Foa_Content_of_RFA-GH-22-001.pdf

Centers for Disease Control and Prevention

Center for Global Health

Enhancing Capacity for Strategic and Applied Research Activities in Support of Control and Elimination of Malaria and Other Parasitic Diseases

RFA-GH-22-001

03/01/2022

Table of Contents 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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

Center for Global Health Notice of Funding Opportunity (NOFO) Title Enhancing Capacity for Strategic and Applied Research Activities in Support of Control and Elimination of Malaria and Other Parasitic Diseases Activity Code U01

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

RFA-GH-22-001

Assistance Listings Number(s) 93.326 Category of Funding Activity HL - Health NOFO Purpose The purpose of this notice of funding opportunity (NOFO) is to assist with the implementation of research studies that will provide critical information on ways to monitor, control, and potentially eliminate parasitic diseases including malaria. Through this funding announcement, the Division of Parasitic Diseases and Malaria seeks to fund critical research and evaluation activities with the potential to yield high impact public health findings and to improve strategies that will decrease the overall burden of parasitic diseases and increase the health and wellbeing of affected populations. Research topics include identifying and tracking morbidity, developing and testing better diagnostic tools, improving surveillance, and developing and evaluating interventions that can reduce or interrupt transmission of parasitic diseases including reduction of their vectors. This is a 2-category research NOFO – Category 1: Schistosomiasis and/or Soil- Transmitted Helminths in Kenya, and Category 2: Malaria in sub-Saharan Africa. Applicants can only apply for 1 category. If an applicant applies to both categories, their applications will not move forward for review and consideration of funding.

Key Dates Publication Date:

To receive notification of any changes to RFA-GH-22-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

02/01/2022

Application Due Date:

03/01/2022 03/01/2022

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.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on 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 http://grants.nih.gov/support/index.html.

E-mail: commons@od.nih.gov Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

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:

04/05/2022 Secondary Review:

05/03/2022 https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

Estimated Start Date:

09/30/2022 Expiration Date:

09/29/2022 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - 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.

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

Applications that do not comply with these instructions may be delayed or may not be accepted for review.

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

Executive Summary Purpose: The purpose of this notice of funding opportunity (NOFO) is to assist with the implementation of research studies that will provide critical information on ways to monitor, control, and potentially eliminate parasitic diseases including malaria. Through this funding announcement, the Division of Parasitic Diseases and Malaria seeks to fund critical research and evaluation activities with the potential to yield high impact public health findings and to improve strategies that will decrease the overall burden of parasitic diseases and increase the health and wellbeing of affected populations. Research topics include identifying and tracking morbidity, developing and testing better diagnostic tools, improving surveillance, and developing and evaluating interventions that can reduce or interrupt transmission of parasitic diseases including reduction of their vectors. This is a 2-category research NOFO – Category 1: Schistosomiasis and/or Soil-Transmitted Helminths in Kenya and Category 2: Malaria in sub-Saharan Africa.

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 $12 million. The number of awards will be up to 4 awards. Awards issued under this NOFO are contingent upon availability of funds and enough meritorious applications. Because the nature and scope of the proposed research will vary from application to application, 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.

https://grants.nih.gov/grants/how-to-apply-application-guide.html

Budget and Project Period: The estimated total funding (direct and indirect) for the first budget period, 09/30/2022 to 09/29/2023 will be the following:

o Category 1 (Schistosomiasis and/or Soil-Transmitted Helminths in Kenya) – $500,000 per award o Category 2 (Malaria in Sub-Saharan Africa) - $700,000 per award

The estimated total funding (direct and indirect) for the entire project period (5 years) will be $12 million. The 5-year project period total funding estimate is:

o Category 1 (Schistosomiasis and/or Soil-Transmitted Helminths in Kenya) – $2.5 million per award o Category 2 (Malaria in Sub-Saharan Africa) - $3.5 million per award

The project period is anticipated to run from 09/30/2022 – 9/29/2027.

Application Research Strategy Length: Section IV. “Application and Submission Information” of this announcement clearly specifies page limits for the Research Strategy.

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

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

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

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

Application Type. New

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

Special Date(s):

Letter of Intent Due Date: February 1st, 2022.

Application Due Date: March 1st, 2022 Applicants must submit their questions by e-mail to cgherpo@cdc.gov within 3 calendar weeks after the publication date of this NOFO in grants.gov. Questions received after this time will not be considered for response. All changes and updates, including the Q/A, will be added as an amendment to the NOFO and will be posted on www.grants.gov within a reasonable time.

Section I. Funding Opportunity Description Statutory Authority Section 301(a) of the Public Health Service Act [42 USC § 241(a)], as amended and Section 307 of the Public Health Service Act [42 USC §242l], as amended, as well as the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123) and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, 2020 P.L. 116-136

1. Background and Purpose The mission of the CDC Center for Global Health, Division of Parasitic Diseases and Malaria (CDC/CGH/DPDM) is to protect and improve the health of Americans and the global community from parasitic disease threats through evidence based public health action. Parasitic infections cause a tremendous burden of disease in both the tropics and subtropics as well as in more temperate climates. Of all parasitic diseases, malaria causes the most deaths globally, killing more than 400,000 people each year. Neglected Tropical Diseases (NTDs), including Schistosomiasis and/or Soil-Transmitted Helminths, affect more than 1.75 billion people worldwide, largely in rural areas of low- and middle-income countries (LMICs). These diseases exert a large toll on endemic populations, including lost ability to attend school or work, stunting of growth in children, impairment of cognitive skills and development in young children, and a serious economic burden on entire countries. DPDM works with domestic and international partners to prevent and control parasitic diseases by co-implementing the President’s Malaria Initiative. DPDM provides essential entomologic, diagnostic, and clinical assistance, and conducting vital research and program evaluation.

This 2-category research NOFO will focus on distinct parasitic diseases that negatively impact the health and wellbeing of communities around the globe: Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya, and Category 2. Malaria in Sub-Saharan Africa. Through this NOFO, DPDM seeks to fund critical research and evaluation activities with the potential to yield high impact public health findings and to improve strategies that will decrease the overall burden of parasitic diseases and increase the health and wellbeing of affected populations.

Successful applications will have well developed, research workplans that clearly show short, intermediate, and long-term objectives with a focus on how to identify and track morbidity, develop and test better diagnostic tools, improve surveillance, and develop and evaluate interventions, with the goal of reducing or interrupting transmission of parasitic diseases, including through reduction of their vectors.

mailto:cgherpo@cdc.gov

CATEGORY 1: SCHISTOSOMIASIS AND/OR SOIL-TRANSMITTED HELMINTHS IN

KENYA

Schistosomiasis is a disease caused by parasitic worms that infect more than 200 million people worldwide every year. A high proportion of infections occur in LMICs. When infected people urinate or defecate in fresh water used by communities, it becomes contaminated with Schistosoma spp. eggs. The schistosome eggs hatch upon contact with fresh water and release a larval form that infects appropriate intermediate host snails. After an incubation period during which asexual reproduction occurs, infectious larvae are released in water and penetrate the skin of persons in contact with the contaminated water. Worms mature and live in the blood vessels of the human host. The female parasite produces eggs that travel to the bladder and intestine and are passed back into the environment through urine or stool.

Soil-transmitted helminths (STH) are a group of worms that include hookworms (Necator and Ancylostoma spp.), roundworms (Ascaris lumbricoides), and whipworms (Trichuris trichiura) that live in the intestines of human hosts and pass eggs into the environment via feces. Over 1.5 billion people in the world suffer from STH infections, with children most heavily affected by malnutrition, anemia, and cognitive impairment. Heavy roundworm infections in some children may cause intestinal blockage or rectal prolapse. Roundworms and whipworms are transmitted when feces contaminate food (sometimes through the use of night soil) and eggs are ingested.

Hookworm is transmitted when larval forms of the parasite that have hatched from the eggs penetrate the skin, usually through bare feet.

Control programs for both schistosomiasis and STH are based on mass drug administration (MDA) of therapies that kill adult worms. MDA has been useful in reducing infection levels in many areas. However, MDA alone is unlikely to interrupt transmission of these diseases. Other control measures such as provision of water, sanitation, and hygiene (WASH) are needed.

Furthermore, the diagnostic tools for these infections can have low sensitivity in persons with light infections and are currently too expensive to use for routine annual monitoring and evaluation. The critical infection levels associated with morbidity are also poorly understood for these diseases and evidence-based targets for control are lacking.

An applicant applying for Category 1 should develop a proposal about Schistosomiasis and/or Soil-Transmitted Helminths, and designate which specie(s) they intend to focus on. Species to designate are the following: Schistosomiasis - Schistosoma mansoni and Schistosoma haematobium; Soil-Transmitted Helminths - hookworms (Necator and Ancylostoma spp.), roundworms (Ascaris lumbricoides), and whipworms (Trichuris trichiura).

Category 1 applicants should focus their Year 1 activities on the key goals (#1 and #2) in bold below.

The key goals for Category 1 are:

1. Determine the factors associated with schistosomiasis and STH morbidity. For example, what is the prevalence level of these infections below which disease is no longer observed in the community? Develop and evaluate improved methods to monitor morbidity (Focus for Year 1).

2. Determine WASH levels associated with increased impact of MDA. Validate a WASH assessment tool that can identify community targets to help reduce prevalence (Focus for Year 1).

3. Evaluate and validate new methods for diagnosis of schistosomiasis and STH that are cost effective to use in monitoring and evaluating control programs.

4. Determine the frequency and geographic level of surveillance that provide reliable data to drive control program decisions as well as rapidly identify hotspots of infection.

5. Identify interventions beyond MDA (e.g., snail monitoring and control for schistosomiasis) that can be employed to increase programmatic success.

6. As new treatments or new formulations of existing treatments become available for schistosomiasis and soil transmitted helminths, evaluate dose, efficacy, impact, required frequency, and any side effects.

7. Improve routine surveillance platforms and ensure that they are collecting high-quality, actionable data, and work with the Ministry of Health to improve utilization of these data.

CATEGORY 2: MALARIA IN SUB-SAHARAN AFRICA

CDC supports the Global Malaria Programme of the World Health Organization and the Roll Back Malaria (RBM) Partnership to coordinate global malaria scale-up and evaluation efforts under the frameworks of the Global Technical Strategy (GTS) for Malaria, 2016—2030. As a partner, CDC has been building and working with numerous international networks, consortia, and partnerships to achieve the GTS targets. The intent of this cooperative agreement is to expand CDC’s network of collaborating institutes for both research and technical assistance to targeted malaria-endemic countries in sub-Saharan Africa. Activities funded through this mechanism will focus on research synthesis and malaria operational research aimed at controlling and ultimately eliminating malaria.

An applicant applying for Category 2 should focus their Year 1 activities on the key goals (#1 and #2) in bold.

The key goals for Category 2 are:

1. In coordination with global partners, evaluate community-level case management activities and practices for severe and complicated malaria to strengthen the ability of health facilities and community intervention efforts to provide timely and appropriate care and treatment to vulnerable populations (Focus for Year 1).

2. Evaluate surveillance as a core intervention (Focus for Year 1).

3. Evaluate novel prevention strategies, such as malaria vaccines, for efficacy and feasibility, and understand how to optimally implement these strategies.

4. 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.

5. Evaluate the continued effectiveness of intermittent preventive treatment during pregnancy and alternative strategies and approaches for prevention of malaria in pregnancy.

6. Evaluate the efficacy of novel vector control tools and technologies such as insecticide treated materials, including use of combination insecticide-treated bed nets, insecticide-treated wall liners, spatial repellents, attractive targeted sugar baits.

7. Monitor the efficacy of first- and second-line antimalarial drugs.

8. Disseminate results from these operational research and prevention activities through written publications, oral presentations, hosting of study tours, or by other means.

9. Assist Ministries of Health in translating operational research findings into public health policy and practice in sub-Saharan Africa, and ensure sharing of expertise and research findings with other partners and countries.

Healthy People 2030 and other National Strategic Priorities This program addresses "Healthy People 2030" focus areas(s) of Global Health (https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health ) with emphasis on improving global capacity to prevent, detect and respond to public health threats.

The project aims to contribute through the rapid identification and control of emerging infectious disease which helps: (1) increase the number of individuals trained globally to prevent, detect, or respond to public health threats (GH-D01); (2) increase the number of globally important public health events that are tracked and reported (GH-D02); (3) increase laboratory diagnostic testing capacity, surveillance, and reporting globally (GH-D03).

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 program implementation in countries where malaria, schistosomiasis, and soil transmitted helminths are endemic. Secondly, these activities will ultimately help to reduce morbidity and mortality due to malaria, schistosomiasis, and soil transmitted helminths through the identification and scale-up of evidence-based intervention strategies and on-going evaluations of these strategies.

Relevant Work This NOFO builds on CDC's Division of Parasitic Diseases and Malaria’s (DPDM) strategic priorities to work with domestic and global partners "to eliminate the global burden of malaria and neglected tropical diseases." A critical focus of the division is to expand scientific leadership and technical support to accelerate the eradication and elimination of malaria and targeted neglected tropical diseases, and to strengthen the global capacity to control parasitic infections worldwide.

CATEGORY 1: SCHISTOSOMIASIS AND/OR SOIL-TRANSMITTED HELMINTHS IN

KENYA

CDC has been collaborating with researchers in Kenya for over 25 years to better understand schistosomiasis. Advances during this time include:

A better understanding of how co-infections with HIV or malaria affect schistosomiasis and how schistosomiasis affects these infections

Investigation of differences in persons who rapidly become reinfected compared to those who appear more resistant

Evaluation of circulating antigen-based diagnostic tools Discovery, and description of geographic hotspots of infection https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health

Evaluation of different MDA schedules for reducing prevalence and morbidity in communities with moderate or high baseline prevalence, and

Introduction of new methods for ultrasound evaluation of intestinal morbidity that make this diagnostic tool more accessible to control programs.

DPDM’s work on soil-transmitted helminths is much less extensive and focused primarily on risk factors for their transmission in urban informal settlements

CATEGORY 2: MALARIA IN SUB-SAHARAN AFRICA

For more than 75 years, CDC has been a leader in the fight against malaria since its successful elimination in the United States. Building on that success, CDC experts continue to develop and evaluate malaria control interventions to reduce malaria illness and death with the ultimate goal of global elimination. CDC’s strategic research helped develop and evaluate critical tools that are 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)

CDC continues to pursue the strategic goal of reducing the global burden of malaria. Despite the scale up of proven strategies, the pace of malaria reduction has slowed in recent years. More research is needed to identify the optimal combinations of interventions and how best to implement them to drive down transmission. Additionally, CDC seeks to:

Identify the optimal means of scaling up case management, Assess the utility of drug-based prevention strategies, Understand how and where to best implement malaria vaccines, Identify novel vector control methods to control malaria more effectively, and Develop health facility and routine community surveillance platforms and assess how these can be used in decision making. The goal is for these platforms to eventually reduce or eliminate the need for costly ad hoc surveys to monitor the impact of interventions on malaria burden and transmission.

2. Approach Collaborative public health research will provide critical information on ways to monitor, control, and potentially eliminate parasitic diseases including malaria, schistosomiasis, and soil-transmitted helminths.

Approaches for Category 1. Schistosomiasis and/or Soil-Transmitted Helminths include the following. The applicant is expected to select a subset of these approaches to address in their application to meet the year 1 priority goals (stated in 1. Background and Purpose - Section 1. Funding Opportunity Description - Part 2. Full Text):

1. Conduct operational research, monitoring, and evaluation of Schistosomiasis and/or Soil-

Transmitted Helminths activities to assess the efficacy/ effectiveness of NTD control tools, including diagnosis and improvement of routinely collected surveillance data.

2. Evaluate and measure the effectiveness and impact of control interventions for Schistosomiasis and/or Soil-Transmitted Helminths including mass drug administration (MDA), intermediate host control approaches, sanitation, and other methods of transmission reduction.

3. Explore approaches to measure the force of transmission and evaluate its importance in prevalence and intensities of Schistosomiasis and/or Soil-Transmitted Helminths infections.

4. Evaluate new diagnostic tools for Schistosomiasis and/or Soil-Transmitted Helminths.

5. Evaluate surveillance approaches for Schistosomiasis and/or Soil-Transmitted Helminths to identify the best frequency and granularity of surveys that will inform control programs in a cost-effective manner.

6. Build epidemiological, entomological, laboratory, health economics, and social science capacity for NTD investigations.

Approaches for Category 2. Malaria includes the following. Applicants are expected to select a subset of these approaches to address in their application. However, approaches 1 and 2 should be a focus for year 1:

1. Evaluate community-level case management activities and practices for severe and complicated malaria (focus for year 1).

2. Evaluate surveillance as a core intervention (focus for year 1).

3. Conduct malaria epidemiological surveillance for infection, morbidity, and mortality.

4. Conduct entomological surveillance, including but not limited to insecticide resistance, vector composition and behavior of malaria and arboviral diseases. Elucidate the mechanisms of insecticide resistance, measure the impact of insecticide resistance on the efficacy of current interventions and develop/ evaluate new tools to mitigate the impact of insecticide resistance.

5. Conduct research on the development or assessment of new tools, including new vaccines and new vector control tools and technologies.

6. Conduct clinical research aimed at reducing morbidity and mortality in the vulnerable populations of children below 5 years of age and pregnant women.

7. Monitor or measure use, coverage, efficacy, and effectiveness of known and newly proven interventions (ITNs, IPTp, IRS, CM, malaria vaccine). This includes monitoring antimalarial drug efficacy/resistance both in vivo and in vitro.

8. Conduct operational research, including but not limited to social-cultural research, aimed at improving uptake of known/proven malaria control strategies.

9. Leverage resources to support research and infrastructure (e.g., enhanced data systems for real-time access to data, physical space) to accelerate progress towards malaria elimination in sub-Saharan African countries, including testing new tools/interventions to further reduce malaria transmission with the ultimate goal of malaria elimination.

10. Provide technical support to Malaria Control Units within Ministries of Health, and support translation of research to policy/practice.

Objectives/Outcomes Objectives specific to each category are stated below and applicants may propose a variety of projects that address these objectives.

CATEGORY 1. SCHISTOSOMIASIS AND/OR SOIL-TRANSMITTED HELMINTHS

Better understanding of community factors associated with schistosomiasis and STH morbidity, including ways to measure or predict where morbidity will occur.

Improved methods for measuring WASH at the community level and investigating what WASH measures are associated with more effective MDA.

Improved field- and laboratory-based diagnostic tools that provide community-level monitoring and evaluation.

Cost-effective sampling schemes that provide timely information to control programs so that adjustments to intervention approaches can be implemented.

Validated interventions beyond MDA and WASH that are effective at reducing NTD prevalence.

CATEGORY 2. MALARIA

Improved understanding of the efficacy of currently deployed malaria control interventions in sub-Saharan Africa, especially those interventions threatened by insecticide-resistant vectors and drug-resistant parasites.

Additional data on innovative interventions that address key challenges in vector control including interventions that address:

o Insecticide resistance and outdoor transmission o Improving malaria case management at health facility and community levels o Accessing hard-to-reach populations o Reducing transmission through targeting the parasite reservoir, and o Developing new tools to improve surveillance, monitoring, and evaluation.

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

Enhanced information about the feasibility and impact of transforming surveillance into a key malaria intervention.

Identification and assessment of 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.

Target Population The target population includes persons at risk for schistosomiasis, soil-transmitted helminths, and malaria in affected countries throughout the world. Sub-population target groups within malaria transmission zones should include those most at-risk e.g., children under five years of age and pregnant women.

Collaboration/Partnerships Applications are required to include a letter of support from Health Ministries in countries in which they propose to work to verify previous and ongoing collaborations. Documentation of any Memoranda of Understanding/Memoranda of Agreement (MOU/MOA) should also be included in the appendix to the application.

Successful applicants will be expected to collaborate closely and have regular communication with their governmental Health Ministries, in addition to the CDC country offices, CDC in-country point of contacts, and other CDC-funded partners where applicable.

Please see Section III.5 - Eligibility Information, Responsiveness.

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

Evaluations/performance measures will be established by specific program areas dependent upon the category for which the awardee is funded.

Translation Plan 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 plan. The translation of findings should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users.

Questions to consider in preparing this section include:

How will the scientific findings inform the public health policy or practices of local governments and other stakeholders?

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

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

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

How will the research improve health outcomes?

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

CA (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:

$12,000,000 Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya: $5 million Category 2. Malaria in sub-Saharan Africa: $7 million

Estimated Total Annual Budget Period Funding:

Year 1: $2.4M Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya: $1M Category 2. Malaria in sub-Saharan Africa: $1,400,000 Year 2: $2.4M Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya: $1M Category 2. Malaria in sub-Saharan Africa: $1,400,000 Year 3: $2.4M Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya: $1M Category 2. Malaria in sub-Saharan Africa: $1,400,000 Year 4: $2.4M Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya: $1M Category 2. Malaria in sub-Saharan Africa: $1,4700,000

Year 5: $2.4M Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya: $1M Category 2. Malaria in sub-Saharan Africa: $1,400,000 *Estimated total funding available for first year (first 12 months), including direct and indirect costs: $2.4M Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya: $1M Category 2. Malaria in sub-Saharan Africa: $1,400,000 *Estimated total funding available for entire project period, including direct and indirect costs: $12 million Category 1. Schistosomiasis and/or Soil-Transmitted Helminths in Kenya: $5 million Category 2. Malaria in sub-Saharan Africa: $7 million

Anticipated Number of Awards:

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

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

Federal government.

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

Award Ceiling:

$2,400,000 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 (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.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Other:

Faith-based or Community-based Organizations

Regional Organizations

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/ AC135Public/Docs/US%20Instructions%2 0for%2 0NSPA%20NCAGE.pdf.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/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 N/A

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.

int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

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

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

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

1. Applicants may not exceed the budget limit specified for Year 1 of the respective category to which they are applying. Applicants may not apply for more than $500,000 for Category 1 and $700,000 for Category 2 for Year 1. If an applicant requests a funding amount greater than the ceiling as indicated in Section II. of this NOFO, CDC will consider the application non-responsive, and the application will not enter the review process. CDC will notify the applicant that the application did not meet the submission requirements.

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://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 http://www.Grants.gov/

2. This is a 2-Category research NOFO – Category 1: Schistosomiasis and/or Soil- Transmitted Helminths in Kenya, and Category 2: Malaria in Sub-Saharan Africa. Only one application per institution (normally identified by having a unique DUNS number) is allowed, and each applicant can only apply for 1 category. If an applicant applies to both categories, their applications will be considered non-responsive and will not move forward for review and consideration for funding.

3. Applications must include a documented letter of support, as well as provide documentation of any MOU/MOA, from Health Ministries in countries in which they propose to work, to verify previous and ongoing collaborations.

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.

PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS. If already registered in SAM.gov, a UEI was automatically generated for your entity and is visible in both SAM.gov and Grants.gov. Entities registering in SAM.gov prior to April 2022 must still obtain a DUNS number before registering in SAM and a UEI will be assigned during SAM.gov registration.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code:

https://eportal.nspa.nato.int/AC135Public/Docs/US Instructions for NSPA NCAGE.pdf

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

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete.

However, it is best to start the registration process at least two weeks prior to application submission.

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal 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 an active eRA Commons account in order to https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov 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.

PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS. If already registered in SAM.gov, a UEI was automatically generated for your entity and is visible in both SAM.gov and Grants.gov. Entities registering in SAM.gov prior to April 2022 must still obtain a DUNS number before registering in SAM and a UEI will be assigned during SAM.gov registration.

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 SAM.gov and the SAM.gov Knowledge Base.

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.

http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0

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

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

Only one application per institution (normally identified by having a unique DUNS number) is allowed for each Category. Additionally, the same organization can not apply for both Category 1 AND Category 2. If they do, neither application will move forward for review nor receive funding. PLEASE NOTE: For applications due on or after January 25, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. Grant application forms and instructions will be updated to reflect and require UEI instead of DUNS.

As defined in the HHS Grants Policy Statement,…