RFA-GH-20-00 Amended.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Conducting Public Health Research in Colombia

RFA-GH-20-003

Application Due Date: 03/26/2020

Conducting Public Health Research in Colombia

RFA-GH-20-003

TABLE OF CONTENTS

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

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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Center for Global Health Notice of Funding Opportunity (NOFO) Title Conducting Public Health Research in Colombia Activity Code U01

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

RFA-GH-20-003

Assistance Listings (CFDA) Number(s) 93.326 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support the following activities:

Conduct and monitor epidemiologic, and laboratory-based projects, surveillance, and research of important diseases in Colombia including, but not limited to, activities to address acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats of local importance: and

Incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Colombia, strengthen public health capacity as outlined in the Global Health Security Agenda, and the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

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

Letter of Intent Due Date: N/A https://www.grants.gov

N/A

Application Due Date: 03/26/2020

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: 04/13/2020

Secondary Review: 05/20/2020

Estimated Start Date: 09/01/2020

Expiration Date: 03/27/2020 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.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

Executive Summary Executive Summary Purpose:

The purpose of this Notice of Funding Opportunity (NOFO) is to support the following activities:

Conduct and monitor epidemiologic, and laboratory-based projects, surveillance, and research of important diseases in Colombia including, but not limited to, activities to address acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats of local importance: and

Incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Colombia, strengthen public health capacity as outlined in the Global Health Security Agenda, and the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

Mechanism of Support: Cooperative Agreement Funds Available and Anticipated Number of Awards.

Approximate Number of Awards: 1 Average Year 1 Award Amount: $2,000,000 Total Period of Performance Funding: $10,000,000

Awards issued under this NOFO are contingent upon availability of funds and a sufficient meritorious application.

Budget and Period of Performance.

o Budget Period: 9/30/2020 to 9/29/2021 o Period of Performance: 9/30/2020 to 9/29/2025

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

Eligible Institutions/Organizations: Institutions/organizations listed in Section III.1 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) qualified PD/PI for each application.

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

Application Type: New Special Date(s): N/A Application Materials: See Section IV.1 for application materials.

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 This work is authorized under the Public Health Service Act 301 and 307 (42 USC 241 and 242l).

1. Background and Purpose The US Government (USG) envisions a world safe and secure from global health threats posed by emerging and re-emerging infectious diseases. In partnership with the country government, and local, national and international stakeholders, CDC seeks to accelerate progress toward a world safe and secure from infectious disease threats by generating necessary data to inform Colombia-specific public health policy. These activities and the data collected will allow CDC to achieve its mission to assist countries in achieving the International Health Regulations (WHO 2005) compliance within the framework outlined by the Global Health Security Agenda

(GHSA).

Colombia has made impressive progress toward improving the health status of the population, with progress that equals or surpasses that of neighboring countries. These improvements in health outcomes are attributable to developments in the country’s health care system, however, many difficulties and challenges still remain. Health sector reviews have identified a number of issues including infectious diseases (HIV/AIDS, influenza, arboviruses, and antibiotic-resistance pathogens), an emerging burden of non-communicable diseases (cardiovascular diseases, cancer, diabetes, etc.), and requirements to strengthen public health technologies and improve the application of public health research findings in the national health system.

Colombia is particularly vulnerable to serious zoonotic and emerging infectious disease threats because of its geographic location, climate, and significant amount of travel and trade across borders, especially Venezuela, Brazil, and Panama. In addition, the country’s health system remains challenged with how to improve detection and response to emerging and re-emerging disease threats. The regional increase of measles and malaria in migrants from Venezuela and successive regional outbreaks of dengue, chikungunya and Zika viruses since 2012 are examples of these vulnerabilities. Colombia’s capacity and regional leadership to quickly and effectively respond to public health threats and emerging outbreaks has been increasingly critical to protecting the health of the global community.

CDC’s collaborative projects extend across Colombia at the national, provincial, and local level and reinforce the strong bilateral relationships between Colombia and the United States. CDC has supported the Colombian Government’s public health priorities through focusing on surveillance, emergency management, laboratory capacity, and workforce development.

This NOFO supports activities that will fulfill four broad goals:

1. Conduct high quality research in acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats including non-communicable diseases to characterize disease threats and better understand the populations affected in Colombia;

2. Provide training for public health professionals and select staff in basic and applied public health research, program planning, and evaluation;

3. Strengthen institutional capacity to conduct research, plan, implement, and evaluate public health programs, including the capacity to detect and respond to emerging and re-emerging infectious diseases; and

4. Incorporate and promote the results of research into operational disease prevention and control programs and policy development.

Healthy People 2020 and other National Strategic Priorities This project supports the following Healthy People 2030 goal and objectives:

Increase the number of public health events of international importance that are monitored and reported

Increase the number of individuals trained globally to prevent, detect, or respond to public health threats

Increase the laboratory diagnostic testing capacity, strengthen surveillance systems and routine disease reporting in individual countries and regionally

In addition, activities funded through this cooperative agreement must align with the following HHS/CDC strategies and policies:

CDC’s strategy for improving global health security (GHS), is based on three broad goals embedded in the agency’s mission to protect public health worldwide: 1) Prevent

2) Detect 3) Respond https://www.cdc.gov/globalhealth/security/index.htm The Department of Health and Human Services’ (HHS) Global Health Strategy https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html International Health Regulations (IHR) and supporting policies and frameworks https

://www.who.int/topics/international_health_regulations/en/

Public Health Impact The impact of the research conducted under this NOFO will generate data to inform public https://www.cdc.gov/globalhealth/security/index.htm https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html https://www.who.int/topics/international_health_regulations/en/ https://www.who.int/topics/international_health_regulations/en/ health leaders about the causes of disease and the populations at risk in Colombia. This information is needed to better allocate and prioritize resources, implement and improve public health practices and interventions, ensure coordination between public health and clinical medicine, and develop sustainable laboratory and surveillance systems to identify and mitigate the impact of health threats. Through better understanding of disease threats, and their control and prevention, morbidity and mortality may be lowered, and global health security increased.

Relevant Work U.S. Centers for Disease Control and Prevention (CDC) and the Government of Colombia have collaborated since 1992 when Colombia’s Field Epidemiology Training Program (FETP) was established to develop a cadre of disease detectives. This work has been carried out under the auspices of the Instituto Nacional de Salud (INS). INS is a governmental, scientific-technical public health institution with national coverage, which contributes to the protection of health in Colombia through knowledge management, monitoring the health situation of the population, and the providing of public health goods and services. INS is part of the National Health System and the National System of Science, Technology and Innovation.

For more than two decades the partnership between CDC and INS has focused on strengthening surveillance, emergency preparedness and response, laboratory capacity building, workforce development, and improving the use of data for public health action. INS directly support the government of Colombia by conducting public health research to inform both policy decisions at the Ministerio de Salud y Proteccion Social (MSPS) and institutional goals to develop and strengthen surveillance systems for the identification and response to emerging and re-emerging disease threats.

CDC has been working with INS to develop national laboratory strategic plans, policies and guidelines for biosafety, and implementation of a quality management system to strengthen laboratories. Additionally, multiple groups within CDC [Influenza Division; Division of High- Consequence Pathogens and Pathology; Division of Foodborne, Waterborne, and Environmental Diseases; Division of Global Health Protection, Division of Vector Borne Diseases; Division of Congenital and Developmental Disorders; and other groups within CDC] and external public health partners [Pan-American Health Organization (PAHO), Training Programs in Epidemiology and Public Health Interventions Network (TEPHINET), PulseNet International, and numerous national and international universities and other organizations] have collaborated with the INS network and has improved Colombia’s capacity to detect novel emerging pathogens and improve laboratory and surveillance practice in the country.

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:

www.cdc.gov/globalhealth www.cdc.gov/globalhealth/healthprotection/ghs/index.html www.cdc.gov/globalhealth/ihregulations.htm www.cdc.gov/globalhealth/ghi

2. Approach http://www.cdc.gov/globalhealth http://www.cdc.gov/globalhealth/healthprotection/ghs/index.html http://www.cdc.gov/globalhealth/ihregulations.htm http://www.cdc.gov/globalhealth/ghi

The applicant should submit one overall research proposal in response to this application, which may include no more than three projects as part of the first year of award proposal. The research proposal may include epidemiologic projects, laboratory-based projects, evaluation of interventions and control methods including therapeutic and preventative treatments. Projects can focus on multiple infectious disease syndrome(s) or a group of diseases that are clinically or functionally related, to an identifiable public health concern or problem affecting health in Colombia. Projects may be new activities for the applicant or may be aimed at continuing and enhancing activities, previously funded by other partners or institutions, addressing public health concerns in Colombia.

The applicant must submit a separate research plan and budget for each proposed project within the proposal. No more than three research plans and budgets should be submitted for the first year of award proposal. The research plan for each project should not exceed 25 pages per project inclusive of the technical proposal as well as budget for each project. The research plan for each proposed project should address administrative tasks and oversight for the project as well as coordination of research objectives with other projects as appropriate. Please note CDC prefers not to receive one project to cover all administrative tasks and costs, but instead appropriate administrative tasks and costs should be included in each project budget.

Objectives/Outcomes Applicants may propose a variety of project that address these objectives. For each project proposed, the focus should be on an identifiable public health concern or problem impacting health in Colombia. Applicant may propose new projects, as well as continuation of existing projects (if applicable) that propose new objectives and activities to address emerging diseases as well as risk factors associated with the leading causes of death in Colombia. This may include disease surveillance, data collection, epidemiologic studies, laboratory-based studies, and the evaluation of interventions and/or control methods including therapeutic and preventative treatments.

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

1. Acute febrile illness (AFI);

2. Antimicrobial resistance (AMR);

3. Healthcare-associated infections (HAI) (nosocomial or hospital acquired infections);

4. Vaccine-preventable diseases;

5. Vector-borne diseases;

6. Respiratory illness and influenza;

7. Enteric illnesses and diseases, including typhoid fever; and,

8. Other public health issues of regional and local importance, including non-communicable diseases

RESEARCH CATEGORIES

Applicants must propose projects that focus on the disease area(s) selected in at least one of the following research categories. In the first year of award, applicants may only submit up to three project activities under research category A and/or B. All projects can be proposed in one research category or can be a combination of the two categories: A or B.

Examples of projects are provided under each research category:

Category A: Characterize Public Health Threats Includes conducting research activities to identify modifiable risk factors for priority diseases through community and/or population-based observational 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 projects that characterize public health threats are:

Develop, maintain, or expand one or more surveillance systems in Colombia combining population-based and facility-based surveillance designed to determine burden of disease, transmission dynamics, risk factors, relative contribution of different pathogens to disease syndromes, and control of infectious agents. A multi-site system could include population/ site diversity with regard to urban/rural, socioeconomic factors, etc.

Support the development or strengthening of laboratories and/or platforms used for etiologic investigation, evaluation of novel diagnostic assays for faster and easier detection, and characterization of pathogens.

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

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 Colombia in order to strengthen surveillance at national and regional levels

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. Includes research on the most effective implementation approaches for responding to global public health threats and building global health security capacity.

Examples of projects that address effective implementation approaches are:

Project Category B: Determine Most Effective Implementation Approaches:

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

Develop cost of disease estimates and cost effectiveness estimates for priority diseases and associated interventions, e.g., vaccines, infection prevention and control in healthcare settings.

Develop processes for collecting and analyzing information on the costs associated with surveillance and research activities and the potential savings at the population level of early detection and control.

Target Population

The target populations for this NOFO include, but are not limited to, those individuals infected and affected by infectious diseases, or at risk for becoming infected by an infectious disease or effected by non-communicable diseases. The work under this NOFO may also target increased capacity at the national and sub-national level to implement activities in alignment with the objectives of this NOFO.

Recipients are expected to use epidemiologic, social determinants, and linked laboratory, epidemiological, and surveillance data to identify communities disproportionately affected by infectious diseases or non-communicable diseases in the target areas to ensure that program activities appropriately cover these populations. Recipients should ensure that supported services are accessible and available to all patients regardless of age, sex, race/ethnicity, sexual orientation, gender identity, or socio-economic status in order to achieve the objectives of this

NOFO.

Collaboration/Partnerships INS is located in the Colombia capital city of Bogota and operates through network in all states and municipalities of Colombia. In addition to the U.S. Governmental agencies (CDC, USAID, Department of Defense, and Department of State), INS collaborate with the following partners to improve global health security and advance the country’s ability to combat infectious diseases:

Domestic

1. Ministerio de Salud y de Protección Social

2. Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

3. Ministerio de Agricultura y Desarrollo Rural

4. Departamento Administrativo de Ciencia, Tecnología e Innovación (Colciencias)

5. National Universities International partners

International partners

1. World Health Organization (WHO)

2. World Organization for Animal Health (OIE)

3. Food and Agriculture Organization of the United Nations (FAO)

4. Pan-American Health Organization (PAHO)

5. International Association of National Public Health Institutes (IANPHI)

6. Training Programs in Epidemiology and Public Health Interventions Network

(TEPHINET)

7. PulseNet International

8. PulseNet Latin America and Caribbean

9. Association of Public Health Laboratories (APHL)

10. American Society for Microbiology (ASM)

Evaluation/Performance Measurement The grantee will work with CDC to jointly develop formal evaluation criteria and an evaluation plan based on activities within each project. During post award process, Recipient will provide quarterly reporting as outlined in the plan on the agreed upon indicators and on an ad hoc basis as required by CDC. The purpose of collecting and reporting these data is to determine the progress toward achieving increased public health capacity in host countries. The results will also be used for program planning, development and improvement, accountability and reporting, and for sharing with partners and other stakeholders. CDC will work with the recipient throughout the life of this award to ensure that all activities and expected outcomes are in alignment with current USG and the recipient’s strategies and goals. The recipient should dedicate funds made available under this NOFO for evaluation and performance monitoring within each project.

In the application, 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.

The final funding amount will be agreed upon by both CDC and the recipient; however, it should be expected that approximately 3% (of a given project’s funding) will be dedicated to monitoring, reporting, and evaluation activities. CDC and the recipient will agree upon the specific funding amounts within review of each project’s plan and budget.

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 the government in Colombia as well as other stakeholders on needed public health policies or practices at the local and national level?

2. How will the research project improve or affect the translation of study findings into policy or practice in order to assist countries achieve International Health Regulations (WHO 2005) compliance?

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: $10,000,000

Anticipated Number of Awards: 1

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

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

Award Ceiling: $2,000,000 Per Budget Period Award Floor: $0 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:

Other:

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

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. Additional Information on Eligibility

Only the application from the Instituto Nacional de Salud (INS) in Colombia will be accepted.

4. Justification for Less than Maximum Competition This single eligibility request is submitted for the Instituto Nacional de Salud (INS) in Colombia to expand their collaboration with CDC. The INS of Colombia is an official public entity and part of the Government of Colombia as a public establishment of the Executive Branch of the national order. Its mission and activities are defined by Law, in accordance with Decree 4109 of 2011. Per the decree, INS serves as the scientific-technical authority and has as its goals: (i) the development and management of scientific knowledge in health and biomedicine to help improve people's health conditions; (ii) to conduct basic and applied scientific research in health and Biomedicine; (iii) the promotion of scientific research, innovation and the development of studies in accordance with the priorities of public health which are known by the Institute; (iv) surveillance and health security issues within its competence; the production of biological supplies; and (v) Act as National Laboratory Reference and Coordinator of the special networks, in the framework of the General System of Social Security and the System of Science, Technology and Innovation; and in directly and closely collaboration with the Ministry of Health 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 and Social Protection of Colombia. http://www.ins.gov.co/Paginas/inicio.aspx INS is the most qualified and appropriate entity to conduct activities specified under this NOFO:

1. INS is the only entity that has the legal mandate, obligation, and technical capacity to implement activities nationally and regionally. The Government of Colombia relies heavily upon INS to execute essential functions that will advance the country’s public health goals.

2. INS is the only entity that has technical capacity to implement the proposed activities nationally. The Government of Colombia and the Ministry of Health relies heavily upon the INS to execute functions that advance the country’s public health agenda.

3. INS is positioned to oversee and safeguard public health and to collect, analyze, and disseminate information via research reports. INS has the ability to use existing public health networks and other partners to fulfill the research goals of this NOFO.

4. INS has the infrastructure and capacity to effectively conduct research activities in Colombia. CDC working through its strong partnerships with the INS will ensure the implementation and evaluation of public health research programs that will result in the prevention and control of diseases both communicable and non-communicable.

5. INS is a well-established, highly functional National Public Health Institute (NPHI).

Investments from Colombia and CDC in strengthening INS’s surveillance and emergency functions, along with a strong collaborative relationship with the Ministry of Health, have helped INS become the go-to public health institution in Colombia and the region.

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.

http://www.ins.gov.co/Paginas/inicio.aspx https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf 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

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

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

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its 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 http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html

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.

Applicant organization may submit only one application.

Section IV. Application and Submission Information

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

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

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

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

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to 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.

3. Letter of Intent Due Date for Letter of Intent: [Insert 0 days from date of publication] http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf

N/A

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 http://grants.nih.gov/grants/how-to-apply-application-guide.htm for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

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

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

http://grants.nih.gov/grants/how-to-apply-application-guide.htm must be followed along with any additional instructions provided in the NOFO.

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

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

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

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

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

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

and

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

Examples of DMPs may be found here: USGS, http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans

PHS 398 Research Plan Component

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.

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 100 pages for all appendices. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans

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.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems.

The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes.

Organizations must submit applications using the ASSIST web-based application preparation and submission process.

ASSIST will validate applications before submission. If the system detects errors, then the applicant must correct errors before their application can be submitted.

Applicants are responsible for viewing their application in ASSIST after submission to ensure accurate and successful submission through Grants.gov. If the submission is not successful and post-submission errors are found, then those errors must be corrected and the application resubmitted in ASSIST.

Applicants are able to access, view, and track the status of their applications in the eRA Commons.

Information on the submission process is provided in the SF-424 (R&R) Application Guidance and ASSIST User Guide at https://era.nih.gov/files/ASSIST_user_guide.pdf.

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