N62645-PA-20-1- Application Instructions.pdf

PDF 95 KB Posted

Attached to
Conduct of Clinical Trials to Facilitate the Development and Approval of Novel Countermeasures (vaccines, devices, drugs) for Use by the Warfighter
Opportunity number
N62645-PA-20-01
Issued by

About this file

Application Instructions

View the file

Other files

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

1 | N62645-PA-20-1 Application Instructions

APPLICATION INSTRUCTIONS

1. Application and Submission Process

Applications shall be submitted by the application submission deadlines stipulated on the title page of the Program Announcement. Failure to meet any of the deadlines will result in application rejection.

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 no later than 10:00 AM Eastern Time on 22 October 2019 to the Navy Medical Logistics Command (NMLC) Grants Officer via email at jennifer.m.mcmurry.civ@mail.mil and Jaclyn.P.Svincek.civ@mail.mil.

Please cite the funding opportunity number in the subject line.

The application submission deadline is: 10:00 A.M. Eastern Time, 08 November 2019.

2. Content and Format of Applications

Applications submitted for the purposes of this award, to conduct Clinical Trials to Facilitate the Development and Approval of Novel Countermeasures (vaccines, devices, drugs) for Use by the Warfighter, 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-19-3. 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

(5) SF-LLL- Disclosure of Lobbying Activities

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 shall 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), Cover Page, Table of Contents (TOC) and Federalwide Assurance (FWA))

Items to be included in the Technical Volume:

(1) Cover Page;

(2) Table of Contents;

(3) Technical/Management Approach Narrative;

(4) Statement of Work (SOW);

(5) Deliverables Narrative;

mailto:jennifer.m.mcmurry.civ@mail.mil mailto:Jaclyn.P.Svincek.civ@mail.mil http://www.grants.gov/

2 | N62645-PA-20-1 Application Instructions

(6) Qualifications Narrative;

(7) Required Assurances for Human Subject Research; and

(8) Current and Pending Project and Application Submissions Narrative.

Cover Page: This shall include the words “Technical Volume” and the following:

(1) N62645-PA-19-3;

(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); and

(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 shall consist of a clear description of the technical/management approach being proposed. This discussion shall 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 shall detail how the applicant intends to meet the goals of the program listed in the Program Announcement; mainly their ability to provide manpower, materiel support, and clinical trial support for research efforts in two focus areas: 1) Clinical Research for Vaccines, Drugs and other Biologics and 2) Clinical Research for Novel Rapid Diagnostic Devices for FDA clearance.

The goal of the collaborative research is to conduct clinical trials to deliver life-saving products, knowledge, technology, and medical materiel that sustain the effectiveness of the uniformed service members. The award will be issued as a cooperative agreement between the awardee and the Government (NAMRU-6). The awardee will collaborate with NAMRU-6 to develop and implement clinical studies, scientific research efforts, and share substantial programmatic involvement.

Collaborative research personnel provided by the awardee must have the necessary work permits/visas, medical qualifications, and security clearances in place for access to NAMRU-6 facilities and Information Technology (IT) networks. Likewise, research personnel provided by the awardee must have all clearances and be medically qualified to work in facilities that are part of the collaborative effort outside of NAMRU-6. Collaborative research personnel provided by the awardee must be equipped with tablets, laptops, cellphones and appropriate support services necessary to communicate and interface with Department of Defense data management systems. The study site provided by the awardee must meet the physical security standards as required in FDA regulated studies. The awardee must have the capacity to award sub-grants and subcontracts as needed to meet research and development needs. It is critical that the awardee must possess the ability to conduct clinical trials in Peru. More specifically, the awardee must be certified by the General Office for Research and Technology Transfer (OGIT in Spanish); this entails being registered at the Peruvian Clinical Trial Registry (REPEC) to conduct clinical trials in the field of infectious diseases.

The awardee shall have at least one active trial site approved and registered in Peru at the time of selection.

Statement of Work (SOW): The proposed SOW shall clearly detail the scope and objectives of the effort. The proposed SOW shall be consistent with the proposed technical 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 Narrative: A detailed description of the results and products to be

3 | N62645-PA-20-1 Application Instructions 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 Narrative: 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.

All human subject use in research is subject to the regulations listed in the Program Announcement at VI.3.

The applicant’s application shall 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 a copy of the approved FWA in its application response.

(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 submission unacceptable and it will not be eligible for award.

Proposed Extramural Research Involving Human Subjects

Proposals that intend to use award funds for extramural research that involves human subjects shall address the involvement of human subjects and protections from research risk related to their participation in the proposed research project. The applicant shall 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 219.104(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. In the event that an exemption is claimed, the applicant shall submit or indicate an intention to submit prior to award: (1) IRB Exemption Determination Letter; (2) IRB Approved Protocol for Non Exempt Research; and (3) IRB Approved Informed Consent Form for Non Exempt Research (or documented exemption in protocol).

If the research is determined by the IRB to be greater than minimal risk, the applicant also shall provide the name and contact information for the independent research monitor. This documentation

4 | N62645-PA-20-1 Application Instructions shall be submitted to the designated government organization’s Human Research Protection Officer (HRPO) by way of the Grants Officer.

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 all sources (e.g., Federal, State, local or foreign government agencies, public or private foundations, industrial or other commercial organizations).

The information shall 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. Information provided is to include the following:

(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), shall 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 60-month period of performance (divided into five 12-month budgets), shall accompany each application. The award will include a single 60-month period of performance. The budget is broken into five 12-month periods for ease of cost proposal evaluation. 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 shall be uploaded to the Research & Related Budget form after completion of the budget. At the time of application submission to Grants.gov, the Authorized Organizational Representative (AOR) 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 have a tentative start date of 25 days after the date the proposal is submitted. 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.

5 | N62645-PA-20-1 Application Instructions

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

o 2 CFR Part 200 Subpart E: Cost Principles o 2 CFR Part 200 Appendix III: Indirect (F&A) Cost Identification and Assignment, and Rate

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

Determination for Nonprofit Organizations o 2 CFR Part 200 Appendix V: State and Local Government and Indian Tribe – Wide Central

Service Cost Allocation Plans o 2 CFR Part 200 Appendix VI: Public Assistance Allocation Plans o 2 CFR Part 200 Appendix VII: State and Local Government and Indian Tribe Indirect Cost

Proposal o 2 CFR Part 200 Appendix VIII: Nonprofit Organizations Exempted from Subpart E: Cost

Principles o 2 CFR Part 200 Appendix XI: Hospital Cost Principles o 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 shall be entered in U.S. dollars. Recipients performing research outside of the United States shall 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 on the award resultant from this funding opportunity, unless specified otherwise.

Budget Instructions: Complete the Research & Related Budget form 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 will reject the application.

Section A: Senior/Key Person:

Prefix; First, Middle and Last Name; and Suffix: Beginning with the Principal Investigator (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 shall be included on the R & R

6 | N62645-PA-20-1 Application Instructions

Subaward Budget Attachment(s) Form. Consultant costs shall 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

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.

7 | N62645-PA-20-1 Application Instructions

• 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 shall 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 shall 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 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 shall be supported in the subaward/consortium/contractual costs provided in the R & R Subaward Budget Attachment(s) Form.

8 | N62645-PA-20-1 Application Instructions

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 shall be described in detail and clearly justified in the budget justification. Organizationally-provided services shall 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

• 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) shall be applied. If the rate(s) has been approved by other than a federal agency, indicate the source of the approval.

In accordance with 2CFR 200.414, a non-Federal entity that has never received a negotiated indirect cost rate may elect to charge a de minimis rate of 10% of modified total direct costs.

Costs shall be consistently charged as either indirect or direct costs, but may not be double-charged or inconsistently charged as both. If this methodology is chosen, it shall be used consistently for all Federal awards until such time as the non-Federal entity choses to negotiate for a rate.

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).

9 | N62645-PA-20-1 Application Instructions

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/) websites 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 form.

Organizations shall 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. Research & Related Personal Data

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

Each application must include this form with the name fields of the PD/PI and any Co-PD(s)/Co-PI(s) completed; however, provision of the demographic information in the form is voluntary. If completing the form for multiple individuals, each Co-PD/Co-PI can be added by selecting the “Next Person” button. The demographic information, if provided, will be used for statistical purposes only and will not be made available to reviewers. Applicants who do not wish to provide some or all of the information should check or select the “Do not wish to provide” option.

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

The Degree Type and Degree Year fields on the Research & Related Senior/Key Person Profile (Expanded) form will be used by DoD as the source for career information. In addition to the required fields on the form, applicants must complete these two fields for all individuals that are identified as having the project role of PD/PI or Co-PD/Co-PI on the form. Additional senior/ key persons can be added by selecting the “Next Person” button.

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

In the “PROFILE – Project Director/Principal Investigator” section, enter the PI’s User into the data field labeled “Credential, e.g., agency login”.

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

Complete a separate detailed Research & Related Budget form 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 shall 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, https://rates.psc.gov/fms/dca/negotiations.html http://www.onr.navy.mil/Contracts-Grants/manage-grant/indirect-cost-proposal.aspx http://www.dcaa.mil/

10 | N62645-PA-20-1 Application Instructions 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 shall 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

Grants.gov will provide an electronic acknowledgment of receipt of the application to the email address of the applicant with the Authorized Organizational Representative (AOR) role who submitted the application. Again, proof of timely submission shall be the official date and time that Grants.gov receives your application. Applications received by Grants.gov after the established due date for the program will be considered late and will not be considered for funding.

4. Submission of Applications through Grants.gov

There are several one-time actions that shall be completed in order to submit an application through Grants.gov. These include obtaining a Dun and Bradstreet Data Universal Numbering System (DUNS) number; Commercial and Government Entity (CAGE) Code; registering with the System for Award Management (SAM); and registering with Grants.gov.

If an organization does not have a DUNS number, an authorized business official of the organization can request one by calling 866-705-5711 or by registering online (https://fedgov.dnb.com/webform).

Organizations located outside of the United States can request and register for a DUNS number online via web registration. Web registration can take 1-2 business days. Allow up to 8 weeks for the completion of the Grants.gov registration process. Registering early is advised.

Directions for these actions are located at: https://www.grants.gov/web/grants/applicants/organization-registration.html

Applicants who are not registered with SAM and Grants.gov shall allow several weeks to complete these requirements. Any questions relating to the registration process, system requirements, how an application form works, or the submittal process shall be directed to Grants.gov Contact Center at 1- 800-518-4726; International 1-606-545-5035 or support@grants.gov.

Entity registrants in SAM have an annual expiration. Verify the status of your organization’s Entity registration in SAM well in advance of the application. The General Services Administration (GSA) has implemented fraud prevention security measures in the SAM that require every new registrant to provide a written (hard copy), notarized letter confirming that the entity’s Administrator is authorized to register the entity in the SAM database or to make changes to its registration. Notarized letters are required for all new and existing SAM-registered entities. Additional information and directions are found in the SAM User Guide and other GSA training materials in the Help area at https://www.sam.gov.

Download application package components for N62645-PA-20-1 from Grants.gov (http://www.grants.gov) and create a Grants.gov Workspace. The Workspace allows online completion and collaboration of the application components and routing of the application Workspace package through the applicant organization for review prior to submission.

The applicant organization shall have a CAGE Code. The Defense Logistics Information Service in Battle Creek, Michigan, is the only authorized source of CAGE Codes. CAGE Codes will be assigned to registrants as their SAM registration advances through the validation process. Foreign registrants in SAM shall be assigned a North Atlantic Treaty Organization CAGE Code (NCAGE). An NCAGE code can be obtained by contacting the National Codification Bureau of the country where the organization is located or by visiting the website (https://cage.dla.mil/Request). On average, CAGE Code or NCAGE https://fedgov.dnb.com/webform https://www.grants.gov/web/grants/applicants/organization-registration.html https://www.grants.gov/web/grants/applicants/organization-registration.html mailto:support@grants.gov

11 | N62645-PA-20-1 Application Instructions

Code validation in SAM occurs within 3 business days after the TIN is validated.

Application Package Submission

• Create a Grants.gov Workspace: Add participants (investigators and Business Officials) to the Workspace, complete all required forms, and check for errors before submission.

• Submit a Grants.gov Workspace Package: An application may be submitted through Workspace by clicking the “Sign and Submit” button on the “Manage Workspace” page, under the “Forms” tab.

Grants.gov recommends submission of the application package at least 24-48 hours prior to the close date to allow time to correct any potential technical issues that may disrupt the application submission. Each application submission shall include the completed Grants.gov application package of forms associated with the specific Program Announcement/Funding Opportunity in Grants.gov (http://www.grants.gov/).

Tracking a Grants.gov Workspace Package: After successfully submitting a Workspace package, a Grants.gov Tracking Number is automatically assigned to the package. The number will be listed on the “Confirmation” page that is generated after submission.

A compatible version of Adobe Reader shall be used to view, complete, and submit an application package consisting of PDF forms. If more than one person is entering text into an application package, the same version of Adobe Reader software shall be used by each person. Check the version number of the Adobe software on each user’s computer to make sure the versions match. Using different versions of Adobe Reader may cause submission and/or save errors – even if each version is individually compatible with Grants.gov. Refer to the Application Instructions and the “Apply For Grants” page of Grants.gov (https://www.grants.gov/web/grants/applicants/apply-for-grants.html) for further information about the Grants.gov Workspace submission process.

Grants.gov will reject an application package that is opened at any time by an individual with an incompatible version of Adobe Reader.

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

https://www.grants.gov/web/grants/applicants/adobe-software-compatibility.html.

A no-cost compatible version of Adobe Reader can be downloaded at http://get.adobe.com/reader/otherversions/.

5. Application Submission Checklist: Instructions for these documents are available on Grants.gov and also available when downloading the forms listed below.

Grants.gov Application Components Action Completed

SF-424 (R&R) Application for Federal Assistance Fully complete form.

Attachments Form Upload Technical Volume (TechnicalVolume.pdf) as Attachment 1.

Research & Related Budget Form

Complete form as instructed. Attach Budget Justification to the appropriate field (BudgetJustification. pdf).

Research & Related Senior/Key Person Profile (Expanded) [V2.0]

Complete form as instructed.

Research & Related Personal Data [V1.2]

Complete form as instructed.

R & R Subaward Budget Attachment(s) Form Complete form as instructed.

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

12 | N62645-PA-20-1 Application Instructions

SF-LLL Disclosure of Lobbying Activities Complete form as instructed.

Section A: Senior/Key Person:
Section B: Other Personnel:
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 or...
Section D: Travel: Travel costs may include:
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
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) shall be applied. If the rate(s) has...

File details come from the government source that posted it.