final foa july 8 2015.pdf

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

Funding Opportunity Announcement and Cooperative Agreement Application Instructions

Funding Opportunity Title: The Biomedical Advanced Research and Development Authority Special Projects

Funding Opportunity Number: EP-IDS-15-002

Catalog of Federal Domestic Assistance (CFDA) Number: 93.360

Technical Assistance Conference Call July 17, 2015, 11:00 am – 12:00 pm US EST 1 (866) 423-3634 Code: 1401352

Application Deadline Date: September 4, 2015 at 11:59 pm EST

Issuance Date: July 6, 2015

FY 2015

Table of Contents

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

ATTACHMENTS

Attachment A: Instructions for Completing Required Forms Attachment B: Budget Narrative/Justification – Page 1 – Sample Format Attachment C: Project Work Plan, Page 1 – Sample Template Attachment D: Instructions for Completing the Project Summary/Abstract Attachment E: Potentially Application Public Policy Requirements Attachment F: N/A Attachment G: Research and Related Project Information

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-15-002

Catalog of Federal Domestic Assistance (CFDA) Number: 93.360 Biomedical Advanced Research and Development Authority (BARDA), Biodefense Medical Countermeasure Development

Dates: All applications must be submitted via Grant.gov by: September 4, 2015 at 11:59 PM EST

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

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

Summary and Project Overview:

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), supports advanced development and availability of medical countermeasures (MCMs) for chemical, biological, radiological and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases through advanced product development, stockpile acquisition, building manufacturing infrastructure, and product innovation. BARDA establishes and maintains business collaborations by means of grants, cooperative agreements, contracts, and other transactions with the public and private sectors, domestically and internationally.

BARDA has grown significantly since inception, acquiring new capabilities and employing new business approaches leading to unprecedented success in the development and acquisition of MCMs. Twenty-one products supported by BARDA have received FDA approval, licensure or clearance against the threats within BARDA’s purview and twelve products have been procured under Project BioShield for the Strategic National Stockpile. BARDA has also played a key role in responding to newly emerging threats, including most prominently the 2009-H1N1 influenza pandemic as well as the ongoing Ebola epidemic in West Africa. The National Strategy for Combating Antibiotic Resistant Bacteria (2014) identifies BARDA as having a key role in the nation’s response to the more slowly, but inexorably emerging threat of antimicrobial resistance (AMR).

By their unpredictability and potentially explosive nature, emerging threats present unique challenges, particularly with respect to the development of MCMs, which normally takes years, requires substantial investment, and is associated with high rates of attrition. Many of the challenges are technical; some are economic. The problem of AMR presents special hurdles in that the discovery of novel drug targets unique to the resistant pathogens has proved increasingly difficult. Having a mechanism in place to engage external subject matter experts and develop far-reaching, but focused, technical reports that provide recommendations on how to address such challenges would facilitate progress in the development of MCMs against these national health security threats.

There are a limited number of MCMs available today to treat or prevent a number of emerging infectious diseases. In addition, rising resistance rates are reducing the number of therapeutic options available for common infections once considered very treatable. The work performed under this cooperative agreement will directly benefit the public in that it is meant to facilitate and expedite the development of novel MCMs to address a rising unmet medical need.

In order to inform the agency’s strategic direction and business practices, BARDA has a need to conduct special projects and develop focused technical reports which may include:

• Objective 1: An expert review and analysis of the potential role of nontraditional antibacterial therapies (mAbs, immunomodulatory and other host directed approaches, phage, microbiome-oriented, etc.) in addressing the threat of antimicrobial resistance and the technical and regulatory challenges facing the development of such products.

• Objective 2: Expert assessment of financial incentives and business models that could support MCM development for emerging infectious diseases, given the unpredictable incidence of such diseases, uncertainties concerning the threat they pose, and limited commercial markets for MCMs against them.

Performance of these tasks may include face to face meetings with BARDA in the DC area, expert interviews, literature reviews, assembling teams of experts for workshops, and preparing final reports with findings and recommendations that will inform BARDA’s strategic direction.

Under this award, BARDA may request completion of tasks such as the following:

Objective 1: An expert review and analysis of the potential role of nontraditional antibacterial therapies (mAbs, immunomodulatory and other host directed approaches, phage, microbiome-oriented, etc.) in addressing the threat of antimicrobial resistance and the technical and regulatory challenges facing the development of such products.

An emerging public health crisis now exists as a result of increasing rates of antibiotic resistance at a time when the number of pharmaceutical companies engaged in antibiotic development has declined. Antibiotic resistant (AR) infections are a global problem and are increasing in frequency, leading to increased mortality and health care costs.

Unfortunately, the antibiotic development pipeline does not currently contain a sufficient number of therapeutics to keep up with the pace at which AR infections are emerging. In recent decades, drug developers have shifted their focus away from antibiotic development, resulting in a profound development gap. Illustrative of this trend is the fact that no antibiotics with novel mechanisms of action against Gram negative infections have been approved in 40 years.

Historically, industry has focused on generating small molecule drugs that slow or clear infections by inhibiting a key enzyme or pathway required for bacterial survival or virulence. Under selective pressure, bacteria have responded by developing mechanisms of resistance that have become increasingly prevalent, resulting in an “arms race” that we appear to be at risk of losing, with grave consequences for health care and society. Unfortunately, identifying new pathways to target with small-molecule antibiotics has proved challenging and in any case will only result in a new stage of the arms race. Alternative approaches to the management of the problem of antibiotic resistance, some of which are included in the task definition, have been proposed but evidence of clinical efficacy is limited and none have demonstrated effectiveness in reducing the incidence of AR infection or commercial viability in the market.

As part of this task, applicants should be prepared to perform a deep literature review, conduct a workshop of subject matter experts, and prepare a report that:

• Assesses the pipeline of nontraditional antibacterial therapeutics,

• Identifies the barriers, challenges and opportunities related to the development, commercialization, and use of these products, and

• Recommends strategies and initiatives that could be employed to speed the development of these nontraditional therapies.

Objective 2: Expert assessment of financial incentives and business models that could support MCM development for emerging infectious diseases, given the unpredictable incidence of such diseases, uncertainties concerning the threat they pose, and limited commercial markets for MCMs against them.

Emerging infectious diseases (EIDs) present unique challenges with respect to developing MCMs. Some, such as Middle East Respiratory Syndrome (MERS) and Nipah virus, are still quite rare and thus do not present an attractive commercial opportunity to the private sector, resulting in limited (if any) spontaneous investment in the development of MCMs against them. The recent Ebola epidemic, however, has demonstrated the potential of such diseases to increase significantly in incidence and cause massive disruption without a great deal of warning. Other infectious agents, such as Chikungunya virus or West Nile virus, may have substantial impact in certain regions of the world and then appear suddenly and explosively in new regions. For the vast majority of such diseases, no approved therapies are available. As a preparedness organization, BARDA has a keen interest in ensuring that therapies will either exist in the marketplace or be at a stage of technical and manufacturing readiness such that the product can be quickly manufactured and distributed to those who need it.

Traditional drug development typically follows a trajectory where product candidates progress through discovery, preclinical, and clinical stages and finally achieve licensure or approval. The product is then sold on the commercial market, with sales of the product allowing the developer to recoup sunk research and development costs and make a profit. MCMs against emerging infectious diseases may require a different business model, however. The performance of statistically powered clinical trials to demonstrate efficacy may not be feasible and there is likely to be a limited or no commercial market for the product unless incidence rates change dramatically. Commercial sales will thus not allow the company to cover their development costs. With biodefense products, U.S. Government procurements for stockpiling purposes have provided an alternative source of revenue to commercial sales, but stockpiling for EIDs that do not pose a specific threat as potential agents of bioterrorism is not currently envisioned.

In light of the regularity with which EID threats have occurred in recent years, BARDA is committed to establishing a new division within its organizational structure specifically committed to the development of MCMs for EIDs. BARDA will adapt the incentives and processes that it has evolved to address CBRN and pandemic influenza threats to support the development of MCMs against EIDs, but the private sector may require additional provisions or incentives before it is willing to assume the opportunity costs of developing such products. Therefore, the overall goal of this Objective is to assess what kinds of business models and incentives may be required for BARDA to achieve its goal of having MCMs either available or in a state of “readiness” such that the product could be very rapidly manufactured and dispensed to patients. These approaches should be cost effective for BARDA while at the same time aimed to attract pharmaceutical/biotech companies to this space.

As part of this task, Applicants should be prepared to take into account: intellectual property rights, regulatory mechanisms by which the product could be made available to patients, the infrastructure required to manufacture the product, the collection of clinical data in an emergency (if needed), and costs to the government as well as our industry partners.

As part of this task, Applicants should be prepared to perform a deep literature review, conduct a workshop of subject matter experts and industry partners, and prepare a report that:

• Assesses the pipeline of candidate MCMs for selected EIDs (MERS-CoV, Nipah, Chikungunya, etc., to be determined in collaboration with BARDA)

• Identifies the barriers, challenges and opportunities related to the development, commercialization, and use of these products, and

• Recommends business models, incentives, strategies, and initiatives that could be employed to speed the development of these and related products.

II. AWARD INFORMATION

Total Estimated Project Cost (FY2015-FY2018): Estimate $500,000 (subject to availability of funding)

Total Funding Amount (FY2015): $200,000

Anticipated Number of Awards: 1

Project Period Length: 3 years

Budget Period Length: 1 year for Objective 1

Ceiling of Individual Award Range for Project Period: $500,000 (subject to availability of funding in future budget years)

Anticipated Start Date: September 28, 2015

Expected Duration of Support: 3 years

Type of Application Sought: Cooperative Agreement

Funding beyond the first year is dependent on availability of appropriated funds in subsequent fiscal years, satisfactory awardee performance, and a decision that continued funding is in the best interest of the Federal Government.

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.

ASPR Responsibilities

ASPR/BARDA will be responsible for the review and approval of program activities including, but not limited to, the proposed use of funds and activities to meet 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 timelines and milestones and the oversight of proposed activities through semi-annual reports and on-site joint visits with principal investigator / program managers and others in the United States Government (USG) as needed.

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 grantee(s) on expectations, regulations and key management requirements, as well as reporting requirements, 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.

• Participate in periodic site visits to the awardee(s) and provide the awardee(s) with requested input and expert assistance as appropriate.

• 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 APSR/BARDA 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 twice with the awardee, review progress towards each objective, and assess, review, and validate progress and accomplishments, and revise work plans as necessary. Collaborate with the awardee on designing and implementing the activities listed above, including, but not limited to the provision of technical assistance to develop program activities, participation on expert assessment panels (as appropriate) the presentation and possibly publication of program results and findings, and the management and tracking of finances related to the projects in conjunction with ASPR.

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 U.S.

law and 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 program plans. 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, if any) affiliates into consolidated semi-annual and annual 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 performing the special projects above.

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

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

• Submit required technical reports, progress reports and program and financial data.

• Ensure that technical data from both the awardee and any possible “subrecipients” necessary to evaluate the progress of the program are available to BARDA.

• Have in place fiscal and programmatic systems to document accountability and improvement.

III. ELIGIBILITY INFORMATION

• Eligible applicants that can apply for this funding opportunity are listed below:

• Nonprofit with 501C3 IRS status (other than institution of higher education)

• Nonprofit without 501C3 IRS status (other than institution of higher education)

• For-profit organizations (other than small business)

• Small, minority, and women-owned businesses

• Universities

• Colleges

• Research institutions

• Hospitals

• Community-based organizations

• Faith-based organizations

• Federally recognized or state-recognized American Indian/Alaska Native tribal governments

• American Indian/Alaska native tribally designated organizations

• Alaska Native health corporations

• Urban Indian health organizations

• Tribal epidemiology centers

• State and local governments or their Bona Fide Agents (this includes the District of Columbia, the

Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)

• Political subdivisions of States (in consultation with States)

• Non-domestic (non-U.S.) entity - Unless the authorizing legislation under which an award would be made specifically authorizes awards to foreign entities or the grant is for research (not research-related grants), foreign entities are not eligible for HHS grants

Cost Sharing or Matching:

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

Mandatory Meetings:

If awarded, grantee is required to attend a kick-off meeting in Washington DC.

Screening and Responsiveness Criteria

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 must be submitted electronically via http://www.grants.gov by September 4, 2015 at 11:59 PM

Eastern Time.

If applicant is providing a letter of intent, it must be submitted electronically to Dr. Melissa Stundick at Melissa.Stundick@hhs.gov by July 13, 2015 at 5:00 PM US Eastern Time

A Technical Assistance Conference Call will be held on July 17 2015 11:00 am – 12:00 pm US Eastern Time 1-866-423-3634 Code: 1401352

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.

3. The Project Narrative must not exceed 30 pages. NOTE: The Project Work Plan, Letters of Commitment, budget narrative and justification forms, Vitae of Key Project Personnel and Other Relevant Annexes are not counted as part of the Project Narrative for purposes of the 30-page limit.

Application Responsiveness Criteria

Applications that do not meet the following responsiveness criteria will be administratively eliminated and will not be reviewed:

• Applications submitted after the due date and time will not be reviewed.

• Applications submitted by non-eligible entities will not be reviewed.

• Applications submitted by individuals will not be reviewed.

• Applications failing to include the required forms will not be reviewed.

• ASPR will not accept applications with a Project Narrative that exceeds 30 pages. NOTE: The Project Work Plan, Letters of Commitment, budget narrative and justification forms, Vitae of Key Project Personnel and Other Relevant Annexes are not counted as part of the Project Narrative for purposes of the 30-page limit.

IV. APPLICATION AND SUBMISSION INFORMATION

Application Package

Application materials can be obtained from http://www.grants.gov. You must register with grants.gov prior to submitting an application. Applicants previously registered must assure that the registration is still valid and up-to-date. Registration and re-registration may take up to 10 working days to process. Failure to submit the application on time due to late registration will result in ASPR not accepting the application.

http://www.grants.gov/ mailto:Dr.%20Melissa

Applicants are strongly encouraged to send a letter of intent to the program office by July 13, 2015, outlining the project abstract and approximate funding request. Letters of intent should be sent by email to the attention of Dr.

Melissa Stundick at Melissa.Stundick@hhs.gov

Applications must be submitted electronically through grants.gov by the application deadline of September 4, 2015 at 11:00 PM Eastern Time. ASPR will not accept any applications that are not submitted electronically via grants.gov.

Grants.gov (http://www.grants.gov) will automatically send applicants a tracking number and date of receipt verification electronically once the application has been successfully received and validated in http://www.grants.gov. After ASPR retrieves your application form from http://www.grants.gov, a return receipt will be emailed to the applicant contact. This will be in addition to the validation number provided by http://www.grants.gov.

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 (e.g., 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 sub-awards 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, ASPR:

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 sub-award recipients (i.e., direct sub-recipient) must have a DUNS number at the time the sub-award is made.

CCR registration may be made online at https://www.sam.gov/portal/public/SAM/

Content and Form of Application Submission (See section VIII. OTHER INFORMATION)

The following document and sections need to be submitted to ASPR in order to be considered for funding; forms are available on grants.gov within the application package:

Application for Federal Assistance – Standard Form SF 424. By signing the SF 424 the applicant agrees not only to assurances and certification, as described on the form, but to all the requirements for this specific appropriation including, but not limited to, the insurance statement as seen on Attachment E.

Budget Information – Standard Form SF 242A

Assurances (Non-Construction Programs) - Standard Form SF 424B If human subjects are involved you must complete and submit Attachment G

**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 can use smaller font sizes to fill in the Standard Forms and Sample Formats. ASPR will not accept applications with a Project Narrative for Track 1 that exceeds 30 pages. The Monitoring and Evaluation Plan, Curriculum Vitae of Key Personnel, and other Annexes are not counted as part of the Project Narrative for purposes of the 30-page limit, but all of the other sections noted below are included in the limit.

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

Abstract Goal(s) and Objective(s) Proposed Approach, Work Plan, and Timeline of Proposed Activities – these plans may be in narrative or chart form (see attachments for suggested formats). Any forms submitted to meet this required section will be counted as part of the page limitation.

Evaluation Plan – these plans may be in narrative or chart form (see attachments for suggested formats). Any forms submitted to meet this required section will be counted as part of the 30 page limitation.

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

Key Personnel CV – only required if new key personnel are part of this project Letters of Commitment – only required between collaborating agencies Budget Narrative – see suggested format in attachment section Self-monitoring plan and contingency activities identified to ensure project completion and funding outlays are completed within the 12 month project period Other documents, as needed

The Project Narrative is the most important part of the application, since it will be used as the primary basis to determine whether or not the project meets the minimum requirements for grants under sections 301 of the Public Health Service Act. The Project Narrative should provide a clear and concise description of the project. ASPR recommends that the project narrative include the following components.

**Abstract**

This section should include a brief (no more than 265 words maximum) 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.

**Goal and Objectives**

This section should consist of a description of 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 and objectives, but they must similarly align with the ones proposed in this Funding Opportunity Announcement.

**Workplan and Timeline of Proposed Activities**

Each proposed grant activity should have clear timelines for execution and completion.

The Project Work Plan should reflect and be consistent with the Project Narrative and Budget and should cover all of the project period. It should include a statement of the project’s overall goal, anticipated outcome(s), key objectives, and the major tasks / action steps that will be pursued to achieve the goal 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 should include an organizational capability statement. The organizational capability statement should describe 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.

This description should cover capabilities of the applicant agency not included elsewhere in the narrative, such as any current or previous relevant experience and/or the record of the project team in producing cogent and useful reports, publications, or other products.

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 as: leadership of the project; monitoring the project’s on-going progress; preparation of reports; and communications with other partners and ASPR. Curriculum vitae for key project personnel should feature in the annexes.

Annexes

**Key Personnel**

Please attach short curriculum vitae for key project staff only (no more than one page). Neither curriculum 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 the 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**

The Budget Narrative/Justification should be provided. The Budget Narrative is used to determine reasonableness and allowability of costs for the project. All of the proposed costs listed, whether supported by federal funds or non-federal match, must be reasonable, necessary to accomplish project objectives, allowable in accordance with applicable federal cost principles, auditable, and incurred during the budget period.

http://www.grants.gov/ mailto:asprgrants@hhs.gov

A sample format is included as 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. The Budget Narrative should include travel and relevant expenses to attend the awardee meeting in Washington, DC.

A self-monitoring plan and contingency activities should be identified to ensure project completion and funding outlays are completed within the 24 month project period.

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

Funding Restrictions

The following activities are not fundable:

• Cost of money is not allowed even if it’s in your negotiated rate agreement

• All salaries are capped at the rate of Executive Level II.

• Construction is not allowed.

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

• To advocate or promote gun control.

• Funds cannot be used to lobby.

• Pre-award costs are not allowed.

• Lobbying Restrictions: http://www.hhs.gov/grants/grants/grants-policies-regulations/lobbying-restrictions.html In addition to the restrictions listed above the following funding restriction apply to all foreign entities applying under this application:

• Continuation of existing projects without expansion or new and innovative approaches

• A&R. Major A&R or construction costs are unallowable under foreign grants and domestic grants with foreign components. (unless specifically authorized in legislation)

• Customs and import duties. These costs, which include consular fees, customs surtax, value-added taxes, and other related charges, are unallowable under foreign grants and domestic grants with foreign components.

• Indirect costs. With the exception of the American University of Beirut, which is not considered a foreign organization, and the World Health Organization, indirect costs will not be reimbursed.

• Research patient care costs. Research patient care costs are allowable only in exceptional circumstances as determined by the OPDIV.

V. APPLICATION REVIEW INFORMATION

1. Criteria

The application will be reviewed using the following criteria. Scores assigned will assist the reviewer in scoring the applications. It is ASPR’s practice to fund only those projects that score in the fundable range.

http://www.hhs.gov/grants/grants/grants-policies-regulations/lobbying-restrictions.html http://www.hhs.gov/grants/grants/grants-policies-regulations/lobbying-restrictions.html

The following scoring system will be used:

1. Project Relevance/Current Needs – 5 points

2. Organizational capacity – 60 points

3. Budget Allocation – 10 points

4. Project Evaluation – 10 points

5. Impact of Project Outcomes – 15 points

Criterion 1. Project Relevance/Current Needs (5 points)

i. Does the application adequately and appropriately describe and document the key problem(s)/condition(s) relevant to the purpose of the funding opportunity? (5 points)

Criterion 2. Organizational Capacity (60 points)

i. Does the applicant organization clearly identify capacity for carrying out the proposed project and evaluation?

(15 points)

ii. Is the proposed project director capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program’s intended goal? Is the governance and organization structure appropriate for the project? (10 points)

iii. Do the proposed project director, key staff and consultants have the background, experience, and other qualifications required to carry out their designated roles? Do the technical staff/consultants have prior operational experience performing projects of similar scope and complexity? Does the applicant have personnel capable of extensive and ongoing on-site consulting? (10 points)

iv. Are letters from participating organizations included, and do they express the clear commitment and areas of responsibility of those organizations, consistent with the work plan description of their intended roles and contributions? (5 points)

v. Does the organization primarily use in-house staff to fulfill its organization capabilities? If the applicant requires consultants and subcontractors to fulfill technical competencies, are letter of commitments appropriate? (5 points)

vi. Does the applicant provide documentation demonstrating prior experience and capacities in the performance of expert assessments similar to those provided as examples above?

Criterion 3. Budget Allocation (10 points)

i. Is the budget justified with respect to the adequacy and reasonableness of resources requested? Are budget line items clearly delineated and consistent with work plan objectives? (10 points)

Criterion 4. Project Evaluation (10 points)

i. 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, especially those who might be interested in replicating the project? (10 points)

Criterion 5. Project Impact (20 points)

i. Are the expected project benefits/results clear, realistic, and consistent with the objectives, purpose of the project, and intended public health impact? Are the proposed outcomes quantifiable and measurable, consistent with the definition of a project outcome contained in Attachment D of the Funding Opportunity Announcement?

(15 points)

Protections for Human Subjects

If the research involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 , the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation. The committee will assess any IRB materials included in the application, including IRB assessment of standard review criteria (1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

If the proposed research involves the use of human data and/or biological specimens, a justification must be provided for the claim that no human subjects are involved in the Protection of Human Subjects section of the Research Plan.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resource Sharing Plans http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr46_main_02.tpl

Recipients of grant awards should make research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.

Budget and Period of Support Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Research partnerships or collaborations with organizations in the affected regions and their specific role and contribution to the conduct of the proposed study should be reflected in the proposed budget.

NOTE: Preference will be given to applications submitted by entities that are based or have significant operations in one of the states, including the District of Columbia, identified as a major disaster area (see eligibility criteria).

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 Financial Planning and Analysis. 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 2 CFR 200 (Subparts A through F), 45 CFR Part 75 and the Standard Terms and Conditions implemented through the HHS Grants Policy Statement located at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.

The signature of the authorized organizational representative on the application indicates that the organization complies, or intends to comply, with all applicable public policy requirements as listed in Attachment E of this document.

3. Reporting

Applicants funded under this announcement will be required to electronically submit quarterly program progress reports and Federal Financial Reports (FFR) SF-425. Final performance and financial reports are due 90 days after the end of the project period.

Progress Reporting: Applicants funded under this announcement will be required to electronically submit quarterly program progress reports. As part of the progress report, financial information will be reported both per major http://www.hhs.gov/grantsnet/adminis/gpd/index.htm category of expense, and by objectives. Grantees will include sub-recipient monitoring activities that were completed during each quarter.

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. 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 quarterly 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 (after each 12 month period) Tangible Property Report (SF 428). Final SF 428 reports are due 90 days after the end of the project period.

Annual A-133 Audits: In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal assistance awards will have a single or a program-specific audit conducted for that year.

Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. Grantees will be required to audit this program as a major program.

ASPR will closely monitor all grants and, throughout the course of the project, the grantee may be asked to submit additional reports and other documents.

ASPR will conduct a financial and management capability review. Applicants/grantees will be asked to provide financial and management documents to allow ASPR to complete this requirement.

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: (202) 809-4144, e-mail: brenda.cox@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: Dr. Melissa Stundick Telephone: 202-205-7479 e-mail: Melissa.Stundick@hhs.gov http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=65430b8cd60ba715d7bbf033c2c00425&tpl=/ecfrbrowse/Title02/2cfr170_main_02.tpl mailto:asprgrants@hhs.gov

VIII. OTHER INFORMATION

Review and Selection Process Proposals will be reviewed and evaluated by a panel of subject matter experts that are either federal employees of, or consultants to, BARDA. Proposals will be scored based on the Application Review Criteria listed in Section V. above. The two proposals with the highest technical scores will be further evaluated based cost. The review and selection process permits tradeoffs among cost or price and non-cost factors and allows the Government to award to other than the lowest priced proposal or other than the highest technically rated Applicant. The Applicant that represents the best value to the Government will be invited into negotiations. If negotiations are successful, the Government will make an award to the Applicant that represents the best value to the Government.

Application Elements

a. SF 424 – Application for Federal Assistance

b. SF 424A – Budget Information

c. Separate Budget Narrative/Justification

d. SF 424B – Assurances

e. Lobbying Certification.

f. Proof of non-profit status, if applicable

g. 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.

h. Project Narrative with Work Plan

i. Organizational Capability Statement and Vitae for Key Project Personnel.

j. Letters of Commitment from Key Partners.

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 in lieu of the standard instructions attached to SF 424 and 424A to complete these forms.

a. Standard Form 424

1. Type of Submission: (Required): Application

2. Type of Application: (Required) 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: Leave this field 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.

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.

d. Address:…