PKG00248569-instructions.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Advancing Public Health Research in Bangladesh

RFA-GH-19-005

Application Due Date: 02/27/2019

Advancing Public Health Research in Bangladesh

RFA-GH-19-005

TABLE OF CONTENTS

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

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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations Center for Global Health Extramural Research Program Office (CGH ERPO) Center for Global Health (CGH) National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) National Center for Environmental Health (NCEH) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) National Center for Immunization and Respiratory Diseases (NCIRD) National Center for Injury Prevention and Control (NCIPC) Notice of Funding Opportunity (NOFO) Title Advancing Public Health Research in Bangladesh Activity Code U01- Cooperative Agreement

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

RFA-GH-19-005

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

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to conduct high quality public health research and surveillance activities to support the government of Bangladesh and other partners to detect, prevent, and respond to disease threats.

Research projects may be quantitative, qualitative, and /or mixed methods epidemiological studies, laboratory-based studies, or other types of research projects that focus on:

a) Characterizing priority diseases in Bangladesh,

b) Determining most effective implementation approaches and interventions, and

c) Measuring impact of public health efforts.

All funded research projects should be conducted in partnership with the Government of Bangladesh and include clear mechanisms for advancing public health policy and practice at local, national, regional, and/ or global levels.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-19-005, return to the synopsis page of this announcement at

Letter of Intent Due Date:

N/A

Application Due Date:

www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

N/A

02/27/2019

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: 04/23/2019

Secondary Review:

Estimated Start Date:

Expiration Date:

Due Dates for E.O. 12372:

05/29/2019

09/30/2019

02/28/2019 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.

https://www.grants.gov

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 Notes:

The Research Strategy component of the Research Plan is limited to 25 pages per project.

When submitting multiple projects, each project needs to have all the research plan sections completed along with a separate budget and should be uploaded as separate files in the Appendix section since the SF424 R& R page will allow only one research plan to be submitted.

Executive Summary The purpose of this Notice of Funding Opportunity (NOFO) is to conduct high quality public health research and surveillance activities that support the government of Bangladesh and other partners to better detect, prevent, and respond to disease threats. Projects may be quantitative, qualitative, or mixed methods epidemiological studies, laboratory-based studies, or other types of research projects focus on:

• Characterizing priority diseases in Bangladesh,

• Determining most effective implementation approaches and interventions, and

• Measuring impact of public health efforts All research projects should be conducted in partnership with the Government of Bangladesh and include clear mechanisms for advancing public health policy and practice at local, national, regional, and/ or global levels.

• Mechanism of Support: Cooperative Agreement Funds Available and Anticipated Number of Awards: The estimated total level of funding available in U.S. dollars (USD), including direct and in-direct costs, for entire 5-year project period is $0. The expected number of awards will be up to 1 (one) award. Awards issued under this NOFO are contingent upon availability of funds and a sufficient meritorious application.

Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

• Budget and Period of Performance: The budget period is anticipated to run from 09/30/2019 to 09/29/2020. The project period is anticipated to run from 09/30/2019 to http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

09/29/2024. The estimated total funding (direct and indirect) for the first budget period;

9/30/2019 to 9/29/2020, is estimated to range from $0 USD to $4,000,000 USD. The estimated total funding (direct and indirect) for the entire period of performance; 9/30/2019 to 9/29/2024 is estimated to be $0 USD. This is based on availability of funds . The Approximate Project Period of Performance Funding Estimated Total Funding for the Total 5 year Project Period is None. Award ceilings for years 2-5 will be set at continuation.

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

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

Application due date is 2/21/2019 Application Materials. See Section IV.1 for application materials. Please note that Form E is to be used when downloading the application package.

• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1-888- 232-6348

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority 307 42 U.S.C. Sections 242 and 317(k) (2) of the Public Health Service Act, 42 U.S.C. Sections 241(a) and 247b (k) (2), as amended

1. Background and Purpose With a population of more than 160 million people in a country the size of the U.S. State of Iowa, Bangladesh is the most densely populated country in the world (with the exception of city-countries like Singapore). That density increases even more during the annual monsoon, when nearly 1/3 of the land mass is covered with water as the Ganges delta swells with rain and run-off from the Himalayas. With the help of development assistance, Bangladesh has reduced the poverty rate from over half of the population to less than a third, has achieved Millennium Development Goals for maternal and child health, and has made great progress in food security.

Scientists agree that Bangladesh is a particularly susceptible to the emergence of novel influenza virus and other novel pathogens.

In 2014 and 2015, the governments of both Bangladesh and the United States agreed to support an organized Global Health Security Agenda (GHSA), which is a coordinated effort among more than 64 nations to work together to detect, prevent, and respond to emerging infectious disease threats. As part of that effort, the U.S. Government focuses resources and technical support for achieving GHSA milestones of the in 17 countries, including Bangladesh.

The Centers for Disease Control and Prevention (CDC) has been working in Bangladesh for the last 50 years, with a primary focus to understand infectious diseases and evaluate strategies that address those diseases in Bangladesh. With the advent of the United States Government and the Government of Bangladesh’s commitment to the global health security agenda, CDC research and public health projects continue to increase focus on activities that have strong potential to result in changes to public health policy and practice that result in in improved health outcomes as well as global health security capacities.

Healthy People 2020 and other National Strategic Priorities While Healthy People 2020 goals are generally specific to US domestic programs, the global health activities within this NOFO extends the national strategic priorities through:

• (GH-5)- Increase host country and regional diagnostic testing capacity through the Global Disease Detection (GDD) Regional Centers.

• 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 Public Health Impact of this proposed work will provide high quality public health research and implementation science projects that will guide stakeholders to prioritize resources, develop policies, and implement practices and interventions that mitigate the impact of health threats on the population. Research projects should be relevant to exploring strengthening surveillance capacity that results in a tiered laboratory system, strengthening Bangladesh’s public health workforce, supporting effective emergency response capacities, and improving clinical care and prevention interventions. Improvements in these areas should increase the ability of the government of Bangladesh and other partners to detect, prevent, and respond to disease threats, in order to improve population health outcomes and reduce the risk of global pandemics.

Relevant Work For more 50 years, the Centers for Disease Control and Prevention (CDC) has been working with Bangladesh, often in close collaboration with the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), a premier global health research institution in Dhaka on research and surveillance activities in a broad range of technical areas. CDC has awarded icddr,b three past research cooperative agreements (FY2004-2009, FY2009-2014, FY2014- 2019) and one non-research cooperative agreement (FY2014-2019). More than a hundred research projects and capacity building activities have been conducted jointly under the terms of these awards. While early activities focused on diarrheal disease, the collaboration has grown to encompass research and surveillance activities in areas ranging from emerging infectious diseases, influenza, and polio immunogenicity studies. Many of these efforts have had important impacts on public health policy practice, including providing evidence for updating of polio immunization guidelines, evidence for introduction of rotavirus vaccine, and a much deeper understanding of the newly identified Nipah Virus.

Building on the icddr,b-CDC joint efforts to support core capacity development in outbreak response and surveillance, CDC has also developed a direct-bilateral relationship with the Institute of Epidemiology Disease Control and Research (IEDCR) within the Bangladesh Ministry of Health and Family Welfare (MoHFW) to support research activities that facilitate the implementation of the Global Health Security Agenda. Icddr,b has been a long-time, valuable partner of the Institute for Epidemiology, Disease Control and Research (IEDCR) within the MoHFW. Under the terms of updated Memorandum of Understanding, icddr,b and IEDCR have established guidelines for an effective collaboration on all of the icddr,b-implemented surveillance, outbreak response, and relevant research projects.

Moving forward, CDC will continue to focus efforts in Bangladesh on research activities that continue to develop and strengthening systems, create policy, and implement practices to detect, prevent, and respond to disease threats.

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

https://www.ghsagenda.org/ 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

Objectives/Outcomes Applicants may propose up to 15 research projects in the first year of award intended to strengthen the ability of the government of Bangladesh and other partners to detect, prevent, and respond to disease threats through high quality public health research and surveillance activities.

Specifically, the projects should focus on: a) determining burden, trends, etiology, and risk factors of priority diseases in Bangladesh, b) developing and evaluating interventions and diagnostics, c) evaluating the effectiveness of vaccinations d) informing global policy, and e) strengthening the Government of Bangladesh's surveillance, laboratory and outbreak response capacity.

Disease Areas Applicants may submit an application on one or more of the following eligible disease areas:

1. Acute febrile illness (AFI),

2. Encephalitic illness (including Nipah Virus and Japanese Encephalitis),

3. Antimicrobial resistance (AMR) and/or healthcare-associated infections (HAI),

4. Vaccine-preventable diseases,

5. Influenza and other respiratory illnesses,

6. Zoonotic diseases, and

7. Other public health issues of global, regional and/or local importance CDC’s funding is largely disease specific, as such funding decisions will be based on alignment with particular disease areas.

RESEARCH CATEGORIES

Applicants may propose projects that focus on the disease area(s) selected in at least one of the following research categories. In the first year of award, applicants may only submit up to 15 projects total. All fifteen projects may be proposed in one research category or can be a combination of the three categories: A, B, or C. Examples of projects are provided under each research category:

Category A: Characterize Priority Diseases in Bangladesh Conduct research activities to determine burden, trends, etiology, and risk factors for priority diseases in Bangladesh. These research activities may be laboratory-focused, observational, epidemiological, or utilize other rigorous methods.

Examples of projects that characterize priority diseases include:

• Develop, maintain, or expand a multi-site sentinel surveillance system in Bangladesh to determine burden of disease, transmission dynamics, risk factors, relative contribution of different pathogens to disease syndromes, and/or control of infectious agents.

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

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

• Conduct research on the human-animal interface of zoonotic diseases and risks of transmission from animals to humans.

• Develop and test innovative solutions identified through research to develop early warning systems to report sentinel organisms in humans that can serve as an alert for multidrug resistant organisms and interventions for adequate antimicrobials Project Category B: Determine Most Effective Implementation Approaches and Interventions Conduct research to identify the most effective implementation approaches for responding to global public health threats and building global health security capacity.

Examples of projects that address effective implementation approaches include:

• Conduct research to evaluate the effectiveness of different vaccine delivery methods, for example comparing immune responses to vaccinations provided on different schedules or when co-administered with other vaccinations.

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

• Develop new interventions, evaluate the effectiveness of interventions, and/or make recommendations for scale-up of interventions designed to reduce the spread of disease (for example, infection control methods or poultry slaughtering methods).

• Develop and test new diagnostic or laboratory testing methods to build stronger laboratory, surveillance, and response capacity.

Project Category C: Measuring Impact Conduct research on the current capacity of the Bangladesh health system; examine impact of investments by donors for Global Health Security Agenda and international health regulation capabilities, or specific program effectiveness. Projects should lead to the development and/or improvement of national and regional policies and programs for disease prevention, monitoring and control.

Examples of projects that measure impact include:

• Conduct evaluations of surveillance programs in Bangladesh to determine coverage rates, barriers, best practices, and effectiveness.

• Measure the impact of enhancements in public health surveillance in a country (in terms of outbreaks controlled, cases averted, time lags from specimen detection to collection etc.).

• Conduct research to estimate the direct and indirect costs, and document the economic burden of priority diseases and/or develop cost effectiveness estimates of prevention and control programs for a priority disease.

• Conduct a systematic review of Antimicrobial Resistance/Hospital Acquired Infections (AMR/HAI) activities in Bangladesh. This includes the development of a catalogue of research and public institutions working in AMR/HAI to include information on location, description of activities, populations served, and a summary of relevant publications in the last 5 years.

Target Population The prospective applicant must identify the target populations to be addressed through this NOFO, including 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 will be inclusive of all affected populations.

Collaboration/Partnerships Collaborations with a broad range of partners will be increasingly critical to generate data, make recommendations, and implement those recommended actions and policies relevant to the Global Health Security Agenda. The successful applicant must maintain close working relationships with the Bangladesh Ministry of Health and Family Welfare (MoHFW), particularly the Institute for Epidemiology Disease Control and Research; the Bangladesh Ministry of Fisheries and Livestock (MoFL), and the Bangladesh Ministry of Agriculture (MoA). In addition, the applicant should maintain relationships with other stakeholders such as the World Health Organization and other multinational health organizations (OIE, FAO, and UNICEF). All proposed activities should align with the goals of the Global Health Security Agenda and/or Bangladesh’s strategic priorities and identified gaps, for example those outlined in the sector planning process or the Joint External Evaluation. Applicants are encouraged, but not required, to collaborate with academic and other health related organizations on research projects in which partnership(s) would add value to the project.

Evaluation/Performance Measurement As part of the application, the applicant 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 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 program direction/principle investigator with management and technical experience, responsible for managing the planning, implementation, and evaluation of the program and serving as the CDC point of contact.

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

Fiscal management Programs must use funding to support activities in alignment with requirements of this NOFO.

Programs must develop and maintain systems for sound fiscal management, including:

monitoring the cooperative agreement award and program contracts and grants, ensuring the funds are expended in support of approved activities; tracking.

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.

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.

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 future public health policies or practices at the local and national level?

a. What are some recommendations could come from my research questions?

b. How does my study respond to priorities of the government or other stakeholders?

c. How could my findings inform future scientific inquiry?

2. Who are the key stakeholders in the government who could implement the recommendations or use the information that comes out of my research study?

3. How can I design my project so that stakeholders will be interested in the results of my project and be more likely to pay attention to the findings?

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: $0

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: $4,000,000 Per Project Period Award Floor: $0 Per Project 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.

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 Only the application from Bangladesh Icddr,b will be accepted.

4. Justification for Less than Maximum Competition icddr,b (formerly the International Centre for Diarroheal Disease Research, Bangladesh) is an international not-for-profit research institution headquartered in Dhaka, Bangladesh. The institute has a long history of working on the frontlines of global health and producing high quality and impactful science. In addition, the institution maintains the largest diarrheal hospital in the world and the longest running demographic surveillance system in Asia. This grantee received an approved single eligibility status for all prior research and non-research cooperative agreements--in 2004 and 2009.

icddr,b is uniquely qualified to conduct the activities outlines under the this funding opportunity announcement.

1. CDC has a 40 year history of collaborations with icddr, b. This includes 3 past research cooperative agreements (FY2004-2009, FY2009-2014, and FY2014-2019) and one non-research cooperative agreement (FY2014-2019). Over the last 15 years, CDC has started several projects with icddr, b that we hope will continue beyond FY 2018, including 3 syndromic hospital-based sentinel surveillance platforms, a cohort of children examining respiratory outcomes, and ongoing outbreak responses to disease clusters in partnership with the government. Through the research the findings have informed public health practice both in Bangladesh and around the world (e.g., evidence for updating of polio immunization guidelines, evidence for introduction of rotavirus vaccine, etc.). Most recently, together with CDC, icddr, b collaborated on the Child Health and Mortality Prevention Surveillance (CHAMPS) project funded by Gates Foundation.

2. Past investments of CDC has strengthened critical scientific credibility and expertise among icddr, b staff and ensured expanded laboratory capacity that is used to implement activities. icddr, b has been a long-time, valuable partner of the Ministry of Health and Family Welfare, including CDC's primary Global Health Security Partner. Under the terms of their recently updated MOU, icddr, b and the Institute of Epidemiology Disease 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

Control and Research (IEDCR) leadership of the two institutions collaborate on plans of mutual value and have established guidelines for an effective collaboration on all of the icddr, b-implemented surveillance, outbreak response, and applicable research projects.

The leadership of the two institutions often meet to discuss plans and the Ministry of Health values the contributions from icddr, b.

3. icddr, b is the only non-diplomatic partner currently known to CDC that has direct legal authority and operational expertise to process the import of laboratory supplies and reagents, including time sensitive reagents. Further, it is currently the only known entity with direct existing agreements with major biomedical transportation organizations and maintains an updated material transfer agreement (MTA) with CDC for shipping samples.

4. Icddr, b has a long history of employing both third country nationals and Bangladeshis with strong scientific skills--a requirement for the effective implementation of the NOFO activities. Along with their organizational history and reputation as a premier public health institution, Icddr, b has a competitive hiring process and offers benefits on par with other major development program partners and research organizations in other parts of the world.

5. Icddr, b has a strong and active biosafety committee and a Senior Biosafety Officer who is the only known certified biosafety cabinet certifier in the country. Until 2014, icddr, b was the only institution within the country to have a certified BSL-3 laboratory.

Unfortunately, the laboratory was damaged in an earthquake and icddr, b is now following BSL-2+ guidelines and follows all international standards for biosafety and biosecurity until the BSL-3 capabilities are fully restored and will once again be the only institution with a BSL-3 laboratory.

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

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.

Applicant organizations may submit only one application.

Section IV. Application and Submission Information

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

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

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

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

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

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

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

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

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: [Insert 0 days from date of publication]

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 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 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

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.

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

Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the NOFO.

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

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

Supporting materials for the Research Plan narrative included as appendices may not exceed 20 PDF files with a maximum of 150 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…