Request for Waiver of the US Manufacturing Requirement

Federal agencies have the authority to waive the preference for United States industry requirement when a contractor (see 37 CFR 401.2 (b)) assigns or licenses a contractor owned invention (35 U.S.C. 204). Extramural institutions may request such a waiver on behalf of its licensees. Agencies will comply with 35 U.S.C. 204 in making determinations regarding the grant of a waiver of the U.S. manufacturing requirement. Section 204 states:

Notwithstanding any other provision of this chapter, no small business or firm or nonprofit organization which receives title to any subject invention and no assignee of any such small business firm or nonprofit organization shall grant to any person the exclusive right to use or sell any subject invention in the United States unless such person agrees that any products embodying the subject invention or produced through the use of such invention will be manufactured substantially in the United States. However, in individual cases, the requirement for such an agreement may be waived by the Federal agency under whose funding agreement the invention was made upon a showing by the small business firm, nonprofit organization, or assignee that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.

The approval process requires that contractor organizations provide information and justification for the request as outlined below. In addition to addressing the questions, any other information which the contractor believes pertinent to why the assignment is necessary and in the public interest may be submitted.

Request for Waiver Form Please note that this form is only compatible with PCs - please e-mail the agency for assistance if you are using a MAC.

After filling out the form, please attach and e-mail the request to the Federal agency for disposition. Please note that the review that can lead to the approval of U.S. Manufacturing waiver request will not commence until the answers to the questions and all pertinent information has been received. Should you have further questions, or should you prefer to submit information in hard copy, please direct inquiries and information to:

NIST Technology Partnerships Office
ATTN: US Manufacturing Waiver Requests
100 Bureau Drive, Mail Stop 2200
Gaithersburg, MD 20899 ; 301-975-2573

Appeals to determinations under this authority will be addressed in accordance with 37 CFR 401.11.

Requests for waivers from the National Institutes of Health (NIH) should be completed and submitted directly to NIH: Requests for Waiver.

Created April 08, 2013, Updated September 21, 2016