PKG00293358.pdf

CD26_01 General Application Instructions 1

General Application Instructions for the Defense Health Agency Version CD26_01

CD26_01 General Application Instructions 2

Table of Contents

I. GENERAL INFORMATION

A. How to Use the General Application Instructions B. Current Funding Opportunities and Email Notifications C. Agency Contacts D. Application and Award Information

II. INTRODUCTION TO APPLICATION SUBMISSION

A. Applications Involving Intragovernmental or Intramural DOW Organizations B. Pre-Application and Full Application Submission Portal Systems C. Application Submission Overview

III. PRE-APPLICATION SUBMISSION

A. eBRAP Registration B. Content and Form of Pre-Application Submission – eBRAP

IV. FULL APPLICATION SUBMISSION THROUGH GRANTS.GOV

A. Grants.gov Registration B. Content and Form of Full Application Submission – Grants.gov C. Additional Application Materials D. Submission to Grants.gov E. Applicant Verification of Grants.gov Submission in eBRAP

V. FULL APPLICATION SUBMISSION THROUGH eBRAP A. Content and Form of Full Application Submission – eBRAP B. Additional Application Materials C. Applicant Verification of Full Application Submission in eBRAP

APPENDIX 1. Recipient Qualification and Restriction Information APPENDIX 2. Formatting Guidelines APPENDIX 3. Appeals and Inquiry Review Process APPENDIX 4. Use of DOW or U.S. Department of Veterans Affairs Resources APPENDIX 5. Research BioSafety Requirements APPENDIX 6. Research Protections Review Requirements APPENDIX 7. Administrative Information APPENDIX 8. National Policy Requirements APPENDIX 9. Reporting Requirements APPENDIX 10. DOW and VA Websites APPENDIX 11. Definition List APPENDIX 12. Acronym List

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I. GENERAL INFORMATION

A. How to Use the General Application Instructions

The General Application Instructions (GAI) are designed to be read in conjunction with the program announcement for a funding opportunity offered by the Congressionally Directed Medical Research Programs (CDMRP). The program announcement provides basic information necessary to prepare an application (i.e., what to submit), whereas the GAI provides additional details and instruction for both application preparation and submission (i.e., how to submit). For accurate referencing, ensure that the version on the cover page of the GAI matches the version specified on the front page of the program announcement.

The following symbols are used throughout the GAI:

Marks particularly helpful or important information.

Refers the reader to the program announcement for specific instructions or additional information.

B. Current Funding Opportunities and Email Notifications

Funding opportunities currently issued by the CDMRP may be viewed at the Grants.gov Search Grants page; users should enter Assistance Listing (AL) Number 12.420 when searching for CDMRP funding opportunities. Applicants should subscribe on Grants.gov to receive official notifications of new funding opportunity postings and updates. Applicants are encouraged to sign up to receive notifications of changes to specific funding opportunities through either: (1) the Subscribe button on the Synopsis page for the specific program announcement; or (2) the Manage Subscriptions option on the Connect pull-down menu.

It is incumbent upon the applicant to check for published updates to the funding opportunity and the application package prior to submission; the applicant is responsible for using the latest version of the full application package. If the Grants.gov application package is updated or changed, then previous versions of the application package may not be accepted by Grants.gov.

Information about funding opportunities is available on the CDMRP Open Funding Opportunities page and on the electronic Biomedical Research Application Portal (eBRAP) Funding Opportunities and Forms page. Applicants can receive email notifications of funding opportunity releases by subscribing on eBRAP. Email notifications of funding opportunities from eBRAP are sent as a courtesy.

To facilitate that email correspondence is delivered correctly, and not treated as spam, Principal Investigators (PIs) and organizational representatives should keep email addresses up to date in both Grants.gov and eBRAP; and place the following domains into any available email “safelists”: health.mil, eBRAP.org and Grants.gov. The same email addresses should be used when submitting both the pre-application and the full application.

C. Agency Contacts eBRAP Help Desk: Questions related to program announcement content or submission requirements, as well as questions related to submission of pre-applications, or full applications https://simpler.grants.gov/search https://simpler.grants.gov/search http://www.grants.gov/connect/manage-subscriptions/ https://www.grants.gov/connect/manage-subscriptions/ https://cdmrp.health.mil/funding/ https://ebrap.org/eBRAP/public/Program.htm https://ebrap.org/eBRAP/public/Program.htm https://ebrap.org/eBRAP/programSubscription/Subscribe.htm

CD26_01 General Application Instructions 4 from intramural organizations, should be directed to the eBRAP Help Desk, which is available Monday through Friday from 8:00 a.m. to 5:00 p.m. Eastern Time (closed on most U.S. federal holidays). Response times may vary depending on the volume of inquiries. The eBRAP Help Desk will not provide Grants.gov submission assistance.

Phone: 301-682-5507

Email: Help@eBRAP.org

Grants.gov Support Center: Questions related to application submission through the Grants.gov portal should be directed to the Grants.gov Support Center, which is available 24 hours a day, seven days a week (closed on U.S. federal holidays).

Phone: 800-518-4726; International 1-606-545-5035

Email: support@grants.gov

D. Application and Award Information

Timelines: Awards made from CDMRP funding opportunities will be funded with Defense Health Program Research, Development, Test and Evaluation (RDT&E) appropriations. RDT&E funds must be obligated to a specific award or purpose within 24 months from the start of the fiscal year in which the funds were appropriated (e.g., fiscal year 2026 [FY26] funds must be obligated no later than September 30, 2027, Figure 1). In addition to obligation deadlines, RDT&E funds are available for use for a limited time period and close for disbursement five years after the obligation deadline. Closed (i.e., undisbursed) funds are returned to the U.S.

Treasury at the end of the five-year disbursement period (e.g., FY26 funds close for disbursement to performers on September 30, 2032).

Figure 1. RDT&E Funds Obligation and Disbursement Timeline mailto:help@eBRAP.org https://grants.gov/support mailto:support@grants.gov

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Pre-Award Costs: An institution of higher education, hospital, other nonprofit or for-profit organization may, at its own risk and without the government’s prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: (1) are necessary to conduct the project; and (2) would be allowable under the award, if awarded. If specific expenditures would otherwise require prior approval, the recipient must obtain the Grants Officer’s approval before incurring the cost.

Government prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

Incurring pre-award costs in anticipation of an award imposes no obligation on the government to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred or in the absence of appropriations. The government expects the recipient to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the organization’s ability to accomplish the project objectives within the approved timeframe or in any way adversely affect the conduct of the project.

II. INTRODUCTION TO APPLICATION SUBMISSION

A. Applications Involving Intragovernmental or Intramural DOW Organizations

To provide information specific to intragovernmental and intramural DOW investigators contributing to the submission of an application, the CDMRP developed a Guide for Intragovernmental and Intramural DOD Applicants. Applicants are encouraged to reference this guide for additional information and considerations unique to intragovernmental and intramural organizations.

Funding to Intragovernmental and Intramural DOW Organizations: Intragovernmental and intramural DOW organizations must be prepared to accept the entirety of the requested budget for the proposed work in the fiscal year funds specified in the funding opportunity.

Appropriations for a given CDMRP program or topic are not part of the requested DOW budget, and there is no guarantee of future funding. Intragovernmental and intramural DOW investigators are responsible for coordinating the use of funding agreements, contractual or otherwise, to support any extramural collaborators as appropriate. Intragovernmental and intramural DOW investigators and collaborators are reminded to coordinate the receipt and commitment of funds through their respective Resource Manager (RM), Task Area Manager, Comptroller or equivalent Business Official.

The Defense Health Agency Research and Development, Medical Research and Development Command (DHA R&D, MRDC) will “direct fund” Intragovernmental/Intramural DOW Organizations by utilizing Title 41 United States Code (USC) 6307, the Project Order Statute, or 31 USC 1535, the Economy Act Statute, as appropriate. Provided all criteria are met, the CDMRP will use the Project Order Statute as the preferred transactional authority to fund intramural DOW organizations. The DHA R&D, MRDC will fund by the authorized method through the Military Interdepartmental Purchase Request (MIPR), Funding Authorization Document (FAD) or Direct Charge Work Breakdown Structure processes. Transfer of funds is contingent upon appropriate safety and administrative approvals.

Funding of Extramural Organizations Collaborating with an Intragovernmental or Intramural DOW Organization: Direct transfer of funds from any extramural award recipient to an intragovernmental or intramural DOW organization is not allowed except under very limited https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://uscode.house.gov/view.xhtml?req=(title:41%20section:6307%20edition:prelim)%20OR%20(granuleid:USC-prelim-title41-section6307)&f=treesort&edition=prelim&num=0&jumpTo=true https://uscode.house.gov/view.xhtml?req=(title:31%20section:1535%20edition:prelim)%20OR%20(granuleid:USC-prelim-title31-section1535)&f=treesort&edition=prelim&num=0&jumpTo=true

CD26_01 General Application Instructions 6 circumstances. As noted above, funding of intragovernmental or intramural DOW organizations, including research collaborators, will be managed through a direct funds transfer from the DHA

R&D, MRDC.

Cooperative Research and Development Agreement (CRADA): If an extramural collaborator will be involved in the performance of the proposed research with an Intragovernmental or Intramural DOW organization, a CRADA or other instrument (as authorized by law or regulation) with the collaborator may be necessary before work between the organizations can begin. The CRADA (or other instrument) is not required at the time of application submission. A timeline for execution of the CRADA should be included within the project’s Statement of Work (SOW).

B. Pre-Application and Full Application Submission Portal Systems eBRAP is a secure web-based system that allows PIs and/or organizational representatives to receive communications from the CDMRP and to submit their pre-applications. Intramural DOW organizations may submit full applications through eBRAP.

Additionally, the eBRAP system allows a submitting organization’s representatives and PIs to view and modify certain components of their full application submission package(s) during a specified verification period. eBRAP validates full application files against the specific program announcement requirements and notes discrepancies in an email to the PI as well as in the Full Application Files tab in eBRAP. During the verification period, it is the applicant’s responsibility to review all application components for accuracy and to ensure proper ordering as specified in the program announcement. All verification periods are specified in the program announcement.

Grants.gov is an e-government system that provides a centralized location for grant seekers to find and apply for federal funding opportunities being openly competed. Full applications for CDMRP funding opportunities may only be submitted to Grants.gov after submission of a pre-application through eBRAP. Extramural organizations must submit full applications through Grants.gov.

C. Application Submission Overview

Application submission is a two-step process. Successful completion of BOTH steps is required for all applications.

STEP 1. Pre-application submission: All pre-applications for both extramural and intramural DOW organizations must be submitted through eBRAP.

STEP 2. Full application submission: Full applications must be submitted through the online portals as described below.

Grants.gov: Full applications from extramural organizations must be submitted through Grants.gov Workspace. Refer to Section IV, Full Application Submission Through Grants.gov, for application preparation and submission instructions.

eBRAP: Only intramural DOW organizations may submit applications through eBRAP. Refer to Section V, Full Application Submission Through eBRAP, for application preparation and submission instructions. Full applications from extramural organizations, including non-DOW federal organizations, received through eBRAP will be withdrawn.

https://usamraa.health.mil/PAN/#:%7E:text=APAN%20%2D%20(Assistance/Procurement%20Advisory%20Notice)15%2D01%20%2D%20Supporting%20Military%20Facilities%27%20Costs%20when%20Performing%20Collaborative%20Research%20with%20Extramural%20Awardees https://ebrap.org/eBRAP/public/index.htm https://grants.gov/

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Regardless of submission portal used, all pre-application and application components must be submitted by the deadlines stipulated in the program announcement. Failure to meet any of the deadlines will result in application rejection.

The following information must be identical between the pre-application and the full application for eBRAP to process the submission: application title, PI information; Business Official(s) information, performing organization and contracting organization.

Additionally, the correct eBRAP log number associated with the application must be used throughout the entire submission process. Inconsistencies may delay application processing and limit or negate the ability to view, modify and verify the application in eBRAP during the application verification period.

If the funding mechanism allows for Partnering PIs, the Defense Health Agency Contracting Activity (DHACA) requires separate full application package submissions for the Initiating PI and each Partnering PI, even if the PIs are located within the same organization. The Partnering PI application is an abbreviated package that only includes components required to make a separate award. Initiating and Partnering PIs will each be assigned a unique eBRAP log number. Each full application package must be submitted using the unique eBRAP log number.

All associated applications (the Initiating PI’s and Partnering PI’s) must be submitted by the full application submission deadline.

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III. PRE-APPLICATION SUBMISSION

General information about eBRAP registration and pre-application submission is provided in this section. The eBRAP Applicant User Guide contains detailed instructions for these two processes.

A. eBRAP Registration

PIs must register in eBRAP to submit a pre-application.

It is strongly recommended that PIs start the eBRAP registration process early to ensure sufficient time for completion prior to the submission deadline. There is no grace period.

PIs are required to utilize an Open Researcher and Contributor ID (ORCID) identifier and should enter that information in the appropriate field in the My Profile tab in the Account Information section of eBRAP.

During eBRAP registration, the PI must request to be affiliated with their organization from the list of organizations already registered with eBRAP. If the PI’s organization is not already registered with eBRAP, the PI must invite an Authorized Organizational Representative (AOR) to register the organization. The AOR does not need to complete the organization registration in eBRAP prior to the pre-application submission deadline in order for the pre-application to be submitted. However, the organization’s eBRAP registration must be completed before the full application submission deadline to allow for processing, viewing and modifying select components of the full application package during the application verification period.

Extramural Organizations: Applicants should ensure that the names and email addresses used during eBRAP registration are the same as the names and email addresses used on the Application for Federal Assistance Standard Form 424 (Research & Related), SF424 (R&R) Form, submitted through Grants.gov Workspace.

Intramural DOW Organizations: Applicants should ensure that the names and email addresses used during eBRAP registration are the same as the names and email addresses that will be provided when the full application package is submitted through eBRAP.

B. Content and Form of Pre-Application Submission – eBRAP

For specific instructions regarding content of the pre-application submission components, refer to Section 5.3.1, Pre-Application Submission, in the program announcement.

All pre-application components must be submitted through eBRAP by the deadline specified in the program announcement.

To start a new pre‐application, select the New Pre‐Application link associated with the relevant program and award mechanism, and follow the prompts in eBRAP. Select the appropriate submission type (i.e., extramural or intramural). Information used to identify the pre‐application will be requested at this step, including application title, keywords and research characteristics.

https://ebrap.org/eBRAP/public/UserGuide.pdf https://orcid.org/ https://ebrap.org/eBRAP/public/UserGuide.pdf#page=3&zoom=0,0,1

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The incorrect selection of submission type will delay processing.

If an error was made in selecting extramural versus intramural and the pre-application submission deadline has passed, the PI or Business Official must contact the eBRAP Help Desk to request a change in designation prior to full application submission.

Once a new pre-application is created, eBRAP will assign a unique eBRAP log number. The eBRAP log number remains with the application through the entire application and review process, and throughout the life of the award if the project is recommended for funding.

Applicants should use this log number when referencing the application.

The pre-application consists of the following components, organized in eBRAP by separate tabs:

Summary Tab: This tab displays the information previously entered for the pre‐application, such as application title, PI, Business Official, performing organization, contracting organization, etc. As the steps of the pre‐application are completed, additional information will display on this tab.

Tab 1 – Application Information: This tab is prepopulated with information provided when creating a new pre-application. Prepopulated information can be changed in this tab, including the application submission type. Enter additional information as prompted.

Tab 2 – Application Contacts: Enter/update contact information for the PI and the Business Official responsible for sponsored program administration. For extramural applications, this will be the “Person to be contacted on matters involving this application” in Block 5 of the Grants.gov SF424 (R&R) Form. The Business Official must be either selected from the eBRAP list or invited to allow the pre-application to be submitted. If the Business Official cannot be found in eBRAP, an invitation must be sent to them to register in eBRAP.

The invitation to register must be sent prior to the pre-application deadline, but the Business Official has until the full application deadline to complete the registration. This registration is required for the Business Official to view, modify and verify the application in eBRAP after submission.

Select the performing organization and the contracting organization. The organization(s) must be either selected from the options available in eBRAP or invited in order for the pre-application to be submitted.

It is recommended that applicants identify an Alternate Submitter in the event that assistance with pre-application submission is needed.

Tab 3 – Collaborators and Key Personnel: Enter the name, organization and role of all collaborators and key personnel associated with the application, including partnering PI(s), if applicable.

No member of the Programmatic Panel may be named as a Collaborator or Key Personnel for the proposed research project, nor assist in preparing or submitting any component of the pre-application or application. Refer to the specific program announcement for a link to the list of Programmatic Panel members.

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Tab 4 – Conflicts of Interest: To avoid conflicts of interest during the screening and review processes, list all individuals, other than collaborators and key personnel, who may have a conflict of interest in the review of the application. Include individuals with whom the PI has a personal or professional relationship.

Tab 5 – Pre-Application Questions and/or Files: Upload individual PDF files and/or enter requested data in specified text boxes: refer to the program announcement for any detailed program specific instructions. Documents should conform to the formatting guidelines outlined in Appendix 2.

Tab 6 – Submit Pre-Application: Enter your eBRAP password and click the Submit button.

Click the Confirm Submission button to complete the pre-application submission. This finalizes the pre-application submission process.

Following completion of pre-application submission, the status of the pre-application in eBRAP will change from DRAFT to SUBMITTED and a confirmation email will be sent to the PI and the named Business Official.

The pre-application is not submitted until Tab 6 is complete. Pre-applications not submitted remain in DRAFT status. An applicant with a pre-application in DRAFT status after the pre-application submission deadline is ineligible to submit a full application. There is no grace period.

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IV. FULL APPLICATION SUBMISSION THROUGH GRANTS.GOV

A. Grants.gov Registration

To apply through Grants.gov, an organization, foreign or domestic, must first complete the Grants.gov registration process. Allow up to eight weeks for the completion of the Grants.gov registration process; this could take longer if the organization does not already have a unique entity identifier (UEI) from SAM.gov. Registering early is advised.

Foreign organizations doing business outside of the U.S. must also fulfill any/all supplementary requirements for doing business with the U.S. government. If business is conducted with the federal government on a continuing basis, it is likely that some of the required actions have already been completed. Detailed information, links, automated tools and checklists are available at the Grants.gov Quick Start Guide for Applicants page.

The following steps are required as part of the Grants.gov registration process:

1. Obtain Unique Entity Identifier from System for Award Management

The applicant organization must be registered as an Entity in the System for Award Management (SAM.gov) and receive confirmation of an Active status before submitting an application through Grants.gov. All federal awards, including but not limited to grants, cooperative agreements and contracts, must use the UEI generated by the SAM.

The SAM validates organization information and electronically shares the secure and encrypted data with federal agencies’ finance offices to facilitate paperless payments through electronic funds transfer. An organization must identify an Accounts Receivable point of contact (POC), an electronic business (E-Biz) POC, and a government business POC during the SAM registration process. Entity registrations in SAM have an annual expiration. Verify the status of your organization’s entity registration in the SAM well in advance of the application submission deadline. If your organization does not have either an Employer Identification Number (EIN) or Tax Identification Number (TIN), allow at least five weeks to receive this information from the U.S. Internal Revenue Service. Once an EIN or TIN is obtained, allow three to four weeks to complete the entire SAM registration process.

Additional information and step-by-step registration directions are detailed in the SAM User Guide and other U.S. General Services Administration (GSA) training materials at the SAM.gov Help page.

Applications will be rejected by Grants.gov if: (1) the organization’s entity registration in SAM is not active; or (2) during the SAM registration process, the organization did not answer “Yes” when asked “Do you want to be eligible for grants and other federal assistance?”

2. Obtain a Commercial and Government Entity Code

The applicant organization must have a commercial and government entity (CAGE) code. The Defense Logistics Information Service in Battle Creek, Michigan, is the only authorized source of CAGE codes. CAGE codes will be assigned to registrants as their SAM registration advances through the validation process. Foreign registrants in the SAM must be assigned a North Atlantic Treaty Organization CAGE code (NCAGE). An NCAGE code can be obtained by https://www.grants.gov/quick-start-guide/applicants https://sam.gov/content/home https://sam.gov/content/help

CD26_01 General Application Instructions 12 contacting the National Codification Bureau of the country where the organization is located or by visiting CAGE. Validation of the CAGE code or NCAGE code in the SAM can take 10 to 15 business days to process after the EIN or TIN is validated.

3. Register an AOR

An AOR is the Business Official designated as a member of the Grants.gov Workspace grant team who is authorized to submit the completed Workspace full application package. At the time of application submission to Grants.gov, the AOR certifies that, to the best of their knowledge, all information provided in the application is current, accurate and complete. For applications submitted through Grants.gov, the name of the AOR submitting the application is inserted into the application’s signature line, serving as the electronic signature.

An AOR must first register with the Grants.gov credential provider at Grants.gov to obtain a username and password. PIs do not register with Grants.gov. Once an AOR has completed the registration process, Grants.gov will notify the E-Biz POC of the registration; an individual may serve as both the E-Biz POC and the AOR. The E-Biz POC must then log in to Grants.gov and assign and authorize the appropriate roles, giving the AOR permission to complete and submit applications on behalf of the organization. After the E-Biz POC approves an AOR, Grants.gov will send the AOR a confirmation email.

Individuals who make legally binding commitments on behalf of an organization must be authorized as AORs by the E-Biz POC. This step, often overlooked by applicants, is crucial for valid and timely submissions.

4. Create Grants.gov Workspace

Applicants must create a Grants.gov Workspace, which allows the application components to be completed online and routed through the applicant organization for review prior to submission.

Once the Workspace has been created, participants (grant team members) can be added, and the required forms can be completed and reviewed before submitting. Specific information regarding the application process through Grants.gov Workspace is available on the Grants.gov How to Apply For Grants page.

Each application submission must include the completed application package of forms associated with the specific funding opportunity in Grants.gov.

Applicants who prepare the application outside Workspace must download the individual PDF forms from Grants.gov, complete and save the forms, and upload them to Workspace. Ensure a version of Adobe Acrobat Reader that is compatible with Grants.gov is used to download, complete and submit grant applications. If multiple users are completing Workspace PDF forms, it is recommended that the same version of Adobe Acrobat Reader software be used by each user to avoid version compatibility issues. It is the applicant’s responsibility to verify their Adobe software’s compatibility with Grants.gov.

The CDMRP cannot make allowances/exceptions to its policies for submission problems encountered by the applicant organization using system-to-system interfaces with Grants.gov.

https://cage.dla.mil/Home/UsageAgree https://www.grants.gov/register https://www.grants.gov/applicants/grant-applications/how-to-apply-for-grants https://grants.gov/applicants/adobe-software-compatibility https://grants.gov/applicants/adobe-software-compatibility

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B. Content and Form of Full Application Submission – Grants.gov

The following information must be identical between the pre-application and the full application for eBRAP to process the submission: application title, PI information; Business Official(s) information, performing organization and contracting organization.

Additionally, the correct eBRAP log number associated with the application must be used throughout the entire submission process. Inconsistencies may delay application processing and limit or negate the ability to view, modify and verify the application in eBRAP during the application verification period.

(a) SF424 (R&R) – Application for Federal Assistance Form

All appropriate information must be entered into this form to allow for auto-population of subsequent forms in the Grants.gov application package.

• Block 1 – Type of Submission. For original submissions, select the Application box.

For changes that must be made after the original submission, the complete Grants.gov application package must be resubmitted with the Changed/Corrected Application box selected.

• Block 2 – Date Submitted. Enter the date the application is submitted.

Applicant Identifier. Enter the submitting organization’s Control Number, if applicable. If there is no Organization Control Number, leave this field blank.

• Block 3 – Date Received by State and State Application Identifier. Not applicable.

• Block 4a – Federal Identifier. Enter the eBRAP log number assigned during pre-application submission.

Entering the eBRAP log number in Block 4a is a critical step to link the pre-application to the full application.

• Block 4b – Agency Routing Identifier. Not applicable.

• Block 4c – Previous Grants.gov Tracking ID. For changed/corrected applications, enter the Grants.gov Tracking Number for the original application.

• Block 5 – Applicant Information. Enter the information for the applicant organization.

The “Person to be contacted on matters involving this application” is the Business Official.

• Block 6 – Employer Identification. Enter the EIN or TIN as assigned by the U.S.

Internal Revenue Service. If applying from an organization outside the United States, enter 44-4444444.

• Block 7 – Type of Applicant. Enter the information for the applicant organization.

• Block 8 – Type of Application. Select New for all submissions. Indicate whether the application is, or will be, submitted to other agencies.

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• Block 9 – Name of Federal Agency. Populated by Grants.gov.

• Block 10 – Catalog of Federal Domestic Assistance Number. Populated by Grants.gov.

• Block 11 – Descriptive Title of Applicant’s Project. Enter the same project title as used for the pre-application.

• Block 12 – Proposed Project. Enter the estimated start and end dates for the project.

Actual start and end dates will be determined during negotiations if the application is recommended for funding.

• Block 13 – Congressional District of Applicant. Find your congressional district at the U.S. Census My Congressional District page. If the applicant organization is outside the United States, enter 00000.

• Block 14 – Project Director/Principal Investigator Contact Information. Enter information for the individual PI responsible for the overall scientific and technical direction of the application. If outside the United States, select the appropriate country from the drop-down menu.

• Block 15 – Estimated Project Funding. Enter the total funds (direct + indirect costs) requested for the entire performance period of the project. These figures should match those provided in the Research & Related Budget Form.

• Block 16 – Is Application Subject to Review by State Executive Order 12372 Process? Select option b., “NO, program is not covered by E.O. 12372.”

• Block 17 – Complete Certification. Select the “I agree” checkbox to provide the required certifications and assurances. By checking “I agree” on the SF424 (R&R) Form in block 17, you agree to abide by the following:

○ 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. Refer to 18 USC 1001, the Statements or Entries Generally section of the Crimes and Criminal Procedure.

○ By signing this application, I certify the proposing entity is in compliance with Section 223(a) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 which requires that: (a) the PI and other key personnel certify that the current and pending support provided on the proposal is current, accurate and complete; (b) agree to update such disclosure at the request of the agency prior to the award of support and at any subsequent time the agency determines appropriate during the terms of the award; (c) the PI and other key personnel have been made aware of the requirements under Section 223(a)(1) of this Act. Refer to 42 USC 6605(a), the Disclosure Requirement subsection of Disclosure of Funding Sources in Applications for Federal Research and Development Awards.

○ Compliance with the National Policy Requirements noted in Appendix 8.

https://www.census.gov/mycd/ https://uscode.house.gov/view.xhtml?req=(title:18%20section:1001%20edition:prelim)%20OR%20(granuleid:USC-prelim-title18-section1001)&f=treesort&edition=prelim&num=0&jumpTo=true#changeofname-note https://uscode.house.gov/view.xhtml?req=(title:42%20section:6605%20edition:prelim)%20OR%20(granuleid:USC-prelim-title42-section6605)&f=treesort&edition=prelim&num=0&jumpTo=true https://uscode.house.gov/view.xhtml?req=(title:42%20section:6605%20edition:prelim)%20OR%20(granuleid:USC-prelim-title42-section6605)&f=treesort&edition=prelim&num=0&jumpTo=true

CD26_01 General Application Instructions 15

• Block 18 – SFLLL (Disclosure of Lobbying Activities) or Other Explanatory Documentation. If applicable, complete and attach Standard Form LLL (SFLLL) to disclose lobbying activities pursuant to 31 USC 1352, Limitation on Use of Appropriated Funds to Influence Certain Federal Contracting and Financial Transactions.

• Block 19 – Authorized Representative. Enter the contact information for the applicant AOR organization’s authorized representative. The Signature of Authorized Representative is automatically completed upon submission of the Grants.gov application package.

• Block 20 – Pre-Application. Not applicable.

• Block 21 – Cover Letter Attachment. Not applicable.

If a revised Project Narrative or Research & Related Budget Form is needed, an updated Grants.gov application package must be submitted via Grants.gov as a “Changed/Corrected Application” with the previous Grants.gov Tracking ID entered in Block 4.c. of the SF424 (R&R) Form prior to the full application submission deadline.

(b) Attachments Form

Grants.gov does not validate for the presence of attachments on the Attachments Form.

Each attachment in the Attachments Form must be uploaded as an individual PDF file in accordance with the formatting guidelines listed in Appendix 2. Use of PDF portfolios is discouraged. For all attachments, ensure that the file names are consistent with the guidance in the program announcement and below. Grants.gov will reject attachments with file names longer than 50 characters or incompatible file names that contain characters other than the following: A-Z, a-z, 0-9, underscore, hyphen, space, period, parenthesis, curly braces, square brackets, ampersand, tilde, exclamation point, comma, semi colon, apostrophe, at sign, number sign, dollar sign, percent sign, plus sign and equal sign. Grants.gov suggests limiting the file size of the entire grant application package including all the attachments to 200MB.

Do not password protect any files of the application package.

All documents that require signatures must be signed. Both electronic and hand signatures will be accepted. Any document that is signed by hand should be scanned at a resolution of 100-150 dots per inch.

For specific instructions regarding application attachments, attachment numbers, content and page limits, refer to Section 4.3, Full Application Components, in the program announcement. Attach each as a separate PDF file, named as specified in the announcement.

The following must be included as attachments unless otherwise stated in the funding opportunity:

• Project Narrative: Attach as “ProjectNarrative.pdf”. The Project Narrative is the main body of the application. The page limit applies to text and non-text elements (e.g., https://uscode.house.gov/view.xhtml?req=(title:31%20section:1352%20edition:prelim)%20OR%20(granuleid:USC-prelim-title31-section1352)&f=treesort&edition=prelim&num=0&jumpTo=true

CD26_01 General Application Instructions 16 figures, tables, graphs, photographs, diagrams, chemical structures, drawings) used to describe the project. Inclusion of URLs (uniform resource locators) that provide additional information that expands the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the application.

• Supporting Documentation: Combine and attach as a single PDF file named “Support.pdf”. Begin each document on a new page. The Supporting Documentation attachment should not include additional information such as figures, tables, graphs, photographs, diagrams, chemical structures or drawings. These items should be included in the Project Narrative. Submitting material that is not requested may be viewed as an attempt to gain an unfair competitive advantage; such material will be removed, or the application may be administratively withdrawn. Letters of support not requested in the program announcement, such as those from members of Congress, will be removed from the application package.

A complete list and descriptions of required Supporting Documentation is included in the program announcement.

• Technical Abstract: Attach as “TechAbs.pdf”. The technical abstract is used by all reviewers. Abstracts of funded research projects are posted publicly. Do not include proprietary or confidential information. Use only characters available on a standard QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols.

Graphics are not allowed.

• Lay Abstract: Attach as “LayAbs.pdf”. The lay abstract is used by all reviewers and addresses issues of particular interest to the affected community. Abstracts of all funded research projects will be posted publicly. Do not include proprietary or confidential information. Use only characters available on a standard QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols. Graphics are not allowed. Do not duplicate the Technical Abstract.

• Statement of Work: Attach as “SOW.pdf”. The SOW is an outline of the proposed research project that includes the specific aims, proposed tasks and project milestones that will be accomplished during the award period of performance. All study site locations should be listed, including the country(s) where DOW-funded research will be performed. The SOW should contain sufficient detail to be informative as a stand-alone document, and there is no limit to the number of specific aims, tasks or subtasks that are described within the SOW page limit. Applicants are strongly encouraged to use the suggested SOW format available on eBRAP and to follow the detailed guidance provided within the Examples to prepare their SOWs.

• Suggested Intragovernmental/Intramural Budget Form, if applicable: Attach as “IGBudget.pdf”. If an intramural DOW organization will collaborate in the performance of the project, complete a separate Suggested Intragovernmental/Intramural Budget Form for each intramural DOW organization involved in the project and upload as a single document. For additional support, review the detailed instructions for completing the Suggested Intragovernmental/Intramural Budget Form.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical,Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20Intragovernmental/Intramural%20Budget

CD26_01 General Application Instructions 17

C. Additional Application Materials

The following are additional application materials for application submission. Follow the instructions provided to prepare each: Research & Related Senior/Key Person Profiles, Biographical Sketches, Current/Pending Support documentation, Research & Related Budget forms, Project/Performance Site Location(s) forms, and Research & Related Subaward Budget Attachment(s) forms.

i. Research & Related Senior/Key Person Profile (Expanded)

Complete a Profile for each person who will contribute in a substantive, meaningful way to the scientific development or execution of the proposed research project, including the provision of degree information. All fields marked with an asterisk are required. For the application PI, in the “PROFILE – Project Director/Principal Investigator” section, enter the PI’s User Name provided by eBRAP into the data field labeled “Credential, e.g., agency login” (Green Box, Figure 2).

Additional Senior/Key persons can be added by selecting the Next Person button.

A biographical sketch and full description of each PI and Senior/Key Person’s current/pending support information must be attached to the individual’s Profile in the Attach Biographical Sketch and Attach Current & Pending Support fields, respectively.

Figure 2. PI’s eBRAP User Name

• Biographical Sketch: This file must be titled “Biosketch_LastName.pdf” where “LastName” is the last name of the PI or Senior/Key Person.

The CDMRP staff and reviewers utilize the biographical sketch to ensure that research teams are equipped with the expertise necessary to carry out the proposed research.

CD26_01 General Application Instructions 18

Applicants may use the instructions provided within the Biographical Sketch Common Form to construct a biographical sketch, or may use a PDF form created in SciENcv for the National Institutes of Health (NIH) or the U.S. National Science Foundation (NSF).

• Current/Pending Support: This file must be titled “Support_LastName.pdf” where “LastName” is the last name of the PI or Senior/Key Person.

Applicants may use the instructions provided within the Current and Pending (Other) Support Common Form to construct current and pending support documentation, or may use a PDF form created in SciENcv for NIH or NSF.

ii. Research & Related Budget

The Budget and Budget Justification is used by the CDMRP staff and reviewers to determine whether proposed costs are allowable, allocable and reasonable for the proposed research.

An estimate of the total cost for the proposed research, with a breakdown of all cost categories for each year of the project, must be submitted using the Grants.gov Research & Related Budget Form. For limits on funding amounts, types of costs and period of performance, refer to the program announcement. A budget justification for the entire period of performance must be uploaded to Section L in the Budget Period 1 portion of the Research & Related Budget Form. The budget and budget justification should include sufficient detail for the government to determine whether the proposed costs are allowable, allocable and reasonable for the proposed research. At the time of application submission to Grants.gov, the AOR is certifying to the best of their knowledge that all costs are current, accurate and complete. The government reserves the right to request a revised budget and budget justification and/or additional information.

If the budget fails eBRAP validation or needs to be modified, an updated Grants.gov application package must be submitted prior to the application submission deadline via Grants.gov as a “Changed/Corrected Application” with the previous Grants.gov Tracking ID.

Budget Regulations and Restrictions:

• Administrative and Cost Principles: Recipients are required to comply with the following, as applicable:

○ Code of Federal Regulations, Title 2, Part 200, or 2 CFR 200, Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards, as implemented by Chapter XI of Title 2 CFR.

○ Provisions of Chapter I, Subchapter C of 32 CFR, DOD Grant and Agreement Regulations, specifically: (1) 32 CFR 26, Governmentwide Requirements for Drug- Free Workplace (Financial Assistance); (2) 32 CFR 28, New Restrictions on Lobbying; and (3) 32 CFR 34.16, Audits; and also 2 CFR, Chapter XI, Parts 1100- 1199, Federal Agency Regulations or Grants and Agreements for the Department of Defense.

https://www.nsf.gov/bfa/dias/policy/researchprotection/commonform_biographicalsketch.pdf https://www.nsf.gov/bfa/dias/policy/researchprotection/commonform_biographicalsketch.pdf http://www.ncbi.nlm.nih.gov/sciencv/ https://www.nsf.gov/bfa/dias/policy/researchprotection/commonform_cps.pdf https://www.nsf.gov/bfa/dias/policy/researchprotection/commonform_cps.pdf http://www.ncbi.nlm.nih.gov/sciencv/ https://www.ecfr.gov/current/title-2/part-200 https://www.ecfr.gov/current/title-32/subtitle-A/chapter-I/subchapter-C https://www.ecfr.gov/current/title-32/part-26 https://www.ecfr.gov/current/title-32/part-28 https://www.ecfr.gov/current/title-32/section-34.16 https://www.ecfr.gov/current/title-2/subtitle-B/chapter-XI

CD26_01 General Application Instructions 19

○ Federal Acquisition Regulation (FAR) Part 31, Contract Cost Principles and Procedures.

It is prohibited to charge a fee or profit to an assistance agreement, either by the recipient/awardee or subrecipient/subawardee.

• Cost of Preparing Applications: The cost of preparing applications in response to a program announcement is not considered an allowable direct charge to any resultant award.

• Currency: All costs must be entered in U.S. dollars.

Budget Instructions: Complete Sections A through L of the Research & Related Budget Form following the instructions below. Begin by entering the organizational UEI, Budget Type, Name of Organization and anticipated start and end dates. Funds requested should be specific to the proposed research project and should be consistent with the work outlined in the Project Narrative and SOW.

Ensure that the UEI is entered accurately or Grants.gov will reject the application.

Section A: Senior/Key Person

• Prefix; First, Middle and Last Name; and Suffix: Beginning with the PI, list all Senior/Key persons from the applicant organization who will be involved in the proposed research project, whether or not salaries are requested. Include all investigators, research associates, etc. If applicable, all investigators outside the applicant organization should be included on the Research & Related Subaward Budget Attachment(s) Form. Consultant costs should be listed under Section F.3 of the Research & Related Budget Form (Other Direct Costs, Consultant Services).

• Base Salary: Enter the current annual base salary (based on a full-time appointment) for each individual listed for the proposed research project. Establish labor costs using current labor rates or salaries. Labor rates or salaries may not be increased as a result of receiving an award. Any proposed increases in rates or salaries over the period of the award must be consistent with the applicable cost principles and organization’s estimating procedures. For most federal agencies, funding cannot be applied toward federal salaries; therefore, these salaries should not be included in the requested budget.

• Level of Effort (Calendar, Academic and Summer Months): For each Senior/Key person, including unpaid personnel, demonstrate the level of effort by listing the number of…