rfa-gh-15-0060102supp16 dec 22 15.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Institutional Research Collaboration between the Liverpool School of Tropical Medicine and the Centers for Disease Control and Prevention

RFA-GH-15-0060102SUPP16

Application Due Date: 02/23/2016

Institutional Research Collaboration between the Liverpool School of Tropical Medicine and the Centers for Disease Control and Prevention

RFA-GH-15-0060102SUPP16

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

GH15-006-SUPP-16

Institutional Research Collaboration between the Liverpool School of Tropical Medicine and the Centers for Disease Control and Prevention

ANNOUNCEMENT PUBLICATION | VALIDATE & APPROVE

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) Funding Opportunity Announcement (FOA) Title Institutional Research Collaboration between the Liverpool School of Tropical Medicine and the Centers for Disease Control and Prevention Activity Code Non-competing program expansion supplement

Funding Opportunity Announcement Type Reissue of RFA-GH-15-006 Funding Opportunity Announcement Number

RFA-GH-15-0060102SUPP16

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

Health FOA Purpose The purpose of this cooperative agreement is to assist with the development of operational research, surveillance, and monitoring and evaluation activities in sub-Saharan Africa and Asia. Through this funding announcement, the Malaria Branch seeks to fund innovative research projects and evaluation activities with the potential to yield high impact public health findings or strategies that will decrease the overall burden of malaria and increase the health and well-being of the populations. CDC's Malaria Branch is a partner of the Roll Back Malaria (RBM) initiative, a partnership that seeks to support and coordinate global malaria program scale-up, surveillance, and evaluation efforts in malaria endemic countries.

Key Dates Publication Date: To receive notification of any changes to GH15-006-SUPP-16, 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:February 23, 2016, FEDEX to CDC OGSTIMS by 5 P.M. EST

On-time submission requires that applications be error-free and made available to CDC Office of Grants Services(OGS) 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: 03/07/2016

Secondary Review: 03/14/2016

Estimated Start Date: 09/01/2015

Expiration Date: 03/08/2016 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 16 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 assist with the development of operational research, surveillance, and monitoring and evaluation activities in sub-Saharan Africa and Asia. Through this funding announcement, the Malaria Branch seeks to fund innovative research projects and evaluation activities with the potential to yield high impact public health findings or strategies that will decrease the overall burden of malaria and increase the health and well-being of the populations.

Mechanism of Support. Cooperative agreement Funds Available and Anticipated Number of Awards. $17,500,000. We anticipate one award under this FOA contingent upon availability of funds.

Budget and Project Period. $3,500,000 for the first year 12 month budget period and the estimated total funding $17,500,000 for the entire project period. The project period will run from 04/06/2016 – 08/31/2020.

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

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.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 PDs/PIs. State the authoritative structure you expect to see in submitted applications.

Number of Applications. Eligible applicant institutions may only one application.

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

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

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

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority 301(a) and 317(k) (2) of the Public Health Service Act, [42 U.S.C. Sections 241(a) and 247b (k) (2), as amended.

1. Background and Purpose Background

Malaria prevention and control are major foreign assistance objectives of the U.S. Government (USG). In May 2009, President Barack Obama announced the Global Health Initiative (GHI), a six-year, comprehensive effort to reduce the burden of disease and promote healthy communities and families around the world. Through the GHI, the United States will invest $63 billion over six years to help partner countries improve health outcomes, with a particular focus on improving the health of women, newborns and children.

The GHI aims to maximize the impact the United States achieves for every health dollar it invests, in a sustainable way. The GHI's business model is based on: implementing a woman and girl-centered approach;

increasing impact and efficiency through strategic coordination and programmatic integration;

strengthening and leveraging key partnerships, multilateral organizations, and private contributions;

encouraging country ownership and investing in country-led plans and health systems; improving metrics, monitoring and evaluation; and promoting research and innovation. The GHI will build on the USG’s accomplishments in global health, accelerating progress in health delivery and investing in a more lasting and shared approach through the strengthening of health systems.

The President’s Malaria Initiative (PMI) is a core component of the GHI, along with HIV/AIDS and tuberculosis. As part of the USG Malaria Strategy 2009-2014 [PDF, 483KB], an expanded PMI strategy has been developed to achieve Africa-wide impact by halving the burden of malaria in 70 percent of at-risk populations in sub-Saharan Africa, approximately 450 million people, thereby removing malaria as a major public health problem and promoting economic growth and development throughout the region. Since its launch in 2005, PMI has reinforced the principles that are part of GHI, including: encouraging country ownership and investing in country-led plans and health systems; increasing impact and efficiency through strategic coordination and programmatic integration; strengthening and leveraging key partnerships, multilateral organizations, and private contributions; implementing a woman- and girl-centered approach;

improving monitoring and evaluation; and promoting research and innovation.

Purpose

The purpose of this cooperative agreement is to 1) conduct operations research in malaria in sub- Saharan Africa and Asia, 2) support the establishment of monitoring and evaluation systems for malaria program activities, including those supported by the PMI and 3) establish feasible and effective opportunities for integration with other child survival, vector control and infectious disease programs. This Funding Opportunity will support ongoing research and collaboration and additionally support the evaluation of the efficacy and safety of the PfSPZ vaccine.

The following are specific activities for the recipient to address in collaboration with CDC and the Ministries of Health and Population (MoH): a) In coordination with global partners, strengthen the ability of health facilities and community intervention efforts to provide timely and appropriate care and treatment of sick children under 5 years of age by evaluating case management activities and practices, including the use of rapid diagnostic tests and pre-referral rectal artesunate at the community level, b) Promote the http://www.pmi.gov/resources/reports/usg_strategy2009-2014.pdf importance of administering the correct anti-malarial drug and correct dosage by drug sellers, pharmacists, and other MoH designated agents in the community, c) Evaluate the use and impact of vector control intervention measures such as insecticide treated materials, including use of combination insecticide-treated bednets, insecticide-treated wall liners, spatial repellents and toxic baited sugar traps; d) Evaluate the impact of strategies such as intermittent mass screen and treat and mass drug administration on malaria transmission; e) Evaluate the continued effectiveness of intermittent preventive treatment during pregnancy and alternative strategies and approaches for prevention of malaria in pregnancy; f) Monitor the efficacy of first- and second-line antimalarial drugs; g) Determine thesafety and efficacy of the PfSPZ Vaccine; h) Disseminate results from these operational research and prevention activities through written publications, oral presentations, hosting study tours, or by other means, and i) Assist the MoH in translating operational research findings into public health practice in sub-Sahara Africa and Asia, and ensure sharing of expertise and research findings with other partners and countries.

Healthy People 2020 and other National Strategic Priorities The President’s Malaria Initiative (PMI) is a core component of the GHI, along with HIV/AIDS and tuberculosis. As part of the USG Malaria Strategy 2009-2014 [PDF, 483KB], an expanded PMI strategy has been developed to achieve Africa-wide impact by halving the burden of malaria in 70 percent of at-risk populations in sub-Saharan Africa, approximately 450 million people, thereby removing malaria as a major public health problem and promoting economic growth and development throughout the region. Since its launch in 2005, PMI has reinforced the principles that are part of GHI, including: encouraging country ownership and investing in country-led plans and health systems; increasing impact and efficiency through strategic coordination and programmatic integration; strengthening and leveraging key partnerships, multilateral organizations, and private contributions; implementing a woman- and girl-centered approach;

improving monitoring and evaluation; and promoting research and innovation.

Public Health Impact The Public Health Impact of this proposed work will be two-fold. First, these evaluations and studies will provide critical scientific knowledge to inform and guide malaria program implementation in sub-Saharan Africa and Asia. Public health policy (Malaria Control Program) may be changed based on the outcomes from these research findings. The effectiveness of the specific projects being tested in reducing malaria transmission, morbidity, and mortality will be measured. Second, the ultimate impact of these activities will be reduced morbidity and mortality due to malaria through the scale-up of evidence-based intervention strategies and on-going evaluations of these strategies.

Relevant Work

2. Approach Scientific knowledge to be achieved through research supported by this program includes:

Evaluation of potentially efficacious vaccines to complement current malaria control measures, and development of new tools to improve surveillance, monitoring and evaluation;

Ensure that operational research findings are translated into better public health practice globally.

Objectives/Outcomes Evaluate the safety, tolerability, and efficacy against P falciparum infection during 6 months http://www.pmi.gov/resources/reports/usg_strategy2009-2014.pdf

Evaluate the safety, tolerability, and efficacy against P falciparum infection during 6 months follow-up of PfSPZ Vaccine administered as 3 doses by DVI at 900,000 PfSPZ per dose or 450,000 PfSPZ per dose, or in 4 doses at 900,000 PfSPZ per dose. The secondary objectives include the evaluation of the immunogenicity of the vaccine and efficacy against infection during 12 months follow-up.

Target Population Target populations should include people living or working in epidemiological defined areas of malaria transmission in sub-Saharan Africa and Asia. 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.

Collaboration/Partnerships Key stakeholders and partnerships include National Malaria Control Programs, the United States Agency for International Development (USAID), PMI implementing partner organizations, the United Nations Children’s Fund (UNICEF), the World Health Organization (WHO), and the Global Fund.

Evaluation/Performance Measurement Monitoring and Evaluation

Work with CDC and other global partners as appropriate to develop and implement an evaluation plan to measure the impact of the activities outlined in this funding opportunity announcement (evaluation framework, evaluation design, indicators, process and outcome evaluation, and information/data collection plan).

Program Capacity

Establish or retain a full-time staff person with management and technical experience, responsible for managing the planning, implementation, and evaluation of the program and serving as the CDC point of contact.

Establish or retain a part-time staff person with data management and mobile data collection experience responsible for the programming and trouble-shooting of data collection instruments, cleaning of data, development of data dictionaries and storage of datasets.

Establish or retain additional staff with demonstrated knowledge, skills, and expertise in administrative and fiscal management to meet the needs of the program.

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

Fiscal management

Programs must use funding to support programs in alignment with requirements of this FOA.

Programs must develop and maintain systems for sound fiscal management, including: monitoring the cooperative agreement award and program contracts and grants, ensuring the funds are expended in support of approved activities; tracking expenditures in a timely manner; and preventing excessive unobligated balances.

Translation Plan Applicant should use appropriate scientific journals to disseminate research findings to the broader scientific community in conjunction with CDC scientists. Applicant should present important evaluation and research findings at relevant international scientific meetings and conferences.

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:

Revision (formerly Competing Supplement) - Request for additional funds for a current award to expand the scope of work. Applicants should contact the awarding agency for advice on submitting any revision/supplement application.

Estimated Total Funding: $17,500,000

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: $0 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:

Other:

Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

2. Foreign Organizations Foreign 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

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 Applicants must demonstrate an ability to organize malaria-focused consortia to conduct malaria epidemiologic and entomologic studies in sub-Saharan Africa and Asia. This should include a proven track record in organizing and managing large groups of diverse research institutions, international public health groups, and Ministries of Health for the purpose of identifying the malaria research agenda and implementing research studies across multiple sites and epidemiologic transmission zones. Applicants must demonstrate previous malaria research or public health activities in sub-Saharan Africa and Asia.

Applicants should document eligibility through manuscripts showing previous work in these regions or through reference letters from public health officials.

4. Justification for Less than Maximum Competition The Liverpool School of Tropical Medicine (LSTM) is uniquely qualified for this award based on the following experience and capabilities:

The LSTM is the central coordinating body for several international malaria consortia, there-by making it uniquely suitable to conduct these activities. These include:

Malaria in Pregnancy (MIP) Consortium: This is a global partnership of 42 research institutions worldwide active in malaria control in pregnancy research. LSTM is the coordinating institution and is responsible for the coordination of the research activities of the Consortium, advocates for the topic, hosts the MIP resource centre, and acts as the host of the drug safety database of antimalarials in pregnancy. This is the only centralized database for combining results from several multi-centre trials. Because this is the main international research network in this field, LSTM is the only institution that is in a position to conduct this kind of international research collaboration for operational research of malaria in pregnancy.

The Cochrane Infectious Diseases Group: This is a group that since 1994 has specialized in the field of meta-analysis and has been preparing systematic reviews on the benefits and harms of healthcare interventions for infectious diseases, particularly malaria, tuberculosis, diarrhea, and tropical diseases. The editorial base is located at the LSTM and hence, they are uniquely positioned to conduct the meta-analysis of the malaria focused multi-centre trials proposed in this program.

Innovative Vector Control Consortium (IVCC). This research program is the largest malaria vector control partnership in the world and involves institutions from the US, UK, Asia and Africa. LSTM is the coordinating institution for the IVCC, and hence plays a pivotal role in development and delivery of new products and tools in reducing transmission of vector-borne diseases, effective campaigns to control malaria, and malaria elimination.

In addition LSTM participates with CDC and other partners on several other global research and policy forum: The Antimalarial Combination Therapy Consortium, The WHO Technical Expert Group on 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

Containment of Antimalarial Drug Resistance, The Roll Back Malaria Partnership (including Malaria in Pregnancy, Vector Control and Case Management Working Groups), and the International Centers of Excellence for Malaria Research.

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

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 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.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package 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 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 http://www.Grants.gov mailto:pgotim@cdc.gov 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.

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.

Section IV.6. 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 16 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 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 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 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: February 23, 2016, FEDEX to CDC OGSTIMS by 5 P.M. EST

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

Section IV.10. Intergovernmental Review

10. Intergovernmental Review (E.O. 12372)

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

11. Funding Restrictions 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.

This policy applies to all New and Renewal awards issued on applications submitted on or after September 24, 2015, and to all non-competing continuation awards issued on or after that date. CDC grantee institutions and their investigators conducting life sciences research subject to the Policy have a number of responsibilities that they must fulfill. Institutions should reference the policy, available at http://www.phe .gov/s3/dualuse, for a comprehensive listing of those requirements.

Non-compliance with this Policy may result in suspension, limitation, or termination of United States Government (USG) funding, or loss of future USG funding opportunities for the non-compliant USG-funded research project and of USG funds for other life sciences research at the institution, consistent with existing regulations and policies governing USG funded research, and may subject the institution to other potential penalties under applicable laws and regulations.

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 mailto:www.pgotim@cdc.gov http://www.whitehouse.gov/omb/grants_spoc http://www.phe.gov/s3/dualuse

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 75. A non-Federal audit is required, if during the grantees fiscal year, the grantee expended a total of $500,000.00 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.

Provide technical assistance or advice on any information collections on 10 or more people that are planned or conducted by the awardee. All such information collections – where CDC staff will be or are approving, directing, conducting, managing, or owning data – must undergo Office of Management and Budget (OMB) project determinations by CDC and may require OMB Paperwork Reduction Act (PRA) clearance prior to the start of the project.

12. Other Submission Requirements and Information

Application Submission Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

Applicants must complete all required registrations before the application due date. Section III.6 "Required Registrations" contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide /url_ redirect.htm? id=11144).

Important reminders: All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

If the applicant has an FWA number, enter the 8-digit number. Do not enter the letters “FWA” before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of the SF 424 (R&R) Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http:// grants.nih. gov/grants/ Electronic Receipt /avoiding _errors.htm or http:// grants. nih.gov/grants/ Electronic Receipt/submit _app.htm Upon receipt, applications will be evaluated for completeness by the CDC Office of Grants Services http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144 http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm

(OGS) and responsiveness by OGS and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process. As part of the CDC mission (http:// www.cdc.gov/ about/ organization/ mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are there plans for 1) protection of human subjects from http://www.cdc.gov/about/organization/mission.htm research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success?