oppRFA-GH-18-005-cfda93.326-cidRFA-GH-18-005-instructions.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Enhancing Capacity for Strategic and Applied Research Activities in Support of Control and

Elimination of Malaria and Neglected Tropical Diseases

RFA-GH-18-005

Application Due Date: 03/12/2018

Signature Date

Enhancing Capacity for Strategic and Applied Research Activities in Support of Control and

Elimination of Malaria and Neglected Tropical Diseases

RFA-GH-18-005

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) Notice of Funding Opportunity (NOFO) Title Enhancing Capacity for Strategic and Applied Research Activities in Support of Control and Elimination of Malaria and Neglected Tropical Diseases Activity Code U01 – Cooperative Agreements

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

RFA-GH-18-005

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 advance strategic and applied research in support of malaria and neglected tropical disease (NTD) control and elimination, particularly in sub-Saharan Africa, Asia, and Hispaniola. Through this funding announcement, the Division of Parasitic Diseases and Malaria (DPDM) seeks to fund critical implementation research projects and evaluation activities in two critical areas: Component A: Malaria and Component B:

NTDs.

Centers for Disease Control and Prevention (CDC) is a partner of the Roll Back Malaria (RBM) initiative and a World Health Organization (WHO) Collaborating Center, and seeks to support and coordinate global malaria program scale-up, surveillance, and evaluation efforts in malaria endemic countries. In addition, along with the US Agency for International Development(USAID), CDC’s Malaria Branch co-implements the US President’s Malaria Initiative (PMI). While there has been tremendous recent progress toward malaria elimination, there is a critical need for ongoing research to improve malaria control interventions. Supported malaria research activities will be based on the WHO Global Technical Strategy for Malaria, 2016—2030, and will be designed to yield high impact public health findings and to improve strategies aimed at controlling and ultimately eliminating malaria. CDC also provides technical assistance in support of and conducts operational research related to efforts to eliminate onchocerciasis where possible, eliminate blinding trachoma and lymphatic filariasis as public health problems, and control schistosomiasis and soil-transmitted helminths. CDC supports global NTD control and elimination efforts in collaboration with the USAID and WHO>.

Supported NTD research strategies will be focused on identifying strategies to strengthen NTD program scale up, and surveillance and evaluation efforts in NTD endemic countries in order to meet elimination and control goals.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-18-005, 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: 02/12/2018

Application Due Date: 03/12/2018

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: 04/02/2018

Secondary Review: 05/02/2018

Estimated Start Date: 09/30/2018

Expiration Date: 03/09/2018 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

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

Purpose: The purpose of this FOA is to assist with the development of malaria and NTD-focused strategic and applied research, surveillance, and monitoring and evaluation activities, particularly in sub-Saharan Africa, Asia, and Hispaniola. Through this funding announcement, the Division of Parasitic Diseases and Malaria Branch seeks to fund critical implementation research projects and evaluation activities with the potential to yield high impact public health findings or to improve strategies that will decrease the overall burden of malaria and NTDs and increase the health and well-being of affected populations.

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 5-year project period is approximately $13,300,000. The expected number of awards will be up to 2 awards for the malaria objectives (Component A: one through five), and up to two awards for the NTD objective (Component B: Obejective six). Applicants may apply only for Component A or Component B. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The budget period for both Components A and B is anticipated to run from 09/30/2018 to 09/29/2019. The project period for both Component A and Component B is anticipated to run from 09/30/2018 to 09/29/2023.

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 qualifications, skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

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

Number of Applications. Applicants may only apply for Component A or Component

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

Application Type. New.

Special Date(s). LOI date is 2/08/2018; Application due date is 3/08/2018.

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 301(a) and 317(k) (2) of the Public Health Service Act, [42 U.S.C. Sections 241(a) and 247b (k) (2), as amended

1. Background and Purpose CDC supports WHO and the Roll Back Malaria (RBM) Partnership to coordinate global program implementation and evaluation efforts related to malaria and NTDs under the frameworks of the Global Technical Strategy (GTS) for Malaria, 2016—2030 and the Fourth WHO Report on Neglected Tropical Diseases. As a partner, CDC has been building and working with numerous international networks, consortia, and partnerships to achieve the GTS and NTD targets. This cooperative agreement is intended to expand CDC’s network of collaborating institutes for both research and technical assistance to targeted malaria- and NTD-endemic countries, particularly in Africa, Asia, and Hispaniola with a particular focus on research synthesis and operational research aimed at controlling and ultimately eliminating malaria and selected NTDs.

Component A - Malaria: The President’s Malaria Initiative (PMI) is a core component of US bilateral investments in global health diplomacy. An expanded USG Malaria Strategy 2015- 2020, has been developed to achieve Africa-wide impact by halving the burden of malaria in 70 percent of at-risk populations in sub-Saharan Africa, thereby removing malaria as a major public health problem and promoting economic growth and development throughout the region.

Since its launch in 2005, PMI has reinforced the principles of: encouraging country ownership and investing in country-led plans and health systems; increasing impact and efficiency through strategic coordination and programmatic integration; strengthening and leveraging key partnerships, multilateral organizations, and private contributions; implementing a woman- and girl-centered approach; improving monitoring and evaluation; and promoting research and innovation.

Component B - Neglected Tropical Diseases: NTDs are a group of parasitic and bacterial diseases that cause substantial morbidity and disability in more than 1 billion people globally.

Selected parasitic and bacterial NTDs can be controlled or eliminated through yearly mass drug administration (MDA). To date, through coordinated global efforts and private public partnerships that have made sustained donation of medicines possible, there has been substantial progress in control of a number of NTDs. In 2015, more than 990 million people received MDA for at least one of the NTDs that can be controlled or eliminated with preventive chemotherapy.

As a result of program scale up through the 2000s, 350 million individuals in 41 countries previously at risk of NTDs no longer require yearly treatment. With the maturation of NTD elimination and control programs, new tools and strategies are needed to ensure that they reach and treat all groups who remain at risk of NTDs and can rapidly and efficiently detect any resurgence of these diseases after treatment is stopped. CDC works in coordination with WHO, USAID, the Bill and Melinda Gates Foundation, and the Consortium for Operational Research on Neglected Tropical Diseases Task Force for Global Health to conduct operational research http://www.pmi.gov/resources/reports/usg_strategy2009-2014.pdf http://www.pmi.gov/resources/reports/usg_strategy2009-2014.pdf that addresses critical NTD program implementation challenges.

The purpose of this cooperative agreement as it relates to NTDs is to conduct strategic and applied research to 1) inform NTD control and elimination activities, including surveillance and program monitoring and evaluation, in countries endemic for lymphatic filariasis, blinding trachoma, onchocerciasis, schistosomiasis and soil transmitted helminths, particularly in sub- Saharan Africa, Asia and Hispaniola; 2) conduct research activities that will provide tools and information that will improve NTD program activities; and 3) support integration of evaluation and surveillance activities for multiple NTDs where feasible.

The following are specific activities for the recipient to address in collaboration with CDC and the respective Ministries of Health (MoH): a) Evaluate the performance and use of novel or improved laboratory tools, such as antibody assays and rapid diagnostic tests, and epidemiologic methods for program decision making, including for mapping of NTDs, stopping MDA, and conducting post-treatment surveillance for NTDs; b) Investigate causes of and evaluate interventions to address ongoing NTD transmission in areas where NTD programs have been scaled up ; c) Disseminate results from these operational research and prevention activities through written publications, oral presentations, hosting of study tours, or by other means; and h) Assist the MoH in translating operational research findings into public health policy and practice in sub-Saharan Africa, Asia, and Hispaniola, and ensure sharing of expertise and research findings with other partners and countries.

The purpose of this cooperative agreement as it relates to malaria is to 1) conduct strategic and applied research to inform control and elimination activities in malaria endemic countries, particularly in sub-Saharan Africa, Asia, and Hispaniola, 2) support the establishment and strengthening of monitoring and evaluation systems for malaria program activities, including those supported by PMI and, 3) conduct evaluations to inform feasible and effective opportunities for integration of malaria control activities with other child survival, vector control and infectious disease programs.

The following are specific activities for the recipient to address in collaboration with CDC and the respective Ministries of Health (MoH): a) In coordination with global partners, strengthen the ability of health facilities and community intervention efforts to provide timely and appropriate care and treatment of vulnerable populations by evaluating case management activities and practices, including the use of rapid diagnostic tests and pre-referral rectal artesunate at the community level,and definitive management of severe and complicated malaria; b) Evaluate the use and impact of novel vector control tools and technologies such as insecticide treated materials, including use of combination insecticide-treated bednets, insecticide-treated wall liners, spatial repellents, attractive targeted sugar baits; c) Evaluate the impact of drug-based strategies, including but not limited to, intermittent mass test and treat, reactive case detection and treatment, and mass drug administration on malaria morbidity, mortality and transmission in a targeted geographic area, transmission focus, or segment of a population; d) Evaluate the continued effectiveness of intermittent preventive treatment during pregnancy and alternative strategies and approaches for prevention of malaria in pregnancy; e) Monitor the efficacy of first- and second-line antimalarial drugs; f) Evaluate surveillance as a core intervention; g) Disseminate results from these operational research and prevention activities through written publications, oral presentations, hosting of study tours, or by other means; and h) Assist the MoH in translating operational research findings into public health policy and practice in sub-Sahara Africa and Asia, and ensure sharing of expertise and research findings with other partners and countries.

Healthy People 2020 and other National Strategic Priorities N/A

Public Health Impact The Public Health Impact of this proposed work will be two-fold. First, these evaluations and studies will provide critical scientific knowledge to inform and guide malaria and NTD program implementation in malaria and NTD endemic countries, especially in sub-Saharan Africa, Asia, and Hispaniola. Second, the ultimate impact of these activities will be reduced morbidity and mortality due to malaria and NTDs through the identification and scale-up of evidence-based intervention strategies and on-going evaluations of these strategies.

Relevant Work For more than 75 years, the Centers for Disease Control and Prevention (CDC) has been a leader in the fight against malaria since successfully eliminating it in the United States. Building on that success, CDC experts continue to develop and evaluate malaria control interventions to reduce malaria illness and death and ultimately to eliminate malaria globally. CDC’s strategic research helped develop and evaluate critical effective tools now used throughout the world to prevent and control malaria including:

Insecticide-treated bed nets (ITNs) Intermittent preventive treatment for pregnant women (IPTp) and infants (IPTi) Improved management of malaria illness with rapid diagnostic tests (RDTs) and artemisinin-containing combination therapies (ACTs) Indoor residual spraying (IRS)

Massive scale-up of these proven interventions in the last decade has led to unprecedented gains in the fight against malaria. From 2000 to 2015, 6.8 million lives were saved globally, and malaria deaths in Africa were cut by more than half.

CDC also played a key role in the research that demonstrated that annual community treatment with antiparasitic medications can interrupt transmission of lymphatic filariasis which led to the global strategy to eliminate lymphatic filariasis as a public health problem. CDC’s discovery and operational research supports the development, validation and scale up of the use of novel laboratory tools, field friendly diagnostic formats and techniques, and epidemiologic methods needed by lymphatic filariasis, trachoma, onchocerciasis, soil transmitted helminth, and schistosomiasis control and elimination programs for program implementation, evaluation, and surveillance.

2. Approach Outcomes to be achieved through activities supported by this program include:

For malaria:

Increased information about the efficacy of currently deployed malaria control interventions in selected malaria-endemic countries, particularly in sub-Saharan Africa and Asia, especially those threatened by the development of resistance to insecticides by disease vectors and resistance to drugs by parasites;

Increased evidence related to innovative interventions addressing key challenges in vector control interventions including outdoor transmission, strategies to improve malaria case management at the health facility and community levels, management of insecticide resistance, accessing hard-to-reach populations, reduction of transmission through targeting the parasite reservoir, and development of new tools to improve surveillance, monitoring and evaluation;

Improved translation of operational research findings into better public health practice globally.

Improved information about feasibility and impact of transforming surveillance into a key malaria intervention and

Identify and assess improved and cost-effective approaches to monitoring changes in malaria burden;

Expanded capacity of Ministries of Health to conduct operational research, surveillance, and monitoring and evaluation of malaria control activities

For NTDs:

Improved laboratory diagnostic tools that are appropriate for use in program settings and adequately sensitive for program decision making as NTD elimination is approached

Expanded information about population serologic profiles by age and endemicity status as populations transition from high NTD endemicity to control to elimination

Improved data and streamlined strategies for program monitoring, surveillance, and decision-making and to make more efficient use of program resources

Increased NTD program and MOH laboratory capacity to conduct NTD program monitoring and sustain surveillance post-elimination.

Strengthened evidence base for NTD elimination science and facilitates progress towards achievement of elimination.

Objectives/Outcomes Objective 1: Conduct malaria strategic and applied research and monitoring and evaluation activities in selected malaria-endemic countries, particularly in sub-Saharan Africa and Asia in conjunction with National Malaria Control Programs and other partners to assess the efficacy / effectiveness of currently deployed malaria control tools. Examples may include but are not limited to the following:

Evaluate the effectiveness of malaria control interventions including long-lasting insecticide-treated nets (LLITNS), indoor residual spraying (IRS) and other methods of transmission reduction;

Evaluate the effectiveness of all aspects of the case management pathway including appropriate referral, diagnosis, correct prescribing and appropriate messaging at all levels of the health systems; Evaluate the therapeutic efficacy of antimalarials to treat uncomplicated and severe malaria; and

Evaluate the therapeutic efficacy of antimalarials used to address the negative consequences of malaria in pregnancy.

Objective 2: Develop and validate the impact of revised, enhanced or novel interventions that will contribute to effective malaria control in sub-Saharan Africa and Asia. Examples may include but are not limited to the following:

Evaluate the use of innovative vector control intervention measures such as insecticide treated materials, including use of combination insecticide-treated bednets and insecticide-treated wall liners;

Evaluate the use of new strategies that target the malaria parasite reservoir such as mass test and treat and mass drug administration; and

In collaboration with PMI and other partners, develop or refine approaches to strengthen the ability of health facilities and community intervention efforts to provide timely and appropriate care and treatment of sick children under 5 years of age by evaluating case management activities and practices, including the use of rapid diagnostic tests and pre-referral rectal artesunate at the community level.

Objective 3: Assist Ministries of Health in translating implementation research findings into public health practice, and ensure sharing of expertise and research findings with other partners and countries. Examples of such efforts may include, but not be limited to, the following:

Disseminate results from these implementation research and prevention activities through written publications, oral presentations, hosting study tours, or by other means;

and

Assist National Malaria Control Programs in developing activities focused on malaria interventions consistent with global and regional initiatives, such as the Roll Back Malaria (RBM) Initiative.

Objective 4: Assist Ministries of Health in improving malaria surveillance systems and monitoring and evaluation activities. Examples of such efforts may include, but not be limited to, the following:

Develop surveillance systems that can more accurately estimate the burden of malaria and monitor artemisinin resistance and are both timely and inclusive of all malaria cases presenting to all sectors (i.e. community level, private sector, and non-governmental organizations);

Evaluate enhanced surveillance systems in the collection of real-time case information and data use in identifying populations at increased risk of malaria infection;

Contribute to the evidence and experience base for transforming surveillance into a core malaria intervention as recommended in the Global Technical Strategy for Malaria, 2016--2030

Improve monitoring of insecticide resistance among malaria vectors; and Improve monitoring and evaluation tools for low transmission and pre-elimination settings.Objective 6: Develop and validate the use of revised, enhanced or novel strategies that will contribute to effective implementation, monitoring, evaluation and surveillance of selected NTDS targeted by CDC for control or elimination, particularly lymphatic filariasis, blinding trachoma, onchocerciasis, soil transmitted helminths, and schistosomiasis, in sub-Saharan Africa, Asia, and Hispaniola. Examples may include but are not limited to the following:

Objective 5: Assist Ministries of Health in building capacity around operational research, surveillance, and monitoring and evaluation of malaria.

Objective 6: Develop and validate the use of revised, enhanced or novel strategies that will contribute to effective implementation, monitoring, evaluation and surveillance of selected NTDS targeted by CDC for control or elimination, particularly lymphatic filariasis, blinding trachoma, onchocerciasis, soil transmitted helminths, and schistosomiasis, in sub-Saharan Africa, Asia, and Hispaniola. Examples may include but are not limited to the following:

Determine NTD serologic profiles in geographic or epidemiologic settings, or longitudinally in populations where they remain incompletely characterized, in order to generate the evidence base needed to incorporate these NTD surveillance tools into program use.

Evaluate post-treatment and post-validation surveillance strategies for lymphatic filariasis, such as stratifying areas at risk and targeting intensity of surveillance efforts, or determining surveillance thresholds for action and response.

Develop and evaluate post-treatment surveillance strategies for trachoma that utilize trachoma specific antibody.

Operationalize the point of care circulating cathodic antigen test as a schistosomiasis program tool for monitoring and evaluation by defining sampling strategies, cutoffs, and appropriate frequency of testing as schistosomiasis programs move from mapping to control.

Evaluate the impact of enhanced or novel strategies to increase uptake and coverage of mass drug administration, including those that address microplanning, social mobilization, systematic non-compliance, rapid assessment and mop up during MDA, and MDA in urban areas, border areas, conflict areas, and other hard to reach populations.

Target Population Target populations should include people living or working in epidemiological defined areas of malaria and NTD transmission in endemic countries, particularly in sub-Saharan Africa, Asia, and Hispaniola. Sub-population target groups within these malaria transmission zones should include those most at-risk e.g. children under five years of age and pregnant women

Collaboration/Partnerships Applicants to Component A: Malaria are required to provide a letter of support from the Ministry of Health’s’ National Malaria Control Program from the country where the research will be conducted.

Letters of support provide information to evaluate investigator and environment criteria.

Key stakeholders and partnerships include National Malaria Control Programs, National NTD Control and Elimination Programs, the United States Agency for International Development (USAID), PMI implementing partner organizations, partner organizations implementing NTD control programs, the United Nations Children’s Fund (UNICEF), the World Health Organization (WHO), and the Global Fund and its in-country Principle Recipients for malaria grants.

Evaluation/Performance Measurement As part of the application, the PI should include measurable goals and aims based on a one-year research project period. The grantee 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.

Monitoring and Evaluation

Work with CDC and other global partners as appropriate to develop and implement an evaluation plan to measure the impact of the activities outlined in this funding opportunity announcement (evaluation framework, evaluation design, indicators, process and outcome evaluation, and information/data collection plan).

Program Capacity

Establish or retain a full-time staff person with management and technical experience, responsible for managing the planning, implementation, and evaluation of the program and serving as the CDC point of contact.

Establish or retain a part-time staff person with data management and mobile data collection experience responsible for the programming and trouble-shooting of data collection instruments, cleaning of data, development of data dictionaries and storage of datasets.

Establish or retain additional staff with demonstrated knowledge, skills, and expertise in administrative and fiscal management to meet the needs of the program.

Over the course of the project period establish and retain other staff, contractors, and consultants sufficient in number and expertise to ensure project success.

Fiscal management

Programs must use funding to support activities in alignment with requirements of this NOFO. Programs must develop and maintain systems for sound fiscal management, including: monitoring the cooperative agreement award and program contracts and grants, ensuring the funds are expended in support of approved activities; tracking expenditures in a timely manner; and preventing excessive unobligated balances.

Translation Plan

Applicant should plan for adequate resources to disseminate findings with in-country research and malaria control partners as well as with communities that contributed to the research program. Applicant should use appropriate scientific journals to disseminate research findings to the broader scientific community in conjunction with CDC scientists. Applicant should present important evaluation and research findings at relevant international scientific meetings and conferences.

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: $13,300,000 Estimated Total Project Period Funding Component A Malaria: $5,000,000 Year 1: $1,000,000 Year 2: $1,000,000 Year 3: $1,000,000 Year 4: $1,000,000 Year 5: $1,000,000 *Estimated total funding available for first year, including direct and indirect costs:

$1,000,000 *Estimated total funding available for entire project period for Component A: Malaria, including direct and indirect costs: $5,000,000 *Anticipated number of awards: up to 2 *Estimated Total Project Period Funding Component B NTDs: $8,300,000 Year 1: $300,000 Year 2: $2,000,000 Year 3: $2,000,000 Year 4: $2,000,000 Year 5: $2,000,000

*Estimated total funding available for first year, including direct and indirect costs:

$300,000 *Estimated total funding available for entire project period for Component B: NTDs, including direct and indirect costs: $8,300,000 *Anticipated number of awards: up to 2 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.

Anticipated Number of Awards: 4 Component A: Malaria - 2 Component B: NTDs - 2 Awards issued under this FOA 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: $3,000,000 Per Budget 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: Nonprofits having a 501(c)(3) status with the

IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

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

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher

Education)

Other:

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. Special Eligibility Requirements Applicants under Component A: Malaria and Component B: NTDs must demonstrate an ability to conduct epidemiologic and entomologic studies where they propose to work in sub-Saharan Africa, Asia or Hispaniola. This should include a proven record of accomplishment in organizing and managing large groups of diverse research institutions, international public health groups, and Ministries of Health for the purpose of identifying the malaria or NTD research agendas and implementing research studies across multiple sites and epidemiologic transmission zones.

Applicants must demonstrate previous malaria or NTD research or public health activities in sub- Saharan Africa, Asia, or Haiti. Applicants should document eligibility through manuscripts showing previous work in these regions or through reference letters from public health officials.

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

Applicants under Component A: Malaria and Component B: NTDs must demonstrate an ability to conduct epidemiologic and entomologic studies where they propose to work in sub-Saharan Africa, Asia, or Hispaniola. This should include a proven record of accomplishment in organizing and managing large groups of diverse research institutions, international public health groups, and Ministries of Health for the purpose of identifying the malaria or NTD research agendas and implementing research studies across multiple sites and epidemiologic transmission zones. Applicants must demonstrate previous malaria or NTD research or public health activities in sub-Saharan Africa, Asia, or Hispaniola. Applicants should document eligibility through manuscripts showing previous work in these regions or through reference letters from public health officials.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Responsiveness: Applications will be deemed non-responsive if the following criteria are not met and will not be moved forward for review.

Applicants may apply only for Component A or Component B in this NOFO.

Applicants should stay within the scope of the Component, to which they are applying for within this NOFO.

If applicant exceeds budget limit, applications will be deemed non-responsive.

Applicants are required to submit a Letter of Intent (LOI) by the required date of submission of

LOI.

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 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 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 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-http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf 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 organizations may submit only one application.

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 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 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.Grants.gov mailto:pgotim@cdc.gov 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 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: 02/12/2018

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:

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, 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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf

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…