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Presented by Emily Linde & Maria Koszalka...Presented by Emily Linde & Maria Koszalka ... -Letters...

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Presented by Emily Linde & Maria Koszalka Office of Policy for Extramural Research Administration, OER, NIH
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Page 1: Presented by Emily Linde & Maria Koszalka...Presented by Emily Linde & Maria Koszalka ... -Letters of Reference - PHS 398 Checklist -Research & Related Budget -PHS 398 Training Budget

Presented by Emily Linde & Maria Koszalka

Office of Policy for Extramural Research Administration, OER, NIH

Page 2: Presented by Emily Linde & Maria Koszalka...Presented by Emily Linde & Maria Koszalka ... -Letters of Reference - PHS 398 Checklist -Research & Related Budget -PHS 398 Training Budget

• General information

• Preparing/completing the SF424 (R&R) Forms

• Completing PHS398 Components

• Preparing NRSA and Career Development Awards

• Tips and helpful hints

• Where to find help

• Questions?

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• SF424 (R&R) stands for “Standard Form 424 Research and Related family of forms.

• Used for applying for Research and Research-related grant opportunities, including NIH and many Federal agencies.

• NIH grant applications: consists of SF-424 R&R and PHS 398 components.

• Most NIH applications submitted through Grants.gov and eRA Commons.

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http://grants.nih.gov/grants/ElectronicReceipt//

http://grants.nih.gov/grants/ElectronicReceipt/

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• Find grant opportunities in

Grants.gov or NIH Guide to Grants

and Contracts.

• Read Funding Opportunity

Announcements (FOAs) carefully!

• Click on “Apply for Grant Electronically” button in the FOA.

• Download applications/instructions using FOA links in Grants.gov. Use the FOA number to search and confirm correct announcement.

• Must complete SF 424 (R&R) using package attached FOA (Information is drawn from specific FOA and auto-completed for use in the forms)

• Complete data entry in all necessary components and upload appropriate attachments.

• Follow all application instructions, page limits, deadlines!

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• Three types of SF424 (R&R) Application Guides (http://grants.nih.gov/grants/forms.htm):

1. General Instructions

2. SBIR/STTR

3. Fellowships

• Three parts of the Application Guide:

o Part I: Instructions for Preparing and Submitting an Application

o Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan

o Part III: Policies, Assurances, Definitions And Other Information

• Agency-specific instructions denoted with HHS Logo

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http://grants.nih.gov/grants/funding/424/index.htm 7

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SF424 (R&R) Components: Agency-Specific Components

(NIH required):

-SF424 (R&R)-application cover

component

-PHS Cover Letter

-PHS 398 Cover Page Supplement

(supplements R&R Cover)

-Research & Related

Project/Performance Site Location(s)

-PHS 398 Modular Budget

-PHS 398 Research Plan

-Research & Related Other Project

Information

-PHS 398 Career Development

Award Supplemental Form

-Research & Related Senior/Key

Person-Expanded

-Letters of Reference

- PHS 398 Checklist

-Research & Related Budget -PHS 398 Training Budget Forms

-R&R Subaward Budget Attachment -PHS 398 Research Training

Program Plan 8

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Header Information

Prefilled from Announcement

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Item 1, Type of Submission

• Pre-application — do not use unless specified in FOA.

• Changed/Corrected Application — use only when correcting an application that failed NIH system validations. This is NOT a resubmission.

• Item 4b, Agency Routing Identifier do not use unless specifically noted in FOA

• Item 5, Organizational DUNS must match DUNS in eRA Commons profile.

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• Grant Application Package includes all appropriate forms, components that are required (mandatory) and those that are optional.

o Some forms listed as optional are actually

mandatory. Click on form and move it to

submission box, then open to complete form.

• Fields highlighted in red and shaded in yellow are mandatory!

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SF424 (R&R)

Cover Component

Page 1

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• Start with Cover Component

• Item 1, Type of Submission

o Pre-application — do not use unless specifically noted in FOA.

o Changed/Corrected Application — use only when correcting an application that failed NIH system validations. This is NOT a resubmission.

• Item 4b, Agency Routing Identifier do not use unless specifically noted in FOA

• Item 5, Organizational DUNS must match DUNS in eRA Commons profile.

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• Item 8, Type of Application-

o New is an application submitted for the first time

o Resubmission a revised or amended application to

address reviewer feedback

o Renewal Competing for additional years of funding to

continue project.

o Continuation NIH does not use SF424 R&R

continuation applications.

o Revision request for additional funds to expand scope

• Item 13, Congressional District for applicant organization only

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SF424 (R&R)

Cover

Component

Page 2

See Application

Guide Section III

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• More than 30 locations requires an attachment

• Available at

http://grants.nih.gov/grants

/funding/424/index.htm

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Other

Project

Information

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• Items 1 and 2, Human Subject Involvement and Vertebrate Animal Use – Approval dates provided as JIT

o Check yes to “Is the IRB Review Pending” and “Is the IACUC Review Pending” even if process has not begun at time of submission.

• Item 8, Project Narrative – Use for the public health relevance section

• Item 12, Other Attachments – complete only when requested in FOA

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Senior/Key

Person Profile -

Expanded

• More than 40 Senior/Key Persons requires an attachment

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• Captures personal profile information on PD/PI, key personnel, and other significant contributors.

• eRA Commons “Credential” mandatory for all individuals with PD/PI role

• For multiple PD/PI applications, individual designated as contact PD/PI must be affiliated with applicant organization in the eRA Commons

• Attach a Biographical sketch for all key personnel.

• Format and samples are available from the SF424 (R&R) Forms Page.

• Do not attach “Current & Pending Support” unless requested in FOA.

R&R Forms Page available at: grants.nih.gov/grants/funding/424/index.htm 20

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• R&R Budget Form is one of two “optional” budget components. The other is the PHS 398 Modular Budget Form.

o See FOA and SF424 (R&R) Instruction Guide for which type of budget component to use

• Complete components only for your own organization.

• Subawardees will complete components for their organization and provide to applicant organization.

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• Applicant prepares a detailed budget for every budget period

• A detailed cumulative budget will be system-generated based on budget period data.

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R&R Budget Sections A & B

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Personnel separated into 2 sections:

• A. Senior/Key Person

o Allows 8 named individuals • Information on additional Senior/Key persons provided in .pdf attachment

o Provide time in “person-months” units, not percent effort

o PD/PI field must be completed

• B. Other Personnel

o Postdocs, Grad Students, Undergrads: Only number of personnel required (not specific names or responsibilities).

o More detail provided in Budget Justification

o NIH recommends providing actual “Base Salary”

Person-month FAQs: grants.nih.gov/grants/policy/person_months_faqs.htm 24

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R&R Budget Form Senior/Key Personnel

Include only personnel

employed by (e.g., receiving

salary from) your

organization.

Include all personnel

considered senior or key,

regardless of employer.

Consultants should be

included in Section F Line 3

Consultants, not in Sections

A or B.

Include if considered senior

or key, regardless of

employer.

If effort is unknown include in

Section B (e.g., other

significant contributors).

Effort commitments not

relevant to this section.

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R&R Budget

Sections C - E

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• Item C, Equipment allows itemization of up to 10 pieces of equipment. If more, include total dollars in line 11 and provide details in the attachment.

• Item D, Travel separates Domestic and Foreign travel, but NIH awards as a single category.

• Item E, Participant/Trainee Support Costs not used unless requested in FOA.

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R&R Budget

Sections F - K

•Include tuition

remission in Item F,

Other Direct Costs

•Item F(5),

Consortium Costs is

not auto-populated.

•Next Period Button

not available until all

required data fields are

completed, including

the budget justification

attachment.

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• Used for detailed budget from consortia

• Subawardees use correct software version

• Applicant sends R&R Subaward budget component to Subawardee(s); it is completed and returned; applicant attaches it in this component

• Allows up to 10 separate subaward budget attachments

o Provide one budget for each consortium grantee

o If more than 10 subawardees, include details for additional subawardees in budget justification (Section K)

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SBIR/STTR

Information

Page 1

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SBIR/STTR Information

Page 2

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• Item 1a, Eligibility – Applicants must meet SBIR/STTR eligibility requirements at time of award, not time of application.

• Item 6, Disclosure Permission Statement – Allows NIH to share contact information and project title to outside parties for possible collaborations or investments.

• Item 7, Commercialization Plan – Include as a PDF attachment.

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• Form pages required in addition to standard SF 424 R&R, and included in the NIH form set:

o PHS Cover Letter File o PSH 398 Cover Page Supplement (supplements the

R&R Cover) o PHS 398 Modular Budget o PHS 398 Research Plan o PHS 398 Checklist o PHS 398 Career Development Award Supplemental

Form o PHS Fellowship Supplemental Form o PHS 398 Training Forms

• Allows NIH to collect information not provided to other research agencies.

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• A suggested format for cover letters is

described in the SF424 (R&R) Application

Guide and the PHS 398 instructions.

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PHS 398

Cover Page

Supplement

Page 1

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PHS 398

Cover Page

Supplement

Page 2

37

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• Companion forms to the (R&R) Cover Component providing NIH with additional needed information

• Item 2. Human Subjects - includes Clinical Trial and Agency-Defined Phase III Clinical Trial indicators

• Item 3. Applicant Organization Contact, includes complete contact information (title & mailing address missing from section 5 of the R&R Cover)

• Item 4. Human Embryonic Stem Cells 38

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PHS 398

Modular

Budget

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• Alternative to the R&R Budget form that doesn’t require detailed categorical information.

• Available to certain applicants requesting Direct Costs of $250,000 or less per year.

• Consortium F&A costs are not included in the $250,000 limit.

• Applicants must request total direct costs in “modules” of $25,000.

• Cumulative Budget is system-generated

• Budget Justifications PDF text attachments

o for Personnel, Consortium and Other

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PHS 398

Research

Plan

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• Same formatting requirements in the PHS 398 apply here—margins, page limits, etc.

• Separate PDF attachments for each section Appendix Material

o Allows up to 10 separate attachments

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•Captures data

on Inventions

and Patents

PHS398

Checklist

Page 1

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PHS398

Checklist

Page 2

•Captures

additional

information on

sources of

Program Income

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Career

Development

Award

Attachments

• Candidate Info

• Statements of Support

• Environ/Inst Commitment

• Research Plan

• Human Subjects

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Career

Development

Award

Attachments

- Other

Research

Plan Sections

- Appendix

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• Item B. - Research Training Plan includes: specific aims and a research strategy

• Item B. 1 - Introduction to application required for resubmissions – only

• Item B. 17 – Respective Contributions: describe collaboration between fellow and sponsor.

• Item C. 10 - Applicants must meet citizenship requirements at time of award, not time of application.

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• Mandatory for NRSA grant programs.

• Consult FOA for non-NRSA programs to determine, which budget form pages to use.

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PHS 398 Research

Training Program Plan

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• Item 2.2-2.4 – combined page limit is 25 pages

• Item 2.5 – Plan for Instruction in Responsible Conduct of Research is required for all training grant activity codes (except T36).

• Item 2.13 Data Tables – the attachment for the user defined bookmarks will be pulled into the NIH application image.

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• Create as a single document using any word processing software. Separate only at the end before uploading

• Do not include headers or footers

• Do include a section heading as part of the text; e.g., Use heading of Significance, Innovation, and Approach in Research Strategy

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• Do not scan paper documents.

• Use meaningful titles for file names

• Only use standard characters in file names: A-Z, 0-9, Underscore ( _ ).

• Disable write-protection features.

• A zero-byte attachment is an invalid PDF.

More at: http://grants.nih.gov/grants/ElectronicReceipt/pdf_guidelines.htm 58

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• Save final application document and click “Check Package for Errors” on Grant Application Package Screen.

• Once all documents are properly completed “Save & Submit” button becomes active.

• After clicking “Save & Submit,” Application Submission Verification and Signature screen will appear.

• Confirm you are responding to correct FOA.

• After clicking “Sign and Submit Application” applicants will receive a Grants.gov Tracking Number.

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Click Sign and

Submit

Application.

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Grants.gov Tracking #

Print/Save your

Confirmation screen info

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• Training

o http://grants.nih.gov/grants/ElectronicReceipt/training.htm

• Other

o Frequently Asked Questions http://grants.nih.gov/grants/ElectronicReceipt/faq.htm

o Avoiding Common Errors http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm

o Communications Resources (brochures, presentations, drop-in newsletter articles) http://grants.nih.gov/grants/ElectronicReceipt/communication.htm

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• Review application instruction guide(s)

• Grants Info

o Phone: 301-435-0714

o 301-451-0088 (TTY)

o Email [email protected]

• eRA Commons Help Desk

o Phone: 301-402-7469/866-504-9552

o 301-451-5939 (TTY)

o Email [email protected]

o http://itservicedesk.nih.gov/era/

Enter your own

help ticket!

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