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Multiple Lawsuits Filed Against NIH Indirect Cost Move

On Monday, two separate lawsuits were filed in response to a policy change from the National Institutes of Health (NIH) announced late Friday. In the first suit, filed Monday morning, attorneys general from 22 states, including Washington, sought to prevent NIH’s move to unilaterally lower the “indirect cost” rates on research grants to 15 percent.

The action in question occurred Friday evening, when the NIH announced a significant reduction in grant funding for research institutions. The announcement declared that the NIH will limit the amount granted to research universities for indirect costs at 15 percent moving forward, on both future and existing grants.

Indirect costs, also referred to as “facilities and administration” (F&A) costs, are the essential-but-behind-the-scenes costs of conducting research. These costs include, but are not limited to, laboratory materials, high-speed data processing, security protections, patient safety, radiation safety and hazardous waste disposal, personnel required to support administrative and compliance work, and many other necessary activities.

Typically, when the government provides a grant to a research university, it includes support for both direct and indirect costs. The indirect cost rates are based on allowable direct costs of research that can be assigned to a research grant. Historically, the federal government has reimbursed the university for a percentage of these allowable direct costs. Indirect costs are never fully reimbursed by the federal government, meaning full costs of research are never fully recovered by the institution performing the research. The level of F&A expenses that the federal government covers for each institution is determined by either the Department of Defense Office of Naval Research or the Department of Health and Human Services and is reviewed every 2 to 4 years through a comprehensive negotiation process.

Late last evening, the court in Massachusetts issued a temporary restraining order against the NIH in response to the suit.

Given the potential implications of such a move by the NIH, three higher education associations in which UW is active—the Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and American Council on Education (ACE)—took the unprecedented step of also filing a separate lawsuit against the agency Monday evening. The suit seeks a temporary restraining order as well as an injunction against the NIH.

Currently, as a result of the language in funding bills for the NIH dating back to FY2017, the NIH is prohibited from lowering the indirect cost rates unilaterally.

The NIH’s move has received criticism from several Members of the Senate, including Republicans. Appropriations Committee Chair Susan Collins (R-ME), has issued a statement strongly opposing the NIH move. Republican Senator Katie Britt of Alabama issued a statement encouraging the agency to take a “smart, targeted approach…in order to not hinder life-saving, groundbreaking research at high-achieving institutions…”

Over the weekend, Sen. Patty Murray of Washington, the Ranking Member of the Appropriations Committee, issued a statement raising strong objections about the NIH move.

Please continue to check back here for additional updates.

Monica Bertagnolli, M.D. Confirmed as New NIH Director

Monica Bertagnolli, M.D. was confirmed as the new NIH Director last week. Now that she is confirmed, she has taken the helm immediately as the 17th director. She is the first surgeon and the second woman to hold the position and joins the NIH after being the director at the National Cancer Institute.

In his nomination announcement earlier this year, President Biden stated: “Dr. Bertagnolli has spent her career pioneering scientific discovery and pushing the boundaries of what is possible to improve cancer prevention and treatment for patients and ensuring that patients in every community have access to quality care. Dr. Bertagnolli is a world-class physician-scientist whose vision and leadership will ensure NIH continues to be an engine of innovation to improve the health of the American people.”

Read more about about Dr. Bertagnolli and her confirmation here.

Nominee to Head NIH Clears Committee

Earlier this morning, the nomination of Monica Bertagnolli to head the National Institutes of Health (NIH) was approved by the Senate Health, Education, Labor, and Pensions Committee by a bipartisan vote of 15 to 6.  Bertagnolli, the current director of the National Cancer Institute, was nominated by President Biden earlier this year to take over the NIH, which has not had a permanent head since the retirement of Francis Collins.

Sen. Appropriations Committee Finishes Its Work, Clears Last 4 Bills

By clearing the last four bills yesterday, the Senate Appropriations Committee has reported out all 12 spending bills for a fiscal year for the first time in five years.  The committee reported out favorably yesterday the following FY2024 spending measures:  Labor-HHS-Education; Defense; Interior and the Environment; and Homeland Security.  Unlike the situation in the House, where the leadership had to pull the Agriculture spending bill from a floor vote because it lacked enough support even among the Republicans, the committee process in the Senate yesterday was very bipartisan.  The Interior bill passed by a vote of 28 – 0, the Defense bill was approved 27 – 1, the Labor-HHS bill was adopted 26 – 2, and the vote was 24 – 4 on the Homeland Security legislation.  

Labor-HHS-Education

HEALTH AND HUMAN SERVICES

  • NIH

The Senate legislation would fund the National Institutes of Health at a total of $47.8 billion, an increase of $943 million above the current level.  The total includes $1.5 billion for ARPA-H, which represents level funding under the Senate version of the bill.  Within the NIH, the bill would increase, among other programs, mental health and Alzheimer’s research by $100 million each and while cancer research would see an increase of $60 million.

  • Title VII Health Professions and Title VIII Nursing Programs

The legislation proposes to fund the Title VII Health Professions programs at a total of $529 million, an increase of $20 million.

At the same time, the Title VIII Nursing programs would see a total of $302.5 million, a $2-million increase over this year.

DEPARTMENT OF EDUCATION

  • Student Aid and Higher Education
    • Pell Grant– The maximum award would increase by $250 to $7,645
    • SEOG– $900 million (a decrease of $10 million)
    • Federal Work Study– $1.22 billion (a decrease of $10 million)
    • International Education– $85.7 million (level funded)
    • TRIO– $1.19 billion (level funded)
    • GEAR UP– $338 million (level funded)
    • GAANN– $23.5 million (level funded)
  • Institute of Education Sciences (IES)
    • IES would be funded at $793 million, a cut of $14.5 million

Interior

USGS

  • Climate Adaptation Science Centers– $63.1 million (level funded)
  • ShakeAlert– $29.6 million (level funded)

NATIONAL ENDOWMENT FOR THE HUMANITIES

  • $207 million (level funded)

Defense

Under the committee-approved bill, defense basic research would be see an increase of 10.5 percent for a total of $3.22 billion.

  • Army basic research:  $672.5 million (an increase of 5.8%)
  • Navy basic research:  $793.5 million (an increase of 15.2%)
  • Air Force basic research:  $711.9 million (an increase of 16.3%)
  • Defense-wide basic research:  $862.3 million (a decrease of 7.0%)
  • DARPA:  $4.1 billion (0.7% increase)

Both chambers are now in recess until after Labor Day. 

President Biden Announces Intent to Nominate Dr. Bertagnolli as NIH Director

President Biden announced today his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH).

Dr. Bertagnolli is currently the Director of the National Cancer Institute and was previously the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.

Read more about Dr. Bertagnolli and President Biden’s statement here.