JHU FOA FINAL 09-19-14.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: Single Source Cooperative Agreement with Johns Hopkins University for Rapid influenza testing with Cepheid XPert Flu in Emergency Department Practice

Funding Opportunity Number: EP-IDS-14-017

Catalog of Federal Domestic Assistance (CFDA) Number: 93.360

Application Due Date: September 24, 2014 at 11:00pm EST

Issuance Date: September 19, 2014

FY 2014

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: Insurance Statement Attachment F: Potentially Applicable Public Policy Requirements 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-14-017 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 15, 2014 at 11:00 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 countermeasures for CBRN threats, pandemic influenza, and emerging infectious diseases through advanced product development, stockpile acquisition/building, manufacturing infrastructure building, and product innovation. BARDA establishes and maintains business collaborations by means of grants, cooperative agreements, and contracts with the public and private sectors, domestically and internationally.

The current cooperative agreement between ASPR and Johns Hopkins University (JHU) integrates rapid influenza molecular testing into Emergency Department (ED) clinical practice with assessment of clinical course following antiviral treatment and adoption of electronic communications that can assist clinicians and public health practice with local management of influenza infections. The existing JHU cooperative agreement (IDSEP130014) successfully completed one season of a clinical study across four EDs, enrolling 1,997 adult patients at 4 sites with over one-third hospitalized (also 592 admitted pediatric patients from two of the sites). The rapid influenza molecular test identified more than fifty adult influenza patients during their ED visit at two of these sites, many of which were hospitalized.

During the second influenza season, adult patients presenting to the ED with potential symptoms of influenza will receive a rapid molecular influenza test during the triage process.

Subjects with confirmed influenza through the on-going study can be recruited to participate in a sub study at the Johns Hopkins University ED. This sub study is facilitated by the systematic testing during the ED triage process and will contribute to inter-agency efforts to validate a standardized method for the assessment of influenza symptoms from patients with a positive rapid molecular test. Findings from the sub study can enhance public health preparation and response capabilities to pandemic influenza by enabling severity assessments in both outpatients and hospitalized patients.

Project Objective:

In addition to the objectives of the existing cooperative agreement, during the 2014-15 influenza season, the sub study will:

1. Recruit at least fifty adult patients with influenza infections confirmed by the rapid molecular test during their ED presentation who meet all other eligibility criteria and consent to participate in a symptom self-assessment questionnaire for up to 14 days.

2. Implement and monitor use of the on-line questionnaire.

3. Consolidate self-assessment questionnaire data in the central study database and provide de-identified data for statistical analyses by a designated party following recommendation from the FDA and patient-reported outcome methodology experts to validate the self-assessment diagnostic tool.

The protocol, informed consent form, and any participant information materials will be submitted to and approved by the JHU Institutional Review Board. The confidentiality of all study participants will be protected in accordancee, local, state and U.S. Federal laws.

II. AWARD INFORMATION

Total Project Cost (FY2015): Estimate $80,000

Total Estimated Funding Amount (FY2014): $80,000

Anticipated Number of Awards: 1

Project Period Length: 1 year

Budget Period Length: 1 year

Ceiling of Individual Award Range: $80,000

Anticipated Start Date: September 30, 2014

Expected Duration of Support: 1 year

Type of Application Sought: Cooperative Agreement

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, 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 protocol with goals, objectives, outputs, timelines and milestones and the oversight of proposed activities incorporated into quarterly 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 and formats and contents.

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

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

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

• 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.

• 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, data management and analysis, quality assurance, the presentation and possibly publication of program results and findings.

• Coordinate activities and synergies with interagency partners.

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 into consolidated quarterly 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 goals of the sub study.

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

• Ensure timely delivery of site visit reports with summaries of progress for each “sub recipients” and organize and participate in regular updates with BARDA project coordinator(s). Inform BARDA immediately of potential problems arising from “sub recipients” 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.

• Ensure that all technology development or transfer activities related to potential intellectual property issues, mediated by the awardee, in support of the “sub recipients” are reported to BARDA.

• Ensure that technical data from both the awardee and “sub recipients” necessary to evaluate the progress of the program are available to the internal BARDA evaluation committee.

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

• Ensure work supported by the cooperative agreement complies with all biosafety and Good Clinical Practice guidelines

III. ELIGIBILITY INFORMATION

John Hopkins University, School of Medicine is the only eligible applicant; it is the only organization that has an on-going clinical study infrastructure in place to identify influenza positive patients presenting to an Emergency Department with a likelihood of hospital admission that can expeditiously meet requirements to complete the influenza symptom assessment tool (FLU-PRO) validation outlined in this proposal. JHU has an existing cooperative agreement funded by ASPR to integrate rapid influenza molecular testing into Emergency Department clinical practice with assessment of clinical course following diagnosis and adoption of electronic communications that can assist clinicians and public health practice with local management of influenza infections.

Cost Sharing or Matching:

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

Mandatory Meetings:

As determined under the terms of the existing cooperative agreement

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 24, 2014 at 11:00 PM

Eastern Time.

http://www.grants.gov/

2. The Project Narrative must not exceed 5 pages. NOTE: The Project Work Plan, Letters of Commitment, budget narrative and justification forms, Other Relevant Annexes are not counted as part of the Project Narrative for purposes of the 5-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 5 pages. NOTE: The Project Work

Plan, Letters of Commitment, budget narrative and justification forms, Other Relevant Annexes are not counted as part of the Project Narrative for purposes of the 5-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.

Contact person regarding this Funding Opportunity Announcement is:

Roxanne Shively

HHS/ASPR/BARDA

Roxanne.Shively@hhs.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.

mailto:Roxanne.Shively@hhs.gov

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 5 pages. The Monitoring and Evaluation Plan, and other Annexes are not counted as part of the Project Narrative for purposes of the 5-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:

Background Goal(s) and Objective(s) Methodology to include study design, sample size, participant selection, enrollment and data collection, data management and analysis, protection of human subjects, ethical conduct , informed consent, confidentiality protections, 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 10 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 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.

** Evaluation Plan**

Applicant should develop an Evaluation plan. The plan should track what outcomes project management is promising to deliver.

**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. The workplan should emphasize engagement with the vaccine manufacturers.

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.

Annexes

**Key Personnel**

Please attach short curriculum vitae for any new 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 or fax them to the ASPR Office of Grants Management at 202-245-0789 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.

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.

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

• 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.

• Preaward costs are not allowed.

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.

The following scoring system will be used:

1. Project Relevance/Current Needs – 35 points

2. Organizational capacity – 35 points

3. Budget Allocation – 10 points

4. Project Evaluation – 10 points

5. Impact of Project Outcomes – 10 points

Criterion 1. Project Relevance/Current Needs (35 points)

i. Does the application adequately and appropriately document the key problem(s)/condition(s) relevant to the purpose of the funding opportunity? (35 points)

Criterion 2. Organizational Capacity (35 points)

i. Does the applicant organization clearly identify capacity for carrying out the proposed project and evaluation? (30 points)

ii. 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)

iii. Does the organization primarily use in-house staff to fulfill its organization capabilities? (5 points)

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? (10 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 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr46_main_02.tpl 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 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 is fully justified and reasonable in relation to the proposed research.

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 45CFR Part 74 and 92 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 F 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.

http://www.hhs.gov/grantsnet/adminis/gpd/index.htm

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 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 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=65430b8cd60ba715d7bbf033c2c00425&tpl=/ecfrbrowse/Title02/2cfr170_main_02.tpl mailto:asprgrants@hhs.gov

Attn: Roxanne Shively Telephone: +1(202) 260-1615 e-mail: Roxanne.Shively@hhs.gov

VIII. OTHER INFORMATION

Review and Selection Process Proposals will be reviewed and evaluated by a panel of USG reviewers.

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: (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: Complete

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: 93.095

12. Funding Opportunity Number/Title: (Required)

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 format: 2 characters State Abbreviation – 3 characters District Number, e.g., 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, i.e. all districts within all states are affected, enter US-all.

17. Proposed Project Start and End Dates: (Required)

18. Estimated Funding: (Required) Enter the amount requested.

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.

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.

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

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 Other.

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.

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.

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

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 (1) 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.

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:

insurance, medical and dental costs (i.e. for project volunteers this is different from personnel fringe benefits),non-contractual fees and travel paid directly to individual consultants, postage, space and equipment rentals/lease, printing and publication, computer use, training and staff development costs (i.e. registration fees). If a cost does not clearly fit under another category, and it qualifies as an allowable cost, then rest assured this is where it belongs.

Line 6i: Total Direct Charges: Show the totals of Lines 6a through 6h.

Line 6j: Indirect Charges: Enter the total amount of indirect charges (costs), if any. If no indirect costs are requested, enter “none.” Indirect charges may be requested if: (1) the applicant has a current indirect cost rate agreement approved by the Department of Health and Human Services or another federal agency; or (2) the applicant is a state or local government agency. State governments should enter the amount of indirect costs determined in accordance with DHHS requirements. An applicant that will charge indirect costs to the grant must enclose a copy of the current rate agreement. Indirect Costs can only be claimed on Federal funds, more specifically, they are to only be claimed on the Federal share of your direct costs. Any unused portion of the Awardee’s eligible Indirect Cost amount that are not claimed on the Federal share of direct charges can be claimed as un-reimbursed indirect charges, and that portion can be used towards meeting the recipient match.

NOTE:. If indirect costs are to be included in the application, a copy of the approved indirect cost agreement must be included with the application. Further, if any sub-contractors or sub-Awardees are requesting indirect costs, copies of their indirect cost agreements must also be included with the application.

Line 6k: Total: Enter the total amounts of Lines 6i and 6j.

Line 7: Program Income: As appropriate, include the estimated amount of income, if any, you expect to be generated from this project that you wish to designate as match (equal to the amount shown for Item 15(f) on Form 424). Note:

Any program income indicated at the bottom of Section B and for item 15(f) on the face sheet of Form 424 will be included as part of non-Federal match and will be subject to the rules for documenting completion of this pledge. If program income is expected, but is not needed to achieve matching funds, do not include that portion here or on Item 15(f) of the Form 424 face sheet. Any anticipated program income that will not be applied as Awardee match should be described in the Level of Effort section of the Program Narrative.

Section C - Non-Federal Resources Line 12: Enter the amounts of non-Federal resources that will be used in carrying out the proposed project, by source (Applicant; State; Other) and enter the total amount in Column (e). Keep in mind that if the match requirement is not met, Federal dollars may be reduced.

Section D - Forecasted Cash Needs - Not applicable.

Section E - Budget Estimate of Federal Funds Needed for Balance of the Project

Line 20: Section E is relevant for multi-year grant applications, where the project period is 24 months or longer. This section does not apply to grant awards where the project period is less than 17 months.

Section F - Other Budget Information

Line 22: Indirect Charges: Enter the type of indirect rate (provisional, predetermined, final or fixed) to be in effect during the funding period, the base to which the rate is applied, and the total indirect costs. Include a copy of your current Indirect Cost Rate Agreement.

Line 23: Remarks: Provide any other comments deemed necessary.

c. Standard Form 424B - Assurances This form contains assurances required of applicants under the discretionary funds programs administered by the Assistant Secretary for Preparedness and Response. Please note that a duly authorized representative of the applicant organization must certify that the organization is in compliance with these assurances.

d. Certification Regarding Lobbying This form contains certifications that are required of the applicant organization regarding lobbying. Please note that a duly authorized representative of the applicant organization must attest to the applicant’s compliance with these certifications.

Proof of Non-Profit Status

Non-profit applicants must submit proof of non-profit status. Any of the following constitutes acceptable proof of such status:

• A copy of a currently valid IRS tax exemption certificate.

• A statement from a State taxing body, State attorney general, or other appropriate State official certifying that the applicant organization has a non-profit status and that none of the net earnings accrue to any private shareholders or individuals.

• A certified copy of the organization’s certificate of incorporation or similar document that clearly establishes non-profit status.

Indirect Cost Agreement Applicants that have included indirect costs in their budgets must include a copy of the current indirect cost rate agreement approved by the Department of Health and Human Services or another Federal agency. This is optional for applicants that have not included indirect costs in their budgets.

Attachment B: Budget Narrative/Justification – Page 1 – Sample Format

The Budget Summary 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.

Non-Federal Match: (include when grant requires the match/cost sharing) Matching funds provide support for the purpose and goals of this proposal and enhance the Federal budget request.

Applicant is required to provide a detailed listing of all match used to meet the match requirement. In the narrative justification sections describe how the funds support the project and enhance the Federal budget.

All funding used for match must be documented in the same manner as Federal funds.