5 tips to write an NIH SBIR proposal

Freelance grant writer Portia Ndlovu provides 5 important tips to keep in mind while writing an NIH SBIR proposal.

The National Institutes of Health (NIH) is one of the agencies operating under the Small Business Innovative Research (SBIR) program, to provide grant funding to small businesses with demonstrated innovative technologies. The NIH grant funding program has three proposal deadlines set each year. According to the NIH/SBIR website, the submission process can take up to eight weeks to complete. As such, if you are a business looking to submit an NIH proposal, you need to plan your time well and make sure you have ample time for both the writing and submission process.

Below are 5 Key Tips to writing an NIH SBIR grant application:

Before you start writing your NIH SBIR proposal

Tip 1: Understand and Fulfil all the Requirements of the NIH SBIR Program

The NIH program funds early stage small businesses seeking to bring to market innovative biomedical technologies through non-dilutive funding that does not require equity from the companies. Make sure your business qualifies as a small business and your proposed innovation is unique and you have established Freedom to Operate, through patenting and patent searches. You should have a clear idea of what differentiates your technology from the state-of-the-art and competing technologies

The NIH SBIR program requires the primary investigator (PI) to be an employee of the participating company, with at least 50% of his/her time dedicated to the business. This means that if the PI is employed on a full-time basis by another organisation, they can participate in the grant as the PI. For example, if he/she is in full employment as a professor at a university, they cannot be PI or they may have to quit their professorship. Also make sure that the profile of the PI is sufficient to exhibit significant contributions to science through their qualification, scientific publications, etc.

Make sure to complete all the Required Registrations before submitting your application. This process can take between six to eight weeks and includes EIN, DUNS, SAM, Grants.gov, eRA, and SBA company registry registrations.

Tip 2: Structure Your Responses

A good structure will help you to express yourself more clearly. At this point, it is helpful to utilize the review criteria provided by the NIH.  With these in mind, clarify your thoughts and the purpose of your communication before you start writing. Identify the key points, facts and themes and decide on a logical order in which to present your information. One way to make sure you do not miss anything is to create a checklist of all the required sections and documents. Some of the questions, based on the review criteria, that you need to ask yourself and address before you start writing are:

• What is the problem being solved by your innovation and of what importance is it to the global and America health system?
• Who is your company’s PI and do they have the requisite qualifications and expertise to lead this effort?
• Is your technology truly innovative? Is it new, unique and novel and how does it different to current state-of-the-art offerings? How do you plan to protect your intellectual property? Do you have the Freedom to Operate?
• What is your experimental design and methods for delivering your Specific Aims? Are they appropriate for the aims and do they deliver quantifiable deliverables? Have you considered the technical barriers that may exist, the mitigation strategy and alternative strategies?
• Does your company have the necessary facilities and equipment required to deliver the tasks of this framework? What other facilities do you have access to?
• Consider the economic, scientific and social impacts of the project if successful.
• The Phase II application requires all the above and a 12-page commercialization plan that is detailed and realistic. You should include both Letters of Intent from your collaborators and Letters of Support from potential commercialization partners.

As you write your NIH SBIR grant proposal

Tip 3: Engage and Connect with the Program Officer

One of the most important tips for a successful NIH proposal application is engaging and connecting with your Program Officer. This link on the NIH website provides the contacts of possible program officials at the NIH. Identify your Program Manager early and reach out to them to share your proposed technology and get their input and insights regarding the types of innovation they are looking for and how your technology fares in that regard. They will also address any questions or concerns you may have regarding the application process. By introducing your technology to the PO early, you gain a competitive advantage over the other applicants because during the evaluation process, the PO will be able to remember and identify your application.

Tip 4: Exhibit Good Grantsmanship

Good grantsmanship is important and should focus on enhancing legibility and readability. Your product may be innovative, but if your application is difficult for the evaluator to read and follow, your proposal may be marked down and lose the chance to receive funding. Make sure the proposal is well-presented, and easy to read, including the text in figures and diagrams. The following tips are helpful in enhancing readability and eligibility of your proposal:

• Avoid jargon. Use common professional, industry or business vocabulary that is easily identifiable and understood. Avoid unnecessarily big or ‘ technical-sounding’ words and slang. While, your proposal may be evaluated by an expert in your field, make sure it can be easily understood by someone who is not an expert in the field. You will need to strike a balance between providing sufficient technical detail and making it easily accessible to a wider audience.
• Use English at all times. The NIH is a United States program and English is the standard language for communication. Avoid the use of other language names or phrases. Do not use literary Latin, French or Greek in the proposal.
• Spell out acronyms: Spell out acronyms in full and include the appropriate abbreviation in parentheses the first time they are used in each application section/attachment. Thereafter, you can use the abbreviation.
• Use Anchor sentences at the beginning of a section, in the middle, and at the end, add summarizing sentences to anchor the reader to the main point. This is crucial to prevent the reader from getting lost within the proposal. Also, use short paragraphs and sentences rather than long, rambling ones. Keep to one idea per paragraph and put your point in the first line, then add the supporting information and concluding remarks at the end.
• Make Use of Headings and Labels for the different sections of the proposals to visually distinguish them and make them easier to follow. Headings and labels help key points to stand out more clearly for the reader. Also consider using visualizations, bullet points, bold text and underlined text to highlight key information. This enables the evaluator to quickly identify the key messages in your application.
• Use Active voice rather than Passive. Avoid using passive language as much as you can. Instead use the active use and include the name of the person performing the task wherever possible. For example, instead of saying “An implantation study will be conducted”, say “[company/PI] will conduct an implantation study” develop a cell line.”

After Writing Your NIH SBIR Proposal

Tip 5: Utilize the Just-in-Time (NIH) Procedures

This is a very important tip that you need to consider after submitting your application. The NIH portal provides Just-in-Time (JIT) procedures that you can utilize as you await project awards. This procedure will provide you with tools and resources to help you complete and submit all the requisite documentation. These tools will help you speed up your evaluation and award timeline for your project, so make use of them.

Checklist and Structure of Required Documents

1. Specific Aims

• 1-page limit for both Phase 1 and Phase 2 proposals
• Start by giving the background to the technology as well as the problem addressed by your technology

2. Research Strategy – 6 pages (Phase 1) and 12 pages (Phase 2)

2.1 Significance

• 6-page limit for Phase 1 proposals and 12 pages for Phase 2
• Discuss the problem and background to the technology in more detail
• Make sure to reference existing credible literature that highlight the problem
• Include a competitor landscape analysis
• Elaborate your business model including pricing and revenue models, and commercialization strategy

2.2 Innovation

• Here, describe your solution and the technology supporting it, making sure to include relevant graphics
• Discuss the technology features and how they make your solution better than current offerings on the market
• Include details on how will the customers and end users benefit from your product
• You need to demonstrate your freedom to operate and your Intellectual Property (IP) protection strategy

2.3 Approach

• This section describes in detail, the experimental methods and experimental design of the Specific Aims
• Make sure to assign specific people to each task
• Provide the rationale behind your selected methodology, sample size, etc.
• Include a risk analysis table and the mitigation strategies to address them

3. Commercialization Plan

• 12-page limit for Phase 2 proposals
• This document should clearly provide the market potential of your offering, value created and how your product addresses a clear market need for an identified target market
• Include details about business model, pricing strategy, commercialization strategy, etc.

4. General Information

• Cover Letter
• Biographical sketched for the team members – 5 pages only
• PHS Assignment Request Form
• Project Summary/ Abstract limited to no more than 30 lines
• Project Narrative of no more than 3 sentences
• Bibliography and References Cited – no page limit
• Facilities and Other Resources Statement that does not include equipment – no page limit
• A separate Equipment Statement – no page limit

5. Budget Sections

• Budget and Budget Justification – no page limit

6. Human Subjects Sections

• Protection of Human Subjects
• Data Safety Monitoring Plan
• Inclusion of Women and Minorities
• Inclusion of Children
• PHS Inclusion Enrollment Report

7. Other Documentation

• Vertebrate Animals
• Select Agent Research
• Multiple PD/PI Leadership Plan
• Letters of Intent from collaborators and Letters of support from potential partners
• Consortium Arrangements
• Resource sharing Plan

8. Appendices

• Clinical trial protocols Investigator’s brochure from Investigational New Drug (IND), as appropriate
• Blank informed consent/assent forms
• Blank surveys, questionnaires, data collection instruments
• FOA-specified items

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References

1. National Institutes of Health SBIR/STTR website. https://sbir.nih.gov/
2. Office of the VPR: RAS. NIH Checklists and Preparation Guides. https://ras.mit.edu/grant-and-contract-administration/sponsor-information/nih/nih-checklists-and-preparation-guides
3. 3. UC MERCED Health Sciences Research Institute. NIH Proposal Checklist. https://hsri.ucmerced.edu/member-services/grants-assistance/nih-proposal-checklist

About the author

Portia Ndlovu is a Public Health expert, currently working as a Freelance Innovation Consultant for health projects across Europe and the US. Portia has spent the last decade writing winning proposals for the European Commission and US Air Force grant schemes. Her expertise spans across EIC Accelerator, Department of Defense (DoD) AFWERX, SBIR/STTR National Institute of Health (NIH), Fast Track to Innovation (FTI), and Innovate UK proposals. Portia is currently studying for her Masters in Public Health at the University of Suffolk, UK, and holds an Honors Degree in Environmental Health. Contact her directly for a project.