Expansion FOA .pdf

U.S. Department of Health and Human Services

Office of the Assistant Secretary for Preparedness and Response

Office of Emergency Management

Division of National Healthcare Preparedness Programs

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic, Infectious Diseases

Division of Healthcare Quality Promotion

Funding Opportunity Announcement and Cooperative agreement Application Instructions

Funding Opportunity Title:

National Ebola Training and Education Center (NETEC) Program Expansion

(CFDA# 93.825)

Funding Opportunity Number: EP-U3R-15-003

Application Due Date: September 09, 2016

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

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

Title VI of Division G of the Consolidated and Continuing Appropriations Act, 2015 and section 311 of the Public Health Service Act, as amended.

Government agency

The Office of the Assistant Secretary for Preparedness and Response (ASPR), within the

Office of the Secretary, U.S. Department of Health and Human Services (HHS), leads the nation’s efforts to prevent, protect against, mitigate, respond to and recover from the adverse health effects of public health incidents. ASPR focuses on preparedness planning and response; federal emergency medical operational capabilities; countermeasures research, advance development, and procurement; and grants to strengthen the capabilities of hospitals and health care systems to prepare for, respond to, and recover from public health emergencies and medical disasters. ASPR also provides federal support, including medical professionals through its National Disaster Medical System, to augment state and local capabilities during an incident.

The Centers for Disease Control and Prevention (CDC) works 24/7 to protect America from health, safety and security threats, both foreign and in the U.S. CDC increases the health security of our nation. As the nation’s health protection agency, CDC saves lives and protects people from health threats. To accomplish its mission, CDC conducts critical science and provides health information that protects the nation against expensive and dangerous health threats, and responds when these arise. CDC’s Division of Healthcare

Quality Promotion (DHQP) works to protect patients; protect health care personnel; and promote safety, quality, and value in both national and international health care delivery systems. DHQP is the agency’s lead on infection prevention and control, including creation of guidelines that are utilized in U.S. health care facilities.

Executive Summary

Beginning in March of 2014, West Africa experienced the largest Ebola virus disease

(Ebola) outbreak on record. Unlike many smaller preceding outbreaks of Ebola, this particular outbreak spread to multiple African countries and caused (as of December 2015) more than 28,000 suspected human cases. In August 2014, the first American Ebola patient was flown to the U.S. for treatment. Additional patients have subsequently been medically-evacuated to the U.S. Two returned travelers were diagnosed and treated in

Dallas, Texas and New York City, New York. Both of these experiences, as well as the secondary infections of two health care workers in a Dallas hospital, identified opportunities to improve preparedness for and treatment of suspected and confirmed patients with Ebola.

Under a separate funding opportunity announcement (FOA) published February 20, 2015, titled Hospital Preparedness Program (HPP) Ebola Preparedness and Response

Activities, HHS supported (1) development of a network of up to ten regional Ebola and other special pathogen treatment centers that can be ready within a few hours to receive a confirmed Ebola patient from their region, across the U.S., or medically-evacuated from outside of the U.S., as necessary; (2) state- or jurisdiction-designated Ebola centers that can http://www.grants.gov/view-opportunity.html?oppId=274709 http://www.grants.gov/view-opportunity.html?oppId=274709 http://www.grants.gov/view-opportunity.html?oppId=274709 safely care for patients with Ebola in the event of a cluster of patients that overwhelms the regional and other special pathogen treatment centers; (3) assessment hospitals that can safely receive and isolate a patient until an Ebola diagnosis is confirmed and they are subsequently transferred; and (4) frontline health care facilities that may identify a potential patient with Ebola and transfer them to an Ebola assessment hospital. This network builds upon the state- and jurisdiction-based tiered approach released in December

2014, titled Interim Guidance for U.S. Hospital Preparedness for Patients under

Investigation or with Confirmed Ebola Virus Disease: A Framework for a Tiered

Approach, which outlines the different roles U.S. acute health care facilities can play as an

Ebola treatment center, assessment hospital, or frontline health care facility.

Recognizing the complex nature of preparing the U.S. health care system to safely assess and care for patients with suspected or confirmed Ebola, ASPR and the CDC also supported the development of a National Ebola Training and Education Center (NETEC), awarded July 1, 2015. The NETEC offers state health departments, regional Ebola and special pathogen treatment centers, state- and jurisdiction-based Ebola treatment centers, and assessment hospitals expertise, training, technical assistance, peer review, monitoring, recognition, and certification, if feasible. The NETEC builds a comprehensive set of activities and deliverables for public health departments, U.S. health care providers, and facilities needed to safely and successfully identify, isolate, assess, transport, and treat patients with Ebola or persons under investigation for Ebola, and develops and leads a national peer review and recognition program for regional Ebola and other special pathogen treatment centers and Ebola treatment centers.

Purpose

This supplemental FOA offers an important opportunity for the NETEC to address gaps in educational materials and technical assistance for the clinical management of Ebola and emerging infectious diseases and other special pathogens. This will also allow the NETEC to establish an infrastructure for information sharing and coordination of rapid clinical research and the development of readiness metrics for Ebola, airborne and other special pathogens of high consequence.

The applicant should propose providing sub-awards to other entities, such as state and local health departments, professional organizations (e.g., critical care, infectious diseases, patient safety, emergency preparedness, emergency medical services (EMS), exercise design, health care epidemiology and infection control, quality, research coordination experts), health care facilities, emergency medical services/transport agencies, waste management experts, and individuals and international groups with expertise in treating patients with Ebola and other special pathogens.

Project Outcomes

The additional areas of support include the following activities:

• Increase hospital readiness site visits conducted and include participation of regional Ebola and other special pathogen treatment center personnel in readiness site visits within their region http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/hospitals.html http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/hospitals.html http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/hospitals.html http://apply07.grants.gov/apply/opportunities/instructions/oppEP-U3R-15-003-cidEP-U3R-15-003-051258-instructions.pdf

• Conduct an annual metric review and revision to include special pathogens (as agreed upon by CDC, ASPR, and the NETEC). Conduct continued evaluation, revision and validation of metrics annually for four years

• Establish educational curricula and develop educational material, resources and tools, supplemental activities

• Develop online educational materials, supplemental activities

• Establish a resource repository and on demand electronic-based technical assistance

• Establish 24/7 real-time telephonic support

• Establish a platform for real-time sharing and dissemination of clinical management information

• Coordinate research proposals and implement a master protocol

Implementation

Applicant must address all activities and strategies listed below in their application.

Activity A: Metrics, Readiness Assessment, and Annual Readiness Report

The NETEC, in collaboration with ASPR and CDC, and state health departments will, depending on the amount of requests from states and health care facilities, increase the number of hospital readiness site visits conducted for state- or jurisdiction-based Ebola

Treatment Centers (ETCs) and a small number of assessment hospitals that require additional assistance; include regional Ebola and other special pathogen treatment center personnel in future readiness site visits within their region; and implement an annual metric review and revision to include preparedness and response metrics for Ebola and other special pathogens (as agreed upon by CDC, ASPR and the NETEC).

Strategy 1: Increase hospital readiness site visits conducted and include participation of regional Ebola and other special pathogen treatment center personnel in readiness site visits within their region.

The NETEC, in collaboration with ASPR, CDC, and other stakeholders will continue and expand its peer review and readiness site visits of state- and jurisdiction-based ETCs and some assessment hospitals that require additional assistance. The number of visits will depend on the amount of requests from state health departments and health care facilities.

The NETEC will expand the flexibility of the structure of readiness site visits to incorporate the specific needs of each health department, health care facility, and/or EMS agency. Specifically, the NETEC will:

• Conduct up to an additional 60 hospital site visits/peer reviews for the duration of the project period (this number is highly dependent on the number of visits requested by state health departments and health care facilities). Additional trips would allow all state- and jurisdiction-based ETCs (designated by State Health

Officers), including those that never received a CDC Rapid Ebola Preparedness

(REP) visit, to receive a NETEC readiness site visit. In addition, the NETEC will conduct assessment hospital readiness site visits, as directed by state health departments, ASPR and CDC, based on needs identified during their initial CDC

Ebola Readiness Assessment (ERA) or state health department-led visit.

• The NETEC will provide technical assistance throughout the readiness site visit by disseminating the NETEC metrics (currently under development) self-assessment tool to each facility prior to the NETEC’s arrival along with a request for applicable policies, procedures, and standard operating procedures (SOPs). The NETEC will review these documents prior to the visit to tailor the readiness site visit team to provide expertise in areas that require more focused assistance.

• The NETEC, in collaboration with health department assessment teams, will provide additional technical assistance to assessment hospitals to mitigate remaining significant capability gaps identified by the state health department or

CDC during their initial visit.

o The NETEC will coordinate post-visit telephone/web-based technical assistance and participate in a follow-up web conference after each readiness site visit to gauge a facility’s progress in addressing any issues noted by the NETEC during their readiness site visit and provide technical assistance for additional issues arising since the readiness site visit.

o Additional telephone/web based technical assistance will be provided as needed.

• The NETEC will also expand hospital readiness site visit/peer review teams to include personnel from the regional Ebola and other special pathogen treatment center facilities and EMS/transport agencies. This expanded participation in

NETEC hospital readiness site visits/peer reviews will enhance regional collaboration and planning.

• The NETEC will assess and provide technical assistance to EMS agencies that collaborate with the hospitals involved in the NETEC’s readiness site visits to ensure these transport agencies have resources and capabilities to safely care for, transport, and transfer a patient from anywhere in the region (including airports) to an assessment hospital or regional Ebola and other special pathogen treatment center. This includes well-trained staff led by medical oversight, having appropriate equipment and protocols, and completed exercises for Ebola and other special pathogens. The NETEC will also ensure that the EMS system trains and exercises in collaboration with regional Ebola and other special pathogen treatment centers to:

o Identify a patient at risk for Ebola and other special pathogens;

o Communicate and coordinate with health care facilities, health departments, and emergency management throughout the system;

o Quickly implement protocols to effect personal protection of care providers such that there is consistency in the use of PPE and donning and doffing throughout the system;

o Isolate the patient;

o Provide patient care and transport;

o Safely transfer the patient from homes/places of work/ground transport, or aircraft to the ambulance and from the ambulance to a facility; and o Safely manage waste.

Strategy 2: Conduct an annual metric review and revision to include special pathogens (as agreed upon by CDC, ASPR, and the NETEC). Conduct continued evaluation, revision and validation of metrics annually for four years.

The NETEC, in collaboration with ASPR, CDC and other stakeholders, will continue to develop and refine metrics to measure facility and health care worker readiness to safely care for patients of Ebola and other special pathogens, as well as the process by which it will evaluate and validate metrics.

• Develop metrics that allow for the expansion of Ebola contact isolation metrics to account for precautions necessary for isolation of airborne infectious diseases and other special pathogens (as agreed upon by CDC, ASPR, and the NETEC).

• Establish an annual formal review and revision process that includes internal review of metric performance related to hospital assessment, exercise templates, education and technical assistance. The review process will include maintaining metrics in the online hospital assessment system as well as identifying best practices from hospital and EMS readiness site visit findings.

• Conduct an annual meeting to review and validate metrics. Participants should include subject matter experts from the three NETEC consortium institutions, external stakeholders from ASPR, CDC, regional Ebola and other special pathogen treatment centers, ETCs, and other domestic and international subject matter experts.

Activity B: Establish Educational Curricula and Develop Educational Materials, Resources and Tools

The NETEC will build an advanced education model to enhance resilience, empowerment, and knowledge within the U.S. health care structure related to care of a highly infectious disease patient. The NETEC, in collaboration with ASPR and CDC, will expand their current comprehensive curriculum and educational materials, resources, and tools. The materials will be consistent with existing ASPR and CDC materials, and should include information gathered from a wide range of experts in the field who have extensive experience caring for Ebola patients and other special pathogens, both domestically and internationally. The education model should be capable of rapidly including new knowledge as it emerges. In addition to educational curricula and materials, the awardee will support ASPR and CDC in reviewing national guidance for Ebola and other special pathogens as needed during outbreaks of emerging threats or emergency responses. The review will include input from multiple disciplines and expertise based on the topic of the guidance (e.g., critical care, infectious disease, nursing, occupational safety, environmental services). This activity will continue to allow participants the opportunity to obtain continuing education credit (CE, CME, etc.) appropriate to their discipline.

Strategy 1: Establish educational curricula and develop educational material, resources and tools, supplemental activities

The NETEC will supplement current educational resources by conducting additional annual in-person, advanced-level courses. These advanced courses will build on the

NETEC’s recently-completed infection control and preparedness courses and will incorporate patient care clinical training and simulations at simulation centers. Activities that will be performed under this strategy will include, but are not limited to:

• Create and facilitate additional educational courses covering ideal patient care strategies, train-the-trainer, research education, executive education, just-in-time vignettes and skills labs

• Teach 15 advanced-level courses to train up to 500 additional health care workers annually utilizing in-person courses, skills labs, and simulation labs

• Broaden training and exercises for ASPR-funded regional Ebola and other special pathogen treatment centers beyond Ebola to include other special pathogens (as determined by CDC, ASPR, and the NETEC).

Strategy 2: Develop online educational materials, supplemental activities

The NETEC will expand the course offerings in the Learning Management System to include virtual training for Ebola preparedness efforts by frontline health care facilities. Supplemental activities performed under this strategy will include, but are not limited to:

• Create online courses within the Learning Management System that will enable an unlimited number of health care workers to access the training courses and obtain continuing education credit appropriate to their discipline.

• Build upon existing ASPR and CDC Ebola preparedness training materials for facilities not designated as ETCs or assessment hospitals (i.e., frontline health care workers and facilities).

• Address gaps in current Ebola preparedness and training (i.e., Category A waste management, laboratory issues).

• Work with ASPR and CDC to plan and implement risk assessments in U.S.

hospitals that are regional Ebola and other special pathogen treatment centers and

ETCs to identify gaps in preparedness for emerging threats (i.e., preparing for an emerging respiratory threat).

Strategy 3: Review and provide technical input on national guidance

The NETEC will support ASPR and CDC to rapidly review and provide technical input on national guidance for Ebola and other special pathogens.

• The NETEC will work with ASPR and CDC to review national guidance for infection control measures and treatment of Ebola and other special pathogens as needed during outbreaks of emerging threats or emergency responses.

• NETEC will coordinate input from a variety of disciplines and experts in the review of national guidance.

• NETEC will assist ASPR, CDC, and coordinate with appropriate disciplines to support dissemination of national guidance.

Activity C: Virtual Technical Assistance

The NETEC will develop mechanisms to provide real-time technical assistance to health care facilities and providers via telephonic and web-based support for Ebola and other special pathogens.

Strategy 1: Establish a resource repository and on demand electronic-based technical assistance

The NETEC will expand NETEC.org to include a centralized and searchable repository of resources and develop a mechanism to quickly provide specialized technical assistance as requested.

• The NETEC will develop a robust, searchable repository for real-time use by facilities, including regional Ebola and other special pathogen treatment centers, Ebola Treatment Centers, assessment hospitals, frontline health care facilities, and

EMS systems o The NETEC will develop a centralized repository to facilitate the provision of technical assistance.

• NETEC.org will be configured to allow facilities to submit requests for on demand

SME-based technical assistance via email o The NETEC.org Technical Assistance email account will be actively monitored and all inquiries will be initially triaged and responded to within

48-72 business hours

Strategy 2: Establish 24/7 real-time telephonic support

The NETEC will establish 24/7 telephonic support to provide real-time technical assistance and consultation to health care facilities on clinical care issues. CDC is available to provide technical assistance on public health issues.

Strategy 3: Establish a platform for real-time sharing and dissemination of clinical management information

The NETEC, in coordination with ASPR, CDC and NIH, will establish a platform for coordination of rapid collection and analysis of clinical, virologic, and immunologic data, and disseminate new clinical knowledge to guide management of patients with emerging and special pathogens resulting in critical illness.

• Develop and implement an infrastructure, to include educational and information sharing platforms that already exist, and that supports data collection, analyses, and rapid dissemination of clinical knowledge to health care providers, ASPR, CDC, and NIH.

• Develop protocols and a web-based tool to understand pathogenesis, and response to clinical interventions to inform clinical management. Data elements should include, but not be limited to clinical, virologic, and immunologic data.

Activity D: Creation of the Special Pathogens Research Network

The NETEC, in collaboration with ASPR, CDC and NIH, will establish the infrastructure for a research network that will support rapid implementation of protocols for investigational interventions for Ebola and other special pathogens. The applicant should collaborate with a clinical research organization, and/or a network of organizations specializing in critical care and infectious disease research to support the development, design, planning, conducting, monitoring, and collation and interpretation of data from clinical trials. This collaborative will not directly fund research.

Strategy 1: Coordinate research proposals and implement a master protocol

The goal of this strategy is to coordinate research proposals and implement a master protocol to enable clinicians at the regional Ebola and other special pathogen treatment centers and other health care facilities to be prepared to consider, administer, and monitor experimental therapeutics and other interventions for Ebola and other emerging pathogens, in the event they receive a person under investigation (PUI) and/or a person confirmed to have one of these conditions. Activities that will be performed under this strategy will include, but are not limited to:

• Engage and maintain the 10 regional centers in a research network

• Engage research partners such as NIH, CDC, IRF, USAMRIID, DARPA, BARDA, DOD, and Department of State to coordinate research initiatives for emerging special pathogens that result in critical illness

• Create a master protocol for research

• Develop and implement a training protocol for the research staff at the regional centers, emphasizing special issues pertaining to emerging pathogens

• Develop model uniform policies and procedures for the conduct of clinical research in biocontainment units

• Develop universal case report forms and questionnaires that include clinical, virologic, and immunologic data

• Develop a web-based clinical data capture tool and database that have the capability to collect and coordinate data from the research network and can conduct rapid analyses to provide feedback that informs therapeutics and clinical management

• Hold an annual investigator’s meeting with the clinical research teams from regional treatment facilities as well as other domestic and international partners in order to develop, discuss and revise protocols and research resources

• In collaboration with ASPR and CDC, create policies and procedures for a biorepository

Evaluation and Performance Measurement

ASPR and CDC will work with the awardee post-award to develop the evaluation and performance measurement strategy.

Eligibility and Funding Strategy

Eligible applicants are limited to health care facilities that have safely and successfully evaluated and treated patients with Ebola in the U.S. The applicant must work directly with the other health care facilities that have safely and successfully evaluated and treated patients with Ebola in the U.S. The applicant will collaborate, coordinate, plan, and work directly with the other facilities on appropriate activities described in this FOA, as well as distribute funds from this FOA to support those activities.

Program Guidelines

Under this cooperative agreement, the applicant must develop a consortium project and follow the guidance below.

• The eligible health care facility submitting the cooperative agreement application on behalf of the consortium should be designated as the applicant.

The award will be made to a single awardee with either a single lead project director/principal investigator (PD/PI) or multiple PD/PIs from multiple institutions. The decision to apply for a single PD/PI or a multiple PD/PI cooperative agreement is the responsibility of the investigators and the applicant organization.

All PD/PIs must be qualified and have appropriate expertise to serve as a PD/PI and the appropriate level of authority and responsibility to direct the project or program as part of the leadership team. Each PD/PI must have a defined role on the project.

All PD/PIs—even if from multiple institutions—share equally the authority and responsibility for leading and directing the project, intellectually and logistically.

All multiple PD/PI applications are required to include a leadership plan. The purpose of the leadership plan is to facilitate project outcomes, implement activities and strategies, and establish a decision-making process. The plan must describe a rationale for choosing the multiple PD/PI approach. The governance and organizational structure of the leadership team should be described, including communication plans, process for making decisions on project direction, and procedures for resolving conflicts. The roles and administrative, technical, and project responsibilities should be delineated for the PD/PIs.

Applicants must include budget allocation information for specific PD/PIs as part of the leadership plan.

The applicant organization must designate one of the PD/PIs as the contact PD/PI to serve as a primary point of contact with ASPR and CDC. The contact PD/PI must be listed first on the application and must be associated with the applicant organization. The contact

PD/PI is responsible for communication between the PD/PIs and ASPR and CDC, but has no special authorities or responsibilities within the leadership team. Responsibilities of the contact PD/PI may include communication between the leadership team and ASPR and

CDC, assembly of the application materials, and coordination of progress reports.

Multiple PD/PI applications will submit a single budget for the entire project, including a detailed budget for each consortium member. The budget must include a detailed budget for year one showing the personnel cost by individual salaries and fringe benefits, consultants, travel, supplies, and any other costs and estimated budget for years two through five.

The applicant can propose providing sub-awards to other entities, such as professional organizations, health care facilities, and individuals with expertise in infection control, patient safety, and quality.

The applicant is expected to detail their proposed collaborations as part of the cooperative agreement application. If the application is approved as submitted, no further approval is required unless, during performance, the awardee plans to undertake additional or alternative collaborations that would constitute a change in the scope of the approved project.

The following information must be provided to ASPR as part of an application that proposes consortium arrangements:

A listing of all proposed performance sites; those of the applicant organization and the consortium participant(s);

A scope of work for each consortium member that states the specific activities and strategies to be performed, identifies individual(s) responsible for overseeing, conducting and reporting results of the project, percent of time and effort for each individual, and the sum of funds to be received;

A separate letter of agreement or intent signed by the consortium member(s) that outlines the member(s) scope of work and attests to their good faith in carrying out the proposed scope of work if the application is approved and funded.

The signature (or electronic equivalent) of the Authorized Organizational Representative

(AOR) on the application signifies that the applicant organization and all proposed consortium members understand and agree with the following statement:

"The appropriate programmatic and administrative personnel of each organization involved in this cooperative agreement application are aware of the ASPR consortium agreement guidelines and are prepared to establish the necessary inter-organizational agreement(s) consistent with those guidelines."

Administrative Requirements for Consortium Collaborations

The applicant must enter into a formal written agreement (subaward) with each consortium member that addresses the negotiated arrangements for meeting the administrative, financial, and reporting requirements of the cooperative agreement, including those necessary to ensure compliance with all applicable federal regulations and policies and facilitate an efficient collaborative venture.

At a minimum, this agreement (subaward) must include the following:

Identification of the individual who will serve as the consortium lead project director/principal investigator (PD/PI) and other individuals responsible for the project activity at each consortium participant along with their roles and responsibilities.

When multiple PD/PIs are involved at different organizations, only the contact PD/PI is required to have the official relationship with the applicant organization. PD/PIs in the leadership team at other organizations must have a documented relationship with a consortium organization, but need not be employees. Any consortium agreement must address the unique aspects to these individuals holding the PD/PI role.

Procedures to be followed in reimbursing each consortium member for its effort, including dollar ceiling, method and schedule of reimbursement, type of supporting documentation required, procedures for review and approval of expenditures of cooperative agreement funds at each organization and timing of applicable reporting requirements. This includes provisions on access to core facilities and resources and whether access will be provided as a fee-for-service.

If different from those of the applicant, a determination of policies to be followed in such areas as travel reimbursement and salaries and fringe benefits must be consistent with 45

CFR part 75.

A provision addressing ownership and disposition of data produced under the consortium agreement, including the provision that during the five-year period and after, ASPR and

CDC will have right to reproduce, publish, or otherwise use any work subject to copyright that was developed, or for which ownership was purchased, under this award for federal purposes, and to authorize others to do so.

The applicant must include in consortium agreements (subawards) the applicable HHS and government-wide regulations outlined in 45 CFR 75 and HHS Grants Policy

Statement to a consortium participant that is a non-profit organization. This includes the application of Facilities and Administrative (F&A) rates in determining consortium budgets and the reimbursement of costs.

The applicant is responsible for negotiating F&A rates with consortium participants that receive awarded funds under ASPR grants, unless the consortium participant is a foreign organization, the award is for training purposes or the consortium participant has a negotiated rate agreement. If the consortium participant is a foreign organization or the award is for training purposes, F&A will be limited in accordance to policy for those classes of awards.

The applicant is responsible for obtaining ASPR’s approval for any actions to be undertaken by consortium participants that require prior approval. Applicants may establish requirements for review of consortium participants' activities consistent with those requirements and with any authorities provided to the applicant; however, an applicant may not provide any authority to a consortium participant that the applicant has not been provided under its ASPR award.

The applicant must require consortium participants to comply with the requirements of 45

CFR 75 Subpart F, as applicable, for audit of ASPR cooperative agreement funds expended by consortium participants. A consortium participant also may be a direct ASPR awardee or contractor or may be receiving funds only under the consortium agreement.

Regardless, if a non-Federal consortium participant meets the 45 CFR 75.501 threshold criterion of aggregate annual expenditures of $750,000 or more under applicable federal awards, the awardee must receive a copy of that organization's single audit and take appropriate action based on any findings that relate to the consortium agreement. The applicant is responsible for establishing requirements, as necessary, to ensure compliance by for-profit and commercial organizations (including for-profit hospitals) as required by

45 CFR 75.501(h)(i)(j). If a consortium participant will not reach that expenditure threshold, the awardee is responsible for monitoring the organization's activities to ensure compliance with 45 CFR 75 requirements. The applicant may not require a consortium participant to have an audit and charge the audit costs to ASPR cooperative agreement funds unless required or authorized by 45 CFR 75.501.

Other Important Notes about this Funding Opportunity Announcement

II. AWARD INFORMATION

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 and CDC 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.

Estimated Total Project Cost: USD

Estimated Funding Amount: up to $12,000,000 subject to availability of funds

Anticipated Number of Awards: 1

Project Period Length: 45 months

Budget Period Length: 9 months

Anticipated Start Date: October 1, 2016

Expected Duration of Support: 45 months

Type of Assistance Instrument: Cooperative Agreement

ASPR may award all or part of the funds, up to $12,000,000, subject to availability of funds.

III. ELIGIBILITY INFORMATION

Health care facilities that have safely and successfully evaluated and treated patients with

Ebola in the U.S.

Cost Sharing and Maintenance of Funding

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

Maintenance of effort/funding is not required for this program.

Other Requirements

Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive federal funds constituting a grant, loan, or an award.

IV. APPLICATION AND SUBMISSION INFORMATION

Application Screening Criteria

1. Applications should be submitted electronically via http://www.grants.gov by

September 09, 2016.

2. The Project Narrative section of the Application must be double-spaced, on 8 ½” x

11” plain white paper with 1” margins on both sides, and a font size of not less than

11.

The Project Narrative must not exceed 100 pages.

Address to Request Application Package

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

Contact person regarding this FOA is:

Melissa Harvey

Director, Division of National Healthcare Preparedness Programs

Telephone (202) 384-2146

Email: Melissa.Harvey@hhs.gov

Applicants must download the application package associated with this funding opportunity from grants.gov. If the applicant encounters technical difficulties with grants.gov, the applicant should contact grants.gov customer service. The grants.gov contact center is available 24 hours a day, 7 days a week, with the exception of all federal holidays. The contact center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the grants.gov support center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CDs, or thumb drives of applications will not be accepted.

Applicants are encouraged to submit their application prior to the due date.

Required Registrations

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

Requirements:

Except for those entities exempt from requirements listed at 2 CFR §25.110(b) or

(c) (individuals), effective October 1, 2010, HHS requires all entities that plan to apply for and ultimately receive federal grant funds from any HHS Operating/Staff Division

(OPDIV) or receive subawards directly from recipients of those grant funds to:

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

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

OPDIV/STAFFDIV; and http://www.grants.gov/ http://www.grants.gov/ mailto:Melissa.harvey@hhs.gov mailto:support@grants.gov

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

OPDIV/STAFFDIV.

An award cannot be made until an applicant has complied with these requirements. At the time an award is ready to be made, if the intended recipient has not complied with these requirements, the OPDIV/STAFFDIV:

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

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

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

Applicants must provide a Dun and Bradstreet (DUNS) number to apply for a grant or cooperative agreement from the federal government. ASPR applicants are required to provide their DUNS number on the face page of the application. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access the Dun and

Bradstreet website at http://www.dnb.com/get-a-duns-number.html or call 1-866-705-

5711. To expedite the process, let Dun and Bradstreet know that you are a public/private nonprofit organization getting ready to submit a federal grant application. In addition, you must be registered in the System for Award Management (SAM). Registration in the

System for Award Management (SAM) is mandatory. Failure to register with SAM will lead to an application being deemed ineligible and will not proceed to peer review. Due to the possibility of heavy traffic at the sam.gov website, applicants are strongly encouraged to register well in advance of the application due date. SAM information must be updated at least every 12 months to remain active (for both recipients and sub-recipients). Once you update your record in SAM, it will take 48 to 72 hours to complete the validation processes. Grants.gov will reject submissions from applicants who are not registered in SAM or those with expired SAM registrations (Entity Registrations). The DUNS number you use on your application must be registered and active in SAM for the anticipated start date of the award. To create a user account, Register/Update an entity and/or Search Records go to SAM, at http://www.sam.gov or by phone at 1-877-252-2700.

Grants.gov registration – All entities must register and/or renew registration with grants.gov prior to submitting an application. Grantees 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.

Application Screening Criteria

Applications must be submitted electronically via http://www.grants.gov by September

09, 2016 at 11:59 pm EDT.

http://www.dnb.com/get-a-duns-number.html http://www.sam.gov/ http://www.grants.gov/

Content and Form of Application Submission

The following required documents and sections must be included in the application package in order to be considered for funding.

Cover Letter (optional)

Cover letters should be addressed to the following:

Virginia Simmons

Chief Grants Management Officer

Acquisition Management Contracts and Grants

Office of the Assistant Secretary for Preparedness and Response

U.S. Department of Health and Human Services

200 Independence Ave. S.W.

Washington, DC 20201

Telephone: (202) 260-0400 E-mail: asprgrants@hhs.gov

Required Forms

SF424, SF424A, SF424B, Certification Regarding Lobbying, Proof of Non-Profit Status, Indirect Rate Agreement

Project Abstract

A project abstract must be completed in the grants.gov application forms. The project abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary or confidential information.

Project Narrative

A project narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting it via grants.gov. The narrative should address activities to be conducted over the entire project period, with a more detailed work plan for the first year. The project narrative should be succinct, self-explanatory, and submitted in the order outlined in this section.

The narrative must be submitted in the following format:

The project narrative must be double-spaced, on 8 ½” x 11” paper with 1” margins on both sides, and a font size of not less than 11. You may use smaller font sizes to fill in the Standard Forms and Sample Formats. Forms do not need to be double spaced. ASPR will not accept applications that exceed 100 pages. If the narrative exceeds the page limit, only the pages which are within the page limit will be reviewed.

mailto:asprgrants@hhs.gov

The components of the project narrative counted as part of the 100 page limit include:

• Background

• Current capacity

• Approach and work plan

• Budget narrative and justification

• Performance measurement and evaluation strategy

Any other relevant additional information that does not count toward the 100 page limit including:

• Curricula vitae for key project personnel in the consortium

• Letters of agreement

• Copy of the applicant’s most recent indirect cost agreement, if requesting indirect costs

• Other documents, as needed

The project narrative is the most important part of the application, since it is the primary basis on which ASPR determines whether or not a project meets the minimum requirements for grants under Public Health Service Act, Section 311 (42 U.S.C. Section

243). The project narrative should provide a clear and concise description of the project.

The following is a brief description of each required component:

Background

Applicants must describe the core background information relative to the project. The core background information must help reviewers understand how the applicant's response to the FOA will address the competency of health care and public health workers and the capability of health care facilities to deliver efficient and effective patient care.

Current Capacity

Address the consortium’s current capacity to successfully implement the proposed project and associated activities, including describing staff and other infrastructure already in place in which to build upon, to meet project period outcomes.

Approach and Work Plan

Applicant must clearly identify the outcomes they expect to achieve by the end of the project period and provide a clear and concise description of the strategies and activities they used to achieve the project’s outcomes. Briefly introduce the activity(ies) being proposed and describe what the expected outputs (e.g., milestones) will be over the first 12 months of the project and a higher-level description for each subsequent year.

Define the expected outcomes that align with resolving the problem of closing the gaps.

The outcomes should define what changes or improvements will occur in health care facilities and public health departments. Outcomes should be well-defined, specific, measurable, realistically achievable, and contribute to closing the gaps identified in the problem statement. Ideally, outcomes should link to planned activities, quantify the targeted change, and include an estimated timeline for achieving the change. The applicant can include as many outcomes as needed.

List the intermediate activities the consortium will undertake, including tasks and estimated start and end dates, which will lead to the associated outcome and contribute to resolving the identified issue or problems. The applicant can include as many planned activities as needed.

List the proposed outputs that will be produced as a result of the planned activities, such as the development of metrics to evaluate health care facility readiness to serve in its intended role (regional or state Ebola treatment facility, or assessment hospital). The applicant can include as many planned outputs as needed.

Budget Narrative and Justification

A detailed budget with supporting justification must be provided and be related to activities that are stated in the applicant’s work plan. The applicant must note the following budget-related issues:

• If indirect costs are requested, it will be necessary to include a copy of the organization’s current negotiated Federal Indirect Cost Rate Agreement or a Cost

Allocation Plan for those applicants under such a plan.

• Travel for program implementation should be justified and related to implementation activities.

• Budgets that include costs for equipment (e.g., training-related equipment) must be detailed in the budget narrative and justification.

The budget narrative or justification should be provided using the instructions included in

Attachment A (Instructions for Completing Required Forms) of this FOA. Applicants are encouraged to pay particular attention to Attachment B (Budget Narrative/Justification

Sample Format), which provides an example of the level of detail sought.

Performance Measurement and Evaluation Strategy

The applicant will be required to report on a small set of ASPR- and CDC-defined performance measures that will demonstrate, or show progress toward, the accomplishment of program outcomes of the cooperative agreement. ASPR and CDC expect to release information and guidance containing these required performance measures following the posting of the funding announcement.

As part of this application the applicant should describe in a brief narrative a plan to affirm and acknowledge the applicant’s ability to collect and respond to required ASPR- and CDC-defined performance measures. The applicant may also describe how evaluation data will be shared with key stakeholders and used by the consortium to improve program quality and demonstrate the value of this funding.

Additional Information

Additional information may be included in the application appendices. The appendices must be uploaded to the "Other Attachments Form" of application package in grants.gov.

Note: appendices will not be counted toward the narrative page limit.

Submission Deadline Dates and Times

The deadline for the submission of applications under this FOA is September 09, 2016.

Applications must be submitted electronically by 11:59 p.m. Eastern Time on September

09, 2016.

Intergovernmental Review

This FOA is not subject to the requirements of Executive Order 12372, “Intergovernmental

Review of Federal Programs.”

Funding Restrictions

The following activities are not fundable:

• Recipients may not use funds for research.

• Recipients may not use funds for clinical care.

• Recipients may not use funds for construction, alternations, or renovations.

• Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

• The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

• Recipients may not use funds to carry out any program of distributing sterile…