Employee-inventors may request to retain title to their inventions which have not been elected by the grantee/contractor subject to certain conditions set forth by the regulations appearing in 35 U.S.C. Section 202(d) and 37 CFR 401.9. Once a nonprofit grantee/contractor organization has waived rights to a particular Subject Invention, the Government must approve the requested assignment.  As an alternative to approving the assignment, the Government may choose to retain rights if it is the opinion of the awarding agency that this is in the public's best interest. In order to make this determination, a thorough review of the history of the invention, including patent and commercialization efforts, must be undertaken by the awarding agency. The review by NIH that can lead to the approval of an assignment of rights to the inventor will not commence until all of the following actions have been taken by the grantee/contractor organization and inventor(s) and respective documents received by the NIH.   A copy of the original invention disclosure must have been received by the NIH.  There is no specific format for this document.  It must be a written description of the invention indicating the title of the invention, the names of all inventors, the source of federal funding, and the date of disclosure as indicated through the signature and date of the inventors.  If the disclosure has been previously sent to the NIH, but can not be located, the NIH will contact the grantee/contractor organization to receive an additional copy. An inventor certification form must be completed. The signed, completed form serves two purposes in the assignment request. The signatures of all inventors (either on the form or in counterpart) certify that the inventors recognize and understand their legal obligation to comply with the Bayh-Dole Act regulations. For instances in which not all inventors wish to assume the rights and Bayh-Dole-related obligations, signed statements indicating relinquishment of all rights and interest in the invention must accompany the executed inventor certification form. The second requirement met by the form is a statement of the willingness of the grantee/contractor organization to release the rights.  The signature of an authorized representative of the grantee/contractor organization attests this decision.  It is important to understand that this signatory must be an organizational official with complete legal authority to waive all right and title to inventions made by the institution. A complete copy of all patent applications and issued patents pertaining to the invention must be provided to the NIH. Patent-related information must include documentation to account for all PTO office actions.  This information is necessary for the NIH to review the extent of effort that was put forth to commercialize the invention. A completed set of invention commercialization questions must be submitted to the NIH. The answers to these questions will allow the NIH to further resolve the extent of commercialization efforts undertaken by the grantee/contractor organization prior to the decision to waive invention rights.  Once the questions have been completed on-line, the answers can be submitted to NIH automatically via an e-mail link at the bottom of the interactive form page. Please note that the review for approval of assignment of rights to the inventor(s) will not commence until all four sets of information listed above have been received by the NIH.  You must direct all information either by fax or U.S. mail to:   Division of Extramural Inventions & Technology Resources (DEITR), OPERA, OER National Institutes of Health (NIH) Attn: Inventor Waiver Review 6705 Rockledge Drive, Suite 310, MSC 7980 Bethesda, MD 20892-7980   Information may be faxed to NIH at (301) 480-0272.