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

Annotated Form Set for NIH Small Business (SBIR/STTR) Grant Applications

FORMS-E Series ? Application due dates on/after January 25, 2018

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 Human Subject and Clinical Trial Form 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 17 19 23 24

NOTES:

? The Funding Opportunity Announcement (FOA) and application guide, and NIH Guide notices remain the official documents for defining application requirements. This resource complements, not replaces, 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., 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-E 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).

Updated: October 3, 2019

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APPLICATION FOR FEDERAL ASSISTANCE

SF 424 (R&R) Use Application for first submission

1. TYPE OF SUBMISSION

attempt for due date.

Pre-application

Application

Changed/Corrected Application

OMB Number: 4040-0001 Expiration Date: 10/31/2019

3. DATE RECEIVED BY STATE

4. a. Federal Identifier b. Agency Routing Identifier

State Application Identifier If New (box 8), leave blank. If Revision/ Resubmission/ Renewal (box 8), use institute and serial # of previous NIH grant/application # (e.g., use CA987654 from 1R41CA987654-01).

2. DATE SUBMITTED

Applicant Identifier

Do not use Pre-application unless specifically noted in FOA.

5. APPLICANT INFORMATION

Legal Name:

Use Changed/Corrected when c. Previous submitting again to Tracking ID

to correct eRA identified errors/

Organizational DUNS:

warnings.

Department:

Division:

Street1:

Street2:

For Notices of Special Interest, include notice number (e.g., NOT-IC-FY-XXX).

If Changed/Corrected (box 1), provide previous tracking #. (e.g., GRANT12345678).

Must match DUNS used for System for Award Management (SAM), and eRA Commons registrations. Must be 9 or 13 digits; no letters or special characters.

City:

County / Parish:

State:

Country:

USA: UNITED STATES

Person to be contacted on matters involving this application

Prefix:

First Name:

Last Name:

Province:

Small business

ZIP / Postal Code:

must be in the U.S.

Middle Name: Suffix:

Must provide zip+4 for all zip codes.

Position/Title:

Street1:

Street2:

City:

County / Parish:

State:

Province:

Country:

USA: UNITED STATES

ZIP / Postal Code:

Phone Number:

Fax Number:

Email:

Contact e-mail is required by NIH. If not included, or improperly formatted, the AOR e-mail provided in item 19 will be used.

6. EMPLOYER IDENTIFICATION (EIN) or (TIN): 7. TYPE OF APPLICANT:

Please select one of the following

Must select "Small Business" for SBIR/STTR applications.

Other (Specify):

Do not use these Small Business

Small Business Organization Type

Women Owned

Socially and Economically Disadvantaged

Organization Type checkboxes.

8. TYPE OF APPLICATION: See application If Revision, mark appropriate box(es).

New

Resubmission guide for definitions. A. Increase Award B. Decrease Award

NIH/CDC/FDA use SAM data to gather this information. C. Increase Duration D. Decrease Duration

Renewal

Continuation

Revision

E. Other (specify):

Is this application being submitted to other agencies? Yes No What other Agencies?

9. NAME OF FEDERAL AGENCY:

10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:

TITLE:

NIH will assign CFDA post-submission.

11. DESCRIPTIVE TITLE OF APPLICANT'S PROJECT:

Phase II should have the same title as awarded Phase I. If Revision (box 8), provide exact title (including punctuation and spacing) as seen in eRA Commons for awarded grant. Limited to 200 characters.

12. PROPOSED PROJECT:

Start Date

Ending Date

13. CONGRESSIONAL DISTRICT OF APPLICANT

Format: 2 character state abbreviation - 3 character District number (e.g., CA-005). 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.

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SF 424 (R&R) APPLICATION FOR FEDERAL ASSISTANCE

14. PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION

Prefix:

First Name:

Last Name: Position/Title:

PD/PI first/last name should match name on file for Commons ID provided in the Credential field of the R&R Senior/Key Person Profile (Expanded) form.

Organization Name:

Middle Name: Suffix:

Page 2

Department: Street1:

Division:

Street2: City:

County / Parish:

State:

Province:

Country: Phone Number: Email:

USA: UNITED STATES Fax Number:

ZIP / Postal Code:

15. ESTIMATED PROJECT FUNDING Manually enter amounts.

a. Total Federal Funds Requested b. Total Non-Federal Funds c. Total Federal & Non-Federal Funds d. Estimated Program Income

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

16. IS APPLICATION SUBJECT TO REVIEW BY STATE EXECUTIVE ORDER 12372 PROCESS?

a. YES b. NO

THIS PREAPPLICATION/APPLICATION WAS MADE

AVAILABLE TO THE STATE EXECUTIVE ORDER 12372

PROCESS FOR REVIEW ON: SBIR/STTR: Check "No -

DATE:

Program is not covered by E.O.

PROGRAM IS NOT COVERED B12Y3E7.2O.. 12372; OR

PROGRAM HAS NOT BEEN SELECTED BY STATE FOR REVIEW

17. By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein are

true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with any resulting

terms if I accept an award. I am aware that any false, fictitious. or fraudulent statements or claims may subject me to criminal, civil, or

administrative penalties. (U.S. Code, Title 18, Section 1001)

I agree

See the NIH Grants Policy Statement for more information:

HTML5/section_4/4.1_public_policy_requirements_and_objectives.htm

*The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions.

18. SFLLL (Disclosure of Lobbying Activities) or other Explanatory Documentation Add Attachment

Delete Attachment

View Attachment

19. Authorized Representative

Prefix:

First Name:

Last Name:

Position/Title:

Organization:

Department:

Division:

Street1:

Street2:

City:

County / Parish:

State: Country: Phone Number:

USA: UNITED STATES Fax Number:

Middle Name:

Suffix:

Authorized Organization Representative (AOR) in must have signature authority for the organization. The electronic signature of the submitting AOR is recorded with submission.

Province:

In eRA Commons individuals with signature authority are called Signing Officials (SOs).

ZIP / Postal Code:

Email:

Signature of Authorized Representative

Date Signed

20. Pre-application 21. Cover Letter Attachment

Cover letter is posted as a separate document in eRA Commons and is not part of the assembled

application image. Content is only made availablAedtdoAstetalechcmt aegntencyDsetleatfef.AIfttaacphpmliceanttionVpireowpAotstaecshment

the use of human fetal tissue (HFT) from a statement about HFT involvement.

electiveAdadboArtttaiocnhsm,eynotu

mDueslteitnecAluttdaechamCenotverVLieewtteArttwacithhment

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PHS 398 Cover Page Supplement

OMB Number: 0925-0001 Expiration Date: 3/31/2020

1. Vertebrate Animals Section

Are vertebrate animals euthanized?

If "Yes" to euthanasia

Is method consistent with American Veterinary Medical Association (AVMA) guidelines?

If "No" to AVMA guidelines, describe method and provide scientific justification

Answer required if Vertebrate Animals Used is Yes on

Yes

No the R&R Other Project Information form.

Yes

No

Up to 1000 characters.

2. *Program Income Section

*Is program income anticipated during the periods for which the grant support is requested?

Yes

No

If you checked "yes" above (indicating that program income is anticipated), then use the format below to reflect the amount and source(s). Otherwise, leave this section blank.

*Budget Period *Anticipated Amount ($)

*Source(s)

Up to 150 characters.

The number of program income budget periods must be less than or equal to the number of periods included in the budget form.

3. Human Embryonic Stem Cells Section

*Does the proposed project involve human embryonic stem cells?

Yes

No

If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list: . Or, if a specific stem cell line cannot be referenced at this time, check the box indicating that one from the registry will be used:

Specific stem cell line cannot be referenced at this time. One from the registry will be used.

Cell Line(s) (Example: 0004):

Error if provided human embryonic stem cell lines are not listed at at time of submission. Use NIH Registration Number (e.g., 0004, 0005). Provide up to 200 cell lines.

4. Inventions and Patents Section (for Renewal applications) SBIR/STTR: Only applies to Phase II applications.

*Inventions and Patents: Yes

No

If "Yes" then answer the following:

*Previously Reported:

Yes

No

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PHS 398 Cover Page Supplement

5. Change of Investigator/Change of Institution Section Change of Investigator not allowed for Revision applications.

Change of Project Director/Principal Investigator

Name of former Project Director/Principal Investigator: Prefix:

*First Name: Middle Name:

*Last Name: Suffix:

Change of Grantee Institution *Name of former institution:

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1. Are Human Subjects Involved? 1.a. If YES to Human Subjects

RESEARCH & RELATED Other Project Information

OMB Number: 4040-0001

If Human Subjects = Yes, additional information is required on the Expiration Date: 10/31/2019

PHS Human Subjects and Clinical Trials Information form.

Yes

No

Is the Project Exempt from Federal regulations?

Yes

No

If yes, check appropriate exemption number.

1 2 345 6 78

If no, is the IRB review Pending?

Yes

IRB Approval Date:

Human Subject Assurance Number:

2. Are Vertebrate Animals Used?

Yes

No

2.a. If YES to Vertebrate Animals

Is the IACUC review Pending?

Yes

No

IACUC Approval Date:

No IRB Approval Date is not required at time of submission, but may be requested later in the pre-award process as Just-InTime data. Date cannot be in the future.

If Human Subjects = Yes, the Human Subject Assurance Number or the text 'None' must be provided exactly as it appears in eRA Commons institution profile.

If Vertebrate Animals = Yes, additional attachments are required in the PHS 398 Research Plan or equivalent form.

IACUC Approval Date is not required at time of submission, but may be requested later in the pre-award process as Just-In-Time data. Date cannot be in the future.

Animal Welfare Assurance Number:

If Vertebrate Animals = Yes, the Animal Welfare Assurance Number or the text 'None' must be provided. Type the number exactly as it appears in eRA Commons Institution Profile.

3. Is proprietary/privileged information included in the application?

Yes

No

4.a. Does this Project Have an Actual or Potential Impact - positive or negative - on the environment?

Yes

No

4.b. If yes, please explain: If 4a is Yes, then 4b is required. Up to 55 characters.

4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an environmental assessment (EA) or

environmental impact statement (EIS) been performed?

Yes

No

4.d. If yes, please explain: If 4c is Yes, then 4d is required. Up to 55 characters.

5. Is the research performance site designated, or eligible to be designated, as a historic place?

Yes

No

5.a. If yes, please explain: If 5 is Yes, then 5a is required. Up to 55 characters.

6. Does this project involve activities outside of the United States or partnerships with international collaborators?

Yes

No

6.a. If yes, identify countries: If 6 is Yes, then 6a is required. Up to 55 characters.

6.b. Optional Explanation: Up to 55 characters.

7. Project Summary/Abstract 8. Project Narrative

Succinct project summary of proposedAwdodrkA.ttTacyhpmiceanllty 30 lDineelesteoAr tlteascsh;mseynsttem VwiiellwgAivtetacehrrmoernift over 1 page. If awarded this information becomes public. Do not include proprietary or confidential information. Typically 2-3 sentence statement of ApuddblAictthacehamlthenrtelevaDneclee;tesAystttaecmhmweinllt giveVeierrworAitftaocvhemre1ntpage.

9. Bibliography & References Cited

Required unless otherwise noted in opApdodrtAutntaitcyh.mNeontt systeDmeleetnefAotrtcaecdhm. ent View Attachment

10. Facilities & Other Resources

Required unless otherwise noted in AodpdpAortttaucnhitmye. nNtot syDsteelemteeAntftaocrchemde.nt View Attachment

11. Equipment

Required unless otherwise noted in opApdodrtAutntaitcyh.mNeontt systeDmeleetenfAotrtcaechdm. ent View Attachment

12. Other Attachments Add Attachments

Delete Attachments View Attachments

Only provide Other Attachments when requested in the funding opportunity announcement text or application guide. Field accommodates multiple attachments.

If application proposes the use of human fetal tissue from elective abortions, you must include "HFTComplianceAssurance.pdf" and "HFTSampleIRBConsentForm.pdf" attachments. Use the exact filenames requested. Systems will check for an exact match to the letters and spacing of the filenames (not case specific).

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Project/Performance Site Location(s)

OMB Number: 4040-0010 Expiration Date: 9/30/2016

Project/Performance Site Primary Location

I am submitting an application as an individual, and not on behalf of a company, state, local or tribal government, academia, or other type of organization.

Organization Name:

DO NOT check box. NIH only accepts applications from registered organizations.

DUNS Number:

DUNS required and enforced by NIH. Must be 9 or 13 digits; no letters or special characters.

* Street1:

Street2:

* City:

County:

* State:

Province:

* Country: USA: UNITED STATES

* ZIP / Postal Code:

* Project/ Performance Site Congressional District:

Project/Performance Site Location 1

I am submitting an application as an individual, and not on behalf of a company, state, local or tribal government, academia, or other type of organization.

Organization Name: DUNS Number: * Street1: Street2: * City: * State:

Optional for non-primary sites. Helps facilitate application processing, so include it if you have it.

County:

List all performance sites, including any foreign sites. Provide a list of resources available from each site in the Facilities and Resources attachment on the R&R Other Project Information form. Describe any consortium/contractual arrangements in the Consortium/Contractual Arrangements attachment on the PHS 398 Research Plan form or equivalent form.

Province:

* Country: USA: UNITED STATES

* ZIP / Postal Code:

* Project/ Performance Site Congressional District:

Additional Location(s)

Add Attachment

Delete Attachment

Form accommodates up to 300 sites. Use the Additional Locations attachment to include any sites over 300. See Additional Performance Site Format page at:

View Attachment

Updated: October 3, 2019

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OMB Number: 4040-0001 Expiration Date: 10/31/2019

RESEARCH & RELATED Senior/Key Person Profile (Expanded)

PROFILE - Project Director/Principal Investigator

Prefix:

* First Name:

Middle Name:

* Last Name:

Suffix:

Position/Title: Organization Name: * Street1:

Department:

Organization Name required by NIH for all Sr/Key entries. ThDisiviisnifoonr:mation is used by NIH staff to determine potential review conflicts of interest.

Street2:

* City:

County/ Parish:

* State:

Province:

* Country: USA: UNITED STATES

* Zip / Postal Code:

* Phone Number: * E-Mail:

Credential, e.g., agency login:

Fax Number: VALID ERA COMMONS USERNAME MUST BE SUPPLIED. Contact PD/PI must be affiliated in Commons with applicant organization. Commons account designated on this form should not have both the PI and SO roles (if PD/PI also serves as SO, use a separate account for SO functions).

* Project Role: PD/PI Degree Type: Degree Year:

*Attach Biographical Sketch Attach Current & Pending Support

Other Project Role Category: Project Role will default to PD/PI and must remain PD/PI (do not edit).

Required. Limited to 5 pages. Format page, instructions and samples: Attachment View Attachment

Only provide CurrentA&ddPAetntadcihnmgeSnut pporDteiflestepeActtiaficchamllyenret queVsietewdAinttachment FOA. May be requested later in pre-award process as Just-In-Time data.

PROFILE - Senior/Key Person 1

Prefix:

* First Name:

Middle Name:

* Last Name:

Suffix:

Position/Title:

Department:

Organization Name: * Street1:

Street2:

Division: Organization Name required by NIH for all Sr/Key entries. This information is used by NIH staff to determine potential review conflicts of interest.

* City:

County/ Parish:

* State:

Province:

* Country: USA: UNITED STATES

* Zip / Postal Code:

* Phone Number: * E-Mail:

Credential, e.g., agency login:

Fax Number:

For multiple PD/PI applications, you must use the PD/PI role and provide the eRA Commons username in the Credential field for all PD/PIs. If multiple PD/PIs are included, the Multiple PD/PI Leadership Plan on the PHS 398 Research Plan form is required.

* Project Role:

Other Project Role Category:

Degree Type: Degree Year:

Attach Biographical Sketch

Required. Limited to 5 pages. Format page, instructions and samples:

Add Attachment Delete Attachment View Attachment

Attach Current & Pending Support

Add Attachment Delete Attachment View Attachment

Delete Entry

Can collect data for 100 Sr/Key personnel (including PD/PI). Option to provide attachment for additional Sr/Key info is available after the 100 entries are made. See

Next Person

Additional Senior/Key Person Profiles format page at: To ensure proper perffoorrmmasn/acdedoitfiothniasl-fsoermnio; ra-fkteery-apdedrisnogn2-p0roafdildei.thiotmna. l Senior/ Key Persons; please save your application, close the Adobe Reader, and reopen it.

Updated: October 3, 2019

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