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 “information 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.