What are the main goals of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs?
The SBIR and STTR programs are Congressionally-mandated set-aside programs for domestic small business concerns to engage in Research/Research and Development (R/R&D) that has the potential for commercialization. The SBIR Program includes the following objectives: using small businesses to stimulate technological innovation, strengthening the role of small business in meeting Federal R/R&D needs, increasing private sector commercialization of innovations developed through Federal SBIR R&D, increasing small business participation in Federal R/R&D, and fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program. The STTR and SBIR programs are similar in that both programs seek to increase the participation of small businesses in Federal R&D and to increase private sector commercialization of technology developed through Federal R&D. The unique feature of the STTR program is the requirement for the small business concern applicant organization to formally collaborate with a research institution in Phase I and Phase II.
What are the differences between the SBIR and STTR programs?
There are 2 major differences- one relates to the PI and the other relates to a research partner. Under SBIR, the PI must be primarily employed with the small business concern at the time of award and for the duration of the project period, unless a waiver is granted by the NIH. Under the STTR Program, primary employment is not stipulated so the PD/PI may be from the small business or the collaborating non-profit research institution.
With regard to the research partner, SBIR permits, and in fact, encourages, research partnerships. However, STTR requires that the small business concern formally collaborate with a non-profit research institution. Under STTR, the SBC must perform at least 40 percent of the work and the research institution must perform at least 30 percent. The remaining 30% may be with the SBC, the single collaborating non-profit research institution, or an additional third party. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of the SF424 (R&R) application forms.
What is a Fast-Track award?
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. Because both phases undergo review at the same time, the NIH Fast-Track mechanism can reduce or eliminate the funding gap between phases.
What is a Direct Phase II FOA?
As part of the SBIR and STTR Reauthorization of 2011, NIH issued a pilot SBIR Direct to Phase II solicitation (PAR-14-088), which permits small businesses to receive a Phase II award even if they have not previously received a Phase I award for the research/research and development of their technology. In order to be eligible for the Pilot SBIR Direct Phase II award, the small business must have performed the Phase I stage-type of research through other funding sources.
The Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACF SBIR programs. Only the NIH Institutes and Centers listed in Components of Participating Organizations within the solicitation will accept Direct-to-Phase II SBIR submissions.
Applicants are strongly advised to discuss this option with their program officer well in advance of any due date.
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 23 Institutes and Centers (ICs), the CDC, and the FDA. The SBIR and STTR Omnibus Solicitations are parent announcements.
What is a targeted/special funding opportunity announcement?
These 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 Web site. If a receipt date falls on a weekend or holiday, the receipt date is the following business day. The standard due dates are April 5, August 5, and December 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 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-035.html.
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 (http://www.nih.gov/icd) or review group (http://public.csr.nih.gov/StudySections/SmallBusinessTechnologyTransfer/Pages/default.aspx). Requests for IC assignments and also for review group assignments may be included in the cover letter component of the application. CSR makes the final assignment determinations.
How do I know what the estimated start date of my project is?
To select an appropriate beginning date for a new application, consult the following schedule:
SBIR and STTR Due Dates Phase I and Phase II
ESTIMATED Award Date
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.
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.
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:
Where might I find a sample application?
Applications are submitted for evaluation purposes only and because they often contain proprietary information, samples are not currently available. NIH does, however, plan to post a sample sanitized application/s soon. Although it does not include a sample research plan, an annotated set of the SF424 (R&R) forms for the SBIR and STTR programs is available at http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf.
Who needs to be registered in the eRA Commons from my company?
In addition to registering with Grants.gov, both the small business concern and the Project Director/Principal Investigator (PD/PI) must also 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, see eRA Commons Registered Organizations.
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, click on Grantee Registration Steps for Commons (PDF - 105 KB). (Note: This applies to applicants as well as grantees despite the reference to “Grantee”.)
The eRA Commons is so important because this is now THE discrete information exchange system where NIH and the applicant/grantee community are able conduct their extramural research administration business electronically. As announced in a recent NIH Guide Notice, the following changes are currently in place:
In order to avoid delays in the e-notification process, 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.
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.
What kind of applications need to have SBA registration?
All SBIR and STTR applicants are required to register with the Company Registry Database at http://www.sbir.gov/registration 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 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): SBIR - PA-13-234 or STTR - PA-13-235.
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.
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.
My organization is applying for an STTR grant; however the PI on the grant application works in a different organization. On the 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.
How can applicants apply for the NIH SBIR Direct to Phase II Program?
Applicants must apply through the general NIH Direct Phase IIFOA or any other targeted Direct Phase IIFOA. Applicants cannot submit a standard Phase II or a Fast-Track application to a Direct Phase IIFOA.
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 IIFOA 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 applications be screened for responsiveness (i.e., equivalent of Phase I technical feasibility) before going to review?
No, 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.
The Phase I to Phase II Transition Rate Benchmark is new, and seems to only apply for Phase I applications, correct? Does this benchmark somehow 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% 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.
Recently, the budget caps were effectively waived for the Omnibus SBIR/STTR FOA for certain pre-approved topics. Is that true for this Direct-to-Phase II FOA as well?
The budget cap waivers apply to all awards in FY2014 and FY2015 made in response to all FOAs, including the Direct Phase II FOA, as long as the research topic is on the pre-approved waiver topic list.
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.
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. Using the contact list provided in the SBIR and STTR parent funding opportunity announcements (available from the NIH SBIR/STTR website), contact an appropriate IC program officer and discuss the possibility of submitting a Phase II application.
As a result of the SBIR and STTR Reauthorization Act of 2011, 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.
Is it permissible to switch a grant from an SBIR to an STTR and vice versa?
As a result of the SBIR and STTR Reauthorization Act of 2011, 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.
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 (see Section III of the funding opportunity announcement) until the time of award.
Who may apply to the NIH SBIR and STTR programs?
Only those small businesses that meet the eligibility criteria in Section III of the SBIR and STTR parent funding opportunity announcements may apply. Collaborating research institutions, i.e., universities, are subcontractors to the small businesses and may not apply as applicants.
What is the definition of VC-backed companies and what programs are they allowed to apply?
Concerns which are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are called VC-backed companies. Starting from July 2013, VC-backed companies can apply for NIH SBIR program. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern. VC-backed companies cannot apply to the CDC, FDA, ACF or to the NIH STTR program.
For more information about eligibility, please refer to section IV of the parent funding opportunity announcement (FOA) for SBIR program - PA-13-234.
What to do if a company is VC-backed?
Here are the extra steps to follow for submitting an SBIR application for a VC-backed company:
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.
Who can answer questions about eligibility of my company as a small business concern if my company is owned by individuals and venture capital companies?
For SBIR and STTR Solicitations Issued Prior to 1/28/13:
The Small Business Administration defines "small business concern" for purposes of the SBIR Program as one that on the date of award for both Phase I and Phase II/IIB funding agreements meets all of the following criteria:
is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture there can be no more than 49 percent participation by foreign business entities in the joint venture;
is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and,
has, including its affiliates, not more than 500 employees.
For SBIR and STTR Solicitations Issued After 1/28/13:
A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;
i. SBIR and STTR. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR
ii. NIH only and SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR
iii. SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.
Has, including its affiliates, not more than 500 employees.
Note: NIH only. If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.
If you have questions about size standards, each area office in SBA’s Office of Government Contracting has a designated Size Specialist. Contact the office nearest you using the following Web site: < http://www.sba.gov/content/guide-size-standards> (Note: the contact list is at the end of the document)
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 (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions). 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.
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.
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% 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. (Person Months website and calculator: http://grants.nih.gov/grants/policy/person_months_faqs.htm#q2)
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 (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.
NOTE: 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:
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.
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%) 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% of the total amount requested. For Phase II or Phase IIB, normally, a minimum of 50% 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% 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% of the effort and the small business must perform a minimum of 40%. The remaining 30% 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.
Is it permissible to submit a budget that deviates from the time and dollars normally awarded to Phase I or Phase II?
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. In accordance with the SBIR and STTR Reauthorization of 2011, budget hard caps were set that prevented awards from being over 50% of the award guideline (ie: the hard cap was set at $225,000 for SBIR and STTR Phase I awards, and $1,500,000 for SBIR and STTR Phase II awards.)
For awards that go over these recommended guidelines, SBA will need to issue a waiver approving the budget or the topic must be listed on the SBA pre-approved waiver topics list. This list of topics with the waiver must be approved by SBA annually.
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% of the total direct costs. If awarded at a rate of 40% 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. 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% 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
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. However, foreign investigators must come to the United States to perform the work. 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.
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” on page II-1 of the SF424 (R&R) 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 OHRP. The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP. (See <http://www.hhs.gov/ohrp > for further information.)
When do I need Institutional Animal Care and Use Committee (IACUC) approval?
IACUC approval must be obtained prior to award. NIH no longer requires 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.
Please explain the new scoring system.
As part of NIH’s effort to enhance peer review a new scoring system took effect starting with Sept 2009 council (FY2010). Please refer to NOT-OD-09-024. This scoring system was designed to encourage more reliable scoring of applications. Highly rating all applications greatly diminishes the ability of a reviewer or study section to communicate the scientific impact of an application. Therefore, reviewers who carefully consider the rating guidance provided in determining their scores improve not only the reliability of their scores, but also improve their ability to communicate the scientific impact of the applications reviewed. The new scoring system uses a 9-point rating scale (1 = exceptional; 9 = poor). The overall impact score for each discussed application will be determined by calculating the mean score from all the eligible members’ impact scores, and multiplying the average by 10; the overall impact score will be reported on the summary statement. Thus, the overall impact scores will range from 10 - 90. Overall impact scores will not be reported for applications that are not discussed. For a summary of the scoring system and procedure, see http://grants.nih.gov/grants/peer/guidelines_general/scoring_system_and_procedure.pdf.
J. Intellectual Property Protection & Confidentiality
Does my Business have the right to file a patent if the work was funded by an NIH SBIR/STTR grant?
Consistent with 35 USC 200-212 and its implementing regulations, small business concerns normally retain the principal worldwide patent rights to any invention it develops with Government support. 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. Refer to page 220 (III-50) Final Invention Statement and Certification (HHS-568) in the SBIR/STTR grant application instructions SF424 (R&R) Application and Electronic Submission Information.
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.
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 are encouraged to submit reports electronically using Interagency Edison (http://www.iedison.gov). 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
Where can I find out what projects in my research topic area have been supported by NIH?
The Research Portfolio Online Reporting Tool 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 http://report.nih.gov/index.aspx.
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 http://report.nih.gov/index.aspx. 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.