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May 8, 2023

TRANSFORMING TECHNOLOGY FOR THE WARFIGHTER (TTW) AWARD

REQUEST FOR APPLICATIONS

The Uniformed Services University of the Health Sciences through the Henry M. Jackson

Foundation (HJF), announces the funding opportunity for Transforming Technology for the

Warfighter Program (TTW). The TTW Program strives to advance research in the field of

traumatic brain injury (TBI), rehabilitation, and wearable devices, and will utilize a sub-award

mechanism to advance its goals and objectives. Research supported through this program will

focus on Advanced Technology Development (Technology Readiness Level - TRL 3).*

Approved technologies will be competitive for Demonstration and Validation (TRL 4)* and

Engineering and Manufacturing Development (TRL 5)* awards. The premise for this sub-award

is to promote collaborations with USU investigators, enhance and advance technology for the

warfighter such that it aligns with the Secretary of Defense Initiative “Defense Innovation Unit-

Experimental (DIUx)”. DIUx is an East Coast Department of Defense (DoD) effort to strengthen

connections to the American innovation economy and speed technologies into the hands of the

warfighter. USU received an award from Defense Health Agency (DHA) to implement TTW and

seeks sub-award applications through the HJF in order to achieve TTW program areas of

interest.* Technology Readiness Assessment (TRA) Guidance, U.S. Department of Defense, April

2011 (https://www.acq.osd.mil/chieftechnologist/publications/docs/TRA2011.pdf)

AREAS OF INTEREST

Rapid Preventives and Diagnostics Tools – Point of Care – tools easy to use, rapid, inexpensive, portable, operator-independent, and reasonably sensitive and specific to detect impairments suggestive of traumatic brain injury (TBI).

Delivery devices to deliver pharmaceuticals such as ketamine to reduce pain following an acute event and perhaps reduce the likelihood of post-traumatic stress disorder (PTSD).

Novel tourniquet for lay people as well as the military (dual benefit) that can be used in undeveloped areas of the globe.

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https://www.acq.osd.mil/chieftechnologist/publications/docs/TRA2011.pdf

Bag valve that prevents hyperventilation in TBI and during resuscitation, a common but often unrecognized problem.

Operational Precision Medicine/Biomarkers - Microfluidics to enable measuring biomarkers in real time from bodily fluids.

Wearable technologies for the protection of the US armed forces - to enhance warfighter readiness or to monitor therapeutic response.

ELIGIBILITY

Federal Academic organizations which includes full-time civilian or active duty

Uniformed Services University (USU) faculty members, tenure and non-tenure track,

are eligible to serve as Principal Investigator (PI) or Co-investigator (Co-I).

Applicants with demonstrated experience and expertise in advanced technology will

be eligible to receive awards (direct and indirect costs) for up to a three (3) year

period to perform general and specific requirements. For more info regarding USU

PI eligibility please visit: https://www.usuhs.edu/research/policies

Accredited universities, academic institutions and not-for-profit entities with a

portfolio in relevant research. Applicants with demonstrated experience and expertise

in advanced technology can serve as PIs or co-Is and are eligible to receive sub-

awards (direct and indirect costs) for up to a three (3) year period to perform general

and specific requirements. The direct salary limitation follows Executive Level I of

the Federal Executive pay scale. A minimal indirect cost rate will be considered

favorably when determining an overall budget. Federally negotiated and approved

indirect cost rates will be allowed.

GENERAL PERFORMANCE REQUIREMENTS

All of the requirements described below must focus on the technological and rehabilitative

needs of the warfighter and their families. The execution of research activities is expected to be

timely and appropriate. Failure to demonstrate sustained efforts to identify and support relevant

work may result in redirecting funds for more productive efforts within the TTW.

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https://www.usuhs.edu/research/policies

The PI or Co-I must participate in all TTW Administrative Core-sponsored meetings and

activities, including sessions on needs assessment and strategic planning as it relates to

technology advances for the warfighter.

Each sub-award recipient should foster research collaborations between USU faculty and

scientists at sub-recipient institutions.

DATA SHARING AND REPOSITORY REQUIREMENT

If awarded, the sub-award recipient (Institutions of Higher Education, Hospitals, and Other

Profit/Non-Profit Organizations) PIs of the TTW sub-award will provide the TTW principal

director (PD) at USU a copy of all data generated under the sub-recipient TTW award. This

includes a copy of the raw and cleaned data submitted as part of the application, the raw

experimental data and final results generated under the funding of the TTW sub-award, and the

supporting phenotype and anthropometric data. Additionally, simulated or permutated raw and

normalized data generated from studies that are diagnostic or predictive modeling is required to

be submitted to the TTW PD. The sub-award recipients must provide detailed descriptions of all

methods used for data generation. USU will retain the right to combine and use the data

generated under the award with other USU and DoD datasets to enable the creation of new

datasets from multiple sources in the USU data repository and pursue new research

opportunities.

SUB-AWARD INFORMATION

FUNDING CATEGORIES

Proposal submission funding categories are as follows:

Category 1. Total funding request may not exceed $500,000 (including direct and indirect

cost). Proposals can request 1 year of funding. Category 1 proposals involving animals or

human use must already have the appropriate approvals in place in order to meet the 1 year

deadline.

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Category 2. Total funding request may not exceed $1,000,000 (including direct and indirect

cost). Proposals can request 1, 2, or 3 years of funding. Projects must be completed within the

sponsor- approved time frame.

Category 3. Total funding request may not exceed $2,000,000 (including direct and indirect

cost). Proposals can request up to a maximum of 3 years of funding. Projects must be

completed within a maximum of 3 years of receipt of funding.

Note: All funding is contingent on availability of federal funds for the TTW program. The sub-awards are multi-year awards that are anticipated to receive incremental funding each year. Once funding is made available, continued funding to the sub-awards will depend on the research team’s progress, compliance with the award term and conditions, and spending rates. Quarterly, annual, and final reports will be required to be submitted to TTW Program Manager. Failure to provide timely reports may lead to termination of the award.

PERFORMANCE PERIOD

In no case is a sub-award performance period to exceed 3 years in length.

PRE-PROPOSAL: PREPARATION AND SUBMISSION PROCESS

Pre-proposals will be prepared following the guidelines below. The pre-proposals will be

submitted electronically, as a single Adobe PDF file, no later than 5 pm EST on April 2, 2018

(Eastern Time) to [email protected].

PRE-PROPOSAL GUIDELINES

1. General Formatting Requirements

The total page limit for the pre-proposal is Narrative – up to four (4) pages; budget - up to two (2) pages. NIH formatted bio-sketches for PI and Co-I – no limit. A page is defined as 8 1/2 x 11 inches, single-spaced, with one-inch margins in type not smaller than 12 point Times New Roman font, and page numbers. The pre-proposal must be submitted in portrait layout and PDF Format only.

2. Cover Sheet Information (Not part of the page limit)

2.1. Administrative Point of Contact. To include: salutation, last name, first name, organization, street address, city, state, zip code, telephone, fax, email.

2.2. Technical point of contact (Principal Investigator). To include: salutation, last name, first name, organization, street address, city, state, zip code, telephone, fax, email.

2.3. Proposal title.

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2.4. Technical Abstract. The project abstract should be concise (less than 300 words) and provide a summary of the proposed work and demonstrate relevance to the topic being addressed. The abstract should not contain any proprietary data or markings.

2.5. Keywords. Please suggest 5–10 keywords which can be used to describe the content of the proposal.

3. Pre-proposal Narrative Format. (Limit to 4 pages) The white paper itself should provide sufficient information on the proposed project (e.g., the hypothesis, theories, concepts, goals, aims, approaches, data measurements, analysis, figures, graphs etc.) to allow for an assessment by a technical expert.

Introduction/Background. Provide a brief statement on the ideas and reasoning behind the proposed work. Describe the potential scientific impact to the warfighter and civilians and how the research contributes to the TTW science needs. The impact of the research on TTW program must be clearly delineated.Objective/Hypothesis. State the hypothesis to be tested.Specific Aims. Provide a list of specific goals/tasks in a Gantt chart format as appropriate for all years of proposed work. Pre-proposals that include collaborations should carefully detail each PI’s contribution. All collaborations should have a statement of work and a budget that delineate the work performed by location and PI.Technical Approach/ Methods. Clearly state the proposed approach and methods to be used. Outline the project, study strategy, commercialization potential and innovative aspects. Describe any animal or human subject use and a data safety monitoring plan.Relevance. State (i) specific knowledge gap(s) the study will address and (ii) impact of study on the TTW programmatic goals and (iii) military relevance.Bibliography. (Limit to 1 page). Note: The bibliography does not count towards the overall pre-proposal page limit.NIH Bio-sketch. (No limit). NIH bio-sketch to include team and management plan, including details on student and subcontractors involvement Please provide statement outlining any current and pending support related to the proposed effort. This information must be included for each PI listed in the proposal. This statement requires that each PI specify all grants and contracts through which he or she is currently receiving or may potentially receive financial support for this proposed project. . Letters of Support. (No Limit) Please include a letter of support for any Co-Is identified.

4. Budget. (Limit to 2 pages). Cost estimate by year and total dollars required to accomplish the research as presented in the Budget Summary Form in Appendix 1.

NOTE: Applicants may submit more than one pre-proposal for review.

PRE-PROPOSAL: EVALUATION AND SELECTION

The submission of a pre-proposal enables a prospective applicant to vet their project ideas,

which will be reviewed by the TTW Oversight Committee. TTW will solicit full proposals for

those projects that are aligned with the TTW areas of interest and that have a reasonable chance

of success in the sub-award competition process based on analysis of the information provided in

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the pre-proposal. The pre-proposal provides essential information to avoid conflicts of interest in

the establishment of lists of potential reviewers and for determining the number of reviewers

needed for the proposal evaluation process. Pre-proposals not aligning to the TTW focus areas

will not be invited to submit full proposals.

FULL PROPOSAL: PREPARATION AND SUBMISSION PROCESS

Applicants invited to submit an application will be contacted by the TTW Program Manager

by April 9th 2018. Application guidelines can be found in Appendix 2. All applications will be

submitted to HJF through Cayuse starting April 9 with a submission deadline of no later than 5

pm EST on May 7th 2018 (Eastern Time). Applicants will be contacted by staff from the HJF

Strategic Initiatives Office – Proposal Services to assist with creating a Cayuse account. HJF

will submit all proposals that meet the requirements of this RFA to USU Office of Research

Administration for scientific peer review. Incomplete applications will not be considered.

Applications submitted through Cayuse must include the Full Proposal (Appendix 2) as a

PDF file. All collaborations should have a statement of work and a budget that delineates the

work performed by location and PI.

FULL PROPOSAL: EVALUATION AND SELECTION

The full proposals should support the development of novel scientific ideas or new model

systems, tools, or technologies that have the potential for significant impact on TTW areas of

interest. The application is required to have relevant, detailed background material or

preliminary information generated by the applicants. Submissions involving collaborations

and/or early stage investigators are strongly encouraged.

USU VPR Technology Research and Innovation Division will establish an external scientific

peer review to evaluate the invited applications. The scientific peer reviewers will focus their

evaluation on the conceptual framework, the level of innovation, and the potential to

significantly advance our knowledge or understanding. The peer review and evaluation will

consider several criteria to judge the likelihood that the proposed research will make a substantial

contribution towards accomplishing TTW goals. Criteria include, but are not limited to,

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https://cayuse.com/

significance, commercialization potential, research approach, innovation, and

investigators/research team. The peer reviewers will seek to obtain the following:

1. PROGRAMMATIC GOALS. How well does the proposed research address and

align with the TTW areas of interest? Is the proposal consistent with TRL3/4? Will

the research translate into a commercial product?

2. SIGNIFICANCE. What important military medical problem within the TTW area of

interest is addressed in the proposed research? How will the aims of the proposal be

achieved? How will the scientific knowledge, clinical practice, or in general the field

of science be advanced? How will the successful completion of the aims change the

concepts, methods, technologies, treatments, services or preventative interventions

that drive this particular field of science? Does the proposed project have commercial

potential to lead to a marketable product or process?

3. RESEARCH APPROACH. How well does the application specify clear,

appropriate, measurable goals (milestones) that should be achieved? How well is the

overall strategy, conceptual or clinical framework, design, methods, and analyses

developed, well integrated, well-reasoned, and appropriate to the aims of the project?

Does the applicant acknowledge potential problem areas and considers alternative

strategies with proposed research and benchmarks for success?

4. INNOVATION. How well did the applicants outline the innovation of the proposed

research? How will this proposed research challenge existing paradigms or clinical

practice? Does the proposed research address an innovative hypothesis or critical

barrier to progress in the field? How well do the applicants demonstrate that the

project goes beyond the prevailing thinking? How well does the proposed research

develop or employ novel concepts, approaches, methodologies, tools, or technologies

for this area? How well does the proposed research emphasize and address the gaps in

the field? How well did the applicants articulate a clear plan for the development of

the idea?

5. TEAM ORGANIZATIONAL PLAN/ CREDENTIALS. Is the proposed work

appropriate to the general experience level of the Principal Investigator and other

researchers. Does the investigative team bring complementary and integrated

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expertise to the project?. If the proposed work has a collaborator from a different

institution, is the statement of work and budget clearly delineated by location and PI?

6. BUDGET. How well do the applicants state the rationale of the proposed cost and the

requested period of support in relation to the proposed research? How appropriate is

the effort listed for the PI/Co-I for the work proposed? Is the cost proposed category

realistic and justified in terms of the aims and methods of the proposed research?

7. RESOURCES AND DATA SHARING PLAN. How well does the proposed

research outline the appropriateness and adequacy of the proposed resources and data

sharing plan to meet the goals of TTW, including rapid sharing of data with the broad

scientific community?

8. HUMAN/ANIMAL STUDIES. Does the proposed research involve human or

animal subjects? Does the proposed research have any plans to protect human

subjects from research risks? Does the proposed research have any plans to

include/exclude individuals on the basis of sex/gender, race and ethnicity as well as

include/exclude children in terms of the scientific goals and research strategy

proposed? What is the status of the IRB and/or IACUC determinations?

NOTE: Obtaining the appropriate regulatory approvals and access to subjects must be included in the project timeline of the proposal. It is recommended to allow ample time for regulatory review and approval processes for full proposals involving human subjects, human anatomical substances/human data, or animal studies. If human or animal subject use is proposed, proposals with IRB or IACUC approved protocols will be viewed more favorably.

Research involving human subjects or animals at USU and non-USU study sites shall not begin until copies of written IRB and/or IACUC approval from USU through HJF have been obtained. Per the DoD policy, a second-level review is required for all protocols involving human subjects research conducted at a site other than USU (e.g. WRNMMC). A DoD second-level review will be conducted once the protocol has received IRB approval by the local institution. For new projects, funding is contingent based upon approvals.

9. BIOHAZARDS. Reviewers will assess whether materials or procedures proposed are

potentially hazardous to research personnel and/or the environment, and if needed,

determine whether adequate protection is proposed.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

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• Scientific merit (as determined by peer review)

• Translational relevance and programmatic priorities

• Collaborative nature of the proposal

• Availability of funds

REQUIRED FEDERAL CITATIONS:

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy

that women and members of minority groups and their sub-populations must be included in all

clinical research projects unless a clear and compelling justification is provided indicating that

inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING

HUMAN SUBJECTS: The maintains a policy that children (i.e., individuals under the age of 21)

must be included in all human subjects research, conducted or supported unless there are

scientific and ethical reasons not to include them.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT

PARTICIPANTS: The policy requires education on the protection of human subject participants

for all investigators submitting proposals for research involving human subjects.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF

INFORMATION ACT (FOIA): Data that are (1) first produced in a project that is supported in

whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in

support of an action that has the force and effect of law (i.e., a regulation) may be accessed

through FOIA. It is important for applicants to understand the basic scope of this amendment.

Applicants may wish to place data collected under this RFA in a public archive, which can

provide protections for the data and manage the distribution for an indefinite period of time. If

so, the application should include a description of the archiving plan in the study design and

include information about this in the budget justification section of the application. In addition,

applicants should think about how to structure informed consent statements and other human

subject’s procedures given the potential for wider use of data collected under this award.

QUESTIONS

For inquiries regarding this funding announcement - please contact:

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Bruce Doll, DDS, PhD, MBAPrincipal Director Transforming Technology for the Warfighter (TTW) ProgramOffice: (301) 319-0349Email: [email protected] Rafaela Nita, PhDProgram ManagerTransforming Technology for the Warfighter (TTW) ProgramOffice: (301) 295-1118Email: [email protected]

For inquiries regarding Cayuse accounts please contact:

Lisa StrakerSenior Proposal Manager-Team Lead Strategic Initiatives – Proposal ServicesDirect: 240-694-2222Dept: 240-694-4016Email: [email protected]

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mailto:[email protected]

mailto:[email protected]

Appendix 1

Transforming Technology for Warfighters (TTW) ProgramPre-proposal Budget Summary Form

Cost Estimate for Year 1

Name of Principal Investigator (last, first, middle)

BUDGET FROM

THROUGH

PERSONNELTITLE/

POSITION

ANNUAL BASE SALAR

Y

% EFFORT

ON PROJEC

T

DOLLAR AMOUNT REQUESTED (OMIT CENTS)

NAMEROLE ON PROJECT

SALARY REQUESTED

FRINGE BENEFITS

TOTALS

PI

SUBTOTALS $

CONSULTANT COSTS MAJOR EQUIPMENT (ITEMIZE)

MATERIALS, SUPPLIES, AND CONSUMABLES (ITEMIZE BY CATEGORY)

RESEARCH-RELATED SUBJECT COSTS

TRAVEL

OTHER DIRECT COSTS (ITEMIZE BY CATEGORY)

SUBTOTAL DIRECT COSTS FOR THIS BUDGET PERIOD $

SUBCONTRACT COSTS DIRECT COST

INDIRECT COST

TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD $

TOTAL INDIRECT COSTS FOR INITIAL BUDGET PERIOD $

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TOTAL DIRECT AND INDIRECT COSTS FOR THIS BUDGET PERIOD $

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Name of Principal Investigator (last, first, middle)

DETAILED BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT

BUDGET CATEGORY TOTALS1

INITIAL BUDGET PERIOD (FROM

FORM PAGE 1)

ADDITIONAL YEARS OF SUPPORT REQUESTED

TOTAL2nd 3rd 4th 5th

PERSONNEL

FRINGE BENEFITS

CONSULTANT COSTS

MAJOR EQUIPMENT MATERIALS, SUPPLIES, AND CONSUMABLES

SUBJECT-RELATED COSTS

TRAVEL

OTHER DIRECT COSTS SUBTOTAL DIRECT COSTS

SUBCONTRACTCOSTS

DIRECT INDIRECT

TOTAL DIRECT COSTS

TOTAL INDIRECT COSTS

TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PERIOD OF SUPPORT $

TOTAL INDIRECT COSTS FOR ENTIRE PROPOSED PERIOD OF SUPPORT $ TOTAL COSTS FOR THE ENTIRE PROPOSED PERIOD OF SUPPORTTHIS AMOUNT SHOULD AGREE WITH THAT ENTERED IN THE REQUIRED FILES

$

Please state any current and/or pending support related to this proposal. ....... ....... ....... ....... ....... .......

1

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.......

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Appendix 2

Transforming Technology for Warfighters (TTW) ProgramFull Proposal Guidelines

General Formatting Requirements

The total page limit for the full proposal is Technical proposal – up to twenty (20) pages, Bibliography – up to one (1) page, Budget (complete RR Budget in Cayuse), Cost justification – up to five (5) pages, NIH formatted biosketches – no limit. A page is defined as 8 1/2 x 11 inches, single-spaced, with one-inch margins, type not smaller than 12 point Times New Roman font, and page numbers. Please use the subheadings below as template. The full proposal must be submitted in portrait layout and PDF format only as Attachment 1 in Cayuse.

1. Cover Sheet Information (Not part of the page limit)1.1. Administrative Point of Contact.

To include: salutation, last name, first name, street address, city, state, zip code, telephone, fax, email.

1.2. Technical Point of Contact (Principal Investigator).

To include: salutation, last name, first name, street address, city, state, zip code, telephone, fax, email.

1.3. Proposal Title.

1.4. Keywords.

Please suggest 5–10 keywords which can be used to describe the content of the proposal.

2. Technical Proposal (Limit to a total of 20 pages)

2.1. Objective.

Provide a clear and concise objective of the proposed project.

2.2. Executive Summary.

Provide a one page high level overview in layman terms of the proposed project and the approach.

2.3. Background.

Provide the necessary technical and scientific background to support the scientific merit of the proposed project and how it relates to the TTW Mission and medical military relevance. What is the proposed work attempting to accomplish or do? How is it done today, and what are the limitations? What is innovative in your approach? Why is it significant to the military? What are the key technical challenges in your approach and how do you plan to overcome these? Who or

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what will be affected and what will be the impact if the work is successful? How much will it cost, and how long will it take?

2.4. Goals and Impact.

Describe previous work (feasibility studies) that was preformed to support the proposed project. Clearly describe what the team is trying to achieve and the difference it will make (qualitatively and quantitatively) if successful. Describe the innovative aspects of the project in the context of existing capabilities and approaches, clearly delineating the uniqueness and benefits of this project in the context of the state of the art, alternative approaches, and other projects from the past and present. Describe how the proposed project is revolutionary and how it significantly rises above the current state of the art.

Provide a bibliography of relevant references cited (1 page).

2.5. Technical Plan.

This section should provide appropriate measurable milestones (quantitative if possible) at intermediate stages of the program to demonstrate progress, and a plan for achieving the milestones. The technical plan should demonstrate a deep understanding of the technical challenges and present a credible (even if risky) plan to achieve the program goal. Discuss mitigation of technical risk. Potential schedule risk and mitigation plans.

2.5.1. Summary of aims/goals/tasks.

Provide a list/table of aims/goals/tasks as appropriate for all years of proposed work.

2.5.2. Detailed aims/goals/tasks.

Describe the details of all tasks in the above section to allow for an assessment by a technical expert. Describe and address technical challenges inherent in the approach and possible solutions for overcoming potential problems. Please provide sufficient details on methods, assumptions, experimental designs, data analysis plan (if the results are quantitatively measured), and specify the quantitative criteria for measuring success and related rationale. Describe any animal or human subject use, any approved protocols and data management plan. Please include a criteria for success and “Go”/”No-Go” milestones. Please keep in mind that failure to meet “No-Go”: milestones can result in renegotiation of the milestones; acceleration of effort to catch up; and, when particularly critical milestones are missed and/or the work will not be completed as originally proposed, sub-award termination.

2.6. Performance Schedule.

Provide a table of aims/goals/tasks and the duration of performance of each in a Gantt or other suitably formatted chart. Please highlight the “Go”/”No-Go” milestones.

3. Budget (Complete RR Budget in Cayuse)

Provide a budget that includes 1) Personnel: role (principal investigator, postdoctoral, research assistant, graduate students, etc.), level of effort, salary requested, fringe benefits per year; 2) Subcontract cost and type; 3) Consultant fees (indicating daily or hourly rate) and travel expenses and the nature and relevance of such costs; 4) Supplies/materials/equipment: includes animal/human subject use costs, breakdown of total cost; 5) Publication and report costs; 6)

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Travel costs and the relevance to stated objectives; number of trips, destinations, duration, if known and number of travelers per trip. Travel cost estimations should be based on the Joint Travel Regulations (JTR); 7) Other direct costs; 8) indirect costs. Please submit PDF or excel spreadsheet only.

4. Cost Justification. (Limit up to 5 pages)

Justification The cost justification should contain a narrative supporting the budget. The cost estimates should be sufficiently detailed for meaningful evaluation with a break-down of costs on an annual basis and by task.

5. Team Organizational Plan/ Credentials. (no limit)

Provide a summary of expertise of the team, including any subcontractors, and key personnel who will be doing the work. Provide NIH bio-sketches of key personnel to include positions and honors, contribution to science. Identify a principal investigator for the project. Provide a clear description of the team’s organization including an organization chart that includes, as applicable: the programmatic relationship of team members; the unique capabilities of team members; the task responsibilities of team members, the teaming strategy among the team members; and key personnel. Provide a detailed plan for coordination including explicit guidelines for interaction among collaborators/subcontractors of the proposed effort. Include risk management approaches. Describe any formal teaming agreements that are required to execute this program. Provide letters of intent/commitment for any subcontracted work or sub-awardees that are part of the proposed project.

6. Supplemental info (NOT included in the 20 page limit)

6.1. A Statement of Work (SOW) defining the major tasks and timelines for the effort. The SOW does not have a page limit, but should be approximately 3-5 pages in length for incorporation into a sub-award. The SOW should not contain any proprietary data or markings. Pages should be numbered and the initial page should have a date (document date) shown under the title (the title of the SOW should match that of the proposal). The SOW must be provided in portrait layout Word document.

The proposed SOW must accurately describe the research to be performed. The proposed SOW must also contain a summary description of the technical methodology as well as the task description, but not in so much detail as to make the SOW inflexible. Objective. Brief overview of the specialty area. Describe why the research is being pursued and what knowledge is being sought.Scope. Include a statement of what the SOW covers including the research area to be investigated, objectives/goals, and major milestones and schedule for the effort. Background. The applicant must identify appropriate documents, including publications that are applicable to the research to be performed. This section includes any information, explanations, or constraints that are necessary in order to understand the hypothesis and scientific impact that directly relate to the TTW program mission. It may also include previously performed relevant research and preliminary data.Tasks/Scientific Goals. This section contains the detailed description of tasks which represent the research to be performed. Thus, this portion of the SOW should be developed in an orderly progression and presented in sufficient detail to establish the methodology and feasibility of accomplishing the overall program goals. The work effort should be segregated by performance

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period for all tasks to be performed and anticipated milestones realized in that year (e.g., Year 1, Year 2, etc, should be detailed separately). Identify the major tasks in separately numbered sub-paragraphs. Each major task should delineate, by subtask, the research to be performed by year and number each task using the decimal system (e.g., 4.1, 4.1.1, 4.1.1.1, 4.2, etc.). The sequence of performance of tasks and achievement of milestones must be presented by project year and task in the same sequence as in the Technical Proposal. The SOW must contain every task to be accomplished to include a detailed schedule. The tasks must be realistic and clearly stated. Use “the sub-recipient shall” whenever the work statement expresses a provision in the SOW. Use “should” or “may” whenever it is necessary to express a declaration of purpose. Use active voice in describing work to be performed. Do not use acronyms or abbreviations without spelling out acronyms and abbreviations at the first use; place the abbreviation in parentheses immediately following a spelled-out phrase. If presentations/meetings are identified in your schedule, include the following statement in your SOW: “Conduct presentations/meetings at times and places specified in the grant schedule.”

6.2. A summary of any proposed Human Subjects research and any IRB approvals, or a confirmation that the proposed effort does not include Human Subjects research.6.3. A summary of any proposed Animal Subjects research and any IACUC approvals, or a confirmation that the proposed effort does not include Animal Subjects research.6.4. A summary of any proposed Biosafety and Select Agent research, or a confirmation that the proposed effort does not include Biosafety and Select Agent research.6.5. A statement of how the data produced during the project will be stored and shared with USU Data Repository.6.6. A statement of any potential Organizational Conflicts of Interest, or a confirmation of no conflicts.6.7. Authorized Personnel: Applicants must include the name, title, mailing address, telephone number, fax number, and e-mail address of the company and business point of contact regarding decisions made with respect to the applicant and who can obligate the proposal contractually. Also, identify those individuals authorized to negotiate with the HJF and Uniformed Services University (USU) Technology Research Initiative.6.8. A statement outlining any current and pending support related to the proposed effort. This information must be included for each investigator listed in the proposal. This statement requires that each investigator specify all grants and contracts through which he or she is currently receiving or may potentially receive financial support for this proposed project.6.9. A Budget Summary, which should capture the total costs by year (this summary includes total numbers only; supporting detail is included in the Budget).

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ADDENDUM #1

Transforming Technology for the Warfighter Program

Request for Applications

Release: March 29, 2018

Section DATA SHARING AND REPOSITORY REQUIREMENT from page 3 of the RFA has

been amended and the following has been added:

If awarded, the sub-award recipient (Institutions of Higher Education, Hospitals, and Other

Profit/Non-Profit Organizations) PIs of the TTW sub-award will provide the TTW principal

director (PD) at USU a copy of all data generated under the sub-recipient TTW award. This

includes a copy of the raw and cleaned data submitted as part of the application, the raw

experimental data and final results generated under the funding of the TTW sub-award, and the

supporting phenotype and anthropometric data. Additionally, simulated or permutated raw and

normalized data generated from studies that are diagnostic or predictive modeling is required to

be submitted to the TTW PD. The sub-award recipients must provide detailed descriptions of all

methods used for data generation and a plan for sharing the data. USU will retain the right to

combine and use the data generated under the award with other USU and DoD datasets to enable

the creation of new datasets from multiple sources in the USU data repository and pursue new

research opportunities.

If, for legitimate reasons, the data cannot be preserved and/or made available for DoD access, the

sub-award recipients will include a justification citing such reasons as part of their application

for review and approval by the TTW program management. USU recognizes that the sub-award

recipients who collect the data have a legitimate interest in benefiting from their investment of

time and effort. USU defines the “timely release and sharing" to be no later than the acceptance

for publication of the main findings from the final data set. USU will make the data available to

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DoD researchers through the USU common data repository. Reviewers will not factor the

proposed data-sharing plan into the determination of scientific merit or priority score. TTW

Program staff will be responsible for overseeing the data sharing policy and for assessing the

appropriateness and adequacy of the proposed data-sharing plan.

All other aspects of the TTW program RFA remain unchanged.

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