Phase I Outline/Instructions

NIH Phase I SBIR/STTR Proposal Outline
NIH SBIR/STTR Phase I Proposal Outline
Font requirements:
 Use an Arial, Helvetica, Palatino Linotype, or Georgia typeface in black only,
 Font size must be 11 points or larger.
 Symbol fonts may be used to insert special characters; the font size requirement still applies.
 Type density, including characters and spaces, must be no more than 15 characters per inch.
 Type may be no more than six lines per inch. Single spacing works well.
Paper size and margins:
 Use standard paper size (8 ½” x 11).
 Use at least 0.5 inch margins (top, bottom, left, and right) for all pages.
 No information should appear in the margins, including the PI’s name and page numbers. i.e. do
not use any headers or footers. [This includes the biosketches, watch for old-format headers and
Page Formatting
 Use only a standard, single-column format for the text.
 Do not include any information in a header or footer of the attachments. A header will be systemgenerated that references the name of the PD/PI and page numbers will be system-generated in
the complete application.
Figures, Graphs, Diagrams, Charts, Tables, Figure Legends, and Footnotes
 Smaller type size is allowed, but it must be in a black font color, readily legible, and follow the font
typeface requirement. It must still be readable.
 Color can be used in figures; however, all text must be in a black font color, clear and legible.
A resubmission must include a brief Introduction that summarizes the substantial additions,
deletions, and changes. The Introduction must also include responses to the criticisms and
issues raised in the Summary Statement. Note: This is ONLY required for a resubmission.
Page Limit: One Page
 State concisely the goals of the proposed research and summarize the expected
outcome(s), including the impact that the results of the proposed research will exert on
the research field(s) involved.
 List succinctly the specific objectives of the research proposed, e.g., to test a stated
hypothesis, create a novel design, solve a specific problem, challenge an existing
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NIH Phase I SBIR/STTR Proposal Outline
paradigm or clinical practice, address a critical barrier to progress in the field, or develop
new technology.
Page Limit: One Page.
a. Suggested Subheadings
 Introduction – Introduce the Company and state the goal of this SBIR/STTR
 Significance
 Problem to be solved – Describe the problem and its significance. Quantify
the problem in terms of its impact on human health.
 Gap in knowledge – Outline what is currently available and describe what is
missing to solve the problem.
 The Product – What are you actually going to ‘sell’ at the end of the SBIR/STTR?
 The Technological Innovation – What is new/novel/distinctive about your
technology? How will it change current practice?
 Impact
 Long Term Goal – of the project, not the company.
 Rationale for the goal – Briefly explain the reasoning behind the goal and
your approach.
 Phase I Hypothesis -- What research question are you asking in this Phase I and
how will it prove feasibility? (A Phase I must address feasibility.)
 Specific Aim 1…..
o Criteria for acceptance (quantitative if possible)
 Specific Aim 2…..
o Criteria for acceptance (quantitative if possible)
 Expected Outcomes – What do you expect to achieve in this Phase I?
 Plans for Phase II -- What R&D will you carry out in Phase II after proving
feasibility in Phase I?
 Commercial Application -- Describe the market for your technology, and briefly
state your company’s commercialization strategy for the product.
Organize the Research Strategy in the specified order and using the instructions provided
below. Start each section with the appropriate section heading—Significance, Innovation,
Approach. Cite published experimental details in the Research Strategy section and provide
the full reference in the Bibliography and References cited section.
Overall Page Limit: Six Pages
(a) Significance (suggest 1-2 pages)
 Explain the importance of the problem or critical barrier to progress in the field that the
proposed project addresses.
 Explain how the proposed project will improve scientific knowledge, technical
capability, and/or clinical practice in one or more broad fields.
 Describe how the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field will be changed if the proposed aims are
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NIH Phase I SBIR/STTR Proposal Outline
 Describe the commercial potential of the project to lead to a marketable
product, process or service.
i. Problem to be solved
ii. Product to be developed
a. Impact of proposed product to provide a solution
b. Impact of product/innovation on state of the science/technology
iii. Value of the solution to the problem
iv. Commercial Potential
a. Intellectual Property Issues
b. Market analysis
c. Competition (competing technologies and competitors)
d. Commercialization strategy
e. Other applications of the technology
(b) Innovation (suggest 1 page)
 Explain how the application challenges and seeks to shift current research or clinical
practice paradigms.
 Describe any novel theoretical concepts, approaches or methodologies,
instrumentation or intervention(s) to be developed or used, and any advantage over
existing methodologies, instrumentation or intervention(s).
 Explain any refinements, improvements, or new applications of theoretical concepts,
approaches or methodologies, instrumentation or interventions.
The technological innovation (describe)
Relevance to current state of the science
a. Why is it innovative?
b. How does it move the field forward?
c. What future advancements will this innovation enable?
(c) Approach (suggest 2-4 pages)
 Describe the overall strategy, methodology, and analyses to be used to accomplish the
specific aims of the project. Include how the data will be collected, analyzed, and
interpreted as well as any resource sharing plans as appropriate.
 Discuss potential problems, alternative strategies, and benchmarks for success
anticipated to achieve the aims.
 If the project is in the early stages of development, describe any strategy to establish
feasibility, and address the management of any high risk aspects of the proposed work.
 Point out any procedures, situations, or materials that may be hazardous to personnel
and precautions to be exercised.
 Include information on Preliminary Studies as part of the Approach section. Discuss the
PD/PI’s preliminary studies, data, and/or experience pertinent to this application.
Preliminary data can be an essential part of a research grant application and help to
establish the likelihood of success of the proposed project.
Prior Work
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NIH Phase I SBIR/STTR Proposal Outline
Rationale (why did you carry out the studies?)
Aims of the preliminary studies (what were the research aims?)
Results and conclusions
Summary (summarize how the preliminary studies apply to this SBIR/STTR)
For each specific aim, use the following sub-headings.
Specific Aim #
a. Rationale (why is this aim important to the project?)
b. Experimental Design & Methods
c. Data Analysis & Interpretation
d. Potential Pitfalls / Alternative Approaches
e. Expected Outcomes
Project Timeline:
Include a simple Project Development Chart (e.g., Gantt) with milestones.
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