ip-13-002 foa final 12.19.12.doc

Table of Contents

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary Part 2. Full Text Section I. Funding Opportunity Announcement Description Section II. Award Information 1Section III. Eligibility Information

Section IV. Application and Submission Information Section V. Application Review Information 2Section VI. Award Administration Information

Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information

Funding Opportunity Announcement Type

New

Key Dates

Publication Date

To receive notification of any changes to RFA-IP-13-002, 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.

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).

Required Application Instructions

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

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

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 “Apply Electronically” at www.grants.gov.

Executive Summary Purpose. To strengthen the capacity in Panama and the countries of Central America region, to detect, describe, and conduct studies on transmission, disease, and economic burden of influenza and emerging and re-emerging infectious diseases of public health importance and to evaluate new diagnostics, vaccines, antivirals, risk assessment methods, and other interventions that may offer approaches toward their prevention or treatment. Mechanism of Support. Cooperative Agreement.

Funds Available and Anticipated Number of Awards. Estimated total funding available including direct and indirect costs for first year (12 month budget period): $1,000,000. Estimated total funding available including direct and indirect costs for entire project period (5 year project period) $5,000,000. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. Estimated total funding available including direct and indirect costs for first year (12 month budget period): $1,000,000. Estimated total funding available including direct and indirect costs for entire project period (5 year project period) $5,000,000. The project period will run from 09/1/2013 to 08/30/2018.

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 submit one application.

Application Type. New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round. (Type 1) Special Date(s). Program should insert dates for any planned technical assistance conference calls or other special dates.

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 Announcement Description

Statutory Authority

Public Health Service Act 307; 42 U.S.C. 242l

1. Background and Purpose

The purpose of the program is to strengthen the capacity in Panama and the countries of Central America region, to detect, describe, and conduct studies on influenza and emerging and re-emerging infectious diseases of public health importance and to evaluate new diagnostics, vaccines, antivirals, risk assessment methods, and other interventions that may offer approaches toward disease prevention and treatment.

Healthy People 2020 and other National strategic priorities – This program addresses the “Healthy People 2020” focus area(s) of Immunization and Infectious Diseases and is in alignment with NCIRD’s performance goal(s) to protect Americans from infectious diseases and “Protecting the Nation’s Health in an Era of Globalization: CDC’s Global Infectious Disease Strategy”.

Public Health Impact - This program is intended to strengthen influenza surveillance and generate data elements for regional health authorities to better time influenza prevention and control, determine the value of various influenza prevention and control strategies, and ultimately assist countries in better mitigating the impact of influenza epidemics on populations most at risk of developing severe complications as a result of illness.

Relevant work- Not Applicable

2. Approach The FOA seeks to strengthen the capacity in Panama and the countries of Central America region, to detect, describe, and conduct studies on influenza and emerging and re-emerging infectious diseases of public health importance and to evaluate new diagnostics, vaccines, antivirals, risk assessment methods, and other interventions that may improve disease prevention and treatment strategies and management. The FOA research objectives and anticipated timeline for study span a five year project period.

Objectives/Outcomes- The following research objectives are anticipated to be included in budget year one activities and must be addressed by the applicant in the research plan of the application to be considered for funding.

· Establish and/or maintain partnerships with regional ministries of health and agriculture, academic institutions, COMISCA, and the Pan American Health Organization or others to facilitate access and cooperation in meeting research study objectives

· Estimate the incidence and economic burden of acute lower respiratory tract infections and the fraction attributable to influenza virus and other pathogens in Panama and the countries of Central America

· Identify risk factors for severe influenza and other respiratory infections such as age, underlying medical conditions, malnutrition, co-infection with other pathogens, and environmental exposures

· Identify and evaluate clinical predictors of severe influenza and other respiratory infections in target populations

· Conduct epidemiological studies to identify groups at high risk for influenza or other infectious diseases, and identify modifiable risk factors for illness and characterize influenza and other respiratory infections in at-risk populations by use of different approaches including longitudinal cohort studies (e.g. among persons infected with HIV, tuberculosis, or malaria, indigenous people, etc.)

· Conduct trials to evaluate influenza vaccine efficacy, effectiveness, cost-effectiveness, and impact of other potential influenza prevention or treatment strategies such as antiviral drugs

· Perform or arrange to have performed, laboratory influenza assays including: serology for influenza antibodies by CDC approved methods, typing and subtyping of strains, antigenic characterization, sequencing and isolation of viruses as appropriate, and other laboratory assays such as for cell-mediated immunity and nutritional markers

· Define burden of disease caused by influenza and other infectious diseases that may include estimates of morbidity and/or mortality, demands on the health care system, and direct and indirect economic costs

· Develop and evaluate strategies such as use of antiviral medications, influenza vaccines, or modification of environmental exposures to prevent, control, or treat influenza and other infectious diseases

· Assess and monitor antimicrobial resistance of influenza viruses and infectious disease agents in Panama and Central America

· Participate in scientific training meetings, scientific collaborations and CDC sponsored proficiency testing to include, but not limited to training events and cooperative meetings and conferences The following research objectives are anticipated to be included in budget year one activities and must be addressed by the applicant in the research plan of the application to be considered for funding.

· Estimate the attack rate of influenza and other respiratory infections in target populations through the use of serology studies

· Detect infections with and characterize animal influenza viruses

· Evaluate diagnostic tests for influenza and other emerging pathogens, such as multiplex PCR platforms, serological tests, and rapid diagnostic tests

· Conduct studies on the immune response to influenza virus infection and influenza vaccines

· Evaluate case definitions for influenza and other emerging pathogens

· Estimate and characterize influenza-associated mortality using verbal autopsy data and post-mortem respiratory tract sampling

· Estimate direct and indirect costs associated with the management of influenza and other respiratory infections

· Conduct training and capacity building in influenza and other respiratory pathogen surveillance in Central America region

· Document health utilization patterns for and caregivers’ recognition and interpretation of pneumonia and other respiratory illnesses

· Document antibiotic use patterns for acute lower respiratory tract infections

Target population -Panama and Central America region including the Dominican Republic.

Collaboration/Partnerships -Applicant must demonstrate partnerships with regional ministries of health and agriculture, academic institutions, COMISCA, and the Pan American Health Organization and/or others and provide detail of cooperative activities and program support through formal or informal agreements. Demonstrations can be provided through formal or informal communications, letters or other correspondence.

Evaluation/Performance measurement- Applicants must detail and track proposed and cooperative study activities and project milestones as part of their application. CDC will monitor progress toward study outcomes of the project though meetings, discussions, conference or other agreed upon means. Applicants are encouraged to detail study objectives using SMART format and provide attributes that are Specific, Measurable, Achievable, Realistic and Time-bound.

Translation plan –When relevant to the goals of the research project, the PI should describe how the significant findings may be used to promote, enhance, or advance translation of the research to policy or practice. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that were translated into public health policy or practice and how the findings have been or may be adopted in public health settings. Or, if they cannot be applied yet, this section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:

· How will the scientific findings be translated into public health policy or practice?

· How will the project improve or effect 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 or practices?

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

Section II. Award Information

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.

Funds Available and Anticipated Number of Awards

Year 1: $1,000,000

Year 2: $1,000,000

Year 3: $1,000,000

Year 4: $1,000,000

Year 5: $1,000,000

List anticipated number of awards here: 1

Estimated total funding available including direct and indirect costs for first year (12 month budget period): $1,000,000

Estimated total funding available including direct and indirect costs for entire project period (5 year project period) $5,000,000.

Floor amount of $100,000 (total costs). This floor is for the first 12 month budget period.

Applications greater than the ceiling of $1,000,000 will not be accepted or reviewed

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://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

Eligible Applicants

Gorgas Memorial Institute for Health Studies (GMI)

Avenida Justo Arosemena y Calle 35 APDO. 0816-02593

Panama, Republica de Panama

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign components of U.S. Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/grantinformation/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: http://www.dlis.dla.mil/Forms/Form_AC135.asp.

Program should indicate if it is permissible to use foreign consultants or collaborators below.

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

3. Justification for Less than Maximum Competition: Date of approval 10/24/13.

Influenza Division believes it is important to have information about the circulating influenza strain throughout the world for the health security of the United States. A presence in Central

America will help assess the potential threats of novel influenza strains and generate data useful to guide United States vaccine policy. Eligibility is limited to the Gorgas Memorial Institute for Health Studies (GMI) in Panama and the countries of Central America region, because we judge it to be the only sufficiently advanced laboratory in the region that can perform the sophisticated analyses necessary to quantify influenza burden of disease in Central America:

• The Gorgas Memorial Institute for Health Studies (GMI) is an autonomous public institution that works closely with the Ministry of Health. Its vision is to improve the health of Panama and Central America. Its mission is to develop health research in

Panama, to fulfill the functions of a national public health laboratory and to provide education to health care workers of the region

• GMI has contributed to better the health of Panama and the Central American countries by acting as a reference laboratory to diagnose diseases like yellow fever, arbovirus febrile illness, viral encephalitidies, hantavirus cardiopulmonary syndrome

• GMI is the leading research Institute, and is also the National Health Laboratory

(National Reference Center) in Panama

• GMI has recently been accredited as a World Bank-Pan-American Health

Organization reference laboratory for human immunodeficiency virus (HIV) for the

Central American region

• GMI's has research agreements and research projects with academic centers of US; and developed strong links with the epidemiology programs of all the countries in Central

America, with the World Health Organization (WHO), the Center for Diseases Control of the United of America (CDC, with the Pan-American Health Organization (PAHO) and with institutions like the Smithsonian Tropical Research Institute (STRI)

• GMI has the only NIC existing in Panama accredited in 2007 which is responsible for the influenza surveillance national network based on the laboratory in Panama. GMI is responsible for collecting influenza specimens and for performing preliminary virus isolation and antigenic characterization prior to shipment to WHO

• GMI has increased its virology diagnostic capacity in order to strengthen the surveillance of influenza virus in Panama and Central America and to develop a Regional Training

Center for community health care workers of the Central American Region

• GMI possesses the scientific and management capability to meet program requirements without jeopardizing or compromising the quality of the research and other activities

• GMI is conveniently located in Central America and has the adequate space, including office space, laboratories, meeting space, advanced communications network, and capacity to expand to accommodate additional staff.

4. Responsiveness: Not Applicable

5. Required Registration 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: http://www.dlis.dla.mil/Forms/Form_AC135.asp

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, http://www.grants.gov/applicants/org_step2.jsp.

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.

6. Universal Identifier Requirements and Central Contractor Registration

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), the replacement system for the Central Contractor Registration (CCR) database. 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.

7. 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.

8. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

9. Number of Applications

Only one application per institution (normally identified by having a unique DUNS number) is allowed As defined in the HHS Grants Policy Statement, (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), 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

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 (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard 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/guide/url_redirect.htm?id=12000), 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 and uploaded as Attachment A from the following link: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

3. 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.

4. 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/guide/url_redirect.htm?id=12000) 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_Adobe_VerB.pdf) must be followed along with any additional instructions provided in the FOA.

5. 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.

6. Page Limitations

All page limitations described in this individual FOA must be followed. For this specific FOA, the

Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 100 pages for all appendices.

7. 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/guide/url_redirect.htm?id=12000).

8. Submission Dates and 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 CDC PGO TIMS at 770-488-2700; www.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.

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.

9. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

10. Funding Restrictions

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

11. 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. Eligibility Information 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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

Applicants are reminded to enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8-digit number. Do not enter the 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 this 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/ElectronicReceipt/avoiding_errors.htm or http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO 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? Does the project address all of the primary (budget year 1) and secondary (budget years 2-5) research objectives?

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? Do the applicants describe how they may interact with regional stakeholders such as local ministries of health and agriculture, academic institutions, COMISCA, Department of State, Health and Human Services, and World Health Organization members?

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 provide reasonable assurance of successful accomplishment of 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? Does the proposal include plans to measure progress toward achieving the stated objectives? Is there an appropriate work plan and time line included? Do the applicants specify how they plan attain specific benchmarks in order to complete project objectives in a timely fashion? Do the applicants introduce an evaluation plan to ensure that they are appropriately spending funds in order to meet project benchmarks? Do the applicants have a plan to communicate project findings with stakeholders and help guide regional policy?

If the project involves clinical research, are there plans for 1) protection of human subjects from 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? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there an effective and well-defined working relationship of applicant with performing organization and with outside entities that will ensure timely implementation of the proposed activities? Is documentation of cooperation and support documented?

2. Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

If the research involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46 , the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the HHS/CDC Requirements under AR-1 Human Subjects Requirements (http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar1).

If your proposed research involves the use of human data and/or biological specimens, you must provide a justification for your claim that no human subjects are involved in the Protection of Human Subjects section of the Research Plan.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the policy on the Inclusion of Women and Racial and Ethnic Minorities in Research (http://www.cdc.gov/OD/foia/policies/inclusio.htm) and the policy on the Inclusion of Persons Under21 in Research (http://aops-mas-iis.cdc.gov/Policy/Doc/policy496.pdf).

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11150).

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

3. Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans

HHS/CDC policy requires that recipients of grant awards make research resources and data readily available for research purposes to qualified individuals within the scientific community after publication. Please see:

http://www.cdc.gov/od/foia/policies/sharing.htm. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

4. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate peer review group, in accordance with CDC peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

· Will undergo a selection process in which all responsive applications will be discussed and assigned an overall impact/priority score.

· Will receive a written critique.

Applications will be assigned to the appropriate HHS/CDC Center, Institute, or Office. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review. The following will be considered in making funding decisions:

· Scientific and technical merit of the proposed project as determined by scientific peer review.

· Availability of funds.

· Relevance of the proposed project to program priorities.

· Funding decision criteria will include a priority score and programmatic importance/value relative to program priorities. Proposals can be funded out of rank order based on the following listed in order of priority: (1) research portfolio balance (e.g., geographic diversity), (2) diversity of practice types, and (3) sub-populations served, (e.g., ethnicity, and SES), in order to allow the most generalizable results to be obtained from this study.

· Applications will be assigned to the appropriate HHS/CDC Center, Institute, or Office. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review.

5. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be…