The Bayh-Dole Act (35 USC §§ 200-212) and its implementing regulations (37 CFR 401) require Contractors to report information related to inventions and patents to the federal agency which awarded the relevant funding. The purpose of this legislation included promoting utilization of inventions resulting from federal R&D funding, encourage collaboration between non-profit and for-profit entities, increase commercialization and public availability of inventions made in the United States, and to ensure that the Government obtains sufficient rights in federally funded inventions to meet the needs of the Government and protect the public. To facilitate these and other objectives as well as to track both compliance with and effectiveness of this legislation, collection of data is required.
The Bayh-Dole Act (35 USC 18) and its implementing regulations (37 CFR 401) allow agencies to ask Contractors for periodic reports on the utilization of a subject invention or on efforts at obtaining such utilization. Under the regulations, these reports shall include âinformation regarding the status of development, date of first commercial sale or use, gross royalties received by the contractor, and such other data and information as the agency may reasonably specify. These new questions are deemed reasonable to request for a number of reasons. The new questions include a follow-up question to provide details when an invention is not licensed or commercialized to ensure that practical application is being timely achieved and additional information regarding product manufacturing to ensure that contractors, assignees, and licensees are compliant with any domestic manufacturing requirements.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.