Decoding the Food and Drug Administration SBIR: A Comprehensive Guide for Small Businesses

The FDA’s Small Business Innovation Research (SBIR) program offers substantial funding opportunities for small, American-owned, and independently-operated businesses engaged in research and development. This program aims to stimulate technological innovation, meet federal R&D needs, increase private-sector commercialization, and encourage participation from socially and economically disadvantaged individuals.

The FDA SBIR program boasts various facets:

• Focus on small businesses: The FDA SBIR program is exclusively meant for small businesses. With the understanding that such organizations are often the breeding ground for innovative ideas and technological breakthroughs, the program intends to provide businesses with the funding they need to conduct critical R&D.
• Non-dilutive grants: One of the most appealing features of the SBIR program is that it offers non-dilutive grants. This means that small businesses receive funding without the requirement of giving up any equity or incurring debts.
• Phased approach: The FDA SBIR program operates on a phased approach. The first phase (Phase I) is designed to establish the feasibility of the research, while the second phase (Phase II) is for further development and commercialization.
• Areas of interest: The FDA SBIR program supports a wide array of research areas that align with FDA’s mission to protect and promote public health. These areas span everything from drug and device development to food safety and health information technology.
• Support beyond funding: The FDA SBIR program provides recipients with technical assistance and networking opportunities. This comes in the form of workshops, resources, and partnerships that can prove invaluable in navigating the path from idea to market.

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• Program Description: The NOFO opens with an overview of the funding opportunity, including an explanation of the program’s purpose, goals, and objectives. In the case of the FDA SBIR program, this section would detail its intent to support innovative research in small businesses, and its alignment with the FDA’s mission to protect and promote public health.
• Federal award information: This section provides a wealth of information regarding the grant’s financial aspects. It includes details about the total amount of funding available, expected number of awards, type of award (grant, cooperative agreement, etc.), and the expected amount of each award.
• Eligibility Information: This section details who can apply for the grant, including criteria based on business size, operation type, and more. For the SBIR program, eligible applicants are predominantly small businesses involved in R&D.

• Application and submission information: A NOFO provides a detailed roadmap on how to apply. It includes information about registering with various government systems, like grants.gov, preparing and submitting applications, and important deadlines.
• Application review information: This section describes the evaluation process, including the review criteria and process that will be used to assess applications. For the FDA SBIR program, the review involves panels of independent experts in relevant scientific, technical, and business areas.
• Federal award administration information: This part of the NOFO provides guidance about administrative and national policy requirements, reporting, and other post-award processes.
• Agency contacts: Finally, the NOFO concludes with contact information for those who may need assistance or have questions during the application process.

• Center for Biologics Evaluation and Research (CBER/FDA): Regulates biological products, which include a wide range of products such as vaccines, blood and blood products, allergenics, tissues, and cellular and gene therapies. Their mission is to ensure the safety, purity, potency, and effectiveness of these biological products.
• Center for Drug Evaluation and Research (CDER/FDA): Performs an essential public health task by making sure safe and effective drugs are available to improve the health of people in the United States. It regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
• Center for Food Safety and Applied Nutrition (CFSAN/FDA): Oversees the safety of the nation’s food supply, cosmetics, dietary supplements, and products that emit radiation. It also regulates ingredients and packaging materials that come into contact with food.

• Center for Devices and Radiological Health (CDRH/FDA): Regulates firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, it also has jurisdiction over radiation-emitting electronic products (medical and non-medical), such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions.
• Center for Veterinary Medicine (CVM/FDA): Oversees the manufacture and distribution of food additives and drugs given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals.
• Office of Critical Path Programs (CPI/FDA): Re-engineers the medical product development process. It identifies, prioritizes, and coordinates the implementation of critical path opportunities with the greatest potential to modernize the medical product development process.
• Office of Orphan Products Development (OOPD/FDA): Promotes the development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.

• Stimulating technological innovation: At its core, the program provides critical funding to small businesses, encouraging them to explore, develop, and commercialize groundbreaking technologies that can advance the mission of the FDA.
• Meeting federal R&D needs: The FDA SBIR program serves to meet specific federal R&D needs. By aligning its objectives with the FDA’s mission, the program ensures that the innovation it supports directly contributes to the FDA’s goals.
• Increasing private-sector commercialization: A major goal of the FDA SBIR program is to support small businesses in transforming their research into viable commercial products, and the program sees that the benefits of these innovations reach the public.
• Encouraging participation from underrepresented groups: The FDA SBIR program fosters and encourages participation in innovation and entrepreneurship by socially and economically disadvantaged individuals. By removing some of the barriers to entry, the program helps to ensure that diverse perspectives and ideas can contribute to the innovation process.

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• American-owned: The small business must be owned and controlled by U.S. citizens or lawfully admitted permanent resident aliens.
• Independently operated: The small business must be independent of control by any other entities.
• For-profit organization: The small business must be a for-profit entity. Non-profit organizations are not eligible for the SBIR program.
• Size limitation: The small business, including its affiliates, must not exceed 500 employees.
• Principal researcher employment: The primary employment of the principal investigator must be with the small business at the time of the award and during the conduct of the proposed research.
• Project work: The work proposed in the SBIR application must be performed in the United States.
• R&D involvement:The small business must be engaged in research and development activities that align with the SBIR program’s objectives.

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• How much is the SBIR Phase I award?

• • SBIR Phase I awards generally do not exceed $150,000 total costs for six months for standard projects. However, for projects targeting hard-to-treat or rare diseases, the ceiling might be higher. Applicants are advised to check the current NOFO for the most accurate funding amount information.

• How long is SBIR Phase I?

• • The period of performance for Phase I projects typically does not exceed six months. However, timelines can depend on the specific nature of the project and certain types of projects might require an extended performance period. Always refer to the specific NOFO for the precise duration information for Phase I projects.

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• How much is the SBIR Phase II award?

• • The monetary award for Phase II projects is typically larger to support the expanded scope of R&D. Standard SBIR Phase II awards generally do not exceed $1 million total costs for a period of two years. Again, for specific types of projects, the funding cap might be higher. The specific funding amount for a project is determined based on the costs required for the project, which are evaluated during the review process.
    For the most up-to-date information on Phase II award amounts, applicants should refer to the current NOFO or directly consult with the FDA SBIR program officials.

• How long is SBIR Phase II?

• • Phase II periods of performance are generally up to two years. The exact duration can vary depending on the specific needs and timeline of the project. The NOFO will provide the precise details about the expected duration for Phase II projects.
    

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1. Identify a topic: The first step to applying for an SBIR award is to identify an appropriate research topic that aligns with the SBIR’s program objectives and the FDA’s mission. Review the current SBIR topics list to find an area that fits your business’s expertise and interests.
2. Read the NOFO: The NOFO details the specifics about the SBIR program for that cycle. It is crucial to read the NOFO carefully to understand the program’s priorities, the specific requirements for the proposal, the funding available, and the timeline for the application process.
3. Register on Grants.gov: All applications for FDA SBIR awards are submitted electronically through the Grants.gov portal. Therefore, you need to register your business on this site well ahead of the submission deadline. Remember that registration can take up to a month, so it’s important to start this process early.
4. Prepare Your application: Applications usually consist of several components, including a project narrative, budget, biographical sketches for key personnel, and letters of support, among other things. Each of these components should be prepared carefully following the guidelines outlined in the NOFO. Be sure to give your team plenty of time to prepare a compelling, thorough, and accurate application.
5. Submit Your application: Once your application is complete, you can submit it through the Grants.gov portal. Make sure to submit your application well ahead of the deadline to avoid any last-minute issues.
6. Await review: After submission, your application will undergo a thorough review process to assess its scientific and technical merit, potential for commercial success, and alignment with the SBIR program’s goals. The review process typically takes several months.

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1. Initial Administrative Review

   Upon submission, each application undergoes an initial administrative review by SBIR program staff to ensure it is complete and meets all the eligibility requirements.

2. Peer Review

   Applications that pass the initial review are then evaluated by a panel of independent experts from the scientific, technical, and business community. These panels review the proposal’s technical and scientific merit, commercial potential, and alignment with the SBIR program’s objectives.

   This review process involves evaluating several factors, such as:

• Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

• Principle Investigator(s): Are the project leaders and team well-suited to the project? Do they have appropriate experience and training, and have they demonstrated an ongoing record of accomplishments?
• Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?
• Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed?

3. Secondary Review

   After peer review, applications that are deemed to be the most promising are subject to a secondary review by the FDA’s advisory council. This review takes into account the input from the initial peer review along with considerations of programmatic priorities and available funding.

4. Award Decision

   Following the secondary review, the final funding decisions are made. Successful applicants are then notified, and the process of award negotiation and issuance begins.

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The current submission dates for FDA SBIR topics are as follows:

• September 5, 2023
• January 5, 2024
• April 5, 2024

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Company: Venarum Medical, LLC

Phase II Award Amount: $831,482

One noteworthy example of the success that can come from Phase II of the FDA’s SBIR program is the story of Venarum Medical. This innovative small business sought to address a common problem in our furry friends—urinary incontinence (UI) in dogs, which is when dogs can’t control their urine flow. This issue affects more than 20 percent of spayed female dogs in the U.S., which equates to around 5 million pets. Current treatment options are not consistently effective and carry potential risks.

Venarum Medical devised a solution called the Canine INCONTrol Urethral Valve System (K9-ICT). This unique device, delivered through a catheter, is placed in the urethra of the dog, effectively controlling urine flow and reducing leakage. The valve is embedded within a biocompatible polymer and can even be retrieved if necessary, reducing risks associated with poor placement or potential adverse reactions.

With the support from the FDA SBIR Phase II, Venarum Medical plans to fine-tune the K9-ICT system, conduct rigorous safety testing, and engage with veterinary professionals and canine UI experts to find the best route to commercialization. Their efforts showcase how SBIR funds can be instrumental in bringing solutions to market that not only positively impact the health of our beloved pets but also potentially transform treatment approaches.

Company: Nanohmics, Inc.

Phase II Award Amount: $585,293

Addressing a critical need in food safety, Nanohmics, a small business funded by the FDA SBIR Phase II program, has embarked on a mission to revolutionize the way we test for foodborne pathogens. This innovative team is developing a portable, low-cost, and highly sensitive device called MetaDot™. The device offers rapid multiplex screening for harmful pathogens from farm-to-fork, ensuring a safer food supply chain.

Unlike many existing pathogen test systems that can be costly, non-portable, or require specialized technicians, MetaDot™ provides high signal-to-noise ratio measurements. This portable, low-cost device outperforms commercial surface plasmon resonance (SPR) detection systems by having a greater microscopic surface area, thus increasing overlap between pathogens and reflected light.

The MetaDot reader will be easy to use and inexpensive to manufacture. Its flexibility will also allow it to be extended for other uses like first-aid wound infection diagnosis, on-site dental pathogen assessment, and screening for infectious diseases at ports of entry.

Company: En Solución Inc.

Phase II Award Amount: $2,241,172

In response to increasing consumer demand for fresh produce and concerns about foodborne illnesses, En Solución has developed a groundbreaking solution for the postharvest washing of produce. Supported by the FDA SBIR Phase II program, this innovation aims to eliminate contaminants that cause foodborne diseases.

En Solución is pioneering a new approach using nano-sized ozone gas bubbles, recognized by the FDA as safe and effective in reducing microbial contamination. Unlike traditional ozone bubbles, these nanobubbles stay in solution much longer, making the washing process more effective and safe for workers, as the ozone doesn’t outgas into the environment but reverts back to oxygen in the solution.

This technology not only enhances overall system efficiency but also improves water management by reducing the need for fresh water and enabling the reuse of water, as ozone leaves no harmful byproducts.

During Phase I, En Solución collaborated with experts in food safety, nanotechnology, applied science, workplace health, and sustainable agriculture practices to develop and validate this technology. In Phase II, the team will perform extensive field testing in various commercial fresh-cut vegetable processing facilities to prove its efficacy.

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Key elements of these accounting requirements include:

• Detailed Records: You must maintain comprehensive and accurate records of all costs incurred under the grant. These records include direct and indirect costs, labor hours, materials, equipment usage, and more. You need to keep these records up to date and ensure they are easily accessible for potential audits or reviews.
  
• Single Audits: If your company expends a certain threshold amount of federal funds in a fiscal year, you will be required to conduct a single audit, also known as a Uniform Guidance audit. This audit is a rigorous review of your company’s financial statements, federal award transactions, and compliance with applicable federal guidelines.
  
• Financial Reports: You must regularly submit financial reports as prescribed by the FDA SBIR program. These reports, which detail the financial status and progress of the funded project, help the FDA track the utilization of grant funds.