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GENERAL APPLICATION GUIDE FOR NIH AND OTHER PHS AGENCIES
SF424 (R&R) - Forms Version D
Released: March 24, 2017

G.440 - SBIR/STTR Information Form

Who should use the SBIR/STTR Information Form:

All SBIR and STTR grant applicants must complete this form.

Introductory Fields

Program Type (select only one): SBIR/STTR/Both

A selection is required.

Check the correct box to indicate whether you are applying under the SBIR program or the STTR program. Note: HHS does not accept 'Both' as a choice.

SBIR/STTR Type (select only one): Phase I / Phase II / Fast-Track

A selection is required.

Check the correct box to indicate whether you are submitting a Phase I, Phase II, or Fast-Track Application.

Note: When submitting a Phase II Application following an awarded Phase I, please include the Phase I SBIR/STTR grant number in the "Federal Identifier" field on the G.200 - SF 424 (R&R) Form, Federal Identifier.

Questions 1-7 must be completed by all SBIR and STTR Applicants:

1a. Certification of Small Business Eligibility

A selection is required.

If you certify that at the time of award your organization will meet the eligibility criteria for a small business as defined in the FOA, check "Yes." Otherwise, check "No."

1b. Anticipated Number of personnel to be employed at your organization at the time of award.

This information is required. Enter the number of personnel anticipated to be employed by the small business at the time of award.

2. Does this application include subcontracts with Federal laboratories or any other Federal Government agencies?

A selection is required.

If this application includes subcontracts with federal laboratories or any other Federal Government agencies, check "Yes" and insert the name of the federal laboratories/agencies in the space provided. Otherwise, check "No."

3. Are you located in a HUBZone?

A selection is required.

If you are located in a HUBZone, check "Yes." Otherwise, check "No."

To find out whether your business is in a HUBZone, use the mapping utility provided on the Small Business Administration website.

4. Will all research and development on the project be performed in its entirety in the United States?

A selection is required.

If all research and development on the project will be performed in its entirety in the United States, check "Yes." Otherwise, check "No."

If you have answered "No" to this question, provide an explanation of the research and development that is being performed outside the United States in an "Explanation" attachment. Attach this information as a PDF file. See NIH's Format Attachments page.

5. Has the applicant and/or Program Director/Principal Investigator submitted proposals for essentially equivalent work under other Federal program solicitations or received other Federal awards for essentially equivalent work?

A selection is required.

If the applicant and/or PD/PI has submitted proposals for essentially equivalent work under other federal program solicitations or received other federal awards for essentially equivalent work, check "Yes" and enter the names of the other federal agencies in the space provided. Otherwise, check "No."

6. Disclosure Permission Statement

A selection is required.

If this application does not result in an award, and the Government is permitted to disclose the title of your proposed project, and the name, address, telephone number, and e-mail address of the official signing for the applicant organization, to organizations that may be interested in contacting you for further information (e.g., possible collaborations, investment), check "Yes." Otherwise check "No."

Your response will not affect any peer review or funding decisions.

7. Commercialization Plan

Who must complete the "Commercialization Plan" section:

If you are submitting a Phase II, Phase IIB, Phase I/Phase II Fast-Track, or Commercialization Readiness Pilot Program (CRP) Application, you must include a "Commercialization Plan" attachment.

Format:

Follow the page limits for the Commercialization Plan in the NIH Table of Page Limits unless otherwise specified in the FOA. You do not have to use the maximum number of pages allowed for your Commercialization Plan.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

The Commercialization Plan must be written in accord with the solicitation and these instructions.

Organize your Commercialization Plan into six separate sections, following the headings and order below. Start each section with the appropriate heading - Value of the SBIR/STTR Project, Expected Outcomes, and Impact; Company; Market, Customer, and Competition; Intellectual Property Protection; Finance Plan; and Revenue Stream. Provide a description for each of the following areas:

a. Value of the SBIR/STTR Project, Expected Outcomes, and Impact

Describe, in layperson's terms, the proposed project and its key technology objectives. State the product, process, or service to be developed in Phase III. Clarify the need that is addressed, specifying weaknesses in the current approaches to meet this need. In addition, describe the commercial applications of the research and the innovation inherent in this application. Be sure to also specify the potential societal, educational, and scientific benefits of this work. Explain the non-commercial impacts to the overall significance of the project. Explain how the SBIR/STTR project integrates with the overall business plan of the company.

b. Company

Give a brief description of your company, including corporate objectives, core competencies, present size (annual sales level and number and types of employees), history of previous federal and non-federal funding, regulatory experience, commercialization, and any current products/services that have significant sales. Include a short description of the origins of the company. Indicate your vision for the future, how you will grow/maintain a sustainable business entity, and how you will meet critical management functions as your company evolves from a small technology R&D business to a successful commercial entity.

c. Market, Customer, and Competition

Describe the market and/or market segments you are targeting and provide a brief profile of the potential customer. Tell what significant advantages your innovation will bring to the market (e.g., better performance; lower cost; faster, more efficient or effective, new capability). Explain the hurdles you will have to overcome in order to gain market/customer acceptance of your innovation.

Describe any strategic alliances, partnerships, or licensing agreements you have in place to get FDA approval (if required) and to market and sell your product.

Briefly describe your marketing and sales strategy. Give an overview of the current competitive landscape and any potential competitors over the next several years. A thorough understanding of the competition is essential to a successful application.

d. Intellectual Property (IP) Protection

Describe how you are going to protect the IP that results from your innovation. Also note other actions you may take that will constitute at least a temporal barrier against others aiming to provide a solution similar to yours.

e. Finance Plan

Describe the necessary financing you will require to commercialize the product, process, or service, and when it will be required. Describe your plans to raise the requisite financing to launch your innovation into Phase III and begin the revenue stream. Plans for this financing stage may be demonstrated in one or more of the following ways:

f. Production and Marketing Plan

Describe how the production of your product/process/service will occur (e.g., in-house manufacturing, contract manufacturing). Describe the steps you will take to market and sell your product/process/service. For example, explain plans for licensing, Internet sales, etc.

g. Revenue Stream

Explain how you plan to generate a revenue stream for your company should this project be a success. Examples of revenue stream generation include, but are not limited to, manufacture and direct sales, sales through value added resellers or other distributors, joint venture, licensing, and service. Describe how your staffing will change to meet your revenue expectations.

Your Phase III funding may be from any of a number of different sources, including, but not limited to:

Applicants are encouraged to seek commitment(s) of funds and/or resources from an investor or partner organization for commercialization of the product(s) or service(s) resulting from the SBIR/STTR grant. Place any relevant letters in the G.400 - PHS 398 Research Plan Form, Letters of Support attachment, following letters from consultants and collaborators.

SBIR-Specific Questions

8. Have you received SBIR Phase II awards from the Federal Government? If yes, provide a company commercialization history in accordance with agency-specific instructions.

A selection is required if you are submitting this application under the SBIR program.

If you have received SBIR Phase II awards from the Federal Government, check "Yes" and attach a statement or a company commercialization history in accordance with the instructions below. Attach this information as a PDF file. See NIH's Format Attachments page. Otherwise, check "No."

If the applicant small business has received an SBIR Phase II awards issued by NIH or any other Federal Government agency, attach a file that includes either:

(1) 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

(2) a company commercialization history if the applicant small business has received more than 15 Phase II SBIR awards from the Federal Government during the preceding five fiscal years.

The company commercialization 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.

For each Phase II award, the history must include: (1) name of awarding agency; (2) award number and date; (3) amount of award; (4) title of project; (5) source, date, and amount of Phase III funding agreement; and (6) commercialization status of each Phase II award.

9. Will the Project Director/Principal Investigator have his/her primary employment with the small business at the time of award?

A selection is required if you are submitting this application under the SBIR program.

If the PD/PI will have his/her primary employment with the small business at the time of award, check "Yes." Otherwise, check "No."

STTR-Specific Questions

10. Does the Project Director/Principal Investigator have a formal appointment or commitment either with the small business directly (as an employee or contractor) OR as an employee of the Research Institution, which in turn has made a commitment to the small business through the STTR application process; AND will the Project Director/Principal Investigator devote at least 10% effort to the proposed project?

A selection is required if you are submitting this application under the STTR program.

Check "Yes" if both of the following conditions are true:

  1. The PD/PI has a formal appointment or commitment either with the small business directly (as an employee or a contractor) OR as an employee of the Research Institution, which in turn has made a commitment to the small business through the STTR application process; and
  2. The PD/PI will devote at least 10% effort to the proposed project.

Check "No" if either or both of these two conditions is false.

11. In the joint research and development proposed in this project, does the small business perform at least 40% of the work and the research institution named in the application perform at least 30% of the work?

A selection is required if you are submitting this application under the STTR program.

If in the joint research and development proposed in this project, the small business performs at least 40% of the work and the research institution named in the application performs at least 30% of the work, check "Yes." Otherwise, check "No."