This is a basic tool which must be used in conjunction with the Application Guide for NIH [SF424 (R&R)] and the Funding Opportunity Announcement to ensure compliance with the specific program requirements.

For NIH applications with due dates on and after January 25, 2023, refer to SF424 (R&R) – Version H.

See the High-Level Grant Application Form Change Summary: FORMS-H for a full list of form changes.

For program specific (“R”, “K”, “T”, “F” “M” and “B” Series) see the application guide for additional application instructions.

Funding opportunity announcements/program announcements (known at ASU as FOA)

• Carefully read through the funding announcement
• Confirm ASU and PI are eligible to submit
• If limited submission, confirm PI has approval to submit
• Ensure that you are familiar with any applicable NIH Policy Notices

* Note that NIH requires specific forms for each FOA and these forms are located within the FOA

General

• For detailed instructions on completing an application to NIH, see the How to Apply – Application Guide
• All investigators have completed the PHS Annual Questionnaire
• File names ≤ to 50 characters including spaces (do not begin file name with space or include space before the .pdf extension)
• Use any of the following characters in a file name: A-Z, a-z, 0-9, underscore, hyphen, space, period, parenthesis, curly braces, square brackets, tilde, exclamation point, comma, semicolon, apostrophe, at sign, number sign, dollar sign, percent sign, plus sign, and equal sign
• Title does not exceed 200 characters including spaces and punctuation
• All formatting requirements have been met including: font size, line spacing, margins, type density, no pagination/headers/footers used

• All uploaded documents are in PDF format
• ASU’s Standard Institutional Info is correct on the SF424 and PHS Cover Page Supplement, including the

UEI (NTLHJXM55KZ6)

EIN (1860196696A1)

• Only use hyperlinks when NIH requests or in relevant citations and publications in biosketches and publication list attachments; do not use hyperlinks anywhere else in the application

SF424 (R and R)

• Project Dates and Budget totals are consistent with NIH submission schedule
• SF424 budget and justification, including subcontracts
• Descriptive title is limited to 200 characters, including spaces and punctuation

Cover Letter (Attached to SF424)

• Attach cover letter in the “21. Cover Letter Attachment” field, and not to the “20. Pre-application” field
• DO NOT include assignment or review/donot review requests.  Use PHS Assignment Request Form instead
• For late applications or changed/corrected applications submitted after deadline, must include specific information about the timing and nature of the delay causing late submission
• Explanation of any subaward budget that is not active during all periods of the proposed grant
• Intent to submit a video as part of the proposal (NOT-OD-24-067)
• Statement if proposed studies will generate large-scale human or non human genomic data (NOT-OD-14-11 and NOT-OD-15-027)
• Statement if proposed studies involve human fetal tissue (Section 2.3.7.11, Section 4.1.14 and Section 4.1.14.2)
• Any approval documentation required by the FOA and/or type of proposal (e.g., applications $500K or more, approval for Conference Grant/Cooperative Agreement (R13/54), etc.).  Include NIH official documentation as part of the cover letter, where appropriate

PHS Cover Page Supplement Form

• Required for all applications except fellowships

R and R Other Project Information Form

• Human/animals marked pending unless ORIA has reviewed protocol
• Human Subjects Assurance (00009102) / Animal Assurance (D16-00136)
• Projects that involve the use of human materials that check no for human subject must give a clear explanation of why the project does not constitute human subjects research (Human Subject Policy)
• Review the Page Limits for specific instructions on page limits for each application type
• Includes project summary, project narrative, bibliography & references cited, facility & other resources, and equipment attachments
• Facilities and Other Resources statement does not include equipment, a separate Equipment Statement must be attached
• Additional space for other attachments – review FOA to see if documents should be included
• If you selected ‘Yes’ to question 6 ‘Does this project involve activities outside of the United States or partnerships with international collaborators?’, then you must upload a foreign justification to the Other Attachments section

Project/Performance Site Location(s) Form

• Include all performance site locations, including subaward performance sites

R&R Senior/Key Person Profile

• Organization field must be completed for each person
• Credential must be listed for all individuals listed on the R&R Senior/Key Person Profile Form
• Co-PD/PI role has not been selected (unallowable NIH role)
• Co-PD/PI role has not been used for other institutions’ investigators – use “other”/type in “Consortium PD/PI” or “Consortium Investigator”
  • Keep in mind – when NIH uses the word “Consortium”, they are referring sub-recipient partners.
• For Multiple PD/PI proposals, all PD/PIs must be assigned the “PD/PI” role
• Other Significant Contributors should be listed after all senior personnel
• Biosketch limited to 5 pages, unless FOA states otherwise
• Biosketch prepared in the specified format, recommended to use SciENcv
• Biosketch appointments must be listed in reverse chronological order for all current positions and scientific appointments
• Profiles for remaining senior personnel, other than the PD/PI, should be added in order of importance. If several project personnel have the same role, those profiles can be alphabetized by last name.
• Do not upload Current and pending information unless the FOA specifically requires

Budget

• Review NIH’s Develop Your Budget site
• Appropriate Budget Component used (R&R vs. Modular)
• Budget must adhere to all NIH and FOA requirements –  including salary cap
• No participant support costs are included, unless FOA specifically allows
• Senior/Key Person Effort on SF424 R&R budget form is > zero
• Any adjustment for salary limits will be made at the time of award; therefore, requested salary should be based on institutional base salary at the time the application is submitted and not adjusted for any limitation.
• Costs must be allowable, allocable, and reasonable under 2 CFR 200 (uniform guidance)
• Consortium F&A is not been counted toward the funding cap
• Check that correct annual escalation, ERE, tuition, and F&A rates are used
• Check that F&A has been included on the first $25K for each subcontract
• Detailed subcontract budget should not be used with modular budget
• If you have a subaward that will not be active the entire period of performance, you must still include an R&R Period for the inactive budget period. List the calendar months of the PI at 0.01, salary = $0, and fringe benefits = $0. The budget justification must include an explanation of the inactive periods.

Budget Justification

• Budget justification must be appropriate to budget component used. Modular budgets vs R&R budgets have different requirements for the Budget Justifications
• No cost sharing is included unless required by the FOA
• If Data Management and Sharing (DMS) Plan is required in the proposed application, include brief justification of proposed activities that will incur costs and provide estimated dollar amount (total direct costs)
  • If no costs will be incurred for the DMS Plan, provide statement

R&R Budget Justifications:

• Travel costs describe who, what, when, and where
• Consultant rates are documented via signed letter

For Modular Budget Justifications:

• Personnel Justification – List personnel, names, percent effort, and roles. Do not provide salary information.
• Consortium Justification – Provide estimate of subaward costs (direct + indirect) for each budget period rounded to nearest $1,000. List all personnel, names, percent effort, and roles. Do not provide salary information.
• Additional Narrative Justification – Explain variations in number of modules requested, DMS plan costs, describe direct costs that were excluded from total direct costs (MTDC)
  • Additional explanation for variations in the number of modules requested annually is not needed in applications to FOAs with direct cost limits that do not spread evenly across budget periods (e.g., R21 FOAs that allow $275,000 in direct costs over two years).

PHS 398 Research Plan Form

• Specific Aims upload is required unless otherwise specified in the FOA – see NIH Table of Page Limits
• Research Strategy upload is required – see NIH Table of Page Limits
• Progress Report Publication List upload is only required for renewal proposals
• Vertebrae Animals upload is only required if answered “Yes” to “Are Vertebrae Animals Used?”
• Select Agent Research upload only required if proposed activities include select agents at any project location
• Multiple PD/PI Leadership Plan upload required if submitting a multiple PI/PD application
• Consortium/Contractual Arrangements upload only required if application includes consortiums/contracts in the budget – Explain programmatic, fiscal, and administrative arrangements
  • You will also need to include the following:
    • All proposed performance sites
    • For non-modular grant applications – must include complete detailed budgets for each consortium participant
    • For modular grant applications – must include estimate of consortium total costs (IDC + DC) rounded to the nearest $1000 in consortium justification. Indicate if the collaborating institution is foreign or domestic.
  • There should be a consortium lead investigator. If submitting a multiple PI/PD application – they will be listed as a PD/PI. If not submitting a multiple PI/PD application – they will be listed as a different Senior/Key Personnel role.
  • For Multi-project applications, you may include the attachment in one of the following ways (unless FOA states differently):
    • Single attachment in Overall Component
    • Component-specific attachments within components that include subawards
    • Single attachment in Overall Component and component-specific attachments within components that include subawards
• Letters of Support upload only allowed if specified in the FOA – must combine into single PDF
• Resource Sharing Plan upload required in specific circumstances, see the NIH application guide and FOA for when to include
• Other Plans upload for Data Management and Sharing (DMS) Plan is required if the project will generate scientific data (see: Research Covered Under the Data Management & Sharing Policy). If applicable, this should also address genomic data sharing (GDS)
• Authentication of Key Biological and/or Chemical Resources upload is only required if applicable to the project
• Appendix upload is only allowed for including specific documents as listed below:
  • Blank data collection forms, blank survey forms, and blank questionnaires (or screenshots)
  • Simple list of interview questions
  • Blank informed consent/assent forms
  • FOA-specified/required appendix materials

PHS 398 Research Plan Form

• Must respond to the “Are Human Subjects Involved?” question
  • If responding ‘No’, do not need to complete the remainder of the form
• If Human Subjects are involved, must add a Study Record for each proposed study involving human subjects
  • Must complete all sections 1 – 3
  • If answered ‘Yes’ to all Clinical Trial Questionnaire questions, must also complete section 4
  • If answered ‘Yes’ to all Clinical Trial Questionnaire questions and FOA requires attachment, must also complete section 5
  • Must include PDF attachments as listed in the NIH Application Form Instructions

PHS Assignment Request Form

• The form is optional and used to communicate specific awarding component assignments or review preferences