FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 1 General Submission Instructions

General Submission Instructions for Funding Opportunity Number: HT9425-23-S-SOC1

Broad Agency Announcement for Extramural Biomedical and Human Performance Research and Development

Fiscal Year 2023 – Fiscal Year 2028 Department of War United States Special Operations Command (USSOCOM)

Updated 29 July 2026

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 2

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 Information

K. Data Management and Sharing Purpose Data sharing enables researchers to rigorously test the validity of research findings, strengthen analyses through combined datasets, reuse hard-to-generate data, and explore new frontiers of discovery. In addition, USSOCOM emphasizes the importance of good data management practices, which provide the foundation for effective data sharing and improve the reproducibility and reliability of research findings. USSOCOM encourages data management and data sharing practices consistent with the FAIR data principles

(https://www.go-fair.org/fair-principles/) USSOCOM expects researchers and institutions to implement data management and sharing practices as described Definitions

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For the purposes of this BAA, terms are defined as follows:

Scientific Data: The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens

Data Management: The process of validating, organizing, protecting, maintaining, and processing scientific data to ensure the accessibility, reliability, and quality of the scientific data for its users

Data Sharing: The act of making scientific data available for use by others (e.g., the larger research community, institutions, the broader public), for example, via an established repository

Metadata: Data that provides additional information intended to make scientific data interpretable and reusable (e.g., date, independent sample and variable construction and description, methodology, data provenance, data transformations, any intermediate or descriptive observational variables)

Data Management and Sharing Plan (Plan): A plan describing the data management, preservation, and sharing of scientific data and accompanying metadata

Scope This guidance applies to all research, funded or conducted in whole or in part by USSOCOM, that results in the generation of scientific data. This includes research funded or conducted by extramural grants, contracts, Intramural Research Projects, or other funding agreements regardless of USSOCOM funding level or funding mechanism. This guidance does not apply to research and other activities that do not generate scientific data, including training, infrastructure development, and non-research activities Managing and Sharing Scientific Data

USSOCOM expects that in drafting Plans, researchers will maximize the appropriate sharing of scientific data, acknowledging certain factors (i.e., legal, ethical, or technical) that may affect the extent to which scientific data are preserved and shared. Any potential limitations on subsequent data use should be communicated to individuals or entities (e.g., data repository managers) that will preserve and share the scientific data

Considerations for Scientific Data Derived from Human Participants: USSOCOM prioritizes the responsible management and sharing of scientific data derived from human participants. Applicable federal, Tribal, state, and local laws, regulations, statutes, guidance, and institutional policies govern research involving human participants and the sharing and use of scientific data derived from human participants. USSOCOM also respects Tribal sovereignty in the absence of written Tribal laws or polices. This USSOCOM guidance is consistent with federal regulations for the protection of human research participants and other USSOCOM expectations for the use and sharing of scientific data derived from human participants, including the NIH’s 2014 Genomic Data Sharing (GDS) Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD- 14124.html ) 2015 Intramural Research Program Human Data Sharing Policy (https://policymanual.nih.gov/3016), and 45 CFR 46

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(https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html).

Researchers proposing to generate scientific data derived from human participants should outline in their Plans how privacy, rights, and confidentiality of human research participants will be protected (i.e., through de-identification, Certificates of Confidentiality (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html), and other protective measures)

USSOCOM strongly encourages researchers to plan for how data management and sharing will be addressed in the informed consent process, including communicating with prospective participants how their scientific data are expected to be used and shared.

Researchers should consider whether access to scientific data derived from humans, even if de-identified and lacking explicit limitations on subsequent use, should be controlled

Data Repository Selection: USSOCOM strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data. The Supplemental Information to the NIH Policy for Data Management and Sharing:

Selecting a Repository for Data Resulting from NIH-Supported Research (https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientificdata/selecting-a-data-repository) assists researchers in selecting a suitable data repository(ies) or cloud-computing platform

Data Preservation and Sharing Timelines: Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first. Researchers are encouraged to consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, journal policies) as guidance for the minimum time frame that scientific data should be made available, which researchers may extend. Depending on the research project, the PI may be required to participate in the following, which will be specified in the award:

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

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.

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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 2023 – Fiscal Year 2028 (FY23-FY28) 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 HT9425-23-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 Defense Health Agency Contracting Activity (DHACA). The DHACA Contracting Officials 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, health.mil, eBRAP.org, and Grants.gov. Also, use the same email address when submitting both the pre-proposal/preapplication to eBRAP and the full proposal to Grants.gov.

On occasion, the Grants.gov proposal package may be updated or changed. The applicant must use the latest version of the Grants.gov submission package; proposals 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 through eBRAP, should be http://www.grants.gov/ http://www.grants.gov/ http://www.grants.gov/ https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/index.htm http://www.grants.gov/

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 6 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 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 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 submission through eBRAP (https://eBRAP.org/) and (2) full proposal 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 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 electronically through a secure connection, to view and edit the content of their pre-proposals and full proposals, 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 submissions associated with them. eBRAP will validate Grants.gov proposal 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 components for accuracy as well as to ensure proper ordering as specified in the BAA.

https://ebrap.org/ https://ebrap.org/ https://ebrap.org/ https://ebrap.org/eBRAP/public/UserGuide.pdf https://ebrap.org/eBRAP/public/UserGuide.pdf https://ebrap.org/eBRAP/public/UserGuide.pdf http://www.grants.gov/ http://www.grants.gov/ http://orcid.org/ http://orcid.org/ http://orcid.org/

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 7 eBRAP does not confirm the accuracy of file content!

To submit a pre-proposal, 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 to be submitted. However, before the full proposal 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 and the full proposal/application for eBRAP to process a proposal. Mismatched information may delay the availability of the proposal 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 submission must match the information provided in the SF424 of the Grants.gov submission package.

During pre-proposal 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 deadline to allow the Business Official to view/modify the full proposal files in eBRAP after submission.

During pre-proposal 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 preproposal.

B. Submission Dates and Times

This BAA is continuously open for a 5 year period, from 1 August, 2023 through 31 July, 2028, 11:59 p.m. Eastern Time. Pre-proposals 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 submission components, refer to the BAA.

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

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Tab 1 – Application Information: Enter the information as described in eBRAP before continuing the pre-proposal. 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 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 preapplication.” The organization(s) must either be selected from the eBRAP drop-down list or invited to allow the pre-proposal 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. 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 and full proposal, including, but not limited to, concept design, proposal 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 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.

To preserve the integrity of its peer and programmatic review processes, the USSOCOM discourages employees or contracted personnel performing proposal review functions from participating or submitting proposals. For FY23-FY28, the peer review contractor is General Dynamics Information Technology (GDIT). The programmatic review contractor https://ebrap.org/eBRAP/public/program.htm https://ebrap.org/eBRAP/public/program.htm

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 9 may vary. Proposals 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 (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: Enter eBRAP password and click the “Submit” button.

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

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

Pre-proposals not completed are left in DRAFT status.

Following completion of pre-proposal/pre-application submission, the status of the preproposal 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 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. An invited full proposal must be submitted electronically through a Grants.gov Workspace (http://www.grants.gov). Proposals 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 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 8 weeks for the completion of the Grants.gov registration process.

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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 verification period.

It is the applicant’s responsibility to verify his/her Adobe Reader’s compatibility with Grants.gov: https://www.grants.gov/applicants/adobe-software-compatibility

A no-cost compatible version of Adobe Reader can be downloaded at http://get.adobe.com/reader/otherversions/. Resubmission of a proposal 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 Unique Entity Identifier (UEI) number via 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. UEI and SAM

As of April 4, 2022, all organizations applying online through Grants.gov must register with the SAM and will receive a(UEI number. Failure to register with SAM will prevent your organization from applying through Grants.gov. Applicant organizations and all subrecipient organizations must have an active registration in the (SAM) number to submit proposals to Grants.gov. The applicant organization must also be registered in the Entity Management functional area of the SAM with an “Active” status to submit proposals through the Grants.gov portal. Verify the status of the applicant’s organization’s Entity registration in SAM well in advance of the proposal submission deadline. Allow several weeks to complete the entire SAM registration process. If an applicant has not fully complied with the requirements at 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.

2. SAM Registry

The applicant organization must be registered as an entity for all awards in SAM (https://www.sam.gov) and receive confirmation of an “Active” status before submitting a proposal through Grants.gov. The SAM validates organization information and electronically shares the secure and encrypted data with Federal agencies’ finance offices to facilitate paperless https://www.grants.gov/applicants/adobe-software-compatibility http://get.adobe.com/reader/otherversions/ http://get.adobe.com/reader/otherversions/ http://www.grants.gov/web/grants/applicants/organization-registration.html http://www.grants.gov/web/grants/applicants/organization-registration.html https://www.sam.gov/ https://www.sam.gov/ https://www.sam.gov/

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 11 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 SAM well in advance of the proposal 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/.

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.

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 submission, the AOR must be registered to submit on behalf of the organization at Grants.gov (https://www.grants.gov/web/grants/applicants/registration.html).

An AOR must first register with the Grants.gov credential provider at https://www.grants.gov/applicants/applicant-registration 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 https://www.sam.gov/portal/SAM/#1 https://www.sam.gov/portal/SAM/#1 https://www.sam.gov/portal/SAM/#1 https://www.sam.gov/portal/SAM/#1 https://cage.dla.mil/Request https://cage.dla.mil/Request https://www.grants.gov/applicants/applicant-registration

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 12 permission to complete and submit applications on behalf of the organization. When an EBiz POC approves an AOR, Grants.gov will send the AOR a confirmation email.

At the time of proposal submission to Grants.gov, the AOR is certifying to the best of his/her knowledge that all information provided in the proposal 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 submission must include the completed Grants.gov submission package of forms associated with the BAA in Grants.gov (https://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 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 must be resubmitted using a new Grants.gov submission package and a supported version of Adobe Reader prior to the proposal 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 must use matching compatible versions of Adobe software when editing and preparing proposal 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 submission deadline.

https://www.grants.gov/ http://www.grants.gov/ https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html http://get.adobe.com/reader/otherversions/ http://get.adobe.com/reader/otherversions/

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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 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 submission.

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

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

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

• 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.

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• 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.

• 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 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. 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 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, eBRAP will notify the organizational representatives and PI by email to log into the eBRAP to view, modify, and verify the Grants.gov proposal submission. eBRAP will validate retrieved files against the BAA guidelines. Discrepancies will be noted in both the email and in the Full Application tab.

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 15 eBRAP does not confirm the accuracy of file content. It is the applicant’s responsibility to review all proposal 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.

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. 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. 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.

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 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.

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 16

All proposals 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 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 https://cdmrp.health.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.

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 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.

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

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 17

As applicable, estimated times to complete each task should include time for local USSOCOM and the Defense Health Agency- Research & Development-Medical Research and Development Command (DHA R&D- MRDC ) 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 DHA R&D- MRDC Office of Human Research Oversight (OHRO); 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: 813-826-6548; Email: 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 (R&R) Personal Data

This form will be used by DoW 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)/CoPI(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).

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 18

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 (includes period of time awaiting funding status and/or period of time awaiting start date) research support, include the title, time commitments, supporting agency, name and address of the funding agency’s procuring Contracting Officer, performance period, 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.

○ List all positions and scientific appointments, both domestic and foreign, held by senior/key personnel that are relevant to an application, including affiliations with foreign entities or governments. This includes titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).

○ Report all resources and other support for all individuals designated in an application as senior/key personnel – including for the PI and for other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation. Information must be provided about all current support for ongoing projects, whether such support is provided through the applicant https://ebrap.org/eBRAP/public/Program.htm

FY23-FY28 DoW USSOCOM BAA for Extramural Biomedical Research and Development– 19 organization, through another domestic or foreign organization, or is directly provided to an individual who supports the senior/key personnel’s research efforts.

○ Report all current projects and activities that involve senior/key personnel, even if the support received is only in-kind (e.g., office/laboratory space, equipment, supplies, employees). All research resources including, but not limited to, foreign financial support, research or laboratory personnel, lab space, scientific materials, selection to a foreign “talents” or similar-type program, or other foreign or domestic support must be reported.

○ Consistent with National Security Presidential Memoranda-33, individuals are required to disclose grants and contracts associated with participation in programs sponsored by foreign governments, instrumentalities, or entities, including foreign government- sponsored talent recruitment programs.