signature authority for the organization. The electronic signature of the ..... Once the required fields are completed,
Annotated Form Set for NIH Small Business (SBIR/STTR) Grant Applications FORMS-D Series
Table of Contents Forms SF424 (R&R) PHS 398 Cover Page Supplement R&R Other Project Information Project/Performance Site Location(s) R&R Senior/Key Person Profile (Expanded) SBIR/STTR Information PHS Inclusion Enrollment Report PHS Assignment Request Form R&R Budget R&R Subaward Budget Attachment(s) Form PHS 398 Research Plan
Page # 2 4 6 7 8 9 11 12 14 18 19
NOTES: •
The Funding Opportunity Announcement (FOA) and associated application guide remain the official documents for defining application requirements. This resource is meant to complement, not replace, those documents.
•
NIH application packages include a subset of the forms included in this resource. You will only need to complete the forms provided to you with a specific FOA.
•
The actual display of the forms depends on your submission method (e.g., downloadable forms, ASSIST). The same forms, form fields and guidance apply regardless of submission option even if the display is slightly different.
•
This resource is for FORMS-D application packages, see Do I Have the Right Forms for My Application?
•
Registration in multiple systems is needed prior to submission, see Get Registered! Can take 6 weeks – start early!
•
Don’t forget to periodically check the Related Notices section of the FOA for any updates to instructions or policies since the opportunity was posted.
•
The blue annotations throughout this resource represent processing notes and eRA system business rule checks (i.e., validations). Notes & business rules
** Updated: December 21, 2016
FORMS-D Series
Page 1 of 19 **
Fill out the SF424 (R&R) form first. It populates fields in other forms. ü
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If New (box 8), leave blank unless otherwise instructed in FOA. If Resubmission, Renewal or Revision (box 8), use institute and serial # of previous NIH grant/application # (e.g., use CA987654 from 1R01CA987654-01).
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Generally, SBIR Phase I awards do not exceed 6 months and STTR Phase I awards do not exceed one year. Generally, SBIR and STTR Phase II awards do not exceed two years.
** Updated: December 21, 2016
FORMS-D Series
Page 2 of 19 **
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30 subaward budgets, budgets 31 and above should be converted to PDF and included as part of the Budget Justification of the parent budget in Section K of the R&R Budget form. This form should only be used in conjunction with the R&R Budget form. ò
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Do not include the Subaward Budget Attachment form with applications that use the PHS 398 Modular Budget form. ** Updated: December 21, 2016
FORMS-D Series
Page 18 of 19 **
PHS 398 Research Plan
OMB Number: 0925-0001 Expiration Date: 10/31/2018
Introduction 1. Introduction to Application (Resubmission and Revision)
Limited to 1 page. Required for Resubmission Revision applications. Add Attachment and Delete Attachment View Attachment
Research Plan Section 2. Specific Aims
Required. Limited to 1 page.
3. *Research Strategy
Required: Phase I SBIR/STTR: limited to 6 pages. Phase II: SBIR/ Add Attachment Delete Attachment View Attachment STTR and Fast Track SBIR/STTR: limited to 12 pages.
4. Progress Report Publication List
Add Attachment
Add Attachment
Delete Attachment
Delete Attachment
View Attachment
View Attachment
Human Subjects Section Attachments typically required if Human Subjects is Yes on the Other Project Information form. 5. Protection of Human Subjects
Required if Human Subjects is Yes. Add Attachment
6. Data Safety Monitoring Plan
Required if Clinical Trials is Yes Add on the PHS 398 Cover Supplement form. Attachment Delete Page Attachment View Attachment
7. Inclusion of Women and Minorities
Required if Human Subjects is Yes exemption number is not 4. View Attachment Addand Attachment Delete Attachment
8. Inclusion of Children
Required if Human Subjects is Yes exemption number is not 4. View Attachment Add and Attachment Delete Attachment
Delete Attachment
View Attachment
Other Research Plan Section Required for all apps. (except S10), if Vertebrate Animals is Yes on Add Attachment Delete Attachment View Attachment the Other Project Information form.
9. Vertebrate Animals 10. Select Agent Research 11. Multiple PD/PI Leadership Plan
Add Attachment
Delete Attachment
View Attachment
Required if more than one PD/PI Add is specified on R&R Sr/Key Person Profile form. Attachment Delete Attachment View Attachment
12. Consortium/Contractual Arrangements
Add Attachment
Delete Attachment
View Attachment
13. Letters of Support
Add Attachment
Delete Attachment
View Attachment
14. Resource Sharing Plan(s)
Add Attachment
Delete Attachment
View Attachment
15. Authentication of Key Biological and/or Chemical Resources
Required if project involves key biological and/or chemical resources. View Recommend 1 Add Attachment Delete Attachment Attachment page. No system validation enforcement.
Appendix 16. Appendix
Add Attachments
Delete Attachments
View Attachments
Allows for up to 10 appendices. See Application Guide and announcement for restrictions. Appendices are stored separately in the eRA Commons (not as part of the application image) and are accessible to appropriate agency staff and peer reviewers. DO NOT use Appendix attachments to circumvent page limits in other sections of the application. Such actions will be noted at time of review. See NIH Guide notice NOT-OD-11-080 (for applications to due dates before Jan. 25, 2017) and NOTOD-16-129 (for applications to due dates on/after Jan. 25, 2017).
** Updated: December 21, 2016
FORMS-D Series
Page 19 of 19 **