RFA-IP-20-003.pdf

Centers for Disease Control

National Center for Immunization and Respiratory Diseases Extramural Research Program

Office

Network of Modeling Centers to Improve Evidence Base for Seasonal and Pandemic Influenza

Prevention and Control

RFA-IP-20-003

Application Due Date: 11/15/2019

Network of Modeling Centers to Improve Evidence Base for Seasonal and Pandemic Influenza

Prevention and Control

RFA-IP-20-003

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations National Center for Immunization and Respiratory Diseases Extramural Research Program Office (NCIRD ERPO) Notice of Funding Opportunity (NOFO) Title Network of Modeling Centers to Improve Evidence Base for Seasonal and Pandemic Influenza Prevention and Control Activity Code U01 – Research Project - Cooperative Agreement

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-IP-20-003

Assistance Listings (CFDA) Number(s) 93.185 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support applied research that will develop, advance, and apply mathematical models to investigate the utility and impact of prevention and control strategies for seasonal and pandemic influenza, including vaccination and treatment. This NOFO will establish a network of Influenza Modeling Centers that conducts research to facilitate the rapid development, harmonization, validation, synthesis, and communication of multiple mathematical models and their results for seasonal and pandemic influenza prevention and control. This NOFO is expected to generate advancements in the rapid sharing of validated modeling results from multiple models that will improve the evidence base for public health action and inform policy development.

Key Dates Publication Date: To receive notification of any changes to RFA-IP-20-003, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 09/16/2019

Application Due Date: 11/15/2019 https://www.grants.gov

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 01/16/2020

Secondary Review: 02/20/2020

Estimated Start Date: 08/01/2020

Expiration Date: 11/16/2019 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 15 pages.

Applications that do not comply with these instructions may be delayed or not accepted http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to support applied research that will develop, advance, and apply mathematical models to investigate the utility and impact of prevention and control strategies for seasonal and pandemic influenza, including vaccination and treatment. This NOFO will establish a network of Influenza Modeling Centers that conducts research to facilitate the rapid development, harmonization, validation, synthesis, and communication of multiple mathematical models and their results for seasonal and pandemic influenza prevention and control. This NOFO is expected to generate advancements in the rapid sharing of validated modeling results from multiple models that will improve the evidence base for public health action and inform policy development.

Mechanism of Support: U01 – Research Project – Cooperative Agreement.

Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire five (5)-year project period is $9,375,000. The number of awards will be up to five (5). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $1,875,000 with individual awards ranging from $300,000 to $375,000 for the first year. The estimated total funding (direct and indirect) for the entire project period will be $9,375,000. The project period is anticipated to run from 08/01/2020 to 07/31/2025.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III of this announcement are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for each application.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Application Type. New.

Application Materials. See Section IV.1 for application materials. Please note that

Form E is to be used when completing the application package.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 317(k)(1) of the Public Health Service Act [42 U.S.C. §247b(k)(1)], as amended.

1. Background and Purpose Seasonal influenza disease activity is associated with a substantial health burden in the United States and results in an estimated 140,000 to 960,000 hospitalizations and 12,000 to 79,000 deaths annually (CDC, Disease Burden of Influenza website). In addition to the impact of seasonal influenza, influenza can cause pandemics, which happen when a new (novel) influenza A virus emerges that can infect people easily and spread from person to person in an efficient and sustained way (HHS 2017). Pandemics can be associated with millions of deaths worldwide and billions of dollars in economic losses.

Routine annual influenza vaccination is the best way to prevent seasonal influenza (Grohskopf 2018). Since 2010, CDC and CDC’s Advisory Committee on Immunization Practices has recommended all persons aged ≥6 months, who do not have contraindications, receive an annual influenza vaccination (Grohskopf 2018). A variety of influenza vaccine products is licensed and available from several different manufacturers and no preferential recommendation is made for use of any influenza vaccine product over another. Influenza antiviral medications are an important adjunct to influenza vaccine and can be used to treat influenza and, in some instances, prevent influenza (CDC, antiviral medication website). Antiviral treatment is recommended as early as possible for any patient with confirmed or suspected influenza who is hospitalized; has severe, complicated, or progressive illness; or is at higher risk for influenza complications, which includes older adults, very young children, pregnant women, and those with certain chronic medical conditions. Additional tools to prevent and control seasonal and pandemic influenza include (but are not limited to): 1. Community mitigation, which aims to slow the spread of influenza virus in communities through the use of non-pharmaceutical interventions (NPIs), such as school closures; and 2. Medical countermeasures, which include (in addition to vaccines and influenza antiviral medications) diagnostic devices, respiratory protective devices, and ventilators (HHS 2017).

Because of the variety of interventions available to prevent and control influenza, public health authorities must decide on an appropriate set of measures for implementation during influenza seasons and pandemics, including how and when to implement measures that are disruptive to society. Therefore, public health officials need objective evaluations of the impact that interventions are most likely to have in terms of averting health and/or economic outcomes. In addition, a number of important policy-relevant questions remain about the use of influenza vaccination. For example, a growing number of influenza vaccine types have become available in recent seasons, which may differ in effectiveness; assessments of the impact of vaccination strategies that vary the use of different vaccination types (e.g., the broader use of high dose or adjuvanted influenza vaccines) are needed. In addition, declines in vaccine-induced immunity over an influenza season (i.e., waning immunity) have been observed but the mechanisms contributing to this observation remain unclear, making recommendations about the optimal timing of vaccination difficult. Quantifying the long-term strategies for, and impacts of, influenza vaccination is complicated because vaccine effectiveness and the risk of infection in the current season may be modified by influenza infection or vaccination in previous seasons and by viral evolution. Furthermore, the impact of influenza vaccination is likely greater than the direct observed vaccine effectiveness through indirect protection, where non-immune individuals are protected from illness because of reduced opportunities to acquire infection from individuals who received the influenza vaccine. The magnitude of this effect and the contribution from various vaccination strategies remains unclear.

Mathematical modeling can provide quantitative assessments for the above topics by estimating the impact of different interventions both separately and together, highlighting the importance of key decisions or assumptions, or simulating influenza seasons or countermeasures with differing characteristics (Gambhir 2015). For example, the benefits of a vaccination campaign can vary depending on the timing of administration, the administration rate, the targeted population, and the vaccine effectiveness; modeling can quantify the effect of each. When providing these assessments, modeling groups can take multiple approaches to estimate the impact. Results can vary between models, depending on the methods (e.g., agent-based, compartmental), structure (e.g., age-stratified, risk-stratified), and model assumptions or inputs used (e.g., attack rates) (Gambhir 2015).

Currently, there are no formal, long-term methods to engage with multiple modeling groups to develop or modify mathematical models related to the prevention and control of influenza using a set of common inputs, assumptions, or methods to validate and synthesize the resulting outputs. This would produce a more robust evidence-base to inform policy development or the public health response. To this end, CDC seeks to establish a network of Modeling Centers that facilitates: 1) the real-time sharing of standard modeling assumptions and inputs; and 2) compares validated mathematical modeling results to inform influenza prevention and control decisions in both seasons and pandemics. This effort will identify results from distinct modeling approaches that are similar and different; advancements in the rapid sharing of modeling assumptions and the results from multiple models will improve the public health response and inform policy development.

Healthy People 2020 and other National Strategic Priorities Preparedness Goal: To strengthen and sustain communities' abilities to prevent, protect against, mitigate the effects of, respond to, and recover from incidents with negative health effects. https://www.healthypeople.gov/2020/topics-objectives/topic/preparedness Immunization and Infectious Diseases Goal: Increase immunization rates and reduce preventable infectious diseases. https://www.healthypeople.gov/2020/topics-objectives/topic /immunization-and-infectious-diseases This NOFO aligns with these strategic priorities by supporting applied research that will develop, harmonize, validate, synthesize, and communicate multiple mathematical models and their results for seasonal and pandemic influenza prevention and control strategies, including influenza vaccination and treatment.

Public Health Impact https://www.healthypeople.gov/2020/topics-objectives/topic/preparedness https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases

This NOFO intends to fund Modeling Centers to conduct modeling research that will develop, advance, and apply mathematical models to investigate the usefulness and impact of prevention and control strategies for seasonal and pandemic influenza and improve the evidence base for public health action and policy development.

Relevant Work

Centers for Disease Control and Prevention. Disease Burden of Influenza. 2018. https ://www.cdc.gov/flu/about/burden/index.html

Centers for Disease Control and Prevention. Influenza Antiviral Medications: Summary for Clinicians. https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm.

Gambhir M, Bozio C, O'Hagan JJ, Uzicanin A, Johnson LE, Biggerstaff M, Swerdlow DL. Infectious disease modeling methods as tools for informing response to novel influenza viruses of unknown pandemic potential. Clinical Infectious Diseases. 2015.

Apr 10;60 (suppl_1):S11-9.

Grohskopf LA, Sokolow LZ, Broder KR, Walter EB, Fry AM, Jernigan DB. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices-United States, 2018-19 Influenza Season.

MMWR Recomm Rep 2018;67(3):1–20.

US Department of Health and Human Services (HHS). Pandemic Influenza Plan 2017 Update. Washington, DC: 2017. Available online at https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf

2. Approach The proposed approach will establish Modeling Centers that each involve multiple modeling experts led by a Principal Investigator. Awardee institutions will work together to plan, initiate, complete, evaluate, analyze, and report out accomplishments and/or findings of the project. The Modeling Centers will work to identify key questions, similarities and differences in results from distinct modeling approaches, advancements in the rapid sharing of modeling assumptions, and the results from multiple models.

For the purposes of this NOFO, mathematical modeling is defined as methods that include the mechanism of transmission of infection from an infected to an uninfected host. These are distinct from most methods in epidemiology because they explicitly model the transmission process and, therefore, the cause of infection; a major risk factor for infection is the population infection prevalence itself. Examples include, but are not limited to, compartmental models, agent-based models, and network models. In order for modeling results to be appropriately used, decision-makers must understand the limitations of the data and methods used, the assumptions and inputs employed by the model, and how these choices affect the results.

Uncertainty and sensitivity analyses, model validation, and clear communication are crucial for the successful use of model results to inform public health decisions.

Applicants should submit evidence of their knowledge and experience in mathematical modeling, including their use of innovative methodologies and any previous participation working collaboratively in multi-institution modeling networks or consortiums.

https://www.cdc.gov/flu/about/burden/index.html https://www.cdc.gov/flu/about/burden/index.html https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf

Objectives/Outcomes Improve the public health response and inform policy development for seasonal and pandemic influenza by building a network of Modeling Centers to: 1) identify key questions surrounding the prevention and control of influenza and 2) facilitate the sharing of mathematical modeling approaches, assumptions, and inputs and the comparison of validated results.

Specific aims:

Identify key questions surrounding the prevention and control of influenza Develop new scientifically valid mathematical models or modify existing approaches to answer key questions identified with other Modeling Centers Develop methods to harmonize key modeling assumptions and inputs between Modeling

Centers Identify approaches for model verification (determining that a model has been correctly implemented) and validation (determining if the model is a reasonable representation of the actual system) between Modeling Centers

Develop a process to synthesize the results of multiple models Build a repository of validated modeling approaches and tools Publish scientific articles documenting individual models, results and applications, or the collective findings, of the Modeling Center network Develop communication products and data visualization methods to describe modeling results and uncertainty for federal and state public health officials.

Research activities for the above objectives should be done in collaboration with other Modeling Centers. Modeling questions will be based on CDC priorities and will be determined by the Modeling Center Steering Committee. Priorities are likely to focus on impact of influenza vaccination, antiviral treatment, and community mitigation in influenza seasons and pandemics, both separately and together. Modeling questions could include, but are not limited to:

Estimate the effects (both direct and indirect) of seasonal vaccination campaigns Identify the triggers and estimate the separate and joint effects for layered medical countermeasures (including vaccination and antiviral treatment) and community mitigation (including school closure) on the timing and impact of seasonal influenza or an emerging influenza pandemic

Develop and adapt modeling approaches that estimate the effects associated with antiviral treatment and chemoprophylaxis

Develop and adapt modeling approaches that assess the impact of observed declines in vaccine-induced immunity over an influenza season

Develop and adapt modeling approaches to estimate the effects of repeated seasonal influenza vaccination over a short (1 to 5 years), medium (5 to 10 years), and long (10+ year) time.

Develop and adapt modeling approaches to evaluate novel strategies that vary the use of different vaccination types (e.g., the broader use of high dose or adjuvanted influenza vaccines) or vaccination approaches (e.g., the administration of a second influenza vaccine within a season) during influenza seasons in the United States.

The anticipated outcomes of the proposed research should result in evidence that allows public health officials, policymakers, and the research community to:

Identify results from distinct modeling approaches that are similar and different Identify advancements in the rapid sharing of modeling assumptions and results across multiple Modeling Centers Identify standard methods for model validation Identify communication approaches and products that improve the understanding of influenza modeling results among the public health officials and policymakers Improve the modeling evidence-base for seasonal and pandemic influenza prevention and control

Target Population The target population is all residents of the U.S. and U.S. territories.

Collaboration/Partnerships Numerous methods and data sources may be used to create mathematical models for key seasonal and pandemic influenza questions. In addition, expertise in data visualization and scientific communication may be necessary to advance methods in the communication of models. Therefore, it is expected that this project will bring together multiple groups to ensure that a wide variety of methods can be evaluated and synthesized as part of the project. A well-developed Steering Committee is integral to the program's success. Principal Investigators from each awardee institution will act as network representatives on the Steering Committee. The Steering Committee, with technical and programmatic input from CDC Project Officers/Program Officials, will work collaboratively to serve in an advisory role to the Modeling Center Network, as needed, but will not serve as an advisory committee to the CDC.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5)-year research project period. The application should outline specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project plan, and describe the development and implementation of project performance measures based on specific programmatic objectives.

Some performance measures may be in year one (1), but not in succeeding years, and others may be in subsequent years only. The performance measures should be closely tied to the pertinent strategies, activities, and outcomes. There may be both qualitative and quantitative data collected for evaluation purposes.

Overall, reports summarizing the progress and short-term outcomes of each project will be submitted, at a minimum, on an annual basis. Performance measures may include:

Descriptions of methods to harmonize key modeling assumptions and inputs between Modeling Centers

Descriptions of verification and validation of influenza models developed or updated as a result of this NOFO

Descriptions of methods to synthesize the results of multiple models The number of modeling summaries and results submitted to CDC and other funded

Modeling Centers The number of manuscripts documenting models and applications resulting from the

NOFO

Descriptions of communication products and data visualizations appropriate for federal and state public health officials

Applications should describe an evaluation plan that includes methods or metrics to evaluate progress toward completion of the objectives and specific aims identified in the application, including the development of peer-reviewed articles that report on outcomes from completion of research objectives, and presentation of findings and outcomes from progress toward completion of research objectives at meetings and conferences.

Translation Plan Applications should provide a plan for the routine sharing of modeling methods, inputs, and results with CDC and other Modeling Centers as well as the presentation of research findings at appropriate scientific meetings and for publication in peer-reviewed literature. In addition, relevant findings should be made available to federal, state, and local public health officials.

The anticipated outcome of the proposed research should facilitate the rapid sharing of mathematical modeling approaches, assumptions, and inputs and the comparison of validated results to inform public health decisions and policy development during both influenza seasons and pandemics. These decisions and policies may include the development and use of pharmaceutical (e.g., vaccine and influenza antivirals) and non-pharmaceutical (e.g., school closures and social distancing, travel restrictions) countermeasures and the use of Strategic National Stockpile assets (e.g., ventilators).

Applicants funded under this NOFO are expected to work collaboratively toward core data collection measures and methods that will enable the rapid sharing of mathematical modeling approaches, assumptions, and inputs and the comparison of validated results. Consistent with achieving the goals of the program, steps are expected that enable sharing of research findings with the broader research and public health communities. Applications are expected to provide a well thought-out plan for sharing the data and resources generated by the research project. After all awards have been made, the Steering Committee, composed of members of the funding agencies and the individual project teams, will develop a unified protocol for data and resource release. The Steering Committee, with technical and programmatic input from CDC Project Officers/Program Officials, will work collaboratively to serve in an advisory role to the Modeling Center Network, as needed, but will not serve as an advisory committee to the CDC.

Section II. Award Information Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $9,375,000 Estimated Total Annual Budget Period Funding (including direct and indirect costs):

Year 1: $1,875,000 Year 2: $1,875,000 Year 3: $1,875,000 Year 4: $1,875,000 Year 5: $1,875,000 Estimated total funding available for the entire five (5)-year period of performance, including direct and indirect costs: $9,375,000

Anticipated Number of Awards: 5 The award ceiling and floor are for the first 12-month budget period only.

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $375,000 Per Budget Period Award Floor: $300,000 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required.

Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs):

FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A

FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8 -44f2-43df-a0e7-9f379e8c48ed

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility Nonprofit private institutions of higher education The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Nonprofit Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

4. Justification for Less than Maximum Competition N/A

5. Responsiveness N/A

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https:// eportal.nspa.nato. int/ AC135Public/ Docs/ US%20Instructions%2 0for%20NSPA%20NCAGE.pdf https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed https://dap.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=5e3079b8-44f2-43df-a0e7-9f379e8c48ed https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its https://www.sam.gov/portal/SAM https://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons https://www.grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html

DUNS number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms.

Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Letters of Support from partner organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please include all of the eight (8) mandatory forms listed below in the application package:

Mandatory

1. SF424(R&R)[V2.0];

2. PHS 398 Cover Page Supplement [V4.0];

3. Research and Related Other Project Information [V1.4];

4. Project/Performance Site Location(s) [V2.0];

5. Research and Related Senior/Key Person Profile (Expanded) [V2.0];

6. Research and Related Budget [V1.4];

7. PHS 398 Research Plan [V4.0];

8. PHS Human Subjects and Clinical Trials Information [V1.0].

Please include the one (1) optional form listed below, if applicable, in the application package:

Optional

1. R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT.

3. Letter of Intent Due Date for Letter of Intent: 09/16/2019

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. “Overview Information”, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s)

Names of other key personnel Participating institutions Number and title of this notice of funding opportunity (NOFO)

The letter of intent should be sent to:

Gregory Anderson, MPH, MS Extramural Research Program Office Office of the Associate Director of Science National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, Mailstop US8-1 Atlanta, GA 30333 Telephone: 404-718-8833 Fax: 404-718-8822 Email: GAnderson@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/generalforms-e.pdf and https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf requirements of the NOFO.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation and Approach. Describe the proposed research plan, including staffing and time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here:

https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• A description of the data to be collected or generated in the proposed project;

• Standards to be used for the collected or generated data;

• Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights -this section should address access to identifiable and de-identified data);

• Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use;

and

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf data).

Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

Letters of Support from partner organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please note: According to the Additional Requirement-25 (AR-25) (https://www.cdc.gov/grants /additionalrequirements/ar-25.html), investigators who plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application as follows:

The DMP must describe how investigators will make data readily available. Investigators who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds. A Data Management Plan (DMP) is required for each collection of public health data proposed. The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include the following five elements:

A description of the data to be collected or generated in the proposed project;

Standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);

Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and de-identified data).

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

* PLEASE NOTE all page limitations in this NOFO. Pages over the limit will be removed and not peer reviewed, possibly negatively impacting the overall impact score and funding.

7. Page Limitations All page limitations described in this individual NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 15 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices.

https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php…