AUTM Updates

AUTM Survey on Domestic Manufacturing Waivers Finds Few are Requested, Agency Response Times Improved

 
To better understand and inform critical policy discussions impacting the commercialization of university innovations, AUTM conducted a targeted survey on domestic manufacturing waivers. This initiative was launched to gather data and insights directly from tech transfer offices regarding their experiences and challenges with domestic manufacturing requirements. This 2025 survey served as a crucial follow-up to a similar survey conducted in 2023.

While response rates from agencies are improving, challenges still exist. The process improvements implemented by the National Institute of Standardds and Technology (NIST) through the updated iEdison portal have contributed to improved response time, but advances are still needed at the agency level.

Findings
Data was collected from 52 technology transfer offices with the following results:
  • 30 respondents (57%) reported research expenditures above $300 million.
  • 92% of respondents did not report filing a waiver in the past year. The remaining 8% (4 institutions) each reported filing a single waiver.
  • 17 respondents (32.6%) reported filing at least one waiver in the past 5 years. This is an increase from the 2023 survey, which reported 13 respondents (25%) filing at least one waiver in the past 5 years.
  • 6 respondents reported that all or some of their waivers had been granted, 6 respondents reported that all or some of their waivers were not granted, and an unspecified amount are either pending or have yet to receive a response.
  • 14 institutions responded to the question about the average time it took to hear back from the funding agency regarding their waiver request:
    • 22% of the time, a response was provided in less than 3 months. Showing a substantial increase from 3% in 2023.
    • 14% of the time, a response came between 3 and 6 months, an increase from 3% in 2023.
    • 14% of the time, a response came within 6 months to a year, an increase from 3% in 2023.
    • However, 50% of the time, the response rate was not at the speed of business as there was either no response provided, or the response took more than one year. While this shows marked improvement, the slow response rate is inhibiting commercialization of technologies.
*Not all institutions responded to every question.

Survey Comments
Respondents were encouraged to provide details about their US Manufacturing Waiver experience and provided the following comments:
  • Waivers decisions are not being made in a timely manner, affecting commercialization of new technologies:
    • Over a year since our submission, we were able (through our connections) to find the group at the NIH and have a meeting with them. They explained that these were about 10% of their time and they had a huge backlog. We're now at three years since the licensee asked us to request the waiver. We have received no substantive response from the NIH.
    • I currently have an IIA with an Australian university for joint IP and the Australian university has optioned the technology to an Australian company. That company is concerned about the waiver process. We've said we would be willing to work with the company to submit a waiver, but we've made it clear that the process is not an easy one and that the response time is unknowable.
    • We filed in Fall 2023. We directly communicated with the IP office of the agency to facilitate a smooth waiver submission. Nearly 2 years went by with no update. The waiver request was withdrawn in January 2025.
  • A single, streamlined domestic manufacturing waiver process is needed (in a time with multi-Agency funding):
    • This involved a Phase 3 drug. Invention had been funded by Army and NIH. Army indicated they were prepared to approve but would not do so without NIH also approving. At the 9-month mark, NIH indicated they would not be able to review the waiver any time soon.
  • Domestic Manufacturing Waivers applications are rarely sought:
    • In over 25 years working in university technology transfer, the offices I've worked in have never submitted one (during my time in each of those offices).