The NIH has announced it has once again contracted with Foresight Science and Technology to provide 50 SBIR Phase I awardees with Technology Niche Analyses (TNA™). Only FY09 or FY10 SBIR awardees are eligible to apply. Each company is only eligible for one assessment even if you have received multiple awards. The earliest start date for Group A is July 27th.
Each TNA™ will examine the commercial potential and market for the product/service being developed using NIH SBIR funds. This report can be beneficial in identifying partners, investors or customers.
In an effort to make the peer review process more transparent the NIH has been phasing in new guidelines for grant review. Of interest to the SBIR/STTR applicant the scale on which an application is scored has been changed.
Instead of being scored 1 to 5 (exceptional to poor) and the average multiplied by 100, SBIR/STTR grants are now scored 1 to 9 (exceptional to poor) with the average multiplied by 10. In addition, applications that were not discussed in study section will now receive their initial criterion score as part of their summary statement. This may give you some insight into why your application was not discussed.
But what do these new scores mean? How can you know whether your application is likely to be funded? Previously a score of 180 or below meant you had a pretty good chance of being funded. If you extrapolate that to a 90 point system would a score of 32 or below translate into an awarded grant?
Only time will tell.
The August 5th NIH SBIR/STTR deadline is rapidly approaching. All applications are submitted electronically through
www.grants.gov. If you intend to submit an application for this receipt date you need to have begun the online registration process. This is mandatory and the NIH will not make any exceptions. What needs to be accomplished?
- Register with grants.gov which requires
- TaxID
- DUNS Number
- CCR Registration
- Bank routing number … and other numbers and IDs.
- Register with the NIH eRA Commons
- This process is much simpler and detailed instructions have been provided by the NIH.
Registration can take up to four weeks and the NIH requires you to begin your NIH eRA Commons registration at least 2 weeks prior to the submission deadline.
Administrivia is never fun, but sometimes there is no way around it.
In a
press release issued last Tuesday the NIH reported a record number of grants submitted on April 27th in response to the Challenge Grant RFA. Each of the 20,000 applications will be reviewed by 3 scientific reviewers and a summary statement compiled. This process will require more than 18,000 scientists to complete. To put it into perspective the NIH reviews approximately 16,000 applications in each of 3 rounds annually. Each round requires 8,000 reviewers.
The NIH estimates it will review approximately 40,000 applications in direct response to either the Challenge Grant or other ARRA associated funding. This process is going to require more than 28,000 reviewers.
The outcome? Approximately 200 Challenge Grants will be selected and $200 Million awarded.
If you are patiently waiting for your summary statement they are estimated to be available in August. Check your eRA Commons account.
Two new solicitations from the NIH were released yesterday that will be of interest to the bioscience small business community. While only one uses the SBIR R43 funding mechanism the other is open to for-profit entities and those with fewer than 500 employees will be given preference. A few pertinent details on each are described below. I encourage all applicable small businesses to apply.
You will never know if you don't try
Both have a submission date of:
September 1, 2009, 5PM local time
Letters of Intent are not required but encouraged and due on:
August 3, 2008
Discuss your application with an NIH Program Manager prior to composing your proposal.
The purpose of this funding opportunity is to bridge the "valley of death" that occurs between research and development and market launch. This is similar to the NCI's SBIR Bridge Award. Preliminary pre-clinical work is encouraged. If you need to complete activities for regulatory filings such as an IND application these funds are for you.
A Budget of up to $1M in total costs for up to 3 years may be proposed. $35M has been committed to this funding opportunity and the NIH anticipates awarding 10 grants in FY2010.
This funding opportunity uses the SBIR R43 mechanism which means it is only open to small businesses. HIgh-risk, high-return opportunities are encouraged to apply. If you are curious whether your project meets those specifications contact one of the program managers listed in the solicitation (linked above).
A Budget of up to $200K in total costs for up to 1 year may be requested. $5M has been committed to this funding opportunity and 20 to 25 awards are anticipated.
If you are a Georgia company and would like assistance with your proposal please contact us.
You’ve spent time writing what you think is a pretty decent proposal and now you are ready to submit it…or so you think. Have you thought about how will you submit it? Read the solicitation and read it early (see The Basics: Reading, Writing, and Arithmetic (Part 1)). Each agency is different. Does the agency require a paper or electronic submission? If paper submission, did you allow time for the physical delivery of your proposal? Have you obtained all necessary data elements and completed any necessary electronic registration processes?
IMPORTANT: Electronic registration and obtaining basic data elements can take a few days, but it might take weeks (for example, NIH recommends new companies start no later than 6 weeks before proposals are due). There are several steps that MUST be completed prior to the actual registration. Each step is dependent on information generated from the previous step. Your hands are tied when waiting for each data element to be supplied/validated from its issuing organization. The length of time for the whole registration process depends on how many elements your company will need to obtain.
So how many elements will your company need? That depends on how established your company is, what you have already obtained by conducting other normal business, and if you have previously submitted a proposal. You might need to obtain some, all, or none of these basic data elements before you can submit a SBIR or STTR proposal:
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Does your company have a Tax ID Number (also known as an EIN)? New companies will need to obtain one from the IRS. Once assigned, the EIN will need to be validated (numbers are assigned immediately, but it can take 2-5 weeks to activate a new number).
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With activated EIN in hand, you can next apply for a Data Universal Numbering System (DUNs) Number from Dun and Bradstreet (D&B). This 9-digit number is a unique number for each physical location of your business. Once requested, a DUNs number is issued within 24-72 hours.
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With EIN and DUNs, you are now ready to register in Central Contractor Registration (CCR). CCR is the primary registrant database for the Federal Government. Registration will not only require your EIN and DUNs, it will also require banking Electronic Funds Transfer (EFT) Information for payment of invoices. Your CCR registration will be processed complete after 24-48 hours. Note: If you do not have a CAGE code(Commercial and Government Entity Code), necessary for any DOD submissions, CCR will assign one.
With these basic data elements in hand, you are now ready to register with the specific agency to which you will submit your proposal–read the agency's solicitation to know which system (grants.gov, FastLane.com, eRA Commons, dodsbir.net, EHB, etc). I will cover these specific registrations in future postings…
At the NIH there are rules governing your allowable indirect cost rate. First time Phase I applicants are allowed to request an indirect cost rate of up to 40% of all direct costs. If you request an indirect cost rate of 25% or less, however, the rate will be granted without further justification. The NIH does not negotiate indirect costs on Phase I proposals. So if you do not have a previously negotiated rate with the federal government you are limited to 40% of all direct costs.
I always recommend first time Phase I applicants request between 25 and 30% in indirect costs. This will cover your most basic indirect costs such as rent and benefits.
SBIR and STTR Phase II NIH applicants are not limited in the amount of indirect costs they can request. Unless you want to provide extensive justification, however, you are only allowed to request an indirect cost rate of 25% or less. Many first time Phase II applicants have been caught up in months of indirect cost rate negotiations. These occur after the notice of grant award which could be 9 or 10 months after submission. In short you could be waiting for over a year to receive funds.
Well the NIH now allows first time applicants to request an indirect cost rate of up to 40% of all direct costs without further justification. This is good news for newbies. Many companies, however, have indirect cost rates much higher than 40% and may still need to request a higher rate. If you do not have a negotiated F&A rate with the federal government just be forewarned that the negotiation process can be lengthy.
To find out how to estimate your indirect cost rate contact SBIR GA!
In response to the Recovery and Reinvestment Act of 2009 (Recovery Act) the NIH has designated at least $200 M in FY 09-10 for a new initiative: NIH Challenge Grants in Health and Science Research (RCI grants). These funds will support research in both the biomedical and behavioral fields that address specific scientific and health research challenges. The funds will be awarded to projects that will benefit from a jumpstart in funds over the next two years.
These funds are not subject to the SBIR/STTR set-aside requirement. However, small businesses ARE eligible and encouraged to apply.
Key Dates
Release/Post Date: March 4, 2009
Opening Date: March 27, 2009
Application Due Date: April 27, 2009, 5:00 PM
No letter of intent required
To receive emails from the NIH concerning the Recovery Act please go to:
On Friday the NIH announced the reissue of three funding opportunities applicable to the SBIR community.
- RFA-ES-005 solicits Phase II SBIR applications for the development of environmental sensors for personal exposure assessment.
- PA-09-113 encourages Phase I SBIR applications for the development of technologies related to advanced processing, manufacturing processes, equipment and systems, and manufacturing workforce skills and protection. PA-09-114 is the STTR counterpart.
- PA-09-115 is targeted toward applications that require a longer award period and larger award amount. Specifically technologies that will require FDA approval such a vaccine, biologic or drug delivery system. PA-09-116 is the STTR counterpart.
The first two opportunities highlight interest by the NIH in applications outside of traditional life science. If you are in the business of sensor development or manufacturing processes you may have a technology eligible for funding.
Check out all the current NIH funding announcements at:
“There is no grantsmanship that will turn a bad idea into a good one,
but there are many ways to disguise a good one.”
- Dr. William Raub, Former Deputy Director, NIH
Contact SBIR Georgia for assistance with your proposal.
The PHS 2009-2 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for SBIR/STTR Grant Applications and SF 424 (R&R) Application Guide for SBIR/STTR Grant Applications are now available.
The due dates are April 5, August 5, and December 5.
AIDS and AIDS-related applications are due May 7, September 7, 2009, and January 7, 2010.