CDC-RFA-GH17-005.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Conducting Public Health Research in China

RFA-GH-17-005

Application Due Date: 05/08/2017

Signature Date

Conducting Public Health Research in China

RFA-GH-17-005

TABLE OF CONTENTS

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

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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations Center for Global Health Extramural Research Program Office (CGH ERPO) Center for Global Health (CGH) Funding Opportunity Announcement (FOA) Title Conducting Public Health Research in China Activity Code U01

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-GH-17-005

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.326 Category of Funding Activity:

Health FOA Purpose The purpose of this FOA is to:

A. Conduct field and laboratory research on important human diseases, with an emphasis on emerging and re-emerging infectious diseases, neglected tropical diseases, tuberculosis, HIV/AIDS, influenza and other diseases with pandemic potential as well as other identifiable public health problems, such as environmental health issues, chronic diseases, maternal and child health, public health preparedness, bio-safety, and injury control and prevention.

B. Incorporate the results of research into operational health promotion, disease prevention and control programs and policy development in China and ensure the sharing of expertise and research findings with other nations, non-governmental agencies and academic institutions.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-17-005, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: [Insert 45 days from date of publication]

Application Due Date: 05/08/2017

On-time submission requires that electronic applications be error-free and made available to CDC for http://www.grants.gov

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

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

Scientific Merit Review: 05/24/2017

Secondary Review: 06/16/2017

Estimated Start Date: 09/30/2017

Expiration Date: 05/06/2017 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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

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

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

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

Executive Summary Purpose. The purpose of this FOA is to:

A. Conduct field and laboratory research on important human diseases, with an emphasis on emerging and re-emerging infectious diseases, neglected tropical diseases, tuberculosis, HIV/AIDS, influenza and other diseases with pandemic potential as well as other identifiable public health problems, such as environmental health issues, chronic diseases, maternal and child health, public health preparedness, bio-safety, and injury control and prevention.

B. Incorporate the results of research into operational health promotion, disease prevention and control programs and policy development in China and ensure the sharing of expertise and research findings with other nations, non-governmental agencies and academic institutions.

Mechanism of Support. Cooperative agreement Funds Available and Anticipated Number of Awards. The estimated total funding (direct and indirect) for the first year (12 month budget period) is $5,000,000 and the estimated total funding (direct and indirect) for the entire project period is $25,000,000. It is anticipated that up to five awards will be issued contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. The budget period will be 09/30/2017- 09/29/2018; the project period will be 09/30/2017 to 09/29/2022.

Application Research Strategy Length: The Research Strategy component of the Research Plan is limited to 25 pages. The Administrative Core component of each Project’s Research Plan is limited to http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV

5 pages. Page limits for the Research Strategy are clearly specified in Section IV. ; Application and Submission Information of this announcement.

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

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

Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

Application Type. Only applications that are submitted for funding for the first time (New) are accepted.

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

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

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 307 and 317 (k)(1) and (k)(2) of the Public Health Service Act (42 USC 242/ and 247b(k)(1) and (k)(2)), as amended.

1. Background and Purpose Reducing the burden of disease in China requires a multifaceted approach. Over the past several years, a variety of pilot research and non-research programs have successfully prevented new infections, improved care and treatment of existing diseases, and strengthened the capacity to collect and use surveillance and research data.

Since the 1980s, the Chinese government and the U.S. Centers for Disease Control and Prevention (U.S.

CDC) have collaborated on public health priorities that affect China, the United States and the global community. U.S. CDC’s collaborative projects extend across China at the national, provincial, and local level to build strong bilateral relationships between China and the United States.

Project areas in China have included projects on emerging and re-emerging infectious diseases, influenza, immunization, public health workforce development, risk communications and emergency response, birth defects, chronic diseases, injury prevention and control, laboratory quality and safety, and HIV/AIDS.

Emerging and Re-emerging Infectious Diseases: Programs build capacity to detect and respond to emerging and re-emerging infectious diseases through several areas:

Emerging Infections: U.S. CDC and China CDC experts work to strengthen public health surveillance, to prevent transmission of infections, and to improve laboratory detection of infectious diseases, such as acute respiratory infections, food borne infections, and drug-resistant tuberculosis. This comprehensive approach helps China identify and contain infectious disease outbreaks before they spread globally.

Epidemiology Capacity Building: Established in 2001, the Chinese Field Epidemiology Training Program (CFETP) strengthens China’s disease surveillance, applied epidemiology, and response capacities. Through a 2-year field program, CFETP has trained more than 100 of China’s top http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 epidemiologists to respond to health emergencies in China and serve as the public health leaders of tomorrow.

Health Communication Strategies: To enhance the delivery of research and health information to the public by Chinese officials, U.S. CDC advises on science-based communication strategies, integration of emergency and risk communication principles, and use of eHealth (technology based) channels.

This work helps China more effectively mitigate public health threats and address its public health priorities.

Influenza: For more than 20 years, U.S. CDC has supported the Chinese National Influenza Center to monitor and conduct research on seasonal and novel influenza viruses with pandemic potential. For more than 10 years, U.S. CDC has worked with numerous additional Chinese partners to combine expertise in the areas of pandemic influenza preparedness, influenza surveillance, and rapid response to prevent, identify, and control influenza.

Non-communicable Diseases and environmental health: Recognizing the significant public health burden of non-communicable diseases and environmental health, US-China collaborations have aimed at these leading causes of death. Initial areas of focus have included behavioral risk factor surveillance, prevention and control of hypertension through sodium reduction, and tobacco control, diabetes control, and air pollution.

Injury prevention and control: Since 2012, U.S. CDC has been working with Chinese counterparts on road traffic related injury and violence against children prevention and control to improve the awareness, build surveillance capacity, and conduct epidemiology investigations to initiate interventions.

HIV/AIDS: Programs work to introduce innovative HIV detection and prevention strategies, advise China’s National Free Antiretroviral Treatment Program and collaborate with the central and 15 provincial CDCs.

These partnerships ensure thousands of persons living with HIV/AIDS in China know their status and have access to treatment, care, and supportive services.

Immunization: U.S. CDC works with Chinese public health officials to increase immunization and prevent disease , disability, and death.

Purpose

The purpose of this program is to fulfill four broad goals: (1) To conduct high quality research around influenza, emerging and re-emerging infectious diseases, HIV/AIDS, and other public health programs, including non-communicable diseases; (2) To provide training for public health professionals and select staff in basic and applied public health research, public health program planning and evaluation; (3) To strengthen China CDC’s institutional capacity to conduct research, plan, implement and evaluate public health programs, including the capacity to detect and respond to emerging and re-emerging infectious diseases; and

(4) To incorporate and promote the results of research into operational disease prevention and control programs and policy development.

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

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

Other national and international priorities include:

The Department of Health and Human Services’ (HHS) Global Health Strategy maintains three goals to support HHS’ global health vision of a healthier, safer world: 1) protect and promote the health and well-being of Americans through global health action; 2) provide leadership and technical expertise in science, policy, programs and practice to improve global health; and 3) advance United States interests in international diplomacy, development, and security through global health action.

IHR’s Article 44, supporting WHO International Health Regulation and Global Health Security Agenda requirements.

Public Health Impact Since the 1980s, the Chinese government and the U.S. Centers for Disease Control and Prevention (U.S.

CDC) have collaborated on public health priorities that affect China, the United States and the global community. U.S. CDC’s collaborative projects extend across China at the national, provincial, and local level to build strong bilateral relationships between China and the United States.

Project areas in China have included projects on emerging and re-emerging infectious diseases, influenza, immunization, public health workforce development, risk communications and emergency response, birth defects, chronic diseases, injury prevention and control, laboratory quality and safety, and HIV/AIDS.

Relevant Work Over the past 10 years through multiple cooperative agreements with U.S. CDC, China CDC has strengthened field epidemiology training programs, influenza surveillance and control programs, emerging infections programs, TB surveillance programs, NCD programs, HIV/AIDS prevention, care, training and surveillance programs, and has scaled up successful pilot projects. China CDC has achieved goals and accomplished objectives that have led to improving the health and quality of life of Chinese citizens.

Furthermore, China CDC has shared advances in research and lessons learned in the public health practice with U.S. CDC and the rest of the world.

2. Approach This research program is being implemented to fulfill four broad goals: (1) To conduct high quality research around influenza, emerging and re-emerging infectious diseases, HIV/AIDS, and other public health programs, including non-communicable diseases; (2) To provide training for public health professionals and select staff in basic and applied public health research, public health program planning and evaluation; (3) To strengthen China CDC’s institutional capacity to conduct research, plan, implement and evaluate public health programs, including the capacity to detect and respond to emerging and re-emerging infectious diseases; and (4) To incorporate and promote the results of research into operational disease prevention and control programs and policy development.

Specific projects that may be developed for this Funding Opportunity Announcement are detailed under Objectives/Outcomes below.

Objectives/Outcomes Projects may be developed for this Research Cooperative Agreement addressing the following public health issues/priorities:

Research addressing emerging and re-emerging infectious diseases as well as neglected tropical diseases and influenza, including developing and expanding innovative and improved detection, interventions, treatments, and responses and the implementation or expansion of sustainable surveillance systems;

Improved capacity to respond to disease outbreaks and other public health emergencies;

Evaluations of vaccines and other interventions to prevent influenza, tuberculosis, other respiratory, vector-borne, diarrheal and other infectious diseases, including water-and-food borne illnesses;

HIV Prevention Research projects/studies to determine incidence of HIV sero-conversion and retention of study participants, continued treatment evaluations and selected disease intervention projects;

Global AIDS Projects addressing disease prevention, treatment, and control, including assessments of individual and community-based intervention methods;

Conduct assessments of the leading causes, communicable and non-communicable, of death in China and provide assistance in the establishment or expansion of effective and efficient interventions to reduce premature death and disability in China.

Applicant may propose projects that address these focus areas or priorities. Within each project, applicant must submit separate Research Plans and Budgets. Applicant must clearly state how the proposed research will impact public health and improve population health for the target population. Applicant must provide assurance of coordinated management and administrative support. The administrative core is necessary to carry out the objectives of the China CDCs and plan for new activities and research proposals. The Centers must have strong leaders who are committed to the program and are capable of providing scientific leadership for the administration and integration of the program. Assessment of the ability of the program’s principal investigators and program staff to lead a highly integrated program of the different research activities will be an important consideration in the evaluation of the application.

The core supports the administration and infrastructure costs of the program and should not be duplicated with any other components. The responsibilities and activities of the core include:

Appropriate and adequate organization and facilities for activities such as computer support, workshops, seminars, and other activities that supports various activities.

A data/statistical support activity may be included in the administrative core if needed for the center for various activities.

Target Population The target population is the general population of China.

Collaboration/Partnerships Collaborations may occur across all levels of China CDC (national, provincial, local) and with other organizations including U.S. CDC.

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

A plan for ongoing monitoring of study activities should also be included in the application, including investigator monitoring of regulatory compliance, strength of research design, data quality, laboratory quality, and surveys that reflect target population, as applicable to the proposed research. A timeline with measures of study progress should be described in the application. Progress towards those measures will be reported annually and at project closeout.

Translation Plan The application should include a timeline for completing the report of the main research findings and for developing and implementing a plan that builds country-capacity. Research partners will share findings with local stakeholders to facilitate partnerships and collaboration whenever possible.

Translation plans are expected to include a process for adapting, translating and disseminating project instruments and training materials as a part of the annual report. The plan should be specific to the project(s) objectives and designed to ensure that the research findings have maximum public health impact.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement

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

Application Types Allowed:

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

Estimated Total Funding: $25,000,000 The estimated total funding (direct and indirect costs) for the first 12 month budget period is $5,000,000.

The total estimated total funding (direct and indirect costs) for the entire project period is $25,000,000. It is anticipated that up to five awards will be made under this FOA.

Anticipated Number of Awards:

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

Award Ceiling: $5,000,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length:

5 year(s)

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

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

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http ://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https ://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf .

Foreign components of U.S. Organizations are not eligible to apply.

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

3. Special Eligibility Requirements Eligibility for this program is limited to the China Center for Disease Control and Prevention (China CDC), including national, provincial and local level CDCs. No other applications are solicited.

4. Justification for Less than Maximum Competition Eligibility for funding under this FOA is limited to China CDC at the national (central), provincial, and local level in order to expand the collaboration between U.S. CDC and China CDC. There is one national China CDC in Beijing, as well as provincial and local CDCs in each of the provinces and counties, all of which provide essential public health services for the populations of their respective jurisdictions. These are the only organizations which have the legal mandate and obligation and technical capacity to implement activities supported in this FOA at the national, provincial, and local level in China.

China CDC, including national, provincial, and local level CDCs, is the most appropriate and qualified agency to conduct the activities specified under this FOA for the following reasons:

(a) China CDC (including the national, provincial, and local levels) is the only organization in China that possesses the requisite scientific and technical expertise and the infrastructure capacity, and who has the legal mandate and obligation from the Chinese government to provide technical advice and execute essential public health functions for the populations of their respective jurisdictions. These combined attributions make China CDC (including national, provincial, and local levels) uniquely qualified as the only organization in China capable of effectively conducting the research activities proposed for this umbrella

FOA.

(b) China CDC at the national, provincial, and local level is uniquely positioned - in terms of governmental authority, mandate and ability - to oversee and safeguard public health, and to collect, analyze and disseminate information via research reports related to multiple health issues. It has the ability to utilize existing public health networks and other partners to assure the accomplishments of research goals as required in this cooperative agreement.

(c) The activities in this FOA are integrated in and develop public health systems at the national, provincial, and local levels (e.g., provincial arbovirus surveillance). Therefore, only entities that maintain primary responsibility for the development and maintenance of these systems should be eligible to apply.

(d) China CDC is the key governmental agency that will enable U.S. CDC to execute its approved global health strategy. Specifically, U.S. CDC working through its strong partnerships with China CDC, will assure the implementation and evaluation of public health research programs that will result in the prevention and control of diseases both communicable and non-communicable in China.

(e) U.S. CDC's presence in China is at the invitation of the Chinese government to collaborate with its sanctioned public health agencies, i.e., China CDCs, and not to other outside entities.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf sanctioned public health agencies, i.e., China CDCs, and not to other outside entities.

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5. Responsiveness Applications submitted after the deadline will be considered non-responsive.

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

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

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform https://www.sam.gov/index.html grantee organization.

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

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

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

The applicant organization may submit more than one application, provided that each application is scientifically distinct.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf, except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

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

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/forms.htm from http://grants.nih.gov/grants/forms.htm

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year. Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted. Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.”

The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

If multiple projects are submitted by the applicant, each project submitted must include the required components included in the PHS-398 application instructions and a include budget specifically for the individual project. Each project must be labelled and uploaded in the Appendix.

3. Letter of Intent Due Date for Letter of Intent: [Insert 45 days from date of publication] N/A

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

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

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

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

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY) http://grants.nih.gov/grants/forms.htm http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 (R&R) Application Guide unless otherwise specified in the FOA. All instructions in the SF424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf must be followed along with any additional instructions provided in the FOA.

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

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

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

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

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

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

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

The following materials may be included in the Appendix:

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf%20 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php

The following materials may be included in the Appendix:

Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.

Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment.

Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.

Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that is not also represented within the Research Plan.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 100 pages for all appendices.

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

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

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/ http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

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

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center ( 1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact TIMS at 770-488-2700; ogstims@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

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

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

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

2. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed. b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 05/08/2017

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

10. Intergovernmental Review (E.O. 12372)

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

11. Funding Restrictions

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

For more information on expanded authority and pre-award costs, go to:

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

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

Fulfilling the data-sharing requirement must be documented in a Data Management Plan (DMP) that is developed during the project planning phase prior to the initiation of generating or collecting public health data and must be included in the Resource Sharing Plan(s) section of the PHS398 Research Plan Component http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 mailto:support@grants.gov mailto:www.pgotim@cdc.gov http://www.whitehouse.gov/omb/grants_spoc http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf of the…