PKG00294523.pdf

Food and Drug Administration (FDA) Notice of Funding Opportunity

Application Guide

LAST REVISED: May 2026

FY 2027

About the Application Guide

This guide helps you prepare and apply to a FDA Notice of Funding Opportunity

(NOFO).

Please review each section of this guide for helpful information about key parts of the application process, including registration, required attachments, and completing the budget. The guide also provides information about federal policies and regulations you must follow if you receive federal funding.

Contents

About the Application Guide

Section A: Registration and Application Submission

1. GETTING STARTED: REGISTER ON THREE REQUIRED SYSTEMS

1.1 Register Your Organization with SAM

1.2 Register on Grants.gov

1.3 Register on eRA Commons

2. COMPLETE YOUR APPLICATION

2.1 Standard Application Components

Other Supporting Documents

2.2 Additional Documents for Submission

3. SUBMIT YOUR APPLICATION

3.1 How to Submit Electronically (eRA ASSIST or Grants.gov Workspace)

Submitting with eRA ASSIST

Submitting with Grants.gov Workspace

3.2 Deadline

3.3 How to Get Assistance If You Have Trouble Submitting

4. AFTER SUBMITTING YOUR APPLICATION

4.1 System Validation and Tracking

First: Grants.gov Validation

Second: eRA Commons Validation

Section B: Formatting Requirements and System Validation for FDA Grant Applications ……. 14

1. FDA Formatting Requirements

2. Grants.gov Formatting and Validation Requirements

3. eRA Commons Assist Formatting and Validation Requirements eRA Commons Validation Table

Common Budget Errors

Section C: Budget and Justification Narrative

Section D: Standards for Financial Management and Standard Funding Restrictions and Principles

Standards for Financial Management

Standard Funding Restrictions

Standard Principles for Funding Discretionary Awards

Section E: Administrative and National Policy Requirements

Section A: Registration and Application Submission

1. GETTING STARTED: REGISTER ON THREE REQUIRED SYSTEMS

You must be registered with these three systems to apply for FDA funding:

1.1) System for Award Management (SAM)

1.2) Grants.gov

1.3) eRA Commons

1.1 Register Your Organization with SAM

SAM is a registry of all organizations that work with the Federal Government. When you register your organization with SAM, you receive a Unique Entity Identifier (UEI). You cannot apply for an award without a UEI.

If you are new to SAM:

• Go to https://www.sam.gov. Create a user account.

• Follow the instructions to register your organization and obtain a UEI.

▪ A UEI is required for both grant recipients and all sub-recipients.

• SAM.gov will send you an email when your registration is active.

• Start the SAM registration process at least six weeks before the NOFO application is due. It can take up to 10 business days for your registration to activate and to receive your UEI.

• After you receive your UEI, you must keep your account active by updating your information every 12 months.

If you already have a SAM account:

• Log in and confirm that your organization’s registration is active. The expiration date appears on the registration page.

• If your organization’s registration has expired, it will take 48 to 72 hours to renew. Note that Grants.gov (see 1.2 in this Section) rejects applicants with an expired registration.

• If you can’t log in because your account is inactive, please allow up to 14 days for SAM.gov to renew your account.

You must keep your SAM registration active (both recipients and sub-recipients) with up-to-date information while your organization has an active federal award or an application under consideration by an agency. This does not apply if you are an individual or federal agency that is exempted from those requirements under 2

CFR § 25.110.

1.2 Register on Grants.gov

Grants.gov is an online portal for submitting federal award applications. It requires a one-time registration. eRA Commons registration (see 1.3 in this Section) is separate, but you can register for both at the same time.

• Go to https://grants.gov/register to register.

• The person who submits your application must be registered with Grants.gov as the Authorized Organization Representative (AOR) for the UEI number entered in box 8c on the first page of the SF-424. See the Grants.gov Online User Guide.

1.3 Register on eRA Commons

eRA Commons allows applicants, award recipients, and federal staff to securely share, manage, and process award-related information. Your organization needs a valid and active UEI from SAM.gov to complete the eRA Commons registration.

Your application will not be accepted if your organization does not register or have an active and valid eRA Commons Principal Investigator/Project Director (PI/PD) account by the NOFO deadline. No exceptions will be made.

If you are new to eRA Commons:

• Register to receive your organization’s eRA Commons Username. With this username, you can access your electronic submission, receive notifications on your application status, and get award information.

• Identify your Signing Official (SO) who will complete the Register Institution Form. This person must be registered as the Authorized Organizational Representative (AOR) role in Grants.gov and be listed in the Authorized Representative section (#21) on page 3 of the SF-424 (Application for Federal Assistance).

• The SO must complete and submit the online Register Institution form. This is a one-time registration. For instruction on how to register, go to Register in eRA Commons.

• After completing the Register Institution form, the SO will receive an email with registration approval and an eRA Commons User ID for the SO account role.

• Once the account is active, the SO can create additional user accounts for the organization, including the required account for the PI/PD.

• If the person in the SO role for your organization needs to change, contact the eRA Service Desk for guidance on how to make this change.

2. COMPLETE YOUR APPLICATION

After successfully registering with SAM, Grants.gov, and eRA Commons, download all required application components.

2.1 Standard Application Components

The following table includes a description of each required document and where it can be found.

IMPORTANT: All files uploaded with the Grants.gov application MUST be in Adobe

PDF.

1. The SO must create a Commons user account with the PI/PD role. The PD must complete setting up their user account.

2. The PD’s eRA Commons username must be entered in Line 4 (Applicant Identifier) of the SF-424.

3. The PD’s information must be entered in Section 8f (name and contact information of the person to be contacted on matters involving this application) on page 1 of the SF-424.

4. The same person cannot be entered on the form as the SO and the PD.

5. More than one person can hold each role, but only the eRA Commons account holders named on the SF-424 are designated as the contact persons for the application.

Standard Application

Components Instructions

Where to Find Document

1 SF-424 Application for Federal Assistance Form

Complete all sections of this form.

✓ Line 4 – Applicant Identifier. Enter the PD’s eRA Commons username.

✓ Section 8b. Employer/Taxpayer Identification

Number (EIN/TIN). enter the recipient organization’s 12-character EIN and suffix as registered with the Payment Management System (PMS), if applicable. If not registered in PMS, enter the recipient organization’s

EIN.

✓ Section 8d: Address. Use your organization’s legal mailing address. The address cannot be a P.O. Box.

✓ Section 8f: Name and contact information of person to be contacted on matters involving this application. Enter the PD’s name, title, organization, phone, and email.

✓ Page 3 – Authorized Representative. Enter the SO’s name, title, phone, and email.

IMPORTANT:

• All Notices of Award (NoAs) will be emailed via eRA Commons to the PD and the SO identified on the SF-424.

• The PD listed on the SF-424 must match the PD in the Personnel Costs Section in the budget.

Grants.gov/forms

2 SF-424A Budget Information – Non- Construction Programs Form

Fill out Sections A, B, D, and E. Only complete Section C if there is a cost sharing requirement stated in the Notice of Funding Opportunity Announcement.

Grants.gov/forms

3 Project/Performance Site Location(s) Form

Provide complete information on the physical location of the site or sites where you will implement the project. You may not use a P.O. Box.

Grants.gov/forms

4 Project Abstract Summary

Write a one-page project abstract. Your abstract should include:

✓ A project summary within the first five lines.

FDA will use this summary in publications, reports to Congress, or press releases if your project is funded.

✓ Project name

✓ Service area, including demographics and characteristics

✓ Strategies you plan to implement

✓ Project goals and measurable objectives, including quantitative data.

Not Applicable

Standard Application

Components Instructions

Where to Find Document

5 Project Narrative Attachment

The Project Narrative is your response to the Funding Opportunity and will be evaluated as outlined in the evaluation criteria published in the Notice of Funding Opportunity Announcement.

✓ Follow instructions as published in the Notice of Funding Opportunity Announcement.

See Notice of Funding

Opportunity Announcement

6 Budget Justification and Narrative Attachment

Submit a detailed Budget Narrative with Budget Form SF-424A.

✓ Follow the guidelines in the Budget and Justification section of the Notice of Funding Opportunity Announcement. This section details what budget categories to include and how to separate amounts for different program functions or activities.

✓ Submit the budget narrative and justification with the file name “BNF.”

See Notice of Funding

Opportunity Announcement

7 SF-424B Assurances for Non-Construction Form

By checking the box marked “I Agree” and signing the SF-424 you agree to the assurances listed on the SF- 424B. You must acknowledge that you have read and understand the list of assurances.

Not Applicable

8 Grants.gov Lobbying Form

SF-LLL Disclosure of Lobbying Activities Form

Federal law prohibits the use of appropriated funds for publicity or propaganda purposes or for the preparation, distribution, or use of the information designed to support or defeat legislation pending before Congress or state legislatures.

All applicants must submit the Grants.gov Lobbying Form. If your organization participates in lobbying activities, you must also submit a signed copy of the Disclosure of Lobbying Activities Form (SF-LLL).

Grants.gov/forms

9 Other Attachments Form Refer to Other Supporting Documents section below.

Other Supporting Documents

You must submit the supporting documents listed in the table below with your application, along with the Standard Application Components. Attach each document (Adobe PDF format only) using the Other Attachments Form in eRA ASSIST or Grants.gov.

Supporting Documents

Instructions

Where to Find the Document

1 Biographical Sketches and Position Descriptions

(Attachment 5)

✓ These documents allow FDA to evaluate the qualifications of program staff and to understand the duties they will perform.

4 Additional Documents in the NOFO

Review the NOFO to find out if there are additional attachments that you must include in your application.

See Notice of Funding

Opportunity Announcement

5 Current Negotiated Indirect Cost Rate Agreement (NICRA) or Cost Allocation Plan

(Attachment 9)

If your organization has a negotiated cost rate agreement, submit it with your application. If your rate agreement is currently under negotiation, submit proof of proposal submission.

FDA will review your organization’s NICRA to ensure that your budget reflects the negotiated rate.

Not applicable

Supporting Documents

Instructions

Where to Find the Document

6 Other Active Federal Awards

Provide a list of your organization’s active federal awards with the grant number, designated key personnel, and their individual levels of effort for each award.

Key personnel or other grant-supported staff must not exceed 100% level of effort across all current federal and non-federal funding sources.

2.2 Additional Documents for Submission

The Notice of Funding Opportunity Announcement may include additional materials you may need to complete your application. All applicants are responsible for reading the Notice of Funding Opportunity Announcement in its entirety and submitting a complete application. Incomplete applications will not be accepted or advanced for objective review.

3. SUBMIT YOUR APPLICATION

3.1 How to Submit Electronically (eRA ASSIST or Grants.gov Workspace)

After you complete all registration and application requirements, you must electronically submit your application to Grants.gov. You may do this using one of two methods:

1. eRA Common’s ASSIST, which will automatically route your application to Grants.gov; or

2. Grants.gov Workspace.

Regardless of how you submit, your application will be subject to the same registration requirements, completed with the same data items, routed through Grants.gov, validated against the same agency business rules, assembled in a consistent format for review consideration, and tracked in eRA Commons.

Tip: Submit your application 24–72 hours before the deadline. This allows time to fix submission errors or issues and to resubmit your application if needed.

Submitting with eRA ASSIST

FDA strongly recommends that you use eRA ASSIST to prepare your application using the SF-424 forms, to submit through Grants.gov to FDA and other participating agencies, and to track your application. eRA ASSIST will allow you to ensure your application is submitted error-free in Grants.gov. NOTE: ASSIST requires the ID you received when you registered in eRA Commons.

To submit your application using eRA ASSIST:

1. Visit eRA Modules, User Guides, and Documentation | Electronic Research Administration for instructions.

2. Use the “ASSIST Validate Application” function to check your draft application for any errors or warnings. You must correct errors before your application can be successfully submitted.

3. Once no errors or warnings are found, you can submit your application.

Submitting with Grants.gov Workspace

Grants.gov Workspace allows you to collaborate with others on the various forms within the application.

To submit your application using the Grants.gov Workspace, see Grants.gov Workspace Overview.

3.2 Deadline

Your electronic application must be error-free, submitted, and validated by Grants.gov and eRA Commons no later than 11:59 p.m. Eastern Time on the application due date.

Applications submitted after the due date will not be considered. No late applications will be accepted.

See Section 4.1 for more information about validation.

3.3 How to Get Assistance If You Have Trouble Submitting

If you have problems in Grants.gov, contact the Grants.gov Service Desk:

• Email: support@grants.gov.

• Phone: 1-800-518-GRANTS. The Grants.gov Service Desk is available 24 hours a day, 7 days a week, except on federal holidays.

Make sure you receive a case, ticket, or reference number that documents the issues with Grants.gov.

Additional support is also available from the eRA Commons Service Desk:

• Submit a service request ticket: http://grants.nih.gov/support/index.html

• By phone: 301-402-7469 or (toll-free) 1-866-504-9552. The eRA Commons Service desk is available Monday through Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

4. AFTER SUBMITTING YOUR APPLICATION

After you submit your application, it will go through two validation processes with both Grants.gov and eRA Commons. Your application must pass both validations successfully before FDA receives it.

4.1 System Validation and Tracking

First: Grants.gov Validation

After you successfully submit your application, Grants.gov will:

1. Email you to confirm receipt of your application and provide a tracking number.

2. Email you again to validate your application or reject it due to errors. If Grants.gov says your application was “Rejected with Errors,” you must address all errors and resubmit.

Once Grants.gov validates your application, it will go through the eRA Commons validation process.

Tip: Your Grants.gov tracking number is the only indication that Grants.gov received and validated your application.

If you do not receive a Grants.gov tracking number, contact the Grants.gov support center for assistance.

You can check your application status at any time by logging into your Grants.gov Workspace account. Note: this only confirms that an application was successfully retrieved by eRA Commons. Thereafter in the process, eRA Commons reviews and processes the applications independent of Grants.gov and does not report the status to Grants.gov.

Second: eRA Commons Validation eRA Commons will email you if it finds errors during the validation process. There is a difference between system errors and warnings.

• If you receive a “Systems Error” notification:

✓ You must correct the error and resubmit your application.

✓ You must resubmit the application through Grants.gov before the due date and time.

✓ When resubmitting an application after making revisions, ensure the Project Title is identical to the Project Title in the originally submitted application. In addition, check the Changed/Corrected Application box in #1.

✓ Once you correct and resubmit your application, check your application status in eRA Commons to ensure it was successfully submitted.

• If you receive a “Warning” notification:

✓ You are not required to resubmit the application.

✓ The email notification will describe the reason for the warning.

✓ You can then decide whether to correct and resubmit the application.

You can track your application’s progress in eRA ASSIST at any time.

1. Look for a link in ASSIST called “View Submission Status Details.”

2. The link will show a 7-digit agency tracking number.

3. Click on the link to verify that your application successfully processed and was submitted to FDA.

Section B: Formatting Requirements and System Validation for FDA Grant Applications

1. FDA Formatting Requirements FDA created these formatting requirements to standardize the process for all applicants.

• All attachments must be submitted as Adobe PDF files. See “eRA ASSIST

Formatting and Validation Requirements” in this section for more on PDF requirements.

• Text must be legible. Your application must be in black type and single-spaced. Use

Times New Roman 12-point font and one-inch margins on all sides. Times New Roman

10-point may only be used for charts and tables.

• See Application Review Information in the NOFO for the Project Narrative page limit. The application will not be reviewed if it is over the page limit.

• Citations may be submitted as a PDF attachment instead of part of the Project Narrative.

2. Grants.gov Formatting and Validation Requirements

• Grants.gov allows only the following characters when naming your attachments: A–Z, a– z, 0–9, underscore, hyphen, space, and period. See items 8 and 9 in the eRA Commons

Validation Table in this section.

• You must save any scanned images as PDFs at 150–200 dpi/ppi. Using a higher resolution or different file type could result in your application being rejected.

• Any files uploaded or attached to the Grants.gov application must be PDFs and contain a valid file format extension in the filename.

3. eRA Commons Assist Formatting and Validation Requirements

The application must be ‘error free’ to be processed through the eRA Commons. There may be additional validations which will result in “Warnings” but these will not prevent the application from processing through the submission process.

Files uploaded to ASSIST must be:

• PDFs

• Less than 6MB file size

• 8.5” x 11” page size

• Flattened for fillable PDFs

• Error-free

Files must NOT have:

• Password protection

• Live hyperlinks (Use only plain text URLs.)

• Bookmarks or signature boxes

• A filename exceeding 50 characters including spaces

Complete these steps for fillable PDFs:

Fillable PDFs are documents with fields that can be edited manually. An example is the SF-424.

If you are submitting fillable forms, you will need to “flatten” them to ensure that the information you entered in the fields is saved. Flattening a form is different from “locking” it. Locking a form restricts access to editing, printing, and copying the document. Do not lock your fillable PDFs.

To flatten a fillable PDF:

1. Go to print settings by selecting File > Print.

2. On the printer pull-down menu of options, choose Adobe PDF or Microsoft Print to

PDF, then click OK.

3. After clicking OK, a pop-up window will open with options to save the PDF. Give this

PDF a different file name than the original PDF. File names cannot exceed 50 characters.

4. Open the document to confirm that the information you entered in the fields was saved.

You will receive an email from era-notify@mail.nih.gov to correct and resubmit your application if it has any of these errors.

If you experience any system validation or technical issues after hours on the application due date, contact the eRA Commons Service Desk and submit a web ticket to document your attempt to submit your application.

eRA Commons Validation Table

The following table includes formatting requirements and system validations required by eRA Commons. If you do not meet a requirement, an error message will result.

eRA Validations eRA Error Messages

Item 1: Insert your Applicant Identifier in Item 4 on the SF-424

You must provide the Program Director or Program Investigator Credentials (Commons Username).

"The Commons Username must be provided in the Applicant Identifier field for the PD/PI.

The username provided must match a valid eRA Commons account.

“The Commons Username provided in the Applicant Identifier is not a recognized Commons account.”

The username must be affiliated with the organization that submits the application and the PI.

“The Commons account provided in the Applicant Identifier field for the PD/PI is either not affiliated with the applicant organization or does not hold the PI role. Check with your Commons Account Administrator to make sure your account affiliation and roles are set up correctly.”

Item 2: The Unique Entity Identifier (UEI) number that you provide must include valid characters that consist of 12 numbers)

“The UEI number provided has invalid characters (other than 12 numbers)”

Item 3: You must submit the documentation (forms) required in the NOFO.

The format of the application does not match the format of the NOFO. Contact the eRA Service Desk for help.

Item 4: If you make a change or correction to address an error, you must select “Changed/Corrected” in Item 1 on the SF-424).

“This application has been identified as a duplicate of a previous submission. The ‘Type of Submission’ should be set to Changed/Corrected if you are addressing errors/warnings.”

Item 5: The application cannot exceed 1.2 GB.

“The application did not follow the agency-specific size limit of 1.2 GB. Resize the application to be 1.2 GB or less before submitting.”

Item 6: The correct NOFO number must be provided.

“The Funding Opportunity Announcement number does not exist.”

Item 7: You must submit at all documents and attachments as PDFs.

“The <attachment name> attachment is not in PDF format. All attachments must be provided to the agency as PDFs with a .pdf extension.

Item 8: All attachments must comply with the following formatting requirements:

PDF attachments cannot be empty (0 bytes).

PDF attachments cannot have metadata missing, be encrypted, password protected, or secured documents.

The size of PDF attachments cannot be larger than 8.5” x 11” (horizontally or vertically). (Note:

FDA suggests you limit the size of attachments to 35 MB.)

PDF attachments must have a valid file name. Valid file names must include the following UTF-8 characters: A–Z, a–z, 0–9, underscore (_), hyphen (-), space, period.

“The <attachment name> attachment contained formatting or features not currently supported by NIH: [condition returned].”

“Filename <file name> cannot be larger than U.S. standard letter paper size of 8.5” x 11.”

“The <attachment name> attachment filename is invalid. Valid filenames may only include the following characters: A–Z, a–z, 0–9, underscore ( _), hyphen (-), space, or period. No special characters (including brackets) can be part of the filename.”

Item 9: The email addresses for the Contact Person (SF-424 8f) and the Authorized Representative (SF-424 below Section 21) must contain a ‘@’, with at least 1 and at most 64 characters preceding and following the ‘@’. Control characters (ASCII 0 through 31 and 127), spaces and special characters < > ( ) [ ] \ , ; : are not valid.

“The submitted email address for the person to be contacted <email address>, is invalid. Must contain a ‘@’, with at least 1 and at most 64 characters preceding and following the ‘@’.

Control characters (ASCII 0 through 31 and 127), spaces, and special characters < > ( ) [ ] \ , ; : are not valid.”

Item 10: Congressional district code of applicant (after truncating) must be valid. (SF-424, items 16 a and 16 b.)

“Congressional district <Congressional District> is invalid. To locate your district, see house.gov.”

Common Budget Errors

SF424-A: Section A – Budget

Summary

The numbers at the end of each row or at the bottom of each column must add up correctly.

The total should be the same as the sum of the individual numbers in that row or column.

SF424-A: Section A – Budget Summary The numbers at the end of each row or at the bottom of each column must add up correctly. The total should be the same as the sum of the individual numbers in that row or column.

SF424-A: Section B – Budget

Categories

The Total in Section B (Column 5

- Row k) must equal the Total in

Section A – Budget Summary

(Row 5, Column g).

“Ensure the TOTALS l (Column 5, Row k, column 5) equals the Budget Summary Totals in section A, Row 5, Column g.”

SF424-A: Section D –

Forecasted Cash Needs

The Federal Total for the 1st Year

(Line 13) must equal the Total in

Section A (Row 5, Column g).

“Ensure the Federal Total for the 1st year, in

Section D-Forecasted Needs equals Section A, New or Revised Budget Federal Totals (Column e, Row 5) amount.”

The Non-Federal Total for the 1st

Year sum must equal Estimated

Unobligated Funds Non-Federal

Totals in Section A (d-5) + New or

“Ensure the Non-Federal Total for the 1st year equals the sum of Estimated Unobligated Funds

Non-Federal Totals (Column d, Row 5) and New

Revised Budget Non-Federal

Totals (f-5).

or Revised Budget Non-Federal Totals (Column f, Row 5) in Section A.”

The 1st Year TOTAL in Section D must equal the Total (Row 5, Column G) in Section A.

“Ensure the Forecasted Cash Needs: Row 15

TOTAL equals SECTION A – Budget Summary

Totals: Line 5, Column (g).”

SF424-A: Section E – Budget

Estimates of Federal Funds

Needed for Balance of the

Project7

The number of budget years/periods must match the span of the project. The number of years in the project period in

Block 17 on the SF-424 must align with the future funding periods.

“Ensure the project period years on the SF 424 block 17 match the budget periods in the SF-

424A. Enter data for the first budget period in

Section D and enter future budget periods in

Section E.”

Section C: Budget and Justification Narrative

Your application must include a detailed budget and narrative justification for each year of support requested. In the budget, include federal and non-federal expenditures broken out by the object class cost categories listed on SF-424A − Section B (Budget Category) for non-construction awards.

• Your budget must match the costs identified on the SF-424A and the total costs on the SF-424.

• The budget and justification must be consistent with the Project Narrative.

• Your justification must be concrete and specific. It should explain the basis of each proposed cost in your budget and how it was calculated.

▪ Examples to consider when justifying the basis of the estimates can be ongoing activities, market rates, quotes received from vendors, or historical records. Your proposed costs must be reasonable, allowable, allocable, and necessary for the supported activity.

• Refer to the program specific Funding Restrictions/Limitations in the NOFO (Step 1), Standards for Financial Management and Standard Funding Restrictions, and 2 CFR 200 for applicable administrative requirements and cost principles.

Awards are generally for periods of performance (budget periods) of one to five years.

FDA bases the release of subsequent year funds on the submission and approval of your progress report(s) and any other required reports. Funding beyond the first-year budget period is subject to availability of funds and satisfactory progress of your program. FDA evaluates progress based on required performance measures, satisfactory achievement of goals and objectives, providing services to the projected number of people specified in the application, and satisfactory resolution of barriers and challenges.

Completing the SF-424A: Budget Cost Categories

Direct Costs: Costs charged directly to a federal award are typically incurred specifically for that federal award. Costs that otherwise would be treated as indirect costs may also be considered direct costs if they are directly related to a specific award

(2 CFR 200.413).

Personnel Costs: Explain personnel costs by providing the names and titles of each staff member involved in the project, along with their percentage level of effort, proposed hours, and annual salary. If a staff member has not been identified, you may write "To Be Hired" as the Name. You may not use award funds to pay an individual's salary exceeding Executive Level II. An individual’s base salary, per se, is NOT constrained by the statutory provision for a limitation of salary. This limitation applies to FDA awards, subawards, subcontracts, and cooperative agreements.

However, it does not apply to consultants.

The Project Director name, base salary, and percentage level of effort must be listed in the budget narrative justification, including in-kind, and must match the name listed on the SF-424, section 8f.

NOTE: If your organization receives an award and chooses to move forward with filling a Key Personnel position before receiving formal FDA approval, this will be done at your organization’s own risk. If FDA’s review of the Key Personnel request results in the proposed individual not being approved for the position, you must submit a qualified candidate for the Key Personnel position. FDA will not be liable for any costs incurred or pay for the salary of a Key Personnel position that it has not approved.

Fringe Benefits: Fringe benefits typically include such items as health insurance, taxes, unemployment insurance, life insurance, retirement plans, tuition reimbursement, and paid absences. Fringe benefits are recoverable in accordance with your organization’s federally approved indirect cost rate agreement, if applicable, or the organization’s accounting practices, provided those practices are consistent with federal cost principles and result in a fair and equitable allocation of fringe benefits.

Travel: List travel costs for local and/or long-distance travel. For local travel, enter the mileage rate, number of miles, reason for travel, and staff member/consumer completing the travel. The budget should also reflect the travel expenses like airfare, lodging, parking, and any per diem for each person and trip associated with participating in meetings and other proposed trainings or workshops. Name the traveler(s), if possible, describe the purpose of the travel, provide number of trips involved, the destinations, and the number of individuals you seek funds for. Ensure that the travel rates used comply with the allowable reimbursable U.S. General Services Administration’s (GSA) rates.

Equipment: List equipment costs (such as large items of medical equipment) and justify the need for the equipment. You must also provide the status of current equipment when requesting funds for the purchase of items that meet the definition of equipment (a unit cost of $10,000 or more and a useful life of one or more years).

Supplies: Include the programmatic items (such as examination gloves) necessary for program implementation. In contrast, note that general office supplies (such as paper and pencils) are typically considered as part of indirect costs and can be recovered through a federally approved indirect cost rate or the de minimis indirect cost rate.

Per 2 CFR 200.314, property will be classified as supplies if the acquisition cost is less than $10,000. Items such as laptops, tablets, and desktop computers are classified as a supply if the value is less than the $10,000 equipment threshold.

Vendor Contracts/Subawards & Subcontracts/Consortiums/Consultants: Provide an explanation about the purpose, basis for how you estimated costs, and specific deliverables. You must ensure that your organization has adequate procurement and merit review systems with fully developed written procedures for awarding and monitoring vendor contracts and subawards/subcontracts, respectively. You must notify potential subrecipients that they must provide you with their UEI number (see 2 CFR Part 25). For consultant services, list the total costs for all consultant services. In the narrative justification, identify each consultant, the services they will perform, total number of days, travel costs, and total estimated costs.

Other: Include all costs that do not fit into any other category and provide a justification and narrative description of each cost in this category (e.g., provider licenses, dedicated space rental).

Indirect Costs: Indirect costs are costs incurred for common or joint objectives that you cannot readily or specifically associate with a particular program but are necessary to the operations of your organization. This could include the cost of operating and maintaining facilities, depreciation, and administrative salaries. For some institutions, the term “facilities and administration” (F&A) is used to describe indirect costs.

You may request full indirect costs, subject to statutory and regulatory limitations and submission of an approved Negotiated Indirect Cost Rate Agreement (NICRA) established by the cognizant federal agency (typically the agency that provides the majority of the funds). If you claim indirect costs, you must submit a copy of the NICRA in Attachment 9 of your application. If you are unable to obtain a NICRA from the cognizant agency at the time of application, you may choose to recover indirect costs using a de minimis rate. Otherwise, you may only be reimbursed for allowable direct costs.

If you cannot obtain a NICRA at the time of application, you may choose a 15 percent de minimis rate, subject to statutory and regulatory limitations.

You may use the 15 percent de minimis rate indefinitely and apply it to the Modified Total Direct Costs (MTDC). MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and up to the first $50,000 of each subaward (regardless of the period of performance of the subawards under the award). MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs, and the portion of each subaward in excess of $50,000.

Violation of cost accounting principles is not permitted when re-budgeting or charging costs to awards. Rather, you must consistently charge costs as either direct or indirect costs. Additionally, once elected, you must apply the 15 percent de minimis rate to all existing awards. If the cognizant agency issues a NICRA after the award, the negotiated rate may not be retroactively applied.

Waived Indirect Costs: You may also choose to waive recovery of indirect costs on any award. If so, write “None Requested” in Item J of the budget.

You may request full indirect costs, subject to statutory and regulatory limitations and submission of an approved Negotiated Indirect Cost Rate Agreement (NICRA) established by the cognizant federal agency (typically the agency that provides the majority of the funds). If you claim indirect costs, you must submit a copy of the NICRA in Attachment 9 of your application. If you are unable to obtain a NICRA from the cognizant agency at the time of application, you may choose to recover indirect costs using a de minimis rate. Otherwise, you may only be reimbursed for allowable direct costs.

If you cannot obtain a NICRA at the time of application, you may choose a 15 percent de minimis rate, subject to statutory and regulatory limitations.

You may use the 15 percent de minimis rate indefinitely and apply it to the Modified Total Direct Costs (MTDC). MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and up to the first $50,000 of each subaward (regardless of the period of performance of the subawards under the award). MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs, and the portion of each subaward in excess of $50,000.

Violation of cost accounting principles is not permitted when re-budgeting or charging costs to awards. Rather, you must consistently charge costs as either direct or indirect costs. Additionally, once elected, you must apply the 15 percent de minimis rate to all existing awards. If the cognizant agency issues a NICRA after the award, the negotiated rate may not be retroactively applied.

Section D: Standards for Financial Management and Standard Funding Restrictions and Principles

If FDA funds your project, your organization must follow the financial management requirements and cost principles in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards 2 CFR 200 (Subparts D and E), unless superseded by a program statute.

• Subpart D has federal financial management requirements for grant recipients.

• Subpart E has applicable cost principles that specify allowable and unallowable expenditures.

Standards for Financial Management

Your financial management systems must meet the standards in 2 CFR 200 Subpart D.

These standards require your financial management systems to retain a grant award’s distinct identity to (a) permit the accurate reporting of financial results for each federal award, and (b) track expenditures to establish that funds have been used by your organization for their intended purposes, in accordance with federal statutes, regulations, and the terms and conditions of your federal award.

As a result, you may not comingle individual federal awards with other federal and non-federal awards and expenditures. Commingling typically occurs when an organization combines funds and expenditures from multiple grant awards into a single account.

Common Commingling Mistakes

• Commingling Cost Centers. Every business activity constitutes a cost center.

Examples of cost centers include: a federal award, a state award, a private award, matching costs for a specific award, a self-funded project, fundraising activities, membership activities, lines of business, unallowable costs, and indirect costs. You must set up a unique account in your accounting system to capture and accumulate expenditures for each cost center, apart from other cost centers.

• Commingling Cost Categories. You must avoid budget fluctuations that violate programmatic restrictions. You must also avoid applying indirect cost rates to prohibited cost categories, such as equipment, participant support costs, and the portion of each subaward in excess of $50,000. As a result, you must establish unique object codes in the accounting system to capture and accumulate costs by budget category, such as salaries, fringe benefits, consultants, travel, participant support costs, and subcontracts.

• Commingling Time Worked and Not Worked. You cannot directly charge an award for employees’ time not spent working on the award. Therefore, you may not recover paid time off (PTO), such as vacation, holiday, sick, and other paid leave, directly from awards. You must instead allocate PTO to all your awards, projects, and cost centers over an entire cost accounting period through either an indirect cost or fringe benefit rate.

• Commingling Labor Costs - Unsupported Labor Costs. Time and attendance sheets alone, showing an employee worked a certain number of hours during a given day or time period, are inadequate to support salaries and wages. Rather, you must support charges for direct and indirect salaries and wages by using timekeeping documentation that identifies the work performed. For example, you may use hourly timesheets that encompass all hours worked and not worked each day. The timesheet should identify the: (a) grant award, project, or cost center worked on; (b) number of hours worked on each; (c) description of work performed; and (d) PTO hours. The total hours recorded each day should align with a person’s employment status in accordance with established policy (i.e., full-time employees work eight hours each day).

• Commingling Direct and Indirect Costs – Inconsistent Treatment of Costs.

You must treat costs consistently across all federal and non-federal awards, projects, and cost centers. For example, you may not direct-charge federal awards for costs typically considered indirect in nature, unless you do so consistently. Examples of indirect costs include administrative salaries, rent, accounting fees, and utilities. Additionally, in most cases, the cost to develop an accounting system adequate to justify direct charging of the aforementioned items outweighs the benefits. As a result, use of an indirect cost rate is the most effective mechanism to recover these costs and not violate federal financial requirements of consistency, allocability, and allowability.

Standard Funding Restrictions

In addition to 2 CFR 200, Subpart E’s guidance regarding allowable/unallowable expenditures, you may not use FDA funds to:

• Propose activities in your application and budget narrative that do not align with the current Executive Orders (EOs) and FDA Strategic Priorities.

• Pay for promotional items including, but not limited to, clothing and commemorative items, such as pens, mugs/cups, folders/folios, lanyards, and conference bags. (See 2 CFR 200.421(e)(3))

• Pay for the purchase or construction of any building or structure to house any part of the program. Minor alterations and renovations (A&R) may be authorized for up to 25 percent of a given budget period or $150,000 (whichever is less) for existing facilities, if necessary and appropriate to the program. Minor A&R may not include any structural change, such as to the foundation, roof, floor, or exterior or loadbearing walls of a facility, or extension of an existing facility, to increase the floor area or change the facility’s function and purpose. FDA must approve all minor A&R.

• Purchase firearms.

• Executive Level II pay amount is a person’s base salary exclusive of fringe and any income that an employee may earn outside of the duties to your organization. The salary limitation does not apply to consultants but does apply to subrecipients. Note that these or other salary limitations will apply in future fiscal years, as required by law.

Discretionary awards shall also not be used to fund, promote, encourage, subsidize, or facilitate:

• racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation.

• denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic.

• illegal immigration; or

• any other initiatives that compromise public safety or promote anti-American values.

Standard Principles for Funding Discretionary Awards

The following are standard principles that may be considered when funding discretionary awards:

• Discretionary awards must, where applicable, demonstrably advance the President’s policy priorities.

• All else being equal, preference should be given to institutions with lower indirect cost rates.

• Discretionary grants should be awarded to a broad range of recipients rather than to a select group of repeat players. Research grants should be awarded to a mix of recipients likely to produce immediately demonstrable results and recipients with the potential for potentially longer-term, breakthrough results, in a manner consistent with the funding opportunity announcement.

• Applicants should commit to complying with administration policies, procedures, and guidance respecting Gold Standard Science.

• Discretionary awards should include clear benchmarks for measuring success and progress towards relevant goals and, as relevant for awards pertaining to scientific research, a commitment to achieving Gold Standard Science.

• To the extent institutional affiliation is considered in making discretionary awards, agencies should prioritize an institution’s commitment to rigorous, reproducible scholarship over its historical reputation or perceived prestige. As to science grants, agencies should prioritize institutions that have demonstrated success in implementing Gold Standard Science.

Section E: Administrative and National Policy Requirements

If FDA funds your project, you must follow all terms and conditions of the Notice of Award (NoA).

HHS Grants Policy Statement (GPS)

You must comply with the requirements in the HHS Grants Policy Statement (GPS) unless the NoA includes statutory, regulatory, or award-specific requirements to the contrary.

HHS Award Regulations

Your program and any related activities are subject to all provisions in 2 CFR 200, other Department regulations and policies, and applicable statutory provisions in effect or implemented during the period of the award.

Additional Terms and Conditions

Depending on your funding opportunity and proposed program, your NoA may include additional terms and conditions.

Performance Goals and Objectives

FDA will hold your organization accountable for the performance targets you provide in your application. When making an annual recommendation to continue the award and the funding amount, FDA program officials will consider your progress implementing the required activities and meeting your goals and objectives. In your progress report, you will also be expected to describe barriers or challenges you encountered and strategies you put in place to overcome them.

Failure to meet your stated goals and objectives may result in suspension or termination of your award or in reduction or withholding of continuation awards (see 2 CFR 200.202, 2 CFR 200.301, and 2 CFR 200.329).

Termination of Federal Award

All FDA awards are subject to the termination provisions at 2 CFR 200.340, to include termination of awards that no longer effectuate program goals or agency priorities.

Accessibility Provisions for All Award Application Packages and Funding Opportunity Announcements

You must take reasonable steps to provide meaningful access to people with limited English proficiency and make sure your programs are accessible to and usable by persons with disabilities.

• For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by people with limited English-language proficiency, see Limited English Proficiency.

• For information on your specific legal obligations for serving qualified people with disabilities, including providing program access, reasonable modifications, and effective communication, see Discrimination on the Basis of Disability. In addition, see information below on products developed with award funds.

In addition,

▪ HHS-funded health and education programs must be administered in an environment free of sexual harassment.

• You must administer your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated antidiscrimination laws, see Your Protections Against Discrimination Based on Conscience and Religion.

Acknowledgment of Federal Funding

As required by HHS appropriations acts, all HHS recipients must acknowledge federal funding when issuing statements, press releases, publications, requests for proposal, bid solicitations, and other documents, such as tool kits, resource guides, websites, and presentations, describing the projects or programs funded in whole or in part with HHS federal funds.

You must clearly state: (1) the percentage and dollar amount of the total costs of the program or project funded with federal money; and (2) the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

Supplement, Not Supplant

You may use funds to supplement existing activities. However, you cannot use award funds to supplant current funding of existing activities. “Supplant” is defined as replacing funding of a recipient’s existing program with funds from a federal award.

Mandatory Disclosures

A term may be added to the NoA that states: “Consistent with 2 CFR 200.113, an applicant, recipient, or subrecipient of a Federal award must promptly disclose whenever, in connection with the Federal award (including any activities or subawards thereunder), it has credible evidence of the commission of a violation of Federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations found in Title 18 of the United States Code or a violation of the civil False Claims Act (31 U.S.C. 3729- 3733). The disclosure must be made in writing to the Federal agency, the agency’s Office of Inspector General, and pass-through entity (if applicable). Recipients and subrecipients are also required to report matters related to recipient integrity and performance in accordance with 2 CFR 200 Appendix XII.”

You must send disclosures in writing to the HHS Office of the Inspector General (OIG) at:

Office of Counsel to the Inspector General

Office of Inspector General

U.S. Department of Health and Human…