who-acvvr-fy2015 foa -final-20150708.pdf

U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response

Funding Opportunity Announcement and Grant Application Instructions

Funding Opportunity Title:

Smallpox Research Oversight Activities: WHO Advisory Committee on Variola Virus Research

Funding Opportunity Number:

EP-IDS-15-003

FY 2015

Table of Contents

Smallpox Research Oversight Activities: WHO Advisory Committee on Variola Virus Research

I. FUNDING OPPORTUNITY DESCRIPTION

II. AWARD INFORMATION

III. ELIGIBILITY INFORMATION

IV. APPLICATION AND SUBMISSION INFORMATION

V. APPLICATION REVIEW INFORMATION

VI. AWARD ADMINISTRATION INFORMATION

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

Appendix

U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA)

Announcement Type: New Funding Opportunity Number: EP-IDS-15-003

Catalog of Federal Domestic Assistance (CFDA) Number:

• 93.019 – Assistance and Provision for Foreign Hospitals and Health Organizations

Dates: All applications must be submitted by: September 10, 2015 11:59 PM Eastern Standard Time via GrantSolutions

I. FUNDING OPPORTUNITY DESCRIPTION

1. Statutory Authority

42 U.S.C. 241 and 247d-7e (Sections 301 and 319L of the Public Health Service Act)

2. Background

Smallpox is an acute contagious disease caused by variola virus, a member of the Orthopoxvirus genus. It was one of the world's most feared diseases until it was eradicated by a collaborative global vaccination program led by the World Health Organization. The last known natural case was in Somalia in 1977. Upon eradication, all existing stockpiles of the virus were moved, by international agreement, to two “WHO International Collaborating Centres”—the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, USA, and the State Research Center of Virology and Biotechnology, Novosibirsk, Russia. Under this agreement, any and all work with Variola virus by either group must be directly approved through an oversight committee established by the WHO. The U.S. maintains a need to work directly with the virus for its strategic needs in developing medical countermeasures, such as vaccines, drugs, and diagnostic systems as a defense against potential bioterrorism threats.

The U.S. Government supports the development of medical products, including vaccines and drugs, for use within the U.S. upon verification of a smallpox case. The U.S. government, through the Office of the Assistant Secretary for Preparedness and Response (ASPR), has successfully developed vaccine products, and is actively engaged in the development of several drug candidates for smallpox therapies, which require access to the Variola virus to satisfy regulatory requirements for product approvals.

3. Project Overview

A natural re-emergence of smallpox is not deemed possible, but if it were to occur as a result of a terrorist or deliberate event, it would be a potentially devastating threat to public health worldwide and would constitute a public health emergency of international concern (PHEIC) under the International Health Regulations (IHR) (2005). A case of smallpox detected by a member state requires notification to WHO as soon as possible, and any confirmed smallpox case would generate an immediate global public health response.

Since May 1999, when the 52nd World Health Assembly (WHA) resolved to postpone the destruction of the Variola virus to allow for this essential research (WHA 52.10), WHO has been charged with convening a group of experts to advise on the need for continuing such research, to review proposals for research involving viable Variola virus, to review the progress of such research, and to report to the WHA each year.

The need to support the activities described in this project has not changed. The Variola virus research and stocks destruction are expected to be substantive agenda items at the 70th World Health Assembly in 2017.

4. Proposed Goals, Objectives and Activities:

Goal: To ensure the development of medical countermeasure products to protect against a potential emergence of smallpox and to establish a diagnostic capacity able to identify a re-emergence of smallpox, particularly under conditions where systemic orthopoxvirus infections such as monkeypox, vaccinia virus infection or cowpox, and other non-pox viral rash illnesses, such as chicken pox, may cause clinical diagnostic confusion.

Objective 1: To support the advisory groups for the review and analysis of pertinent research with regard to variola virus research.

Objective 2: To evaluate any available information forthcoming from the smallpox biological synthesis working group on the implications for ACVVR regarding research needs related to medical countermeasure development.

5. Cooperative Agreement Award

The Federal Grant and Cooperative Agreement Act of 1977, 31 U.S.C. 6305, defines the cooperative agreement as similar to a grant in that a thing of value is transferred to a recipient to carry out a public purpose. However, a cooperative agreement is used whenever substantial federal involvement with the recipient during performance is anticipated. The difference between grants and cooperative agreements is the degree of federal programmatic involvement rather than the type of administrative requirements imposed.

The administrative and funding mechanism used for this program will be the cooperative agreement for which substantial ASPR programmatic involvement with awardees is anticipated during the performance period. This award is subject to the awardee(s) and collaborative requirements and responsibilities set forth in the Cooperative Agreement outlined in the program announcement under this funding opportunity and are hereby incorporated by reference as terms and conditions of this award.

6. ASPR Responsibilities

This award is being co-funded by HHS components, including the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the Office of the Secretary, NIH and CDC. ASPR will be administering the award.

ASPR/BARDA will be responsible for the review and approval of program activities including, but not limited to, ensuring that funds are used and activities are conducted in accordance with the terms and conditions of the award. ASPR/BARDA will also approve timelines and review progress of the program as well as monitor reporting requirements. Progress evaluation will include the development of a matrix with goals, objectives, outputs, timelines and milestones and the oversight of proposed activities through quarterly reports and on-site joint visits with program managers and others in the United States Government (USG) as needed.

7. HHS – ASPR Activities

ASPR/BARDA staff collaborator(s) and/or designee(s) activities for this program are as follows:

• Participate in orientation and/or summary update meetings with the awardee on expectations, regulations and key management requirements, as well as reporting requirements and formats and contents.

• Participate in the development, review and approval of the awardee’s annual work plan, detailed budget, and monitoring and evaluation plan.

• Meet via teleconference on a monthly basis with the awardee to assess technical and financial progress

• Provide awardee with technical assistance and consultation in identification of appropriate resources outside of both the awardee and HHS to support awardee activities.

• Coordinate activities and synergies with the awardee for this FOA with other ASPR/BARDA awardees.

• Work cooperatively with the awardee to assure that all necessary information and progress resulting from this cooperative agreement is provided to the Assistant Secretary for Preparedness and Response in a format that will allow the Department of Health and Human Services to assess the continuing benefits and communicate the successes of the cooperative agreement to the general public.

• Meet at minimum on an annual basis with the awardee, review annual progress report for each USG Fiscal Year, and assess, review, and validate progress and accomplishments, and revise annual work plans as necessary.

8. Awardee Responsibilities

The awardee has the primary authority and responsibility for defining objectives and approaches for planning, conducting, analyzing, publishing results and interpreting project outcomes. The awardee will retain custody of and primary rights to any data developed under this award, subject to US Government rights of access consistent with current Department of Health and Human Services (HHS) and Public Health Service (PHS) regulations and policies.

Awardee will be responsible for coordinating activities approved under the award.

The awardee will be responsible for developing achievable programming activities.

The awardee will also be responsible for tracking that all activities and processes, follow terms and conditions of the grant, and satisfactorily adhere to budget and Monitoring and Evaluation (M&E) reporting plans. Awardee will compile program results from subrecipient (contract and subawards) affiliates into consolidated reports.

The awardee will be responsible for planning and participating collaboratively with ASPR/BARDA under this cooperative agreement. Through participation in monthly conference calls, the awardee will work with ASPR/BARDA staff collaborator(s) and/or designee(s) in order to make progress toward its goal of building sustainable influenza vaccine production capacity worldwide.

The following is a summary of the cooperative agreement’s annual program requirements for awardees:

• Submit all required funding components, including project narratives, work plans, milestones, and budgets as outlined in Section IV.

• Perform activities related to support of the ACCVR committee. Activities will include:

• Conducting the yearly meeting for the Advisory Committee Variola Virus Research (ACVVR) to oversee all research using live variola virus, as well as provide scientific advice on smallpox research, including arranging participant travel and facilities management. The awardee will publish all reports that are produced through this meeting.

(ASPR/BARDA)

• Convene a 15-member committee of experts to provide an up-to-date assessment of the current and imminent technologies for biological synthesis, in relation to tier potential relevance to smallpox eradication, including the public health, ethical, security and other relevant aspects.

The awardee will prepare and publish the report arising from this committee. (CDC, HHS)

• Inform BARDA immediately of potential problems arising from “subrecipients” activities that might impinge upon the US government’s reputation as a funding agency in this cooperative agreement.

• Submit required progress reports and program and financial data, including progress toward bridging project-relevant gaps based on the results obtained after implementing and reporting of project activities under the “Monitoring and Evaluation Plan” section of this Funding Opportunity Announcement. In addition, the awardee will also be required to report on accomplishments and the outcomes of annual preparedness and response activities implemented including strengths, weaknesses and associated corrective actions. Reports must describe the preparedness activities that were conducted with cooperative agreement funds, the purposes for which these funds were spent and the recipients of the funds; describe the extent to which the awardee has met stated goals and objectives; and describe the extent to which funds were expended consistent with the awardee’s funding application.

• Collaborate with the internal BARDA evaluation committee.

Final cost to be allocated upon acceptance of the budget submitted with this application.

II. AWARD INFORMATION

Estimated Total Project Cost: $315,000 USD (direct and indirect costs)

Estimated Funding Amount: up to $315,000 USD subject to availability of funds

Anticipated Number of Awards: One (1) Award

Project Period Length: Sept. 30, 2015 through Sept. 29, 2016

Anticipated Start Date: Sept. 30, 2015

Expected Duration of Support: 12 months

Type of Application Sought: Cooperative Agreement

ASPR may award all or part of the funds, up to $USD 315,000, subject to the availability of funds. All meetings must be approved prior to issuance of an award.

If not approved, funding will not be included for those costs. If final amount of available funds is less than estimated, awardee will be asked to submit a revised work plan and budget to reflect the allowed amount. Funding allocation for activities is dependent on final approved work plan and budget.

III. ELIGIBILITY INFORMATION

1. Eligible Applicants

WHO is the only eligible applicant; it is the only organization that is allowed by international agreements to address the issues outlined in this proposal. WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. In the 21st century, health is a shared responsibility, involving equitable access to essential care and collective defense against transnational threats.

States Parties to the U.N. have agreed to international standards on reporting public health incidents of concern under IHR (2005). Additionally, a majority of States Parties have also agreed to specific work-frames for pathogens such as smallpox under the Biological Weapons Convention.

Since May 1999, when the 52nd WHA resolved to postpone the destruction of the Variola virus to allow for essential research (WHA 52.10), WHO has been charged with convening a group of experts to advise on the need for continuing such research, to review proposals for research involving viable Variola virus, to review the progress of such research, and to report to the WHA each year. The need to support the activities described in this project has not changed. In fact, WHO Member States continue to exert pressure for the WHO Secretariat to carry out this work.

The WHO ACVVR was established in 1999 to determine what essential research, if any, must be carried out with live Variola virus. The ACVVR monitored the research progress in order to reach global consensus on the timing for the destruction of existing Variola virus stocks. In 2007, the WHA requested the ACVVR undertake a thorough review of the approved research program with a report presented in 2010.

The results were presented at the 64th WHA meeting in May of 2011. The ACVVR continues to serve a critically important function for global public health, and to oversee research requested specifically by the U.S. to complete its national strategic goals. This includes the development of new antiviral agents, safer vaccines, and better diagnostics, thus strengthening our national security.

2. Cost Sharing and Maintenance of Funding

There is no cost sharing or match requirement for this project.

Maintenance of Effort/Funding is not required for this program.

3. Application Screening Criteria

Applications that fail to meet the screening criteria described below will not be reviewed and will receive no further consideration.

1. Applications may be submitted electronically via GrantSolutions. (email submission is exclusive to this application)

2. The Project Narrative section of the Application must be double-spaced, on 8 ½” x 11” plain white paper with 1” margins on both sides, and a font size of not less than 11.

The Project Narrative must not exceed 20 pages. Hotel costs should be within Government guidelines for per diem rates.

http://www.gsa.gov/portal/content/104877?utm_source=OGP&utm_medium=print-radio&utm_term=perdiem&utm_campaign=shortcuts

IV. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

Application materials can be obtained from http://www.grants.gov.

Contact person regarding this Funding Opportunity Announcement is:

Chuong Huynh

HHS/ASPR/BARDA

Chuong.Huynh@hhs.gov +1-202-260-2177

2. Required registrations:

Central Contractor Registration (CCR) and Data Universal Numbering System (DUNS) Requirements:

Except for those entities exempt from requirements listed at 2 CFR Part 25 ( individuals), effective October 1, 2010, HHS requires all entities that plan to apply for and ultimately receive Federal grant funds from any HHS Operating/Staff Division (OPDIV) or receive subawards directly from recipients of those grant funds to:

• Be registered in the CCR prior to submitting an application of plan;

• Maintain an active CCR registration with current information at all times during which it has an active award or an application or plan under consideration by an OPDIV; and

• Provide its DUNS number in each application or plan it submits to the OPDIV.

An award cannot be made until an applicant has complied with these requirements.

At the time an award is ready to be made, if the intended recipient has not complied with these requirements, the OPDIV:

• May determine that the applicant is not qualified to receive an award; and

• May use that determination as a basis for making an award to another applicant.

Additionally, all first-tier subaward recipients (e.g., direct subrecipient) must have a DUNS number at the time the subaward is made.

CCR registration may be made online at http://www.sam.gov or by phone at 1-877- 252-2700.

http://www.grants.gov/ http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=65430b8cd60ba715d7bbf033c2c00425&rgn=div5&view=text&node=2:1.1.1.4.1&idno=2 http://www.sam.gov/

Due to the possibility of heavy traffic at the SAM website, applicants are strongly encouraged to register at the CCR well in advance of the application due date.

Applicants must assure that the CCR registration is current for the anticipated start date of the award. Applications will not be reviewed if applicant is not registered with CCR or CCR registration is no current.

3. Content and Form of Application Submission

(See section VIII. OTHER INFORMATION -Application Elements)

**Cover Letter** Cover Letters should be to the following:

Ms. Brenda Cox Grants Management Officer Acquisition Management Contracts and Grants Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services 200 Independence Ave. S.W.

Washington, DC 20201 Telephone: (202) 809-4144, e-mail: asprgrants@hhs.gov

The following document and sections need to be submitted to ASPR in order to be considered for funding:

Application for Federal Assistance – Standard Form SF 424 Budget Information – Standard Form SF 242A Assurances (Non-Construction Programs) - Standard Form SF 424B – if applicable

**Project Narrative** The Project Narrative must be double-spaced, on 8 ½” x 11” paper with 1” margins on both sides, and a font size of not less than 11. You may use smaller font sizes to fill in the Standard Forms and Sample Formats. Forms do not need to be double spaced.

ASPR will not accept applications with a Project Narrative that exceeds 20 pages

The components of the Project Narrative counted as part of the 20 page limit include:

• Abstract

• Context and Problem Statement

• Goal(s) and Objective(s)

• Proposed Intervention and Activities

• Overview of Monitoring and Evaluation (M&E) Plan

• Work Plan and Timeline of Proposed Activities

• Organizational Capability

Any Other Relevant Annexes that do not count toward the 20 page limit including:

mailto:asprgrants@hhs.gov

• M&E Grid

• Key Curricula Vitae

• Letters of Commitment

• Budget Narrative

• Other documents, as needed

The Project Narrative is the most important part of the application, since it is the primary basis on which we determine whether or not your project meets the minimum requirements for grants under Section 319L of the PHS Act (42 U.S.C. 247d- 7e). The Project Narrative should provide a clear and concise description of your project. ASPR recommends that your project narrative include the following components:

**Abstract** This section should include a brief (no more than 265 words) description of the proposed project, including: goal(s), objectives, outcomes, and products to be developed. Detailed instructions for completing the abstract are included in Attachment D of this document.

**Problem Statement** This section should describe, in both quantitative and qualitative terms, the nature and scope of the particular problem or issue the proposed intervention is designed to address.

**Goal and Objectives** This section should describe the project’s goal(s) and major objectives. Unless the project involves multiple, complex interventions, we recommend you have only one overall goal. The goal and objectives stated in Section 1 “Funding Opportunity Description” are suggestions and the applicant is free to modify, edit or propose other goal(s) and objectives, but they must similarly align with the ones proposed in this Funding Opportunity Announcement.

**Proposed Intervention and Activities** This section should provide a clear and concise description of the intervention you are proposing to address the problem described in the “Problem Statement”. You should also describe the rationale for using the particular intervention, including factors such as: 1)“lessons learned” for similar projects previously tested in your community; 2)factors in the larger environment that have created the “right conditions” for the intervention ( existing social, economic or political factors of which you can take advantage, etc.). Also note any major barriers you anticipate encountering, and how your project will be able to overcome those barriers. Be sure to describe the role and makeup of any strategic partnerships you plan to involve in implementing the intervention, including other organizations, funders, and/or consumer groups.

** Monitoring and Evaluation Plan** Applicant should develop a Monitoring and Evaluation Plan. The plan should track the outcomes that project management is promising to deliver. The outcomes are more detailed than the objectives and the goal(s), and should be measured through the use of objective indicators. The outcomes should address the main causes of the problem the target group faces.

Indicators provide the project team with a quantifiable basis on which to judge the project’s success in reaching its objectives. The specification of indicators acts as a check on the viability of the outcomes and project objectives. It forms the basis for a project monitoring system. Once the indicators are defined they should be developed to provide details of quantity, quality and time. An application will be scored on the clarity and nature of the proposed results, not on the number of results/outcomes and indicators cited. Since reports will be submitted on a semi-annual and annual basis, progress on monitoring and evaluation of the cooperative agreement should be submitted at the same time.

Applicant may use Attachment C to list measurable outcomes in the attached Work Plan grid under “Measurable Outcomes” or adapt the document to suit the needs of the applicant. In addition, applicant should discuss outcomes in the narrative along with a description of how the project might benefit the field at large. The resulting grid can be part of the annex, while the description of the monitoring plan should appear in the project narrative.

**Work Plan and Timeline of Proposed Activities** The Project Work Plan should reflect and be consistent with the Project Narrative and Budget and should cover all years of the project period. It should include a statement of the project’s overall goal(s), anticipated outcome(s), key objectives, and the major tasks / action steps that will be pursued to achieve the goal(s) and outcome(s). For each major task / action step, the Work Plan should identify timeframes involved (including start- and end-dates), and the lead person responsible for completing the task. Please use the Sample Work Plan format included in Attachment C.

**Organizational Capability** Each application must include an organizational capability statement that describes how the applicant agency (or the particular division of a larger agency which will have responsibility for this project) is organized, the nature and scope of its work and/or the capabilities it possesses. It should also include the organization’s capability to sustain some or all project activities after Federal financial assistance has ended (to be included in the annex if needed).

This description should cover capabilities of the applicant agency not included in the Project Narrative, such as any current or previous relevant experience and/or the record of the project team in preparing cogent and useful reports, publications, and other products. If appropriate, include an organization chart showing the relationship of the project to the current organization.

This section should also include a clear delineation of the roles and responsibilities of project staff, consultants and partner organizations, and how they will contribute to achieving the project’s objectives and outcomes. It should specify who would have day-to-day responsibility for key tasks such, e.g. project leadership; monitoring the project’s on-going progress; preparation of reports; and communications with other partners and ASPR. It should also describe the approach that will be used to monitor and track progress on the project’s tasks and objectives. Curricula vitae for key project personnel should feature in the annexes.

**Any Other Relevant Annexes** Please attach short curricula vitae for key project staff that will include, but is not limited to, the Senior Editor and the Senior Thematic Advisor (no more than one page). Neither curricula vitae nor an organizational chart will count towards the narrative page limit. Also include information about any contractual organization(s) that will have a significant role(s) in implementing project and achieving project goals.

**Letters of Commitment** Include confirmation of the commitments to the project (should it be funded) made by key collaborating organizations and agencies in this part of the application. Any organization that is specifically named to have a significant role in carrying out the project should be considered an essential collaborator. For applications submitted electronically via http://www.grants.gov, signed letters of commitment should be scanned and included as attachments. Applicants unable to scan the signed letters of commitment may email them to asprgrants@hhs.gov by the application submission deadline. In your fax, be sure to include the funding opportunity number and your agency name.

**Budget Narrative/Justification** The Budget Narrative/Justification should be provided using the format included in the example Attachment B of this Funding Opportunity Announcement. Applicants are encouraged to pay particular attention to Attachment B, which provides an example of the level of detail sought. A combined multi-year Budget Narrative/Justification, as well as a detailed Budget Narrative/Justification for each year of potential grant funding is required.

4. Submission Dates and Times

The deadline for the submission of applications under this Funding Opportunity Announcement is September 10, 2015. Applications must be submitted electronically by 11:59 p.m. Eastern Standard Time via GrantSolutions.

5. Intergovernmental Review

This funding opportunity announcement is not subject to the requirements of Executive Order 12372, “Intergovernmental Review of Federal Programs.”

6. Funding Restrictions

The following activities are not fundable:

• Construction activities

• Basic research

• To carry out any program of distributing sterile needles or syringes for hypodermic injections of any illegal drug

• To advocate or promote gun control

• Salaries may not exceed the rate Executive Level II

• Lobbying activities

• Fund raising

• Cost of Money – even if part of the negotiated rate agreement

• Vehicles

• Salaries for back filling positions

7. Other Submissions Requirements

Complete Applications should be e-mailed to:

Brenda Cox e-mail: Brenda.Cox@hhs.gov

V. APPLICATION REVIEW INFORMATION

1. Criteria –

The application will be reviewed and scored using the following criteria. It is ASPR’s practice to fund only those projects that score in the fundable range. All funding decisions are final.

The following scoring system will be used:

Organizational capacity – 20 points, Approach, Work plan, and Budget Allocation – 40 points, Project Relevance and Evaluation, and Impact of Project Outcomes – 40 points, **Organizational Capacity**

i. Does the applicant organization clearly identify its capacity for carrying out the proposed project and evaluation? (5 points)

ii. Do the proposed project director, key staff and consultants have the background, experience, and other qualifications required to carry out their designated roles? (5 points)

iii. Does the proposed project clearly and adequately identify the relevance of the priority areas, as described in this Funding Opportunity Announcement, in relation to current countries’ needs? (5 points).

iv. Does the application adequately and appropriately describe and document the key problem(s)/condition(s) relevant to the applicant’s purpose/need? Is the proposed project justified in terms of the most recent, relevant, and available information and knowledge? (5 points)

**Approach**

Does the proposed intervention and activities relate to the goals and objects of the proposed project? (15 points)

**Work Plan ** Is the project Work Plan clear and comprehensive? Does it include sensible and feasible timeframes for the accomplishment of tasks presented? Does the Work Plan include specific objectives, tasks and deliverables that are linked to measurable outcomes? Does the proposal include a clear and coherent management plan? Are the roles and responsibilities of project staff, consultants and partners clearly defined and linked to specific objectives and tasks? Are the qualifications of the project staff, consultants and/or partners, and the proposed level of effort, adequate to carry-out the project? (15 points)

**Budget**

i. Is the Budget justified with respect to the adequacy and reasonableness of resources requested? (5 points)

ii. Are Budget line items clearly delineated and consistent with Work Plan objectives?

(5 points)

**Project Relevance and Evaluation** Does the project evaluation reflect a thoughtful and well-designed approach that will be able to successfully measure whether or not the project has achieved its proposed outcomes? Does the plan include the qualitative and/or quantitative methods necessary to reliably measure outcomes? Is the evaluation also designed to capture “lessons learned” from the previous overall effort that might be of use to others in the field of preparedness, especially those who might be interested in replicating the project? (15 points)

**Project Impact**

i. Are the expected project benefits/results clear, realistic, and consistent with the objectives, purpose of the project, and intended public health impact? Is the anticipated outcome of the proposed project likely to be achieved and will it significantly benefit U.S. healthcare system, and the field of national health security preparedness as a whole? (15 points)

ii. Is there a realistic plan to try to secure resources to develop and publish a thematic issue after Federal planning financial assistance has ended? (10 points)

VI. AWARD ADMINISTRATION INFORMATION

1. Award Notices

The Notice of Award is the authorizing document from the ASPR authorizing official, the Officer of Grants Management, and the ASPR Office of Budget and Finance. The Notice of Award will be sent electronically upon successful review of the application.

The Notice of Award sets forth the amount of funds granted, the terms and conditions of the award, the effective date of the award, the budget period for which initial support will be given, the non-federal share to be provided (if applicable), and the total project period for which support is contemplated.

Each applicant will receive written notification of the outcome of the objective review process, including a summary of the expert committee’s assessment of the application’s strengths and weaknesses, and whether the application was selected for funding. Applicants who are selected for funding may be required to respond in a satisfactory manner to Conditions placed on their application before funding can proceed. Letters of notification do not provide authorization to begin performance.

2. Administrative and National Policy Requirements

The award is subject to HHS Administrative Requirements, which can be found in 45CFR Part 75 and the Standard Terms and Conditions implemented through the HHS Grants Policy Statement located at http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html or http://www.hhs.gov/asfr/ogapa/aboutog/ogpoe/grants_mgmt_policy_sources.html

3. Reporting

Applicants funded under this announcement will be required to electronically submit a semi-annual program progress report and Federal Financial Report (FFR) SF-425.

In addition, applicants must submit an end-of-year program progress report and end-of-year Federal Financial Report, both due 90 days after the budget period ends.

Awardees will receive instructions for both reports with their Notice of Award. Final performance and financial reports are due 90 days after the end of the project period.

For more information see DHHS / ASPR Standard Terms and Conditions.

Progress Reporting: Applicants funded under this announcement will be required to electronically submit a final program progress report. As part of the progress report financial information will be reported both per major category of expense, and by objectives.

Subaward and Executive Compensation Reporting: Applicants must ensure that they have the necessary processes and systems in place to comply with the sub-award and executive total compensation reporting requirements established under OMB guidance at 2 CFR Part 170, unless they qualify for an exception from the requirements, should they be selected for funding

Cash Transaction Reporting Recipients must report cash transaction data using the Federal Financial Report (FFR), SF-425. Recipients will utilize the SF-425 lines 10.a through 10.c to report cash transaction data to the Division of Payment Management.

http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html http://www.hhs.gov/grants/grants/grants-policies-regulations/index.html http://www.hhs.gov/asfr/ogapa/aboutog/ogpoe/grants_mgmt_policy_sources.html http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=65430b8cd60ba715d7bbf033c2c00425&tpl=/ecfrbrowse/Title02/2cfr170_main_02.tpl

The FFR SF-425 (lines 10.a through 10.c) is due to the Payment Management System 30 days after the end of each calendar quarter. The FFR SF-425 electronic submission and dates for the new quarters will be announced through the Payment Management/SmartLink Payment System’s bulletin board. Funds will be frozen if the report is not filed on or before the due date.

Federal Disbursement Reporting: The SF-425 will also be used for reporting of expenditure data to meet ASPR’s semi-annual and annual financial reporting requirement. All other lines except 10.a through 10.c should be completed.

Tangible Property Report: Awardees will be required to submit an annual Tangible Property Report (SF 428) at the time the annual SF 425 is submitted to ASPR. Final SF 428 reports are due 90 days after the end of the project period.

Other Reporting Requirements: Throughout the course of the project the awardee may be asked to submit additional reports as needed.

VII. AGENCY CONTACTS

Grants Management Officer:

U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response Washington, DC 20201 Attn: Brenda Cox Telephone: +1 (202) 809-4144, e-mail: asprgrants@hhs.gov

Project Officer:

U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response Washington, DC 20201 Attn: Chuong Huynh

HHS/ASPR/BARDA

Telephone: +1 (202) 260-2177, e-mail: Chuong.Huynh@hhs.gov mailto:Chuong.Huynh@hhs.gov

VIII. OTHER INFORMATION

1. Application Elements a.) SF 424 – Application for Federal Assistance b.) SF 424A – Budget Information.

c.) Separate Budget Narrative/Justification (See Attachments B for a Budget Narrative/Justification Sample Format with Examples and a Sample Template).

e.) Copy of the applicant’s most recent indirect cost agreement, if requesting indirect costs. Upon issuing a contract or sub-award copies of their indirect cost agreements must be forwarded to the Division of Grants.

f.) Vitae for Key Project Personnel.

g.) Letters of Commitment from Key Partners.

Appendix

Attachment A:

Instructions for Completing Required Forms

(SF 424, Budget (SF 424A), Budget Narrative/Justification)

Attachment B:

Budget Narrative/Justification Format – Sample Format with Examples

Attachment C:

Project Work Plan - Sample Template

Attachment D:

Instructions for Completing the Summary/Abstract

Attachment E:

Grants to Foreign Organizations, International Organizations, and Domestic Grants with Foreign Components and Subawards to Foreign Organizations

Attachment A: Instructions for Completing Required Forms (SF 424, Budget (SF 424A), Budget Narrative/Justification)

This section provides step-by-step instructions for completing the four (4) standard federal forms required as part of your grant application, including special instructions for completing Standard Budget Forms 424 and 424A. Standard Forms 424 and 424A are used for a wide variety of federal grant programs, and federal agencies have the discretion to require some or all of the information on these forms. ASPR does not require all the information on these Standard Forms. Accordingly, please use the instructions below to complete these forms in lieu of the standard instructions attached to SF 424 and 424A.

a. Standard Form 424

1. Type of Submission: (Required): Select one type of submission in accordance with agency instructions.

• Application

2. Type of Application: (Required) Select one type of application in accordance with agency instructions.

• New

3. Date Received: Leave this field blank.

4. Applicant Identifier: Leave this field blank

5a Federal Entity Identifier: Leave this field blank

5b. Federal Award Identifier: For new applications leave blank..

6. Date Received by State: Leave this field blank.

7. State Application Identifier: Leave this field blank.

8. Applicant Information: Enter the following in accordance with agency instructions:

a. Legal Name (Required): Enter the name that the organization has registered with the Central Contractor Registry. Information on registering with CCR may be obtained by visiting the Grants.gov website (http://www.grants.gov).

b. Employer/Taxpayer Number (EIN/TIN)(Required): Enter the Employer or Taxpayer Identification Number (EIN or TIN) as assigned by the Internal Revenue Service.

c. Organizational DUNS (Required): Enter the organization’s DUNS or DUNS+4 number received from Dun and Bradstreet. Information on obtaining a DUNS number may be obtained by visiting the Grants.gov website (http://www.grants.gov).

d. Address (Required): Enter the complete address including the county.

e. Organizational Unit: Enter the name of the primary organizational unit (and department or division, if applicable) that will undertake the project.

f. Name and contact information of person to be contacted on matters involving this application: Enter the name (first and last name required), organizational affiliation (if affiliated with an organization other than the applicant organization), telephone number (Required), fax number, and email address (required) of the person to contact on matters related to this application.

9. Type of Applicant (Required): Select the applicant organization “type” from the drop down list.

10. Name of Federal Agency (Required): Enter U.S. Assistant Secretary for Preparedness and Response

11. Catalog of Federal Domestic Assistance Number/Title: The CFDA number can be found on page one of the Funding Opportunity Announcement.

12. Funding Opportunity Number/Title (Required): The Funding Opportunity Number and title of the opportunity can be found on page one of the Funding Opportunity Announcement.

13. Competition Identification Number/Title: Leave this field blank.

14. Areas Affected By Project: List the largest political entity affected (cities, counties, state etc).

15. Descriptive Title of Applicant’s Project (Required): Enter a brief descriptive title of the project.

16. Congressional Districts Of (Required): 16a. Enter the applicant’s Congressional District, and 16b. Enter all district(s) affected by the program or project. Enter in the following format: 2 characters state abbreviation – 3 characters district number, CA- 005 for California 5th district. If all congressional districts in a state are affected, enter “all” for the district number, (e.g. MD-all for all congressional districts in Maryland).

If nationwide enter US-all.

17. Proposed Project Start and End Dates (Required): Enter the proposed start date and final end date of the project. Therefore, if you are applying for a multi-year grant, such as a 3 year grant project, the final project end date will be 3 years after the proposed start date. The Grants Office can alter the start and end date at their discretion.

18. Estimated Funding (Required): Enter the amount requested or to be contributed during the first funding/budget period by each contributor. Value of in-kind contributions should be included on appropriate lines, as applicable. NOTE:

Applicants should review cost sharing or matching principles contained in Subpart C of 45 CFR Part 74 or 45 CFR Part 92 before completing Item 18 and the Budget Information Sections A, B and C noted below.

19. Is Application Subject to Review by State Under Executive Order 12372 Process? Check appropriate box

20. Is the Applicant Delinquent on any Federal Debt? (Required): This question applies to the applicant organization, not the person who signs as the authorized representative. If yes, include an explanation on the continuation sheet.

21. Authorized Representative (Required): To be signed and dated by the authorized representative of the applicant organization. Enter the name (first and last name required) title (required), telephone number (required), fax number, and email address (required) of the person authorized to sign for the applicant. A copy of the governing body’s authorization for you to sign this application as the official representative must be on file in the applicant’s office. (Certain federal agencies may require that this authorization be submitted as part of the application.)

b. Standard Form 424A

NOTE: Standard Form 424A is designed to accommodate applications for multiple grant programs; thus, for purposes of this ASPR program, many of the budget item columns and rows are not applicable. You should only consider and respond to the budget items for which guidance is provided below. Unless otherwise indicated, the SF 424A should reflect a one year budget.

Section A - Budget Summary Line 5: Leave columns (c) and (d) blank. Enter TOTAL federal costs in column

(e) and total non-federal costs (including third party in-kind contributions and any program income to be used as part of the awardee match) in column (f). Enter the sum of columns (e) and (f) in column (g).

Section B - Budget Categories Column 3: Enter the breakdown of how you plan to use the federal funds being requested by object class category (see instructions for each object class category below).

Column 4: Enter the breakdown of how you plan to use the non-federal share by object class category.

Column 5: Enter the total funds required for the project (sum of Columns 3 and 4) by object class category.

Separate Budget Narrative/Justification Requirement Applicants requesting funding for multi-year grant programs are REQUIRED to provide a combined multi-year Budget Narrative/Justification, as well as a detailed Budget Narrative/Justification for each year of potential grant funding. A separate Budget Narrative/Justification is also REQUIRED for each potential year of grant funding requested.

For your use in developing and presenting your Budget Narrative/Justification, a sample format with examples and a blank sample template have been included in these Attachments. In your Budget Narrative/Justification, you should include a breakdown of the budgetary costs for all of the object class categories noted in Section B, across three columns: federal; non-federal cash; and non-federal in-kind. Cost breakdowns, or justifications, are required for any cost of $1,000 or for the thresholds as established in the examples. The Budget Narratives/Justifications should fully explain and justify the costs in each of the major budget items for each of the object class categories, as described below.

Non-federal cash as well as, sub-contractor or sub-Awardee (third party) in-kind contributions designated as match must be clearly identified and explained in the Budget Narrative/Justification The full Budget Narrative/Justification should be included in the application immediately following the SF 424 forms.

Line 6a - Personnel: Enter total costs of salaries and wages of applicant/awardee staff. Do not include the costs of consultants, which should be included under 6h - Other.

In the Justification: Identify the project director, if known. Specify the key staff, their titles, and time commitments in the budget justification.

Line 6 - Fringe Benefits: Enter the total costs of fringe benefits unless treated as part of an approved indirect cost rate.

In the Justification: If the total fringe benefit rate exceeds 35% of personnel costs, provide a break-down of amounts and percentages that comprise fringe benefit costs, such as health insurance, FICA, retirement, etc. A percentage of 35% or less does not require a break down but you must show the percentage charged for each full/part time employee.

Line 6c - Travel: Enter total costs of all travel (local and non-local) for staff on the project. NEW: Local travel is considered under this cost item not under the “Other” cost category.

Local transportation (all travel which does not require per diem is considered local travel). Do not enter costs for consultant’s travel - this should be included in line 6h.

In the Justification: Include the total number of trips, number of travelers, destinations, purpose (attend conference), length of stay, subsistence allowances (per diem), and transportation costs (including mileage rates).

Line 6d - Equipment: Enter the total costs of all equipment to be acquired by the project. For all awardees, “equipment” is non-expendable tangible personal property having a useful life of more than one year and an acquisition cost of $5,000 or more per unit. If the item does not meet the $5,000 threshold, include it in your budget under Supplies, line 6e.

In the Justification: Equipment to be purchased with federal funds must be justified as necessary for the conduct of the project. The equipment must be used for project-related functions. Further, the purchase of specific items of equipment should not be included in the submitted budget if those items of equipment, or a reasonable facsimile, are otherwise available to the applicant or its sub-awardees.

Line 6e: Supplies - Enter the total costs of all tangible expendable personal property (supplies) other than those included on line 6d.

In the Justification: For any grant award that has supply costs in excess of 5% of total direct costs (federal or non-federal), you must provide a detailed breakdown of the supply items ( 6% of $100,000 = $6,000 – breakdown of supplies needed). If the 5% is applied against $1 million total direct costs (5% x $1,000,000 = $50,000) a detailed breakdown of supplies is not needed. Please note: any supply costs of $5,000 or less regardless of total direct costs does not require a detailed budget breakdown (5% x $100,000 = $5,000 – no breakdown needed).

Line 6f - Contractual: Regardless of the dollar value of any contract, you must follow your established policies and procedures for procurements and meet the minimum standards established in the Code of Federal Regulations (CFR’s) mentioned below.

Enter the total costs of all contracts, including procurement contracts (except those which belong on other lines such as equipment, supplies, etc.). Note: The 33% provision has been removed and line item budget detail is not required as long as you meet the established procurement standards. Also include any contracts with organizations for the provision of technical assistance. Do not include payments to individuals on this line.

In the Justification: Provide the following three items – 1) a list of contractors indicating the name of the organization; 2) the purpose of the contract; and 3) the estimated dollar amount. If the name of the contractor and estimated costs are not available or have not been negotiated, indicate when this information will be available. The federal government reserves the right to request the final executed contracts at any time. If an individual contractual item is over the small purchase threshold, currently set at $100K in the CFR, you must certify that your procurement standards are in accordance with the policies and procedures as stated in 45 CFR

74.44 for non-profits and 45 CFR 92.36 for states, in lieu of providing separate detailed budgets. This certification should be referenced in the justification and attached to the budget narrative.

Line 6g - Construction: Leave blank since construction is not an allowable costs for this program.

Line 6h - Other: Enter the total of all other costs. Such costs, where applicable, may include, but are not limited to:…