SBIR/STTR Instructions for NIH and Other PHS Agencies

1 FORMS VERSION E SERIES. Released: September 25, 2017. Revised: December 7, 2018. SBIR/STTR Instructions FOR NIH. AND Other PHS Agencies . SF424 (R&R) APPLICATION PACKAGES. Guidance developed and maintained by NIH for preparing and submitting applications via to NIH and Other PHS. Agencies using the SF424 (R&R). SBIR/STTR Instructions for NIH and Other PHS Agencies - Forms Version E Series TABLE OF CONTENTS. TABLE OF CONTENTS 2. - How to Use the Application Instructions 3. - Application Process 6. - Significant Changes 10. - Program Overview 15. - SF 424 (R&R) Form 18. - PHS 398 Cover Page Supplement Form 36.

2 - R&R Other Project Information Form 40. - Project/Performance Site Location(s) Form 50. - R&R Senior/Key Person Profile (Expanded) Form 55. - R&R Budget Form 66. - R&R Subaward Budget Attachment(s) Form 82. - PHS 398 Research Plan Form 86. - SBIR/STTR Information Form 105. - PHS Human Subjects and Clinical Trials Information 113. - PHS Assignment Request Form 148. Form Screenshots i TABLE OF CONTENTS B-2. SBIR/STTR Instructions for NIH and Other PHS Agencies - Forms Version E Series - How to Use the Application Instructions Use these application Instructions to fill out the forms that are posted in your funding opportunity announcement.

3 View the How to Apply Video Tutorials. Quick Links Step 1. Become familiar with the application process Step 2. Use these Instructions , together with the forms and information in the funding opportunity announcement, to complete your application Step 3. Choose an application instruction format Step 4. Complete the appropriate forms Step 5. Stay informed of policy changes and updates Step 6. Understand what data NIH makes public Helpful Links The information on the following pages may be useful in the application process l OER Glossary l Grants Policy Statement l Guide to Grants and Contracts l Frequently Asked Questions Step 1.

4 Become familiar with the application process. Understanding the application process is critical to successfully submitting your application. Use the - Application Process section of these Instructions to learn the importance of completing required registrations before submission, how to submit and track your application, where to find page limits and formatting requirements, and more information about the application process. - How to Use the Application Instructions B-3. SBIR/STTR Instructions for NIH and Other PHS Agencies - Forms Version E Series Step 2. Use these Instructions , together with the forms and information found in the funding opportunity announcement, to complete your application.

5 The funding opportunity announcement (FOA) will include specific Instructions and the forms needed for your application submission. Remember that the FOA Instructions always supersede these application Instructions . Step 3. Choose an application instruction format. Do you know your activity code, but don't know which application Instructions to use? Refer to NIH's table on Selecting the Correct Application Instructions to determine which set of application Instructions applies to your grant program. Comprehensive Instructions Program-Specific Instructions Use the General (G) Instructions , available in Take advantage of the filtered PDFs to view both HTML and PDF format, to complete specific application Instructions for: the application forms for any type of grant l Research (R).

6 Program. l Career Development (K). l Training (T). l Fellowship (F). l Multi-project (M). l SBIR/STTR (B). Step 4. Complete the appropriate forms. Unless otherwise specified in the FOA, follow the standard instruction, as well as any additional program-specific Instructions for each form in your application. Program-specific Instructions are presented in gray call-out boxes that are color coded throughout the application Instructions . Consult the - Program Overview section for context for program specific Instructions . Step 5. Stay informed of policy changes and updates. l Refer to the - Significant Changes section for the most recent changes to these application Instructions .

7 L Review Notices of NIH Policy Changes since the posting of the Application Guide. - How to Use the Application Instructions B-4. SBIR/STTR Instructions for NIH and Other PHS Agencies - Forms Version E Series Step 6. Understand what data NIH makes public. Information submitted as part of the application will be used by reviewers to evaluate the scientific merit of the application and by NIH staff to make the grant award and monitor the grant after award. The exception to this is the - PHS Assignment Request Form, which is only seen by staff in the Division of Receipt and Referral (DRR), Center for Scientific Review (CSR).

8 If the application is funded, the following fields will be made available to the public through the NIH Research Portfolio Online Reporting Tool (RePORTER) and will become public information: l Name of Project Director/Principal Investigator (PD/PI), to also include Project Leaders on sub- projects to multi-project projects l PD/PI title l PD/PI email address l Organizational name l Institutional address l Project summary/abstract l Public health relevance statement In addition, key elements related to ongoing funded projects will be made available to the public, including those listed in the data dictionary at ExPORTER.

9 Additional elements may be made available after announcements through the NIH Guide for Grants and Contracts, a weekly electronic publication that is available on NIH's Funding page, or additions to the NIH Grants Policy Statement, as needed. - How to Use the Application Instructions B-5. SBIR/STTR Instructions for NIH and Other PHS Agencies - Forms Version E Series - Application Process Understanding the application process is critical to successfully submitting your application. Use this section of this guide to learn the importance of completing required registrations before submission; how to submit and track your application; where to find information about page limits, formatting requirements, due dates, and submission policies; and more information about the application process.

10 This application process information is also available on our How to Apply Application Guide page. Quick Links Prepare to Apply and Register Write Application Submit Related Resources Prepare to Apply and Register Systems and Roles Learn about the main systems involved in application submission and the role you and your colleagues play in the submission process. The main systems are , eRA Commons, and ASSIST. Register Determine your registration status. Organizations, organizational representatives, investigators, and others need to register in multiple federal systems in order to for you to submit a grant application.