Frequently Asked Questions

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• What is a parent funding opportunity announcement?

  A parent funding opportunity announcement (FOA) allows an applicant to submit an investigator-initiated project for consideration by any of the NIH 24 Institutes and Centers (ICs), the CDC, and the FDA. The Parent SBIR and STTR announcements can be found on the funding announcements page.

• What is a targeted/special funding opportunity announcement?

  These targeted FOAs are periodically issued by one or more Institutes and Centers (ICs) and focus on specific areas of science that are priorities to the issuing institutes or centers. Special nuances and/or requirements (i.e., amount of funds that may be requested) may be imposed under these announcements.

• When may I submit an application?

  Receipt dates and related policies are posted on the NIH Grants website and here. If a receipt date falls on a weekend or holiday, the receipt date is the following business day. The standard due dates are September 5, January 5, and April 5 for applications submitted in response to a parent funding opportunity announcement. Submission dates for targeted/special announcements vary so you must check the announcement for its specific date(s).

• If I am unable to submit my application by the due date, may I submit it late?

  If an application is submitted after the required date, it must be accompanied by a cover letter explaining the reasons for the delay. Late applications are handled on an individual basis, considering the length of delay and the reasons provided. It is generally not possible to accommodate late applications for RFAs or other special receipt dates. Contacting Division of Receipt and Referral staff, review staff, or Institute program staff in advance will not result in permission to submit a late application. More information concerning NIH’s late policy is available can be found here.

• Where do I find the SBIR/STTR application submission package and instruction guide?

  The simplest way is to click the “Apply for Grant Electronically” button within the funding opportunity announcement to which you are responding. Both are also available from Grants.gov.

• Do I need to identify the Institute or Center to which I would like to submit my application?

  No, the Receipt and Referral Office of the NIH Center for Scientific Review (CSR) will assign each application to an appropriate Institute/Center (IC) for funding consideration. When the scientific areas and the research proposed in a grant application are sufficiently relevant to the research areas of two or more awarding institutes, CSR may assign your application to all such ICs. If your application is scientifically meritorious but the primary institute does not select your application for award, then the other assigned ICs may consider your application for funding. You are encouraged to contact program staff to discuss the appropriateness of your research area for a particular IC or review group.

  You may use the optional Assignment Request Form in the SF424 Forms-D to request a specific institute or study section assignment: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.600-phs-assignment-request-form.htm https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-008.html

• How do I know what the estimated start date of my project is?

  To select an appropriate beginning date for an application, consult the following schedule:

  SBIR and STTR Due Dates Phase I and Phase II		ESTIMATED Award Date
  September 5		March
  January 5		July
  April 5		September or December

• What funding opportunities are available after completion of my Phase II project?

  Some NIH Institutes/Centers offer Phase IIB Competing Renewal awards for those projects that require extraordinary time and effort in the R&D phase and may or may not require FDA approval for the development of projects such as drugs, devices, vaccines, therapeutics, and medical implants. Depending on the IC, the budget may be requested for up to $1M per year for up to 3 years. See the Omnibus Solicitation Program Descriptions and Research Topics for a full listing of those ICs that accept Phase II competing renewals. Prospective applicants are strongly encouraged to contact NIH program staff prior to submission.

• Can Phase I or II awardees from other federal organizations apply for NIH Phase II or Phase IIB as long as the specific aim of the project aligns with the mission of the Institute or Center?

  Yes, as long as the NIH Institute with whom you would apply is interested in receiving a Phase II or IIB. If the applicant SBC has a Phase I or a Phase II award from another agency, and they want to apply for a Phase II or Phase IIB at the NIH, the applicant must receive buy-in from the Program Officer ahead of time. The Program Officer is required to do internal paperwork to make sure the application can be submitted successfully, so it is imperative that the SBC and Program Officer have a conversation before the application is submitted.

• What is the difference between a “resubmission” and a “revision?”

  Resubmissions are applications that were previously submitted and reviewed but not selected for an award and are being resubmitted for evaluation again. These applications include an introduction addressing the comments of the previous reviewers. Revisions are competing supplemental applications to request support for a significant expansion of a project’s scope or research protocol.

• I’m submitting a Phase II. Is this a New, Renewal, or Continuation?

  It is a Renewal.

• How long does a grantee have to submit the Phase II application after the Phase I project ends?

  The grantee may submit a Phase II application either before or after expiration of the Phase I budget period. To maintain eligibility to seek Phase II support, a Phase I grantee should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period. If the grantee is outside of the six receipt period timeframe, they must contact their Phase I Program Officer and if the Program Officer is willing to receive an application, a waiver may be granted.

• What is the current NIH policy on resubmissions?

  Before April 16, 2014, NIH permitted one resubmission (A1) of an unfunded application (see NOT-OD-09-016). The extension on the NIH grant number could follow the pattern (A0, A1). A first-time submission is informally referred to as an A0, and the first resubmission is known as an A1. Any virtual A2s would be flagged by the NIH Center for Scientific Review.

  For all application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date (see NOT-OD-18-197).

  Resubmissions (A1) must be submitted within 37 months of the new (A0) application (see NOT-OD-10-140). For more details on the Resubmission Policy, visit the Resubmissions webpage and the Guide Notice, NOT-OD-18-197.

• How does NIH’s current resubmission policy affect SBIR/STTR Applicants?

  For all Phases, when submitting or re-submitting between an RFA and an investigator-initiated funding opportunity (PA, including Omnibus, PAR, PAS) see the below guidance found in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-100.html.

  • When an application that was submitted in response to an RFA is not funded and the investigator wishes to submit an application on this topic as an investigator-initiated application (PA, PAR, PAS), it is to be submitted as a New application, unless provision for a resubmission is clearly delineated in the RFA. In addition, if a subsequent RFA specifically solicits resubmissions of unfunded applications from a previous RFA, the instructions in the second RFA should be followed. In all other cases, an application submitted in response to an RFA and then resubmitted as an investigator-initiated application must be prepared as a New application. 
  • When a previously unfunded application that was originally submitted as an investigator-initiated application is to be submitted in response to an RFA, it is to be prepared as a New application. 

  In all other cases see the below guidance.

  Please review the four case studies for Phase I, Phase II/Phase IIB, Fast-Track, and Direct Phase II to understand how the current NIH resubmission policy relates to SBIR/STTR applicants.

  • Phase I
    • A Phase I application is a “Type 1” or “New” application. When the applicant submits a New Phase I application (A0) and it is not funded, the applicant can address reviewer comments and submit as a Resubmission A1 for the next appropriate application due date, or they can submit a New application (A0).
  • Fast-Track
    • A Fast-track application is also a “Type 1” or “New” application and follows the same rules as a Phase I. If a New Fast-track (A0) is not funded, the applicant can address reviewer comments and submit as a Resubmission Fast-track A1, or they can submit a New Fast-track (A0) for the next appropriate application due date.
    • If the Fast-track (A0 or A1) was not funded, the applicant can also revise down the scope of their application and submit as a New Phase I (A0).
  • Phase II/Phase IIB
    • A Phase II and Phase IIB are considered “Type 2” or “Renewal” applications. If an applicant does not get funded on the first submission (A0), they can re-submit an A1 for a Phase II/IIB.
    • If a Phase II or Phase IIB resubmission (Type 2, A1) is not funded, the applicant may submit a New Phase I, Fast-track, or SBIR Direct Phase II (Type 1, A0). However, the project will lose any association with the previously funded grant, and the New project must be substantially different than the previous project to avoid duplicative funding. If the applicant decides to submit a SBIR Direct Phase II, they must also have previously completed the Phase I equivalent work without any SBIR/STTR funds.
  • Direct Phase II
    • A Direct Phase II application is considered a “Type 1” or “New” application, but in order to be eligible for a Direct Phase II, the small business applicant must demonstrate the Phase I equivalence of their preliminary data in their Direct Phase II application. If a New SBIR Direct Phase II (A0) is not funded, the applicant can address reviewer comments and submit as a Resubmission SBIR Direct Phase II A1, or they can submit a SBIR New Direct Phase II (A0) for the next appropriate application due date. The small business applicant is not able to apply for a new Phase I or Fast-track (A0) unless they substantially change their project scope to prevent funding for a Phase I-like work already completed by the applicant.

   

• How much time do I have after the submission deadline to correct errors in my application and still submit for the same deadline?

  NIH has eliminated the error correction window from the application submission process. See NOT-OD-10-123. Please submit your application several days early to allow time to correct errors before the deadline. Your application must be submitted AND error-free by 5 PM your organization’s local time on the receipt date.

• If I incur problems with my electronic submission, who should I contact?

  Contact the Helpdesks for grants.gov and/or the eRA Commons:

  • Grants.gov:
    • Web:http://www.grants.gov/web/grants/support.html
    • Contact Center Phone: 1-800-518-4726
    • Business Hours: 24 hours a day, 7 days a week (closed on federal holidays)
    • Email support@grants.gov
  • eRA Commons:
    • Web: http://grants.nih.gov/grants/ElectronicReceipt/support.htm#desk
    • Toll-free: 1-866-504-9552
    • Phone: 301-402-7469
    • Hours: Mon-Fri, 7a.m. to 8 p.m. Eastern Time (closed on federal holidays)
• Where might I find a sample application?

  Sample Phase I & Phase II applications from the National Institute of Allergy and Infectious Diseases (NIAID) can be found here. Also, an annotated set of the SF424 SBIR/STTR (R&R) Application Forms can be found on this page. 

• Who needs to be registered in the eRA Commons from my company?

  The small business concern and the Project Director/Principal Investigator (PD/PI) must complete a one-time registration in the eRA Commons in order to submit applications to NIH. Organizational officials are responsible for registering the PD/PI in the eRA Commons. To find out if your organization is already Commons-registered, a "List of Commons Registered Organizations" can be found here.

  The PD/PI registration must be done by an organization official or their delegate who is already registered in the Commons. The PD/PI should work with their Authorized Organizational Representative (also known as Signing Official in the eRA Commons) to determine their institutional process for registration. For a step-by-step account, view the SBIR/STTR Annotated Form Set and the SBIR/STTR SF424 (R&R) Application Guide that can be found on this page.

  The eRA Commons is the discrete information exchange system where NIH and the applicant/grantee community are able conduct their extramural research administration business electronically. Please note:

  • It is vital that all Applicant/Grantee Organizations, Principal Investigators are registered in the eRA Commons and e-mail addresses are checked periodically for accuracy to avoid delays in the e-notification process
  • Special Note for STTR applicants: The STTR applicant organization must officially affiliate the PD/PI with the small business concern in the Commons if the PD/PI is not an employee of the small business concern.

  Following are the steps to affiliate a PD/PI to the applicant organization/institution:

  • PD/PI gives Commons user ID and email address to the administrator of the applicant institution. (The email address must be the one that is contained in the Personal Profile for the PI.)
  • Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
  • Administrator selects "Administration" tab and then "Accounts" tab.
  • Administrator selects "Create Affiliation" tab.
  • Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."

  Note: The account cannot have any other roles attached to it other than the PD/PI.

• If I'm employed by a university and own a small business, do I need two distinct eRA Commons names for each entity?

  A PI does not need two distinct eRA Commons names for each entity. An individual only needs one eRA Commons PI account, which will follow them throughout their career. A PI may have multiple affiliations with a university and a small business. However, a small business official at the small business concern must have a separate organizational eRA Commons account for the small business.

• When I try to submit any phase SBIR or STTR application using ASSIST or Workspace, I get a Global Validation Error that states my company is not eligible to submit to this FOA. All of our required registrations are valid, why is this happening?

  Call the eRA Commons Service Desk as soon as possible for advice and to confirm your eligibility. The signing official must access the company institutional eRA Commons profile, where they will find a new checkbox that needs to be checked, stating that you are eligible to apply.

• For Question #8 of the SBIR/STTR Information component, "Have you received SBIR Phase II awards from the Federal Government," how do I answer if my business has received less than 15 Phase II awards? If more than 15 Phase II awards?

  If your company has received any SBIR Phase II awards from the federal Government (including NIH), check the YES box. Then attach a file that includes either:

  • a statement indicating that the applicant small business has not received more than 15 SBIR Phase II awards from the federal Government during the preceding five fiscal years; or
  • a company commercialization history if you have received more than 15 Phase II SBIR awards from the federal Government during the preceding five fiscal years. The history must document the extent to which the company was able to secure Phase III funding to develop concepts resulting from previous Phase II SBIR awards, and for each Phase II award the history must include:
    • name of awarding agency;
    • award number and date;
    • amount of award;
    • title of project;
    • source, date, and amount of Phase III funding agreement; and
    • commercialization status of each Phase II award.

  If you have not received SBIR Phase II awards, then check the NO box.

• Is SAM the only registration that's annual? Do we have to worry about the other registrations also expiring?

  SAM is the only registration that must be renewed annually, which requires the SBC to log into SAM and renew their registration. The other registrations (DUNS, Grants.gov, eRA Commons and the SBA Company Registry) are one time and should only be updated if information changes. If the SBC moves or changes their address, they will have to go into all of the systems and update their information.

• My organization is applying for an STTR grant, and the PI on the grant application works in a different organization. On the SBIR/STTR SF424 (R&R) Cover component, the PI information in Item 15 reflects his organization, which is different than the applicant organization information in Item 5. When I go to the budget forms for period 1, the "Enter name of organization" is already pre-filled with the PI's organization name. This field does not allow edits; therefore I cannot change this field to reflect my organization name. What do I do?

  The Research and Related Budget component is incorrectly pre-populating the Organization Name. In order to proceed with your submission, please just ignore this field. The applicant organization should prepare its Research & Related Budget pages, making sure they indicated “Project” for the Budget Type. If a subaward/consortium is involved, the consortium grantee should complete their budget pages, making sure they indicate “Subaward/Consortium” for the Budget Type. The Budget Type field will help NIH staff properly distinguish between the 2 budgets until this glitch in the forms is fixed.

• Will you please explain the five-step registration process?

  Applicant organizations must complete and maintain the following registrations as described in the SF424 SBIR/STTR (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • SBA Company Registry – New requirement as per the Reauthorization. See “SF424(R&R) Other Project Information Component” for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
• My organization is applying for an STTR and the PI works for the partnering non-profit research organization. On the SBC budget pages, the PI is automatically entered, even though the PI is employed by the research organization. What should I do?

  The STTR form incorrectly prepopulates the research organization PI’s information. The applicant should put zero salary and zero effort for the academic PI on the SBC budget and relist them on the subaward budget page with the appropriate effort and dollar amount for salary.

• Is there anything that you should not discuss with the NIH SBIR or STTR Program Officer?

  This question brings up the differences between grants and contracts. Over 95 percent of NIH’s SBIR and STTR awards are in the form of grants; however, NIH also awards contracts. For grant awards, the applicant can call their Program Officer and discuss anything that is relevant to their application. There is no blackout period, and the applicant can discuss pre-review and post-review. The Program Officer might not have any updates or information to share at certain times, but the applicant is never barred from calling them.

  For contacts, the applicant’s only point of contact is the contracting officer before award. Applicants may not ask a Program Officer any information specific to their application while preparing or submitting a proposal or when it is under technical review.

• My organization has an NIH SBIR contract and would like to apply for an NIH SBIR/STTR Phase II or Phase IIB award. What should I enter for the Federal Identifier on the SF 424 (R&R) application page?

  In this scenario, the applicant should submit a New application (as opposed to a Renewal) with a predetermined ‘alternative’ Grant Number used for the Federal Identifier. The Federal Identifier will be the awarding IC code, followed by six 0s. For example, if the applicant would like for NHLBI to be the awarding institute, they’d enter HL000000.
  
  It is critically important for the applicant to inform the appropriate NIH SBIR/STTR Program Manager before they submit an application. The applicant should also include a cover letter indicating that the application is a Phase II or Phase IIB, and that the Phase I was from an NIH SBIR contract.
  
  Please contact eRA Help Desk with questions.

• My organization has received an SBIR/STTR award from another agency and would like to apply for an NIH Phase II or Phase IIB award. What should I enter for the Federal Identifier on the SF 424 (R&R) application page?

  In this scenario, the applicant should submit a New application (as opposed to a Renewal) with a predetermined ‘alternative’ Grant Number used for the Federal Identifier. The Federal Identifier will be the awarding IC code, followed by six 0s. For example, if the applicant would like for NHLBI to be the awarding institute, they’d enter HL000000.
  
  It is critically important for the applicant to inform the appropriate NIH SBIR/STTR Program Manager before they submit an application. The applicant should also include a cover letter indicating that the application is a Phase II or Phase IIB and indicate which agency funded their Phase I award.
  
  Please contact eRA Help Desk with questions.

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• What are clinical trials?

  NIH defines clinical trials here: https://grants.nih.gov/policy/clinical-trials/definition.htm

• What are the clinical trial requirements for grants and contracts?

  NIH policies for grants and contracts requiring clinical trials changed in January 2018. Review updated requirements here: https://grants.nih.gov/policy/clinical-trials.htm

• Under which funding opportunity should a small business apply if the research project includes a clinical trial?

  The NIH Office of Extramural Research – Clinical Trial Requirements page explains the requirement(s) for submitting applications through an FOA designated specifically for clinical trials: https://grants.nih.gov/policy/clinical-trials/specific-funding-opportunities.htm.

  • Funding Opportunity Announcements (FOAs) for Omnibus/Parent Solicitations: Researcher-initiated ideas are proposed via the SBIR and STTR Omnibus grant solicitations (also called funding opportunity announcements or FOAs) and can be found here: https://sbir.nih.gov/funding#omni-sbir
  • Funding Opportunity Announcements (FOAs) for Targeted Solicitations: Targeted SBIR/STTR grant solicitations are focused on specific research areas  can be found here: https://sbir.nih.gov/funding/individual-announcements

  See flowchart below.

   

• Is Good Clinical Practice (GCP) training required?

  Yes, see here: https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm

• Are there additional review criteria for research projects including a clinical trial?

  Yes, see here: https://grants.nih.gov/policy/clinical-trials/review-criteria.htm

• What are the requirements for registering and reporting NIH-funded clinical trials in ClinicalTrials.gov?

  All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov. Resources for understanding and complying with this policy are here: https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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• Are small businesses that have won federal SBIR/STTR Phase I or Phase II funds eligible to be a sole source provider to the government? How would this provision work?

  Yes, any small business that has received an SBIR or STTR Phase I or Phase II award from any federal agency is eligible to become a sole source provider to the government without having to go through an open contract competition.

  This enables the small business to propose a business solution or directly sell the product that was developed with the SBIR or STTR funding to any governmental agency. If the proposal meets the government’s needs and the agency wants to purchase the technology, the small business does not have to compete for the contract with other vendors in the open market. Instead, the government agency works internally with their acquisition experts to negotiate a contract agreement with the small business who can be the sole bidder for any business opportunity that does not have to be formally issued in FedBizOpps.gov. Normally, the government requires a full competition for the issuance of any Federal funds, thus the primary purpose of this sole source provision is to support the growth of small business.

  As a small business outside the government, it can be challenging to understand what the needs of the government are. The best way for the small business to know this is to leverage their networks and collaborate with the government agency or institute.

  The small business is not limited to offer their services and products only to the government agency which funded their SBIR/STTR project. For example, if a small business won an NIH SBIR Phase I or II award, they can be a sole source provider to any other federal agency like the Departments of Defense, Energy, Homeland Security, etc.

  The legal provision cited below can be found within each NIH SBIR or STTR solicitation, listed under the second paragraph of "Section I. Funding Opportunity Description" in "Part 2. Full Text of Announcement."

  "The competition for SBIR/STTR Phase I and Phase II awards satisfies the competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the Competition in Contracting Act. Therefore, an agency that wishes to fund an SBIR/STTR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III SBIR/STTR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is a SBIR/STTR Phase III award that is derived from, extends, or logically concludes efforts performed under prior SBIR/STTR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 253(b)(2)."

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• Overview of Changes
• Given the many changes resulting from the Reauthorization Act, where might I find information about NIH’s plan for implementing the changes?

  To keep up with the many changes to the NIH SBIR and STTR programs as a result of Reauthorization, frequently visit the NIH website entitled “SBIR/STTR Reauthorization Act Of 2011: NIH Implementation Of Key Changes (What to Expect and When)”.

• Funding
• Can you describe the hard cap limits?

  Reauthorization required that total funding support (direct costs, indirect costs, fee) which exceeds the hard caps ($225,000 for Phase I and $1,500,000 for Phase II) receive a waiver of approval from the SBA. The agency – not the applicant – must apply for this waiver. SBA has approved a topics list, which allows budgets to exceed the hard caps as long as the project topics are included on the list. The pre-approved topics list can be found in the Solicitaiton table on the Funding page. The preapproved topics list will be updated annually. Please discuss with an NIH SBIR/STTR Program Officer before submitting a budget over the hard cap limits.

• Eligibility
• VC-Owned Firms:
• Can a small business concern that is owned by multiple venture capitalist companies apply for the NIH SBIR program?

  Yes, as long as the small business concern (SBC) is more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these, and meets all of the other eligibility criteria. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 percent of the concern. For more information, please see NOT-OD-13-071.

  If the SBC is majority owned by multiple VC firms, they will need to complete the SBIR VCOC forms available here. To attach the form to the application, follow these steps:

  • Download the “SBIR Application VCOC Certification.pdf” at the NIH SBIR Forms webpage.
  • Answer the 3 questions and check the certification boxes.
  • The authorized business official must sign the certification.
  • Save the certification using the original file name. The file must be named “SBIR Application VCOC Certification.pdf”. DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
  • When you are completing the application package, attach this certification as a separate file by clicking "Add Attachments" located to the right of Other Attachments field on the “Research and Related Other Project Information” form.
• If a company is majority owned by multiple venture capitalist firms, does this give the company a strategic advantage?

  No, this information is not included within the peer review process nor the funding process. The projects are evaluated on the scientific merit of the project. NIH only uses the venture capital status to track award dollars.

• A small business is 54 percent owned by a VC and 12 percent owned by another VC. In the coming months, the small business expects to lower their 54 percent ownership to below 50 percent. Are they eligibility to apply?

  Yes, as long as the small business meets the eligibility requirements of being less than 50 percent owned by a single VC firm by the time of award (not submission). Currently, the small business IS NOT eligible since the SBC is majority owned by multiple VCs and a single VC owns more than 50 percent

  This company would NOT need to fill out a VCOC form with their application since a single VC owns more than 50 percent at the time of application. If the SBC goes under 50 percent owned by the first VC, the SBC would need to reevaluate after their equity distribution to see if they are majority VC owned and if so submit a VOCC form.

• If a single VC firm owns a majority of an SBC, is the SBC eligible to apply for an SBIR award?

  It depends, a VC can own a majority as long as the VC is more than 50 percent directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States, and the VC, awardee, and all other affiliates, have a total of 500 employees or less. A VOOC form should not be filled out.

  This scenario is an example of the regular eligibility criteria of being more than 50 percent owned and controlled by one or more business concerns (each of which is more than 50 percent directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States).

• My SBC is majority owned and operated by multiple VC firms, and one VC owns 52 percent of my company. Each of the VC firms is majority owned and operated by individuals who are US citizens or permanent residences. The VCs, awardee, and all other affiliates have a total of 500 employees or less. Is my SBC eligible to apply for SBIR?

  No, since the SBC has multiple VC ownership, and one VC owns greater than 50 percent, the SBC is not eligible to apply for SBIR. The multiple owned VC provision only applies if no VC owns more than 50 percent.

• SBA Company Registry
• What kind of applications need to have SBA Company Registration?

  All SBIR and STTR applicants are required to register with the SBA Company Registry Database at the time of application, and attach proof of registration to the application. This applies to all HHS SBIR/STTR programs, including NIH, CDC, FDA, and ACF.

• What do I do if I receive a warning related to SBA Company Registration?

  SBIR and STTR applicants applying to solicitations issued after 1/28/2013 are required to register with SBA through the http://sbir.gov registration web site and must attach their registration confirmation files to their applications. The confirmation file (with the original file name from the SBA in 'SBCxxxxxx.pdf' format) must be attached as a PDF file to the Other Attachments section of the R&R Other Project Information form. For additional information on SBA Registration requirements please refer to section IV of the parent funding opportunity announcement (FOA).

  If applying to SBIR/STTR solicitations issued prior to 1/28/2013, it is safe to ignore this warning. This warning will not stop the application from being received and processed and will not affect its peer review. However, you will be required to submit the SBA registration confirmation prior to award.

• Do subcontractors on the application also need to register with the SBA Company Registry?

  No, only the applicant small business concern should register on the SBA Company Registry. In the case were a small business is collaborating on a subaward with a second small business, the second small business does not need to register.

• SBIR/STTR Switching
• Is it permissible to switch a grant from an SBIR to an STTR and vice versa?

  Yes, NIH SBIR and STTR applicants may now switch programs at Phase II or Phase IIB to any active and open NIH SBIR or STTR solicitation, including SBIR and STTR Omnibus Solicitations and any SBIR or STTR targeted funding opportunity. Applicants must follow the all the rules and policies for the program and solicitation for which they are applying. The employment status of the PI, sub-contracting rules, etc., must be adhered to for the Phase II or IIB application to the opposite program. Applicants are also strongly advised to discuss this option with their Program Officer well in advance of any due date.

  This means that:

  • Phase I STTR Awardees may apply for NIH SBIR or STTR Phase II.
  • Phase I SBIR Awardees may apply for NIH SBIR or STTR Phase II.
  • Phase II STTR Awardees may apply for NIH SBIR or STTR Phase IIB.
  • Phase II SBIR Awardees may apply for NIH SBIR or STTR Phase IIB.
• Cross Agency Awards
• If my company received a Phase I SBIR or STTR award from another agency, may I apply to NIH for Phase II award?

  Yes, providing the NIH Institute or Center (IC) for which your Phase I project is applicable agrees to accept your Phase II application. Please contact an appropriate IC Program Officer and discuss the possibility of submitting a Phase II application.

  You may also switch between the SBIR and STTR programs. If you received an SBIR Phase I award from another agency, your Phase II to NIH could be STTR and vice versa.

• Direct to Phase II FOA
• How can applicants apply for the NIH SBIR Direct to Phase II Program?

  Applicants must apply through the general NIH Direct Phase II FOA or any other targeted Direct Phase II FOA. Applicants cannot submit a standard Phase II or a Fast-track application to a Direct Phase II FOA.

• What is the difference between a Direct Phase II solicitation and a Fast-track Solicitation?

  A Direct Phase II allows small businesses that are ready for the Phase II stage of development to bypass applying for a Phase I grant. The SBC must already have a technology prototype, and must have tested its feasibility (i.e. completed Phase-I-type R&D) to move directly into a Phase-II-type R&D.

  A fast-track incorporates a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together as one application. A fast track is intended to reduce or eliminate the funding gap between phases.

  Talk to an SBIR Program Officer to determine which FOA is appropriate for the SBC.

• What types of technologies are covered by the Direct Phase II solicitation?

  All of the NIH Institutes and Centers (ICS) listed in the Direct Phase II FOA will accept technology on anything within their mission space, with an exception of NINDS (National Institute of Neurological Disease and Stroke). The Direct Phase II is very similar to the Omnibus Solicitation in that as long as an SBC is proposing something within one of the Institute's missions, they will accept it under the Direct Phase II solicitation. NINDS is the exception and has a few topics listed that they will not accept under Direct Phase II; the Direct Phase II solicitation lists these very explicitly. For Direct Phase II as with any FOA, NIH strongly encourages applicants to talk with a Program Officer before submitting an application.

• Can you explain more about the level of feasibility necessary to qualify an application for a Direct Phase II FOA?

  Preliminary data commensurate with what would be accomplished during a Phase I award should be submitted in a Direct Phase II FOA application. Applicants should have “…demonstrated the scientific and technical merit and feasibility of the prototype stage of developing a biomedical technology that has commercial potential, R&D that is characteristic of Phase-I (R43) SBIR projects.” Applicants must demonstrate Phase I equivalence of their preliminary data.

• Will Direct Phase II applications be screened for responsiveness (i.e., equivalent of Phase I technical feasibility) before going to review?

  No, Direct Phase II applications will not be screened for responsiveness. There is an additional Review Criterion designed to cover the Phase I equivalence: “How well did the applicant demonstrate feasibility of the methodology or technology equivalent to meeting Phase I-level objectives, and providing a solid foundation for the proposed Phase II activity?”

• I’ve already submitted a Phase I application, but it is pending. Since that submission, I’ve made further progress. Can I submit the Phase II part of that project to the Direct Phase II FOA?

  Yes, but you cannot be funded for both awards.

• Can a company apply for a Direct Phase II if they did not do the feasibility work, but it was completed at the partnering research institution?

  Yes, but it will would be up to the company to sort out the proper licensing and intellectual property rights with the partnering research institution.

• Why isn’t there an STTR companion Direct Phase II FOA?

  The Reauthorization only authorized NIH to make Direct Phase II SBIR awards. Many prospective STTR applicants would also be able to apply to the SBIR program and are encouraged to speak with their program official to discuss the differences between the programs.

• Benchmark Rates
• What is the Phase I to Phase II Transition Rate?

  In accordance with the 2011 Reauthorization of the SBIR and STTR programs, Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently-completed fiscal year, must meet the benchmark minimum Transition Rate of 0.25.

  The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year.

  More information can be found on the NIH SBIR/STTR Reauthorization Eligibility Page.

• Does the Phase I to Phase II Transition Rate Benchmark only apply for Phase I applications? Does this benchmark also limit the number of Phase II applications my company can submit?

  The Phase I to Phase II Transition Rate Benchmark only applies to companies that have received 20 or more Phase I AWARDS in the past five years, excluding the most recently completed fiscal year.

  Strictly speaking, this only applies to new Phase I applications, but NIH is seeking guidance. Please contact your Program Officer for specific questions.

• My company has submitted more than 20 Phase I applications in the last 5 years and received less than 25 percent of that number in Phase II awards. Does that really mean I cannot submit anymore Phase I applications?

  The Transition Rate Benchmark applies to AWARDS, not applications. Companies that have received more than 20 Phase I AWARDS, must meet the Transition Rate Benchmark.

• What is the Phase II to Phase III Commercialization Rate?

  In accordance with the 2011 Reauthorization of the SBIR and STTR programs, Phase II awardees that have won multiple Phase II awards must meet the Commercialization Rate Benchmark. This requirement applies to companies that have received more than 15 Phase II awards from all agencies over the past 10 years, excluding the two most recently-completed Fiscal Years.

  Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.15 (15%) patents per Phase II award resulting from these awards. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10 year period, excluding the two most recently-completed Fiscal Years.

  More information can be found on the NIH SBIR/STTR Reauthorization Eligibility Page.

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• Do we have to be a formal company before we apply for a SBIR/STTR?

  The grants.gov submission/registration process requires that an applicant be a formal entity in order to submit an application to the federal government. However applicants need not meet the SBIR and STTR eligibility requirements until the time of award.

• Who may apply to the NIH SBIR and STTR programs?

  Only those small businesses that meet the SBIR/STTR eligibility criteria opportunity announcements may apply. Collaborating research institutions, i.e., universities, are subcontractors to the small businesses and may not apply as applicants.

• What is a Women-Owned Small Business (WOSB)?

  As defined by the Small Business Administration (SBA), a Women Owned Small Business (WOSB) must be at least 51 percent owned and controlled by one or more women, and primarily managed by one or more women (who must be US citizens). The firm must be “small” in its primary industry in accordance with SBA’s size standards. Small businesses that meet this criteria should self-certify that they are women-owned when they apply to NIH and every other federal agency. Applicants will find a check box on the application that will ask if they are a WOSB. If so, applicants should check this box.

  The government collects this information solely for tracking purposes. NIH must report this information in aggregate to the SBA and to Congress each year. One of the goals of the SBIR/STTR programs is to increase participation by WOSB and Socially and Economically Disadvantaged Business (SDB), so this information helps the SBIR agencies coordinate targeted outreach to these populations. NIH strongly encourages applicants to find out if they are a WOSB or SDB and check the appropriate boxes consistently on the applications. Checking the appropriate box consistently is important, as it will help NIH keep more accurate records which will help inform the agency’s communication strategy.

• What is a Socially and Economically Disadvantaged Business (SDB)?

  As defined by the Small Business Administration (SBA), a Socially and Economically Disadvantaged Business, also known as a Small Disadvantaged Business (SDB), must be 51 percent or more owned and control by one or more disadvantaged persons. The disadvantaged person or persons must be socially disadvantaged and economically disadvantaged, and the firm must be small, according to SBA’s size standards. The small business concern must self-certify by registering their business in the System for Award Management. Also, they should check a box on the application that is located next to the Women Owned Small Business (WOSB) check box. Businesses can be either, both or neither WOSB and SDB.

  As with the WOSB tracking, this information is used for reporting purposes only and all SBIR agencies encourage applicants to include this information if it is applicable to them.

• Are Women-Owned Small Businesses (WOSB) or Small Disadvantaged Businesses (SDB) given any advantage in the application process?

  No, a small business is never hurt nor helped by checking the WOSB or SDB application box. The government is congressionally-mandated to collect this information to report the statistics of awards. For this reason, it is very important that businesses know their WOSB and SDB status and correctly and consistently indicate this on every SBIR/STTR application. However, SBIR and STTR awards are reviewed on their scientific merit and funding decisions are based on scientific merit, available budget, and program priority.

  However, a WOSB or SDB designation can help small business applicants with federal government service contracts. For more information, please click here.

• Must the Principal Investigator be a U.S. citizen?

  No. The PI, the individual who is responsible for the scientific and technical direction of the project, is not required to have US citizenship, but the PI must legally reside in the United States and must be available to perform the research proposed for the duration of the project.

• May multiple PD/PIs be included on SBIR and STTR applications?

  Yes, more than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Each PD/PI must have a PD/PI role and a leadership plan is required. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application. The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project.

  Please also refer to the SF424 SBIR/STTR (R&R) Application Guide for more information about the requirements for multiple PD/PIs.

• Does the NIH Early Stage Investigator Policy apply to SBIR/STTR awards?

  No, the advantages of Early State Investigator (ESI) status apply only to applicants for traditional NIH research grants (R01s) and NIH Director’s New Innovator Grants (DP2s). More information about the ESI status can be found on the NIH New and Early Stage Investigator (ESI) Policies page.

• Do all the Project Directors/Principal Investigators (PD/PIs) on a multiple PI SBIR grant have to meet the SBIR primary employment requirement? What about STTRs?

  SBIR projects: The individual who serves as the Contact PD/PI must be from the Small Business and meet the primary employment requirement, but other PDs/PIs need not meet this requirement. Primary employment means that more than one half of the PD/PI's time is spent in the employ of the SBC at the time of award and during the conduct of the proposed project. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator’s Office.

  STTR projects: As is the case for an STTR project with a single PD/PI, the PD/PI is not required to be employed by the SBC. However, the Contact PD/PI, the first PD/PI listed, must have a formal appointment with, or commitment to, the SBC, which must be in the form of an official relationship between the parties, but need not include a salary or other form of remuneration. If the Contact PD/PI is not an employee of the SBC, the applicant organization must officially affiliate the PD/PI with the SBC in the Commons.

• Under the Multi-PI model, is there a minimum person-months requirement to qualify as a PD/PI?

  SBIR Applications: No. There is no minimum person-months requirement for individuals identified as PD/PIs. The reviewers will assess whether the level of effort is adequate to achieve the proposed goals. If there are deficiencies in this regard, it will negatively impact the score.

  STTR Applications: Yes. Each PD/PI must commit a minimum of 1.2 calendar months (10 percent effort) to the project and each PD/PI must have a formal appointment with or commitment to the applicant small business concern (SBC), which is characterized by an official relationship between the SBC and that individual. Use the Person Months website and calculator as a reference.

• Under the Multi-PI model, which PD/PIs must be registered in the eRA Commons?

  All PD/PIs must be registered and be assigned the PD/PI role in the eRA Commons prior to the submission of the application. Note: While each PD/PI must hold a PD/PI account in the Commons, PDs/PIs do not register with Grants.gov. Only the applicant organization registers with Grants.gov.

  In addition, all PDs/PIs at the applicant organization must be affiliated with that organization. When PDs/PIs are located at another organization, only the contact PI (the PI named on the SF424 SBIR/STTR (R&R) Cover) must be affiliated with the applicant small business concern (SBC); other PD/PIs need not be affiliated with the SBC, but must be affiliated with their own organization to be able to access the Commons. This affiliation must be done by the AOR/SO or their designee who is already registered in the Commons.

  All PD/PIs will have equal access to information related to the application or grant (e.g., Summary Statement, Notice of Grant Award)

  To affiliate the PD/PI with the small business concern, please follow instructions in the SF424 SBIR/STTR (R&R) Application Guide or use the directions below:

  • PD/PI gives Commons user ID and email address to the administrator of the applicant organization/institution. (The email address must be the one that is contained in the Personal Profile for the PD/PI.)
  • Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
  • Administrator selects "Administration" tab and then "Accounts" tab.
  • Administrator selects "Create Affiliation" tab.
  • Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."
  • On the Research & Related Senior/ Key Person Profile, in the Credential, (e.g., agency login) Field, the Commons UserName must be provided for all individuals assigned the PD/PI Role.
• Does it matter in what order the Multiple PD/PIs are listed on the application?

  Yes. The Contact PD/PI who must be affiliated with the applicant small business concern (SBC) submitting the application will be listed first. For both the SBIR Phase I and SBIR Phase II, the primary employment of the “Contact PD/PI” must be with the SBC at the time of award and during the conduct of the proposed project. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.

• What “Project Role” should be assigned to the multiple PD/PIs?

  All such individuals must be assigned the PD/PI role. Do not assign any individual the role of “Co-PD/PI” as this role is not currently used by NIH and other PHS agencies. If including individuals classified as “Other Significant Contributors (OSCs),” use the “Other” category and indicate “Other Significant Contributor” as the role in the “Other Project Role Category.” OSCs should be listed last after all other Senior/Key Persons have been listed.

• For a Multi-PI application under the SBIR/STTR Program, must the applicant organization always be the small business concern or may a collaborating research institution be so designated? Which organization/institution should be designated as the lead?

  The small business concern (SBC) is ALWAYS the applicant/awardee organization, regardless of whether the project is submitted as an SBIR, STTR, single-PD/PI or multiple PD/PI application. The SBC submitting the application is ALWAYS lead organization and any other organizations (including research institutions) subcontract to the SBC.

• Is there a special review criteria for resubmission applications and Phase IIB Competing Renewal applications submitted under the Multi-PI model?

  For all competing applications including revised applications and Competing Renewal (Phase IIB) applications, peer reviewers will consider whether the designated PD/PIs have appropriate training and experience to carry out the proposed study. A Phase IIB Competing Renewal submitted as a multiple-PD/PI application requesting support for a project that was previously supported through a single-PD/PI award should state the changes in the project's direction and management that led the PD/PIs to now propose the multiple-PD/PI model. In addition, the application should state how the research will be enhanced through the multiple-PD/PI approach.

• Our company recently just went public, does this affect our ability to apply for SBIR or STTR?

  No, public companies are eligible, but they have to ensure they are more than 50 percent directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States.) When a firm goes public, they must include their shareholders in their ownership determinations.

  Please review SBA’s Eligibility Guide for more detailed information.

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• Must all of the work on an SBIR project be completed by the small business?

  No, on an SBIR Phase I project, normally, a minimum of two-thirds (67 percent) of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual agreements to third parties for portions of the scientific and technical effort normally may not exceed 33 percent of the total amount requested. For Phase II or Phase IIB, normally, a minimum of 50 percent of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual agreements to third parties for portions of the scientific and technical effort generally may not exceed 50 percent of the total amount requested. Applicants are strongly encouraged to discuss deviations from these guidelines with NIH program staff listed in the Funding Opportunity Announcement.

• How much effort must be performed by the collaborating non-profit research institution on an STTR project?

  The single, collaborating research institution must perform a minimum of 30 percent of the effort and the small business must perform a minimum of 40 percent. The remaining 30 percent may be attributed to either of these organizations or an additional third party.

• Are subcontractors on an SBIR or STTR application required to provide a letter of support?

  Yes. Each individual and/or collaborating organization must include a letter confirming their role on the proposed project. For STTR, a letter from the collaborating institution must be included.

• Can a small business concern subcontract with a foreign entity?

  No, all work on the SBIR project must be conducted in the US, per statute. Only exceptional circumstances can be considered and possibly granted a waiver by the NIH. Please read the exception in the foreign involvement section of the FAQs. 

  However, if the company is US owned and operated, the PI can be foreign. There is no US citizenship requirement for PIs; however, the PIs must have a legal residency and work status in the US.

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• Is it permissible to submit a budget that deviates from the time and dollars normally awarded to Phase I or Phase II?

  Yes, according to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. Reauthorization required that budgets that exceed the hard caps ($225,000 for Phase I and $1,500,000 for Phase II) receive a waiver of approval from SBA. The agency – not the applicant – must apply for this waiver. SBA has recently approved a topics list, located on this page, which allows budgets to exceed the hard caps as long as the project topics are included on the list.

  Applicants are strongly encouraged to contact program officials prior to submitting any application. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.

• My company does not have a negotiated F&A (overhead) rate with NIH. What am I permitted to charge?

  The payment of facilities & administrative (F&A) costs is based upon rates established through a formal agreement between the grantee organization and the Federal agency. Phase I applicants who do not have a negotiated rate with a Federal agency should propose an estimated rate not to exceed 40 percent of the total direct costs. If awarded at a rate of 40 percent or less, the rate used to charge actual F&A may not exceed the awarded rate. NIH will not negotiate F&A rates for Phase I awards.

  Phase II/IIB applicants who propose a rate of 40 percent of total direct costs or less will not be required to provide further justification if selected for an award. The F&A costs will be awarded at the requested rate. The NIH Division of Financial Advisory Services will only negotiate rates with applicants who request more than 40 percent of total direct costs on a Phase II award. See notice NOT-OD-09-038.

• Please explain what is meant by the “fee.” Is this a direct cost or an indirect cost?

  A reasonable fee, not to exceed 7 percent of total costs (direct and indirect) for each Phase (I and II/IIB) of the project, is available to small business concerns receiving awards under the SBIR/STTR program. The fee is intended to be a reasonable profit factor available to for-profit organizations, consistent with normal profit margins provided to profit-making firms for research and development work. The amount requested for the fee should be based on the following guidelines: (1) it must be consistent with that paid under contracts by the PHS for similar research conducted under similar conditions of risk; (2) it must take into account the complexity and innovativeness of the research to be conducted under the SBIR/STTR project; and (3) it must recognize the extent of the expenditures for the grant project for equipment and for performance by other than the grantee organization through consultant and subaward agreements.

  The fee is not a direct or indirect "cost" item and may be used by the small business concern for any purpose, including additional effort under the SBIR/STTR award. The fee applies solely to the small business concern receiving the award and not to any other participant in the project. However, the grantee may pay a profit/fee to a contractor providing routine goods or services in accordance with normal commercial practice

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• May foreign work be proposed on an SBIR or STTR application?

  In rare and unique circumstances, for example, if a supply or material or the study design (e.g., patient population) is not available in the United States, NIH may allow a small portion of the research /R&D work to be performed by a foreign organization. Foreign involvement will be considered on a case-by-case basis and must be thoroughly justified in the application. Applicants should discuss their unique situations with NIH program staff prior to submission of the application. Whenever possible, non-SBIR/STTR funds should be used for other work outside of the United States that is necessary to the overall completion of the project.

• May grantees use grant funds to pay a foreign consultant’s travel to and from the U.S. site?

  While grant funds may be used to pay for services performed by the foreign consultant on site in the U.S., travel costs for consultants to and from the U.S. performance site must come from non-grant sources.

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• If I subcontract ALL of the Human Subjects work to a University do I still need to address the points in the Research Plan/Strategy?

  Yes, be sure to review the “Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan” in the SF424 SBIR/STTR (R&R) Application Guide.

• I will be using Human Subjects in my research but do not have approval by an Institutional Review Board (IRB) yet. Is this required at the time of submission?

  No, your company will be required to obtain an Assurance (typically a Single Project Assurance) by the time an award is made. Our NIH staff will initiate that process if you do not have an assurance, and you will work closely with your NIH program director and OHRP staff to negotiate such an assurance.

• If the Human Subjects work will be performed by a subcontractor, do I need a Federal Wide Assurance (FWA) also?

  Yes, any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to the Office for Human Research Protections (OHRP). The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP.

• When do I need Institutional Animal Care and Use Committee (IACUC) approval?

  IACUC approval must be obtained prior to award. NIH does not require IACUC approval of the proposed research before NIH peer review of an application. The applicant must address the points under the Vertebrate Animal section of the Other Research Plan section.

• Our project includes vertebrate animal work at our subcontractor site; they have an IACUC approval for the animal work, but we were told by our Grants Specialist that we will need an Interinstitutional Agreement before an award is made. Why is this needed?

  The NIH’s Office of Laboratory Animal Welfare (OLAW) negotiates Interinstitutional Agreement Assurances of Compliance when an awardee institution without an animal care and use program will rely on a research partner to conduct the animal work. This agreement insures that all involved parties are aware of their responsibilities regarding animal use and proper procedures are followed.

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• Please explain the NIH peer review scoring system?

  NIH uses a rigorous dual peer review system to ensure only the most meritorious scientific proposals are funded. Please see our NIH SBIR/STTR Review page for more specific information about the first and second round of review, and the scoring criteria.

• Who is included in the small business peer-review study sections?

  Small business study sections in the Center for Scientific Review (CSR) are specific to SBIR and STTR applications, meaning that SBIR and STTR applications are not reviewed in NIH’s standard academic study sections alongside R01s and R21s. The make-up of the small business study sections includes both academic and industry professionals who have a robust knowledge about the SBIR and STTR programs. CSR aims to have around 25 – 50 percent representation of industry professionals on the review panel. The academic professionals on the panel are also very familiar with the SBIR and STTR programs and frequently collaborate with small businesses on SBIR and STTR awards.

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• What are the page limit requirements?

  The page limits are included in the SF424 SBIR/STTR (R&R) Application Guide. The specific aims are limited to one page, research strategy to 6 pages for Phase I and 12 pages for Phase II/IIB and Fast Track applications, and the commercialization plans for Phase II/IIB and Fast Track applications are limited to 12 pages. Each biosketch is limited to 5 pages (new format). Resubmission introductions are limited to one page for all applications. Please review the Page Limits webpage for more information.

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• Does my Business have the right to file a patent if the work was funded by an NIH SBIR/STTR grant?

  Small business concerns normally retain the principal worldwide patent rights to any invention it develops with Government support, consistent with 35 USC 200-212 and its implementing regulations. Under existing regulations, 37 CFR 401, the Government receives a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world, reserves the right to require the patent-holder to license others in certain circumstances, and requires that anyone exclusively licensed to use or sell the invention in the United States must normally substantially manufacture in the United States any product embodying or product through use of the subject invention. To the extent authorized by 35 U.S.C. 205, the Government will not make public any information disclosing a Government-supported to allow the awardee a reasonable time for filing a patent application, nor will the Government release any information that is part of a patent application. For more information, read about the Bayh-Dole Act.

• Is the inclusion of proprietary information in an application considered disclosure and disqualify my company for applying for patents?

  Applications are submitted for evaluation purposes only and are reviewed in closed private (non-public) sessions by reviewers who are under strict confidentiality agreements with the federal government. Therefore, information contained in applications would normally not be considered as a public disclosure and should not affect the applicant’s ability to apply for patents. However, filing patent applications prior to submission of a funding application is something an applicant should consider in conjunction with their legal counsel. Also, it should be noted that the submitted abstract would be published upon award of the grant, so the abstract should be drafted carefully so as not to be considered as an enabling disclosure. Please review NIH’s Guide Notice (NOT-OD-14-073) about maintaining confidentiality during review.

  Also, according to NIH Grants Policy and Federal law, NIH recipient organizations must promptly report all inventions that are either conceived or first actually reduced to practice using NIH funding. Invention reporting compliance is described at http://www.iedison.gov. Grantees and contractors are required to submit all invention disclosures, related reports and documents electronically via Interagency Edison (iEdison). Paper reporting is not allowed. (See NOT-OD-15-080.) Information from these reports is retained by the NIH as confidential and submission does not constitute any public disclosure. Failure to report as described at 37 CFR Section 401.14 is a violation of 35 U.S.C. 202 and may result in loss of the rights of the recipient organization.

  Inquiries or correspondence should be directed to:

  Division of Extramural Inventions and Technology Resources,
  Office of Policy for Extramural Research Administration, OER, NIH,
  6705 Rockledge Drive, Suite 310, MSC 7980,
  Bethesda, MD 20892-7980,
  Telephone: (301) 435-1986
  Edison@nih.gov

• What do I need to submit to NIH at the end of the grant budget period? When are these reports due?

  The NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

  • Final Progress Report (requirements have changed - please see the NOT-OD-12-152)
  • Final Invention Statement and Certification (HHS 568)
  • Annual Invention Utilization Reports
  • Federal Financial Report (FFR) – replaced the Final Cash Transaction Report (PSC 272)
  • Phase II Data Collection Requirement for Government Tech-Net Database

  Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

  For details about each specific required report, see the section on “Award Guidelines, Reporting Requirements, and Other Considerations,” in the SF424 (R&R) SBIR/STTR Application Guide.

  The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of federal grants to report information about first-tier subawards and executive compensation under federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

• If my small business employs a subcontractor to do certain work under our SBIR/STTR award and the subcontractor makes a subject invention under that subaward, may our small business require the subcontractor to assign rights to that subject invention to our small business as part of the consideration for awarding the subcontract?

  No. 37 CFR 401.14 (a)(g) states "The subcontractor will retain all rights provided for the contractor in this clause, and the contractor will not, as part of the consideration for awarding the subcontract, obtain rights in the subcontractor's subject inventions." Therefore, if the subject invention is solely invented by subcontractor staff, the small business cannot require assignment of rights from the subcontractor as noted above. However, if the subject invention is jointly made by an employee of the small business and an employee of the subcontractor, both the small business and the subcontractor would already be co-owners of the subject invention by virtue of their respective employee's co-inventorship (assuming appropriate employment agreements are in place that requires assignment to the respective employer).

• Are patent costs allowable under an SBIR/STTR funding award?

  Patent costs are generally not allowable under an SBIR/STTR funding award. For more detailed information about the allowability of certain costs and activities under NIH funding awards, view the NIH Grants Policy Statement (GPS). NIH will typically not negotiate patent costs into F&A rates per the NIH Division of Financial Advisory Services (DFAS).

  While patent costs are generally unallowable, it should be noted that there is a reasonable fee/profit available to small business concerns receiving awards under the SBIR/STTR program which can be used for any purpose, such as covering patent expenses; however, this profit/fee must be included in the budget request at the time of application.

• Does my small business need intellectual property agreements as part of my SBIR/STTR grant application?

  A primary goal of the SBIR/STTR programs is the commercialization of technologies under the SBIR/STTR award. When accepting monies under an SBIR/STTR award, the small business is certifying that it is able to conduct the funded research toward commercialization. Therefore, a small business should ensure its ability to achieve that goal under its grant application and to freely move forward with the research. For example, under an STTR award which requires collaboration between a small business and a nonprofit research institution, it is expected that intellectual property issues between the partners that should be addressed early on to ensure that the flow of the research, development, and commercialization of the project continues unimpeded. Accordingly, small businesses and nonprofit research institutions should consider using the "Model STTR Intellectual Property Agreement" to address the allocation of rights in intellectual property and rights to carry out follow-on research, development, or commercialization https://sbir.nih.gov/sites/default/files/STTRModelAgreement.doc for an STTR award. This model agreement may also be considered for addressing similar situations under SBIR awards which may involve subcontractors. While IP agreements/arrangements should be worked out to ensure what the small business is proposing in its SBIR/STTR grant application will be achievable, these need not be submitted as part of the grant application.

• Does the Bayh-Dole Act require patenting under NIH SBIR/STTR funding awards?

  If the small business makes a subject invention under an NIH funding award, the funded organization is required to choose whether it will either elect or not elect title to the subject invention. If the organization chooses to elect title, then the Bayh-Dole Act does require the funded organization to file a patent application on the subject invention in a timely manner. However, if the organization chooses not to elect title, then the organization need not file a patent application under the Bayh-Dole Act.

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• Where can I find out what projects in my research topic area have been supported by NIH?

  The Research Portfolio Online Reporting Tool (RePORT) provides the public access to reports, data, and analyses of NIH research activities, including information on NIH expenditures and the results of NIH-supported research.

• How can I find out the success rates for different institutes and programs?

  The Research Portfolio Online Reporting Tool provides a link to success rates. Success rates are shown by specific activity codes (mechanisms). The Small Business Program consists of two Phases. The STTR Phase I uses the R41 mechanism and Phase II uses the R42 mechanism. The SBIR program Phase I uses the R43 mechanism and Phase II uses the R44 mechanism.