U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

SMALL BUSINESS GRANT PROGRAMS
INSTRUCTIONS FOR PREPARING SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PHASE I AND PHASE II GRANT APPLICATIONS

VI. SMALL BUSINESS RESEARCH GRANT PROGRAMS

A. INTRODUCTION

This section includes instructions to be used when applying for a competing (new Phase I or Phase II) PHS Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) grant. 

Begin by reading Section I, "Preparing Your Application"), and then follow both sets of instructions (Section I and "Specific SBIR/STTR Grant Application Instructions and Requirements" in this section), using the Sequential Guide for Preparing Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications below.

The applicant organization and the Principal Investigator are jointly responsible for the accuracy and validity of all the administrative, fiscal and scientific information in the application. Deliberate withholding, falsification, or misrepresentation of information could result in administrative actions such as withdrawal of an application or the suspension and/or termination of an award, as well as possible criminal penalties.

B. GENERAL INSTRUCTIONS

Note: In addition to reading and following the instructions in this section (Section VI), also refer to Section I-C, "Specific Instructions" and Section III, "Other Information" for important policy information and guidance in preparing an application to NIH.

Grant Application Forms

Read and follow the instructions carefully to avoid delays and misunderstandings.

Use the Public Health Service Grant Application (PHS 398) for all SBIR and STTR (Phase I, Phase II, and Fast-Track) applications. The PHS 398 forms and instructions are available electronically at http://grants.nih.gov/grants/funding/phs398/phs398.html. 

Forms.  Use the Public Health Service Grant Application forms (PHS 398) for all SBIR and STTR applications (Phase I, Phase II, and Phase I/Phase II Fast Track) in accordance with instructions in Chapter VI of the PHS 398.

The following PHS 398 forms (RTF or PDF) apply specifically to SBIR and STTR applicants:

Full Set: (MS Word PDF)

Individual Form Files:

Form Page 1:  Face Page (MS Word PDF)

Form Page 2:  Description, Performance Sites, and Key Personnel (MS Word PDF)

Form Page 3:  Research Grant Table of Contents (MS Word PDF)

Form Page 4:  Detailed Budget for Initial Budget Period (MS Word PDF)

Form Page 5:  Budget for Entire Proposed Period of Support (MS Word PDF)

Modular Budget Format Page (MS Word PDF)

Biographical Sketch Format Page (MS Word PDF)

Resources Format Page (MS Word PDF)

Checklist Form Page (MS Word PDF)

Personal Data Form Page (MS Word PDF)

Continuation Page (MS Word PDF)

Targeted/Planned Enrollment Format Page (MS Word PDF) (if Human Subjects research is proposed)

Enrollment Report Format Page (MS Word PDF) (if Human Subjects research is proposed)

Mailing Address, RFA and SBIR/STTR Labels (MS Word PDF)

STTR Research Institution Budget Form Page (MS Word PDF)

STTR Research Institution Certification Format Page (Modular STTR Budgets Only) (MS Word PDF)

There is NO FORM PAGE for the Research Plan. See http://grants.nih.gov/grants/funding/phs398/section_6.html#9_research_plan for specific instructions.

The PHS 398 Rich Text File (RTF) and Portable Document File (PDF) Form pages as provided are acceptable by NIH. All other sections of the application (e.g., Biographical Sketch, Introduction, if necessary, and the Research Plan) must conform to the specifications described below Deviations from the font size specifications and page limitations will be grounds for the PHS to reject and return the entire application without peer review.

FORMAT SPECIFICATIONS

The application must be clear, legible, and conform to all of the following requirements:

1. The height of the letters must not be smaller than 10 point. Helvetica or Arial 12-point is the NIH-suggested font.

2. Type density, including characters and spaces, must be no more than 15 characters per inch (cpi). For proportional spacing, the average for any representative section of text must not exceed 15 cpi.

3. Figures, charts, tables, figure legends, and footnotes may be smaller in size but MUST be readily legible.

4. There must be no more than 6 lines of type within a vertical inch.

5. Margins, in all directions, must be at least ½ inch.  Margins for all continuations pages must be at least ½ inch.

Type requirements should be checked on the printed document using a standard device for measuring type size, rather than relying on the font selected for a particular word processing/ printer combination.

Adherence to type size and line spacing requirements is necessary for several reasons. No applicant should have the advantage, by using small type characteristics, of providing more text in his/her application than other applicants.  Small type may also make it difficult for reviewers to read the application.

Failure to comply with type size and format specifications will be grounds for the PHS to return the application without peer review.

The Division of Receipt and Referral, Center for Scientific Review (CSR), NIH has the responsibility and authority to make the final determination of legibility, which is final and not appealable. Further inquiries should be directed to the:

Division of Receipt and Referral
CSR
Phone: (301) 435-0715; Fax: (301) 480-1987.

Prepare the application, single-sided and single-spaced. Use standard size, black type that can be photocopied; do not use photo reduction. Use English only and avoid jargon and unusual abbreviations. Draw all graphs, diagrams, tables, and charts in black ink.

Do not include in the body of the application photographs or other materials that are not printed directly on the application page.  Pictures or other materials that are pasted onto application pages are incompatible with the current duplication/scanning process.  You may include black-and-white or color images in the six (6) submitted copies provided such images are printed directly on the application page and are critical to the content of the application. Note, however, that the NIH uses black-ink photocopiers to reproduce applications for distribution to the scientific reviewers.

If you are submitting a Phase I application and scanned-in images are not possible, you must request permission of the Scientific Review Administrator to submit them (5 sets) as separate documents.  If you are submitting a Phase II application, you may submit pertinent photographs or other materials that cannot be photocopied as five collated sets as part of an appendix (see Section I-C-9, Appendix.)  In these circumstances, the original application must include black-ink images so as not to circumvent the page limitations for SBIR/STTR applications.

An SBIR/STTR application should represent a sound approach to the investigation of an important biomedical research, behavioral research, technological, engineering or scientific question, and that it is worthy of support under the stated criteria of this program solicitation.

An application should be self-contained and written with the care and thoroughness accorded to papers for publication.  The applicant should review the application carefully to ensure that information essential for evaluation are included. The scientific and technical merit of the proposed research is the primary concern for all research supported by NIH, CDC and FDA.

Potential applicants are strongly encouraged to contact agency program staff for pre-application guidance and/or for more specific information on the research topics described in this solicitation.

Submit the original and five exact, clear, single-sided photocopies of each application.

Page Limitations

Failure to comply with SBIR/STTR page limitations will be grounds for the PHS to return the application without peer review.

Phase I SBIR/STTR

NOTE: Items a-d of the RESEARCH PLAN are limited to a total of 15 pages for Phase I applications.

SBIR/STTR Phase I applications may not exceed 25 single-spaced standard size (8 «" x 11") pages, excluding:

• Cover letter.

• One-page "Introduction" required when submitting a revised application.

• Biographical Sketch Format Page(s) (maximum of 4 pages, for each key person).

• Sections e-j of the Research Plan

• Checklist Form Page

• Personal Data on Principal Investigator Form Page

• Letters of commitment from collaborators and consultants

• Page(s) furnishing information required under “Prior SBIR/STTR Phase II Awards” (Item k ; p. 92), if applicable.

•  “Research Institution Certification Format Page” (Modular STTR only)

Unless specifically solicited by NIH, Phase I appendices are not permitted and will not be considered in the review of the application.

Phase II SBIR/STTR

Items a-d of the Phase II RESEARCH PLAN are limited to 25 pages. There is no further limitation on the total number of pages for the entire Phase II application. 

Reminder Sheet

Applicants are encouraged to refer to the appropriate Phase I SBIR Reminder Sheet or Phase I STTR Reminder Sheet and, if necessary, Fast Track Reminder Sheet, to ensure that the requirements for submission have been met.

Information Required Prior to Award

If the application has the likelihood for funding, the following items will be routinely requested by the awarding component prior to making the grant award:

• Documentation to establish the "primary employment" of the Principal Investigator with the applicant small business concern. (SBIR only)

• Documentation regarding the  performance site(s) of the applicant  small business concern as shown on  the Face Page of the application, if  that site(s) is not owned by the  applicant organization.

• "Other support" for the Principal  Investigator and the other "Key  Personnel Engaged on Project"  named on Form Page 2, excluding  consultants.

Phase I/Phase II Fast-Track Applications (Applicable to NIH Only)

The SBIR/STTR "Fast-Track" option is designed to expedite the decision of Phase II funding through concurrent submission and peer review of both Phase I and Phase II projects. An advantage of the Fast-Track application process is the reduction or elimination of a funding gap between the Phase I and Phase II.

Fast-Track is an option available to those small business concerns whose Phase I and Phase II applications are scientifically meritorious and whose applications satisfy additional criteria (described below) that will enhance the potential for the project's commercial success. Applications that do not meet these criteria may be redirected for review through the standard review procedures. 

SBIR/STTR Fast-Track Application Instructions

1. Submit a complete Phase I and Phase II application, including, for each, the Face page, Form Page 2 (Description/Abstract), Form Page 3 (Table of Contents), Budget Form Pages, Biographical Sketch, Checklist Form Page, and Research Plan. Incomplete Fast-Track Applications and will be grounds for the PHS to return the application without peer review.  Review the Fast-Track Reminder Sheet before submitting the application.

2. Prepare the Fast-Track application in accordance with specific Phase I and Phase II grant application instructions and requirements.




3. Identify the application by typing the words "Fast Track: Phase I" in Item 2 on the Face Page of the Phase I and "Fast Track: Phase II" in Item 2 on the Face Page of the Phase II application.

4. Submit the completed Phase I and Phase II applications together in a single envelope or box. 5.     Prepare the Research Plan in accordance with specified page limitations for items a-d in each Phase (15 pages for Phase I; 25 pages for Phase II).

5. Specify in the Phase I application clear, appropriate measurable goals (milestones) that should be achieved prior to initiating Phase II. Failure to provide clear, measurable goals may be sufficient reason for the scientific peer review group to exclude the Phase II application from Fast-Track review. The scientific peer review group will evaluate the goals and may suggest other milestones that should be achieved prior to Phase II funding.

6. Submit a concise Product Development Plan (limited to ten pages).  Label this section clearly and include it at the end of the Research Plan (Item J). Address each of the following areas:

   1. Company information: including size; specialization area(s); products with significant sales; and history of previous Federal and non-Federal funding, regulatory experience, and subsequent commercialization (see Section III of this solicitation for definition of “commercialization”).

   2. Value of SBIR/STTR project, including lay description of key technology objectives, current competition, and advantages compared to competing products or services.

   3. Commercialization plans, milestones, target dates, market analyses of market size, and estimated market share after first year sales and after five years.

   4. Patent status or other protection of project intellectual property.

Applicants are ENCOURAGED to seek commitment(s) of funds and/or resources or letters of interest from an investor or partner organization for commercialization of the product(s) or service(s) resulting from the SBIR/STTR grant. 

Before submitting applications under "Fast-Track," applicant small business concerns and investigators are strongly encouraged to consult with the NIH program staff named in the table "Awarding Component/Agency Contact Information." Contacts are provided in the SBIR/STTR Grant Solicitation.

C. SPECIFIC SBIR/STTR GRANT APPLICATION INSTRUCTIONS AND REQUIREMENTS

See also PHS 398 Specific Instructions (Section I) for instructions on items not described in this section. Use the Sequential Guide for Preparing Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications to aid in completing the application.

1. Face Page (MS Word or PDF)

Item 1. Title of Project

See Specific 398 Instructions

Ordinarily, the SBIR/STTR Phase II application should carry the same title as the Phase I grant.

Item 2. Response to Specific Request for Application (RFA) or Program Announcement (PA) or Solicitation

Check "Yes."

For Phase I SBIR/STTR applications, insert the solicitation number (e.g., PHS 2002-2) listed on the cover page of the Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration for SBIR and STTR Grant Applications. Type "Fast-Track," if appropriate. Do not type PHS 398 in this line. 

For Phase II SBIR/STTR applications, type "Phase II SBIR" or "Phase II STTR," as appropriate. 

Attach to the bottom of the face page the appropriate SBIR or STTR label. Mailing labels may be found following the last form page.

If the application is submitted in response to an RFA or a PA, check "Yes" and identify the appropriate announcement number and title of the PA or RFA.

Item 3. Principal Investigator/Program Director

Item 3a. Name of Principal Investigator

Name the ONE person responsible to the applicant small business concern for the scientific and technical direction of the project. 

Note:

Under the SBIR Program, routinely the primary employment  (more than 50 percent time) of the Principal Investigator  must be with the small business concern at the time of  award and during the conduct of the proposed project.  Under the STTR Program, primary employment with the  small business concern is not stipulated.

Primary employment means that more than one half of the Principal Investigator's time is spent in the employ of the small business concern. Primary employment precludes full-time employment with another organization.

Item 3b. Degree(s)

See Specific 398 Instructions

Item 3c. Position Title

See Specific 398 Instructions

Item 3d. Mailing Address

See Specific 398 Instructions 

Item 3e. Department, Service, Laboratory, or Equivalent

See Specific 398 Instructions 

Item 3f. Major Subdivision

See Specific 398 Instructions 

Item 3g. Telephone and Fax Numbers

See Specific 398 Instructions 

Item 4. Human Subjects

See Specific 398 Instructions 

Item 4a. Exemptions from Human Subjects Regulations

See Specific 398 Instructions

Item 4b. Human Subjects Assurance Number

See Specific 398 Instructions

Item 4c. Phase III Clinical Trial

See Specific 398 Instructions

Item 5. Vertebrate Animals

See Specific 398 Instructions 

Item 5a. IACUC Certification

See Specific 398 Instructions

Item 5b. Animal Welfare Assurance

See Specific 398 Instructions

Item 6. Dates of Proposed Period of Support

Phase I: Routinely, SBIR Phase I awards do not exceed six (6) months and STTR Phase I awards do not exceed one year. 

Phase II: Routinely, SBIR and STTR Phase II awards do not exceed two years. 

Under special circumstances, applicants to NIH may propose longer periods of time for completion of the research project (e.g., feasibility demonstration.) Such requests that deviate from the guidelines must be thoroughly justified.

To select an appropriate beginning date for a new application, consult the review and award schedule. (See "Submitting Your SBIR/STTR Grant Application.)

PHS awarding components may not always be able to honor the requested start date. No commitments or obligations should be made until confirmation of the actual start date by the awarding component.

Item 7. Costs Requested for Initial Budget Period

Item 7a. Direct Costs Requested for Initial Budget Period

Enter the direct costs from Form Page 4 or from the Modular Budget Format Page, as appropriate. (Do not include amount requested for fee.)

Item 7b. Total Costs Requested for Initial Budget Period 

Enter the sum of (a) the total direct costs from Form Page 4; (b) the amount requested for fee on Form Page 4, and (c) the indirect costs derived from the Checklist Form Page. 

For Phase I SBIR/STTR applications that do not exceed one year, the direct and total costs for the entire "proposed period of support" (Item 8) will be the same as the direct and total costs for the "initial budget period" (Item 7).

Item 8. Costs Requested for Entire Proposed Period of Support

Item 8a. Direct Costs Requested for Proposed Period of Support 

Enter the "total direct costs for entire project period" from Form Page 5 or the "Modular Budget Format Page."

Item 8b. Total Costs Requested for Proposed Period of Support. 

Enter the sum of (a) the total direct costs from Form Page 5; (b) the amount requested for "Total fee requested for entire proposed period" on Form Page 5 or the "Modular Budget Format Page;" and (c) the indirect costs derived from the Checklist Form Page.

NOTE: The above applies to NIH ONLY, as CDC and FDA do not make awards greater than the stated guidelines.

Item 9.  Applicant Organization

Name the one organization (small business concern) that will be legally and financially responsible for the conduct of activities supported by the award. The small business concern is ALWAYS the applicant organization for an SBIR or STTR.

Item 10.  Type of Organization

Check the appropriate box. 

Small Business Certification

The applicant organization must certify that it will qualify as a small business concern at the time of award. Check the appropriate box under "For-Profit." Check the boxes designating the small business as "woman-owned" or "socially and economically disadvantaged," if appropriate. (See Section III-A, for definition of a small business concern.) Please note that the capture of information on socially and economically disadvantaged small business concerns and women-owned small business concerns is strictly for statistical purposes (as requested by the Small Business Administration).

Item 11.  Entity Identification Number, Duns Number, Congressional District

See Specific PHS 398 Instructions. 

Item 12. Administrative Official to be Notified if Award is Made

See Specific PHS 398 Instructions. 

Item 13. Official Signing for Applicant Organization

See Specific PHS 398 Instructions. 

Item 14. Principal Investigator/Program Director Assurance

See Specific PHS 398 Instructions. 

Item 15. Applicant Organization Certification and Acceptance

See Specific PHS 398 Instructions. 

2. Description, Performance Sites, and Key Personnel

FORM PAGE 2 (MS Word or PDF)

Description (Abstract of Research Plan)

Note the instructions on Form Page 2 for the information requested. In addition, discuss the potential of the research for technological innovation. The Abstract of Research Plan is limited to 200 words. If the application is funded, this description will become public information. Therefore, do not include proprietary or confidential information in the abstract.

Performance Sites

Indicate where the work described in the "Research Plan" will be conducted. One of the sites indicated must be that of the applicant small business concern. If there is more than one performance site, list all the sites and provide an explanation on the Resources Format Page of the application. The research or R&D project activity must be performed in its entirety in the United States. However, based on a rare and unique circumstance, for example, a supply or material or other project requirement that is not available in the United States, agencies may allow that portion of the research or R&D work to be performed or obtained in a country outside of the United States. Approval by the funding officer for such specific condition(s) must be in writing. 

Key Personnel

Key personnel are defined as all individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested. 

Typically, these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level should be included if their involvement meets the definition of key personnel. Consultants should also be included if they meet the definition of "key personnel."

Start with the principal investigator. All other key personnel should be listed in alphabetical order, last name first. For each individual provide: name, organization (their institutional affiliation), and role on the project. Under role on the project, indicate how the individual will function with regard to the proposed project. Use additional pages as necessary.

Disclosure Permission Statement. Check "YES" or "NO." If this application does not result in an award, is the Government permitted to disclose the title of your proposed project, and the name, address, telephone number and email address of the official signing for the applicant organization, to organizations that may be interested in contacting you for further information (e.g., possible collaboration, investment)?

3. Research Grant Table of Contents

FORM PAGE 3 (MS Word or PDF)

Provide the page number for each category listed on the Table of Contents. Number pages consecutively, at the bottom of each page, throughout the application. Do not include unnumbered pages and do not use suffixes, such as 5a, 5b.

Notice of Proprietary Information

Applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application.  When the application contains information that constitutes trade secrets; information that is commercial or financial; or information that is confidential or privileged, identify the information by asterisks (*) and page number in the Research Plan. You may also include a legend on PHS 398 Form Page 3 (Table of Contents) to identify the appropriate page numbers. The information is furnished to the Government in confidence with the understanding that it shall be used or disclosed only for evaluation of this application. If a grant is awarded as a result of, or in connection with, the submission of this application, the Government shall have the right to use or disclose the information to the extent authorized by law. This restriction does not limit the Government's right to use the information if it is obtained without restriction from another source.

4. Modular Applications: Special Instructions for Budgets of $100, 000 Total Costs or Less

Routinely, SBIR and STTR Phase I awards do not exceed $100,000 total costs (direct costs, indirect costs, and negotiated fee.) Routinely, total costs for the entire proposed Phase II period do not exceed $750,000 for SBIR and $500,000 for STTR projects. However, under special circumstances, applicants may propose greater amounts of funds for completion of the project.

Modular Format

• Used ONLY for SBIR/STTR applications requesting up to $100,000 total costs (direct costs, F&A/indirect costs, and profit/fee).

• Do not use Form Pages 4 and 5. Use as internal “worksheets” only in the development of the total direct costs.

• Use only the Modular Budget Format Page (MS Word or PDF)

• Budget requests are NOT made in increments of $25,000 (as they are for other grant mechanisms such as R01, R03, R15, and R21). 

• Under certain circumstances, additional budget information will be requested by the awarding component.

For all other applications, refer to the specific “Instructions for Preparing Budget Requests that Exceed $100,000 Total Costs."

Budget Instructions for SBIR/STTR Modular Grant Applications

SBIR Modular Applications: Complete the Modular Budget Format Page (MS Word or PDF).

 STTR Modular Applications: In addition to the Modular Budget Format Page, also include the STTR Research Institution Certification Format Page (MS Word or PDF). Do NOT include the Research Institution Budget Page. The “Total Cost” (direct and F&A costs) for the Research Institution is included in the Direct Costs of the Small Business Concern’s budget.

Modular Budget Format Page (MS Word or PDF).

Complete the “Initial Budget Period” and, if applicable, “Other Years of Support.” Enter the “Total Direct Costs Requested for Entire Project Period.”

Provide, in narrative format, the following information on Personnel, Consultant Costs, Contractual Costs and Fee. Use continuation page(s), if necessary. See specific STTR instructions, if applicable, for describing the work to be performed by the partnering research institution.

1. Personnel. Do not provide individual salary information. Starting with the Principal Investigator, list the names of all personnel. For STTR applications, also provide information for Research Institution personnel. Label this section as “STTR Personnel.” Include the following information for all SBIR/STTR personnel:

• Role of each individual on the project

• Description of their specific functions

• Percentage of effort that each individual will devote to the proposed project 

2. Consortium/contractual costs. Do not provide individual salary information.  Collaborating institutions must be domestic. The total cost for a consortium or contractual arrangement is included in the overall requested “modular” direct cost amount.

Provide the name of each contractor organization and an estimate of the total costs (direct plus facilities and administrative (F&A) costs for each consortium or subcontract. Describe their specific functions and state the percentage of effort that individuals will devote to the subcontract.

For STTR applications, also provide information for Consortium/Contractual Costs associated with the Research Institution’s portion of the budget. Label this section as “Research Institution Consortium/Contractual Costs.”

SBIR.  The total amount of contractual costs and consultant fees normally may not exceed 33% of the total costs requested on a Phase I SBIR project and 50% of the total costs requested on a Phase II SBIR project. Contractual arrangements for scientific or technical services (e.g., laboratory testing of biological materials, clinical services) may involve costs such as personnel, supplies, and any other allowable expenses, including indirect costs. 

STTR.  The small business concern-- the applicant organization-- must perform at least 40% of the work on the STTR project and a single partnering research institution must perform at least 30% of the work. The principal investigator must spend a minimum of ten percent effort on an STTR grant.

STTR APPLICATIONS: Following the Profit/Fee, indicate the TOTAL COST (sum of direct and F&A costs) of the portion of the project to be performed by the Research Institution on the “Modular Budget Format Page” and on the STTR Research Institution Certification Format Page.

Note:  A letter from the partnering research institution must be included with the application certifying that at least 30% of the work of the project will be performed by the research institution.  Use the STTR Research Institution Certification Format Page. (This 30% requirement applies to the single collaborating organization identified as the “research institution.”)

The “duly authorized representative” of the research institution must be an individual other than someone identified under “Key Personnel Engaged on Project” on Form Page 2 of the application who is authorized to act for and bind the research institution to similar arrangements on a routine basis. This may be the same individual who was authorized by the research institution to sign the agreement allocating between the small business concern and the research institution intellectual property rights and rights, if any, to carry out follow-on research, development, or commercialization applicable to the proposed project (see Model Agreement for Allocation of Rights.)

Costs pertaining to arrangements for a portion of the project to be conducted by other than the “research institution” should also be identified in narrative format on the “Modular Budget Format Page.” Indicate total costs.

3. Consultant Costs.  Provide the names and organizational affiliations of any consultants, other than those involved in contractual arrangements, who have agreed to serve in that capacity.  Include consultant physicians in connection with patient care.  Briefly describe the services to be performed, including the number of days of anticipated consultation, and the total costs requested for each individual. Letters of commitment from consultants and collaborators must be submitted with the application, but are excluded from the 25-page limitation.

The total amount of all consultant costs and contractual costs normally may not exceed 33% of the total costs requested on a Phase I SBIR project and 50% of the total costs requested on a Phase II SBIR project.

4. Fee.  Explain the basis for the amount of profit/fee requested.  A reasonable profit/fee is available to small business concerns receiving awards under the SBIR/STTR program. The amount of the fee approved by the agencies participating in this solicitation normally will not exceed 7% of total costs (direct and indirect) for each Phase (I and II) of the project.  The fee is not a “cost” item and may be used by the small business concern for any purpose, including additional effort under the SBIR/STTR award.  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 profit/fee applies solely to the small business concern receiving the SBIR/STTR 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.

Non-Modular Format

• Used for grant applications requesting more than $100,000 total costs (direct, indirect and profit/fee)

• Use Form Page 4 and Form Page 5

Routinely, SBIR/STTR Phase I total costs do not exceed $100,000.  Routinely, SBIR Phase II awards may not exceed $750,000 in total costs (direct costs, indirect costs, and negotiated fee) for a period normally not to exceed 2 years, and STTR Phase II awards normally may not exceed $500,000 total costs (direct costs, indirect costs, and negotiated fee) for a period normally not to exceed 2 years.

However, applicants may propose a greater amount of funds necessary and appropriate for completion of the research project.  (The above applies to NIH ONLY—applications to CDC and FDA are limited to $100,000 and therefore should use the Modular Budget Format Page.)

Budget Instructions for SBIR/STTR Non-Modular Grant Applications (Budget Requests that Exceed $100,000 Total Costs.)

SBIR budget pages: Submit Form Page 4 (Detailed Budget for Initial Budget Period  – Direct Costs Only) and submit Form Page 5 (Budget for Entire Proposed Period of Support.)

STTR budget pages: Submit Form Page 4, Form Page 5 and STTR Research Institution Budget Form Page.

Include detailed categorical budget information with the application. Budget information on Form Page 4 should reflect the total direct costs requested, which includes the total costs (direct and indirect) of any “contractual costs,” for the initial 12-month period (e.g., the entire Phase I project period or, in the case of a Phase II, the first year of the two-year project.)  All amounts must be in U.S. dollars.

• Refer to the SBIR or STTR Reminder Sheet before submitting the grant application.



• Enter Direct Costs in Item 7a of the Face Page.



• Enter Total Costs (sum of direct, F&A, and profit/fee) in Item 7b of the Face Page.



• Enter Direct Costs for ENTIRE Proposed Period of Support in Item 8a of the Face Page.

• Enter Total Costs (sum of direct, F&A and profit/fee) for ENTIRE Proposed Period of Support in Item 8b of the Face Page.

Do not include any items that are treated by the applicant organization as indirect costs according to a Federal rate negotiation agreement, except for those indirect costs included in consortium/contractual costs.

The following items pertain individually to the completion of Detailed Budget for Initial Budget Period – Direct Costs Only (Form Page 4) for budget requests greater than $100,000 total costs.

5. Detailed Budget for Initial Budget Period

FORM PAGE 4 (MS Word or PDF)

Form Page 4 is completed by the applicant small business concern and reflects the total direct costs for the first 12-month budget period. Phase I budget requests normally do not exceed six months.

Personnel

Name.  Starting with the principal investigator, list the names of all applicant organization employees who are to be involved on the project during the initial budget period, regardless of whether a salary is requested.

Role on Project.  Indicate how the individual will function with regard to the proposed project (for example, principal investigator, statistician.) Describe their specific functions under Justification on Form Page 5.

Type of Employment.  List the number of months per year reflected in an individual's employment agreement with the organization.  If employment is less than full time (e.g., 1/2 time or 3/4 time), enter an asterisk (*) after the number of months and provide a full explanation under Budget Justification on Form Page 5.

Percent Effort on Project. For each individual at the applicant organization, list the percent of each appointment to be spent on this project. If an individual engages in other corporate responsibilities, such as management, the total percentage devoted to all research activities by the individual must be less than 100%. For STTR projects, the Principal Investigator must devote a minimum of 10% effort to the project.

Institutional Base Salary.  The institutional base salary is defined as the annual compensation that the organization pays for the individual's employment, whether that individual's time is spent on research, administration, or other activities. Base salary excludes any income the individual may be permitted to earn outside of duties to the organization.  Base salary may not be increased as a result of replacing corporate salary funds with grant funds.

Dollar Amount Requested

Salary Requested.  Enter the dollar amounts for each position for which funds are requested. The maximum salary that may be requested is calculated by multiplying the individual's institutional base salary, defined above, by the percent of effort on this project.  Congress has imposed and may continue to impose salary caps.  Organizations should request appropriate salary support without regard to Congressional salary caps.  Any amount requested for salary that may be in excess of a salary cap will be adjusted at the time an award is issued.  Calculate the totals for each position and enter the subtotals in each column where indicated.

Fringe Benefits.  Commercial (for-profit) organizations usually treat “fringe benefits” as indirect costs.  These fringe benefits are applied to direct salaries charged to projects either through a fringe benefit rate or as part of an overhead/indirect cost rate.  Therefore, fringe benefits treated as indirect costs should not be included as a direct cost in the Personnel category of the budget on Form Page 4 of the grant application. In certain cases, fringe benefits may be requested as a direct cost to the extent that they are treated consistently by the organization as a direct cost to all sponsors.

Totals.  Calculate the totals for each position and enter the subtotals in each column where indicated.

Consultant Costs

Whether or not costs are involved, provide on Form Page 4 the names and organizational affiliations of any consultants, other than those involved in consortium/contractual arrangements, who have agreed to serve in that capacity.  Include consultant physicians in connection with patient care. See Section III-A. DEFINITIONS for definition of “Key Personnel Engaged on Project.”

REMINDER:  Letters of commitment from collaborators and consultants must be submitted with the application, but are excluded from the Phase I 25-page limitation.

On Form Page 5, briefly describe/justify the services to be performed, including the number of days of anticipated consultation, the expected rate of compensation, travel, per diem, and other related costs. 

Equipment

List each item of equipment separately and justify the request on Form Page 5. Provide the total dollar amount requested.   Explain the need for any item that appears to be duplicated or equivalent to those listed in the “Resources” portion on these forms.

Supplies

Itemize Categories in amounts less than $1,000 do not have to be itemized. Itemize supplies in separate categories, such as glassware, chemicals, radioisotopes, etc. Categories in amounts less than $1,000 do not have to be itemized. Justify the request on Form Page 5. If animals are to be purchased, state the species, the number to be used, their unit purchase cost, and their unit care cost. Provide the total dollar amount requested. 

Travel

Provide the total dollar amount requested.  Justify the request on Form Page 5. Describe the purpose of any travel, giving the number of trips involved, the destinations, and the number of individuals for whom funds are requested, bearing in mind that agency policy re­quires that less than first-class air travel be used.  Travel of a reasonable amount ($1,500-$2,000) may be proposed to attend conferences and similar meetings in the scientific field(s) of endeavor, to learn of new or emerging scientific interests of the PHS awarding components (for example, bioengineering), and to improve post award management. Travel to a scientific meeting in a foreign country is allowable, but this request should be thoroughly justified regardless of the dollar amount requested.

Patient Care Costs

The applicant organization may be reimbursed for inpatient and outpatient charges incurred incident to the proposed research.  Provide the names of the hospitals and/or clinics to be used and the amounts requested for each.  Indicate in detail the basis for estimating costs in this cate­gory, including the number of patient days, estimated cost per day, and cost per test or treatment.  Patient care costs do not include travel, lodging, and subsistence; request these costs in the “Other Expenses” category.  Request consultant physician fees in the “Consultant Costs” category.

Contractual Costs

Each participating consortium/contractual organization must submit a separate detailed budget for both the “Initial (Phase I) Budget Period” (Form Page 4) and, if the project period exceeds one year, the “Entire Proposed Project Period” (Form Page 5).

Consortium arrangements may involve personnel costs, supplies, and other allowable costs, including Facilities and Administrative (indirect) costs. Contractual arrangements for scientific or technical support services (e.g., laboratory testing of biological materials, clinical services, or data processing) may involve costs such as personnel, supplies, and any other allowable expenses, including indirect costs. Such contracts may be of sufficient scope to warrant a similar categorical breakdown of costs.

SBIR: For SBIR projects, the total amount of all contractual costs and consultant fees normally may not exceed 33% of the total costs requested on a Phase I project and 50% of the total costs requested on a Phase II project.

STTR:  STTR projects are required to be conducted through “cooperative research and development,” as that term is defined in Section III, Definitions. At least 40% of the work on the project must be performed by the small business concern and at least 30% of the work on the project must be performed by the single, partnering research institution. See instructions for preparing the  “Budget of Research Institution” at the end of this section.

Other Expenses

Itemize any other expenses by category and unit cost. These might include animal maintenance (unit care costs and number of care days), patient travel, donor fees, publication costs, computer charges, rentals and leases, equipment maintenance, service contracts, and tuition remission in lieu of salary. Justify costs on Form Page 5.

Fee

A reasonable fee 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 fee is not a “cost” item and may be used by the small business concern for any purpose, including additional effort under the SBIR/STTR award.  Therefore, enter the request for profit/fee as a separate line item below the “Total Direct Costs for Initial Budget Period.”  Justify on Form Page 5 the basis for the amount of fee requested.   

However, the amount of the fee approved by the agencies participating in this solicitation normally will not exceed seven 7% of total costs (direct and indirect) for each phase (I and II) of the project.  The fee applies solely to the small business concern receiving the SBIR/STTR 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.

6. Budget for Entire Proposed Period of Support

FORM PAGE 5 (MS Word or PDF)

Form Page 5 is completed by the applicant small business concern and reflects the total direct costs and fixed fee requested for the entire proposed Phase I or Phase II period. Enter the totals for the future year(s) based on the instructions under “Detailed Budget for Initial Budget Period.” Provide necessary justifications for the amount requested for profit/fee and other items described on the form.

Enter the totals under each budget category for all additional years of support requested. Identify with an asterisk (*), and justify any significant increases or decreases from the initial year budget, if applicable. Also, justify budgets with more than a standard escalation from the initial to the future year(s) of support. 

On the Face Page of the application, enter in Item 8a the amount for “Total Direct Costs for Entire Proposed Project Period” as indicated on Form Page 5. Enter in Item 8b, “Total Costs Requested for Proposed Period of Support” the sum of the following amounts: (1) Item 8a; plus (2) Total profit/fee for Entire Proposed Project Period; plus (3) Total F&A costs as indicated on the Checklist Form Page.

SBIR Applicants may proceed directly to the next section, "Biographical Sketch."

STTR applicants must refer to the following instructions on preparing the budget of the research institution.

Budget of Research Institution (STTR Only)

Phase I. Use STTR Research Institution Budget Form Page (MS Word or PDF) (STTR Additional Page) to identify costs pertaining to the portion (minimum 30%; maximum 60%) of the STTR project to be conducted by the "research institution." Provide information for Personnel, Consultant Costs, Equipment, Supplies, Travel, Patient Care Costs, Other Expenses, Total Direct Costs, Facilities and Administrative (F&A) Costs, and Total Costs associated with the research institution's portion of the budget in the same manner as described above.

Note: The partnering research institution must certify at the time of application that at least 30% of the work of the project will be performed by the research institution. This 30% requirement applies to the single collaborating organization identified as the "research institution." Space has been provided on the form for the requisite signature, printed name, title, and date of signature of the duly authorized representative of the research institution affirming certifications made by the research institution upon signing the budget page. 

On the Small Business Concern's Budget Page (Form Page 4) enter the "Direct Costs" and "Facilities and Administrative Costs" for the research institution in the field labeled "Consortium/Contractual Costs." Provide the F&A cost base and rate. That is, when the research institution requests F&A costs, these costs must be included on the Small Business Concern's budget page as a direct cost. If the STTR project period exceeds one year, use Form Page 4 and Form Page 5 to enter the information.

Justify costs under "Budget Justification" on Form Page 5 and identify them as pertaining to the research institution. Total costs of the portion of the project to be performed by the research institution are also to be shown in the Justification section of Form Page 5. 

Phase II. For the "Initial Budget Period," use the STTR Research Institution Form Page (STTR Additional Page) to identify costs pertaining to the portion (minimum 30%; maximum 60%) of the STTR project to be conducted by the "research institution." 

For the "Entire Proposed Project Period", use a separate Form Page 5 to identify costs pertaining to the portion of the STTR project to be conducted by the "research institution." Identify the research institution's budget page by typing "Budget of Research Institution" at the top of Form Page 5. Insert these additional pages after the budget pages of the small business concern (Form Page 4 and Form Page 5), numbering them sequentially. (Do not use 5a, 5b, 5c, etc.)

Provide information for Personnel, Consultant Costs, Equipment, Supplies, Travel, Patient Care Costs, Other Expenses, Subtotal Direct Costs, Total Direct Costs, and Consortium/Contractual Costs associated with the research institution's portion of the budget in the same manner as described above.

On the small business concern's budget pages for Initial Budget Period (Form Page 4) and Entire Proposed Project Period (Form Page 5), enter the "Direct Costs" and "Facilities and Administrative Costs" for the research institution in the field labeled "Consortium/Contractual Costs." Provide the F&A cost base and rate. That is, when the research institution requests F&A costs, these costs must be included on the Small Business Concern's budget page as a direct cost. 

On Form Page 5, justify costs under "Justification" and identify them as pertaining to the research institution. Total costs of the portion of the project to be performed by the research institution are also to be shown in the Justification section of Form Page 5. If space is not available on the form, attach a continuation page(s) for this purpose.

Costs pertaining to arrangements for a portion of the project to be conducted by other than the "research institution" should be identified by way of photocopying budget Form Page 4 and completing it in the same manner as described above. Contractual arrangements for scientific or technical services, such as the laboratory testing of biological materials, clinical services, etc., may involve costs such as personnel, supplies, and any other allowable expenses, including indirect costs. Costs of all contracts that are of sufficient scope to warrant a categorical breakdown of costs must be identified on a photocopied budget Form Page 4.

7. Biographical Sketch

Biographical Sketch Format Page (MS Word or PDF)

There is no form page for the Biographical Sketch. Follow the format on the "Biographical Sketch Format Page." See specific PHS 398 instructions in Section I, Item 6, "Biographical Sketch."

Other Support Information

NOTE: Information on "other support" should NOT be submitted with the application. If "other support" information is included in the application, the application will be returned to the applicant organization without peer review. "Other support" information is required for all applications that are to receive grant awards; however, NIH will request complete and up to date "other support" information from applicants at an appropriate time after peer review. The Institute's or Center's scientific program and grants management staff will review this information prior to award. 

8. Resources

Resources Format Page (MS Word or PDF)

There is no form page for resources. Follow the format on the "Resources Format Page." One of the sites indicated must be that of the applicant small business concern. If there are multiple performance sites, then resources available at each site should be described.

All performance sites identified in Item 8 on the Face Page of the application should be described under "Facilities." Use continuation pages, if necessary.

NOTE: The research to be performed by the applicant small business concern and its collaborators must be in U.S. facilities that are available to and under the control of each party for the conduct of each party's portion of the proposed project. 

9. Research Plan

(NO SPECIFIC FORM PAGE. USE CONTINUATION PAGES)

Items a-d of the Research Plan are limited to a total of 15 pages, including all tables and figures, for a Phase I application. Items a-d of the Research Plan are limited to a total of 25 pages for a Phase II application.

The Research Plan should include sufficient information needed for evaluation of the project, independent of any other document (e.g., previous application.) Be specific and informative and avoid redundancies. Unless specifically solicited by the agency, no appendices may be submitted with Phase I SBIR/STTR applications. 

Introduction. (Revised or Supplemental Applications Only)

All revised and supplemental applications must include an Introduction. Do not exceed one page for a revised Phase I application or supplemental application. Do not exceed three pages for a revised Phase II application. The "Introduction" is excluded from the page limitations of the Phase I or Phase II application.

Insert the Introduction at the very beginning of the Research Plan. In the "Introduction," summarize any substantial additions, deletions, and changes that have been made. Include responses to criticisms in the previous summary statement. Identify these changes within the text of the Research Plan by appropriate bracketing, indenting, or changing of typography. Do not underline or shade changes. Incorporate any work done since the prior version was submitted. A revised application will be returned if substantial revisions are not clearly apparent. Acceptance of a REVISED application automatically withdraws the prior version.

Competing Supplements

In certain well-justified circumstances, SBIR/STTR projects may warrant consideration of a supplemental award. A competing supplemental SBIR/STTR application may be submitted to request support for a significant expansion of a project's scope or research protocol. 

Applications for competitive supplements must be discussed with NIH program staff prior to submission. 

A supplemental application may not extend beyond the term of the current grant. The introduction to the supplemental application should provide an overall description of the nature of the supplement and how it will influence the specific aims, research design, and methods of the current grant. Any budgetary changes for the remainder of the project period of the current grant should be discussed under the budget justification. The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed supplement in relation to the goals of the original application. 

Phase I SBIR/STTR. Items a-d of the Phase I research plan are limited to a total of 15 pages.

Phase II SBIR/STTR. Items a-d of the Phase II "research plan" are limited to 25 pages, including all tables and figures. There is no further limitation on the total number of pages for the entire application. NOTE: A Phase I Progress Report is required for all Phase II SBIR/STTR applications.

Content of Research Plan

Organize Items a-d to answer these questions: (1) What do you intend to do? (2) What are the anticipated commercial products, processes, services and societal benefits? Why is the work important? (3) What has already been done? (4) How are you going to do the work? The suggested format for the Research Plan (see page limitations above) is as follows:

a. Specific Aims

State concisely and realistically what the proposed research is intended to accomplish in terms of its potential for technological innovation and commercial application. Define the proposed product to ultimately be developed. Applicants are encouraged to include milestones for each of the aims. One page is recommended.

b. Significance 

Briefly sketch the background to the present grant application, critically evaluate existing knowledge, and specifically identify the commercial opportunities and societal benefits that the project is intended to address. State concisely the importance of the proposed research by relating its specific aims to the longer-term objectives of Phase II. Two to three pages are recommended.

c. Preliminary Studies/Phase I Final Report

Phase I 

Preliminary data are not required for Phase I applications; however, such results may assist reviewers in assessing the likelihood of success of the proposed project and should be included in this section. Otherwise, note "Not applicable" in Item c, and proceed to Item d. 

Phase II 

Phase I Final Report 
(Applicable to Phase II applications only)

A Phase I Final Report is required for all Phase II applications. The report should be a presentation of the accomplishments of the Phase I effort. Abbreviations and language that may not be generally known to the broader scientific community should be avoided unless clearly defined. 

1. State the beginning and ending dates for the period covered by the SBIR Phase I grant.

2. List all key personnel who have worked on the project during that period, their titles, dates of service, and number of hours devoted to the project. 

3. Summarize the specific aims of the Phase I grant and provide a succinct account of published and unpublished results, indicating progress toward their achievement. Summarize the importance of the findings. Discuss any changes in the specific aims of Phase I since the project was initiated. 

4. List the titles and complete references to publications, manuscripts accepted for publication, patents, invention reports, and other printed materials, if any, that have resulted from the Phase I effort. 

5. Submit five copies of such items, except patent and invention reports, as an APPENDIX. Ten pages are recommended for the narrative portion of the Phase I Final Report.

d. Experimental/Research Design and Methods

Preliminary data are not required for Phase I applications. Discuss in detail the experimental design, procedures and protocols to be used, and the means by which the data will be analyzed and interpreted. Describe any new methodology and its advantage over existing methodologies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. Discuss the criteria that will be used to determine that feasibility has been demonstrated. Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.

e. Human Subjects 

Please give thorough consideration for the need of any human subject involvement in the Phase I feasibility work. 

If Item 4 on the Face Page of the application has been marked "Yes", refer to Section I-E. "Human Subjects Research" of the PHS 398 Specific Instructions. It is very important that you follow the detailed instructions in that section. Be sure to also consult information under "Section III-G, " Assurances and Certifications."

Note: Information under the headings “Protection of Human Subjects ,” the “Inclusion of Women," the "Inclusion of Minorities ,” the “Inclusion of Children in Research Involving Human Subjects,” and the “Data and Safety Monitoring Plan ” MUST be included in this portion of the Research Plan or the application will be designated as incomplete and will be grounds for the PHS to return the application without peer review.

Although no specific page limitation applies to this section of the application, be succinct.

In conducting peer review, Scientific Review Groups (SRGs) will evaluate proposed plans for inclusion of minorities and members of both sexes/genders, plans for sex/gender and racial/ethnic subgroup analyses of NIH defined Phase III clinical trials, plans for recruitment/outreach and retention in the design of clinical trials, and any justifications for exclusion of a sex/gender or racial/ethnic subgroup. This evaluation will be a part of the Approach criterion (see SBIR/STTR Review Criteria). The evaluation of the inclusion plans will be factored into the overall score that the SRGs award for scientific and technical merit of the application. In addition, awards will not be made if the research project does not comply with this policy.

f. Vertebrate Animals

If Item 5 on the FACE PAGE of the application has been marked "YES", address the following five points. Be sure to consult information under Section III. G. Assurances and Certifications.

1. Provide a detailed description of the proposed use of the animals in the work previously outlined in the Experimental Design and Methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.

2. Justify the use of animals, the choice of species, and the numbers used. 

3. Provide information on the veterinary care of the animals involved.

4. Describe the procedures for ensuring that discomfort, distress, pain and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices where appropriate to minimize discomfort, distress, pain and injury.

5. Describe any euthanasia method to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present justification for not following the recommendations.

NOTE: If the applicant small business concern does not have its own animal facilities and plans to utilize the facilities of a collaborating institution, such arrangements must be detailed in the application. Both the applicant small business concern and the collaborating institution, as well as any other performer at a different performance site, must have OLAW-approved Animal Welfare Assurances on file before an award can be made.

g. Literature Cited 

List literature citations at the end of the Research Plan. Each citation must include the title, names of all authors, the name of the book or journal, volume number, page numbers, and year of publication. Be judicious in compiling a relevant and current bibliography. It need not be exhaustive.

h. Contractual Arrangements 

Explain the programmatic and fiscal arrangements made between the applicant small business concern and the contractor(s). The consortium investigator and the authorized official at the consortium institution(s) must provide a signed statement or confirming letters that the appropriate programmatic and administrative personnel of each organization involved in the application are aware of the NIH consortium grant policy and are prepared to establish inter-institutional agreements consistent with that policy. Include confirming letters with application. These letters are excluded from Phase I 25 page count.

i. Consultants 

Attach appropriate letters from each individual confirming his or her role in the project. Include biographical sketches for each consultant. The Phase I 25-page limitation of the application excludes letters of commitment from collaborators and consultants. 

j. Product Development Plan

(Applicable to all Phase II applications and Phase I/ Phase II Fast-Track Applications)

Note: All Phase II applications and Fast Track applications must include a succinct commercialization plan, hereafter referenced as a "Product Development Plan (PDP)." The PDP is limited to ten pages.

Create a section entitled, "Product Development Plan," and address each of the following areas:

1. Company information: including size; specialization area(s); products with significant sales; and history of previous Federal and non-Federal funding, regulatory experience, and subsequent commercialization (see Section III. A for definition of "commercialization".)

2. Value of SBIR/STTR project, including lay description of key technology objectives, current competition, and advantages compared to competing products or services. 

3. Commercialization plans, milestones, target dates, market analyses of market size, and estimated market share after first year sales and after five years. 

4. Patent status or other protection of project intellectual property.

k. Prior SBIR Phase II Awards 

Excluded from Phase I page limitations. A small business concern that submits an SBIR Phase I application and that has received more than 15 Phase II SBIR awards during the preceding five (5) fiscal years must document the extent to which it was able to secure Phase III funding to develop concepts resulting from previous Phase II SBIR awards. The following information must be submitted in the Phase I application regarding each such prior Phase II award: (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 shown in item 1 above.

l. Research Institution Certification 

(Applicable to STTR Phase I and Phase II only)

Non-Modular Applications: Use “STTR Research Institution Budget Page (MS Word or PDF) See instructions under "Budget of Research Institution .

The certification, with the signature, printed name, title, and date of signature of the duly authorized representative of the research institution affirming certifications made by the research institution, must be included with the application or the application will be deemed incomplete and returned without peer review.

10. Appendix

(APPLICABLE ONLY TO PHASE II AND FAST-TRACK SBIR/STTR APPLICATIONS UNLESS SPECIFICALLY SOLICITED FOR PHASE I APPLICATIONS)

See Section I, Item 9 of the Specific PHS 398 instructions. 

11. Checklist 

Checklist Form Page (MS Word or PDF)

Excluded from the Phase I page limitation. This is the next-to-last form page of the application, but is the last page to be numbered. 

Type of Application

Check all that apply.

Inventions and Patents

(Phase II Applications Only). 

Check "No" if no inventions were conceived or reduced to practice during the course of work under this project. The remaining parts of the item are then not applicable.

Check "Yes" if any inventions were conceived or reduced to practice during the previous period of support. Also indicate whether this information has been previously reported to the PHS or to the applicant organization official responsible for patent matters.

Program Income

NIH policy requires applicants for research grants to include in their grant applications an estimate of the amount and source of program income (defined below) expected to be generated as a result of the project for which funding is being sought. The specific policies that govern the treatment of program income under research grants are set forth in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/). See Section III A. DEFINITIONS for a definition of "Program income." 

If no program income is anticipated during the period(s) for which grant support is requested, no other action is necessary.

If the response to this item is "Yes," follow the prescribed format to reflect, by budget period, the amount and source(s) of anticipated program income. If the application is funded, the Notice of Grant Award will provide specific instructions regarding the use of such income. (See NIH Grants Policy Statement for the policy on the treatment of program income earned under research grants.) All program income earned during the budget period must also be identified on the Financial Status Report.

The distribution of any income derived from royalties or licensing of an invention or patent is subject to specific provisions under 37 CFR Part 401. If any such income is anticipated, the applicant small business concern is encouraged to contact the Extramural Inventions and Technology Resources Branch, NIH, Phone: (301) 435-1986; Fax: (301) 480-0272; Email: gs60a@nih.gov or edison@od.nih.gov.

Applicants with questions concerning any aspect of this topic are encouraged to contact the Grants Management Officer of the appropriate PHS awarding component or the Division of Grants Policy, NIH, Phone: (301) 435-0949; Fax: (301) 435-3059.

Assurance/Certifications

Each application to the PHS requires that the following assurances and certifications listed on the Checklist be verified by the signature of the official signing for the applicant organization on the Face Page of the application. See Section III, "Policy and Additional Guidance."

Human Subjects 
Research on Transplantation of Human Fetal Tissue 
Women and Minority Inclusion Policy 
Inclusion of Children Policy 
Research Using Human Embryonic Stem Cells 
Vertebrate Animals 
Debarment and Suspension 
Drug-Free Workplace 
Lobbying 
Delinquent Federal Debt 
Research Misconduct 
Civil Rights 
Handicapped Individuals 
Sex Discrimination 
Age Discrimination 
Financial Conflict of Interest (not applicable to Phase I SBIR/STTR) 
Recombinant DNA 
Certification of Research Institution 
Participation (STTR Only)

Facilities and Administrative Costs

Note: Facilities and Administrative Costs, which are defined as costs that are incurred by a grantee for common or joint objectives and that, therefore, cannot be identified specifically with a particular project or program, were previously known as "indirect costs," and, in most instances, will be referred to in this document as "F&A costs." 

Request F&A costs by completing Section 3 on the Checklist. 

Indicate the applicant organization’s most recent F&A cost rate established with the appropriate PHS agency cost advisory office. If the applicant organization is in the process of initially developing or renegotiating a rate, or has established a rate with another Federal agency, it should, immediately upon notification that an award will be made, develop a tentative F&A cost rate proposal.  This is to be based on its most recently completed fiscal year in accordance with the principles set forth in the pertinent DHHS Guide for Establishing Indirect Cost Rates, and submitted to the appropriate PHS agency cost advisory office. Applicants are encouraged to visit http://ocm.od.nih.gov/dfas/dfas.htm. Questions may be directed to 301-496-2444.

Note:  If the applicant small business concern does not have currently effective negotiated F&A cost rates with a Federal agency, the applicant organization should propose estimated F&A costs. Applicants are encouraged to visit the DFAS website at http://ocm.od.nih.gov/dfas/dfas.htm and or call 301-496-2444.

Phase I applicants

1. Complete line 3a (Initial Budget Period) and, if applicable (e.g., 2-year Phase I), complete subsequent year(s).

2. Under “Explanation”, insert “Estimated F&A costs allocable (applicable) to this project are shown in line 3a” if you do not have a currently negotiated F&A costs rate with a Federal Agency.

Phase II applicants

1. Complete line 3a (Initial Budget Period) for first 12-month budget period, line 3b (-02 Year) for second budget period, and subsequent year(s) as appropriate.

2. Under “Explanation”, insert “Rate to be negotiated with NIH” if you do not have a currently negotiated F&A cost rate with a Federal Agency.

Policy 

Phase I Grants. If the applicant small business concern has a currently effective negotiated F&A costs rate with a Federal agency, it should be used when calculating proposed F&A costs. (However, these rates must be adjusted for independent [self-sponsored] research and development expenses, which are not allowable by the Department of Health and Human Services [HHS]. See "Discussion and Negotiation of Indirect Costs" later in this section.)

Note: If the applicant small business concern does not have a currently effective negotiated indirect costs rate with a Federal agency, the applicant organization should propose estimated indirect costs at a rate not to exceed 40% of the total direct costs. 

Only actual F&A costs are to be charged to projects. (If awarded at a rate of 40% or less, the rate used to charge actual F&A costs to projects cannot exceed the awarded rate unless the small business concern negotiates an F&A cost rate[s] with a federal agency.)

Phase II Grants. If the applicant small business concern has a currently effective negotiated F&A cost rate with a Federal agency, it should be used when calculating proposed F&A costs. (However, these rates must be adjusted for independent [self-sponsored] research and development expenses, which are not allowable by the Department of Health and Human Services [HHS]. (See "Discussion and Negotiation of Indirect Costs" later in this section.)

If the requested F&A rate is 25 percent or less, F&A costs will be awarded at the requested rate. However, applicant organizations are reminded that only actual F&A costs are to be charged to projects. (If awarded at a rate of 25% or less of total direct costs, the rate used to charge actual F&A costs to projects cannot exceed the awarded rate unless the small business concern negotiates an F&A cost rate[s] with a federal agency.) If the requested F&A rate is greater than 25 percent, additional information will be required prior to award.

Discussion and Negotiation of Facilities and Administrative (F&A) Costs

The Division of Financial Advisory Services (DFAS), Office of Contracts Management, NIH, is the office authorized to negotiate F&A cost rates with small business concerns receiving NIH SBIR/STTR awards. Upon request of the NIH, the applicant small business concern should provide DFAS with an F&A cost proposal and supporting financial data for the most recently completed fiscal year. If financial data is not available for the most recently completed fiscal year, proposals showing estimated rates and support for same should be submitted. 

Applicants are encouraged to visit the home page of the DFAS, Office of Contracts Management, at http://ocm.od.nih.gov/dfas/dfas.htm or contact DFAS staff at 301-496-2444.

To facilitate preparation of an F&A cost proposal, applicants are encouraged to read the following information on the DFAS Indirect Cost Branch (http://ocm.od.nih.gov/dfas/rates.htm.) Information on this site includes (1) definitions of the term "F&A costs," (2) a brief discussion of F&A cost rate structures and a simple example of an F&A cost rate computation, (3) a listing of data that should accompany your proposal submission, and (4) a listing of unallowable/unallocable costs extracted from Federal cost principles for commercial organizations, that is, the Federal Acquisition Regulation (FAR Part 31.2). The Federal Acquisition Regulation is available electronically at http://www.arnet.gov/far/. 

Generally, F&A cost rate structures for commercial organizations follow a single, two-rate (for example, fringe and overhead rates), or three-rate (for example, fringe, overhead, and General and Administrative expense rates) system. A Single Rate structure is illustrated at http://ocm.od.nih.gov/dfas/examples.htm. 

Commercial (for-profit) organizations usually treat "fringe benefits" as F&A costs. These fringe benefits are applied to direct salaries charged to projects either through a fringe benefit rate or as part of an overhead/ F&A cost rate. Therefore, fringe benefits treated as F&A costs should not be included as a direct cost in the "Personnel" category of the budget on Form Page 3 of the grant application.

The F&A cost proposal, based on company-wide cost data, should be accompanied by the following supporting information:

1. The profit and loss statement and balance sheet for the applicant organization's most recently completed fiscal year. Certified statements prepared by a CPA engaged to conduct an annual audit should be submitted, if available. The F&A cost proposal should include a reconciliation with the income statement; that is, there should be a cross-referencing from amounts on the income statement to amounts shown in the proposal, and a clear identification of individual elements (labor, materials, other expenses, etc.) of independent (self-sponsored) research and development (IR&D) expenses. IR&D costs are not allowable under NIH awards.

2. A listing of categories of costs normally classified and claimed as direct costs on Federal awards and non-Federally supported projects or activities.

3. An explanation of how the organization accounts for paid absences (vacation, holiday, and sick leave).

4. A Certification of Final Indirect Costs as specified in FAR Part 52.242-4. This Certificate is to be completed by an official at a level no lower than a vice president or chief financial officer of the business segment submitting the proposal. 

In determining what costs should be included in the proposed indirect cost pool(s), the applicant organization should refer to the list below of unallowable/unallocable costs.

Smoke-Free Workplace

Does your organization currently provide a smoke-free workplace and/or promote the nonuse of tobacco products or have plans to do so? Check the appropriate box marked "YES" or "NO." Response to the question has no impact on the review or funding of this application. 

12. Personal Data

Personal Data Form Page (MS Word or PDF)

Self explanatory. 

D. SUBMITTING YOUR SBIR/STTR GRANT APPLICATION

The NIH's Center for Scientific Review (CSR) is the single point of receipt for all NIH, CDC, and FDA SBIR/STTR grant applications.

Receipt Dates

Grant applications submitted under this SBIR/STTR Phase I Grant Solicitation will be considered on time if it is received by or mailed on or before  the published receipt date and a proof of mailing is provided.

Proof of mailing consists of a legibly dated U.S. Postal Service (USPS) postmark or a dated receipt from a commercial carrier or the USPS.

Note that SBIR/STTR applications in response to Request for Applications ((RFAs) or Program Announcements (PAs) with other than standard (Apr 1, Aug 1 or Dec 1) receipt dates must be received by the specified dates. These RFAs/Pas are issued separately through the NIH Guide for Grants and Contracts.

If the receipt date falls on a weekend, it will be extended to the following Monday; if the date falls on a holiday, it will be extended to the following workday. The receipt date will be waived only in extenuating circumstances.  To request a waiver, include an explanatory letter, addressed to the Division of Receipt and Referral, Center for Scientific Review, with the signed, completed application.  No request for a waiver will be considered prior to receipt of the application, and there is no guarantee that the waiver will be granted.

SBIR Receipt, Review and Award Dates

Note SBIR and STTR applications have coincident receipt dates.

* Applications to the Centers for Disease Control and Prevention may be submitted for the April 1 and December 1 receipt dates. CDC and FDA do not participate in the STTR program.

Receipt of Fast Track Applications

Fast Track applications may be submitted on any of the three scheduled receipt dates. The face pages for both the Phase I and Phase II portions should be clearly marked "Fast Track", and copies of both portions should be assembled and submitted together.

Receipt of SBIR/STTR Phase II Applications (Non-"Fast-Track")

Phase II applications may be submitted on any of the three scheduled receipt dates, either before or after expiration of the Phase I budget period. However, Phase II grant applications should be submitted no later than the first six receipt dates following expiration of the Phase I budget period. 

Applicants are cautioned that applications demonstrating insufficient results in Phase I may not receive a score in the peer review process (see Method of Selection and Evaluation Criteria).

Number of Copies

Submit the original and five exact, clear, single-sided photocopies of each application. The original must be signed by the Principal Investigator and a corporate official authorized to act for the applicant organization.

Bindings and Packaging

Do not bind or staple the six sets together, but secure each with rubber bands or paper clips.

Mailing and/or Delivery Addresses

Mailing labels are provided at the end of the forms (MS Word or PDF). Affix the relevant SBIR or STTR label in the forms package to the bottom of the face page of the original, and place the original on top of your entire package. Affix the relevant SBIR or STTR label in the forms package to the bottom of the face page of the original, and place the original on top of your entire package.

Mail or deliver the complete, signed, and typewritten original and five signed, exact, clear, single-sided photocopies of the application in one package to:

Center for Scientific Review 
National Institutes of Health 
6701 Rockledge Drive 
Room 1040-MSC 7710 
Bethesda, MD 20892*-7710 
Phone: (301) 435-0715
*Change zip code to 20817 for express mail or courier service.

Note:  Until further notice, applications delivered by individuals to the NIH Center for Scientific Review will no longer be accepted. They must come either via courier delivery or via the USPS. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

Assignment of Grant Applications

The Center for Scientific Review (CSR) will assign appropriately completed applications to the Scientific Review Groups (commonly referred to as "SRGs" or "study sections") that will perform the scientific/ technical merit review. In addition, CSR will assign each application to the agency awarding component that is the potential funding component Applications submitted in response to special SBIR Program Announcements (PA) or Requests for Applications (RFA) issued through the NIH Guide for Grants and Contracts may be reviewed by the Institute. See the relevant RFA or PA for additional information.

Cover Letters. The small business concern applicant organization is encouraged to include a cover letter with the application to suggest an awarding component(s) to which the application could be appropriately assigned for potential funding, to indicate a specific area of expertise that should be represented on the study section, and/or to indicate peer reviewers who may have a direct conflict of interest.

When the scientific areas and the research proposed in a grant application are sufficiently relevant to the program responsibilities of two or more awarding components, CSR may assign the application to all such components. The component that has the most relevant program responsibility is designated as the primary assignee. The other components that have an interest in the application are designated as secondary assignees. If the application is eligible for funding and the primary assignee does not intend to make an award, the secondary assignees will be given the opportunity to do so. Although these suggestions will be taken into consideration, the final determination will be made by the agencies participating in this solicitation.

Notification of Receipt

Usually within six weeks after the receipt date, the CSR/NIH will send the Principal Investigator and the applicant organization a notification of receipt of the application. The mailer will indicate a grant application assignment number as well as the name, address, and telephone number of the Scientific Review Administrator (SRA) of the Scientific Review Group (SRG) to which the application has been assigned. If this information is not received within that time, contact:

Division of Receipt and Referral 
Center for Scientific Review, NIH 
(301) 435-0715; Fax: (301) 480-1987

Incomplete Applications

Do not submit an incomplete application. An application will be considered incomplete and will be returned if it is illegible, if it does not conform to the instructions, or if the material presented is insufficient to permit an adequate review. 

Supplementary or Corrective Information

Supplementary or corrective material pertinent to the review of an application may be submitted after the receipt date, but only if it is specifically solicited by or agreed to through prior discussion with the Scientific Review Administrator of the SRG. Phase I appendix materials, including demonstration materials (e.g., videos, CD-ROMs) are not permitted unless specifically solicited by the agency.

Method of Selection and Evaluation Criteria

All Phase I and Phase II grant applications will be evaluated and judged on a competitive basis. Initially, applications will be screened for completeness and those found to be incomplete in any way or programmatically unrelated to the agency's mission will be returned without review to the applicant small business concern. Those passing the initial screening will be reviewed for technical and scientific merit. Each application will be judged on its own merit, according to the review criteria described below. The participating agencies are under no obligation to fund any specific application or make any specific number of awards in a given research topic area. Also, they may elect to fund several or none of the proposed projects within a given topic area.

Review Process

Grant applications are subjected to a peer review process involving two sequential steps that are required by law. The first step is performed by the Scientific Review Groups (SRGs), composed primarily of non-Federal scientists, physicians, and engineers (from academia and industry) selected for their expertise and stature in particular scientific fields. The second step is performed by the National Advisory Council or Board of the potential awarding component (Institute, Center, or other unit) to which the grant application is assigned. 

Scientific Review Groups

The first task of the SRGs is to evaluate each SBIR/STTR application for scientific and technical merit and potential for commercialization, and to make an SRG recommendation for each application on the basis of this evaluation. While NIH uses a numerical range from 1.00 (most meritorious) to 5.00 (least meritorious), a streamlined procedure is used to determine those applications that the SRG considers to be in the "upper" or "lower half". Applications in the "upper half" are discussed by the SRG and generally receive a score between 1.0 and 3.0, and applications in the "lower half" are not discussed and receive an "unscored" designation (i.e., those that would generally have received a score between 3.0 and 5.0). However, any review group member may identify an application that he or she believes should be discussed at the meeting and receive a numerical score. Under the currently employed streamlining procedures, a rating of 3.00 would be considered the median score for the cohort of applications that a scientific review group might review.

Individual reviewers mark scores to two significant figures, e.g., 1.2, and the individual scores are averaged and then multiplied by 100 to yield a single overall score for each scored application, e.g., 123. Abstaining members and those not present during the discussion do not assign a numerical rating and are not counted in calculating the average of the individual ratings.

The second task of the SRGs is to make budget recommendations concerning time and dollar amounts that are appropriate for the work proposed. 

Regardless of the study section recommendation, all applicants receive a summary statement that includes a single rating/designation and the essentially unedited, verbatim critiques of two or more assigned reviewers. 

National Advisory Council or Board

The second level of review is performed by the National Advisory Council or Board of the potential awarding component (Institute, Center, or other unit) to which the grant application is assigned. These groups, composed of scientists, physicians, and members of the public, are chosen for their expertise, interest, or activity in matters related to the awarding component's mission. In order for an application to be funded, it must be recommended by the Council or Board.

Release of Grant Application Review Information

Following evaluation of grant applications by the SRGs but prior to National Advisory Council or Board action, summary statements will be sent automatically to Principal Investigators. 

Applicants normally receive their summary statements within four to six weeks following the study section meeting in which it was reviewed. A "summary statement" documents the evaluation of an application by the SRG and conveys the SRG's recommendations to the awarding component and its Council or Board. No one other than the Principal Investigator (and appropriate NIH staff) may receive the summary statement and evaluation rating.

After receipt/review of the summary statement, applicants should contact their Program Director, rather than the Scientific Review Administrator, for guidance and advice. 

SBIR/STTR Review Criteria

"Formulae" do not exist for calculating an individual reviewer's score on an application. In considering the scientific and technical merit of each application, the following criteria will be used:

All SBIR/STTR Applications

1. Significance

   1. Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem?

   2. What may be the anticipated commercial and societal benefits of the proposed activity?

   3. If the aims of the application are achieved, how will scientific knowledge be advanced?

   4. Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? 

   5. Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs?

2. Approach

   1. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project?

   2. Is the proposed plan a sound approach for establishing technical and commercial feasibility

   3. Does the applicant acknowledge potential problem areas and consider alternative strategies? 

   4. Are the milestones and evaluation procedures appropriate?

3. Innovation

   1. Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies?

   2. Are the aims original and innovative?

4. Investigators

   1. Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? 

   2. Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)?

   3. Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?"

5. Environment

   1. Is there sufficient access to resources (e.g., equipment, facilities)? 

   2. Does the scientific and technological environment in which the work will be done contribute to the probability of success?

   3. Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?

In accordance with NIH policy, the following criteria will be applied to ALL applications:

Biohazards

• Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed? 

• Is the proposed protection adequate?

Animal Welfare

• If vertebrate animals are involved, are adequate plans proposed for their care and use? 

• Are the applicant's responses to the five required points appropriate?

• Will the procedures be limited to those that are unavoidable in the conduct of scientifically sound research?

Budget 

• For all applications, is the percent effort listed for the PI appropriate for the work proposed?

• On applications requesting up to $100,000 total costs, is the overall budget realistic and justified in terms of the aims and methods proposed?

• On applications requesting over $100,000 in total costs, is each budget category realistic and justified in terms of the aims and methods? 

In accordance with NIH policy, all applications will also be reviewed with respect to the following:

1. Protection of Human Subjects from Research Risks - for all studies involving human subjects. See "Guidance for Preparing the Human Subjects Research Section." 

   1. If an exemption is claimed, is it appropriate for the work proposed? If no exemption is claimed, are the applicant's responses to the six required points appropriate?

   2. Are human subjects placed at risk by the proposed study? If so, are the risks reasonable in relation to the anticipated benefits to the subjects and others? Are the risks reasonable in relation to the importance of the knowledge that reasonably may be expected to be gained?

   3. Are the plans proposed for the protection of human subjects adequate?

2. Inclusion of Women Plan - for clinical research only. See instructions.

   1. Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent?

   2. Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants?

3. Inclusion of Minorities Plan - for clinical research only. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html

   1. Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? 

   2. Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants?

4. Inclusion of Children Plan- for all studies involving human subjects

   1. Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically?

   2. If not, does the applicant provide an appropriate justification for their exclusion?

5. Data and Safety Monitoring Plan - for clinical trials only

   1. Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB?

Phase II Application Review Criteria

In addition to the above criteria:

1. How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

2. Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in Section I, item 9, J?

3. Does the project carry a high degree of commercial potential, as described in the Product Development Plan?

Amended Applications

In addition to the above criteria, the following criteria will be applied to revised applications.

1. Are the responses to comments from the previous SRG review adequate?

2. Are the improvements in the revised application appropriate?

Phase I/Phase II Fast-Track Application Review Criteria

For Phase I/Phase II Fast Track applications, the following criteria also will be applied:

• Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

• Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in Section I, item 9, J?

• To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization?

• Does the project carry a high degree of commercial potential, as described in the Product Development Plan?

Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review.

Funding Decisions

When making funding decisions, the awarding components take into consideration the following: (1) ratings resulting from the scientific and technical evaluation process; (2) areas of high program relevance; (3) program balance (that is, balance among areas of research); (4) available funds; and (5) the commercialization status where the small business concern has received more than 15 Phase II awards in the prior five (5) fiscal years (see this application requirement under "Prior SBIR Phase II Awards". The awarding component will notify the applicant small business concern of the final disposition of the application.

Phase II Funding Decisions

In addition to the considerations above, awarding components take into consideration when making Phase II funding decisions the potential of the proposed project for commercialization based on:

• the applicant organization's demonstrated record of successfully commercializing SBIR or other research, if applicable;

• the existence of Phase II funding commitments from private sector or non-SBIR funding sources;

• the existence of Phase III follow-on commitments; and

• the presence of other indicators of the commercial potential of the subject research

Commitment agreements should be signed and set forth a few clearly defined and measurable objectives. The agreement should also indicate the amount of funds that will be available to the small business concern and the appropriate date(s) on which the funds would be made available. The terms should not be contingent upon the obtaining of a patent since that process might be quite time consuming.

Any commitment for Phase III funds must be obtained from a source other than the SBIR or the STTR programs of the DHHS.

Note:  Any funding commitment not submitted with the Phase II grant application should be sent to the Grants Management Officer of the awarding component to which the application is assigned within 120 days following submission of the application. Any funding commitment obtained during the period of the grant award should be sent immediately to the Grants Management Officer identified on the Notice of Grant Award.

Phase II Funding Decisions for Fast-Track Applications

Fast-Track Phase II applications that are recommended for approval may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II awards will be recommended based on the project's scientific and technical merit, the awarding component's assessment of the Phase I progress report and determination that the Phase I goals were achieved, an update and verification of the Product Development Plan and any commitment(s) for funds and/or resources from an investor or partner organization, as described above, the project's potential for meeting the mission of the awarding component, the project's potential for commercial success, and the availability of funds.

Revision and Resubmission of Grant Applications

Grant applications that are not funded may be revised for resubmission at a future receipt date. However, applicant organizations may submit no more than two revised (amended) applications within a time period of two years from the receipt date of the initial, original application. The limit of two revisions allows applicant small business concerns and Principal Investigators sufficient time to consider new findings in the area of research and to take a fresh start at their research plans.

Resubmitted applications without substantive changes will not be accepted. The revised application MUST address the issues identified in the previous summary statement for the previous submission that was not fund. Revised sections must be clearly marked (as described in the "Introduction and Application Instructions" portion of this solicitation). Upon acceptance of a revised application by the CSR, the prior version will be withdrawn from further consideration by the awarding components. Acceptance of the revised application will generally mean that it will fall into a later review and award cycle. Resubmission of an application that merely duplicates a previous application is not acceptable and the duplicate application will be returned without review.

Submission of Similar Grant Applications by the Applicant Organization

WARNING – While it is permissible with application notification to submit identical applications or applications containing a significant amount of essentially equivalent work for consideration under numerous Federal agency program solicitations, it is unlawful to enter into funding agreements requiring essentially equivalent effort.  If there is any question concerning this, it must be disclosed to the soliciting agency or agencies before award.

Other support should only be submitted when requested by NIH. If you elect to submit identical applications or applications containing a significant amount of essentially equivalent work under other Federal program solicitations, you must include the following information with your “Other Support” information at the appropriate time:

1. The name and address of the agencies to which applications were submitted or from which awards were received.

2. Date of application submission or date of award.

3. Title, number, and date of solicitations under which application(s) was submitted or awards received.

4. The specific applicable research topics for each application submitted or award received.

5. Titles of research projects.

6. Name and title of principal investigator or project manager for each application submitted or award received.

The submission of similar grant applications to the NIH by the same applicant small business concern is strongly discouraged. Applicants are cautioned not to prepare multiple grant applications with essentially the same research focus, that is, a product or technology that, with non-substantive modifications, can be applied to a variety of purposes. In evaluating groupings of applications with a common scientific focus or objective (for example, implantation sensors/sensor materials, medical applications of lasers, immunology/immunoassays), SRGs are in a position to easily identify multiple grant applications from the same small business concern for essentially the same project. In these cases, the HHS will give funding consideration to only one application.

E. SBIR/STTR POLICY AND ADDITIONAL GUIDANCE

Refer to Section III for important information (e.g., Definitions, Other Support, Inventions and Patents, and Assurances and Certifications) on policy and guidance relating to submission of traditional, solicited and unsolicited, investigator-initiated research project grant and cooperative agreement applications to PHS. The following section includes additional policy information and guidance specific to SBIR/STTR applications. 

Audit Requirements of For-Profit Organizations

The Department of Health and Human Services (HHS) has specified requirements for non-Federal audits of for-profit (commercial) organizations in HHS' Title 45, Code of Federal Regulations (CFR), Part 74.26, "Non-Federal Audits." Per the regulations, a for-profit (commercial) organization is subject to audit requirements for a non-Federal audit if, during its fiscal year, it expended $300,000 or more under HHS awards and at least one award is an HHS grant.

Title 45 CFR Part 74.26 essentially incorporates the thresholds and deadlines of Office of Management and Budget (OMB) Circular No. A-133, "Audits of States, Local Governments and Non-Profit Organizations," but provides for-profit organizations with two options regarding the type of audit that will satisfy the audit requirements either: (1) a financial related audit (as defined in the Government Auditing Standards, GPO Stock #020-000-00-265-4, http://www.gao.gov/govaud/ybk01.htm) of all the HHS awards in accordance with Government Auditing Standards, or (2) an audit that meets the requirements contained in OMB Circular No. A-133, http://www.whitehouse.gov/omb/circulars/a133/a133.html. 

Audits shall be completed and submitted to the office shown below within a period that is either (1) the earlier of 30 days after receipt of the auditor's report(s), or (2) nine months after the end of the audit period (i.e., the organization's fiscal year). 

National External Audit Resources
HHS Office of Audit Services
Lucas Place
323 West 8th Street, Room 514
Kansas City, MO 64105 

The HHS will be identifying organizations not meeting audit requirements. Failure to comply may jeopardize eligibility for receiving future HHS awards.

Time and Effort Reporting for Commercial Organizations

Policy

Commercial (for-profit) organizations must document salaries and wages charged to contracts and grants by maintaining a labor distribution system for all employees regardless of function. The labor distribution system must account for total hours and charge direct and indirect labor to the appropriate cost objectives to accurately identify  labor costs:

• Charged to direct projects.

• Charged to indirect activities.

• Included in the base to which indirect costs are allocated.

Internal Controls

Timekeeping procedures and controls on labor charges are of utmost concern. Unlike other costs, labor is not supported by external documentation or physical evidence, which provides independent checks and balances. It is critical that managers indoctrinate individual employees on their independent responsibility for accurately recording their time. Internal controls over labor charging should meet the following criteria:

• Responsibility for timekeeping and payroll accounting should be separated.

• Procedures must be clear and reasonable so there is no confusion regarding the rationale for the controls or misunderstanding as to what is and is not permissible.

• Maintenance of controls must be verified continually, and violations must be acted upon promptly and effectively to serve as a deterrent to prospective violations.

• Individual employees must be constantly made aware of controls that act as an effective deterrent against violations. This awareness can be accomplished by emphasizing the importance of accurate time and effort reporting in orientation sessions, periodic meetings, and the posting of messages as reminders.

• Changes on timesheets to the number of hours recorded or the cost center identified should be made by the employee and must be initialed by the employee.

• Company policy must state that the nature of the work performed determines the proper distribution of time, not the availability of funding, type of contract/grant, or other factors.
  

• Company policy should emphasize that complete and accurate time and effort reporting is an important part of an employee's job. Careless or improper reporting may lead to disciplinary actions under company policies as well as applicable Federal statutes.

Time and Effort Documentation Requirements and Responsibilities

Detailed instructions for time documentation should be established in written company procedures. A manual system would require handwritten pen and ink entries on a paper timesheet reflecting all the days in the pay period. An automated timekeeping system typically would use remote data entry for recording labor charging data and sending it directly to a central computer for processing. Supporting documentation for an automated system would normally consist of computer printouts showing data that appear on source documents, i.e., timesheets in a manual system.

Employee Responsibilities

Whether a manual or automated time and effort reporting system is in place, the employee is personally responsible for:

• After the fact recording of hours (or fractions thereof) on a daily basis.

• Recording all hours worked and all hours absent. All hours should be recorded whether or not they are paid.

• Recording of hours on the timesheet in ink (manual system only).

• Recording the correct distribution of hours by project or indirect category. The nature of the work performed determines the proper distribution of time, not the availability of funding, type of contract/grant, or other factors. 

• To ensure accuracy, a listing of project numbers/indirect categories and their descriptions should be provided in writing to each employee.

• Any changes/corrections to timesheets should be made by the employee and must show what was initially recorded, i.e., no erasures or "white out" of entries. The employee also must initial any change(s).

• At the end of each pay period, the employee must sign the timesheet or electronically certify the labor distribution in  an automated system. 

Supervisor Responsibilities

• An authorized company official (e.g., supervisor) must cosign timesheets or electronically certify individual time and effort reporting at the end of each pay period. 

• The supervisor is prohibited from completing an employee's timesheet or entering hours in an automated system unless the employee is absent for an extended period of time on some form of authorized leave. 

[ Table of Contents] [Section I ] [Section II ] [ Section III ] [ Section IV ] [ Section V ]