NINDS Small Business Program Frequently Asked Questions (FAQs)

 

Assistance from NINDS Program Staff

When should I contact Program Staff about my application?
We recommend you send a draft Specific Aims page to NINDS Small Business Program staff at least 4-6 weeks prior to the due date. Program staff will respond addressing fit within NINDS small business funding opportunities. If NINDS small business funding opportunities are not the best fit for your project, we may refer you to another IC or another NINDS Program Officer. If you have questions related to your application, please review this FAQ and the linked online resources to see if an answer is provided. If you have additional questions, please include them in your email to program staff so that we can quickly address them and direct you to helpful resources whenever possible. Please note that due to high demand, calls may need to be scheduled many weeks in advance, particularly when approaching submission deadlines. Please note that NINDS Program staff cannot provide technical direction or intellectual contribution to your project.

Can a Program Officer review my application before I submit?
Due to bandwidth limitations and to be fair to all applicants, NINDS Small Business Program Staff cannot review any sections of the application beyond the Specific Aims page.

NINDS Mission Fit

Does my project align with NINDS interests?
Neuroscience is supported by many NIH Institutes. The NINDS mission space encompasses hundreds of neurological disorders including stroke, spinal cord injury, epilepsy, neurodegeneration, traumatic brain injury, and neurogenetic disorders. NINDS small business funding supports a broad scope of modalities (small molecules, devices, biologics, biomarkers, assays) and stages of development (from bench to early clinical trials). Not sure if your proposal is within our mission? Visit NIH RePORT and search the Project RePORTer database to see if research like yours is supported by NINDS. If you are unsure, contact NINDS Small Business Program Staff with a draft Specific Aims page describing your project.

Will my project be assigned to NINDS?
Applicants may request specific assignment to an NIH Institute or Center using the PHS Assignment form. Ultimately, mission alignment governs assignment, and the Division of Receipt and Referral will assign the application to the most applicable IC participating in the NOFO to which you apply.

My product is a platform technology or meant for more than just neurological indications—is my project too broad for NINDS?
The NINDS Small Business Program supports efforts primarily focused on neurological indications. If your product will be regulated and marketed to individual indications, it is recommended that you focus on a single first-to-market indication in your application and contact the IC best aligned with that indication. Broadly-focused projects and platform technologies may be appropriate for other NIH Institutes and Centers (ICs), and we encourage applicants developing platform technologies to contact the NIH SEED Office for guidance toward the appropriate IC.

NOFO and Mechanism

Is there a specific funding opportunity at NINDS to which I should apply?
NINDS accepts a broad range of small business applications that are significant, innovative, and relevant to its mission. While NINDS has specific notices of funding opportunities (NOFOs), many of our applications are investigator-initiated and come in through the NIH SBIR and STTR omnibus solicitations.  After reviewing available funding opportunities, we recommend contacting NINDS Small Business Program Staff with a draft Specific Aims page for your project in order to confirm the best NOFO fit.  

What is the difference between the SBIR program and U44 funding opportunities through the Blueprint Neurotherapeutics Network, CREATE Bio, NINDS Biomarkers, and/or Translational Neural Devices programs?
NINDS has several translational programs that offer dedicated SBIR cooperative agreement (U44) funding opportunities open only to small businesses. Several of these programs provide resources in the form of consultants and contracted services to support research and development. Some U44 funding opportunities may be a particularly appropriate fit for projects that span late late-stage preclinical and early-stage clinical R&D. We highly encourage you to learn more about these programs on the NINDS Division of Translational Research website, reach out to U44 program contacts, and read the funding opportunity closely to understand the requirements for these programs. As stated in our notice, we highly encourage appropriate and eligible applicants to apply to these programs.

I’m interested in a U44 funding opportunity, but my project isn’t quite ready to be competitive.  What can I do?
Applicants who require additional R&D to submit a competitive project for U44 funding opportunities are encouraged to utilize traditional SBIR and STTR grant funding opportunities such as the NIH SBIR and STTR omnibus solicitations to address this gap in readiness.

My research fits with the IGNITE program – should I apply to IGNITE or SBIR/STTR funding opportunities?
The IGNITE NOFOs are open to a wider array of applicant institutions and do not utilize small business set-aside funding. Projects from small businesses that fit under the IGNITE program are likely to fit under the scope of the NIH SBIR and STTR omnibus solicitations. Business applicants who are eligible for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are strongly encouraged to take advantage of the congressionally mandated set-aside specifically for small businesses.

I found a funding opportunity that fits my project, can NINDS fund it?
Only Institutes and Centers listed as participating institutes on a notice of funding opportunity (NOFO) can fund submissions to that NOFO. If you do not see NINDS listed, check the expiration, affiliated notices, and whether the NOFO has been re-issued.

What should I consider if I am interested in a Fast-Track mechanism application?
When considering the Fast-Track mechanism, applicants are encouraged to evaluate whether they are able to demonstrate clear go/no-go criteria for feasibility, whether Phase II plans will not be altered by outcomes in Phase I, and whether they can put forward a strong commercialization plan. Additional information about the fast track mechanism is available at how to apply application guide.

I have demonstrated feasibility with strong Phase I-equivalent data. Can I apply for Phase II funding if I don’t have a funded Phase I?
The Direct to Phase II mechanism allows eligible small business applicants who have demonstrated the equivalent of Phase I feasibility data to receive Phase II SBIR and STTR funding. Please check to see if the NOFO you are interested in permits the Direct to Phase II mechanism and follow the guidance provided for Direct to Phase II applications. Keep in mind that Direct to Phase II applications require a strong commercialization plan, as outlined in NOFOs that permit this mechanism. More information about the Direct to Phase II mechanism is available at how to apply application guide.

When are later stage funding opportunities such as the Phase IIb and Commercialization Readiness Pilot (CRP) appropriate?
NINDS currently participates in Phase IIb and CRP funding opportunities. Companies that have been awarded Phase II SBIR or STTR funding are eligible for Phase IIb and Commercialization Readiness Pilot (CRP) funding opportunities. Applicants should be able to justify the need for additional NIH grant support for the project. Please note matching funding expectations outlined in the NINDS Phase IIB NOFOs. More information here about the Phase IIb mechanism and Commercialization Readiness Pilot program.

SBIR and STTR Policy

Can an Investigator be a PI on an SBIR if they are employed more than half-time by a small business and hold a full-time academic position?
No, this would not qualify as being primarily employed by the small business. This investigator can have another role on the SBIR team including multi-PI (MPI), and they can be the PI on an STTR.

Does my project’s outsourced work count as “fee for service”?
NINDS evaluates fee for service work on a case by case basis. NINDS will evaluate, at a minimum, whether or not the vendor is providing intellectual contribution to project direction and whether team expertise is clear and qualified for directing and interpreting fee for service work. Note that overhead/F&A is not permitted in fee for service work.

Human Subjects Research and Clinical Trials

Does the NINDS Small Business Program support human research and clinical trials? Yes. NINDS accepts and supports SBIR and STTR clinical trial applications through specific funding opportunities.  NINDS does not accept SBIR/STTR clinical trial applications through the Omnibus solicitations. Human subjects research that does not qualify as a clinical trial can be submitted through the Omnibus solicitation. Of note, clinical trial funding announcements often have specific requirements, so please read the funding announcement carefully. Most NINDS SBIR/STTR Clinical Trial funding opportunities expect applicants to have an IND, IDE, or non-significant risk designation from their IRB supporting clinical research in their project at the time of application. SBIR/STTR applicants considering projects involving human subjects research are strongly encouraged to contact NINDS program staff at least 4-6 weeks in advance of submission.

How do I know if my project qualifies as a clinical trial according to NIH?
NIH defines clinical trials here: clinical trials definition. If you are proposing human subjects research, we highly encourage you to utilize the NIH clinical trial decision tool to determine whether NIH defines your study as a clinical trial. Applicants proposing a clinical trial under NINDS SBIR/STTR funding should contact NINDS Small Business Program staff to verify the requirements and appropriate NOFO selection.

Do Clinical Trial NOFOs have specific review requirements?
Yes, see here: review criteria.

Project Budget and Timeline

Is there published guidance on project budgets and timelines for NINDS Small Business applications?
Yes, see detailed NINDS Small Business Program Budget Guidance, including pre-approved budget waiver topics, on our website.

How do I utilize NINDS waiver topics in my application? Do I need to get written approval that a waiver applies to my project?
No, explicit approval of budget waiver eligibility from NINDS program staff is neither needed nor granted prior to application submission. Waiver topic applicability should be determined by the applicant prior to submission. If your project falls within the pre-approved budget waiver topics listed on the NINDS Small Business Program Budget Guidance webpage, you can simply request a budget that meets our guidelines in your application. Program staff will verify waiver eligibility after the full application has been submitted. We strongly encourage that applicants submitting large budgets above the hard caps to contact program officials with a draft Specific Aims page at least 4-6 weeks prior to the submission due date. This will ensure that 1) the project is appropriate for NINDS; 2) the project is in line with one of these topic areas; and 3) NINDS budget considerations are understood.

Can Technical and Business Assistance (TABA) costs for NINDS budgets exceed the wavier maximums?

No, TABA costs must fit within the stated waiver maximum limits for NINDS. NINDS cannot support budgets over $700,000 for Phase I and $3,000,000 for Phase II, unless specified in a NOFO. You can learn more about TABA funding here. 

Application Development and Submission

I’m ready to apply. How do I get started?

1. Confirm small business eligibility
2. Begin required registrations
3. Review NIH SBIR/STTR processes and policies
4. Review the SF424 SBIR/STTR (R&R) Application Guide
5. Refer to the SBIR/STTR Annotated Form Set for step-by-step application instructions

My company has never received NIH SBIR or STTR funding. Are there any resources to help me develop a competitive application?
Small businesses who have not previously received NIH SBIR or STTR funding and are planning to submit a Phase I proposal to NINDS are likely to be eligible for the Applicant Assistance Program, which provides 10 weeks of proposal development coaching and support at no cost to the applicant. Applications for AAP participation typically open 4 months prior to the next submission due date. We highly encourage eligible small businesses to utilize this resource. If you have any questions or would like to receive information about the program, please email NIHAAP@evagarland.com

Where can I find example Specific Aims pages and applications?
Sample SBIR/STTR applications for different mechanisms, including sample Specific Aims pages, can be found at small business sample applications. 

When are applications due?
Most NINDS Small Business funding opportunities utilize standard SBIR/STTR due dates (January 5, April 5, September 5), or have due dates very close to these standard dates. More information on receipt dates and the review timeline can be found at the SEED Applying page. 

Is it important to include letters of support?
Yes, letters of support can help to demonstrate collaborator commitment, the interest of potential and existing partners, and enthusiasm of potential customers and key opinion leaders.  In addition, each individual, collaborating organization, and subcontractor must include a letter confirming their role on the proposed project. For STTR, a letter from the collaborating institution must be included.

How do I meet NINDS rigor guidelines in my application?
Applicants are advised to propose rigorous research and development activities. NINDS has several resources on rigor.

How do I develop strong milestones?
Please review following examples of milestones from NINDS programs: CounterAct and Translational Neural Devices.

Should I address commercialization in a Phase I proposal?
Commercialization potential of the product should be addressed. This may include IP status, market size, advantages over competitors, or other factors that could affect commercialization. Often this information is most appropriately addressed briefly in the significance section. However, please be sure to follow all application form guidance to avoid risk of noncompliance with application instructions. Please note there is no dedicated commercialization plan included in a Phase I application.

Can I include a link in my application, such as to our company website?
Be cautious about including links in your application, as it may put you at risk for violating “overstuffing” policies resulting in your application being withdrawn. For guidance on use of hyperlinks see notice NOT-OD-20-174. When in doubt, do not include links.

My aims are dependent, is this allowed?
Dependent aims may be appropriate for some projects, but applicants are advised to discuss risk mitigation strategies for how later aim(s) will be accomplished if first aim(s) are unsuccessful.  

How do I know if my technology is innovative, or whether a similar project has already been funded?
To find out if NIH has funded project(s) similar to yours, visit NIH RePORT and search the Project RePORTer database.

How do I address potential financial conflicts of interest between the small business and partner university?
It is up to the small business and university to agree to terms in adherence with the following grants policy: Financial Conflicts of Interest.

I’m having issues submitting my application, who can I contact for help?
The eRA Service Desk should be contacted for question related to the application process.

My application was withdrawn, can NINDS program staff reverse this decision?
The NIH Division of Receipt and Referral screens applications for compliance with requirements, including appropriate budget submission. Program staff at individual Institutes and Centers do not play a role in this process. The contact provided to you in communication from the Division of Receipt and Referral is the most appropriate point of contact for this issue.

Review Process

Can you provide an overview of the review process?
Please see the NIH Center for Scientific Review’s information on scoring and the overall review process, as well as the NIH Grants and Funding FAQs. In addition, review CSR’s presentation on advice for SBIR/STTR applicants and slides from a recent webinar presentation on SBIR and STTR review.

How do I request a specific study section?
You may enter up to three preferences for study sections in the “Assign to Study Section” row of the PHS Assignment form. You may list specific individuals who should not review your applications due to conflict of interest along with enough justification. In addition, we advise using the PHS Assignment form to request specific reviewer expertise, and be sure to carefully describe the technology in the form. SROs work hard to put your application in the best spot—this may not always be the SRG you suggest. Panel expertise shifts, and your application is meant to go to the reviewers and panels with the most appropriate expertise.

Do reviewers rotate in SBIR/STTR study sections?
The SBIR/STTR panels are not standing panels, they are special emphasis panels assembled ad-hoc each round with appropriate expertise to cover the assigned applications.

What if Ihave questions and concerns about my study section assignment?
Program and Review staff are kept separate by design. A Scientific Review Officer leads each panel, and Review staff oversee the assignment of applications to study sections and reviewers. If you have additional concerns or questions about the appropriateness of the study section assignment, please contact the Center for Scientific Review at csrdrr@mail.nih.gov and/or the Scientific Review Officer of the assigned study section.  

Can you tell me more about the review discussion of my application?
Following review, applicants will receive a Summary Statement that includes written comments from the assigned reviewers. Program staff may not disclose review information outside of what is included in the review Summary Statement.

Award Process

What is the overall award timeline?
Awards are typically made 6-8 months after the application submission date. For further information see SEED applying page.

When will I find out my funding recommendation?
Typically, funding recommendation notifications are sent out 2-3 weeks following the NINDS Council meeting that occurs 4-5 months post-submission. Please view the NANDS council page for meeting dates.

What is the NINDS SBIR/STTR pay line? Does my Priority Score determine whether I will be funded?
The NINDS small business program does not have a set pay line. NINDS limits consideration of SBIR applications to a zone of scores that may fluctuate due to funding availability. Within this zone, all applications are further evaluated for funding recommendations based on a combination of factors and in accordance with our priority statement.

I received a funding recommendation letter from NINDS—am I getting an award?
A funding recommendation is not an indication of funding. Funding is not guaranteed until a Notice of Award is issued, typically 1-2 months following a funding recommendation.

What happens if my small business loses eligibility prior to receiving a notice of award?
Applicants are required to sign a certification of SBIR/STTR eligibility prior to receiving an award. If your company is ineligible at the time of award, the award may need to be forfeited. Please contact NINDS Small Business Program Staff as soon as eligibility becomes a concern so that we can discuss next steps given your specific situation.

What percent of SBIR and STTR applications are funded?
Information about NIH SBIR/STTR funding is available by year and mechanism.

Resubmission

I want to reapply, what should I consider?
Carefully review the critiques in your Summary Statement and determine whether concerns are addressable. In a resubmission, you will be able to utilize an Introduction Page to constructively respond to reviewer critiques. If you are eligible for the Applicant Assistance Program, we highly encourage you to consider applying to this program prior to resubmitting. For more information on resubmission, see the NIH Small Business FAQ

Will I have the same reviewers and study section assignment on my resubmission?
Reviewers and study section assignment may shift between submissions. Program staff do not play a role in reviewer assignment. If you have additional concerns or questions about the appropriateness of the study section assignment, please contact the Center for Scientific Review at csrdrr@mail.nih.gov and/or the Scientific Review Officer of the assigned study section . 

How can I specify desired reviewer expertise?
In your resubmission, you may use the PHS Assignment form to request reviewer expertise. Make sure you carefully describe the technology.

Additional FAQs and Resources

The NIH Small Business Webpage and the NIH SBIR/STTR FAQ address NIH-wide policy on SBIR and STTR funding opportunities. FAQs on this site include:

• May foreign work be proposed on an SBIR or STTR application?
• Do I need IRB or IACUC approval at the time of application?
• If I am unable to submit my application by the due date, may I submit it late?
• Where do I find the SBIR/STTR application submission package and instruction guide?
• How do I know what the estimated start date of my project is?
• How long does a grantee have to submit the Phase II application after the Phase I project ends?
• How does NIH’s resubmission policy affect SBIR/STTR Applicants?
• Will you please explain the five-step registration process?
• Does the NIH Early Stage Investigator Policy apply to SBIR/STTR awards?
• Please explain what is meant by the “fee.”
• Are patent costs allowable under an SBIR/STTR funding award?
• Does my small business need intellectual property agreements as part of my SBIR/STTR grant application?
• I have a Phase I award, when can I apply for Phase II funding?
• My Phase II resubmission was not funded. Can I resubmit as a Phase II again?
• Can I switch between SBIR/STTR mechanisms in a resubmission?

The Center for Scientific Review Applicant FAQ and SBIR/STTR FAQ address scoring, funding decisions, and resubmission policies. FAQs on this site include:

• What are the biggest problems reviewers find in applications?
• I addressed the concerns from the prior critiques and my score got worse. Why?
• I don’t like the review group you put my application into. What can I do?

• How do you guard against a single reviewer having undue influence at the review?
• When will I receive word on my application?
• Must I wait for my summary statement before submitting my idea again?
• I'm a reviewer, can I submit my application late?
• Who is included in the small business peer-review study sections?
• How do I become an NIH SBIR/STTR application reviewer?

The NIH Grants and Funding FAQs address scoring, funding decisions, and resubmission policies. FAQs on this site include:

• What is the NIH scoring scale?
• What does the score mean; will my application be funded?
• Why wasn’t my application discussed?
• Which relationships constitute a conflict of interest in initial peer review?
• A reviewer scored a criterion at 3 or worse but described no weaknesses. How do I respond to this?
• My application has dual (secondary) assignment to another IC. Can my application be transferred to the other IC for funding?
• I received a request for Just-in-Time (JIT) information. Does this mean my application will be funded?
• When should I resubmit?

The DFAS FAQ addresses questions related to costs, indirect rates, and audits

The iEdison website and FAQs addresses questions around IP rights and reporting requirements

The NIH Policy Statement  contains NIH-wide policy on extramural awards

The Open Mike blog from the Office of Extramural Research contains additional helpful information for applicants

 

NINDS Small Business Program Contact Information

Sign up for the Division of Translational Research Listserv to stay up to date with the latest news and funding opportunities!

Emily Caporello, Ph.D.	Director	emily.caporello@nih.gov
Taryn Aubrecht, Ph.D.	Program Director, Clinical and Research Tools	taryn.aubrecht@nih.gov
Annette Gilchrist, Ph.D.	Program Director, Drug Development	annette.gilchrist@nih.gov
Jessica Forbes, Ph.D.	Health Program Specialist	jessica.forbes@nih.gov
Sara Sameni, Ph.D.	Health Program Specialist	sara.sameni@nih.gov
Sara Dauber, MBA	Strategic Consultant	sara.dauber@nih.gov