RFA-GH-19-015.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Malaria Operations Research to Improve Malaria Control and Reduce Morbidity and Mortality in Malawi

RFA-GH-19-015

Application Due Date: 02/19/2019

Malaria Operations Research to Improve Malaria Control and Reduce Morbidity and Mortality in Malawi

RFA-GH-19-015

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 Malaria Operations Research to Improve Malaria Control and Reduce Morbidity and Mortality in Malawi Activity Code U01

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

RFA-GH-19-015

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

Health NOFO Purpose The purpose of this NOFO is to assist with the implementation of malaria focused operations research, surveillance, and monitoring and evaluation activities, in Malawi. Through this funding announcement, the Division of Parasitic Diseases and Malaria seeks to fund critical operations 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 malaria and increase the health and well-being of affected populations in Malawi.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-19-015, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: N/A N/A

Application Due Date: 02/19/2019

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications https://www.grants.gov must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/23/2019

Secondary Review: 05/17/2019

Estimated Start Date: 08/31/2019

Expiration Date: 02/20/2019 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Applicants must use ASSIST at https://public.era.nih.gov/assist to prepare and submit applications electronically through Grants.gov to CDC. ASSIST provides many features to facilitate the application submission process which improves data quality (e.g. pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review).

It is critical that applicants follow the instructions in the SF 424 (R&;R) ApplicationGuide 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.

Executive Summary Purpose:

The purpose of this Notice of Funding Opportunity (NOFO) is: to assist with the implementation of malaria focused operations research, surveillance, and monitoring and evaluation activities, in Malawi. Through this funding announcement, the Division of Parasitic Diseases and Malaria seeks to fund critical operations 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 malaria and increase the health and well-being of affected populations in Malawi.

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 $10,000,000. The expected number of awards is one.

Budget and Period of Performance: The budget period is anticipated to be 09/01/2019 to 08/31/2020. The project period for is anticipated to run from 09/01/2019 to 08/31/2024.

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: The University of Malawi, College of Medicine, Malaria Alert Centre

Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs: There will only be one (1) qualified PD/PI for each application.

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

Application Type: New Special Date(s): N/A https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf

Application Materials: See Section IV.1 for application materials.

Hearing Impaired: Telecommunications for the hearing impaired are available at:

TTY: 1-888-232-6348.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority 307 and 317(k) (2) of the Public Health Service Act, [42 U.S.C. Sections 241a) and 247b (k) (2), as amended

1. Background and Purpose 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. This cooperative agreement is intended to expand CDC’s network of collaborating institutes for both research and technical assistance to a targeted malaria-endemic country, Malawi. With a particular focus on research synthesis and malaria operational research aimed at controlling and ultimately eliminating malaria.

The purpose of this cooperative agreement is to 1) conduct strategic and applied research to inform control and elimination activities in malaria endemic countries, particularly in Malawi and sub-Saharan Africa, 2) support the establishment and strengthening of monitoring and evaluation systems for malaria program activities, including those supported by President’s Malaria Initiative (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 Ministry 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 efficacy 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 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. Firstly, these evaluations and studies will provide critical scientific knowledge to inform and guide malaria program implementation in malaria-endemic countries, especially in Malawi and other sub-Saharan Africa Countries. Secondly, the ultimate impact of these activities will be reduced morbidity and mortality due to malaria 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.

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.

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 Malawi, 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 insecticide resistance and outdoor transmission, strategies to improve malaria case management at the health facility and community levels, 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

Identification and assessment of improved and cost-effective approaches to monitoring changes in malaria burden;

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

Objectives/Outcomes Objective 1: Conduct malaria strategic and operations research and monitoring and evaluation activities in Malawi in conjunction with the National Malaria Control Program 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 insecticidal treated nets (LLINs), 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 Malawi and sub-Saharan Africa. 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), housing modification (including window screens, eaves tubes, etc., to prevent human contact with mosquito vectors), spatial repellents, attractive targeted sugar baits and larval source management;

• 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 and adults 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 the Malawian Ministry 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 the Ministry 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:

• Strengthen 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 the entomological impact of current vector control interventions and surveillance for insecticide resistance among malaria vectors; and

• Improve monitoring and evaluation tools for low transmission and pre-elimination settings.

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

Target Population Target populations should include people living or working in epidemiological defined areas of malaria transmission in Malawi. 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 N/A

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 FOA. 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: $10,000,000

Anticipated Number of Awards: 1

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

Award Ceiling: $10,000,000 Per Project Period Award Floor: $100,000 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are eligible to apply.

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

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

For this announcement, applicants may include collaborators or consultants from foreign http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements Foreign Organizations; Foreign components of U.S. Organizations; Collaborators or Consultants Single source competition. Only the application from The University of Malawi, College of Medicine will be accepted

4. Justification for Less than Maximum Competition The University of Malawi's College of Medicine (COM) is uniquely qualified for this award based on the following experience and capabilities:

The College of Medicine is the only Malawian institution that possesses the requisite scientific and technical expertise, the infrastructure capacity, the teaching and training environment for operations research and which has conducted longitudinal malaria research in areas of high morbidity and mortality in Malawi. The College of Medicine is the only Malawian institution in the country that has an insectary and a proven track record in raising the principal malaria vector, Anopheles funestus, from eggs to adults. The College of Medicine is located in the southern region of Malawi in an area of extremely high malaria morbidity and mortality and thus is ideally situated to help evaluate approaches to preventing and controlling malaria, other infectious diseases, and other public health problems. The College of Medicine has been collaborating with various health agencies on priority infectious disease research such as malaria, measles, and HIV/AIDS. The College of Medicine has experienced staff to support these collaborations.

The University of Malawi's College of Medicine has worked with CDC (Division of Parasitic Diseases and Malaria) and the MoHP on the following malaria research projects:

- Evaluation of the effectiveness of insecticide-treated bednets in an area of intense pyrethroid resistance;

- A study of the efficacy of sulfadoxine-pyrimethamine for intermittent preventive treatment of malaria in pregnancy

- Evaluation of preferences for net shape in urban and rural areas of Malawi;

- Evaluation of the roll-out of pre-referral rectal artesunate;

- Use of cell phone reminders to improve case management for malaria and other diseases of childhood;

- Evaluation of coverage after a mass campaign to distribute insecticide-treated bednets

- Malawi's only insectary for entomological monitoring, housed at the Malaria Alert Centre at the

COM

Conducted a prospective randomized open-label study on the efficacy and safety of intermittent preventive treatment in pregnancy (IPTp) with Dihydroartemisinin-Piperaquine (DP) versus IPTp with Sulfadoxine-Pyrimethamine (SP) The College of Medicine also has ongoing projects with other collaborators in which CDC is not directly involved:

- International Centre of Excellence in Malaria (NIH)

- Pilot roll-out of malaria rapid diagnostic tests (UNICEF)

- Pilot roll-out of RTS,S/AS01 malaria vaccine (WHO) The CDC's Malaria Branch has engaged in a cooperative agreement(s) with Malawi's College of Medicine/Malaria Alert Centre (COM/MAC) since 2004. The College of Medicine is the only medical school in Malawi and was established in 1991. The Malaria Alert Centre, established in 2001 as part of the College of Medicine, was created to provide a foundation and focus for malaria prevention and control activities involving operations research, monitoring and evaluation, and training of health care workers and public heath students. The Malaria Alert Centre has provided a strong foundation and platform for malaria operations research in a highly endemic area. Importantly, the Malaria Alert Centre has successfully engaged a variety of other external collaborators. The collaborations have included CDC's Global Measles Program, National Institutes of Health, the Integrated Vector Control Consortium, Michigan State University, UNICEF, WHO and the Liverpool School of Public Health. The Malaria Alert Centre has developed a close collaboration with the Ministry of Health and in particular the National Malaria Control Program, the Expanded Program on Immunizations (EPI) and the Integrated Management of Childhood Illnesses (IMCI). MAC is a recognized partner of the National Malaria Control Program and as a member of the National Malaria Advisory Committee (NMAC) and the task force overseeing the development and implementation of the malaria plan of action.

5. Responsiveness N/A

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https:// eportal.nspa.nato. int/ AC135Public/ Docs/ US%20Instructions%2 0for%20NSPA%20NCAGE.pdf

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

Grants.gov eRA Commons

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

https://www.sam.gov/portal/SAM https://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons https://www.grants.gov

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

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

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

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

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

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html

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

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

Number of applications is 1.

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

Section IV. Application and Submission Information

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

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

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

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

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms.

Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Please include all of the eight (8) mandatory forms listed below in the application package:

http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm

Mandatory

1. SF424(R&R)[V2.0];

2. PHS 398 Cover Page Supplement [V4.0];

3. Research and Related Other Project Information [V1.4];

4. Project/Performance Site Location(s) [V2.0];

5. Research and Related Senior/Key Person Profile (Expanded) [V2.0];

6. Research and Related Budget [V1.4];

7. PHS 398 Research Plan [V4.0];

8. PHS Human Subjects and Clinical Trials Information [V1.0].

Please include the one (1) optional form listed below, if applicable, in the application package:

Optional

1. R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT.

3. Letter of Intent Due Date for Letter of Intent: [Insert 0 days from date of publication] N/A

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/generalforms-e.pdf and https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

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

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.

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

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation and Approach. Describe the proposed research plan, including staffing and time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here:

https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf must be followed along with any additional instructions provided in the NOFO.

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

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

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

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

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

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

PHS 398 Research Plan Component

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php

(R&R) Application Guide.

Appendix

7. Page Limitations All page limitations described in this individual NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 25 pages.

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

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

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf.

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

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

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

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

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

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

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

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the grant 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).

Applicants who encounter problems when submitting their applications must attempt to resolve https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://era.nih.gov/files/ASSIST_user_guide.pdf them by contacting the NIH eRA Service desk at:

Toll-free: 1-866-504-9552; Phone: 301-402-7469 http://grants.nih.gov/support/index.html Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time (closed on federal holidays)

Problems with Grants.gov can be resolved by contacting the Grants.gov Contact Center at:

Toll-free: 1-800-518-4726 https://www.grants.gov/web/grants/support.html support@grants.gov Hours: 24 hours a day, 7 days a week (closed on federal holidays) If the applicant encounters problems that prevent the ability to submit an application which cannot be resolved by Grants.gov or NIH eRA Service Desks, then applicants must contact CDC Technical Information Management Section (TIMS) at 770-488-2700; ogstims@cdc.gov for guidance at least 3 calendar days before the deadline date. Therefore, it is important that applicants complete the application submission process well in advance of the due date time.

After submission of your application package, applicants will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. A third and final e-mail message is generated once the applicant's application package has passed validation and the grantor agency has confirmed receipt of the application.

Unsuccessful Submissions: If an application submission was unsuccessful, the applicant must:

1. Track submission and verify the submission status (tracking should be done initially regardless of rejection or success).

a. If the status states "rejected", do #2a or #2b

2. Check emails from both Grants.gov and NIH eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grants Management contact listed in the Agency Contacts section of this announcement and ogstims@cdc.gov explaining why the submission failed.

b. If there is time before the deadline, correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 02/19/2019

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372) Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order 12372 (http://www.archives.gov/federal-register/codification/executive-order/12372.html). This order sets up a system for state and local review of proposed federal http://grants.nih.gov/support/index.html https://www.grants.gov/web/grants/support.html mailto:support@grants.gov http://www.archives.gov/federal-register/codification/executive-order/12372.html http://www.archives.gov/federal-register/codification/executive-order/12372.html assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list:

https://www.whitehouse.gov/wp-content/uploads/2017/11/Intergovernmental_-Review- _SPOC_01_2018_OFFM.pdf.

11. Funding Restrictions All HHS/CDC awards are subject to the federal regulations, 45 CFR 75, terms and conditions, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organization (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award, either as a prime recipient or subrecipient, are strictly prohibited, regardless of the source of funds, from performing abortions as a method of family planning or engaging in any activity that promotes abortion as a method of family planning, or to provide financial support to any other foreign non-governmental organization that conducts such activities. See Additional Requirement (AR) 35 for applicability (https://www.cdc.gov/grants/additionalrequirements/ar-35.html).

For more information on expanded authority and pre-award costs, go to: https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

CDC requires that mechanisms for, and cost of, public health data sharing be included in grants, cooperative agreements, and contracts. The cost of sharing or archiving public health data may also be included as part of the total budget requested for first-time or continuation awards.

Fulfilling the data-sharing requirement must be documented in a Data Management Plan (DMP) that is developed during the project…