Annotated Form Set for NIH Small Business (SBIR/STTR ... - NIH Grants

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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

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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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Use Application for first submission attempt for due date.



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Must provide zip+4 for all zip codes.

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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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Use Changed/Corrected when submitting again to Grants.gov to correct eRA identified errors/warnings.

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Format: 2 character state abbreviation - 3 character District number (e.g., CA-005. Use 00-000 if outside the US. See application guide for additional details.

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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Guideline: SBIR/STTR Phase I - $150K Phase II - $1M

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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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The sum of all subaward budgets (e.g., those attached separately on this form and those provided as part of the budget justification), must be included in Line F.5 Subawards/Consortium/ Contractual Costs of the parent budget. 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 **