cdc-rfa-gh16-003.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Conducting Public Health Research in Thailand: technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH)

RFA-GH-16-003

Application Due Date: 03/01/2016

Conducting Public Health Research in Thailand: technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH)

RFA-GH-16-003

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 and Prevention Components of Participating Organizations Center for Global Health Extramural Research Program Office (CGH ERPO) Center for Global Health (CGH) National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) National Center for Immunization and Respiratory Diseases (NCIRD) National Center on Birth Defects and Developmental Disabilities (NCBDDD) Funding Opportunity Announcement (FOA) Title Conducting Public Health Research in Thailand: technical collaboration with the Ministry of Public Health in the Kingdom of Thailand (MOPH) Activity Code U01

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-GH-16-003

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

Health FOA Purpose The purpose of the cooperative agreement is to conduct epidemiologic, clinical, field and laboratory research on important human infectious diseases, with an emphasis on HIV/AIDS, Malaria, emerging and re-emerging infectious diseases, zoonotic diseases, neglected tropical diseases, Tuberculosis, Influenza and other diseases with pandemic potential. Also included are possible environmental health issues, chronic diseases, birth defects and developmental disabilities, maternal and child health, public health preparedness, bio-safety, and injury control and prevention.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-16-003, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

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

Application Due Date: 03/01/2016

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: 04/01/2016

Secondary Review: 05/01/2016

Estimated Start Date: 09/01/2016

Expiration Date: 03/02/2016 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 60 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 the cooperative agreement is to conduct epidemiologic, clinical, field and laboratory research on important human infectious diseases, with an emphasis on HIV/AIDS, Malaria, emerging and re-emerging infectious diseases, zoonotic diseases, neglected tropical diseases, Tuberculosis, Influenza and other diseases with pandemic potential. Also included are possible environmental health issues, chronic diseases, birth defects and developmental disabilities, maternal and child health, public health preparedness, bio-safety, and injury control and prevention.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. Approximately $35,000,000 is expected to be available for the total project period. Funding to be awarded through this FOA is contingent upon availability of funds.. 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 and program priority as this is an umbrella cooperative agreement.

Budget and Project Period. Budget period 09-01-2016 to 08-31-2017; Project period 09-01-2016 to 08-31-2021.

Application Research Strategy Length: The Research Strategy page limit number is 60 pages.

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

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

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

Number of PDs/PIs. State the authoritative structure you expect to see in submitted applications.

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

Application Type. New Special Date(s). N/A 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 301 (a) and 307 (42 U.S.C. 242/, as amended) of the Public Health Service Act, [42 U.S.C. Sections 241 (a) and 247b (k) (2), as amended.

1. Background and Purpose The Centers for Disease Control and Prevention (CDC) within HHS is committed to achieving the health promotion and disease prevention objectives of the National Prevention Strategy, National HIV/AIDS Strategy, and the National Health Security Strategy. The Thailand Ministry of Pubic Health (MOPH) is the key governmental agency that will enable CDC to execute its approved global health strategy and other public health priorities. The CDC working through its strong partnerships with Ministries of Health, 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 Thailand and apply these to other international settings. Over the past 15 years, MOPH and CDC have achieved goals and accomplished objectives that have led to improving the health and quality of life of Thai citizens. These collaborations between CDC and Thailand MOPH have led to breakthroughs in research, improved programmatic practices, and strengthened laboratory systems. The MOPH has in place the central, provincial and district-based structures required to immediately engage in these and future activities. This is an umbrella cooperative agreement that will facilitate collaboration between multiple CIOs within CDC and the Thailand Ministry of Public Health (MOPH) for the conduct of public health research on diseases of importance to both the United States and Thailand.

The purpose of this cooperative agreement is to conduct epidemiologic, field and laboratory research on important human infectious diseases, with an emphasis on HIV; immunization and infectious diseases;

maternal, infant and child health; public health infrastructure; respiratory diseases; sexually transmitted diseases; health communication and health information technology. Also included are possible environmental health issues, chronic diseases, birth defects and developmental disabilities, maternal and child health, public health preparedness, bio-safety, and injury control and prevention. It is in alignment with HHS/CDC performance goal(s) and Global Health security objectives to prepare for, prevent, detect, respond to and contain health threats globally by providing global health promotion, health protection and health diplomacy and with Center for Global Health (CGH) performance goal(s), “Protecting the Nation’s Health in an Era of Globalization: CDC’s Global Strategy for Addressing Infectious Diseases”.

In addition, many of the lifestyle risk factors for NCDs like improper nutrition, sedentary lifestyle, alcohol and tobacco use are becoming more prevalent. This has led to the emergence of NCDs as important causes of morbidity and mortality. The three leading causes of death in Thailand in 2008 are cancer, cardiovascular diseases and diabetes. NCDs also have an impact on the Thai health care system. There are dramatically increasing numbers of inpatient and outpatient visits for hypertension, diabetes, stroke, and ischemic heart disease even though the death rate for cardiovascular diseases, diabetes and injury delayed and decreased on sharp increasing of the death rate. These trends are also having a major impact on health care financing and made clear the importance of placing more effort on proven health promotion strategies and research that are known to be effective and reduce the burden of NCD and injury. Project proposals submitted in response to this FOA will broadly address:

Health Impact: Improve the health and well-being of people in Thailand, the ASEAN region and the world Health Security: Improve the capabilities to prevent, prepare, detect, and respond Health Capacity: Strengthen and sustain public health capacity, infrastructure, management and monitoring.

Healthy People 2020 and other National Strategic Priorities

Public Health Impact This FOA aligns with the current CDC strategic priorities including strengthening surveillance, epidemiology and laboratory services; supporting public health activities; increasing global health impact;

increasing impact on public health policy; and preventing illness, injury disability and death.

Thailand Ministry of Public Health (MOPH) in collaboration with CDC has produced new disease prevention and intervention strategies that have had significant global public health impacts. From the establishment in 1980 of the Field Epidemiology Training Program to current efforts to meet the growing challenges of drug-resistant malaria, TB, HIV, emerging infectious diseases, migrant and border health, and non-communicable diseases, Thailand MOPH stands ready to work with CDC to meet new challenges.

Relevant Work The MOPH is the only organization in Thailand that possesses the requisite scientific and technical expertise and the infrastructure capacity, and who has the primary responsibility within the Thailand government to address public health issues. These combined attributes make them uniquely qualified as the only organization in Thailand capable of effectively conducting public health research and other program activities proposed for this umbrella cooperative agreement. The MOPH is uniquely positioned in terms of constitutional authority, mandate and ability to oversee and safeguard public health, and to collect and analyze information and disseminate research reports related to multiple health issues. They have the ability to utilize existing public health networks and other partners to assure the accomplishment of research goals as required in this cooperative agreement.

2. Approach Applicant should prepare project proposals based on the overarching objectives and the program specific objectives listed below. Each project should have a project name and ID. Projects that are continuing from prior cooperative agreements should retain the same project name and unique project identifier in the new cooperative agreement. Please refer to Section IV for application submission and guidance for more specific information.

Objectives/Outcomes Projects will address one or more of the following broad focus areas as outlined in the CDC-MOPH Collaboration Framework:

Workforce capacity development and capacity in epidemiology, laboratory and evidence based action1.

Quality public health systems and services2.

Prevention, Preparedness, and response to public health threats3.

Regional and multi-sectoral collaboration4.

Results of this research will be incorporated into operational health promotion, and disease prevention and control programs in the Kingdom of Thailand and to ensure the sharing of expertise and research findings with other nations, non-governmental agencies and academic institutions

PROGRAM SPECIFIC OBJECTIVES:

DIVISION OF HIV/AIDS PREVENTION (DHAP)

Evaluate the efficacy and effectiveness of new and/or improved modalities for HIV and STI (sexually transmitted infections) prevention, including but not limited to biomedical, behavioral and structural interventions, such as vaccines, pharmacological prophylaxis, treatment as prevention and other prevention modalities.

Improve treatment and diagnosis of HIV infection and associated conditions for adults and children, including but not limited to collaborative/network studies and studies of acute infections and potential strategies for cure of HIV infection.

DIVISION OF PARASITIC DISEASES AND MALARIA (DPDM)

Conduct malaria operational research and monitoring and evaluation activities to assess the efficacy/effectiveness of currently deployed malaria control tools including diagnosis and improve routinely collected surveillance data.

Evaluate the effectiveness of malaria control interventions including long-lasting insecticide-treated nets (LLITNS), indoor residual spraying (IRS) and other methods of transmission reduction;

Evaluate the effectiveness of all aspects of the case management pathway including appropriate referral, diagnosis, correct prescribing and appropriate messaging at all levels of the health systems;

Evaluate the therapeutic efficacy of antimalarials to treat uncomplicated and severe malaria; and Evaluate the therapeutic efficacy of antimalarials used to address the negative consequences of malaria in pregnancy.

Evaluate the use of innovative vector control intervention measures such as insecticide treated materials, including use of combination insecticide-treated bednets and insecticide-treated wall liners;

Evaluate the use of new strategies that target the malaria parasite reservoir such as mass screen and treat and mass drug administration To support research and infrastructure to accelerate progress towards malaria elimination in Mekong region, including testing new tools/interventions to further reduce malaria transmission with the ultimate goal of malaria elimination.

To build epidemiological, entomological, laboratory, health economics, and social science capacity at MOPH and other regional Ministries of Health.

DIVISION OF GLOBAL HEALTH PROTECTION (DGHP)

Intervention studies to reduce the burden of priority disease and syndromes Public health research studies to determine disease burden and risk factors in special populations Research studies for the disease burden and risk factors at the animal human interface (One Health) Operational research studies formalizing the monitoring and evaluation for Public Health program implementation for Thailand.

Includes the evaluation of emergency preparedness and response Includes health system strengthening Implement and evaluate systems and projects for increasing capacity for Point of Care diagnostics Evaluate existing and novel technologies and methodologies for disease surveillance

Best practices Relative value

DIVISION OF GLOBAL HIV/AIDS and TUBERCULOSIS (DGHT)

To conduct research on tuberculosis epidemiology, prevention, case finding and diagnosis, and treatment, including clinical trials, implementation-focused research and evaluation, and other forms of investigation.

To improve the use of TB research data to inform public health policy both by building capacity to use data in this manner and also by working with the Ministry of Health to translate findings into action.

INFLUENZA

To monitor influenza viruses and generate evidence to inform estimation of burden, vaccine immunogenicity, efficacy and effectiveness, antiviral effectiveness, pandemic preparedness, outbreak support and capacity building, including support for Thailand to develop capacity to manufacture its own influenza vaccines.

To monitor vaccine effectiveness and uptake, including identifying barriers to vaccination in high-risk groups.

NON-COMMUNICABLE DISEASES (NCD)

Collaborate in the development of field research and program implementation and evaluation on NCD and injury Strengthen in the area of training for public health officer in NCD program planning, research and evaluation Strengthen laboratory capacity and research for screening and diagnosis of NCD Work together to incorporate result of research or study on NCD and injury into operational NCD prevention and control programs. Translate results to develop policies and programs in the region and internationally Strengthen NCD surveillance activity and its data utilization Exchange and share scientific information, materials and tool with CDC and other public health partners Collaborate in the area of dissemination of research and program result through community, national forum and peer-reviewed science articles

Additional Objectives may be addressed as stated below:

Research to address infectious diseases as well as zoonotic diseases, including developing and expanding innovative and improved detection, interventions, treatments, and responses and the implementation or expansion of sustainable surveillance systems;

Research to address non-infectious diseases including: Environmental Health issues, chronic diseases, Maternal and Child Health, Public Health Preparedness, Bio-Safety, and Injury Control and Prevention;

Projects to foster innovations in science and technology for the development of new public health interventions and operational research to improve uptake of known interventions;

Projects to strengthen surveillance activities and impact assessment capacity;

Projects to strengthen laboratory capabilities necessary for the diagnosis of human and animal infectious diseases of public health priority in Thailand and the region;

Projects focusing on improved capacity to respond to disease outbreaks and other public health emergencies.

Applicant may propose a variety of projects that address these priorities. Within each project, the applicants must submit separate Research Plans and Budgets. Applicant must provide assurance of coordinated management and administrative support.

For each project proposed, the focus should be on an identifiable public health concern or problem impacting health in Thailand. Applicant may propose new projects, as well as continuation of, existing projects that propose new objectives and activities to address emerging diseases as well as risk factors associated with the leading causes of death in Thailand. This may include disease surveillance, data collection, epidemiologic studies, laboratory-based studies, and the evaluation of interventions and/or control methods including therapeutic and preventative treatments.

Target Population Target populations at high-risk for influenza-associated morbidity and mortality include individuals aged ≥65 years, individuals with chronic underlying medical conditions, young children aged six months to five years, pregnant women, and healthcare personnel.

Target populations for malaria research should include people living or working in epidemiological defined areas of malaria transmission. Sub-population target groups within these malaria transmission zones should include those most at-risk e.g. children under five years of age and pregnant women.

Target populations at high-risk for HIV/AIDs include people living with HIV, men who have sex with men, and transgender women in geographic areas where those populations are concentrated.

Non-communicable disease and injury interventions/research target populations include general populations groups (all age groups), high risk populations, and populations with NCDs and injuries.

Other target populations for research activities include children less than five years of age at risk for respiratory diseases and vaccine preventable diseases including diphtheria, pertussis, and measles; and all age groups at risk for food and water borne diseases specifically salmonellosis and Hepatitis B and C and non-communicable diseases including road traffic injuries, cancer, hypertension, and diabetes.

Collaboration/Partnerships Applicant should list organizations and Principal Investigators (PIs) that will be involved in the proposed research proposal. Letters of support from partners and collaborators are encouraged

Evaluation/Performance Measurement The awardee will be evaluated on a project by project basis. Evaluation metrics will include

1) the ability to perform research and evaluation addressing the public health priorities outlined in the FOA

2) whether the research has the potential to contribute to reduction of burden of disease, and

3) if recommendations derived from the studies will result in the development or refinement of public health policies or improved implementation of effective prevention, control, and treatment activities.

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

Questions to consider in preparing this section include:

How will the scientific findings inform public health policy or practice?

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

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

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

How will the research improve health outcomes?

Section II. Award Information

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

Application Types Allowed:

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

Estimated Total Funding: $35,000,000

Anticipated Number of Awards: 1

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

Award Ceiling: $7,000,000 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/ asfr/ogapa/aboutog/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 ://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 eligible to apply.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf 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

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

3. Special Eligibility Requirements Eligible applicants: Ministry of Public Health, Kingdom of Thailand (MOPH)

4. Justification for Less than Maximum Competition The MOPH is the only organization in Thailand that possesses the requisite scientific and technical expertise and the infrastructure capacity to address public health issues. MOPH also has the primary responsibility within the Thailand government to address public health issues. These combined attributes make them uniquely qualified as the only organization in Thailand capable of effectively conducting the research and public health program activities proposed for this umbrella cooperative agreement. The MOPH is uniquely positioned in terms of constitutional authority, mandate and ability to oversee and safeguard public health, to collect and analyze information, and to disseminate research findings related to multiple health issues. They have the ability to utilize existing public health networks and other partners to assure the accomplishment of research goals as required in this cooperative agreement.

The MOPH has in place the central, provincial and district-based structures required to immediately engage in the activities listed in this announcement. The MOPH is the key governmental agency that will enable CDC to execute its approved global health strategy. Specifically the Center for Global Health (CGH) working through its strong partnerships with MOPH 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 Thailand. Over the past 15 years with three consecutive Cooperative Agreements, the MOPH has strengthened HIV/AIDS prevention, care, training and surveillance programs; increased TB surveillance; and scaled up the successful pilot projects. Under the second and third Cooperative agreement, the collaboration expanded to include International Emerging Infectious Diseases, migrant and border health (DGMQ), and influenza and non-communicable disease (NCD) activities. The MOPH has achieved their goals and accomplished objectives that have led to improving the health and quality of life of Thai citizens.

These collaborations between CDC and Thailand MOPH have led to breakthroughs in research, improved programmatic practices, strengthened laboratory systems and improved vaccine capacity in Thailand. These advances benefit not only Thailand, but also have had regional and global impact as well.

5. Responsiveness N/A

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

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

Grants.gov eRA Commons 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

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 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/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http: //www.hhs.gov /asfr /ogapa /aboutog /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.

Section IV. Application and Submission Information 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 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

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 Procurement and Grants Office Technical Information Management Section (TIMS) staff at (770) 488-2700 or pgotim@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/funding/ 424/SF424_RR_Guide_General_VerC.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 from http://grants.nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent:

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 Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.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 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.

http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/forms.htm 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)

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 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

Note: Since this is an umbrella cooperative agreement with multiple programs, applicant is recommended to follow the additional instructions below:

Please separate projects by program. If programs have multiple projects, please ensure that each project has all the relevant information (2- 16 as in PHS398). Individual budgets are required along with the justification.

Please identify if project is ongoing/non-competing continuations (from the previous years) or new.

Ongoing projects that have been peer reviewed previously and could not be completed due to technical challenges at the field study site, delay in IRB approvals or because their objectives could not be met during the previous CoAg period could be exempted from peer review. Please indicate these projects as non-competing continuations. Please ensure that the title is the same as the original submission.

All new projects will be peer reviewed.

If all the projects proporals from the various programs cannot be all uploaded in the given page limitation, please upload them under Appendix

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

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 60 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 20 PDF files with a maximum of 200 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 (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.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).

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; pgotim@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.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.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 mailto:support@grants.gov mailto:www.pgotim@cdc.gov

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: 03/01/2016

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 Restrictions, which must be taken into account while writing the budget, are as follows:

Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

Reimbursement of pre-award costs is not allowed.

Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location.

All requests for funds contained in the budget, shall be stated in U.S. dollars. Once an award is made, CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.

Foreign grantees are subject to audit requirements specified in 45 CFR 74.26(d). A non-Federal audit is required, if during the grantees fiscal year, the grantee expended a total of $300,000.00 or more under one or more HHS awards (as a direct grantee and/or as a sub-grantee). The grantee either may have (1) A financial related audit (as defined in the Government Auditing Standards, GPO stock #020-000-00-265-4) of a particular award in accordance with Government Auditing Standards, in those case where the grantee receives awards under only one HHS program; or, if awards are received under multiple HHS programs, a financial related audit of all HHS awards in accordance with Government Auditing Standards; or (2) An audit that meets the requirements contained in OMB Circular A-133.

A fiscal Grantee Capability Assessment may be required, prior to or post award, in order to review the applicant’s business management and fiscal capabilities regarding the handling of U.S. Federal funds.

If research involves human subjects, funds will be restricted until a Federal Wide Assurance (FWA) and Institutional Review Board Approvals (IRB) are in place.

OMB Requirements - Provide technical assistance or advice on any data collections on 10 or more people that are planned or conducted by the awardee. All such data collections-- where CDC staff will be or are approving, directing, conducting, managing, or owning data-- must undergo OMB project determinations by CDC and may require OMB PRA clearance prior to the start of the project

On September 24, 2014, the Federal government issued a policy for the oversight of life sciences “Dual Use Research of Concern” (DURC) and required this policy to be implemented by September 24, 2015.