PKG00244200-instructions.pdf

FY18-FY23 DoD USSOCOM BAA for Extramural Biomedical Research and Development–

General Submission Instructions

General Submission Instructions for Funding

Opportunity Number: W81XWH-18-S-SOC1

Broad Agency Announcement for Extramural Biomedical Research and

Development

Fiscal Year 2018 – Fiscal Year 2023

Department of Defense

United States Special Operations Command

Table of Contents

I. HELPFUL INFORMATION

A. Tips for Success B. Current Funding Opportunity Announcement C. Receiving Emails from eBRAP, and Grants.gov D. Agency Contacts

II. REGISTRATION AND SUBMISSION INFORMATION

A. eBRAP Registration B. Submission Dates and Times C. Content and Form of pre-application Submission

III. Content and Form of Application Submission FOR RESEARCH pROPOSALS A. Grants.gov Submission Package Components for Research Proposals

B. Submission of a Grants.gov Workspace

C. Applicant Verification of Grants.gov Submission in eBRAP D. Application Tracking

APPENDIX 1 Regulatory Requirements A. Safety and Environmental Requirements B. Research Protections Review Requirements

C. Clinical Trial Registry D. Research Involving Recombinant DNA Molecules

APPENDIX 2 Reporting Requirements and Administrative Information A. Reporting Requirements for Awards B. Disclosure of Proprietary Information

C. Marking of Proprietary Information D. Award Notices

E. Inquiry Review F. Information Service

G. Freedom of Information Act Requests H. Information Release I. Contracted Fundamental Research

J. Sharing of Proposal/Application Information K. Sharing of Data and Research Resources L. Property/Equipment M. Title to Inventions and Patents N. PI Changes and Award Transfers

APPENDIX 3 Qualification Information A. Contractor/Recipient Qualification B. Eligibility Information C. J-1 Visa Waiver

D. Conflict of Interest

APPENDIX 4 Formatting Guidelines

APPENDIX 5 National Policy Requirements A. Certification

B. Representations

C. Grant and Cooperative Agreement Proposals:

APPENDIX 6 Acronym List

This General Submission Instructions document must be read in conjunction with the Broad

Agency Announcement, available for downloading from Grants.gov.

I. HELPFUL INFORMATION

A. Tips for Success

This symbol marks helpful hints throughout this document.

This symbol refers to the Broad Agency Announcement for specific instructions.

B. Current Funding Opportunity Announcement

The Fiscal Year 2018 – Fiscal Year 2023 (FY18-FY23) U.S. Special Operations Command

(USSOCOM) Broad Agency Announcement (BAA) can be found by searching Grants.gov

(http://www.grants.gov/) using the Funding Opportunity Number W81XWH-18-S-SOC1 or the

Catalog of Federal Domestic Assistance (CFDA) number 12.420 Military Medical Research and Development.

USSOCOM utilizes the tools and processes provided by Congressionally Directed Medical

Research Programs (CDMRP). Additional information may be found on the CDMRP’s electronic Biomedical Research Application Portal (eBRAP) website at https://ebrap.org/eBRAP/public/index.htm.

The awarding agency will be the U.S. Army Medical Research Acquisition Activity

(USAMRAA). The USAMRAA Contracting and Grants Officers are the only individuals authorized to obligate funds and bind the Federal Government for awards under this BAA.

C. Receiving Emails from eBRAP, and Grants.gov

To help ensure that all email correspondence is delivered correctly and is not treated as spam by email programs, keep your email address up to date in eBRAP and Grants.gov and place the following domains into your safe list: army.mil, us.army.mil, *.mail.mil, eBRAP.org, and

Grants.gov. Also, use the same email address when submitting both the pre-proposal/pre-application to eBRAP and the full proposal/application to Grants.gov.

On occasion, the Grants.gov proposal/application package may be updated or changed. The applicant must use the latest version of the Grants.gov submission package;

proposals/applications submitted with a different version of the Grants.gov submission package will be rejected by Grants.gov. Sign up in Grants.gov (http://www.grants.gov/) for “Send me change notification emails” by following the link on the Synopsis page for the BAA or by responding to the prompt provided by Grants.gov when first downloading the Grants.gov submission package.

D. Agency Contacts

1. eBRAP Help Desk: Questions related to BAA content or submission requirements, as well as questions related to submission of Pre-proposals/Pre-applications through eBRAP, 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. Response times may vary http://www.grants.gov/ https://ebrap.org/eBRAP/public/index.htm http://www.grants.gov/ depending upon the volume of inquiries. Be advised that the eBRAP Help Desk is unable to provide technical assistance with Grants.gov submission.

Phone: 301-682-5507

Email: HELP@EBRAP.ORG

2. Grants.gov Contact Center: Questions related to proposal/application submission through the Grants.gov portal should be directed to the Grants.gov Contact Center, which is available 24 hours a day, 7 days a week (closed on U.S. Federal holidays).

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

Email: SUPPORT@GRANTS.GOV

II. REGISTRATION AND SUBMISSION INFORMATION

Submission is a two-step process requiring both (1) Pre-proposal/pre-application submission through eBRAP (https://eBRAP.org/) and (2) full proposal/application submission through a

Grants.gov Workspace or eBRAP, depending on the type of application being submitted.

General registration information is provided below. For detailed instructions, refer to the eBRAP User Guide (https://ebrap.org/eBRAP/public/UserGuide.pdf) for eBRAP registration, and www.grants.gov for Grants.gov registration.

Submission of Proposals/Applications from U.S. Federal agencies and those proposing collaborations with Military Facilities have unique requirements. Budget requirements and restrictions apply. See Section III.A.5, Research & Related Budget.

For specific guidance regarding changes to the Principal Investigator (PI) or organization, refer to the BAA.

USSOCOM encourages all PIs to participate in a digital identifier initiative through Open

Researcher and Contributor Identification (ORCID). Registration for a unique ORCID identifier can be done online at http://orcid.org/.

A. eBRAP Registration eBRAP is a multifunctional web-based system that allows PIs to submit their pre-proposals/ pre-applications electronically through a secure connection, to view and edit the content of their pre-proposals/pre-applications and full proposals/applications, to receive communications from the USSOCOM, and to submit documentation during award negotiations and throughout the period of performance. A key feature of eBRAP is the ability of an organization’s representatives and PIs to view and modify the Grants.gov proposal/application submissions associated with them. eBRAP will validate Grants.gov proposal/application files against the specific BAA requirements, and discrepancies will be noted in an email to the PI and in the Full

Application Files tab in eBRAP. It is the applicant’s responsibility to review all proposal/application components for accuracy as well as to ensure proper ordering as specified in the BAA.

mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/ https://ebrap.org/eBRAP/public/UserGuide.pdf http://orcid.org/ eBRAP does not confirm the accuracy of file content!

To submit a pre-proposal/pre-application, PIs must be registered in eBRAP.

During eBRAP registration, the PI must request to be affiliated with his/her organization from the list of organizations already registered with eBRAP. If the PI’s organization is not already registered with eBRAP, then 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 in order for the pre-proposal/pre-application to be submitted. However, before the full proposal/application submission deadline, the organization’s eBRAP registration must be complete to allow for processing, viewing, and modifying of the Grants.gov submission package components.

Specific information must be identical between the pre-proposal/pre-application and the full proposal/application for eBRAP to process a proposal/application. Mismatched information may delay the availability of the proposal/application during the proposal/application verification period. For the PI to view/modify files, the PI’s name and email address in the eBRAP pre-proposal/pre-application submission must match the information provided in Standard Form 424

(SF424) of the Grants.gov submission package. For the Business Official to view/modify files, the Business Official’s name and email address in the eBRAP pre-proposal/pre-application submission must match the information provided in the SF424 of the Grants.gov submission package.

During pre-proposal/pre-application submission, the PI must identify a Business Official from the list of Business Officials registered with eBRAP. If the PI’s Business Official is not already registered with eBRAP, the PI must invite the Business Official to register. The Business

Official’s registration must be completed prior to the full proposal/application deadline to allow the Business Official to view/modify the full proposal/application files in eBRAP after submission.

During pre-proposal/pre-application submission, the PI must select the performing organization

(site at which the PI will perform the proposed work) and contracting organization (organization submitting on behalf of the PI) and click on “Add Organizations to this pre-application.” The organization(s) must be either selected from the eBRAP drop-down list or invited to allow submission of the pre-proposal/pre-application.

B. Submission Dates and Times

This BAA is continuously open for a 5 year period, from 1 August, 2018 through 31 July, 2023, 11:59 p.m. Eastern Time. Pre-proposals/pre-applications are required and may be submitted at any time throughout the 5-year period.

C. Content and Form of pre-application Submission

For specific instructions regarding content of the pre-proposal/pre-application submission components, refer to the BAA.

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

Tab 1 – Application Information: Enter the information as described in eBRAP before continuing the pre-proposal/pre-application. Submission of application information includes assignment of primary and secondary research classification codes which can be found at https://ebrap.org/eBRAP/public/program.htm. Note that the codes have recently been revised. Applicants are strongly encouraged to review and confirm the codes prior to making their selection. Click on “Save.”

Tab 2 – Application Contacts: Enter contact information for the PI. Enter the organization’s Business Official responsible for sponsored program administration (the

“person to be contacted on matters involving this application” in Block 5 of SF424 in the

Grants.gov package). Depending on screen resolution, scrolling horizontally may be necessary to locate the box to invite an AOR to register the performing and/or contracting organization. Click on “Add Organizations to this pre-application.” The Business Official must be either selected from the eBRAP list or invited in order for the pre-proposal/ pre-application to be submitted.

If the organization’s Business Official is not in eBRAP, an invitation to the Business

Official to register in eBRAP must be sent.

Depending on the screen resolution, scrolling horizontally may be necessary to locate the box to invite an AOR to register the performing organization (site at which PI will perform the proposed work) and contracting organization (organization submitting on behalf of the

PI; corresponds to Block 5 on SF424), and click on “Add Organizations to this pre-application.” The organization(s) must either be selected from the eBRAP drop-down list or invited to allow the pre-proposal/pre-application to be submitted.

Tab 3 – Collaborators and Key Personnel: Enter the name, organization, and role of all collaborators and key personnel associated with the proposal/application. Click on “Save.”

Note: USSOCOM does not follow National Institutes of Health (NIH) guidelines for role designation of project participants. Unless otherwise noted, applicants should assign the role of each participant in accordance with the participant’s respective involvement in the project.

Federal agency personnel involved in the review process and/or with making funding recommendations are prohibited from being involved in any pre-proposal/pre-application and full proposal/application, including, but not limited to, concept design, proposal/application development, budget preparation, and the development of any supporting documentation.

If formal collaboration with Military Facility personnel is planned (i.e., included in the proposal/application in performance of the research), this prohibition is not applicable;

however, those Military Facility personnel are prohibited from being involved in the review process and/or with making funding recommendations.

https://ebrap.org/eBRAP/public/program.htm

To preserve the integrity of its peer and programmatic review processes, the USSOCOM discourages inclusion of any employee of its review contractors in proposals/applications for funding. For FY18-FY23, the peer review contractor is CSRA, Inc. The programmatic review contractor may vary. Proposals/applications that include names of personnel from a review contractor may be administratively withdrawn unless plans to manage conflicts of interest (COIs) are provided and deemed appropriate by the Government. Questions related to this topic should be directed to the eBRAP Help Desk at help@eBRAP.org or

301-682-5507. Refer to Appendix 3 for additional information.

Tab 4 – Conflicts of Interest (COI’s): To avoid COIs during the screening and review processes, list all individuals other than collaborators and key personnel who may have a

COI in the review of the proposal/application (including those with whom the PI has a personal or professional relationship). Click on “Save.”

Tab 5 – Required Files: Upload all documents as PDF as specified in the BAA.

Documents should conform to the formatting guidelines outlined in Appendix 4. Click on

“Upload.”

eBRAP will truncate characters exceeding the limit specified for each data field as specified in the BAA.

eBRAP will not allow a document to be uploaded in the Required Files tab if the number of pages exceeds the limits specified in the BAA.

Tab 6 – Submit pre-proposal/pre-application: Enter eBRAP password and click the

“Submit” button. Click the “Confirm Submission” button to complete the pre-proposal/pre-application submission. This finalizes the pre-proposal/pre-application process.

The pre-proposal/pre-application is not submitted until Tab 6 is complete.

Pre-proposals/pre-applications not completed are left in DRAFT status.

Following completion of pre-proposal/pre-application submission, the status of the pre-proposal/pre-application in eBRAP will change from “DRAFT” to “SUBMITTED” and a confirmation email will be sent to the PI and named Business Official. A pre-proposal/ pre-application in DRAFT status will not be forwarded for review.

III. CONTENT AND FORM OF APPLICATION SUBMISSION FOR RESEARCH

PROPOSALS

A PI must be invited to submit a full proposal/application. An invited full proposal/application must be submitted electronically through a Grants.gov Workspace (http://www.grants.gov).

Proposals/applications will not be accepted by mail or in person.

Grants.gov applicants must apply online using Workspace. Workspace is a shared, online environment where members of a grant team (investigators and business officials) may simultaneously access and edit different webforms within an application. Applicants must create mailto:help@cdmrp.org a Workspace, invite grant team members to join the Workspace, complete the required forms, and submit their application Workspace package.

To apply through Grants.gov, an organization must first complete the Grants.gov registration process. Allow up to 4 weeks for the completion of the Grants.gov registration process.

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

Any modifications to the Project Narrative or Budget Form require submission of a changed/corrected Grants.gov submission package to Grants.gov. The Project Narrative and

Budget Form cannot be modified during the proposal/application verification period.

It is the applicant’s responsibility to verify his/her Adobe Reader’s compatibility with

Grants.gov: http://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html. A no-cost compatible version of Adobe Reader can be downloaded at http://www.grants.gov/web/ grants/support.html. Resubmission of a proposal/application prior to the Grants.gov deadline must be coded as a “Changed/Corrected Application.”

Foreign organizations doing business outside of the United States are also required to complete the Grants.gov registration process, in addition to fulfilling supplementary requirements for doing business with the U.S. Federal Government.

If business is conducted with the Federal Government on a continuing basis, it is likely that some of the actions have already been completed, e.g., obtaining a Data Universal Numbering System

(DUNS) number or registration as an Entity in the System for Award Management (SAM).

Detailed information, automated tools, and checklists are available at http://www.grants.gov/web/grants/applicants/organization-registration.html.

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

1. DUNS Number

The applicant organization and all subrecipient/subawardee organizations must have a DUNS number. A DUNS number is a unique identification number provided by the commercial company Dun & Bradstreet. If an organization does not have a DUNS number, an authorized business official of the organization can request one by calling 866-705-5711 or by registering online (http://fedgov.dnb.com/webform). Organizations located outside of the United States can request and register for a DUNS number on line via web registration (http://fedgov.dnb.com/ webform). Web registration can take 1-2 business days.

2. SAM Registry

The applicant organization must be registered as an entity in SAM (https://www.sam.gov) and receive confirmation of an “Active” status before submitting a proposal/application through

Grants.gov. The SAM validates organization information and electronically shares the secure and encrypted data with Federal agencies’ finance offices to facilitate paperless payments http://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html http://www.grants.gov/web/grants/support.html http://www.grants.gov/web/grants/support.html http://www.grants.gov/web/grants/applicants/organization-registration.html https://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/ 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 SAM well in advance of the proposal/application submission deadline. An organization can register in SAM online at https://www.sam.gov/. If your organization does not have either an Employer Identification

Number (EIN) or Tax Identification Number (TIN), allow at least 2 weeks to receive this information from the U.S. Internal Revenue Service. Allow several weeks to complete the entire

SAM registration process. If an applicant has not fully complied with the requirements by the time the Federal awarding agency is ready to make a Federal award, the Federal awarding agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant. Additional information and step-by-step registration directions are detailed in the SAM User Guide and other General Services Administration (GSA) training materials in the Help area at https://www.sam.gov/.

NEW REQUIREMENT: In March 2018, the General Services Administration (GSA) implemented fraud prevention security measures in the System for Award Management (SAM) which required every new contractor registrant to provide a written (hard copy), notarized letter confirming the entity's Administrator that is authorized to register the entity in the SAM database, or to make changes to its registration. Effective 29 April 2018, the notarized letter process is now mandatory on all CURRENT registrants at SAM who have a requirement to update data on their SAM record. The notarized letter is mandatory and is required before the

GSA Federal Service Desk (FSD) will activate the entity's registration. The Office of the

Secretary of Defense and GSA realizes the length of time needed to transmit, receive, process, and approve the notarized letters presents a significant impact on the ability of the contracting activity to make timely awards, but in order to mitigate the concern of fraud, these steps and the time needed for processing, is unavoidable. Notarized letters are required for ALL new and existing SAM registered Entities. The notarized letters must be postal service mailed (not emailed or faxed) to the "Federal Service Desk" and must contain the information outlined in the

SAM posted FAQ at: (https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update .

Instructions for domestic entities and instructions for international entities with embedded templates for use are also provided within the SAM Update notice with frequently asked questions at https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update.

Applications will be rejected by Grants.gov if (1) the organization’s Entity registration in SAM is not active, or (2) if 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?”

3. Commercial and Government Entity (CAGE) Code

The applicant organization must have a 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.

https://www.sam.gov/portal/SAM/#1 https://www.sam.gov/portal/SAM/#1 https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update

Foreign registrants in SAM must be assigned a North Atlantic Treaty Organization (NATO)

CAGE Code (NCAGE). An NCAGE code can be obtained by contacting the National

Codification Bureau of the country where the organization is located or by visiting the website https://cage.dla.mil/Request. On average, CAGE Code or NCAGE Code validation in SAM occurs within 3 business days after the TIN is validated.

4. Authorized Organizational Representative

Each organization must have an AOR who is registered with Grants.gov (individual PIs do not register with Grants.gov). An AOR must be a member of the Grants.gov Workspace grant team as the business official authorized to submit the completed Workspace application package. An organization’s E-Biz POC must authorize an AOR. An individual may serve as both the E-Biz

POC and the AOR. Before proposal/application submission, the AOR must be registered to submit on behalf of the organization at Grants.gov (http://apply07.grants.gov/apply/OrcRegister).

An AOR must first register with the Grants.gov credential provider at http://apply07.grants.gov/ apply/OrcRegister to obtain a username and password. Once an AOR has completed the

Grants.gov registration process, Grants.gov will notify the E-Biz POC of the registration. The E-

Biz POC will then log in to Grants.gov and assign and authorize the appropriate roles, which may include the AOR role, thereby giving the AOR permission to complete and submit applications on behalf of the organization. When an E-Biz POC approves an AOR, Grants.gov will send the AOR a confirmation email.

At the time of proposal/application submission to Grants.gov, the AOR is certifying to the best of his/her knowledge that all information provided in the proposal/application is current, accurate, and complete.

When applications are submitted through Grants.gov, the name of the organization’s AOR that submitted the application is inserted into the signature line of the application, serving as the electronic signature. The E-Biz POC must authorize individuals who are able to make legally binding commitments on behalf of the organization as an AOR; this step is often missed and it is crucial for valid and timely submissions.

5. Grants.gov Workspace

Applicants must create a 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.

Each proposal/application submission must include the completed Grants.gov submission package of forms associated with the BAA in Grants.gov (http://www.grants.gov/).

If the applicant decides not to apply by filling out webforms within the Workspace, individual

PDF forms can be downloaded, saved, and uploaded to the Workspace. A compatible version of

Adobe Reader must be used to view, complete, and submit an application package consisting of

PDF forms. If more than one person is entering text into an application package, the same version of Adobe Reader software should be used by each person. Check the version number of https://cage.dla.mil/Request http://apply07.grants.gov/apply/OrcRegister http://apply07.grants.gov/apply/OrcRegister http://apply07.grants.gov/apply/OrcRegister the Adobe software on each user’s computer to make sure the versions match. Using different versions of Adobe Reader may cause submission and/or save errors – even if each version is individually compatible with Grants.gov. Grants.gov will reject a submission package that is opened at any time by an individual with an incompatible version of Adobe Reader. Rejected proposals/applications must be resubmitted using a new Grants.gov submission package and a supported version of Adobe Reader prior to the proposal/application submission deadline. It is the applicant’s responsibility to verify his/her Adobe Reader’s compatibility with Grants.gov:

https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html. A no-cost compatible version of Adobe Reader can be downloaded at http://get.adobe.com/reader/otherversions/. All contributors to the proposal/application must use matching compatible versions of Adobe software when editing and preparing proposal/application components outside the Workspace. The use of different software versions will result in corruption of the submitted file.

Any modifications to the Project Narrative or Budget Form require submission of a changed/ corrected Grants.gov submission package to Grants.gov prior to the proposal/application submission deadline.

A. Grants.gov Submission Package Components for Research Proposals

1. 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 this Grants.gov submission package. See below for clarification to general instructions:

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 submission package must be resubmitted with the “Changed/Corrected Application” box selected.

Block 2 – Date Submitted. Enter the date the proposal/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 Box. Enter in your eBRAP log number assigned during pre-proposal/pre-application submission.

Figure 1. Enter your eBRAP log number in Block 4a.

http://get.adobe.com/reader/otherversions/

Block 4b – Agency Routing Identifier. Not applicable.

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

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

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-proposal/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 proposal/application is recommended for funding.

Block 13 – Congressional District of Applicant. If the applicant organization is outside the United States, enter 00-000.

Block 14 – Project Director/Principal Investigator Contact Information. Enter information for the individual PI responsible for the overall scientific and technical direction of the proposal/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.

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” box to provide the required certifications and assurances.

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 Title 31 of the United States Code, Section 1352 (31 USC 1352).

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

Block 20 – pre-application. Not applicable.

Block 21 – Cover Letter Attachment. Not applicable.

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

2. Attachments Form

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

Following retrieval and processing of the Grants.gov proposal/application, eBRAP will notify the organizational representatives and PI by email to log into the eBRAP to view, modify, and verify the Grants.gov proposal/application submission. eBRAP will validate retrieved files against the BAA guidelines. Discrepancies will be noted in both the email and in the Full

Application tab. eBRAP does not confirm the accuracy of file content. It is the applicant’s responsibility to review all proposal/application components and ensure proper ordering as specified in the BAA. See III.C., Applicant Verification of Grants.gov Submission in eBRAP, for additional details.

Each attachment in the Attachment Form must be uploaded as an individual PDF file in accordance with the formatting guidelines listed in Appendix 4. For all attachments, ensure that the file names are consistent with the guidance. Grants.gov will reject attachments with file names longer than 50 characters or incorrect file names that contain characters other than the following: A-Z, a-z, 0-9, underscore, hyphen, space, and period. In addition, Grants.gov has file size limits that may apply in some circumstances. Individual attachments may not exceed

20 MB and the file size for the entire submission package may not exceed 200 MB. Applicants must contact the Grants.gov Contact Center (support@grants.gov) for written confirmation that a file exceeding the maximum size will be accepted or for other guidance.

For specific instructions regarding content and page limits of the Project Narrative, Supporting Documentation, and all other attachments to this Grants.gov form, refer to the BAA.

mailto:support@grants.gov

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 low resolution such as 100-150 dots per inch.

The following must be included as attachments to this form:

Attachment 1: Project Narrative: Attach as a PDF file named “ProjectNarrative.pdf.”

The Project Narrative is the main body of the proposal/application. The page limit of the

Project Narrative applies to text and non-text elements (e.g., figures, tables, graphs, photographs, diagrams, chemical structures, drawings, etc.) used to describe the project.

Inclusion of URLs that provide additional information to expand on the Project Narrative and could confer an unfair competitive advantage is prohibited and may result in administrative withdrawal of the proposal/application. There is no form for this information. A detailed description of the research to be undertaken should be submitted.

This should include the areas described in the BAA.

Submission of a Project Narrative that exceeds the page limit specified in the BAA will result in administrative rejection of the proposal/application.

Attachment 2: Supporting Documentation: Combine and attach as a single PDF file named “Support.pdf.” Include only supporting documentation as indicated in the BAA.

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 proposal/application may be administratively withdrawn. 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. Any additional material viewed as an extension of the Project Narrative will be removed or may result in administrative withdrawal of the proposal/application.

All proposals/applications are given fair and thorough reviews. Letters of support not requested in the BAA, such as those from members of Congress, do not impact proposal/application review or funding decisions.

For a list and descriptions of required supporting documents, refer to the BAA.

Attachment 3: Technical Abstract: Attach as a PDF file named “TechAbs.pdf.”

Abstracts of all funded research projects will be posted on the CDMRP website at http://cdmrp.army.mil/. 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.

The Technical Abstract will be posted publicly and will be included in the award agreement.

Attachment 4: Lay Abstract: Attach as a PDF file named “LayAbs.pdf.” 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.

http://cdmrp.army.mil/

The Lay Abstract will be posted publicly and will be included in the award agreement.

Attachment 5: Statement of Work (SOW): Attach as a PDF file named “SOW.pdf.”

The SOW outlines and establishes the performance expectations and milestones for which

USSOCOM may provide funding. The SOW for all award types will be incorporated into the award document and, as such, is subject to release under Freedom of Information Act

(FOIA).

SOW Format: There is no limit to the number of specific aims, tasks, or subtasks that are described within the SOW page limit. The suggested SOW format and examples specific to different types of research projects are available on the eBRAP “Funding

Opportunities and Forms” web page (https://ebrap.org/eBRAP/public/Program.htm).

The SOW must be in PDF format prior to attaching. The Government reserves the right to request a revised SOW format and/or additional information.

The SOW should include a list of major tasks that support the proposed specific aims, followed by a series of subtasks outlined step-by-step as they relate to the major tasks and milestones within the period of performance. The SOW should describe only the work for which funding is being requested by this proposal/application and, as applicable, should also:

Include the following information for each study site/subaward site: Organization;

organization address; investigator(s), collaborator(s), consultant(s); description of research with animals, human anatomical substances, and/or human subjects or cadavers to be conducted at the site; and key personnel responsible for each major task and each subtask to be performed at the site.

Indicate the number (and type, if applicable) of research subjects (animal or human) and/or human anatomical samples projected or required for each task and at each site.

As applicable, estimated times to complete each task should include time for local

USSOCOM and USAMRMC regulatory review and approval, as shown below. Refer to Appendix 6 for additional information regarding regulatory review.

○ For studies involving human subjects, include a subtask that allows at least 2 to 3 months for regulatory review and approval by the USAMRMC Human Research

Protection Office (HRPO); this does not include the additional time required for local Institutional Review Board (IRB) review and approval.

For animal studies, include a subtask that allows at least 1 to 2 months for regulatory review and approval by the USSOCOM Veterinarian Review Office (VRO) and international regulatory requirements.

Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The VRO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. PIs must submit the institutional animal use protocol.

Questions concerning animal use and review should be directed to the USSOCOM VRO:

Phone: 813-826-6031; Email: socom_vet@socom.mil https://ebrap.org/eBRAP/public/Program.htm mailto:socom_vet@socom.mil

○ Attachments 6-12: Additional Documents (as applicable): Attach each as a separate

PDF file, named as indicated in the BAA (e.g., “Impact.pdf,” “Transition.pdf,” etc.).

For specific instructions regarding content, titles, and page limits for the Additional

Documents, refer to the BAA.

3. Research & Related Personal Data

This form will be used by DoD as the source of demographic information, such as gender, race, ethnicity, and disability information, for the Project Director (PD)/PI and all other persons identified as Co-PD(s)/Co-PI(s).

Each application must include this form with the name fields of the PD/PI and any Co-PD(s)/Co-

PI(s) completed; however, provision of the demographic information in the form is voluntary. If completing the form for multiple individuals, each Co-PD/Co-PI can be added by selecting the

“Next Person” button. The demographic information, if provided, will be used for statistical purposes only and will not be made available to merit reviewers. Applicants who do not wish to provide some or all of the information should check or select the “Do not wish to provide” option.

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

Include the requested information for each person who will contribute significantly to the proposed research project.

In the “PROFILE – Project Director/Principal Investigator” section, enter the PI’s username provided by eBRAP into the data field labeled “Credential, e.g., agency login” (Figure 2).

Figure 2. PI’s eBRAP User Name

Biographical Sketch Suggested Format: The suggested biographical sketch format is available in a Microsoft Word document on the “Funding Opportunities and Forms” web page

(https://ebrap.org/eBRAP/public/Program.htm) in eBRAP. Use of this document is optional.

The NIH Biographical Sketch may also be used. Each biographical sketch must be in PDF format prior to attachment. Note the page limitation specified in the BAA. Biographical

Sketches should also be used to demonstrate background and expertise through education, positions, publications, and previous work accomplished.

PI Biographical Sketch: This file must be titled “Biosketch_LastName.pdf,” where

“LastName” is the last name of the PI.

PI Previous/Current/Pending Support: This file must be titled

“Support_LastName.pdf,” where “LastName” is the last name of the PI.

○ For all previous (award period of performance ending within the past 5 years), current, and pending research support, include the title, time commitments, supporting agency, name and address of the funding agency’s procuring

Contracting/Grants Officer, period of performance, level of funding, brief description of the project’s goals, and list of the specific aims. If applicable, identify where the proposed project overlaps with other existing and pending research projects. Clearly state if there is no overlap.

○ If there is no previous, current, or pending support, enter “None.” An updated previous, current, and pending support document will be required if an award is recommended for funding.

Key Personnel Biographical Sketches: Each file must be titled

“Biosketch_LastName.pdf,” where “LastName” is the last name of the respective individual.

Key Personnel Previous/Current/Pending Support: Each file must be titled

“Support_LastName.pdf,” where “LastName” is the last name of the respective individual. Refer to content requirements under “PI Previous/Current/Pending

Support” listed above.

5. Research & Related Budget

An estimate of the total proposed research project costs, with a breakdown of all cost categories for each year, must be submitted on the Grants.gov Research & Related Budget form. Include a sufficiently detailed budget and budget justification for each year so that the Government can determine the proposed costs to be allowable, allocable, and reasonable for the proposed research. The budget justification for the entire period of performance must be uploaded to the Research & Related Budget after completion of the budget for Period 1. At the time of proposal/application submission to Grants.gov, the AOR is certifying to the best of his/her knowledge that all costs are current, accurate, and complete.

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

Budget Regulations and Restrictions:

The following must be utilized in developing the budget:

Administrative and Cost Principles. Awardees are required to comply with the following, as applicable:

○ Federal Acquisition Regulation (FAR) Part 31

○ Defense FAR Supplement Part 231

○ Provisions of Chapter I, Subchapter C of Title 32, Code of Federal Regulations

(CFR), “DoD Grant and Agreement Regulations,” Parts 26, 28, 34, 37, and 2 CFR

Part 1125

○ 2 CFR Part 200, “Uniform Administrative Requirements, Cost Principles, and Audit

Requirements for Federal Awards,” implemented by Chapter XI of Title 2, CFR.

Award Funding/Maximum Obligation:

○ Contract Awards: Reference contract funding regulations in FAR 32.7 and

Defense Federal Acquisition Regulation Supplement (DFARS) 232.7.

○ Assistance Agreement Awards: Awards will not be modified to provide additional funds for such purposes as reimbursement for unrecovered indirect/facilities and administrative costs resulting from the establishment of final negotiated rates or for increases in salaries, fringe benefits, and other costs.

Pre-Award Costs: Pre-award costs may be allowable as follows:

○ Contract Awards: An organization may request and negotiate pre-contract costs prior to contract award. An advanced agreement must be executed by the

Contracting Officer prior to incurring any cost. Advanced Agreement Costs (Pre-

Contract Costs) are referenced in FAR 31.205-32 and Advanced Agreements in

31.109.

○ Assistance Agreement Awards: An institution of higher education, hospital, or non-profit organization may, at its own risk and without the Federal Government’s prior approval, incur obligations and expenditures to cover costs up to 90 days before the start date of the period of performance, if such costs (1) are necessary to conduct the project; and (2) would be allowable under the award, if awarded, without the Government’s prior approval. If specific expenditures would otherwise require prior approval, the awardee must obtain the Grants Officer’s approval before incurring the costs. Government prior approval is required for any costs to be incurred more than 90 days before the start date of the period of performance.

For-profit organizations must obtain the Grants Officer’s approval prior to incurring any obligations and expenditures before the start date of the period of performance.

Reference 2 CFR 200.458.

For-profit organizations must obtain the Grants Officer’s approval prior to incurring any obligations and expenditures before the beginning date of the initial budget period of a new award. Reference 32 CFR 34.15.

The incurrence of pre-award costs imposes no obligation on the Government either 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. The Federal Government expects the awardee to be fully aware that pre-award costs may result in borrowing against future support and that such borrowing must not impair the organization’s ability to accomplish the project objectives in the approved timeframe or in any way adversely affect the conduct of the project.

Cost of Preparing Proposals/Applications: The cost of preparing proposals/ applications in response to the BAA is not considered an allowable direct charge to any resultant award. However, the cost of preparing proposals/applications may be an allowable expense included in the indirect/facilities and administrative cost as specified in the organizations applicable cost principles.

Currency: All costs must be entered in U.S. dollars. Recipients performing research outside of the United States should include the cost in local currency, the rate used for converting to U.S. dollars, and justification/basis for the conversion rate used. Foreign currency exchange rates for recipients performing research outside of the United States will be based on the official rate in effect at the time of submission.

Submit a detailed budget and justification that covers the entire period of performance (not just the first year). The Government reserves the right to request a revised budget and budget justification and/or additional information.

Budget Instructions: Complete the Research & Related Budget following the instructions below. Begin by entering the organizational DUNS number, Budget Type, Name of

Organization, and anticipated start and end dates. Ensure that the DUNS number is entered accurately or Grants.gov will reject the proposal/application. For all Federal agencies or organizations collaborating with Military Facilities, special restrictions apply to the budget and are described below.

For Federal Agencies (as applicant): A proposal/application from a Federal agency must include in the budget justification a Federal Financial Plan (Plan). The Plan must address how all funds will be obligated before their period for obligation expires, and how funds will be available to cover research costs over the entire award period. The Plan must include the funding mechanism(s) that will be used to carry over funds between fiscal years.

For Collaborating Military Facilities: A proposal/application from an extramural organization that includes collaboration with a Military Facility (Military Health System facility, research laboratory, medical treatment facility, dental treatment facility, or a DoD activity embedded with a civilian medical center) must submit a Collaborating DoD

Military Facility Budget Form(s).