CDC-RFA-DD20-2002 DOCUMENT 04 13 20.docx

Applicant Information Call Funding Opportunity Announcement (NOFO):

Evaluation of Health Promotion and Prevention Programs for Blood Disorders (CDC-RFA-DD20-2002)

Agenda:

1) Introduction and Welcome – Fiona Bethea

· Good Afternoon, thank you for taking the time to join us today to discuss a new funding opportunity announcement, titled, “Evaluation of Health Promotion and Prevention Programs for Blood Disorders.” My name is Fiona Bethea and I am a Health Scientist with the Bleeding Disorders Team in the Epidemiology and Surveillance Branch and I am the project officer for the hemophilia and von Willebrand component of this program, out of the Division of Blood Disorders in CDC’s National Center on Birth Defects and Developmental Disabilities.

· The purpose of this call is to highlight key sections of the Notice of Funding Opportunity, also known as the NOFO, and to give you an opportunity to ask questions and to clarify items that you may find unclear or confusing. We suggest writing down your questions during the call, and those questions will be answered at the end of the call.

· Before we get started with information about the NOFO, I would like to take a moment to go over today’s agenda and introduce you to a few individuals from CDC.

· As a reminder, before we begin, we would appreciate it if you could please place your phones on mute. Thank you.

· I will serve as the moderator for the call. I will also be providing an overview of the NOFO and at the conclusion of the call I will provide you with some important dates pertaining to the NOFO.

· Also, on the call, we have Vanessa Byams, lead health scientist for the Bleeding Disorders Team in the Epidemiology and Surveillance Branch, and she will give us a brief background of the NOFO and will provide information on the eligibility criteria and award information.

· Thelma Jackson is from the Grants Management Office (GMO) here at CDC and she will go over the application process.

· We are also joined by several colleagues from the Division of Blood Disorders, Epidemiology and Surveillance Branch, who will be involved with this NOFO. Karon Abe is the Branch Chief. Cindy Sayers is a health communications specialist and will be the project officer for the Thalassemia and Venous Thromboembolism components. Nimia Reyes is a medical officer.

· Before we get started, we would like to have a roll call of everyone who is on the call. Please provide your name and the organization you are affiliated. Thank you.

[Individuals on the call provided their name and the organization that they are affiliated with.]

· Now, I will turn it over to Vanessa Byams to give us a brief background of the NOFO.

2) Background – Vanessa

· Thank you Fiona and thank you all for your interest in the Evaluation of Health Promotion and Prevention Programs for Blood Disorders notice of funding opportunity.

· Hemophilia and VWD are the most common inherited bleeding disorders and affect 20,000 and up to 3.2 million people in the US, respectively. People with bleeding disorders have a predisposition to spontaneous or traumatic bleeding episodes following injuries and surgery. The focus areas for this component are treatment (specific to males), inhibitor development, and women with bleeding disorders.

· In males with hemophilia, prophylaxis can reduce joint damage, however, treatment initiation and adherence remain as barriers. I

· Inhibitor development is a large cause of morbidity among persons with hemophilia and type 3 VWD.

· Delayed diagnosis of bleeding disorders in women and delayed treatment can increase complications and reduce quality of life.

· Health information, education, and evidence-based innovative health promotion programs are needed for persons with hemophilia and VWD, and healthcare providers, to increase the knowledge and awareness of: best treatment practices, inhibitor risk factors, and signs, symptoms and treatment of bleeding disorders in women.

· Each year in the US, it is estimated that Venous Thromboembolism (VTE) affects as many as 900,000 people, is responsible for up to 100,000 deaths, and is associated with healthcare costs of approximately $10 billion dollars. Over half of VTE events are associated with a recent hospitalization. Hospital-associated VTE is often preventable but VTE prevention strategies are not applied uniformly or systematically across US hospitals. This funding opportunity supports sustained health promotion and awareness of VTE using credible VTE health information, among individuals at risk for VTE, via existing materials. It additionally seeks to promote VTE best practices that are inclusive of the utilization of standardized risk assessment models and appropriate prophylaxis by providers for their hospitalized adult medical patients and the awareness of technologies, such as natural language processing, used by hospitals for early identification, diagnosis, and treatment of VTE to advance health equity and to improve quality of life through improved patient safety.

· Beta thalassemia major is the most severe form of thalassemia and affects at least 1,000 people in the US. Blood transfusions for thalassemia are the foundation of care; however, transfusion-related complications can result in morbidity and mortality. This component builds on earlier work and previously developed strategies that can be expanded to locate people with thalassemia and disseminate evidence-based, credible health information.

· Again, thank you for your time and interest in this important effort to improve health outcomes for people with bleeding disorders.

· I will now turn it back over to Fiona.

3) NOFO Overview: Approach – Fiona

· Thank you Vanessa. Now I will take a few minutes to provide an overview of the NOFO.

· We want to make sure it is clear that this notice of funding opportunity is for a cooperative agreement, not a grant. The main difference is a grant is an assistance mechanism used when there is no demonstrated need for substantial agency involvement from CDC beyond normal oversight and monitoring activities. A cooperative agreement is an assistance mechanism used when CDC will be substantially involved beyond normal oversight and monitoring activities. We also want to clarify that this NOFO is for a non-research cooperative agreement. Applicants should not submit for research activities.

· The purpose of this NOFO is to provide credible health information and evidence-based training as well as to support the implementation and evaluation of evidence-based health promotion and education programs aimed at reducing or preventing complications of blood disorders on a national level; specifically: Hemophilia and von Willebrand disease, or Venous Thromboembolism, or Thalassemia.

· These health-related activities may include: 1) implementing and evaluating public health promotion and wellness programs and activities; 2) improving access to health promotion programs and activities; 3) developing, disseminating and evaluating health communication materials; and 4) developing, implementing, and evaluating training for healthcare providers.

· Applicants must apply for only one of the three following blood disorders components: either 1) Hemophilia and VWD; or 2) VTE; or 3) Thalassemia.

· We will review component 1, Hemophilia and VWD first. There are three focus areas for applicants that apply for Hemophilia and VWD, treatment related to men; Inhibitors, and Women with bleeding disorders. Applicants for this component must select one of the two funding options. Funding option A – where they select all three focus areas. And Funding option B – where they will select two of the focus areas of their choice.

· Each focus area has key strategies, listed in pages 7-9, as well as short-term and intermediate outcomes that are expected to be achieved by the end of the project period are listed in page 6.

· Applicants for funding option A will only be considered for funding option A; likewise applicants for funding option B will only be considered for funding option B. Applicants for funding option A will not be considered for funding option B.

· Next we will review component 2, Venous Thromboembolism, or VTE. This opportunity supports sustained health promotion and awareness of VTE using credible VTE health information among individuals at risk for VTE using existing materials. It additionally seeks to promote VTE best practices that are inclusive of the utilization of standardized risk assessment models and appropriate prophylaxis by providers for their hospitalized adult medical patients and the awareness of technologies, such as natural language processing, used by hospitals for early identification, diagnosis, and treatment of VTE to advance health equity and to improve quality of life through improved patient safety.

· VTE focuses on key strategies, listed in pages 9-10, as well as short-term outcomes that are expected to be achieved by the end of the project period listed in pages 6-7.

· Finally we will review component 3, Thalassemia. This opportunity builds upon earlier work and previously developed strategies under DD14-1405, to expand to locate people with thalassemia and disseminate evidence-based credible health information.

· Thalassemia will focus on key strategies, listed in page 10, as well as short-term outcomes that are expected to be achieved by the end of the project period listed in page 7.

· For all components, grantee activities are not limited to those specified here, and additional activities may be added, as identified throughout the course of the project period.

· Next, Cindy will give an overview of the application components.

4) Application Components: Cindy Sayers

· Thank you, Fiona. The required components of the application begin on page 27 of the NOFO. Please be sure to cover all of these components in your application, and please note the areas where the NOFO directs you to refer back to sections of the Funding Opportunity Description. Please also note that all components of the project narrative will be scored according to the criteria under the Application Review and Selection Section, beginning on page 34 of the NOFO. I will briefly touch on some of the elements of the application now.

· Applicants are requested, not required, to submit a letter of intent, which is due by Wednesday, April 15th.

· Applicants must include a Table of Contents and a Project Abstract Summary in the application.

· The main sections of the Project Narrative are Background, Approach, Applicant Evaluation and Performance Measurement, Organizational Capacity of Awardee to Execute the Approach, and Work Plan. The project narrative must be no more than 20 pages. The work plan can be uploaded as a separate document that does not count against the 20-page limit.

· Included in the Approach must be a purpose statement, in which applicants must describe how their application will address the problem as described in the CDC background section starting on page 2. Applicants must clearly identify the outcomes they expect to achieve by the end of the project period and describe the strategies and activities they will use to achieve the outcomes.

· Applicants must also provide an overall evaluation and performance measurement plan that is consistent with the CDC Evaluation and Performance Measurement Strategy section of the CDC Project Description beginning on page 14. At a minimum, the plan must describe:

· Each of the performance measures (process and outcome) that will be used.

· How the applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement

· Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g. performance measures proposed by the applicant for each performance measure

· Describe how evaluation and performance measures will yield findings to demonstrate an impact of cooperative agreement activities on the component specific outcomes

· And if applicable, how key program partners will participate in the evaluation and performance measurement planning processes.

· Please note that the recipient will work with CDC post award to set targets and monitor progress towards these targets, and the recipient will be required to submit a more detailed Evaluation and Performance Measurement plan, within the first 6 months of the project, as outlined in the Reporting Section on page 42 of the NOFO.

· Applicants must also develop and submit a Work Plan that covers the first year of the project period and a high-level plan for the subsequent four years. The first-year details should include how they will implement the given strategies and activities. The applicant should describe the activity(s) they will perform to assess gaps or barriers; and if applicable should identify a potential gap or barrier and specify how they will implement a strategy and activity with the target population, to address that gap. For component 1, we recommend a work plan for each of the focus areas.

· CDC will provide feedback and technical assistance to awardee(s) to finalize the work plan post-award.

· All of the required elements of the work plan can be found on pages 17 of the NOFO.

· Under the Organizational Capacity section, applicants must demonstrate the ability to execute program requirements on a national level and meet period of performance outcomes. Successful applicants will demonstrate the necessary skills, relevant experience, and capacity to successfully implement the strategies and activities; as well as their ability to carry out evaluation, performance monitoring, financial reporting, subcontracting, budget management and administration; and their expertise and experience related to the surveillance of conditions among persons with congenital bleeding disorders. All applicants should describe their organizations/institutions experience in working with the target population and describe their understanding of the need for this program as well as their agency’s capacity in implementing and evaluating the activities with their proposed plan. Applicants must provide a description of their organizations structure and proposed staffing for the project. The applicant should identify appropriate team members responsible for each strategy listed in their workplan. The applicant should describe the extent o which team members experience and expertise align with the strategies for which they will be responsible. A CV/Resume is also required for each team member and should clearly indicate their subject matter experience and expertise. Additionally, each component has specific requirements in the organizational capacity section that should be addressed. Please refer to section c: Organizational Capacity of Awardees to Execute the Approach beginning on page 17 of the NOFO for complete details on what is to be included in this section.

· All applicants are also required to submit an itemized Budget Narrative. This is not counted towards the 20 page limit of the project narrative section. This budget narrative may be scored as part of the Organizational Capacity of Recipients to Execute the Approach. When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget must include:

· Salaries and wages

· Fringe benefits

· Consultant costs

· Equipment

· Supplies

· Travel

· “Other” categories

· Contractual costs

· Total Direct costs

· Total Indirect costs

· For guidance on completing a detailed budget, please refer to https://www.cdc.gov/grants/documents/Budget-Preparation-Guidance.pdf

· As you are preparing your budget proposal, please keep in mind funding restrictions listed in the NOFO, starting on page 32.

· At this time, I’ll turn it over to Vanessa who will discuss the eligibility criteria and award information.

5) Eligibility Criteria and Award Information – Vanessa Byams

· Thanks, Cindy. Domestic public or private, non-profit or for-profit organizations are eligible for funding through this funding opportunity announcement. Eligible organizations may include State, local, and Indian tribal governments; institutions of higher education; other non-profit organizations (including faith-based, community-based, and tribal organizations); and for-profit organizations, including small businesses.

· This project will be awarded as a Cooperative Agreement. The budget dollars allocated to this program for fiscal year 2020 will be used to fund program activities for the first year. We anticipate that approximately $1,640,000 will be available for year 1 of the 5-year award and total project funding will be approximately $8,200,000 over the course of the 5 years.

· For Component 1, Hemophilia and vWD, there will be up to three awards. Option A (select all three focus areas) will have one award with an anticipated award amount of $500,000 per budget period. Option B (select two focus areas) will have up to two awards with an anticipated award amount of $320,000 per award per budget period.

· For Component 2, VTE, there will be one award with an anticipated award of approximately $350,000 per budget period.

· For Component 3, Thalassemia, there will be one award with an anticipated award of approximately $150,000 per budget period.

· The floor of individual award range will be $150,000 per budget period. The ceiling of the individual award range is $500,000 per budget period.

· We anticipate an award date of September 1, 2020.

· Please note, throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government. This does not constitute a commitment by the Federal government to fund the entire period. The total project period comprises the initial competitive segment, any subsequent non-competitive continuation award(s), and any no-cost or low-cost extension(s).

Now I will turn it over to Thelma Jackson from the Office of Grant Services (OGS).

6) Application Process – Thelma Jackson

· Thank you Vanessa. I will now give a brief overview of the application process.

· An organization must be registered at three locations before it can submit an application for funding, the Data Universal Numbering System (or DUNS), the System for Award Management (or SAM), and Grants.gov.

· First, all applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements. The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or please go to the DUNS website shown on page 50 of the NOFO The DUNS number will be provided at no charge. If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbers before accepting any funds.

· Second, the SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process usually requires not more than five business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

· Third, the first step in submitting an application online is registering your organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov. All applicant organizations must register with www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants must start the registration process as early as possible.

· Applicants may access the application package at www.grants.gov.

· Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov.

· Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

· If the application is not submitted by the deadline published in the NOFO, it will not be processed. OGS personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application. Please see the Other Submission Requirements section on page 34 for additional details. If the applicant is authorized to submit a paper application, it must be received by the deadline provided by OGS.

· The Due Date for Applications is April 30, 2020, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

· All applicants are required to sign and submit “Assurances and Certifications” documents. Details about where to find the “Assurances and Certifications” and methods for submission can be found on page 25 of the NOFO.

· Applications submitted through www.grants.gov are time/date stamped electronically and assigned a tracking number. The applicant’s Authorized Organization Representative (AOR) will be sent an e-mail notice of receipt when www.grants.gov receives the application. The tracking number documents that the application has been submitted and initiates the required electronic validation process before the application is made available to CDC.

· For assistance with submission difficulties related to www.grants.gov, contact the Contact Center by phone at 1-800-518-4726. Hours of Operation: 24 hours a day, 7 days a week, except on federal holidays. CDC Telecommunications for persons with hearing loss is available at: TTY 1-888-232-6348

· Application submission is not concluded until the validation process is completed successfully. After the application package is submitted, the applicant will receive a “submission receipt” e-mail generated by www.grants.gov. A second e-mail message to applicants will then be generated by www.grants.gov that will either validate or reject the submitted application package. This validation process may take as long as two business days. Applicants are strongly encouraged to check the status of their application to ensure that submission of their package has been completed and no submission errors have occurred. Applicants also are strongly encouraged to allocate ample time for filing to guarantee that their application can be submitted and validated by the deadline published in the NOFO. Non-validated applications will not be accepted after the published application deadline date. If you do not receive a “validation” e-mail within two business days of application submission, please contact www.grants.gov.

· For instructions on how to track your application, refer to the e-mail message generated at the time of application submission or the Applicant User Guide, Version 1.1, page 102.

· Additional information about the application process and validation process are included in the NOFO.

· The Grants Staff Contact information on page 47 of the NOFO has changed. The new information is:

Thelma Jackson, Grants Management Specialist Department of Health and Human Services Office of Grants Services Centers for Disease Control and Prevention 2939 Flowers Road South, MS TV-2 Atlanta, GA 30341 Telephone: 770.488.2823 Email: tjackson12@cdc.gov

· Thank you for your time. I will now turn it back over to Fiona.

7) Questions and Answers – Fiona/Vanessa/Cindy/Karon/Alys/Nimia

· This concludes our overview of the NOFO. At this time we will, to the extent possible, try to answer your questions. Please note that we will post all of the questions and answers from today’s call on the grants.gov site in the coming days.

· I will be taking notes on the questions and answers, so they can be posted later.

· The floor is now open for questions. [Please state your name and organizational affiliation prior to asking your question.]

QUESTIONS RECEIVED & ANSWERS PROVIDED

1) Are there any restrictions around subcontracting with an organization that is also a recipient for this cooperative agreement (DD20-2002)?

· There are no restrictions around subcontracting to an organization that also already receives this cooperative agreement, as long as there is specific logic about why there is a need to subcontract to that organization, and the work that will be subcontracted for the cooperative agreement is not duplicative of work the subcontractor is already doing for their organization.

2) Is there an expectation that cooperative agreement activities will be fully funded by just the cooperative agreement? Or can there be supplementary funding by another organization, such as industry or others?

· Yes, ideally cooperative agreement activities will be fully funded by the cooperative agreement funding. We do not want the cooperative agreement activities to be partially funded by the cooperative agreement and industry because that can blur the lines. (Cooperative agreement activities funded by federal funds cannot appear to be support, endorse, or be influenced by industry)

3) Do you have to do all of the activities for the focus areas selected (component 1)? Can you come up with your own?

a. Applicants will be held accountable for the strategies that are listed in the generic logic model. For component 1, in section iii. Strategies and Activities, we have listed examples of activities that would meet the strategy. You do not have to do all of the proposed examples bulleted and you can come up with your own as long as it meets that strategy.

4) When we are writing this, if we apply for option A (Component 1), do we have to address all of the outcomes and strategies for all three focus areas?

· Yes, you must address all of the outcomes and strategies for all three focus areas if you apply for option A.

5) We saw that the NOFO indicates you can only submit one application per organization. If you wanted to apply under Option A and Option B, how do we do that? Is there an opportunity to apply for both?

· You must submit one application for your organization and you can apply for either Option A or Option B. You cannot apply for both.

6) Any guidance on how applications will be evaluated and scored?

· Please refer back to the NOFO – Section E, titled “Selection and Review Process” on page 35. We will have an objective review panel and the reviewer panelists will use that criteria to evaluate and score applications.

7) Can you talk about the thinking behind separating these components by disorder?

· The driving force within this NOFO is health promotion and each of these components fall under that health promotion umbrella. However, we are looking for very specific outcomes for each of the components that are distinct to that component. And we want the activities to be relevant for each topic.

8) We would like clarification on the budget period, is the budget period for one year? What is the period of performance?

· Yes, the budget period is for one year and the period of performance is five years. Approximately 6 months into the budget period, recipients will submit a continuing application for the next year of funding. This will occur again in the 2nd, 3rd, and 4th year of funding.

8) Important Dates – Fiona Bethea

If there are no more questions, I will provide you with some important dates.

9) Closing – Fiona Bethea

On behalf of the Division of Blood Disorders, I want to extend a sincere thanks to all of you for your time on the call today, and for your interest in this funding opportunity.

This concludes our call today. Thank you and have a good afternoon.