reauthorization bill increases the SBIR set-aside from 2.5 to 3.2 percent and the STTR set-aside from 0.3 to 0.45 percent over the next six years.

Many in the traditional research community have generally opposed increasing the SBIR/STTR set-aside amounts since it would shave away pieces of the already decimated extramural research portfolios at science-funding agencies, like the National Institutes of Health.  For example, these increases would ostensibly cut the NIH extramural budget from today’s level by $222 million. In other words, the NIH would be able to fund almost 500 fewer RPGs.

ASBMB has long supported reauthorizing the SBIR/STTR programs, but opposes increasing the set-aside amount. Last week, ASBMB co-signed a letter from the Federation of American Societies for Experimental Biology urging Congress to remove the SBIR/STTR reauthorization amendment from the final version of the Defense authorization bill.

An FY12 budget for the holidays?

While many of you may be sipping on eggnog or picking out that perfect “white elephant” gift for your office holiday party, the mood has been less than merry in Washington this December. After the embarrassing failure of the supercommittee to produce a debt deal, Congress has been frantically trying to save face by wrapping up the FY12 appropriations process before they break for the holidays.

Just before Thanksgiving, Congress passed a “minibus” bill that combined three appropriations bills for several government agencies, such as agriculture, criminal justice, transportation and housing agencies and several science-funding agencies, including the National Science Foundation. However, there are still nine appropriations bills left for FY12, including the Labor, Health and Human Services, and Education bill, which sets funding for the National Institutes of Health. NIH is currently being funded through a continuing resolution that sets the funding level 1.5 percent BELOW that of FY11.

There are two scenarios circulating as to how these final nine bills could be completed.

1) Omnibus

• Would combine all remaining nine appropriations bills
• More difficult to get this passed because it would mean negotiating spending levels for all the remaining agencies
• NIH funding will probably fall somewhere between the levels set in the House and Senate bills (+3.3% to -0.6% of the FY11 level)

2) Omnibus with a year long CR

• Would combine all remaining bills EXCEPT those for the LHHS and the Interior bills
• Spending for LHHS and Interior would be set by a year long CR
• These two bills are the most controversial and have the most dissimilarity between the House and the Senate funding levels
• Would leave NIH funding at the current level (1.5% below FY11) until Sept. 30.

Not surprisingly, those in the research community favor scenario No. 1. With the current CR set to expire Dec. 16, Congress has a little over a week to negotiate the final spending package.

UPDATE: Hal Rogers (R-Ky.), Chairman of the U.S. House Appropriations committee, announced that the House and Senate will hold a joint Conference Committee meeting to negotiate an omnibus package for the nine remaining appropriations bills. The Conference Report is expected to be released early next week.