N62645-PA-17-1 Application Instructions.doc

APPLICATION INSTRUCTIONS

1. Application and Submission Process Applications shall be submitted by the application submission deadline.

The Government will not entertain requests for meetings from applicants or questions submitted by telephone. Questions of a technical or business nature should be submitted in writing to the NMLC Grants Officer via email at usn.detrick.navmedlogcomftdmd.mbx.research@mail.mil Please cite the funding opportunity number in the subject line.

2. Content and Format of Applications Applications submitted for the purposes of this protective vaccine and countermeasures against infectious disease award are expected to be unclassified.

Each submission must include the completed package of forms identified in www.grants.gov for the Program Announcement/Funding Opportunity N62645-PA-17-1. The Package includes:

(1) SF 424 (R&R) Application for Federal Assistance Form

(2) Research & Related Budget Form

(3) Attachments Form:

a. Attachment 1 - Technical Volume

(4) R & R Subaward Budget Attachment(s) Form

Please note that Attachment 1, Technical Volume shall be submitted using the Attachment Form (under Mandatory Documents) in the application package, scroll down to the Attachment page, and follow the instructions. The file should be titled “TechnicalVolume.pdf.”

By completing Block 17 of the SF 424 the applicant is certifying the statements contained in the list of certifications. Refer to Section V, “Award Administration Information” of the program announcement document for further information.

A. Technical Volume Format:

· Paper Size – 8.5 x 11 inch paper

· Margins – 1 inch

· Spacing – single-spaced

· Font – Times New Roman, 12 point

· The page limit for the Technical Volume is 30 Pages (Excluding Resumes or Curriculum Vitae (CVs) and FWA)

Cover Page: This should include the words “Technical Volume” and the following: 1) N62645-PA-17-1;

2) Title of Technical Volume;

3) Identity of and complete list of subawards.

4) Technical contact (name, address, phone/fax, electronic mail address)

5) Administrative/business contact (name, address, phone/fax, electronic mail address)

6) Proposed period of performance (identify the base period and option periods).

Table of Contents: An alphabetical/numerical listing of the sections within the volume, including corresponding page numbers.

Technical / Management Approach: The major portion of the volume should consist of a clear description of the technical / management approach being proposed. This discussion should provide the technical foundation/justification for pursuing this particular approach/direction and why one could expect it to enable the objectives of the application to be met.

The proposed approach should detail how the applicant intends to meet the scope and objectives of the effort; mainly their ability to provide manpower, materiel support, and clinical trial support for research efforts in four key areas: 1) Development and clinical evaluation of vaccines and other countermeasures against bacterial pathogens responsible for diarrheal illness, 2) Development and clinical evaluation of vaccines against malaria (Plasmodium falciparum and P. vivax) 3) Development and clinical evaluation of vaccines and other countermeasures against rickettsial and emerging viral pathogens and 4) Advancing the use of bacteriophage in treating multi-drug resistant bacteria.

The approach should demonstrate performer proficiency in the use of novel approaches for antigen discovery essential for the development of vaccines and diagnostics against these pathogens. The approach should also demonstrate performance experience with development of countermeasures targeting multi-drug resistant bacteria associated with wound infections, to include passive immunotherapy and refined use of commercial off-the-shelf antimicrobial agents.

The approach should detail which personnel and sub-recipients will be involved. Include a description of the facilities that are required for the proposed effort, along with a description of any Government Furnished Equipment/Hardware/ Software/Information required, by version and/or configuration.

Statement of Work (SOW): The SOW should clearly detail the scope and objectives of the effort. The SOW should be consistent with the proposed technical / management approach. It is anticipated that the proposed SOW will be incorporated into the resultant award. To that end, the application must include a severable, self-standing SOW, without any proprietary restrictions. Include a detailed listing of the technical tasks/subtasks organized by time period.

Deliverables: A detailed description of the results and products to be delivered inclusive of the timeframe in which they will be delivered. Specifically address scientific and technical reports. The following are sample data deliverables that are typically required under a research effort:

· Technical and Financial Progress Reports

· Final Report

Assistance agreements do not include the delivery of software, prototypes, and other hardware deliverables.

Qualifications: Qualifications of personnel working on this requirement shall be provided as appropriate for required positions.

Human Subject Use In Research Application Requirements: The successful applicant may be required to perform human subject research under this award. By submission of its application in response to this funding opportunity, the applicant acknowledges that it has (1) read and (2) will comply with all human subject research requirements included in the funding opportunity in the event that the applicant is selected for award.

The applicant’s application must include:

Required Assurances for Human Subject Research

(1) Federalwide Assurance (FWA) - The applicant shall hold an active (i.e., not expired) FWA appropriate for research to be supported under the award. The FWA shall remain active for the duration of the award. The FWA is issued by the Department of Health and Human Services. The applicant shall provide either of the following in its application response:

(a) A copy of the approved FWA; or

(b) A copy of an application for the FWA

SPECIAL NOTICE: If alternative (b) is selected, then a copy of the approved FWA shall be provided no later than 30 days after the due date for receipt of applications under the funding opportunity. Copy of the approved FWA shall be provided via email at usn.detrick.navmedlogcomftdmd.mbx.research@mail.mil. Please cite the funding opportunity number in the subject line.

There is a lead time associated with obtaining an approved FWA. The applicant is responsible for taking appropriate and timely actions to obtain the approved FWA in the timeframe required by this funding opportunity.

WARNING: Failure to provide a copy of the approved FWA no later than 30 days after the due date for receipt of applications under the funding opportunity will make the applicant’s application unacceptable and it will not be eligible for award. The applicant will be provided notice that is has been excluded from the competition and is no longer being considered for award.

(2) Proposed Subawards - The application requirements identified herein also apply separately to any proposed subaward that may perform human subject research. Failure to address the application requirements for a proposed subaward will make the applicant’s application unacceptable and it will not be eligible for award.

Proposed Extramural Research Involving Human Subjects Proposals that intend to use award funds for research that involves human subjects must address the involvement of human subjects and protections from research risk related to their participation in the proposed research project. The applicant must submit or indicate an intention to submit prior to award: (1) documentation of approval from an IRB; (2) IRB-approved research protocol; (3) IRB-approved informed consent form; and (4) proof of completed human research training (e.g., training certificate or institutional verification of training). In the event that an exemption criterion under 32 CFR.219.101 (b) is claimed, provide documentation of the determination by the IRB Chair, IRB vice Chair, designated IRB administrator or official of the human research protection program including the category of exemption and short rationale statement. If the research is determined by the IRB to be greater than minimal risk, the applicant also must provide the name and contact information for the independent research monitor. This documentation must be submitted to the designated government organization’s Human Research Protection Officer (HRPO) by way of the Grants Officer.

Animal Use In Research Application Requirements: The successful applicant may be required to perform animal research under this award. By submission of its application in response to this funding opportunity, the applicant acknowledges that it has (1) read and (2) will comply with all animal research requirements included in the funding opportunity in the event that the applicant is selected for award. Please note that no assurances are required for intramural research that involves animals, however if the intramural research includes certain animal species (dog, cat, non-human primate, and marine mammals), the protocol must be approved by the Bureau of Medicine and Surgery Veterinary Affairs Department, prior to the initiation of work.

Proposed Extramural Research Involving Animal Species Proposals that intend to use award funds for research that involves animals must address the involvement of animals and protections from research risk related to their participation in the proposed research project. The applicant must submit or indicate an intention to submit prior to award: (1) A copy of the animal use protocol signed and submitted by the principle investigator to the supporting institute; (2) A copy of an approval letter from the IACUC (Institutional Animal Care and Use Committee) that is supporting the animal use; (3) A completed copy of the BUMED Animal Use Appendix for Research Involving Animals; (4) Copies of the last two USDA Inspection reports from the supporting Institute; (5) Confirmation of institutes OLAW Assurance (if applicable); (6) Confirmation of institutes AAALAC Accreditation (if applicable); (7) If neither (5 ) or (6 )applies then: A statement signed by the Institutional Official that states the care and use of animals will be conducted in accordance with the National Research Council's Guide for the Care and Use of Laboratory Animals and applicable Federal and DoD Regulations.

For extramural research involving certain animal species (dog, cat, non-human primate, and marine mammals)), a site visit to the facility may be required at the discretion of the Bureau of Medicine and Surgery Veterinary Affairs Department.

Current and Pending Project and Application Submissions: Applicants are required to provide information on all current and pending support for ongoing projects and applications, including subsequent funding in the case of continuing contracts, grants, and cooperative agreements. Applicants shall provide the following information of any related or complementary application submissions from whatever sources (e.g., Federal, State, local or foreign government agencies, public or private foundations, industrial or other commercial organizations).

The information must be provided for all applications already submitted or submitted concurrently to other possible sponsors, including NMLC. Concurrent submission of an application to other organizations will not prejudice its review by NMLC:

1) Title of Application and Summary;

2) Source and amount of funding (annual direct costs; provide contract and/or grant numbers for current contracts/grants);

3) Percentage effort devoted to each project

4) Identity of prime applicant and complete list of subcontractors, if applicable;

5) Technical contact (name, address, phone/fax, electronic mail address)

6) Administrative/business contact (name, address, phone/fax, electronic mail address);

7) Period of performance (differentiate basic effort);

8) The proposed project and all other projects or activities requiring a portion of time of the Principal Investigator and other senior personnel must be included, even if they receive no salary support from the project(s);

9) The total award amount for the entire award period covered (including indirect costs) must be shown as well as the number of person-months or labor hours per year to be devoted to the project, regardless of source of support; and

10) State how projects are related to the proposed effort and indicate degree of overlap.

B. Research & Related Budget Instructions

An estimate of the total proposed research project cost, with a breakdown of all cost categories for the 18 month base period, must accompany each application. Include a sufficiently detailed budget and budget justification so that the Government can determine the proposed costs to be allowable, allocable, and reasonable for the proposed research. The budget justification for the entire period of performance must be uploaded to the Research & Related Budget after completion of the budget for Period 1. At the time of application submission to Grants.gov, the Authorized Organizational Representative is certifying to the best of his/her knowledge that all costs are current, accurate, and complete. Use the Research & Related Budget form that is available for download on the Grant Application Package page for the Program Announcement/Funding Opportunity in Grants.gov.

Assume that performance will start no earlier than three (3) months after the date the application is submitted. Submit a detailed budget and justification that covers the entire period of performance (not just the base period). The Government reserves the right to request a revised budget and budget justification and/or additional information.

Budget Regulations and Restrictions: The following must be utilized in developing the budget:

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

· Administrative and Cost Principles: Applicants are required to comply with the following, as applicable:

· 2 CFR Part 200 Subpart E: Cost Principles

· 2 CFR Part 200 Appendix III: Indirect (F&A) Cost Identification and Assignment, and Rate Determination for Institutions for Higher Education

· 2 CFR Part 200 Appendix IV: Indirect (F&A) Cost Identification and Assignment, and Rate Determination for Nonprofit Organizations

· 2 CFR Part 200 Appendix V: State and Local Government and Indian Tribe – Wide Central Service Cost Allocation Plans

· 2 CFR Part 200 Appendix VI: Public Assistance Allocation Plans

· 2 CFR Part 200 Appendix VII: State and Local Government and Indian Tribe Indirect Cost Proposal

· 2 CFR Part 200 Appendix VIII: Nonprofit Organizations Exempted from Subpart E: Cost Principles

· 2 CFR Part 200 Appendix XI: Hospital Cost Principles

· Subpart 31.2 of the Federal Acquisition Regulation (48 CFR Subpart 31.2) applicable to commercial firms and those nonprofit organizations in Appendix VIII

· Cost of Preparing Applications: The cost of preparing applications in response to this funding opportunity is not considered an allowable direct charge to any resultant cooperative agreement. However, the cost of preparing applications may be an allowable expense to the indirect/facilities and administrative cost as specified in the organization’s applicable cost principles.

· Currency: All costs must be entered in U.S. dollars. Recipients performing research outside of the United States should include the cost in local currency, the rate used for converting to U.S. dollars, and justification/basis for the conversion rate used.

Extramural and Intramural Collaboration: Research and development which involves awarding to extramural recipients (Non-Government) with collaboration, in part from intramural entities (Government) shall adhere to the following guidance:

Intramural costs shall not be included and contributory to direct or total cost on proposed extramural efforts. Rather these pieces shall be identified and broken out in separate costs within extramural application, as to avoid duplicative expenses to the Government.

The extramural portion will be funded via an assistance agreement through NMLC; the intramural portion shall be funded directly, via a Military Interdepartmental Purchase Request (MIPR) or some other type of Funding Authorization Document (FAD) between the Government entities.

The use of Cooperative Research and Development Agreements (CRADAs) as a mechanism to provide funding to Government entities, in collaboration on Non-Governmental efforts will be prohibited, unless specified otherwise, on the award resultant from this funding opportunity.

Budget Instructions: Complete the Research & Related Budget following the instructions below. Begin by entering the organizational Data Universal Numbering System (DUNS) number, Budget Type, Name of Organization, and anticipated start and end dates. Ensure that the DUNS number is entered accurately or Grants.gov may reject the application.

Section A: Senior/Key Person

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

Project Role: Identify the role of each senior/key person listed. Describe his/her specific functions in the budget justification.

Base Salary: Enter the current annual base salary (based on a full-time appointment) for each individual listed for the proposed research project. Establish labor costs using current labor rates or salaries. Labor rates or salaries may not be increased as a result of receiving an award. Identify and explain in the budget justification any proposed adjustments to rates or salaries.

Any proposed increases in rates or salaries over the period of the award must be consistent with the applicable cost principles and organization’s estimating procedures.

Calendar, Academic, and Summer Months: For each senior/key person, including unpaid personnel, list the number of months to be devoted to the proposed research project in the appropriate box.

Requested Salary: Enter the amount of salary requested for this budget period.

Fringe Benefits: Enter the fringe benefits requested for each individual in accordance with organizational guidelines. If the application is recommended for funding, the organization will be required to provide documentation to support the fringe benefits (e.g., the current Department of Health and Human Services [DHHS] Rate Agreement or other policy document).

Funds Requested: Enter the total funds requested for each senior/key person listed for the proposed research project.

Section B: Other Personnel:

Number of Personnel: For each project role category indicate the number of personnel for the proposed research project, including unpaid personnel.

Project Role: Identify each project role category. Within the budget justification, describe the specific functions of the personnel in each project role.

Calendar, Academic, and Summer Months: For each project role category, list the number of months to be devoted to the proposed research project in the appropriate box.

Requested Salary: Enter the amount of salary requested for this budget period.

Fringe Benefits: Enter the fringe benefits requested for each project role category in accordance with organizational guidelines. If the application is recommended for funding, the organization will be required to provide documentation to support the fringe benefits (e.g., the current DHHS Rate Agreement or other policy document).

Funds Requested: Enter the total funds requested for each project role category listed for the proposed research project.

Section C: Equipment Description: Equipment is any article of non-expendable tangible property to be charged directly to the award and having a useful life of more than 1 year and an acquisition cost of $5,000 or more per unit (unless the applicant organization’s policy has established a limit lower than $5,000). Applicant organizations are encouraged to provide all equipment necessary to conduct the proposed research project. If equipment is requested, provide a detailed list showing the cost of each item. The budget justification for any requested equipment must describe, as applicable:

· Special test equipment to be fabricated for specific research purposes and its cost.

· Standard equipment to be acquired and modified to meet specific requirements, including acquisition and modification costs; list separately.

· Existing equipment to be modified to meet specific research requirements, including modification costs. Do not include as special test equipment those items of equipment that, if purchased by the recipient with recipient funds, would be capitalized for federal income tax purposes.

In addition, requests for equipment must include a rationale for estimated costs.

Section D: Travel: Travel costs may include:

Costs to attend one or more scientific/technical meetings per 12 month period: Include the meeting name, purpose, location, and date, if known, in the budget justification. International travel may be requested but must be well justified and is subject to approval.

Costs for travel associated with the execution of the proposed work (if applicable): Reasonable costs for travel between collaborating organizations should be included. International travel may be requested but must be well justified and is subject to approval.

Costs to attend required meetings (if applicable): Include the meeting name if identified in the Program Announcement/Funding Opportunity and a statement in the budget justification confirming that the PI will attend the required meeting. These travel costs are in addition to those allowed for annual scientific/technical meetings.

Travel costs of DoD employees that are approved for this project will be paid by the Government. No funds will be paid by the recipient to either the DoD or individual DoD employees to cover such costs.

Section E: Participant/Trainee Support Costs: Enter the funds requested for tuition/fees, health insurance, stipends, travel, subsistence, and other costs.

Section F: Other Direct Costs

1. Materials and Supplies: The budget justification for supporting material and supply (consumable) costs should include a general description of expendable material and supplies for each year. For individual or total materials and supplies costing $5,000 or more per year, provide additional breakdown. If animals are to be purchased, state the species, strain (if applicable), number to be used, cost per animal and total costs, proposed vendor, and a copy of the animal per diem cost/rate agreement. If human cell lines are to be purchased, state the source, cost, and description.

2. Publication Costs: Estimate the costs of publishing and reporting research results, including direct charges for clerical preparation, illustrations, reprints, and distribution.

3. Consultant Services: Regardless of whether funds are requested, include in the budget justification the names and organizational affiliations of all consultants, and include the daily consultant fee, travel expenses, nature of the consulting effort, and why consultants are required for the proposed research project.

4. ADP/Computer Services: Include the cost of computer services, including computer-based retrieval of scientific, technical, and education information. Include in the budget justification the provider’s computer service rates.

5. Subaward/Consortium/Contractual Costs: Include the total funds requested for (1) all subaward/consortium organization(s) proposed for the research project and (2) any other contractual costs proposed for the research project. This amount should be supported in the subaward/consortium/contractual costs provided in the R & R Subaward Budget Attachment(s) Form.

All direct and indirect costs of any subaward (subgrant or subcontract) must be included in the total direct costs of the primary award. The total direct costs of the primary award, including the direct and indirect subaward costs, cannot exceed the maximum allowed as specified in the Program Announcement/Funding Opportunity.

6. Equipment or Facility Rental/User Fees: List proposed equipment or facility rental/user fees. Include appropriate information (hours and rates) in the budget justification.

7. Alterations and Renovations: Alteration and renovation (A&R) costs can be requested if the costs are essential to accomplish the objectives of the research project and are a minor portion of the overall budget. A description of the existing facility and detailed description of the requested changes, along with a cost estimate, must be included in the budget justification. Costs for the construction of facilities are not allowable.

8. Other Expenses:

Also itemize other anticipated direct costs such as communication costs and organizationally provided services. These items should be described in detail and clearly justified in the budget justification. Organizationally provided services should be supported by the organization’s current cost/rate schedule.

Computers and software are considered to be general office supplies and are not normally allowable direct cost charges unless the computer/software is essential and unique to the proposed research project. If a computer/software purchase is requested, include the following in the budget justification:

· Detailed explanation for why purchase of computer/software is required to complete the proposed research project.

· Statement verifying that the requested computer/software is not currently available for use by the PI.

· Statement assuring that the requested computer/software will be purchased in accordance with applicable cost principles.

Include itemized research-related subject costs for the proposed research project. These costs are strictly limited to expenses specifically associated with the proposed research project.

Section G: Direct Costs: Include the total direct costs (A-F).

Section H: Indirect Costs: The indirect costs category may include Facilities and Administrative (F&A) costs, overhead, General and Administrative (G&A), and other. The most recent federal agency approved rate(s) should be applied. If the rate(s) has been approved by other than a federal agency, indicate the source of the approval.

Provide details of the direct cost base (modified total direct costs, salary and wage, or other). Identify any costs that have been excluded from the base (in accordance with the approved rate agreement). Also indicate if the rate(s) is an on- or off-site rate(s). If more than one rate is applicable, provide a breakdown of the calculation.

If selected for funding, provide documentation to support the indirect cost rate (e.g., the current DHHS Rate Agreement or other policy document).

If a negotiated approved rate(s) does not exist, provide sufficient detail for a proposed rate (adhering to the applicable cost principles) in the budget justification. Organizations can also visit the DHHS (https://rates.psc.gov/fms/dca/negotiations.html), the Office of Naval Research (http://www.onr.navy.mil/Contracts-Grants/manage-grant/indirect-cost-proposal.aspx), and the Defense Contract Audit Agency (http://www.dcaa.mil/) for additional information on indirect rates.

Section I: Total Direct and Indirect Costs: Include total costs for the proposed research project.

Section J: Fee: Charging a fee or profit to an assistance agreement, either by the recipient/ awardee, subrecipient/subawardee, or subcontractor, is prohibited.

Section K: Budget Justification: Provide a clear budget justification for each item in the budget over the entire period of performance and attach as a single PDF file to section K of the Research & Related Budget.

Organizations must provide sufficient detail and justification so the Government can determine that the proposed costs are allowable, allocable, and reasonable for the proposed research effort.

C. R & R Subaward Budget Attachment(s) Form

Complete a separate detailed Research & Related Budget including a budget justification for each subaward (subgrant or subcontract) in accordance with the instructions listed above. Title each individual subaward, “Research & Related Budget,” with the name of the subawardee organization, and attach to the R & R Subaward Budget Attachment(s) Form.

All direct and indirect costs of any subaward must be included in the total direct costs of the primary award. The total direct costs of the primary award, including the direct and indirect subaward costs, cannot exceed the maximum allowed as specified in the Program Announcement/Funding Opportunity.

A description of services or materials that are to be provided under the subaward is required. Organizations must provide sufficient detail and justification so that the Government can determine that the proposed costs are allowable, allocable, and reasonable for the proposed research effort.

3. Submission of Late Applications Not applicable (N/A)

4. Submission of Applications through Grants.gov There are several one-time actions that must be completed in order to submit an application through Grants.gov. These include obtaining a Dun and Bradstreet Data Universal Numbering System (DUNS) number, registering with the System for Award Management (SAM), and registering with Grants.gov. See http://www.grants.gov, specifically https://www.grants.gov/help/html/help/Get_Started/Get_Started.htm Directions for obtaining a DUBS number, registering with SAM and designating a Business Point of Contact (E-Biz POC) are covered within the user guide (linked above) at https://www.grants.gov/help/html/help/Register/Register_as_an_Organization_Applicant.htm.

Applicants who are not registered with SAM and Grants.gov should allow at least 21 days completing these requirements. The process should be started as soon as possible. Any questions relating to the registration process, system requirements, how an application form works, or the submittal process must be directed to Grants.gov at 1-800-518-4726 or support@grants.gov.

Each application submission must include the completed Grants.gov application package of forms associated with the specific Program Announcement/Funding Opportunity in Grants.gov (http://www.grants.gov/).

All attachments to applications submitted through Grants.Gov must be in Adobe Portable Document Format. Applications with attachments submitted in word processing, spreadsheet, or any format other than Adobe Portable Document Format will not be accepted. A compatible version of Adobe Reader must be used to view, complete, and submit the Grants.gov application package. Grants.gov will reject an application package that is opened at any point in time with an incompatible version of Adobe Reader. If multiple individuals are working on the same application package, all must use a compatible version of Adobe Reader. If an application is rejected due to use of an inappropriate Adobe Reader version, a new application package must be downloaded, completed, and submitted using a supported version of Adobe Reader.

Visit the following website to verify that the version of Adobe Reader being used is compatible with Grants.gov: (https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html). The following links within the user guide will assist you in completing and submitting an application:

https://www.grants.gov/help/html/help/Applicants/Complete_an_Application.htm https://www.grants.gov/help/html/help/Applicants/Submit_an_Application.htm\

5. Application Submission Checklist