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December 30, 2003
Dr. Norka Ruiz Bravo
Deputy Director for Extramural Research
National Institutes of Health
Building One
Bethesda, MD 20892
Re: Policy on Patent Costs in the Revised NIH Grants Policy Statement
Dear Dr. Ruiz Bravo:
The Association of Independent Research Institutes (AIRI) is concerned about
a recent proposed change to the NIH Grants Policy Statement which is
contrary to Circular A-122 government-wide policy. AIRI is a nationwide
association of 89 nonprofit independent research institutes conducting
peer-reviewed basic and applied research in the biomedical and behavioral
sciences. AIRI institutions are distinct from other organizations involved
in research -- such as universities, hospitals, and for-profits -- in their
organization, mission, and size. Independent research institutes receive 11%
of NIH extramural research funds.
On November 26, 2003, NIH issued its revised Grants Policy Statement. As
part of the revision, NIH states that invention, patent, or licensing costs
are unallowable. This change is described as merely a policy clarification.
In contract to the NIH revision, OMB Circular A-122, which governs indirect
cost recovery by nonprofit organizations, states clearly the circumstances
under which patent costs are allowable. Without a change to Circular A-122,
with adequate notice and public comment under the Administrative Procedures
Act, NIH lacks authority to impose the change provided in the revised Grants
Policy Statement. Furthermore, such a change is contrary to the public
policy rationale for allowing such costs under certain circumstances, which
a proper notice and comment process would have exposed.
AIRI strongly recommends that NIH withdraw this provision. Given the lack of
authority for imposing the change and its direct refutation by
government-wide policies, NIH places itself in direct jeopardy of legal
challenge.
Sincerely,
Randall Main
President
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