PKG00250691-instructions.pdf

Centers for Disease Control

National Center for Immunization and Respiratory Diseases Extramural Research Program

Office

Epidemiology, Prevention, and Treatment of Influenza and Other Respiratory Infections in

Panama and Other Countries in the Americas

RFA-IP-20-001

Application Due Date: 07/08/2019

Epidemiology, Prevention, and Treatment of Influenza and Other Respiratory Infections in

Panama and Other Countries in the Americas

RFA-IP-20-001

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 Epidemiology, Prevention, and Treatment of Influenza and Other Respiratory Infections in Panama and Other Countries in the Americas Activity Code U01 – Research Project - Cooperative Agreement

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

RFA-IP-20-001

Assistance Listings (CFDA) Number(s) 93.185 93.083 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to strengthen the capacity in Panama, and other countries in the Americas, to detect, describe, and conduct studies on influenza and emerging and re-emerging infectious diseases of public health importance; to improve risk assessment and evaluate new diagnostics, vaccines, and other interventions that may offer approaches toward the prevention or treatment of influenza and other emerging and re-emerging infectious diseases. The scope of the research performed should include, but is not limited to, activities that: a) determine the impact of influenza among vulnerable populations in the Americas and b) support and guide seasonal epidemic and pandemic influenza prevention and control studies. Research activities for the prevention and control of influenza viruses (including those with pandemic potential) and pandemic preparedness should aim to prevent and control the spread and transmission of novel influenza viruses to other countries, including the United States.

Key Dates Publication Date: To receive notification of any changes to RFA-IP-20-001, 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.

https://www.grants.gov

Letter of Intent Due Date: 06/07/2019

Application Due Date: 07/08/2019

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: 08/13/2019

Secondary Review: 08/27/2019

Estimated Start Date: 11/01/2019

Expiration Date: 07/09/2019 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted 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 strengthen the capacity in Panama, and other countries in the Americas, to detect, describe, and conduct studies on influenza and emerging and re-emerging infectious diseases of public health importance; to improve risk assessment and evaluate new diagnostics, vaccines, and other interventions that may offer approaches toward the prevention or treatment of influenza and other emerging and re-emerging infectious diseases. The scope of the research performed should include, but is not limited to, activities that: a) determine the impact of influenza among vulnerable populations in the Americas and b) support and guide seasonal epidemic and pandemic influenza prevention and control studies.

Research activities for the prevention and control of influenza viruses (including those with pandemic potential) and pandemic preparedness should aim to prevent and control the spread and transmission of novel influenza viruses to other countries, including the United States.

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 $5,000,000. The anticipated number of awards is one. An award issued under this NOFO is contingent upon the availability of funds and a sufficiently meritorious application. Because the nature and scope of the proposed research will vary, it is also anticipated that the size and duration of the award may also vary. The total amount awarded will depend upon the quality, duration and cost of the application received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $1,000,000 with an individual award ranging from $500,000 to $1,000,000 for the first year. The estimated total funding (direct and indirect) for the entire project period is $5,000,000. The project period is anticipated to run from 10/15/2019 to 10/14/2024.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement. PLEASE NOTE the page limits described throughout sections of this NOFO. Pages in excess of these limits may be removed before peer review; this may negatively affect the overall impact score given to the application and subsequent funding decisions.

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.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 307 of the Public Health Service Act, [42 U.S.C. §242l], as amended.

1. Background and Purpose Purpose: The National Center for Immunization and Respiratory Diseases (NCIRD), Influenza Division (ID), seeks to initiate a cooperative agreement with the Gorgas Memorial Institute for Health Studies (GMI) in Panama. The purpose of this collaboration is to strengthen the capacity in Panama, and other countries in the Americas, to detect, describe, and conduct studies on influenza and emerging and re-emerging infectious diseases of public health importance; to improve risk assessment, and to evaluate new diagnostics, vaccines, and other interventions that may offer approaches toward the prevention or treatment of influenza and emerging and re-emerging infectious diseases. The scope of research performed should include, but not be limited to, activities that: a) determine the impact of influenza among vulnerable populations in the Americas and b) support and guide seasonal epidemic and pandemic influenza prevention and control studies. Research activities for the prevention and control of influenza viruses (including those with pandemic potential) and pandemic preparedness should aim to prevent and control the spread and transmission of novel influenza viruses to other countries, including the United States.

Background: Influenza virus’ ability to acquire mutations increases the likelihood for pandemics to occur. Although it was predicted that the next influenza pandemic would emerge in Southeast Asia (following reports of H5N1 and H9N2 infections in the late 1900’s), in 2009, the first influenza pandemic of the 21st century began in the Americas (Veracruz, Mexico) and resulted in approximately 18,000 deaths worldwide. This pandemic disproportionately affected certain communities and countries and further highlighted the need to establish cohorts to better understand risk factors for severe influenza and other respiratory infections such as age, underlying medical conditions, malnutrition, co-infection with other pathogens, and environmental exposures. It also highlighted the need to develop trials to evaluate influenza vaccine efficacy, effectiveness, cost-effectiveness and the impact of other potential influenza prevention or treatment strategies, such as antiviral medications.

CDC’s Influenza Division has collaborated with GMI for more than five years. Some of the activities performed during this collaboration included the establishment of two cohort platforms that followed pregnant women and their children, as well as the initiation of the evaluation of cognitive developmental problems in children born to women exposed to respiratory pathogens during pregnancy. Although recent publications indicate that clinical and biological markers of inflammation in the first five years of life are significantly associated with poor neurodevelopmental outcomes (Jiang, et.al. BMC Pediatr. 2014 Feb 18;14:50. doi: 10.1186/1471- 2431-14-50), further research is needed to evaluate the longevity of this prevalence.

In the Americas, Panama is uniquely positioned for: a) the conduct of implementation research to assess risks associated with seasonal and novel influenza viruses and b) evaluating the benefits and effectiveness of influenza vaccination and other prevention strategies in vulnerable populations. GMI, in Panama, houses a WHO-designated National Influenza Center; as such, GMI is required to routinely perform WHO and CDC proficiency panels, share viruses with international WHO Collaborating Centers for Influenza and the Global Influenza Surveillance and Response System, and maintain the capacity to rapidly identify novel viruses such as, but not limited to, influenza A (H5N1) and A (H7N9) through the use of molecular biology. Further, as noted above, GMI follows two separate cohorts of pregnant women and their children (in Panama and El Salvador), which allows investigators both at CDC and Panama to evaluate the incidence and subsequent impact of newly emerging pathogens in the region (e.g., Zika). Lastly, the country of Panama has also been a pioneer in the promotion of influenza vaccination, as noted in 2016, when the Panama Government announced that it would make nearly one million more doses of vaccine available to the community following an A (H1N1) outbreak that resulted in 22 deaths.

These actions, along with widespread communication messages, significantly increased awareness and uptake of the influenza vaccine in the community.

Despite these advances, information on risk of influenza and effectiveness of influenza vaccination and other prevention measures in vulnerable populations (e.g., pregnant women, persons with underlying medical conditions, the elderly, infants, and healthcare workers), is still limited in the Americas. Addressing these gaps should inform global assessment of the risks posed by novel influenza viruses with pandemic potential, and decisions about the need for influenza vaccine development, procurement, and stockpiling for target groups. Enhanced surveillance, program evaluation, and research, conducted as part of this cooperative agreement, seeks to fill these gaps in our understanding of seasonal and novel influenza epidemiology in the Americas.

Healthy People 2020 and other National Strategic Priorities This program addresses the “Healthy People 2020” focus area(s) of Immunization and Infectious Diseases and is in alignment with NCIRD’s performance goal(s) to protect Americans from infectious diseases and addresses CDC’s Public Health Priorities including: 1) the improvement of health security at home and around the world by detecting presence of novel viruses; 2) prevent leading causes of illness, injury, disability and death by evaluation influenza vaccination practices in the Region; and 3) strengthen public health and healthcare collaboration by partnering with international organizations that specialize in these research areas.

Public Health Impact This program is intended to strengthen influenza surveillance and generate data elements for regional health authorities to better time influenza prevention and control, determine the value of various influenza prevention and control strategies, and ultimately assist countries in the Americas to better mitigate the impact of influenza epidemics on populations most at risk of developing severe complications as a result of illness.

Relevant Work Under a previous funding opportunity announcement (RFA-IP-13-002), investigators at the Gorgas Memorial Institute for Health Studies (GMI) in Panama collected data from an established cohort of pregnant women and children to evaluate: 1) the incidence of respiratory viruses among pregnant women and children in two communities; 2) incidence of psychomotor and cognitive development problems in children following their mother’s exposure to respiratory infections during pregnancy; 3) Knowledge, Attitudes, and Practices regarding influenza vaccination during pregnancy; and 4) Knowledge, Attitudes and Practices regarding Zika virus and exposure.

Further, despite regional establishment of influenza vaccination policies across member states in the Americas, a recent publication by the Pan American Health Organization (WHO-PAHO) concluded that seasonal influenza vaccine use in the Americas remains low, with almost half of the countries reporting coverages of <35% among one or more risk groups including children, elderly adults, pregnant women, and healthcare workers (https://www.paho.org/hq/index.php ?option=com_docman&;view=download&;category_slug=brochures-1581&;alias=42190-immun ization-in-the-americas-2018-summary&;Itemid=270&;lang=en). This low coverage further highlights the need to better understand factors contributing to the lack of influenza vaccination in the Americas.

2. Approach Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

To accomplish the goals of this NOFO, the applicant organization should submit a research application that addresses one or more of the public health issues and priorities identified under the Objectives/Outcomes outlined below:

Objectives/Outcomes

Estimate the incidence of acute lower respiratory tract infections and the fraction attributable to influenza virus and other pathogens among groups at high risk for influenza or other infectious diseases o Evaluate modifiable risk factors for illness and characterize disease by using different methodologies, including longitudinal cohort studies (e.g., among persons infected with HIV, tuberculosis, or malaria, indigenous people, etc.)

Identify and evaluate clinical predictors and risk factors for severe influenza and other respiratory infections such as age, underlying medical conditions, malnutrition, co-infection with other pathogens and environmental exposures in target populations

Define burden of disease caused by influenza and other infectious diseases that may include estimates of morbidity and/or mortality, demands on the health care system, and direct and indirect economic costs

Conduct trials to evaluate influenza vaccine efficacy, effectiveness, cost-effectiveness, and the impact of other potential influenza prevention or treatment strategies such as https://www.paho.org/hq/index.php?option=com_docman&view=download&category_slug=brochures-1581&alias=42190-immunization-in-the-americas-2018-summary&Itemid=270&lang=en https://www.paho.org/hq/index.php?option=com_docman&view=download&category_slug=brochures-1581&alias=42190-immunization-in-the-americas-2018-summary&Itemid=270&lang=en https://www.paho.org/hq/index.php?option=com_docman&view=download&category_slug=brochures-1581&alias=42190-immunization-in-the-americas-2018-summary&Itemid=270&lang=en antiviral drugs Conduct studies on the immune response to influenza virus infection and influenza vaccines including timing of vaccination in target populations Assess and monitor antimicrobial resistance of influenza viruses and infectious disease agents Evaluate prevalence of psychomotor and cognitive development problems in children following mothers’ exposure to respiratory infections during pregnancy Assess factors influencing vaccination uptake among various at-risk groups, including health care workers Conduct training and capacity building in influenza, influenza preparedness, and other respiratory pathogen surveillance in the Americas

Target Population Persons of Panama and other Member States in the Americas, including countries in the Caribbean Public Health Agency (CARPHA) or Caribbean Region.

Collaboration/Partnerships The application should demonstrate partnerships with Regional Ministries of Health and Agriculture, academic institutions, the Council of Ministers of Health from Central America and Dominican Republic (COMISCA), the Pan American Health Organization (PAHO) and/or others and provide details of cooperative activities and program support through formal or informal agreements. Demonstrations can be provided through formal or informal communications, letters or other correspondence.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5)-year project period.

The application should include 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.

Applicants must track proposed cooperative agreement study activities and project milestones as part of the award. CDC will monitor progress toward study outcomes of the project though meetings, discussions, conferences or other agreed upon means.

PI’s of funded applications must submit an annual progress report showing project activities and outcomes based on the overall research goals and timeline. For more information on required Reporting, please see Section VI. of this NOFO.

Translation Plan When relevant to the goals of the research project, the application should describe how significant findings might be used to promote, enhance, or advance translation of the research to inform policy or practice. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The application should identify the research findings that may be translated to inform public health policy or practice and how the findings may be adopted in public health settings. This section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, the application should describe how the results of the proposed project could be generalized to populations and communities outside of the study.

Questions to consider in preparing this section include:

How will the scientific findings be translated to inform public health policy or practice?

How will the project improve or effect the translation of research findings to inform policy or practice?

How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?

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: $5,000,000 Estimated Total Fiscal Year Funding:

Year 1: $1,000,000 Year 2: $1,000,000 Year 3: $1,000,000 Year 4: $1,000,000 Year 5: $1,000,000 Estimated total funding available for first 12-month budget period, including direct and indirect costs: $1,000,000 Estimated total funding available for the entire project period, including direct and indirect costs: $5,000,000

Anticipated Number of Awards: 1 The ceiling and floor amounts below 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: $1,000,000 Per Budget Period Award Floor: $500,000 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: Others (see text field entitled "Additional

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int/AC135 Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf.

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Additional Information on Eligibility:

Single Source Competition http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf

The eligible applicant is:

Gorgas Memorial Institute for Health Studies (GMI) Ave. Justo Arosemena y Calle 35 APDO. 0816-02593 Panama, Rep. de Panama

4. Justification for Less than Maximum Competition Within the larger mission of the CDC's National Center for Immunization and Respiratory Diseases, the Influenza Division works to improve global control and prevention of seasonal and novel influenza disease and improve pandemic preparedness and response. To accomplish this goal, CDC collaborates with domestic and global partners to monitor and assess influenza viruses and illness and improve vaccines and other intervention programs. Investment and partnership with World Health Organization Coordinating Centers (WHO CC) and Pan American Health Organization (PAHO) countries and centers is necessary to obtain information about circulating influenza strains and other emerging or re-emerging infectious diseases in the Central American, South American, and Caribbean Regions. Collaborative research, with technically advanced institutions in the Americas, provides necessary access to global infectious disease data, allows CDC to assess potential threats from novel influenza strains, and informs United States vaccine policy.

Eligibility for this funding opportunity is limited to the Gorgas Memorial Institute for Health Studies (GMI)(i.e., the Instituto Conmemorativo Gorgas de Estudios de la Salud in Panama) because projects identified in this funding opportunity will utilize, and build upon, research data and outcomes generated by GMI from a previous award under RFA-IP-13-002. GMI established, and continues to follow, cohorts of women in both Panama and El Salvador who were potentially exposed to influenza and Zika viruses during pregnancy. Further, GMI also established, and continues to follow, cohorts of children born to these women. The continued follow up of these cohorts is necessary to answer research questions initiated in the previous NOFO, and continued in this NOFO, including the evaluation of the prevalence of psychomotor and cognitive development problems in children born to women in this cohort. Preliminary data indicate possible associations between viral infection of these women during pregnancy and psychomotor and cognitive development in their children. Access to and continued follow up of these cohorts over time is necessary to develop appropriate interventions to prevent or treat such outcomes in children internationally, and to complement studies of viral infections of pregnant women and their babies in the US.

The GMI is an executing unit of the Panamanian Ministry of Health and, as such, functions to improve the health of Panama and Central American countries. Its mission is to develop health research in Panama, to fulfill the functions of a national public health laboratory, and to provide education to healthcare workers in the region. Further justifications that support limiting eligibility to GMI include:

GMI is the only technically qualified laboratory in the Central American Region, recognized by the World Health Organization (WHO) as a National Influenza Center in the Global Influenza Surveillance and Response System, that can perform the sophisticated analyses necessary to quantify influenza burden of disease.

GMI is the leading research institute and the National Health Laboratory (National

Reference Center) in Panama.

GMI established and continues research agreements and research projects with academic centers in the US and strong links with the epidemiology programs of countries in Central and South America and the Caribbean, and with institutions such as the World Health Organization (WHO), the US Centers for Disease Control and Prevention (CDC), and the Smithsonian Tropical Research Institute.

GMI has the only National Influenza Center (NIC) existing in Panama, which is responsible for a national laboratory-based influenza surveillance network. GMI is responsible for collecting influenza specimens and for performing the following assays prior to shipment to WHO CC in Atlanta: immunofluorescence, molecular biology (RT- PCR), viral isolation, hemagglutination inhibition, and cell culture. The average number of samples processed at GMI in a given year is 1,872. In addition to serving as the NIC for Panama, GMI also oversees a Regional Laboratory with PCR capacity, which further increases the number of samples that can be processed using highly sensitive assays.

GMI increased its virology diagnostic capacity to strengthen surveillance for viruses in Panama and Central America and developed a Regional Training Center for community healthcare workers in the Central American Region.

GMI possesses the scientific and managerial capability to meet program requirements, without jeopardizing or compromising the quality of the research and other activities.

GMI is conveniently located in Central America and has adequate space, including office space, laboratories, meeting space, and the capacity to expand to accommodate additional staff, as well as an advanced communications network.

Gorgas Memorial Institute for Health Studies (GMI) is the only institute in Central America that has access to the established cohorts of pregnant women exposed to influenza and Zika (during the Zika outbreak) and their children in Panama and El Salvador. This is a critical factor for ensuring the success of project objectives and the potential for reducing morbidity and mortality in children of pregnant women exposed to respiratory infectious diseases. GMI has established the required infrastructure and networks to carry out this work, possesses the necessary WHO and PAHO credentials, has an executing connection to the Panamanian Ministry of Health, and possess the required scientific and technical expertise. If GMI is not approved as a single eligibility recipient for this award, the significant gains achieved during the prior studies under RFA-IP-13-002 would be lost, along with project continuity. The Agency would need to expend significant additional cost, effort, and time (years) to reconstitute suitable cohorts for similar studies in these countries. Potential interventions, including reducing morbidity and mortality in the cohorts currently enrolled, would be jeopardized.

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

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 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 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 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.

https://www.sam.gov/index.html 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

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 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.

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: 06/07/2019 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 assists CDC staff in planning the peer 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 Institution Descriptive title of proposed research 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

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, MS E-60 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:

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf 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

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 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:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

• 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

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf 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 https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php https://www.cdc.gov/grants/additionalrequirements/ar-25.html submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application.

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 may be removed and not peer reviewed, possibly negatively affecting the overall impact score and funding decisions.

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 25 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.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted 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.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates.