NIAID Small Business Bulletin—January 2021
Welcome to the first NIAID Small Business Bulletin! The Bulletin complements the broader cross-cutting guidance in NIAID Funding News with articles, news, and announcements specifically focused on NIAID’s SBIR/STTR audience. Email NIAIDSBIR@mail.nih.gov to let us know if you find the Bulletin helpful, how frequently you’d like to see it, or any other comments. We welcome your feedback.
Commercialize Your Product: Leveraging SBIR/STTR Technical and Business Assistance
Technical and Business Assistance or “TABA” funding is a little-used feature of the SBIR/STTR programs that can significantly enhance your product development efforts! All applicants may request additional funding support for technical and business services, such as access to technologies, support on product sales, intellectual property protections, market research, and planning:
- $6,500 (per year) in Phase I
- $50,000 (per project) in Phase II
Phase I awardees who do not request this funding in their application can alternatively access TABA resources through the newly launched Needs Assessment Program; phase II awardees should stay tuned for the launch of TABA Consulting Services later this year.
See the December 16, 2020, NIAID Funding News article “Commercialize Your Small Business Products With TABA” for additional details and resources. Also see the TABA Frequently Asked Questions on the NIH SBIR/STTR website for general guidance.
What kinds of commercialization activities and service providers are allowed?
TABA funds must support services directly related to developing or commercializing your SBIR/STTR-funded technology, and that are distinct from the awarded scientific/technical aims. Beyond that, applicants have substantial flexibility to use these funds. To date, NIAID awardees have most commonly sought assistance from regulatory consultants to plan R&D activities consistent with FDA marketing approval requirements and intellectual property (IP) experts to optimize their patent submission strategy.
Most relevant kinds of outside expertise, both technical (e.g., production and manufacturing) and business-related (e.g., market research/validation, sales) are valid. If you can access an otherwise unavailable service that informs better technical decisions, reduces development risks, or demonstrably supports commercialization or product development, it is likely allowable. NIAID’s Small Business Team is always available to provide guidance; feel free to contact us to discuss your plans.
How do you budget for a self-sourced TABA vendor? What supporting materials are expected?
First and foremost, follow the instructions in the SF 424 Application Guide. We expect you to specify a vendor, services it will provide, and total estimated costs as well as discuss expected benefits in your budget justification. Reviewers will consider this information alongside the rest of your budget materials using the same criteria. As with any third-party service provider, a letter of support confirming cost, availability and services is helpful to validate your request.
Unlike consultant/contractor or subaward costs, TABA funding does not count toward the Congressionally mandated “hard caps.” Each NIH Institute and Center has discretion to set its own TABA budget guidelines. Currently, NIAID allows:
- TABA requests at the full levels indicated above, when included in the application.
- TABA requests to be made in addition to (above) our standard SBIR/STTR waiver limits. For example, a one-year NIAID Phase I project may include a total budget request of $300,000 Total Costs (Direct + Indirect + Fee) + $6,500 TABA costs, or $306,500, total.
Lastly, TABA costs are not considered either awardee or third-party costs for the purposes of SBIR/STTR subcontracting/consulting effort restrictions and should not be included in your indirect cost base.
As always, your grants management specialist has final discretion on the allowability of any proposed costs.
Should you self-source a vendor or use NIH TABA Programs?
Keep in mind that you can either request TABA funds for your own vendor or participate in an NIH TABA Program; you cannot do both (in a single award/phase). Receiving any TABA funding as part of your Phase I award (regardless of amount) is disqualifying for the Needs Assessment Program.
Ultimately, you understand your company’s needs and capabilities better than anybody else; if you have a clear plan to use TABA funds to drive your product forward, that’s exactly what they’re available for. However, it’s worth considering that in Phase I, funding is limited. If you’re unsure how you might use it effectively, the Needs Assessment Program can provide a lot of value and is also designed to enable Phase II TABA activities, either by identifying/justifying services to request in your Phase II application, or establishing eligibility for NIH Phase II TABA Consulting Services.
How to identify a vendor
NIAID does not endorse any third-party service providers and there is no pre-approved list of NIH vendors. It can be a challenge to find legitimate, qualified consultants or service providers to help enable your commercialization efforts. Remember, you’re part of a bigger ecosystem—reach out for hints and recommendations wherever you can. Good sources of information include accelerators and incubators across the country that support innovation; local and regional SBA-supported Small Business Development Centers; conferences, trade events and other networking opportunities with other awardees and entrepreneurs facing similar challenges. Also, most universities have some kind of innovation support apparatus that you or your academic collaborators can probably access, even if informally. It may take some creativity, but your network is probably bigger than you know.
NIAID Small Business Program Reminders
- The next standard due dates for the SBIR (PA-20-260) and STTR (PA-20-265) Omnibus Solicitations are April 5 and September 6, 2021.
- The NIAID Phase II Clinical Trial Implementation Cooperative Agreement has been reissued, and now allows Direct-Phase II applications—see PAR-21-082 for details. The next due date is May 14, 2021.
- The next NIAID Application Assistance Program cycle will launch in mid-April 2021 and is available to Phase II, Fast-Track and Direct-Phase II applicants.
- The Needs Assessment Program is currently accepting applications from recent Phase I awardees – first come, first served.
Upcoming Webinars and Virtual Outreach Events
Angel Capital Association 2021 Summit – May 4 to 6 2021
BIO Digital 2021 – June 10 and 11 and June 14 to 18, 2021
NIAID Small Business Program Contacts
Reach us at NIAIDSBIR@mail.nih.gov.
Learn more about the NIAID Small Business Programs Team.
NIAID Information and Resources
NIAID Small Business Program
NIAID SBIR/STTR High-Priority Areas of Interest
NIAID SBIR/STTR Sample Applications
NIAID Resources for Researchers
|
