oppRFA-GH-18-004-cfda93.326-cidRFA-GH-18-004-instructions.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Advancing Public Health Research in Central America (Belize, Costa Rica, Dominican

Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama)

RFA-GH-18-004

Application Due Date: 03/09/2018

Signature Date

Advancing Public Health Research in Central America (Belize, Costa Rica, Dominican

Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama)

RFA-GH-18-004

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 Center for Global Health Extramural Research Program Office (CGH ERPO) Center for Global Health (CGH) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) National Center for Immunization and Respiratory Diseases (NCIRD) National Center on Birth Defects and Developmental Disabilities (NCBDDD) Office of Infectious Diseases (OID) Office of Public Health Preparedness and Response (OPHPR) Notice of Funding Opportunity (NOFO) Title Advancing Public Health Research in Central America (Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama) Activity Code U01- Cooperative Agreements

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

RFA-GH-18-004

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.326 Category of Funding Activity:

Health NOFO Purpose The purpose of this cooperative agreement is:

To conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research of important human diseases in Central America (Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama) including but not limited to acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats.

To incorporate the results of research activities into operational disease detection, prevention, and response or control programs in the Central American Region and ensure increasing local workforce capacity and sharing of findings across the region and with partners.

Other areas for research include emerging and re-emerging infectious diseases, zoonotic and vector borne diseases, environmental health issues effecting infectious diseases such as water and air), neglected tropical diseases, maternal and child health, birth defects and developmental disabilities, vaccine- preventable diseases, bio-safety, injury control and prevention, and other public health threats of local importance.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-18-004, 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: 02/08/2018

Application Due Date: 03/09/2018

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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: 04/09/2018

Secondary Review: 05/07/2018

Estimated Start Date: 09/15/2018

Expiration Date: 03/09/2018 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions 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 20 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 https://www.grants.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

The purpose of this Notice of Funding Opportunity (NOFO) is: to conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research of important human diseases in Central America (Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama) including but not limited to acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats; to incorporate the results of research activities into operational disease detection, prevention, and response or control programs in the Central American Region and ensure increasing local workforce capacity and sharing of findings across the region and with partners; and, to include other areas for research such as emerging and re-emerging infectious diseases, zoonotic and vector borne diseases, environmental health issues, neglected tropical diseases, maternal and child health, birth defects and developmental disabilities, vaccine-preventable diseases, bio-safety, injury control and prevention, and other public health threats of local importance.

• Mechanism of Support: Cooperative Agreement

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire or 5 year project period is $45,000,000. The number of awards will be up to seven (7). 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 budget of the applications received.

• Budget and Project Period:

- Budget Period- 9/15/2018- 9/14/2019.

- Project Period- 9/15/2018- 9/14/2023.

• The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $5,000,000 with individual awards ranging from $100,000 to $500,000 for the first year.

The estimated total funding (direct and indirect) for the entire project period will be $45,000,000. The project period is anticipated to run from 9/15/2018 to 9/14/2023.

• 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.1 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 (1) PD/PI for each application.

• Number of Applications. Only one (1) application per institution (normally identified by having a unique DUNS number) is allowed.

• Application Type. New.

• Special Date(s). Applicant Call- January 17, 2018 at 1:00pm Central America. Phone number:

1-866-6924538, passcode: 69443761#.

• Application Materials. See Section IV.1 for application materials. Please note that Form E is to be used when downloading the application package.

• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1-888- 232-6348

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 307 of the Public Health Service Act [42 USC 242l], as amended and Section 301(a) of the Public Health Service Act [42 USC 241(a)], as amended.

1. Background and Purpose The Central America Region is comprised of Belize, Guatemala, El Salvador, Honduras, Nicaragua, Costa Rica, Panama and the Dominican Republic. The population of 54.8 million people is divided unequally, with 350,000 people living in Belize at the low end and 14.9 million in Guatemala at the highest population level. The region has a substantial rural population that is becoming more urbanized. Every country in the region is classified as a low or upper-middle income country by the World Bank.

Despite progress made in the last decade, Central America and the Dominican Republic are characterized by deep social inequalities, with large segments of the population living in vulnerability and exclusion, limited access to health, education, housing and employment.

Access to improved water supply is generally high, but access to improved sanitation is as low as 36% in Guatemala. Persons below average weight (underweight) is an ongoing issue in most Central American countries. However, birth rates are typical for middle-income countries.

Central American health systems are highly fragmented, and as a result, there is low quality of care for much of the population, inefficient use of resources, and a high burden (of disease).

In addition to urbanization, the population of Central American nations are quite mobile; people are often moving between and through countries in the region. In addition to high numbers of visitors and legal immigrants to the United States, in recent years, violence, poverty, and other social stressors have resulted in highly-publicized illegal migration.

Infectious diseases such as influenza, Chagas’ disease, leptospirosis, Chikungunya, Zika, malaria, typhoid fever, rabies, and many others are endemic in all or part of Central America.

Challenging geography, poor infrastructure, and weak health systems increase Central Americans risks of severe morbidity and mortality from those infections. Limited capacity to detect and identify pathogens causing syndromes such as Acute Febrile Illness (AFI) results in limited surveillance and knowledge of the burden of various health threats. National governments in Central America do not have the information needed to prioritize scarce resources; and, interventions to prevent and control diseases of significance in the region are lacking in many areas.

The Centers for Disease Control and Prevention (CDC), Central America Regional Office’s mission is to protect and promote health in the region through collaboration with partners on science, policy, and evidence-based public health actions, thereby improving global health security. The CDC Central America Regional Office works in close partnership with governments in the region, as well as other local, national, and international partners to improve the understanding and prevention of disease, and to improve the region’s health systems, and epidemiologic and laboratory capacity to study and prevent diseases. Building such public health capacity in partner countries for public health science, surveillance, laboratory expertise and implementation of prevention measures and rapid response to disease threats through collaborative efforts will impact the health and well-being of people around the world and keep Americans safe and healthy.

The goal of this NOFO is to:

1. Study and report on the epidemiology, transmission and causes of infectious agents and their vectors in the Central American Region with an aim to understand trends and detect common pathogens of public health relevance;

2. Conduct research studies on the epidemiology and risk factors of agents for illness, hospitalization, and death in the population as a whole, and in vulnerable populations;

3. Improve capacity to detect the range of infectious organisms in the region through surveillance, response, and laboratory expertise including assessment of new modalities and approaches;

4. Assess effectiveness and evaluate programs of prevention, control, and treatment measures in the region;

5. Understand risk factors for, and burden of, disease caused by environmental hazards (such as toxins), and other diseases of interest in the region in order to inform the development and implementation of potential interventions; and,

6. Assess prevention measures and potential environmental factors (water, air, vectors) interacting with infectious disease for conditions of interest to the region.

Healthy People 2020 and other National Strategic Priorities While Healthy People 2020 is not applicable, this NOFO aligns with other national and current CDC strategic priorities including: strengthening surveillance, epidemiology and laboratory services; supporting public health activities; evaluating public programs; conducting operational research; increasing global health impact; increasing impact on public health policy; preventing illness, injury disability and death; and ensuring Global Health Security through understanding and preventing global health threats before they occur and minimizing those threats nationally, regionally and globally.

As continued progress in public health preparedness is challenged by the current economic times, an eroding public health infrastructure worldwide, and the ever increasing threat of bioterrorism and emerging infectious diseases, applications funded under this NOFO will have a positive impact and reduce the burden on public health resources by addressing the following CDC strategic priorities and initiatives for the broader public health community.

1. Prevent and mitigate threats to the public health of the global community by increasing public health involvement in national and global health security efforts and advancing the ability to measure and address gaps in public health preparedness.

2. Advance surveillance, epidemiology, and laboratory science through the integration of public health preparedness and response data, reporting systems and processes, and increasing the effectiveness of surveillance, epidemiology, and laboratory science research through the application of novel approaches using advanced equipment, modeling approaches, and public health tools.

3. Strengthen public health preparedness and response infrastructure through the development of sustainable public health system capacities (e.g., laboratory, communications, health information, emergency operations centers, response and support staff, and information technology infrastructure) for preparedness and response, and continuously assessing the adequacy of these systems and associated infrastructure.

4. Increase the application of public health science to preparedness and response practice by expanding knowledge that contributes to the reduction/mitigation of threats to the public’s health, and through the development of tools and promising practices, to improve public health preparedness and response practice.

5. Improve the ability of the public health workforce to respond to health threats by enhancing public health preparedness and response workforce competencies.

Public Health Impact The Central America Region is home to 54 million people at risk of severe disease from common illnesses, and at risk for emerging and re-emerging infectious diseases and other health threats. Understanding the spectrum of etiologies of clinical syndromes, risk factors for infection and severe disease, and the effectiveness and advantages of prevention and control programs is key to advancing public health in this region. The intention of the NOFO is to provide a positive health impact through conducting excellent public health research in infectious and non-infectious diseases that can guide stakeholders to prioritize resources and implement health practices and policies to mitigate the impact of health threats on the population. Through better understanding of disease threats, and their control and prevention, morbidity and mortality may be lowered, and global health security increased.

Relevant Work CDC has worked in Central America for more than 40 years. The goal of the work continues to be to develop and strengthen systems that enable the countries in the region to identify and respond to emerging infections. CDC coordinates with local, regional, and global public health entities to rapidly detect, accurately identify, and promptly contain emerging disease threats.

Collaborations with regional partners have yielded important data on the burden of a broad range of infectious diseases, detection of poorly understood and novel pathogens, as well as causes and rates of mortality in the populations under surveillance. As a result of these collaborative efforts, there comes a strengthening the Ministries of Health (MOHs) public health capacity, primarily in collaboration with Departments of Epidemiology and Surveillance, the National Laboratories, the National Public Health Institutes, and other specific disease control programs.

CDC has several activities that support or relate specifically to this NOFO. Prospective applicants should refer to the following websites and related documents for additional information:

http://www.cdc.gov/globalhealth http://www.cdc.gov/globalhealth/gdder/gdd http://www.cdc.gov/globalhealth/gdder/who http://www.cdc.gov/globalhealth/ihregulations.htm http://www.cdc.gov/globalhealth/ghi http://www.cdc.gov/globalhealth/ghi/pdf/GHIStrategy.pdf https://www.cdc.gov/flu/international/program/index.htm

2. Approach

Objectives/Outcomes Applicants must propose activities that support or develop surveillance, public health–related research studies, and/or research activities that will promote, coordinate, and support technical aid activities. Research activities should be focused on the detection, prevention, response, and elimination of communicable diseases, zoonosis, and other emerging public health threats in the Central American Region.

Disease Areas Applicants may focus their application on one or more of the following eligible disease areas:

1. Acute febrile illness

2. Antimicrobial resistance (AMR) and/or hospital acquired infections (HAI) (i.e.

nosocomial or health care acquired infections)

3. Respiratory illness and influenza

4. Enteric illnesses

5. Other public health issues of regional and local importance

PROJECT CATEGORIES

Applicants must propose activities that focus on the disease area(s) selected in at least one of the following project categories. Examples of activities are provided under each project category:

Category A: Surveillance Projects Include conducting community or population-based surveillance research projects that will result in sustainable and scalable surveillance systems to produce evidence that guides public health interventions. Methods such as for innovative and improved pathogen detection and characterization or other methods are encouraged. Examples of surveillance projects are:

o Develop, maintain, or expand one or more surveillance systems in the Central American Region combining population-based and facility-based demographic, morbidity, and mortality surveillance designed to determine burden of disease, transmission dynamics, risk factors and control of infectious and toxic agents. A http://www.cdc.gov/globalhealth http://www.cdc.gov/globalhealth/gdder/gdd http://www.cdc.gov/globalhealth/gdder/who http://www.cdc.gov/globalhealth/ihregulations.htm http://www.cdc.gov/globalhealth/ghi http://www.cdc.gov/globalhealth/ghi/pdf/GHIStrategy.pdf https://www.cdc.gov/flu/international/program/index.htm multi-site system could include population/site diversity with regard to urban/rural, geography within or between countries, socioeconomic factors, etc.

o Support the development of laboratories and/or platforms used for etiologic investigation, evaluation of novel diagnostic assays for faster and easier detection, and characterization of pathogens, including point-of-care diagnostics.

o Develop, maintain and expand sentinel surveillance systems.

o Identify methods to improve efficiency, coverage, and quality of hospital-based laboratory confirmed disease surveillance in representative hospitals and outpatient clinics in the Central America Region.

o Conduct ongoing and systematic collection, analysis and interpretation of biological samples and data for both animal and human health in collaboration with Ministries of Health and Agriculture of Central America in order to strengthen surveillance at national and regional levels.

o Develop and further implement diagnostic tests for identification and characterization of pathogens.

Category B. Research Studies of Risk Factors, Burden, and/or Transmission Projects Include conducting research activities to identify modifiable risk factors for priority diseases through community and/or population-based observational or experimental research. Also included are research on disease burden, transmission or other factors related to risk. Research findings should be presented at international meetings and published in the peer-reviewed literature. Examples of risk factor and associated research studies are:

Conduct research to determine burden of morbidity and mortality, transmission dynamics, risk factors, and control of infectious and toxic agents in the Central American Region.

Conduct active surveillance and laboratory confirmation of pathogens to assess disease burden and the relative contribution of viral infections during pregnancy to the health and development of young children through utilizing an existing cohort.

Develop and implement research of existing and archived specimens in order to answer questions of public health importance.

Conduct qualitative socio-cultural research and surveys of knowledge, attitudes, and practices related to infectious disease and the acceptance of methods of prevention.

Estimate the relative contribution of different pathogens to disease syndromes to understand burden of disease and guide resource utilization.

Develop and/or maintain one or more clinical research sites to investigate and report the interactions between specific pathogens and underlying comorbidities.

Conduct research on the human-animal interface of zoonotic diseases and risks of transmission from animals to humans.

Provide innovative solutions identified through research to develop early warning systems to report sentinel organisms in humans that can serve as an alert for multidrug resistant organisms and interventions for adequate antimicrobials.

Project Category C -Effectiveness Research Includes research on interventions to prevent and control diseases of importance in the Central

American Region. These projects might use various designs and sources of data. The findings should be used to guide the development and/or improvement of national and regional policies and programs for disease prevention, monitoring and control. Examples of effectiveness research are:

o Develop cost of disease estimates and cost effectiveness estimates of priority diseases.

o Conduct operational research on public health program implementation and approaches to outbreak investigations, surveillance, and emergency preparedness and response.

o Conduct evaluations of vaccine programs in the Central America Region to determine coverage rates, barriers, best practices, and effectiveness.

o Conduct research to assess efficacy/effectiveness, immunogenicity and impact of vaccines, treatments, and non-pharmaceutical interventions and other control measures to reduce the burden of influenza disease among vulnerable populations.

o Conduct a systematic review of AMR/HAI activities in the Central American Region. This includes the development of a catalogue of research and public institutions working in AMR/HAI to include information on location, description of activities, populations served, and a summary of relevant publications in the last 5 years.

Conduct research to estimate the direct and indirect costs, and document the economic burden of priority diseases and interventions.

Target Population The target populations for this NOFO are those who are representative of the Central American Region in general, and/or are in high risk groups, such as pregnant women, children, low income persons, rural and/or urban informal housing populations.

Collaboration/Partnerships Applicants are expected to develop and maintain collaborations with key regional organizations, including but not limited to, the Pan-American Health Organization (PAHO), Consejo de Ministros de Salud de Centroamérica y República Dominicana (COMISCA), and research institutions.

Applicants must show evidence of support from Ministries of Health or other ministries as appropriate in any country in which activities are proposed.

Applications must include plans to involve local collaborators and improve local workforce capacity in design, conduct, data analysis and interpretation, and development of written research products (reports, manuscripts, presentations, etc.).

Applicants must develop and maintain collaborations with the Ministries of Health in the countries in which they work and with associated organizations for the execution of proposed activities. Projects must include plans for supporting the use of research findings by Ministries of Health.

Consortia of research institutes, health organizations and other relevant parties are encouraged but not required.

Evaluation/Performance Measurement As part of the application, the PI should include measurable goals and aims within the research project period. The awardee will establish specific, measurable, achievable, realistic, and time-phased (SMART) project objectives for each activity described in the applicant’s project plan, and develop and implement project performance measures that are based on specific programmatic objectives.

Translation Plan The Applicant should describe plans for how research and scientific findings will be reported and disseminated (e.g., peer-reviewed journals, scientific presentations, reports, meetings and conferences) and specify how these activities are integrated into the project plans. The translation of findings should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, health care institutions, professional organizations, community groups, researchers, and other potential users.

Questions to consider in preparing this section include:

1. How will the scientific findings inform governments in the Central American Region as well as, other stakeholders on needed public health policies or practices at the country and regional level

2. How will the research project improve or affect the translation of study findings into policy or practice?

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

4. How will the research findings advance or guide future scientific efforts or related activities?

5. How will the research activities improve public health outcomes, advance workforce development, and enhance response capacity?

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: $45,000,000 Year 1: $5,000,000 Year 2: $10,000,000 Year 3: $10,000,000 Year 4: $10,000,000 Year 5: $10,000,000

Anticipated Number of Awards: 7 Throughout the project period, CDC's commitment to continuation of awards will be conditional on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

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

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

Award Ceiling: $45,000,000 Per Project Period Award Floor: $100,000 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 (https://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: Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education

Additional Eligibility Category:

2. Foreign Organizations https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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 Experience working with ministries of health, academic institutions, and other public health organizations in countries where activities are proposed (Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, or Panama).

Applicants must demonstrate experience working with ministries of health, academic institutions, and other public health organizations in countries where activities are proposed (Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, or Panama).

4. Justification for Less than Maximum Competition Not Applicable

5. Responsiveness Any application that does not fully respond to the items in this section will be deemed "nonresponsive" and will not be moved forward for scientific peer review.

1. Applicant must have submitted an LOI received by the due date of LOI

2. Applicant can apply in more than one project area, but cannot apply in more than 2 Project Categories (A, B, C).

3. The application must specify disease topic areas to be covered by the activity, the Project Category (A, B, or C), countries where the activities will be conducted, and be within the scope of objectives described.

4. Applicants cannot apply to conduct any single activity in more than two countries in Year 1, but can propose the activity in >2 countries in subsequent years. For example, an applicant can propose to begin a surveillance project of AFI risk factors in El Salvador and Belize in Year 1, and add Costa Rica and Dominican Republic in Year 2.

5. Applicant should not exceed budget limit specified in Year 1.

6. Applicant must include a list of investigators who will be involved in the project, their roles, and qualifications for their proposed roles.

7. Applicant must demonstrate experience in working with scientific partners on public health science and animal health activities in the countries where they propose to have activities. This 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 experience might be shown through listing publications and/or project summaries.

8. Applicant must provide letters of support from the Ministry of Health, and Ministry of Agriculture when applicable, in the countries where work activities are proposed

9. For each application, applicant must provide a cover letter on institution letterhead that summarizes and details the activities applied for and the proposed funding level for the activities.

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/#1.

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 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 registration process at least four (4) weeks prior to the application due date.

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 https://www.sam.gov/portal/SAM/%231 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 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 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.

One application per institute.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission 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://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.Grants.gov mailto:pgotim@cdc.gov

It is critical that applicants follow the 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, 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 forms package associated with this NOFO includes all applicable components, mandatory and optional. Please note that some components 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.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application.

While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from http://grants.nih.gov/grants/funding/424/index.htm.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

3. Letter of Intent Due Date for Letter of Intent: 02/08/2018 A letter of intent is mandatory for this NOFO. The information that it contains allows CIO 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:

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 http://grants.nih.gov/grants/funding/424/index.htm

Name of the Applicant Descriptive title of proposed research Applicant should state which component they are applying to Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity announcement

The letter of intent should be sent to:

Lata Kumar Extramural Research Program Office Office of the Associate Director of Science Center for Global Health Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS D-69 Atlanta, GA 30333 Telephone: 404-639-7618 Fax: 404-639-7490 Email: lkumar@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.

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 16 components. Not all 16 components of the Research Plan apply to all Notices of Funding Opportunities(NOFOs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guidehttps://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 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 (R&R) 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, 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 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 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 timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.

Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 (R&R) Application Guide unless otherwise specified in the NOFO. 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.

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

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

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.

Projects under each category should be include all the Research plan components. Applicants submitting more than one project should add the title and submit this under the Appendix section to accommodate space and submission issues in the package.

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 20 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 75 pages for all appendices.

8. Format for…