PKG00248778-instructions.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Advancing Infectious Disease Detection and Response in Liberia

RFA-GH-19-013

Application Due Date: 03/08/2019

Advancing Infectious Disease Detection and Response in Liberia

RFA-GH-19-013

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 Advancing Infectious Disease Detection and Response in Liberia Activity Code U01

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

RFA-GH-19-013

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

Health NOFO Purpose The purpose of this cooperative agreement is:

To conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research of important diseases in Liberia.

To incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Liberia and ensure the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

Amendment 1: Summary of Changes Section VIII. Other Information Added questions and answers from conference call held 1/23/2019

Key Dates Publication Date: To receive notification of any changes to RFA-GH-19-013, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 02/04/2019 https://www.grants.gov

Application Due Date: 03/08/2019

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 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: 04/30/2019

Secondary Review:

Estimated Start Date:

Expiration Date:

Due Dates for E.O. 12372:

06/05/2019

09/30/2019

03/09/2019 Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

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

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

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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

Executive Summary Purpose:

The purpose of this Notice of Funding Opportunity (NOFO) is:

To conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research of important diseases in Liberia.

To incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Liberia and strengthen local workforce capacity and dissemination of findings across the region, with partners, and globally.

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

NOFO are contingent upon availability of funds. Up to five (5) awards may be made.

o Budget and Period of Performance. The estimated total funding (direct and indirect) for the first budget period, 9/30/2019 to 9/29/2020, is $2,500,000 USD, ranging from $0 USD to $2,500,000 USD. The estimated total funding (direct and indirect) for the entire project period of performance; 9/30/2019 to 9/29/2024 is estimated to be $12,500,000. Award ceilings for years 2-5 will be set at continuation based on availability of funds. The application for a specific project should not exceed the budget limit of $500,000 for each research project in year 1.

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

Eligible Institutions/Organizations: Institutions/organizations listed in Section III.1 are eligible to apply.

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

NOTE: CDC does not make awards to individuals directly. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs: There will be only one (1) 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):

Pre-Application Information Sharing Call: January 23, 2019 at 2 P.M Eastern

Standard Time. Call-in information: Phone Number: +1-866-880-0098 Toll Free OR +1-210-795-1100 Toll; Participant Passcode: 7896395522;

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

TTY: 1-888-232-6348.

Letter of Intent: February 4, 2019 Receipt date: March 4 , 2019 Review: April 30 2019 Award: September 2019 Application Materials: See Section IV.1 for application materials.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

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

1. Background and Purpose

The 2014-15 Ebola Virus Disease (EVD) epidemic had a devastating impact in West Africa resulting in 10,678 suspected, probable and confirmed cases and 4,810 deaths in Liberia.

The true magnitude of the outbreak is unknown, as not all individuals, who were infected with Ebola virus (EBOV) had laboratory confirmation of EVD. Due to the size of the outbreak in West Africa, the science of the natural history, behavior of, and counter measures for the disease has increased significantly. However, there remains significant gaps in knowledge about the post Ebola sequelae and the immune response to Ebola and its durability over time. The persistence of EBOV in immunologically-protected sites of EVD survivors have resulted in sexual transmission of the virus and subsequent clusters of disease following the end of widespread transmission, and poses a continued risk for resurgence of cases and the potential for a large-scale outbreak.

CDC has been working in close collaboration with the Government of Liberia (GoL) and partners on malaria prevention and control since 2008. Following the end of the Ebola outbreak, CDC continued to work closely with the GoL and its partners to strengthen the health sector in Liberia. The CDC Liberia Office provides a platform for advancing CDC’s global health security goals to prevent, detect, and respond to disease effectively using multi-sectorial international coordination and communication to support International Health Regulations. This NOFO seeks to establish a platform to study the underlying etiologies, characteristics of, and response to infectious diseases to advance our knowledge on the priority and epidemic-prone diseases in Liberia.

Healthy People 2020 and other National Strategic Priorities Healthy People 2020 goals supported by this NOFO include:

GH-5 - Increase diagnostic testing capacity in host countries and regionally through the Global Disease Detection (GDD) Regional Centers.

Other national and international priorities include:

The Department of Health and Human Services’ (HHS) Global Health Strategy maintains three goals to support HHS’ global health vision of a healthier, safer world:

1) Protect and promote the health and well-being of Americans through global health action;

2) Provide leadership and technical expertise in science, policy, programs and practice to improve global health; and

3) Advance United States interests in international diplomacy, development, and security through global health action.

Public Health Impact The intention of the NOFO is to strengthen public health impact through the implementation of infectious disease public health research in Liberia that can guide stakeholders in prioritizing resources and implement health practices and policies to mitigate the impact of health threats on the population. Through better understanding of disease threats, and their control and prevention, morbidity and mortality may be lowered, and global health security increased.

The proposed public health research activities in Liberia, will be used to examine the surveillance and laboratory data generated and to help define national and sub-national health policies. This would allow for the appropriate allocation of resources and the ability to implement public health interventions for controlling infectious diseases in the community. The goal is to use these data to identify potential disease outbreaks and guide clinical treatment, ensure coordinated linkages between the public health leadership and referral laboratories to identify and respond to emerging/unknown pathogens, and ensure sustainability of a tiered surveillance and laboratory system.

Relevant Work

Since its establishment in 2015, the CDC Liberia office has worked with the GoL, Ministry of Health (MoH), Liberia’s National Public Health Institute (NPHIL), USG agencies, and other partners to improve health systems and outcomes, building on existing disease prevention, detection and response systems. As a GHSA Phase 1 country, CDC works closely with the MoH, NPHIL, and other USG agencies and partners to implement a set of activities supporting GHSA and International Health Regulation priorities. These activities include, but are not limited to, surveillance, laboratory systems, workforce development and emergency management. CDC and partners have worked to better understand the Ebola epidemic and strengthen public health systems to better prepare the country to detect, respond, and prevent the next public health crisis.

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

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

2. Approach Proposals may include epidemiologic projects, laboratory-based projects, evaluation of interventions and control methods including therapeutic and preventative treatments. Projects may be new activities for the applicant, or may be directed at continuing and enhancing on-going activities addressing the described public health concerns in Liberia.

The applicant must submit a separate research plan and budget for each proposed project under each component specified under the Objectives/Outcomes. Each research plan should not exceed 25 pages. Each research plan must be identified with a title that clearly describes the research topic being addressed.

The research plan for each proposed project should address administrative tasks and oversight for the project as well as coordination of research objectives with other projects as appropriate.

Please note CDC prefers not to receive one project to cover all administrative tasks and costs but instead appropriate administrative tasks and costs should be included in each project budget.

Each proposal should include all the components under Section IV. Application and Submission Information 2. Content and Form of Application Submission

Objectives/Outcomes

Objectives/Outcomes

Applicants may submit no more than a total of three project proposals in components A through C as listed below. Project proposals can be from each of the different components or all under one component. Activities should focus on the characterization of public health threats. This includes conducting research activities to identify modifiable risk factors for priority diseases through community and/or population-based observational research, and research on disease burden, transmission or other factors related to risk.

For each project, the applicant must submit a separate Research Plan and Budget. As part of the PHS 398 Research Plan, the Research Strategy is limited to a maximum of 25 pages per project.

A management plan is required for any application with more than one project proposal, should be included as part of the primary project narrative. The management plan should summarize how the organization will manage all projects. Additionally, the management plan should address potential overlap of costs and activities and name the primary principal investigator and other key staff responsible for overall programmatic oversight.

Research Components Component A. Studies of long-term health effects of priority infectious diseases

Studies or activities to examine humoral and cell-based immune responses to Ebola virus disease and other infectious diseases

Studies to address the burden, and long-term health effects of Hepatitis B and C in https://www.cdc.gov/globalhealth/healthprotection/ghs/index.html http://www.cdc.gov/globalhealth/ihregulations.htm http://www.cdc.gov/globalhealth/ghi

Liberia.

Component B. Surveillance of emerging and re-emerging sub-types of priority infectious diseases Surveillance or studies to characterize the emergence of previously undetected meningitis subtypes in the region Surveillance and associated studies to characterize the re-emergence of monkey pox in

Liberia.

Component C. Studies to characterize the risk factors associated with diseases of pandemic potential

• Conduct hospital-based laboratory-confirmed influenza and other respiratory pathogens surveillance in representative hospitals and outpatient clinics in Liberia

Target Population The prospective applicant must identify the target populations to be included through this NOFO, consider the risk factors for disease and impact of increased diagnostics and surveillance by population type. The prospective applicant should use data generated under this NOFO to identify communities disproportionately affected by different infectious diseases, and propose activities/interventions to reduce or eliminate these disparities. The applicant should describe how the activities under this NOFO would be inclusive of all affected populations.

Collaboration/Partnerships

Collaboration with Liberia’s Ministry of Health (MoH) as documented in a letter of support is required with the application. Please see Section III.5 - Eligibility Information, Responsiveness.

In addition, the applicant must demonstrate involvement by local investigators in the proposed project. A list of names and contact information for staff already working in Liberia must be provided.

Evaluation/Performance Measurement As part of the application, the PI 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 applicant’s project plan, and develop and implement project performance measures based on specific programmatic objectives.

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

Questions to consider in preparing this section include:

1. How will the scientific findings inform the government in Liberia as well as other stakeholders on needed public health policies or practices at the local and national level?

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

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

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

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

Section II. Award Information Funding Instrument Type: Cooperative Agreement

A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $12,500,000 The estimated total funding (direct and indirect) for the entire project period of performance;

9/30/2019 to 9/29/2024 is estimated to be $12,500,000. This is based on availability of funds.

Award ceilings for years 2-5 will be set at continuation Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Anticipated Number of Awards: 5

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

Award Ceiling: $12,500,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

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

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

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are eligible to apply.

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

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

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

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements 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.

4. Justification for Less than Maximum Competition N/A

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

1. A mandatory LOI must be submitted by the due date for the LOI as specified in the NOFO.

2. The application for a specific component must be within the scope described under that component.

3. Applicant must not exceed the budget limit of $500,000 for year 1 for each research proposal.

4. Applicants must include a data management plan to demonstrate how the information generated from these studies will be shared with the Liberian Ministry of Health to help inform public health policy.

5. PDs/PIs must provide letters of support from the head of their institution as well as curriculum vitas to show previous work in the subject matter/location of work to be conducted.

6. For each application, applicant must provide a cover letter on institution letterhead 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 that summarizes and details the component applied for and the proposed funding level for that component. This letter must also contain key points of contact including telephone numbers and email addresses for key staff.

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.

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 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 https://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons https://www.grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

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

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

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

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

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

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

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-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.

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.

https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov/assist

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.

Content and Form of Application Submission:

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

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: 02/04/2019 The Letter of Intent for this NOFO is mandatory. Mandatory means that if an organization does http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf not submit an LOI, the application will be considered non-responsive and will not be forwarded for review.

The LOI should be on the institution letter head and should include the following information

Name of PI and institution Potential collaborators in country Application research topic – specify category or categories intended to apply

The letter of intent should be sent to:

Lata Kumar 1600 Clifton Road

MS-D69

Atlanta, GA 30333 Telephone: 404-639-7618 Email: LEK7@cdc.gov A pre-application conference call will be held to provide details of this NOFO and the application submission process. Call-in information for this conference call is as follows:

Date: January 23, 2019 at 2:00 pm Eastern Standard Time Toll Free Phone Number: 1-866-880-0098 Toll Phone Number: 1-210-795-1100 Participant Passcode: 7896395522 Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY: 1-888- 232-6348.

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:

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

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the NOFO.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

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

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

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-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 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

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

All the research components and a separate budget should be included for each of the project proposal. Applicants submitting more than one project proposal should include complete all the research components and upload it in the Appendix. Please title it with the title and component of the project

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

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 100 pages for all appendices.

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 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

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 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: 03/08/2019 https://era.nih.gov/files/ASSIST_user_guide.pdf http://grants.nih.gov/support/index.html https://www.grants.gov/web/grants/support.html mailto:support@grants.gov

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) This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

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 planning phase prior to the initiation of generating or collecting public health data and must be included in the Resource Sharing Plan(s) section of the PHS398 Research Plan Component of the application.

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 (for example, privacy and confidentiality considerations, embargo issues).

Recipients who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with 45 CFR 74.62 or other authorities as appropriate. For further information, please see: https://www.cdc.gov/grants/additionalrequirements/ar-25.html for revised AR-25.

12. Other Submission Requirements and Information Risk Assessment Questionnaire Requirement CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award http://www.whitehouse.gov/omb/grants_spoc http://www.whitehouse.gov/omb/grants_spoc https://foa.grantsolutions.gov/n%20accordance%20with%20the%20United%20States%20Protecting%20Life%20in%20Global%20Health%20Assistance%20policy,%20all%20non-governmental%20organization%20(NGO)%20applicants%20acknowledge%20that%20foreign%20NGOs%20that%20receive%20funds%20provided%20through%20this%20award,%20either%20as%20a%20prime%20recipient%20or%20subrecipient,%20are%20strictly%20prohibited,%20regardless%20of%20the%20source%20of%20funds,%20from%20performing%20abortions%20as%20a%20method%20of%20family%20planning%20or%20engaging%20in%20any%20activity%20that%20promotes%20abortion%20as%20a%20method%20of%20family%20planning,%20or%20to%20provide%20financial%20support%20to%20any%20other%20foreign%20non-governmental%20organization%20that%20conducts%20such%20activities.%20%20See%20Additional%20Requirement%20(AR)%2035%20for%20applicability%20(https:/www.cdc.gov/grants/additionalrequirements/ar-35.html).

https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.cdc.gov/grants/additionalrequirements/ar-25.html conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132…