HT9425-23-S-SOC1-BAA General Submission Instructions.pdf

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

General Submission Instructions for Funding 1

Opportunity Number: HT9425-23-S-SOC1 2

Broad Agency Announcement 4 for Extramural Biomedical Research and 5

Development 6

Fiscal Year 2023 – Fiscal Year 2028 7

Department of Defense 8

United States Special Operations Command 9

Table of Contents 30

I. HELPFUL INFORMATION ................................................................................................ 5 31 A. Tips for Success .................................................................................................................. 5 32 B. Current Funding Opportunity Announcement .................................................................... 5 33 C. Receiving Emails from eBRAP, and Grants.gov ................................................................ 6 34 D. Agency Contacts ................................................................................................................. 6 35

II. REGISTRATION AND SUBMISSION INFORMATION ................................................ 7 36 A. eBRAP Registration ............................................................................................................ 7 37 B. Submission Dates and Times .............................................................................................. 8 38 C. Content and Form of pre-application Submission .............................................................. 8 39

III. Content and Form of Application Submission FOR RESEARCH pROPOSALS ........ 10 40 A. Grants.gov Submission Package Components for Research Proposals ............................ 13 41 B. Submission of a Grants.gov Workspace ........................................................................... 29 42 C. Applicant Verification of Grants.gov Submission in eBRAP .......................................... 29 43 D. Application Tracking ........................................................................................................ 30 44

APPENDIX 1 Regulatory Requirements .................................................................................. 31 45 A. Safety and Environmental Requirements .......................................................................... 31 46 B. Research Protections Review Requirements .................................................................... 31 47 C. Clinical Trial Registry....................................................................................................... 36 48 D. Research Involving Recombinant DNA Molecules .......................................................... 37 49

APPENDIX 2 Reporting Requirements and Administrative Information ........................... 38 50 A. Reporting Requirements for Awards ................................................................................ 38 51 B. Disclosure of Proprietary Information .............................................................................. 39 52 C. Marking of Proprietary Information ................................................................................. 39 53 D. Award Notices .................................................................................................................. 39 54 E. Inquiry Review.................................................................................................................. 39 55 F. Information Service .......................................................................................................... 40 56 G. Freedom of Information Act Requests .............................................................................. 40 57 H. Information Release .......................................................................................................... 40 58 I. Contracted Fundamental Research ................................................................................... 41 59 J. Sharing of Proposal Information ....................................................................................... 41 60 K. Data Management and Sharing ......................................................................................... 42 61 Purpose ..................................................................................................................................... 42 62 Data sharing enables researchers to rigorously test the validity of research findings, strengthen 63 analyses through combined datasets, reuse hard-to-generate data, and explore new 64 frontiers of discovery. In addition, USSOCOM emphasizes the importance of good data 65 management practices, which provide the foundation for effective data sharing and 66 improve the reproducibility and reliability of research findings. USSOCOM encourages 67 data management and data sharing practices consistent with the FAIR data principles 68 (https://www.go-fair.org/fair-principles/) ......................................................................... 42 69

USSOCOM expects researchers and institutions to implement data management and sharing 70 practices as described. ....................................................................................................... 42 71

Definitions ................................................................................................................................ 42 72 For the purposes of this BAA, terms are defined as follows: .................................................. 42 73

Scientific Data: The recorded factual material commonly accepted in the scientific community 74 as of sufficient quality to validate and replicate research findings, regardless of whether 75 the data are used to support scholarly publications. Scientific data do not include 76 laboratory notebooks, preliminary analyses, completed case report forms, drafts of 77 scientific papers, plans for future research, peer reviews, communications with 78 colleagues, or physical objects, such as laboratory specimens. ........................................ 42 79

Data Management: The process of validating, organizing, protecting, maintaining, and 80 processing scientific data to ensure the accessibility, reliability, and quality of the 81 scientific data for its users................................................................................................. 42 82

Data Sharing: The act of making scientific data available for use by others (e.g., the larger 83 research community, institutions, the broader public), for example, via an established 84 repository. ......................................................................................................................... 42 85

Metadata: Data that provide additional information intended to make scientific data 86 interpretable and reusable (e.g., date, independent sample and variable construction and 87 description, methodology, data provenance, data transformations, any intermediate or 88 descriptive observational variables). ................................................................................. 42 89

Data Management and Sharing Plan (Plan): A plan describing the data management, 90 preservation, and sharing of scientific data and accompanying metadata. ....................... 42 91

Scope ........................................................................................................................................ 42 92 This guidance applies to all research, funded or conducted in whole or in part by USSOCOM, 93 that results in the generation of scientific data. This includes research funded or 94 conducted by extramural grants, contracts, Intramural Research Projects, or other funding 95 agreements regardless of USSOCOM funding level or funding mechanism. This guidance 96 does not apply to research and other activities that do not generate scientific data, 97 including training, infrastructure development, and non-research activities. ................... 42 98

Managing and Sharing Scientific Data .................................................................................... 43 99 USSOCOM expects that in drafting Plans, researchers will maximize the appropriate sharing 100 of scientific data, acknowledging certain factors (i.e., legal, ethical, or technical) that may 101 affect the extent to which scientific data are preserved and shared. Any potential 102 limitations on subsequent data use should be communicated to individuals or entities 103 (e.g., data repository managers) that will preserve and share the scientific data. ............. 43 104

Considerations for Scientific Data Derived from Human Participants: USSOCOM prioritizes 105 the responsible management and sharing of scientific data derived from human 106 participants. Applicable federal, Tribal, state, and local laws, regulations, statutes, 107 guidance, and institutional policies govern research involving human participants and the 108 sharing and use of scientific data derived from human participants. USSOCOM also 109 respects Tribal sovereignty in the absence of written Tribal laws or polices. This 110 USSOCOM guidance is consistent with federal regulations for the protection of human 111 research participants and other USSOCOM expectations for the use and sharing of 112 scientific data derived from human participants, including the NIH’s 2014 Genomic Data 113 Sharing (GDS) Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-114 124.html ) 2015 Intramural Research Program Human Data Sharing Policy 115 (https://policymanual.nih.gov/3016), and 45 CFR 46 116 (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html). 117 Researchers proposing to generate scientific data derived from human participants should 118 outline in their Plans how privacy, rights, and confidentiality of human research 119 participants will be protected (i.e., through de-identification, Certificates of 120 Confidentiality (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html), 121 and other protective measures). ........................................................................................ 43 122

USSOCOM strongly encourages researchers to plan for how data management and sharing 123 will be addressed in the informed consent process, including communicating with 124 prospective participants how their scientific data are expected to be used and shared. 125 Researchers should consider whether access to scientific data derived from humans, even 126 if de-identified and lacking explicit limitations on subsequent use, should be controlled.127 ........................................................................................................................................... 43 128

Data Repository Selection: USSOCOM strongly encourages the use of established 129 repositories to the extent possible for preserving and sharing scientific data. The 130 Supplemental Information to the NIH Policy for Data Management and Sharing: 131 Selecting a Repository for Data Resulting from NIH-Supported Research 132 (https://sharing.nih.gov/data-management-and-sharing-policy/sharing-scientific-133 data/selecting-a-data-repository) assists researchers in selecting a suitable data 134 repository(ies) or cloud-computing platform. ................................................................... 43 135

Data Preservation and Sharing Timelines: Shared scientific data should be made accessible as 136 soon as possible, and no later than the time of an associated publication, or the end of 137 performance period, whichever comes first. Researchers are encouraged to consider 138 relevant requirements and expectations (e.g., data repository policies, award record 139 retention requirements, journal policies) as guidance for the minimum time frame that 140 scientific data should be made available, which researchers may extend. Depending on 141 the research project, the PI may be required to participate in the following, which will be 142 specified in the award: ...................................................................................................... 43 143

L. Property/Equipment .......................................................................................................... 44 144 M. Title to Inventions and Patents .......................................................................................... 44 145 N. PI Changes and Award Transfers ..................................................................................... 44 146

APPENDIX 3 Qualification Information.................................................................................. 46 147 A. Contractor/Recipient Qualification ................................................................................... 46 148 B. Eligibility Information ...................................................................................................... 46 149 C. J-1 Visa Waiver................................................................................................................. 47 150 D. Conflict of Interest ............................................................................................................ 47 151

APPENDIX 4 Formatting Guidelines ....................................................................................... 48 152

APPENDIX 5 National Policy Requirements ........................................................................... 49 153 A. Certification ...................................................................................................................... 49 154 B. Representations ................................................................................................................. 50 155

APPENDIX 6 Acronym List ...................................................................................................... 52 156 This General Submission Instructions document must be read in conjunction with the Broad 159 Agency Announcement, available for downloading from Grants.gov. 160

I. HELPFUL INFORMATION 199

A. Tips for Success 201

This symbol marks helpful hints throughout this document. 202

This symbol refers to the Broad Agency Announcement for specific instructions. 203

B. Current Funding Opportunity Announcement 204

The Fiscal Year 2023 – Fiscal Year 2028 (FY23-FY28) U.S. Special Operations Command 205 (USSOCOM) Broad Agency Announcement (BAA) can be found by searching Grants.gov 206

(http://www.grants.gov/) using the Funding Opportunity Number HT9425-23-S-SOC1 or the 207 Catalog of Federal Domestic Assistance (CFDA) number 12.420 Military Medical Research 208 and Development. 209

USSOCOM utilizes the tools and processes provided by Congressionally Directed Medical 210 Research Programs (CDMRP). Additional information may be found on the CDMRP’s 211 electronic Biomedical Research Application Portal (eBRAP) website at 212 https://ebrap.org/eBRAP/public/index.htm. 213

The awarding agency will be the U.S. Army Medical Research Acquisition Activity 214 (USAMRAA). The USAMRAA Contracting Officials are the only individuals authorized to 215 obligate funds and bind the Federal Government for awards under this BAA. 216

C. Receiving Emails from eBRAP, and Grants.gov 217

To help ensure that all email correspondence is delivered correctly and is not treated as spam by 218 email programs, keep your email address up to date in eBRAP and Grants.gov and place the 219 following domains into your safe list: army.mil, us.army.mil, *.mail.mil, health.mil, eBRAP.org, 220 and Grants.gov. Also, use the same email address when submitting both the pre-proposal/pre-221 application to eBRAP and the full proposal to Grants.gov. 222

On occasion, the Grants.gov proposal package may be updated or changed. The applicant must 223 use the latest version of the Grants.gov submission package; proposals submitted with a different 224 version of the Grants.gov submission package will be rejected by Grants.gov. Sign up in 225 Grants.gov (http://www.grants.gov/) for “Send me change notification emails” by following 226 the link on the Synopsis page for the BAA or by responding to the prompt provided by 227 Grants.gov when first downloading the Grants.gov submission package. 228

D. Agency Contacts 229

1. eBRAP Help Desk: Questions related to BAA content or submission requirements, as 230 well as questions related to submission of Pre-proposals through eBRAP, should be 231 directed to the eBRAP Help Desk, which is available Monday through Friday from 232 8:00 a.m. to 5:00 p.m. Eastern time. Response times may vary depending upon the 233 volume of inquiries. Be advised that the eBRAP Help Desk is unable to provide 234 technical assistance with Grants.gov submission. 235

Phone: 301-682-5507 236

Email: HELP@EBRAP.ORG 237

2. Grants.gov Contact Center: Questions related to proposal submission through the 238 Grants.gov portal should be directed to the Grants.gov Contact Center, which is 239 available 24 hours a day, 7 days a week (closed on U.S. Federal holidays). 240

Phone: 800-518-4726; International: 1-606-545-5035 241

Email: SUPPORT@GRANTS.GOV 242 http://www.grants.gov/ https://ebrap.org/eBRAP/public/index.htm http://www.grants.gov/ mailto:help@eBRAP.org mailto:support@grants.gov

II. REGISTRATION AND SUBMISSION INFORMATION 243

Submission is a two-step process requiring both (1) Pre-proposal submission through eBRAP 244 (https://eBRAP.org/) and (2) full proposal submission through a Grants.gov Workspace or 245 eBRAP, depending on the type of application being submitted. General registration information 246 is provided below. For detailed instructions, refer to the eBRAP User Guide 247 (https://ebrap.org/eBRAP/public/UserGuide.pdf) for eBRAP registration, and www.grants.gov 248 for Grants.gov registration. 249

Submission of Proposals from U.S. Federal agencies and those proposing 250 collaborations with Military Facilities have unique requirements. Budget requirements 251 and restrictions apply. See Section III.A.5, Research & Related Budget. 252

For specific guidance regarding changes to the Principal Investigator (PI) or 253 organization, refer to the BAA. 254

USSOCOM encourages all PIs to participate in a digital identifier initiative through Open 255 Researcher and Contributor Identification (ORCID). Registration for a unique ORCID identifier 256 can be done online at http://orcid.org/. 257

A. eBRAP Registration 258 eBRAP is a multifunctional web-based system that allows PIs to submit their pre-proposals 259 electronically through a secure connection, to view and edit the content of their pre-proposals 260 and full proposals, to receive communications from the USSOCOM, and to submit 261 documentation during award negotiations and throughout the period of performance. A key 262 feature of eBRAP is the ability of an organization’s representatives and PIs to view and modify 263 the Grants.gov proposal submissions associated with them. eBRAP will validate Grants.gov 264 proposal files against the specific BAA requirements, and discrepancies will be noted in an email 265 to the PI and in the Full Application Files tab in eBRAP. It is the applicant’s responsibility to 266 review all proposal components for accuracy as well as to ensure proper ordering as specified in 267 the BAA. 268 eBRAP does not confirm the accuracy of file content! 269

To submit a pre-proposal, PIs must be registered in eBRAP. 270

During eBRAP registration, the PI must request to be affiliated with his/her organization from 271 the list of organizations already registered with eBRAP. If the PI’s organization is not already 272 registered with eBRAP, then the PI must invite an Authorized Organizational Representative 273 (AOR) to register the organization. The AOR does not need to complete the organization 274 registration in eBRAP in order for the pre-proposal to be submitted. However, before the full 275 proposal submission deadline, the organization’s eBRAP registration must be complete to allow 276 for processing, viewing, and modifying of the Grants.gov submission package components. 277

Specific information must be identical between the pre-proposal and the full proposal/application 278 for eBRAP to process a proposal. Mismatched information may delay the availability of the 279 proposal during the proposal/application verification period. For the PI to view/modify files, the 280 https://ebrap.org/ https://ebrap.org/eBRAP/public/UserGuide.pdf http://www.grants.gov/ http://www.grants.gov/ http://orcid.org/

PI’s name and email address in the eBRAP pre-proposal/pre-application submission must match 281 the information provided in Standard Form 424 (SF424) of the Grants.gov submission package. 282 For the Business Official to view/modify files, the Business Official’s name and email address in 283 the eBRAP pre-proposal submission must match the information provided in the SF424 of the 284 Grants.gov submission package. 285

During pre-proposal submission, the PI must identify a Business Official from the list of 286 Business Officials registered with eBRAP. If the PI’s Business Official is not already registered 287 with eBRAP, the PI must invite the Business Official to register. The Business Official’s 288 registration must be completed prior to the full proposal deadline to allow the Business Official 289 to view/modify the full proposal files in eBRAP after submission. 290

During pre-proposal submission, the PI must select the performing organization (site at which 291 the PI will perform the proposed work) and contracting organization (organization submitting on 292 behalf of the PI) and click on “Add Organizations to this pre-application.” The organization(s) 293 must be either selected from the eBRAP drop-down list or invited to allow submission of the pre-294 proposal. 295

B. Submission Dates and Times 296

This BAA is continuously open for a 5 year period, from 1 August, 2023 through 31 July, 2028, 297 11:59 p.m. Eastern Time. Pre-proposals are required and may be submitted at any time 298 throughout the 5-year period. 299

C. Content and Form of pre-application Submission 300

For specific instructions regarding content of the pre-proposal submission 301 components, refer to the BAA. 302

The pre-proposal consists of the following components, which are organized in eBRAP by 303 separate tabs: 304

Tab 1 – Application Information: Enter the information as described in eBRAP before 305 continuing the pre-proposal. Submission of application information includes assignment of 306 primary and secondary research classification codes which can be found at 307 https://ebrap.org/eBRAP/public/program.htm. Note that the codes have recently been 308 revised. Applicants are strongly encouraged to review and confirm the codes prior to 309 making their selection. Click on “Save.” 310

Tab 2 – Application Contacts: Enter contact information for the PI. Enter the 311 organization’s Business Official responsible for sponsored program administration (the 312 “person to be contacted on matters involving this application” in Block 5 of SF424 in the 313 Grants.gov package). Depending on screen resolution, scrolling horizontally may be 314 necessary to locate the box to invite an AOR to register the performing and/or contracting 315 organization. Click on “Add Organizations to this pre-application.” The Business Official 316 must be either selected from the eBRAP list or invited in order for the pre-proposal to be 317 submitted. 318 https://ebrap.org/eBRAP/public/program.htm

If the organization’s Business Official is not in eBRAP, an invitation to the Business 319 Official to register in eBRAP must be sent. 320

Depending on the screen resolution, scrolling horizontally may be necessary to locate the 321 box to invite an AOR to register the performing organization (site at which PI will perform 322 the proposed work) and contracting organization (organization submitting on behalf of the 323 PI; corresponds to Block 5 on SF424), and click on “Add Organizations to this pre-324 application.” The organization(s) must either be selected from the eBRAP drop-down list 325 or invited to allow the pre-proposal to be submitted. 326

Tab 3 – Collaborators and Key Personnel: Enter the name, organization, and role of all 327 collaborators and key personnel associated with the proposal. Click on “Save.” 328

Note: USSOCOM does not follow National Institutes of Health (NIH) guidelines for 329 role designation of project participants. Unless otherwise noted, applicants should 330 assign the role of each participant in accordance with the participant’s respective 331 involvement in the project. 332

Federal agency personnel involved in the review process and/or with making funding 333 recommendations are prohibited from being involved in any pre-proposal and full proposal, 334 including, but not limited to, concept design, proposal development, budget preparation, 335 and the development of any supporting documentation. 336

If formal collaboration with Military Facility personnel is planned (i.e., included in the 337 proposal in performance of the research), this prohibition is not applicable; however, those 338 Military Facility personnel are prohibited from being involved in the review process and/or 339 with making funding recommendations. 340

To preserve the integrity of its peer and programmatic review processes, the USSOCOM 341 discourages employees or contracted personnel performing proposal review functions from 342 participating or submitting proposals. For FY23-FY28, the peer review contractor is 343 General Dynamics Information Technology (GDIT). The programmatic review contractor 344 may vary. Proposals that include names of personnel from a review contractor may be 345 administratively withdrawn unless plans to manage conflicts of interest (COIs) are 346 provided and deemed appropriate by the Government. Questions related to this topic 347 should be directed to the eBRAP Help Desk at help@eBRAP.org or 301-682-5507. Refer 348 to Appendix 3 for additional information. 349

Tab 4 – Conflicts of Interest (COI’s): To avoid COIs during the screening and review 350 processes, list all individuals other than collaborators and key personnel who may have a 351 COI in the review of the proposal (including those with whom the PI has a personal or 352 professional relationship). Click on “Save.” 353

Tab 5 – Required Files: Upload all documents as PDF as specified in the BAA. 354 Documents should conform to the formatting guidelines outlined in Appendix 4. Click on 355 “Upload.” 356 mailto:help@cdmrp.org

• eBRAP will truncate characters exceeding the limit specified for each data field as 357 specified in the BAA. 358

• eBRAP will not allow a document to be uploaded in the Required Files tab if the 359 number of pages exceeds the limits specified in the BAA. 360

Tab 6 – Submit pre-proposal: Enter eBRAP password and click the “Submit” button. 361 Click the “Confirm Submission” button to complete the pre-proposal submission. This 362 finalizes the pre-proposal process. 363

The pre-proposal is not submitted until Tab 6 is complete. 364 Pre-proposals not completed are left in DRAFT status. 365

Following completion of pre-proposal/pre-application submission, the status of the pre-366 proposal in eBRAP will change from “DRAFT” to “SUBMITTED” and a confirmation 367 email will be sent to the PI and named Business Official. A pre-proposal in DRAFT status 368 will not be forwarded for review. 369

III. CONTENT AND FORM OF APPLICATION SUBMISSION FOR RESEARCH 370

PROPOSALS 371

A PI must be invited to submit a full proposal. An invited full proposal must be submitted 372 electronically through a Grants.gov Workspace (http://www.grants.gov). Proposals will not be 373 accepted by mail or in person. 374

Grants.gov applicants must apply online using Workspace. Workspace is a shared, online 375 environment where members of a grant team (investigators and business officials) may 376 simultaneously access and edit different webforms within an application. Applicants must create 377 a Workspace, invite grant team members to join the Workspace, complete the required forms, 378 and submit their application Workspace package. 379

To apply through Grants.gov, an organization must first complete the Grants.gov registration 380 process. Allow up to 8 weeks for the completion of the Grants.gov registration process. 381

USSOCOM cannot make allowances/exceptions to its policies for submission problems 382 encountered by the applicant organization using system-to-system interfaces with Grants.gov. 383

Any modifications to the Project Narrative or Budget Form require submission of a 384 changed/corrected Grants.gov submission package to Grants.gov. The Project Narrative and 385 Budget Form cannot be modified during the proposal verification period. 386

It is the applicant’s responsibility to verify his/her Adobe Reader’s compatibility with 387 Grants.gov: http://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html. A 388 no-cost compatible version of Adobe Reader can be downloaded at 389 http://get.adobe.com/reader/otherversions/. Resubmission of a proposal prior to the Grants.gov 390 deadline must be coded as a “Changed/Corrected Application.” 391 http://www.grants.gov/ http://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html http://get.adobe.com/reader/otherversions/

Foreign organizations doing business outside of the United States are also required to complete 392 the Grants.gov registration process, in addition to fulfilling supplementary requirements for 393 doing business with the U.S. Federal Government. 394

If business is conducted with the Federal Government on a continuing basis, it is likely that some 395 of the actions have already been completed, e.g., obtaining a Unique Entity Identifier (UEI) 396 number via registration as an Entity in the System for Award Management (SAM). 397

Detailed information, automated tools, and checklists are available at 398 http://www.grants.gov/web/grants/applicants/organization-registration.html. 399

The following steps are required as part of the Grants.gov registration process: 400

1. UEI and SAM 401

As of April 4, 2022, all organizations applying online through Grants.gov must register with the 402 SAM and will receive a(UEI number. Failure to register with SAM will prevent your 403 organization from applying through Grants.gov. Applicant organizations and all subrecipient 404 organizations must have an active registration in the (SAM) number to submit proposals to 405 Grants.gov. The applicant organization must also be registered in the Entity Management 406 functional area of the SAM with an “Active” status to submit proposals through the Grants.gov 407 portal. Verify the status of the applicant’s organization’s Entity registration in SAM well in 408 advance of the proposal submission deadline. Allow several weeks to complete the entire SAM 409 registration process. If an applicant has not fully complied with the requirements at the time the 410 Federal awarding agency is ready to make a Federal award, the Federal awarding agency may 411 determine that the applicant is not qualified to receive a Federal award and use that 412 determination as a basis for making a Federal award to another applicant. 413

2. SAM Registry 414

The applicant organization must be registered as an entity for all awards in SAM 415 (https://www.sam.gov) and receive confirmation of an “Active” status before submitting a 416 proposal through Grants.gov. The SAM validates organization information and electronically 417 shares the secure and encrypted data with Federal agencies’ finance offices to facilitate paperless 418 payments through electronic funds transfer. An organization must identify an Accounts 419 Receivable point of contact (POC), an Electronic Business (E-Biz) POC, and a Government 420 Business POC during the SAM registration process. Entity registrations in SAM have an 421 annual expiration. Verify the status of your organization’s Entity registration in SAM well in 422 advance of the proposal submission deadline. An organization can register in SAM online at 423 https://www.sam.gov/. If your organization does not have either an Employer Identification 424 Number (EIN) or Tax Identification Number (TIN), allow at least 2 weeks to receive this 425 information from the U.S. Internal Revenue Service. Allow several weeks to complete the entire 426 SAM registration process. If an applicant has not fully complied with the requirements by the 427 time the Federal awarding agency is ready to make a Federal award, the Federal awarding 428 agency may determine that the applicant is not qualified to receive a Federal award and use that 429 determination as a basis for making a Federal award to another applicant. Additional 430 information and step-by-step registration directions are detailed in the SAM User Guide and 431 http://www.grants.gov/web/grants/applicants/organization-registration.html https://www.sam.gov/ https://www.sam.gov/portal/SAM/#1 other General Services Administration (GSA) training materials in the Help area at 432 https://www.sam.gov/. 433

Applications will be rejected by Grants.gov if (1) the organization’s Entity registration in SAM 435 is not active, or (2) if during the SAM registration process, the organization did not answer 436 “Yes” when asked “Do you want to be eligible for grants and other Federal assistance?” 437

3. Commercial and Government Entity (CAGE) Code 438

The applicant organization must have a CAGE Code. The Defense Logistics Information 439 Service in Battle Creek, Michigan, is the only authorized source of CAGE Codes. CAGE Codes 440 will be assigned to registrants as their SAM registration advances through the validation process. 441 Foreign registrants in SAM must be assigned a North Atlantic Treaty Organization (NATO) 442 CAGE Code (NCAGE). An NCAGE code can be obtained by contacting the National 443 Codification Bureau of the country where the organization is located or by visiting the website 444 https://cage.dla.mil/Request. On average, CAGE Code or NCAGE Code validation in SAM 445 occurs within 3 business days after the TIN is validated. 446

4. Authorized Organizational Representative 447

Each organization must have an AOR who is registered with Grants.gov (individual PIs do not 448 register with Grants.gov). An AOR must be a member of the Grants.gov Workspace grant team 449 as the business official authorized to submit the completed Workspace application package. An 450 organization’s E-Biz POC must authorize an AOR. An individual may serve as both the E-Biz 451 POC and the AOR. Before proposal submission, the AOR must be registered to submit on 452 behalf of the organization at Grants.gov 453 (https://www.grants.gov/web/grants/applicants/registration.html). 454

An AOR must first register with the Grants.gov credential provider at 455 https://www.grants.gov/web/grants/applicants/registration.html to obtain a username and 456 password. Once an AOR has completed the Grants.gov registration process, Grants.gov will 457 notify the E-Biz POC of the registration. The E-Biz POC will then log in to Grants.gov and 458 assign and authorize the appropriate roles, which may include the AOR role, thereby giving the 459 AOR permission to complete and submit applications on behalf of the organization. When an E-460 Biz POC approves an AOR, Grants.gov will send the AOR a confirmation email. 461

At the time of proposal submission to Grants.gov, the AOR is certifying to the best of his/her 462 knowledge that all information provided in the proposal is current, accurate, and complete. 463

When applications are submitted through Grants.gov, the name of the organization’s AOR that 464 submitted the application is inserted into the signature line of the application, serving as the 465 electronic signature. The E-Biz POC must authorize individuals who are able to make legally 466 binding commitments on behalf of the organization as an AOR; this step is often missed and it 467 is crucial for valid and timely submissions. 468

5. Grants.gov Workspace 469 https://www.sam.gov/portal/SAM/#1 https://cage.dla.mil/Request https://www.grants.gov/web/grants/applicants/registration.html

Applicants must create a Workspace, which allows the application components to be completed 470 online and routed through the applicant organization for review prior to submission. Once the 471 Workspace has been created, participants (grant team members) can be added and the required 472 forms can be completed and reviewed before submitting. 473

Each proposal submission must include the completed Grants.gov submission package of forms 474 associated with the BAA in Grants.gov (http://www.grants.gov/). 475

If the applicant decides not to apply by filling out webforms within the Workspace, individual 476 PDF forms can be downloaded, saved, and uploaded to the Workspace. A compatible version of 477 Adobe Reader must be used to view, complete, and submit an application package consisting of 478 PDF forms. If more than one person is entering text into an application package, the same 479 version of Adobe Reader software should be used by each person. Check the version number of 480 the Adobe software on each user’s computer to make sure the versions match. Using different 481 versions of Adobe Reader may cause submission and/or save errors – even if each version is 482 individually compatible with Grants.gov. Grants.gov will reject a submission package that is 483 opened at any time by an individual with an incompatible version of Adobe Reader. Rejected 484 proposals must be resubmitted using a new Grants.gov submission package and a supported 485 version of Adobe Reader prior to the proposal submission deadline. It is the applicant’s 486 responsibility to verify his/her Adobe Reader’s compatibility with Grants.gov: 487 https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html. A no-cost 488 compatible version of Adobe Reader can be downloaded at 489 http://get.adobe.com/reader/otherversions/. All contributors to the proposal must use matching 490 compatible versions of Adobe software when editing and preparing proposal components outside 491 the Workspace. The use of different software versions will result in corruption of the submitted 492 file. 493

Any modifications to the Project Narrative or Budget Form require submission of a changed/ 494 corrected Grants.gov submission package to Grants.gov prior to the proposal submission 495 deadline. 496

A. Grants.gov Submission Package Components for Research Proposals 497

1. SF424 (R&R), Application for Federal Assistance Form 498

All appropriate information must be entered into this form to allow for auto-population of 499 subsequent forms in this Grants.gov submission package. See below for clarification to general 500 instructions: 501

Block 1 – Type of Submission. For original submissions, select the “Application” box. For 502 changes that must be made after the original submission, the complete Grants.gov submission 503 package must be resubmitted with the “Changed/Corrected Application” box selected. 504

Block 2 – Date Submitted. Enter the date the proposal is submitted. 505

Applicant Identifier. Enter the submitting organization’s Control Number, if applicable. If 506 there is no Organization Control Number, leave this field blank. 507 http://www.grants.gov/ http://get.adobe.com/reader/otherversions/

Block 3 – Date Received by State and State Application Identifier. Not applicable. 508

Block 4a – Federal Identifier Box. Enter in your eBRAP log number assigned during 509 pre-proposal submission. 510

Figure 1. Enter your eBRAP log number in Block 4a. 511

• Block 4b – Agency Routing Identifier. Not applicable. 514

• Block 4c – Previous Grants.gov Tracking ID. For changed/correct proposal, enter 515 the Grants.gov Tracking Number for the original proposal. 516

• Block 5 – Applicant Information. Enter the information for the applicant 517 organization. “Person to be contacted on matters involving this application” is the 518 Business Official. 519

• Block 6 – Employer Identification. Enter the EIN or TIN as assigned by the Internal 520 Revenue Service. If applying from an organization outside the United States, enter 521 44-4444444. 522

• Block 7 – Type of Applicant. Enter the information for the applicant organization. 523

• Block 8 – Type of Application. Select “New” for all submissions. 524

• Block 9 – Name of Federal Agency. Populated by Grants.gov. 525

• Block 10 – Catalog of Federal Domestic Assistance Number. Populated by 526 Grants.gov. 527

• Block 11 – Descriptive Title of Applicant’s Project. Enter the same project title as 528 used for the pre-proposal. 529

• Block 12 – Proposed Project. Enter the estimated start and end dates for the 530 project. Actual start and end dates will be determined during negotiations if the 531 proposal is recommended for funding. 532

• Block 13 – Congressional District of Applicant. If the applicant organization is 533 outside the United States, enter 00-000. 534

• Block 14 – Project Director/Principal Investigator Contact Information. Enter 535 information for the individual PI responsible for the overall scientific and technical 536 direction of the proposal. If outside the United States, select the appropriate 537 country from the drop-down menu. 538

• Block 15 – Estimated Project Funding. Enter the total funds (direct + indirect costs) 539 requested for the entire performance period of the project. These figures should 540 match those provided in the Research & Related Budget. 541

• Block 16 – Is Application Subject to Review by State Executive Order 12372 Process? 542 Select option b., “NO, program is not covered by E.O.12372.” 543

• Block 17 – Complete Certification. Select the “I agree” box to provide the required 544 certifications and assurances. 545

• Block 18 – SFLLL (Disclosure of Lobbying Activities) or Other Explanatory 546 Documentation. If applicable, complete and attach Standard Form LLL (SFLLL) to 547 disclose lobbying activities pursuant to Title 31 of the United States Code, 548 Section 1352 (31 USC 1352). 549

• Block 19 – Authorized Representative. Enter the contact information for the 550 applicant organization’s authorized representative. The “Signature of Authorized 551 Representative” is automatically completed upon submission of the Grants.gov 552 submission package. 553

• Block 20 – pre-application. Not applicable. 554

• Block 21 – Cover Letter Attachment. Not applicable. 555

If a revised Project Narrative or Budget Form document is needed, an updated Grants.gov 556 submission package must be submitted via Grants.gov as a “Changed/Corrected Application” 557 with the previous Grants.gov Tracking ID found in Block 4.c. of the SF424 (R&R) Form prior 558 to the full proposal submission deadline. 559

2. Attachments Form 560

Grants.gov does not validate for the presence of attachments on this Attachments Form. 561 Following retrieval and processing of the Grants.gov proposal, eBRAP will notify the 562 organizational representatives and PI by email to log into the eBRAP to view, modify, and verify 563 the Grants.gov proposal submission. eBRAP will validate retrieved files against the BAA 564 guidelines. Discrepancies will be noted in both the email and in the Full Application tab. 565 eBRAP does not confirm the accuracy of file content. It is the applicant’s responsibility to 566 review all proposal components and ensure proper ordering as specified in the BAA. See III.C., 567 Applicant Verification of Grants.gov Submission in eBRAP, for additional details. 568

Each attachment in the Attachment Form must be uploaded as an individual PDF file in 569 accordance with the formatting guidelines listed in Appendix 4. For all attachments, ensure that 570 the file names are consistent with the guidance. Grants.gov will reject attachments with file 571 names longer than 50 characters or incorrect file names that contain characters other than the 572 following: A-Z, a-z, 0-9, underscore, hyphen, space, and period. In addition, Grants.gov has file 573 size limits that may apply in some circumstances. Individual attachments may not exceed 574 20 MB and the file size for the entire submission package may not exceed 200 MB. Applicants 575 must contact the Grants.gov Contact Center (support@grants.gov) for written confirmation that a 576 file exceeding the maximum size will be accepted or for other guidance. 577

For specific instructions regarding content and page limits of the Project Narrative, 578 Supporting Documentation, and all other attachments to this Grants.gov form, refer to 579 the BAA. 580

All documents that require signatures must be signed. Both electronic and hand 581 signatures will be accepted. Any document that is signed by hand should be scanned at a 582 low resolution such as 100-150 dots per inch. 583

The following must be included as attachments to this form: 584

Attachment 1: Project Narrative: Attach as a PDF file named “ProjectNarrative.pdf.” 585 The Project Narrative is the main body of the proposal. The page limit of the Project 586 Narrative applies to text and non-text elements (e.g., figures, tables, graphs, photographs, 587 diagrams, chemical structures, drawings, etc.) used to describe the project. Inclusion of 588 URLs that provide additional information to expand on the Project Narrative and could 589 confer an unfair competitive advantage is prohibited and may result in administrative 590 withdrawal of the proposal. There is no form for this information. A detailed description 591 of the research to be undertaken should be submitted. This should include the areas 592 described in the BAA. 593

Submission of a Project Narrative that exceeds the page limit specified in the BAA will 594 result in administrative rejection of the proposal. 595

Attachment 2: Supporting Documentation: Combine and attach as a single PDF file 596 named “Support.pdf.” Include only supporting documentation as indicated in the BAA. 597 Submitting material that is not requested may be viewed as an attempt to gain an unfair 598 competitive advantage; such material will be removed or the proposal may be 599 administratively withdrawn. The Supporting Documentation attachment should not 600 include additional information such as figures, tables, graphs, photographs, diagrams, 601 chemical structures, or drawings. These items should be included in the Project 602 Narrative. Any additional material viewed as an extension of the Project Narrative will 603 be removed or may result in administrative withdrawal of the proposal. 604

All proposals are given fair and thorough reviews. Letters of support not requested in 605 the BAA, such as those from members of Congress, do not impact proposal review or 606 funding decisions. 607

For a list and descriptions of required supporting documents, refer to the BAA. 608

Attachment 3: Technical Abstract: Attach as a PDF file named “TechAbs.pdf.” 609 Abstracts of all funded research projects will be posted on the CDMRP website at 610 https://cdmrp.health.mil/. Do not include proprietary or confidential information. Use only 611 mailto:support@grants.gov characters available on a standard QWERTY keyboard. Spell out all Greek letters, other 612 non-English letters, and symbols. Graphics are not allowed. 613

The Technical Abstract will be posted publicly and will be included in the award 614 agreement. 615

Attachment 4: Lay Abstract: Attach as a PDF file named “LayAbs.pdf.” Do not include 616 proprietary or confidential information. Use only characters available on a standard 617 QWERTY keyboard. Spell out all Greek letters, other non-English letters, and symbols. 618 Graphics are not allowed. 619

The Lay Abstract will be posted publicly and will be included in the award agreement. 620

Attachment 5: Statement of Work (SOW): Attach as a PDF file named “SOW.pdf.” 621 The SOW outlines and establishes the performance expectations and milestones for which 622 USSOCOM may provide funding. The SOW for all award types will be incorporated into 623 the award document and, as such, is subject to release under Freedom of Information Act 624

(FOIA). 625

SOW Format: There is no limit to the number of specific aims, tasks, or subtasks that are 626 described within the SOW page limit. The suggested SOW format and examples specific 627 to different types of research projects are available on the eBRAP “Funding 628 Opportunities and Forms” web page (https://ebrap.org/eBRAP/public/Program.htm). 629 The SOW must be in PDF format prior to attaching. The Government reserves the right 630 to request a revised SOW format and/or additional information. 631

The SOW should include a list of major tasks that support the proposed specific aims, 632 followed by a series of subtasks outlined step-by-step as they relate to the major tasks and 633 milestones within the period of performance. The SOW should describe only the work for 634 which funding is being requested by this proposal and, as applicable, should also: 635

• Include the following information for each study site/subaward site: Organization; 636 organization address; investigator(s), collaborator(s), consultant(s); description of 637 research with animals, human anatomical substances, and/or human subjects or 638 cadavers to be conducted at the site; and key personnel responsible for each major 639 task and each subtask to be performed at the site. 640

• Indicate the number (and type, if applicable) of research subjects (animal or human) 641 and/or human anatomical samples projected or required for each task and at each 642 site. As applicable, estimated times to complete each task should include time for 643 local USSOCOM and the U.S. Army Medical Research and Development Command 644 (USAMRDC) regulatory review and approval, as shown below. Refer to Appendix 6 645 for additional information regarding regulatory review. 646

○ For studies involving human subjects, include a subtask that allows at least 2…