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Centers for Disease Control Center for Global Health Extramural Research Program Office Advancing Infectious Disease Detection and Response Nigeria RFA-GH-19-010 Application Due Date: 03/04/2019 Advancing Infectious Disease Detection and Response Nigeria RFA-GH-19-010 TABLE CONTENTS Part Overview Information Key Dates Required Application Instructions Executive Summary Part Full Text Section Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part Overview Information Participating Organization(s) Centers for Disease Control Components Participating Organizations Center for Global Health Extramural Research Program Office (CGH ERPO) Center for Global Health (CGH) Notice Funding Opportunity (NOFO) Title Advancing Infectious Disease Detection and Response Nigeria Activity Code U01- Cooperative Agreement Notice Funding Opportunity Type New Agency Notice Funding Opportunity Number RFA-GH-19-010 Assistance Listings (CFDA) Number(s) 93.326 Category Funding Activity: Health NOFO Purpose The purpose this Notice Funding Opportunity (NOFO) conduct high quality public health research. Research projects may quantitative, qualitative, and /or mixed methods epidemiological studies conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research important diseases Nigeria, including but not limited address acute febrile illness, emerging and re-emerging infectious diseases, zoonotic and vector borne diseases; environmental health issues effecting infectious diseases (such water and air); vaccine-preventable diseases; biosafety and security; and other public health threats local importance. Research projects should outline clear plans incorporate the results research activities into operational disease detection, prevention, and response control programs Nigeria and ensure the strengthening local workforce capacity and dissemination findings across the region, with partners, and globally. Other areas for research include activities antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats. Key Dates Publication Date: receive notification any changes RFA-GH-19-010, return the synopsis page this announcement www.grants.gov and click the Send Change Notification Emails link. email address Letter Intent Due Date: N/A Application Due Date: needed for this service. N/A 03/04/2019 On-time submission requires that electronic applications error-free and made available CDC for processing from the NIH eRA system before the deadline date. Applications must submitted and validated successfully Grants.gov later than 5:00 U.S. Eastern Time. Applications must submitted using the Application Submission System Interface for Submission Tracking (ASSIST) module which web-based service used for the preparation and submission grant applications CDC through Grants.gov. ASSIST provides the ability for applicants prepare their applications online, and offers the applicant additional capabilities including the ability preview the application image, validate the application against required business rules, and prepopulate data from applicant organizations records, therefore identifying issues earlier the application submission process. Note: HHS/CDC grant submission procedures not provide grace period beyond the application due date time correct any error warning notices noncompliance with application instructions that are identified Grants.gov eRA systems (i.e., error correction window). Scientific Merit Review: 04/23/2019 Secondary Review: 05/29/2019 Estimated Start Date: 09/30/2019 Expiration Date: Due Dates for E.O. 12372: 03/05/2019 Executive Order 12372 does not apply this program. Required Application Instructions **ELECTRONIC APPLICATION SUBMISSION VIA ASSIST PREFERRED** recommended that applicants use ASSIST for the electronic preparation and submission applications through Grants.gov CDC. ASSIST alternative method prepare and submit applications, and provides many features facilitate the application submission process which improves data quality (e.g., pre-population organization data, pre-submission validation business rules, and preview the application image used for review). Use the Grants.gov downloadable Adobe application packages and submission process will still supported. critical that applicants follow the instructions the 424 (RR) Application Guide except where instructed otherwise this NOFO. Conformance all requirements (both the Application Guide and the NOFO) required and strictly enforced. Applicants must read and follow all application instructions the Application Guide well any program-specific instructions noted Section IV. When the program-specific instructions deviate from those the Application Guide, follow the program-specific instructions. Note: The Research Strategy component the Research Plan limited pages. Applications that not comply with these instructions may delayed not accepted for review. Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 Note: The Research Strategy component the Research Plan limited pages per project Executive Summary Purpose: The purpose this Notice Funding Opportunity (NOFO) conduct high quality public health research. Research projects may quantitative, qualitative, and /or mixed methods epidemiological studies conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research important diseases Nigeria, including but not limited address acute febrile illness, emerging and re-emerging infectious diseases, zoonotic and vector borne diseases; environmental health issues effecting infectious diseases (such water and air); vaccine-preventable diseases; biosafety and security; and other public health threats local importance. Research projects should outline clear plans incorporate the results research activities into operational disease detection, prevention, and response control programs Nigeria and ensure the strengthening local workforce capacity and dissemination findings across the region, with partners, and globally. Other areas for research include activities antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats. Mechanism Support: Cooperative Agreement Funds Available and Anticipated Number Awards. The estimated total level funding (in U.S. dollars) available, including direct and in-direct costs, for entire 5-year project period $5,000,000. The number awards will (one). Awards issued under this NOFO are contingent upon availability funds and sufficient meritorious application. Because the nature and scope the proposed research will vary from application application, also anticipated that the size and duration each award may also vary. The total amount awarded and the number awards will depend upon the number, quality, duration and cost the applications received. Budget and Period Performance. The budget period anticipated run from 09/30/2019 09/29/2020. The project period anticipated run from 09/30/2019 09/29/2024. The estimated total funding (direct and indirect) for the first budget period 9/30/2019 9/29/2020, estimated range from USD $1,000,000 USD.. The estimated total funding (direct and indirect) for the entire period performance; 9/30/2019 9/29/2024 estimated $5,000,000 USD. Application Research Strategy Length: Page limits for the Application Research Strategy specified Section IV. Application and Submission Information this announcement. Eligible Institutions/Organizations: Institutions/organizations listed Section III.1 are eligible apply. Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary carry out the proposed research are invited work with their institution/organization develop application for support. NOTE: CDC does not make awards individuals directly. Individuals from underrepresented racial and ethnic groups well individuals with disabilities are always encouraged apply. Number PDs/PIs: There will only one (1) qualified PD/PI for each application. Number Applications: Only one (1) application per eligible institution (normally identified unique DUNS number) allowed. Application Type: New Special Date(s): Application due date 2/21/2019 Application Materials: See Section IV.1 for application materials. Hearing Impaired: Telecommunications for the hearing impaired are available at: TTY: 1-888-232-6348. Part Full Text Section Funding Opportunity Description Statutory Authority 307 U.S.C. Sections 242 and 317(k) (2) the Public Health Service Act, U.S.C. Sections 241(a) and 247b (k) (2), amended Background and Purpose While CDC has worked Nigeria for decades (mostly areas like smallpox eradication nutrition), the agency established permanent country office Abuja February 2001. With the establishment the U.S. President Emergency Plan for AIDS Relief (PEPFAR) 2004, CDC presence Nigeria greatly expanded. 2017, Nigeria signed the Global Health Security Agenda (GHSA) following its agreement meet obligations under the International Health Regulations 2005. CDC works with the Government Nigeria and other partners achieve these requirements focusing workforce development, emergency response, surveillance, laboratory, and border health/point entry interventions. CDC supports efforts protect the public health developing and strengthening health systems Nigeria providing technical leadership rapidly respond disease outbreaks and emerging infectious diseases. Outbreak prevention and global health security considerations are priority international health strategy and for CDC Nigeria. During the West African Ebola outbreak, there were laboratory-confirmed and one probable Ebola cases two states Nigeria (the most populous country Africa) after very sick traveler from Liberia arrived the international airport Lagos July 2014. the time was recognized that the patient carried the Ebola virus, the traveler had exposed people the aircraft, airport, and hospital. appeared that conditions were ripe for the disease spread through the city and the nation. result quick action Nigerian authorities, CDC, team international partners, and the activation Ebola Incident Management Center precursor Nigeria current Emergency Operations Center) the virus was contained within few weeks. With this new research cooperative agreement, CDC strives continue supporting global health security work Nigeria generating evidence-based data for public health action. Healthy People 2020 and other National Strategic Priorities While Healthy People 2020 goals are generally specific domestic programs, the global health activities within this NOFO extends the national strategic priorities. Ensuring Global Health Security national strategic priority, especially GHSA countries and Ebola-affected and related countries. Nigeria priority country for CDC and for the Defense Threat Reduction Agency. The NSC currently reassessing biologic risk profiles; this time there decision GHSA strategic priorities for 2020-2025 but irrespective final priority listings Nigeria remains GHS focus high concern. The Department Health and Human Services (HHS) Global Health Strategy maintains three goals support HHS global health vision healthier, safer world: protect and promote the health and well-being Americans through global health action; provide leadership and technical expertise science, policy, programs and practice improve global health; and advance United States interests international diplomacy, development, and security through global health action. Public Health Impact The intention the NOFO provide global health security impact through conducting public health research infectious diseases that can guide stakeholders prioritize resources and implement health practices and policies mitigate the impact the local and international ramifications health threats. Through better understanding disease threats, and their control and prevention, morbidity and mortality may lowered, and global health security increased. More importantly, the development research partners other countries can accomplished through Cooperative Agreement mentoring and support. The proposed public health research will used understand the data and help define national and sub-national health policies. This allows for the appropriate allocation resources and the ability implement public health interventions for controlling infectious diseases the community. The goal use these data identify potential disease outbreaks and guide clinical treatment, ensure coordinated linkages between the public health leadership and referral laboratories identify and respond emerging/unknown pathogens, and ensure sustainability tiered surveillance and laboratory system. Relevant Work CDC has worked Nigeria with the Federal Ministry Health (FmoH) since 2004. The FMoH the parent organization the Nigeria Center for Disease Control (NCDC). The goal the work develop and strengthen systems enable the identification and response emerging and re-emerging infections. CDC coordinates with local, regional, and global public health entities rapidly detect, accurately identify, and promptly contain emerging disease threats. Collaborations with partners are essential generate important data the burden broad range infectious diseases, detection poorly understood and novel pathogens, well causes and rates mortality the populations under surveillance. The collaborations result the strengthening public health capacity within Ministries Health (MOHs) and Ministries Agriculture (MoAg) primarily collaboration with Departments Epidemiology and Surveillance, the National Laboratories, the National Public Health Institutes, and other specific disease control programs. the last years, NCDC has successfully moved IHR engagement from inactivity Joint External Evaluation and national action plan development and implementation. has built Emergency Operations Center that activated times year, and then added Incident Command Center handle overflow activity associated with the dozens investigations and local responses. has, with the assistance partners, deployed electronic Integrated Disease Surveillance and Response reporting and introduced electronic case management reporting the states most effected outbreaks. has built national reference lab and developed National Reference Laboratory capability, and forging network labs and sample transport. has also led promoted advances Infection Prevention and Control, medical countermeasures and supply chain logistics. CDC has several activities that support relate specifically this NOFO. Prospective applicants should refer the following websites and related documents for additional information: 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 Approach Objectives/Outcomes Applicants may propose three projects the first year award that support develop public health related research activities and studies. Projects should focused the detection, prevention, response, and elimination communicable diseases, zoonosis, and other emerging and re-emerging public health threats Nigeria. Disease Areas Applicants may focus their application one more the following eligible disease areas: Acute febrile illness (AFI) High priority diseases such meningitis viral hemorrhagic fevers Zoonoses and emerging diseases Antimicrobial resistance (AMR) and/or healthcare-associated infections (HAI) (i.e. nosocomial hospital acquired infections) Respiratory illness and influenza Enteric illnesses One Health research Other public health issues regional and local importance RESEARCH CATEGORIES Applicants must propose projects that focus the disease area(s) selected least one the following research categories. the first year award, applicants may only submit three projects total. All three projects can proposed one research category can combination the three categories: Examples projects are provided under each research category: Project Category Characterize Public Health Threats Includes conducting research activities identify modifiable risk factors for priority diseases through community and/or population-based observational research. Also included are research disease burden, transmission other factors related risk. Research findings should presented international meetings and published the peer-reviewed literature. Examples projects that characterize public health threats are: Develop, maintain, expand one more surveillance systems Nigeria, combining population-based and facility-based surveillance designed determine burden disease, transmission dynamics, risk factors, relative contribution different pathogens disease syndromes, and control infectious agents. multi-site system could include population/site diversity with regard urban/rural, socioeconomic factors, etc. Support the development strengthening laboratories and/or platforms used for etiologic investigation, evaluation novel diagnostic assays for faster and easier detection, and characterization pathogens. Develop and/or maintain one more research sites investigate and report the interactions between specific pathogens and underlying comorbidities. Conduct ongoing and systematic collection, analysis and interpretation biological samples and data for both animal and human health collaboration with Ministries Health and Agriculture Nigeria order strengthen surveillance national and regional levels. Conduct research the human-animal interface zoonotic diseases and risks transmission from animals humans. Provide innovative solutions identified through research develop early warning systems report sentinel organisms humans that can serve alert for multidrug resistant organisms and interventions for adequate antimicrobials Project Category Determine Most Effective Implementation Approaches: Includes research the most effective implementation approaches for responding global public health threats and building global health security capacity. Examples projects that address effective implementation approaches are: Conduct qualitative socio-cultural research and surveys knowledge, attitudes, and practices related infectious disease and the acceptance interventions and prevention methods. Develop cost disease estimates and cost effectiveness estimates for priority diseases. Develop processes for collecting and analyzing information the costs associated with surveillance and research activities and the potential savings the population level early detection and control. Project Category Measuring Impact Includes research interventions prevent and control diseases importance. These projects might use various designs and sources data. The findings should used guide the development and/or improvement national and regional policies and programs for disease prevention, monitoring and control. Examples projects that measure impact are: Conduct evaluations surveillance programs Nigeria determine coverage rates, barriers, best practices, and effectiveness. Conduct research assess efficacy/effectiveness, immunogenicity and impact vaccines, treatments, and non-pharmaceutical interventions and other control measures reduce the burden influenza disease among vulnerable populations. Conduct systematic review AMR/HAI activities Nigeria. This includes the development catalogue research and public institutions working AMR/HAI include information location, description activities, populations served, and summary relevant publications the last years. Conduct research estimate the direct and indirect costs, and document the economic burden priority diseases and interventions. Studies measure the impact enhancements public health surveillance country (in terms outbreaks controlled, cases averted, time lags from specimen detection collection etc.). Target Population The prospective applicant must identify the target populations addressed through this NOFO, including risk factors for disease and impact increased diagnostics and surveillance population type. The prospective applicant should use data generated under this NOFO identify communities disproportionately affected different infectious diseases, and propose activities/interventions reduce eliminate these disparities. The applicant should describe how the activities under this NOFO will inclusive all affected populations. Collaboration/Partnerships Nigeria CDC the national focal point for the International Health Regulations and GHSA. the hub through which other ministries and agencies and the federated States coordinate their work. Post JEE and GHSA activity has triggered large coalition partners, including Public Health England and DFID, Robert Koch Institute and GIZ, Japan International Cooperation Agency, and Gates Foundation, name few. WHO has longstanding relationship with NCDC and the FMoH. The World Bank REDISSE program, through ECOWAS and WAHO, has partnered with NCDC implement global health security activities. Through this cooperative agreement, NCDC will build upon the existing programs established these partners and ensure comprehensive approach global health security Nigeria. Evaluation/Performance Measurement part the application, the should include measurable goals and aims based 5-year research project period. The applicant will establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described the applicant project plan, and develop and implement project performance measures that are based specific programmatic objectives. Monitoring and Evaluation Work with CDC and other global partners appropriate develop and implement evaluation plan measure the impact the activities outlined this funding opportunity announcement (evaluation framework, evaluation design, indicators, process and outcome evaluation, and information/data collection plan). Program Capacity Establish retain full-time staff person with management and technical experience, responsible for managing the planning, implementation, and evaluation the program and serving the CDC point contact. Establish retain part-time staff person with data management and mobile data collection experience responsible for the programming and trouble-shooting data collection instruments, cleaning data, development data dictionaries and storage datasets. Establish retain additional staff with demonstrated knowledge, skills, and expertise administrative and fiscal management meet the needs the program. Over the course the project period establish and retain other staff, contractors, and consultants sufficient number and expertise ensure project success. Fiscal management Programs must use funding support activities alignment with requirements 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 support approved activities. Translation Plan The applicant should describe plans for how research and scientific findings will 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 findings should understandable variety audiences, including policy makers, practitioners, public health programs, health care institutions, professional organizations, community groups, researchers, and other potential users. Questions consider preparing this section include: How will the scientific findings inform the government Nigeria well other stakeholders needed public health policies practices the local and national level? How will the research project improve affect the translation study findings into policy practice? How will the research findings help promote accelerate the dissemination, implementation, diffusion improvements public health programs and practices? How will the research findings advance guide future scientific efforts related activities? How will the research activities improve public health outcomes, advance workforce development, and enhance response capacity? Application Approach The applicant should submit one overall research proposal response this application, which may include more than three projects part the first year award proposal. The proposal may include epidemiologic projects, laboratory-based projects, evaluation interventions and control methods including therapeutic and preventative treatments. Projects can focus multiple infectious disease syndrome(s) group diseases that are clinically functionally related, identifiable public health concern problem affecting health Nigeria. Projects may new activities for the applicant may aimed continuing and enhancing ongoing activities addressing public health concerns Nigeria. The applicant should submit separate research plan and budget for each proposed project within the proposal. more than three research plans and budgets should submitted for the first year award proposal. The research plans should not exceed pages per project. The research plan for each proposed project should address administrative tasks and oversight for the project well coordination research objectives with other projects appropriate. Please note CDC prefers not receive one project cover all administrative tasks and costs but instead appropriate administrative tasks and costs should included each project budge Section II. Award Information Funding Instrument Type: Cooperative Agreement support mechanism used when there will substantial Federal scientific programmatic involvement. Substantial involvement means that, after award, scientific program staff will assist, guide, coordinate, participate project activities. Application Types Allowed: New application that submitted for funding for the first time. Includes multiple submission attempts within the same round. Estimated Total Funding: $5,000,000 Anticipated Number Awards: Awards issued under this NOFO are contingent the availability funds and submission sufficient number meritorious applications. Award Ceiling: $1,000,000 Per Budget Period Award Floor: Per Budget Period Total Period Performance Length: year(s) Throughout the Period Performance, CDCs commitment continuation awards will depend the availability funds, evidence satisfactory progress the recipient (as documented required reports), and CDC determination that continued funding the best interest the Federal government. HHS/CDC grants policies described the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply the applications submitted and awards made response this NOFO. Section III. Eligibility Information Eligible Applicants Eligibility Category: Others (see text field entitled Additional Information Eligibility for clarification) Additional Eligibility Category: Foreign Organizations Foreign Organizations are eligible apply. Foreign (non-US) organizations must follow policies described the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (RR) Application Guide. International registrants can confirm DUNS sending e-mail email@example.com, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int/AC135 Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf. Foreign components U.S. Organizations are eligible apply. For this announcement, applicants may include collaborators consultants from foreign institutions. All applicable federal laws and policies apply. Special Eligibility Requirements Foreign Organizations are eligible apply. Foreign (non-US) organizations must follow policies described the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (RR) Application Guide. International registrants can confirm DUNS sending e-mail firstname.lastname@example.org, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCA GE.pdf Additional Information Eligibility Single source competition. Only the application from Nigeria Centre for Disease Control will accepted. Justification for Less than Maximum Competition Nigeria CDC the National Public Health Institute for Nigeria and the government parastatal organization under the MoH, which charged with prevention, detection and response infectious disease outbreaks. NCDC the sole entity with government mandate manage data that includes disease specific information multiple priority diseases prevent and control outbreaks; other organization has the breadth and depth data. NCDC also charged with coordinating the implementation the International Health Regulations.NCDC mandated research functions are based U.S. CDC research functions, and therefore the only candidate with which CDC can develop the governments ability research emerging diseases the context outbreak prevention. The NCDC focus for epidemiological expertise Nigeria supported the FETP program, which provides ready access 100 advanced fellows training, well access the professors the Nigerian universities that sponsor the program and the network graduates the program.The NCDC leads responses outbreaks well smaller investigations. This level direct engagement with the partners interest not available through any other entity. The NCDC manages the two functional Nigerian National Reference Labs Abuja and Lagos. These laboratories have alliterative equivalent Nigeria. The laboratory the influenza lab, the repository the 170,000 sample NEISS HIV study, CDC-supported mega-lab, and key PCR facility for testing Lymphatic Filariasis, Yellow Fever, measles, meningitis and monkeypox.The goal this NOFO both develop research capability and investigate characteristics the current priority pathogens and matched interventions. With this mandate, NCDC the only entity within Nigeria with which CDC can partner sustainable, capacity building approach public health research. Without this mechanism, NCDC and CDC will unable generate the data needed implement evidencebased public health research projects better characterize disease threats, determine the most effective implementation approaches and measure impact. Responsiveness N/A Required Registrations Applicant organizations must complete the following registrations described the 424 (RR) Application Guide eligible apply for receive award. Applicants must have valid Dun and Bradstreet Universal Numbering System (DUNS) number order begin each the following registrations. (Foreign entities only): Special Instructions for acquiring 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 SAM (the replacement system for the Central Contractor Registration) 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 least days prior submitting your application familiarize yourself with the registration and submission processes. The one-time registration process will take three five days complete. However, best start the registration process least two weeks prior application submission. All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials register with the eRA Commons ensure their existing Principle Investigator (PD/PI) eRA Commons account affiliated with the eRA commons account the applicant organization. All registrations must successfully completed and active before the application due date. Applicant organizations are strongly encouraged start the eRA Commons registration process least four (4) weeks prior the application due date. ASSIST requires that applicant users have active eRA Commons account order prepare application. also requires that the applicant organizations Signing Official have active eRA Commons Signing Official account order initiate the submission process. During the submission process, ASSIST will prompt the Signing Official enter their Grants.gov Authorized Organizational Representative (AOR) credentials order complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain DUN and Bradstreet (DB) Data Universal Numbering System (DUNS) number the Universal Identifier when applying for Federal grants cooperative agreements. The DUNS number nine-digit number assigned Dun and Bradstreet Information Services. AOR should consulted determine the appropriate number. the organization does not have DUNS number, AOR should complete the DB D-U-N-S Number Request Web Form contact Dun and Bradstreet telephone directly 1-866-705-5711 (toll-free) obtain one. DUNS number will provided immediately telephone charge. Note this organizational number. Individual Program Directors/Principal Investigators not need register for DUNS number. Additionally, all applicant organizations must register the System for Award Management (SAM). Organizations must maintain the registration with current information all times during which has application under consideration for funding CDC and, award made, until final financial report submitted the final payment received, whichever later. SAM the primary registrant database for the Federal government and the repository into which entity must provide information required for the conduct business recipient. Additional information about registration procedures may found the SAM internet site https://www.sam.gov/index.html. award granted, the recipient organization must notify potential sub-recipients that organization may receive subaward under the grant unless the organization has provided its DUNS number the recipient organization. Eligible Individuals (Project Director/Principal Investigator) Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary carry out the proposed research the Project Director/Principal Investigator (PD/PI) invited work with his/her organization develop application for support. Individuals from underrepresented racial and ethnic groups well individuals with disabilities are always encouraged apply for HHS/CDC support. Cost Sharing This FOA does not require cost sharing defined the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf). 10. Number Applications defined the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received response the same Notice Funding Opportunity generally are scored individually and then ranked with other applications under peer review their order relative programmatic, technical, scientific merit. HHS/CDC will not accept any application response this NOFO that essentially the same 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 Address Request Application Package order use ASSIST, applicants must visit https://public.era.nih.gov/assist where you can login using your eRA Commons credentials, and enter the Notice Funding Opportunity Number initiate the application, and begin the application preparation process. you experience problems accessing using ASSIST, you can refer the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support available from the NIH eRA Service desk via: E-mail: http://grants.nih.gov/support/index.html Phone: 301-402-7469 (toll-free) 1-866-504-9552. The NIH eRA Service desk available Monday Friday, a.m. p.m. Eastern Time, excluding federal holidays. Content and Form Application Submission critical that applicants follow the instructions the SF-424 (RR) 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 this Notice Funding Opportunity otherwise. Conformance the requirements the Application Guide required and strictly enforced. Applications that are out compliance with these instructions may delayed not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms. Please note that some forms marked optional the application package are required for submission applications for this NOFO. Follow the instructions the SF-424 (RR) Application Guide ensure you complete all appropriate optional components. When using ASSIST, all mandatory forms will appear separate tabs the top the Application Information screen; applicants may add optional forms available for the NOFO selecting the Add Optional Form button the left navigation panel. Please include all the eight (8) mandatory forms listed below the application package: Mandatory SF424(RR)[V2.0]; PHS 398 Cover Page Supplement [V4.0]; Research and Related Other Project Information [V1.4]; Project/Performance Site Location(s) [V2.0]; Research and Related Senior/Key Person Profile (Expanded) [V2.0]; Research and Related Budget [V1.4]; PHS 398 Research Plan [V4.0]; PHS Human Subjects and Clinical Trials Information [V1.0]. Please include the one (1) optional form listed below, applicable, the application package: Optional RR Subaward Budget Attachment(s) Form ATT. Letter Intent Due Date for Letter Intent: [Insert days from date publication] N/A Required and Optional Components complete application has many components, both required and optional. The forms package associated with this NOFO Grants.gov includes all applicable components for this NOFO, required and optional. ASSIST, all required and optional forms will appear separate tabs the top the Application Information screen. PHS 398 Research Plan Component The SF424 (RR) Application Guide includes instructions for applicants complete PHS 398 Research Plan that consists components. Not all components the Research Plan apply all Notices Funding Opportunities (NOFOs). Specifically, some the following components are for Resubmissions Revisions only. See the 424 (RR) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/generalformse.pdf and https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional information. Please attach applicable sections the following Research Plan components directed Part Section (Notice Funding Opportunity Description). Follow the page limits stated the 424 unless otherwise specified the NOFO. applicable and specified the NOFO, the application should include the bolded headers this section and should address activities conducted over the course the entire project, including but not limited to: Introduction Application (for Resubmission and Revision ONLY) provide clear description about the purpose the proposed research and how addresses the specific requirements the NOFO. Specific Aims state the problem the proposed research addresses and how will result public health impact and improvements population health. Research Strategy the research strategy should organized under headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and time line. Progress Report Publication List (for Continuation ONLY) Other Research Plan Sections Vertebrate Animals Select Agent Research Multiple PD/PI Leadership Plan. Consortium/Contractual Arrangements Letters Support 10. Resource Sharing Plan(s) 11. Authentication Key Biological and/or Chemical Resources 12. Appendix All instructions the SF424 (RR) Application Guide https://grants.nih.gov/grants/how-toapply-application-guide/forms-e/general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf must followed along with any additional instructions provided the NOFO. Applicants that plan collect public health data must submit Data Management Plan (DMP) the Resource Sharing Plan section the PHS 398 Research Plan Component the application. DMP required for each collection public health data proposed. Applicants who contend that the public health data they collect create are not appropriate for release must justify that contention the DMP submitted with their application for CDC funds. The DMP may outlined narrative format checklist but, minimum, should include: Descriptions the data produced the proposed project How access will provided the data (including provisions for protection privacy, confidentiality, security, intellectual property, other rights) Use data standards that ensure all released data have appropriate documentation that describes the method collection, what the data represent, and potential limitations for use Plans for archival and long-term preservation the data, explaining why long-term preservation and access cannot justified Examples DMPs may found here: University California https://dmp.cdlib.org/, USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php Component (Inclusion Enrollment Report) applies only Renewal and Revision applications for clinical research. Clinical research that which conducted with human subjects (or material human origin such tissues, specimens and cognitive phenomena) for which investigator (or colleague) directly interacts with human subjects. Excluded from this definition are vitro studies that utilize human tissues that cannot linked living individual. Patient-oriented research includes: (a) mechanisms human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development new technologies). Follow the page limits the 424 unless otherwise specified the NOFO Appendix not use the appendix circumvent page limits. maximum PDF documents are allowed the appendix. Additionally, publications may included that are not publically available. Follow all instructions for the Appendix described the SF424 (RR) Application Guide. Page Limitations All page limitations described this individual NOFO must followed. For this specific NOFO, the Research Strategy component the Research Plan narrative limited pages. Supporting materials for the Research Plan narrative included appendices may not exceed PDF files with maximum 150 pages for all appendices. Format for Attachments Designed maximize system-conducted validations, multiple separate attachments are required for complete application. When the application received the agency, all submitted forms and all separate attachments are combined into single document that used peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded the system. CDC requires all text attachments the Adobe application forms submitted PDFs and that all text attachments conform the agency-specific formatting requirements noted the SF424 (RR) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-formse.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf. Submission Dates Times Part Overview Information contains information about Key Dates. Applicants are strongly encouraged allocate additional time and submit advance the deadline ensure they have time make any corrections that might necessary for successful submission. This includes the time necessary complete the application resubmission process that may necessary, errors are identified during validation Grants.gov and the NIH eRA systems. The application package not complete until 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. the system detects errors, then the applicant must correct errors before their application can submitted. Applicants are responsible for viewing their application ASSIST after submission ensure accurate and successful submission through Grants.gov. the submission not successful and post-submission errors are found, then those errors must corrected and the application resubmitted ASSIST. Applicants are able access, view, and track the status their applications the eRA Commons. Information the submission process provided the SF-424 (RR) Application Guidance and ASSIST User Guide https://era.nih.gov/files/ASSIST_user_guide.pdf. Note: HHS/CDC grant submission procedures not provide grace period beyond the grant application due date time correct any error warning notices noncompliance with application instructions that are identified Grants.gov eRA systems (i.e. error correction window). Applicants who encounter problems when submitting their applications must attempt resolve them 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, a.m. p.m. Eastern Time (closed federal holidays) Problems with Grants.gov can resolved contacting the Grants.gov Contact Center at: Toll-free: 1-800-518-4726 https://www.grants.gov/web/grants/support.html email@example.com Hours: hours day, days week (closed federal holidays) the applicant encounters problems that prevent the ability submit application which cannot resolved Grants.gov NIH eRA Service Desks, then applicants must contact CDC Technical Information Management Section (TIMS) 770-488-2700; firstname.lastname@example.org for guidance least calendar days before the deadline date. Therefore, important that applicants complete the application submission process well advance the due date time. After submission your application package, applicants will receive submission receipt email generated Grants.gov. Grants.gov will then generate second e-mail message applicants which will either validate reject their submitted application package. third and final e-mail message generated once the applicants application package has passed validation and the grantor agency has confirmed receipt the application. Unsuccessful Submissions: application submission was unsuccessful, the applicant must: Track submission and verify the submission status (tracking should done initially regardless rejection success). the status states rejected, #2a #2b Check emails from both Grants.gov and NIH eRA Commons for rejection notices. the deadline has passed, he/she should email the Grants Management contact listed the Agency Contacts section this announcement and email@example.com explaining why the submission failed. there time before the deadline, correct the problem(s) and resubmit soon possible. Due Date for Applications: 03/04/2019 Electronically submitted applications must submitted later than 5:00 p.m., ET, the listed application due date. 10. Intergovernmental Review (E.O. 12372) This initiative not subject intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc). 11. Funding Restrictions All HHS/CDC awards are subject the federal regulations, CFR 75, terms and conditions, and other requirements described the HHS Grants Policy Statement. Pre-award costs may allowable expanded authority, but only authorized CDC. accordance with the United States Protecting Life Global Health Assistance policy, all non-governmental organization (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award, either prime recipient subrecipient, are strictly prohibited, regardless the source funds, from performing abortions method family planning engaging any activity that promotes abortion method family planning, provide financial support any other foreign non-governmental organization that conducts such activities. See Additional Requirement (AR) for applicability (https://www.cdc.gov/grants/additionalrequirements/ar-35.html). For more information expanded authority and pre-award costs, 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 included grants, cooperative agreements, and contracts. The cost sharing archiving public health data may also included part the total budget requested for first-time continuation awards. Fulfilling the data-sharing requirement must documented Data Management Plan (DMP) that developed during the project planning phase prior the initiation generating collecting public health data and must included the Resource Sharing Plan(s) section the PHS398 Research Plan Component the application. Applicants who contend that the public health data they collect create are not appropriate for release must justify that contention the DMP submitted with their application for CDC funds (for example, privacy and confidentiality considerations, embargo issues). Recipients who fail release public health data timely fashion will subject procedures normally used address lack compliance (for example, reduction funding, restriction funds, award termination) consistent with CFR 74.62 other authorities appropriate. For further information, please see: https://www.cdc.gov/grants/additionalrequirements/ar-25.html for revised AR-25. The Office Management and Budget (OMB) requires that all projects which CDC staff will provide technical assistance advice any information collections more people that are planned conducted the awardee, all such information collections where CDC staff will are approving, directing, conducting, managing, owning data must undergo OMB project determinations CDC and might require OMB PRA clearance prior the start the project. Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such contractual. The direct and primary recipient cooperative agreement program must perform substantial role carrying out project objectives and not merely serve conduit for award another party provider who ineligible. Reimbursement pre-award costs not allowed. Indirect Costs will not paid (either directly through sub-award) organizations located outside the territorial limits the United States international organizations regardless their location. All requests for funds contained the budget, shall stated U.S. dollars. Once award made, CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance supplemental awards. Foreign grantees are subject audit requirements specified CFR 74.26(d). nonFederal audit required, during the grantees fiscal year, the grantee expended total $500,000.00 more under one more HHS awards (as direct grantee and/or sub-grantee). The grantee either may have (1) financial related audit (as defined the Government Auditing Standards, GPO stock #020-000-00-265-4) particular award accordance with Government Auditing Standards, those case where the grantee receives awards under only one HHS program; or, awards are received under multiple HHS programs, financial related audit all HHS awards accordance with Government Auditing Standards; (2) audit that meets the requirements contained OMB Circular A-133. fiscal Grantee Capability Assessment may required, prior post award, order review the applicant business management and fiscal capabilities regarding the handling U.S. Federal funds research involves human subjects, funds will restricted until Federal Wide Assurance (FWA) and Institutional Review Board Approvals (IRB) are place. Projects, directed CDC staff and involve the collection information from more individuals, and are funded grant/cooperative agreement, will subject review and approval the Office Management and Budget (OMB) under the Paperwork Reduction Act.The Office Management and Budget (OMB) requires that all projects which CDC staff will provide technical assistance advice any information collections more people that are planned conducted the awardee, all such information collections where CDC staff will are approving, directing, conducting, managing, owning data must undergo OMB project determinations CDC and might require OMB PRA clearance prior the start the project. 12. Other Submission Requirements and Information Risk Assessment Questionnaire Requirement CDC required conduct pre-award risk assessments determine the risk applicant poses meeting federal programmatic and administrative requirements taking into account issues such financial instability, insufficient management systems, non-compliance with award conditions, the charging unallowable costs, and inexperience. The risk assessment will include evaluation the applicant CDC Risk Questionnaire, located https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, well review the applicant history all available systems; including OMB-designated repositories government-wide eligibility and financial integrity systems (see CFR 75.205(a)), and other sources historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance federal contracts per Duncan Hunter National Defense Authorization Act 2009; Not Pay list; and System for Award Management (SAM) exclusions. CDC requires all applicants complete the Risk Questionnaire, OMB Control Number 09201132 annually. This questionnaire, which located https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must submitted with your application the closing date the Notice Funding Opportunity Announcement. your organization has completed CDC Risk Questionnaire within the past months the closing date this NOFO, then you must submit copy that questionnaire, submit letter signed the authorized organization representative include the original submission date, organization EIN and DUNS. When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification the type documentation. For example, copy Procurement policy submitted response the questionnaire may labeled using the following format: Risk Questionnaire Supporting Documents Procurement Policy. Duplication Efforts Applicants are responsible for reporting this application will result programmatic, budgetary, commitment overlap with another application award (i.e. grant, cooperative agreement, contract) submitted another funding source the same fiscal year. Programmatic overlap occurs when (1) substantially the same project proposed more than one application submitted two more funding sources for review and funding consideration (2) specific objective and the project design for accomplishing the objective are the same closely related two more applications awards, regardless the funding source. Budgetary overlap occurs when duplicate equivalent budgetary items (e.g., equipment, salaries) are requested application but already are provided another source. Commitment overlap occurs when individual time commitment exceeds 100 percent, whether not salary support requested the application. Overlap, whether programmatic, budgetary, commitment individual effort greater than 100 percent, not permitted. Any overlap will resolved the CDC with the applicant and the PD/PI prior award. Report Submission: The applicant must upload the report under Other Attachment Forms. The document should labeled: Report Programmatic, Budgetary, and Commitment Overlap. Application Submission Applications must submitted electronically following the instructions described the 424 (RR) Application Guide. PAPER APPLICATIONS WILL NOT ACCEPTED. Applicants must complete all required registrations before the application due date. Section III.6 Required Registrations contains information about registration. For assistance with your electronic application for more information the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide /url_ redirect.htm? id=11144). Important reminders: All PD/PIs must include their eRA Commons the Credential field the Senior/Key Person Profile Component the 424(RR) Application Package. Failure register the Commons and include valid PD/PI Commons the credential field will prevent the successful submission electronic application CDC. The applicant organization must ensure that the DUNS number provides the application the same number used the organization profile the eRA Commons and for the System for Award Management (SAM). Additional information may found the SF424 (RR) Application Guide. the applicant has FWA number, enter the 8-digit number. not enter the letters FWA before the number. Project/Performance Site engaged research involving human subjects, the applicant organization responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection human subjects and complies with CFR Part and other CDC human subject related policies described Part the 424 (RR) Application Guide and the HHS Grants Policy Statement. See more resources avoid common errors and submitting, tracking, and viewing applications: http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm https://era.nih.gov/files/ASSIST_user_guide.pdf http://era.nih.gov/erahelp/ASSIST/ Upon receipt, applications will evaluated for completeness the CDC Office Grants Services (OGS) and responsiveness OGS and the Center, Institute Office the CDC. Applications that are incomplete and/or nonresponsive will not reviewed. Section Application Review Information Criteria Only the review criteria described below will considered the review process. part the CDC mission (http:// www.cdc.gov/ about/ organization/ mission.htm), all applications submitted the CDC support public health research are evaluated for scientific and technical merit through the CDC peer review system. Overall Impact Reviewers will provide overall impact/priority score reflect their assessment the likelihood for the project exert sustained, powerful influence the research field(s) involved, consideration the following review criteria and additional review criteria (as applicable for the project proposed). Scored Review Criteria Reviewers will consider each the review criteria below the determination scientific merit, and give separate score for each. application does not need strong all categories judged likely have major scientific impact. For example, project that its nature not innovative may essential advance field. Significance Does the project address important problem critical barrier progress the field? the aims the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice improved? How will successful completion the aims change the concepts, methods, technologies, treatments, services, preventative interventions that drive this field? Investigator(s) Are the PD/PIs, collaborators, and other researchers well suited the project? Have they demonstrated ongoing record accomplishments that have advanced their field(s)? the project collaborative multi-PD/PI, the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Innovation Does the application challenge and seek shift current research clinical practice paradigms utilizing novel theoretical concepts, approaches methodologies, instrumentation, interventions? Are the concepts, approaches methodologies, instrumentation, interventions novel one field research novel broad sense? refinement, improvement, new application theoretical concepts, approaches methodologies, instrumentation, interventions proposed? the proposed research innovation and yet offer reasonable potential for concrete applications interest and value CDC? Does the project have the potential increase efficiency lead costs savings? Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate accomplish the specific aims the project? Are potential problems, alternative strategies, and benchmarks for success presented? the project the early stages development, will the strategy establish feasibility and will particularly risky aspects managed? the project involves clinical research, are there plans for protection human subjects from research risks, and inclusion minorities and members both sexes/genders, well the inclusion children, justified terms the scientific goals and research strategy proposed? Environment Will the scientific environment which the work will done contribute the probability success? Are the institutional support, equipment and other physical resources available the investigators adequate for the project proposed? Will the project benefit from unique features the scientific environment, subject populations, collaborative arrangements? Does the applicant describe how the proposed work will relate other programs sponsored the agency, which are already place planned support strengthen disease surveillance, laboratory systems, emergency response and workforce development? Does the project utilize critical partnerships collaborations? Does the project support key stakeholder involvement throughout the research process? Does the project utilize critical partnerships collaborations including the Ministry Health, Ministry Agriculture, with laboratory capacity including accredited national reference laboratories? Additional Review Criteria applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and providing overall impact/priority score, but will not give separate scores for these items. Protections for Human Subjects the research involves human subjects but does not involve one the six categories research that are exempt under CFR Part 46, the committee will evaluate the justification for involvement human subjects and the proposed protections from research risk relating their participation according the following five review criteria: risk subjects, adequacy protection against risks, potential benefits the subjects and others, importance the knowledge gained, and data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one more the six categories research that are exempt under CFR Part 46, the committee will evaluate: the justification for the exemption, human subjects involvement and characteristics, and sources materials. For additional information review the Human Subjects section, please refer the HHS/CDC Requirements under AR-1 Human Subjects Requirements (https://www.cdc.gov/grants/additionalrequirements/ar-1.html). your proposed research involves the use human data and/or biological specimens, you must provide justification for your claim that human subjects are involved the Protection Human Subjects section the Research Plan. Inclusion Women, Minorities, and Children When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion minorities and members both genders, well the inclusion children. For additional information review the Inclusion section, please refer the policy the Inclusion Women and Racial and Ethnic Minorities Research (https://www.cdc.gov/maso/Policy/Policy_women.pdf and the policy the Inclusion Persons Under Research (https://www.cdc.gov/maso/Policy/policy496.pdf). Vertebrate Animals The committee will evaluate the involvement live vertebrate animals part the scientific assessment according the following five points: proposed use the animals, and species, strains, ages, sex, and numbers used; justifications for the use animals and for the appropriateness the species and numbers proposed; adequacy veterinary care; procedures for limiting discomfort, distress, pain and injury that which unavoidable the conduct scientifically sound research including the use analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and methods euthanasia and reason for selection not consistent with the AVMA Guidelines Euthanasia. For additional information review the Vertebrate Animals section, please refer the Worksheet for Review the Vertebrate Animal Section (https://grants.nih.gov/grants/olaw/VASchecklist.pdf). Biohazards Reviewers will assess whether materials procedures proposed are potentially hazardous research personnel and/or the environment, and needed, determine whether adequate protection proposed. Dual Use Research Concern Reviewers will identify whether the project involves one the agents toxins described the Government Policy for the Institutional Oversight Life Sciences Dual Use Research Concern, and, so, whether the applicant has identified IRE assess the project for DURC potential and develop mitigation strategies needed. For more information about this Policy and other policies regarding dual use research concern, visit the U.S. Government Science, Safety, Security (S3) website at: http://www.phe.gov/s3/dualuse. Tools and guidance for assessing DURC potential may found at: http://www.phe.gov/s3/dualuse/Pages/companion-guide.aspx. Additional Review Considerations applicable for the project proposed, reviewers will consider each the following items, but will not give scores for these items, and should not consider them providing overall impact/priority score. Applications from Foreign Organizations Reviewers will assess whether the project presents special opportunities for furthering research programs through the use unusual talent, resources, populations, environmental conditions that exist other countries and either are not readily available the United States augment existing U.S. resources. Resource Sharing Plan(s) HHS/CDC policy requires that recipients grant awards make research resources and data readily available for research purposes qualified individuals within the scientific community after publication. Please see: https://www.cdc.gov/grants/additionalrequirements/ar-25.html New additional requirement: CDC requires recipients for projects and programs that involve data collection generation data with federal funds develop and submit Data Management Plan (DMP) for each collection public health data. Investigators responding this Notice Funding Opportunity should include detailed DMP the Resource Sharing Plan(s) section the PHS 398 Research Plan Component the application. The AR-25 outlines the components DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation. The DMP should developed during the project planning phase prior the initiation collecting generating public health data and will submitted with the application. The submitted DMP will evaluated for completeness and quality the time submission. The DMP should include, minimum, description the following: Type data produced the proposed project; Mechanisms for providing access and sharing the data (including provisions for the protection privacy, confidentiality, security, intellectual property, other rights); Use data standards that ensure all released data have appropriate documentation that describes the method collection, what the data represent, and potential limitations for use; and Plans for archiving and long-term preservation the data, explaining why long-term preservation and access are not justified. Applications submitted without the required DMP may deemed ineligible for award unless submission DMP deferred later period depending the type award, which case, funding restrictions may imposed pending submission and evaluation. Budget and Period Support Reviewers will consider whether the budget and the requested period support are fully justified and reasonable relation the proposed research. The applicant can obtain guidance for completing detailed justified budget the CDC website, the following Internet address: http://www.cdc.gov/grants/interestedinapplying/applicationresources.html The budget can include both direct costs and indirect costs allowed. Indirect costs could include the cost collecting, managing, sharing and preserving data. Indirect costs grants awarded foreign organizations and foreign public entities and performed fully outside the territorial limits the U.S. may paid support the costs compliance with federal requirements fixed rate eight percent modified total direct costs exclusive tuition and related fees, direct expenditures for equipment, and subawards excess $25,000. Negotiated indirect costs may paid the American University, Beirut, and the World Health Organization. Indirect costs training grants are limited fixed rate eight percent MTDC exclusive tuition and related fees, direct expenditures for equipment, and sub-awards excess $25,000. requesting indirect costs the budget based federally negotiated rate, copy the indirect cost rate agreement required. Include copy the current negotiated federal indirect cost rate agreement cost allocation plan approval letter. Review and Selection Process Applications will evaluated for scientific and technical merit appropriate peer review group, accordance with CDC peer review policy and procedures, using the stated review criteria. part the scientific peer review, all applications: Will undergo selection process which only those applications deemed have the highest scientific and technical merit (generally the top half applications under review), will discussed and assigned overall impact/priority score. Will receive written critique. Applications will assigned the appropriate HHS/CDC Center, Institute, Office. Applications will compete for available funds with all other recommended applications submitted response this NOFO. Following initial peer review, recommended applications will receive second level review. The following will considered making funding decisions: Scientific and technical merit the proposed project determined scientific peer review. Availability funds. Relevance the proposed project program priorities. Review risk posed applicants. Prior making Federal award, CDC required U.S.C. 3321 and U.S.C. 2313 review information available through any OMB-designated repositories government-wide eligibility qualification financial integrity information appropriate. See also suspension and debarment requirements CFR parts 180 and 376. accordance U.S.C. 2313, CDC required review the non-public segment the OMBdesignated integrity and performance system accessible through SAM (currently the Federal Recipient Performance and Integrity Information System (FAPIIS)) prior making Federal award where the Federal share expected exceed the simplified acquisition threshold, defined U.S.C. 134, over the period performance. minimum, the information the system for prior Federal award recipient must demonstrate satisfactory record executing programs activities under Federal grants, cooperative agreements, procurement awards; and integrity and business ethics. CDC may make Federal award recipient who does not fully meet these standards, determined that the information not relevant the current Federal award under consideration there are specific conditions that can appropriately mitigate the effects the non-Federal entitys risk accordance with CFR 75.207. CDC framework for evaluating the risks posed applicant may incorporate results the evaluation the applicants eligibility the quality its application. determined that Federal award will made, special conditions that correspond the degree risk assessed may applied the Federal award. The evaluation criteria described this Notice Funding Opportunity. evaluating risks posed applicants, CDC will use risk-based approach and may consider any items such the following: (1) Financial stability; (2) Quality management systems and ability meet the management standards prescribed this part; (3) History performance. The applicants record managing Federal awards, prior recipient Federal awards, including timeliness compliance with applicable reporting requirements, conformance the terms and conditions previous Federal awards, and applicable, the extent which any previously awarded amounts will expended prior future awards; (4) Reports and findings from audits performed under subpart CFR the reports and findings any other available audits; and (5) The applicants ability effectively implement statutory, regulatory, other requirements imposed non-Federal entities. CDC must comply with the guidelines government-wide suspension and debarment CFR part 180, and require non-Federal entities comply with these provisions. These provisions restrict Federal awards, subawards and contracts with certain parties that are debarred, suspended otherwise excluded from ineligible for participation Federal programs activities. Anticipated Announcement and Award Dates After the peer review the application completed, the PD/PI will able access his her Summary Statement (written critique) and other pertinent information via the eRA Commons. Section VI. Award Administration Information Award Notices Any applications awarded response this NOFO will subject the DUNS, SAM Registration, and Transparency Act requirements. the application under consideration for funding, HHS/CDC will request just-in-time information from the applicant described the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf). formal notification the form Notice Award (NoA) will provided the applicant organization for successful applications. The NoA signed the Grants Management Officer the authorizing document and will sent via email the grantee business official. Recipient must comply with any funding restrictions described Section IV.11. Funding Restrictions. Selection application for award not authorization begin performance. Any costs incurred before receipt the NoA are the recipients risk. These costs may allowable expanded authority, but only authorized CDC. CDC Administrative Requirements Overview Terms and Conditions Award and Requirements for Specific Types Grants Administrative and National Policy Requirements, Additional Requirements (ARs) outline the administrative requirements found CFR Part and the HHS Grants Policy Statement and other requirements mandated statute CDC policy. Recipients must comply with administrative and national policy requirements appropriate. For more information the Code Federal Regulations, visit the National Archives and Records Administration: http://www.access.gpo.gov/nara/cfr/cfr-table- search.html. Specific requirements that apply this NOFO are the following: Additional Policy Requirements The following are additional policy requirements relevant this NOFO: HHS Policy Promoting Efficient Spending: Use Appropriated Funds for Conferences and Meetings, Food, Promotional Items and Printing Publications This policy supports the Executive Order Promoting Efficient Spending (EO 13589), the Executive Order Delivering and Efficient, Effective, and Accountable Government (EO 13576) and the Office Management and Budget Memorandum Eliminating Excess Conference Spending and Promoting Efficiency Government (M-35-11). This policy apply all new obligations and all funds appropriated Congress. For more information, visit the HHS website at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/efficientspending/index.html. Federal Funding Accountability and Transparency Act 2006 Federal Funding Accountability and Transparency Act 2006 (FFATA), P.L. 109 282, amended section 6202 P.L. 110 252, requires full disclosure all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through single, publicly accessible website, www.usaspending.gov. For the full text the requirements, please review the following website: https://www.fsrs.gov/. Plain Writing Act The Plain Writing Act 2010, Public Law 111-274 was signed into law October 13, 2010. The law requires that federal agencies use clear Government communication that the public can understand and use and requires the federal government write all new publications, forms, and publicly distributed documents clear, concise, well-organized manner. For more information this law, to: http://www.plainlanguage.gov/plLaw/index.cfm. Pilot Program for Enhancement Employee Whistleblower Protections All applicants will subject term and condition that applies the terms CFR section 3.908 the award and requires that grantees inform their employees writing (in the predominant native language the workforce) employee whistleblower rights and protections under U.S.C. 4712. Copyright Interests Provision This provision intended ensure that the public has access the results and accomplishments public health activities funded CDC. Pursuant applicable grant regulations and CDC Public Access Policy, Recipient agrees submit into the National Institutes Health (NIH) Manuscript Submission (NIHMS) system electronic version the final, peer-reviewed manuscript any such work developed under this award upon acceptance for publication, made publicly available later than months after the official date publication. Also the time submission, Recipient and/or the Recipient submitting author must specify the date the final manuscript will publicly accessible through PubMed Central (PMC). Recipient and/or Recipient submitting author must also post the manuscript through PMC within twelve (12) months the publishers official date final publication; however the author strongly encouraged make the subject manuscript available soon possible. The recipient must obtain prior approval from the CDC for any exception this provision. The authors final, peer-reviewed manuscript defined the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing copyright agreements concerning submitted articles reserve adequate right fully comply with this provision and the license reserved CDC. The manuscript will hosted both PMC and the CDC Stacks institutional repository system. progress reports for this award, recipient must identify publications subject the CDC Public Access Policy using the applicable NIHMS identification number for three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter. Language Access for Persons with Limited English Proficiency Recipients federal financial assistance from HHS must administer their programs compliance with federal civil rights law. This means that recipients HHS funds must ensure equal access their programs without regard person race, color, national origin, disability, age and, some circumstances, sex and religion. This includes ensuring your programs are accessible persons with limited English proficiency. Recipients federal financial assistance must take the reasonable steps provide meaningful access their programs persons with limited English proficiency. Dual Use Research Concern September 24, 2014, the Government Policy for the Institutional Oversight Life Sciences Dual Use Research Concern was released. Grantees (foreign and domestic) receiving CDC funding after September 24, 2015 are subject this policy. Research funded CDC involving the agents toxins named the policy, must reviewed determine involves one more the listed experimental effects and so, whether meets the definition DURC. This review must completed Institutional Review Entity (IRE) identified the funded institution. Recipients also must establish Institutional Contact for Dual Use Research (ICDUR). The award recipient must maintain records institutional DURC reviews and completed risk mitigation plans for the term the research grant, cooperative agreement contract plus three years after its completion, but less than eight years, unless shorter period required law regulation. project determined DURC, risk/benefit analysis must completed. CDC will work collaboratively with the award recipient develop risk mitigation plan that the CDC must approve. The USG policy can found http://www.phe.gov/s3/dualuse. Non-compliance with this Policy may result suspension, limitation, restriction termination USG funding, loss future USG funding opportunities for the non-compliant USGfunded research project and USG funds for other life sciences research the institution, consistent with existing regulations and policies governing USG funded research, and may subject the institution other potential penalties under applicable laws and regulations. Data Management Plan(s) CDC requires that all new collections public health data include Data Management Plan (DMP). For purposes this announcement, public health data means digitally recorded factual material commonly accepted the scientific community basis for public health findings, conclusions, and implementation. This new requirement ensures that CDC compliance with the following; Office Management and Budget (OMB) memorandum titled Open Data Policy Managing Information Asset (OMB M-13-13); Executive Order 13642 titled Making Open and Machine Readable the New Default for Government Information and the Office Science and Technology Policy (OSTP) memorandum titled Increasing Access the Results Federally Funded Scientific Research (OSTP Memo). The AR-25 https://www.cdc.gov/grants/additionalrequirements/ar-25.html outlines the components DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation. Certificates Confidentiality: Institutions and investigators are responsible for determining whether research they conduct subject Section 301(d) the Public Health Service (PHS) Act. Section 301(d), amended Section 2012 the 21st Century Cures Act, P.L. 114-255 (42 U.S.C. 241(d)), states that the Secretary shall issue Certificates Confidentiality (Certificates) persons engaged biomedical, behavioral, clinical, other research activities which identifiable, sensitive information collected. furtherance this provision, CDC supported research commenced ongoing after December 13, 2016 which identifiable, sensitive information collected, defined Section 301(d), deemed issued Certificate and therefore required protect the privacy individuals who are subjects such research. Certificates issued this manner will not issued separate document, but are issued application this term and condition this award. See Additional Requirement ensure compliance with this term and condition. The link the full text at: https://www.cdc.gov/grants/additionalrequirements/ar-36.html. Cooperative Agreement Terms and Conditions The following special terms award are addition to, and not lieu of, otherwise applicable. U.S. Office Management and Budget (OMB) administrative guidelines, U.S. Department Health and Human Services (DHHS) grant administration regulations CFR Part 75, and other HHS, PHS, and CDC grant administration policies. The administrative and funding instrument used for this program will the cooperative agreement, assistance mechanism (rather than acquisition mechanism), which substantial CDC programmatic involvement with the recipients anticipated during the performance the activities. Under the cooperative agreement, the HHS/CDC purpose support and stimulate the recipients activities involvement and otherwise working jointly with the award recipients partnership role; CDC Project Officers are not assume direction, prime responsibility, dominant role the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project whole, although specific tasks and activities may shared among the recipients and HHS/CDC defined below. The PD(s)/PI(s) will have the primary responsibility for: Complying with the responsibilities for the Extramural Investigators described the Policy Public Health Research and Nonresearch Data Management and Access https://www.cdc.gov/grants/additionalrequirements/ar-25.html CDC staff has substantial programmatic involvement that above and beyond the normal stewardship role awards, described below: Assisting the PI, needed, complying with the Investigator responsibilities described the Policy Public Health Research and Nonresearch Data Management and Access https://www.cdc.gov/grants/additionalrequirements/ar-25 .html Recipient will retain custody and have primary rights the data and software developed under these awards, subject Government rights access consistent with current DHHS, PHS, and CDC policies. Reporting Recipients will required complete Research Performance Progress Report (RPPR) eRA Commons least annually (see https://grants.nih.gov/grants/rppr/index.htm; https://grants.nih.gov/grants/forms/report_on_grant.htm) and financial statements required the HHS Grants Policy Statement. final progress report, invention statement, equipment inventory list and the expenditure data portion the Federal Financial Report are required for closeout award, described the HHS Grants Policy Statement. Although the financial plans the HHS/CDC CIO(s) provide support for this program, awards pursuant this funding opportunity depend upon the availability funds, evidence satisfactory progress the recipient (as documented required reports) and the determination that continued funding the best interest the Federal government. The Federal Funding Accountability and Transparency Act 2006 (Transparency Act), includes requirement for recipients Federal grants report information about firsttier subawards and executive compensation under Federal assistance awards issued FY2011 later. Compliance with this law primarily the responsibility the Federal agency. However, two elements the law require information collected and reported recipients: Information executive compensation when not already reported through the SAM Registration; and Similar information all sub-awards/ subcontracts/ consortiums over $25,000. requirement for recipients Federal grants report information about first-tier subawards and executive compensation under Federal assistance awards issued FY2011 later. All recipients applicable CDC grants and cooperative agreements are required report the Federal Subaward Reporting System (FSRS) available www.fsrs.gov all subawards over $25,000. See the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf). Submission Reports The Recipient Organization must provide HHS/CDC with original, plus one hard copy the following reports: Yearly Non-Competing Grant Progress Report, due 120 days before the end the current budget period. The RPPR form (https://grants.nih.gov/grants/rppr/index.htm; https://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf) completed the eRA Commons website. The progress report will serve the non-competing continuation application. Although the financial plans the HHS/CDC CIO(s) provide support for this program, awards pursuant this funding opportunity are contingent upon the availability funds, evidence satisfactory progress the recipient (as documented required reports) and the determination that continued funding the best interest the Federal government. Annual Federal Financial Report (FFR) 425 (https://grants.nih.gov/grants/forms/report_on_grant/federal_financial_report_ffr.htm) required and must submitted through eRA Commons within days after the end the calendar quarter which the budget period ends. final progress report, invention statement, equipment/inventory report, and the final FFR are required days after the end the period performance. Content Reports Yearly Non-Competing Grant Progress Report: The grantees continuation application/progress should include: Description Progress during Annual Budget Period: Current Budget Period Progress reported the RPPR form eRA Commons (https://grants.nih.gov/grants/rppr/index.htm). Detailed narrative report for the current budget period that directly addresses progress towards the Measures Effectiveness included the current budget period proposal. Research Aims: list each research aim/project Research Aim/Project: purpose, status (met, ongoing, and unmet), challenges, successes, and lessons learned Leadership/Partnership: list project collaborations and describe the role external partners. Translation Research page maximum). When relevant the goals the research project, the should describe how the significant findings may used promote, enhance, advance translation the research into practice may used inform public health policy. This section should understandable variety audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The should identify the research findings that were translated into public health policy practice and how the findings have been may adopted public health settings. Or, they cannot applied yet, this section should address which research findings may translated, how these findings can guide future research related activities, and recommendations for translation. relevant, describe how the results this project could generalized populations and communities outside the study. Questions consider preparing this section include: How will the scientific findings translated into public health practice inform public health policy? How will the project improve effect the translation research findings into public health practice inform policy? How will the research findings help promote accelerate the dissemination, implementation, diffusion improvements public health programs practices? How will the findings advance guide future research efforts related activities? Public Health Relevance and Impact page maximum). This section should address improvements public health measured documented anticipated outcomes from the project. The should consider how the findings the project relate beyond the immediate study improved practices, prevention intervention techniques, inform policy, use technology public health. Questions consider preparing this section include: How will this project lead improvements public health? How will the findings, results, recommendations been used influence practices, procedures, methodologies, etc.? How will the findings, results, recommendations contributed documented projected reductions morbidity, mortality, injury, disability, disease? Current Budget Period Financial Progress: Status obligation current budget period funds and estimate unobligated funds projected provided estimated FFR. New Budget Period Proposal: Detailed operational plan for continuing activities the upcoming budget period, including updated Measures Effectiveness for evaluating progress during the upcoming budget period. Report listed Research Aim/Project. Project Timeline: Include planned milestones for the upcoming year (be specific and provide deadlines). New Budget Period Budget: Detailed line-item budget and budget justification for the new budget period. Use the CDC budget guideline format. Publications/Presentations: Include publications/presentations resulting from this CDC grant only during this budget period. publication presentations have been made this stage the project, simply indicate Not applicable: publications presentations have been made. IRB Approval Certification: Include all current IRB approvals avoid funding restriction your award. the research does not involve human subjects, then please state so. Please provide copy the most recent local IRB and CDC IRB, applicable. any approval still pending time APR due date, indicate the status your narrative. Update Data Management Plan: The DMP considered living document that will require updates throughout the lifecycle the project. Investigators should include any updates the project data collection such changes initial data collection plan, challenges with data collection, and recent data collected. Applicants should update their DMP reflect progress issues with planned data collection and submit required for each reporting period. Additional Reporting Requirements: https://era.nih.gov/docs/Commons_UserGuide.pdf Annual Federal Financial Reporting The Annual Federal Financial Report (FFR) 425 required and must submitted through eRA Commons within days after the end the calendar quarter which the budget period ends. The FFR should only include those funds authorized and disbursed during the timeframe covered the report. The final FFR must indicate the exact balance unobligated funds and may not reflect any unliquidated obligations. There must discrepancies between the final FFR expenditure data and the Payment Management Systems (PMS) cash transaction data. Failure submit the required information timely manner may adversely affect the future funding this project. the information cannot provided the due date, you are required submit letter explaining the reason and date which the Grants Officer will receive the information. The due date for final FFRs will continue days after the Period Performance end date. Recipients must submit closeout reports timely manner. Unless the Grants Management Officer (GMO) the awarding Institute Center approves extension, recipients must submit final FFR, final progress report, and Final Invention Statement and Certification within days the end grant period. Failure submit timely and accurate final reports may affect future funding the organization awards under the direction the same Project Director/Principal Investigator (PD/PI). FFR (SF 425) instructions for CDC recipients are now available https://grants.nih.gov/grants/forms/report_on_grant/federal_financial_report_ffr.htm. For further information, contact GrantsInfo@nih.gov. Additional resources concerning the eFSR/FFR system, including User Guide and on-line demonstration, can found the eRA Commons Support Page: https://grants.nih.gov/support/index.html FFR Submission: The submission FFRs CDC will require organizations register with eRA Commons (Commons) (https:// commons. era.nih.gov/ commons/). CDC recommends that this one time registration process completed least weeks prior the submittal date FFR submission. Organizations may verify their current registration status running the List Commons Registered Organizations query found at: https://era.nih.gov/registration_accounts.cfm. Organizations not yet registered can https://commons.era.nih.gov/commons for instructions. generally takes several days complete this registration process. This registration independent Grants.gov and may done any time. The individual designated the the application must also registered the Commons. The must hold account and affiliated with the applicant organization. This registration must done organizational official their delegate who already registered the Commons. register PIs the Commons, refer the eRA Commons User Guide found at: https://era.nih.gov/docs/Commons_UserGuide.pdf. Final Reports: Final reports should provide sufficient detail for CDC determine the stated outcomes for the funded research have been achieved and the research findings resulted public health impact based the investment. The grantee final report should include: Research Aim/Project Overview: The should describe the purpose and approach the project, including the outcomes, methodology and related analyses. Include discussion the challenges, successes and lessons learned. Describe the collaborations/partnerships and the role each external partner. Translation Research Findings: The should describe how the findings will translated and how they will used inform policy promote, enhance advance the impact public health practice. This section should understandable variety audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers and other potential end users. The should also provide discussion any research findings that informed policy practice during the course the period performance. applicable, describe how the findings could generalized and scaled populations and communities outside the funded project. Public Health Relevance and Impact: This section should address improvements public health measured documented anticipated outcomes from the project. The should consider how the findings the project related beyond the immediate study improved practices, prevention intervention techniques, informed policy, technology systems improvements public health. Publications; Presentations; Media Coverage: Include information regarding all publications, presentations media coverage resulting from this CDC funded activity. Please include any additional dissemination efforts that did will result from the project. Final Data Management Plan: Applicants must include updated final Data Management Plan that describes the data collected, the location where the data stored (example: repository), accessibility restrictions (if applicable), and the plans for long term preservation the data. Section VII. Agency Contacts encourage inquiries concerning this funding opportunity and welcome the opportunity answer questions from potential applicants. Application Submission Contacts Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading navigating forms) Contact Center Phone: 800-518-4726 Email: firstname.lastname@example.org Hours: hours day, days week; closed Federal holidays eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues, FFR submission) Phone: 301-402-7469 866-504-9552 (Toll Free) TTY: 301-451-5939 Email: email@example.com Hours: Monday Friday, 7am 8pm U.S. Eastern Time CDC Technical Information Management Section (TIMS) Telephone 770-488-2700 Email: firstname.lastname@example.org Hours: Monday Friday, 7am 4:30pm U.S. Eastern Standard Time Scientific/Research Contact(s) Daniel Duvall DGHP country Director Nigeria email@example.com Peer Review Contact(s) Hylan Shoob, PhD Scientific Review Officer Center for Global Health Extramural Research Program Office D-69, 1600, Clifton Road Atlanta, 30033 Tel: 404-639-4796 E-mail: firstname.lastname@example.org Financial/Grants Management Contact(s) Angie Willard Office Grants Services Global Health Services Branch Telephone: 770-488-2082 Email email@example.com Section VIII. Other Information Other CDC Notices Funding Opportunities can found www.grants.gov. All awards are subject the terms and conditions, cost principles, and other considerations described the HHS Grants Policy Statement. Authority and Regulations Awards are made under the authorization Sections the Public Health Service Act amended and under the Code Federal Regulations.