Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)

Title: International Centers of Excellence for Malaria Research (U19)

Announcement Type
New

Request For Applications (RFA) Number:  RFA-AI-09-017

Catalog of Federal Domestic Assistance Number(s)
93.856

Key Dates
Release Date: April 8, 2009
Letters of Intent Receipt Date: August 28, 2009
Application Receipt Date: September 29, 2009
Peer Review Date: January, 2010
Council Review Date: May, 2010
Earliest Anticipated Start Date:  September, 2010
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: September 30, 2009

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), invites applications to participate in a research program that will provide a multidisciplinary approach that integrates clinical and field aspects with laboratory, molecular and genomic methods for malaria control and prevention.  The objective of the International Centers of Excellence for Malaria Research (ICEMR) program is to create a group of research centers in malaria-endemic settings that will provide the necessary knowledge, tools, and evidence-based strategies to support intervention and control programs of government organizations and health care institutions.  Ultimately, such a broad-based, multidisciplinary and integrated approach is expected to enhance the research underpinnings for effective malaria elimination and possibly eradication. Data and findings generated by these Centers are expected to provide input critical to inform future research design and evaluation of new interventions and control strategies.  

Background

Although malaria has been eliminated from many parts of the globe, over 40% of the world’s population still lives in areas where they are at risk for contracting the disease.  Control efforts have not been sustainable in many locations and have been associated with the emergence and spread of both parasite drug resistance and vector insecticide resistance.  Currently, there are no point-of-care diagnostic tools available to monitor emerging drug resistance to malaria.  In addition, a malaria vaccine has not yet been licensed, and although a number of promising candidates are in development, a highly effective malaria vaccine may not be available for years to come.  Although various efforts to curb malaria have been launched, it has become increasingly clear that sustainable and effective malaria control requires an improved understanding of the complex interactions among the parasite, the mosquito vector, and the human host in local clinical and field settings.  Furthermore, novel drugs, diagnostics, and vaccines, as well as vector management strategies will need to be developed, evaluated and ultimately utilized in malaria-endemic locations (http://www.who.int/malaria/wmr2008/).  Thus, a multidisciplinary research approach is urgently needed to address these complex interactions at the molecular, cellular, organismic, population and field levels in malaria-endemic areas in order to provide the knowledge base necessary for improved clinical and field management of malaria, as well as to guide the development of new tools and interventions.

Research Scope and Objective

The objective of this solicitation is to establish International Centers of Excellence for Malaria Research program comprised of a network of research centers in malaria endemic regions. Each Center should:  (1) design and conduct multidisciplinary research on the epidemiology, transmission, and pathogenesis of malaria in endemic geographic regions; (2) design and conduct special projects to capitalize on new opportunities and emerging public health needs; and (3) develop and conduct training/career development programs for researchers from malaria-endemic areas. Integral to accomplishing the goals of each Center is the inclusion of milestones which will be used to measure the progress of the individual projects and cores as well as the Center as a whole.  Milestones should identify research outcomes by providing measures of success within specified timelines. In addition to providing a quantifiable measurement of program outcome, it is expected that milestones will facilitate tracking of the successes and failures of individual activities within the Center.  Assigned NIAID staff, through the Cooperative Agreement grant mechanism, and the Scientific Advisory Group will monitor progress toward achieving milestones and work with the Center PD/PI to adjust or modify established milestones as needed to adapt to changes that are supported by strong scientific rationale.   

The majority of Center research projects must be conducted within malaria-endemic geographic regions and must provide for significant involvement of local/regional researchers in study design, development and execution. It is important to note that the ICEMR program is not intended to support research which can be conducted primarily in the U.S. and countries where malaria is not endemic.  In addition, each Center must develop and maintain affiliations with local/regional government agencies and established institutions in the endemic countries to ensure necessary coordination of research activities with ongoing malaria control/intervention programs and to facilitate access to relevant study populations and treatment centers. 

Each Center should have a diverse set of expertise including basic science, vector research (and vector ecology), epidemiology and clinical studies. The PD/PI and Project Leaders from non-endemic areas must be substantially involved with at least 30% of their annual effort spent on-site in the endemic areas where the research program is based.

Each Center must have an existing on-site administrative structure, scientific capacity and training available to enable their proposed field sites to perform the research activities proposed in this grant.

Malaria-Endemic Geographic Regions:  Center research activities should include a minimum of three field sites which could be in the same or different countries at distances that provide for potential variability in the epidemiology and transmission across field sites. The application should describe the epidemiology of malaria at each of the sites to show that there is variability in the epidemiology and transmission of disease. Centers should have all their sites located in one of the following geographic regions:

Applications with sites in malaria-endemic areas where there is a paucity of research and surveillance data are encouraged. It is anticipated that NIAID will make one award from each of the geographic regions listed above contingent upon the availability of funds and submission of a sufficient number of meritorious applications. 

ICEMR PROGRAM COMPONENTS

1.    a Research Component consisting of three or more individual research projects one in the area of Epidemiology and two or more in the area of Transmission and/or Pathogenesis and Diagnosis;

2.    a Training/Career Development Program Component;

3.    a Special Projects Component;

4.    an Administrative Core and a Data Management/Biostatistics Core

5.    one or more optional Cores that support the work within and among the ICEMR.

1.    Research Component (required)

Each Center must include a project on Research Area A - Epidemiology, and must include two or more projects in Research Area B – Transmission, and/or Research Area C – Pathogenesis and Diagnosis. The required Research Area A – Epidemiology project should be a multi-site project involving at least three of the field sites proposed by the Center. Centers should adopt a multidisciplinary approach that integrates clinical and field aspects with laboratory, molecular and genomic methods.  In addition, each Center must (1) possess the capability to evaluate the changing epidemiologic landscape of malaria, (2) provide the flexibility necessary to respond to changes in the parasite population, mosquito vectors,  epidemiologic shifts, and the availability of new or improved control interventions, (3) provide a process for assessing ongoing research projects and modifying, redirecting and/or curtailing ongoing research projects to reflect such changes/shifts, and (4) identify, evaluate the capabilities of, and add new field sites based on the emerging needs and/or changing epidemiological conditions within the geographic region. Addition of new sites will require prior program approval. 

Examples of research activities that are responsive to this FOA include, but are not limited to, the following:

Research Area A – Epidemiology (required)

Research Area B – Transmission

Research Area C – Pathogenesis and Diagnosis

NOTE:  This FOA will NOT support:

2.    Training/Career Development Program (required)

Each Center shall develop and carry out a Training/Career Development Program for endemic country scientists to increase the number of qualified scientific and technical personnel capable of conducting independent malaria research.  Applicants should describe the process and procedures for soliciting, submission, review, assessment and award of career development projects. A minimum of two (2) career development projects will be carried out by each Center as an integral part of the Center’s activities.  Career development projects for individuals may focus on advanced post-doctoral candidates, junior faculty, or established investigators who wish to refocus their careers on malaria research.  Each candidate must have a mentor and each candidate must devote at least 50% effort to the Center project.  The Training/Career Development Program should support the salary and costs of candidates with outstanding potential, as well as other reasonable costs for career development and training activities. Do not submit descriptions of career development projects in the applications.

Additional career development and training activities may be directed to groups of individuals; for example, there may be training programs for graduate students, technicians and other technical personnel to learn special skills.  Applicants should provide a description of the additional career development and training activities that may be made available through this FOA. Funds may not be used to support an academic degree program.

Funds for the Training/Career Development Program not exceeding $50,000 in direct costs per candidate should be included in the overall budget of the application. All candidates should be from the endemic region from where the application is being submitted.

3.    Special Projects (required)

Starting in the third year of the grant, each Center must set aside up to a total of $100,000 per year in direct costs to support special projects designed to capitalize on opportunities and needs resulting from (1) changing epidemiological conditions, (2) implementation of malaria control programs and resulting public health needs, and/or (3) emerging scientific developments and associated research needs.  Special projects may be proposed by the Center or the Program Officer at any time after the second year of the grant and should be completed before the end of the grant. The Scientific Advisory Group (SAG) will be responsible for review, assessment and recommendation for funding approval by the Program Officer prior to implementation.

4.    Core Components

Administrative Core (required)

The Administrative Core is responsible for the overall administration, coordination and management of the Center.  The PD/PI of the application should be the Core Leader of the Administrative Core. The ICEMR Administrative Core will be responsible for managing, coordinating, and supervising the entire range of Center activities, monitoring progress, and ensuring that the project milestones are being met and are being implemented effectively within the proposed timelines. A well-developed administrative plan is integral to the success of the Center and must be clearly defined in the application. The plan should include a discussion of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed and a discussion on how the Center will ensure effective and timely communications between the Center and NIAID staff. In addition to the Core Leader (CL), the Administrative Core should have a research administrator responsible for the daily administration and fiscal management. The Administrative Core must provide both an organizational and administrative structure that is conducive for ensuring collaborative efforts and interaction among network sites, and appropriate integration of endemic country scientists into the research project.  This Administrative Core should clearly identify personnel and resources needed to oversee the Center and ensure management of subcontract funds and resources necessary for the success of all network sites. The core must provide a clear and explicit discussion of how fiscal and other resources will be prioritized, allocated, and managed.  A description of how subcontracts will be managed, how communications such as periodic meetings and conference calls with minutes will be organized and managed should be provided. Each ICEMR must have a well delineated organizational structure and administrative mechanisms that foster interactions among investigators, accelerate the pace of research, enable translation of basic research findings to clinical applications, and ensure a productive research effort. There should be a budget and plan on how research related travel and training will be organized and managed. All travel should follow NIH travel guidelines. In addition to the institutional allowance, awards may include a single economy or coach round-trip travel fare. No allowance is provided for dependents. U.S. flag air carriers must be used to the maximum extent possible when commercial air transportation is the means of travel between the United States and a foreign country or between foreign countries. This requirement shall not be influenced by factors of cost, convenience, or personal travel preference.  

Data Management and Biostatistics Core (required)

All Centers should have access to dedicated statistical expertise that informs the research study design and provides the ability to conduct statistical data analysis.  They should also provide training to biostatisticians/data management specialists from endemic areas and work collaboratively with them in the areas of study design and sampling, sample size and power determination, statistical analyses and assist with the writing of manuscripts. Support should provide for activities such as study design and protocol development and where appropriate, generating interim tables, preliminary statistical analyses for progress reports, and assisting with statistical issues related to laboratory testing and results. 

All Centers and field sites should have computers, connectivity to the internet and communications capabilities.  For sites without such capabilities, funding for such infrastructure should be budgeted in this core and should be in place before the end of the first year of the grant. Redundancy, like having multiple power sources, uninterrupted power supply and multiple internet service providers is encouraged to ensure minimal downtime and greater reliability.

A data management system and a full-time Data Manager must be present at the Center and/or each of the sites.  The Data Management system must collect and manage data from the participating study sites ensuring uniformity of procedures and high quality data.  Applications must provide a detailed description of the existing or planned data management system and how it will serve the diverse needs of all the sites.  The data management system should ideally include:

The Data System should reside at the endemic area and data management staff from the endemic sites will collaborate on the design, development and testing of databases and data management software, validation of the data system, training of data management and field personnel on data collection procedures and activities, maintenance of the database and software systems, documentation of changes, and preparation of data dictionaries and standard operating procedures for all aspects of data management. 

Applications must also address how such a system will be planned and implemented, as well as the time frame within which all design, development, testing, validation, and training activities will take place to achieve a fully operational data management system and appropriately trained staff. Plans and procedures must be in place to provide security against anticipated risks, including loss of confidentiality of subject electronic records and data summaries.

A large part of the computerized data management system should be tested and implemented before the end of the first year.

NIAID/DMID must be provided access to and may periodically review all data generated under this cooperative agreement.

Shared Resource Cores (optional)

Shared Resource Cores provide scientific and/or clinical services or resources to at least two research projects. Shared Resources Cores must be well justified and clearly non-duplicative of other services or facilities available to ICEMR investigators. Examples of services provided by a shared scientific core are laboratory support monoclonal antibody production, peptide synthesis, microbiology laboratory services, insectary or vector biology laboratory, and immunology/molecular biology support. Shared clinical cores could provide a source of patients and healthy volunteers, patient specimens or represent a facility for procedures that require health care personnel supervision.  Each Core must be headed by a Core Leader. Applications proposing Shared Resource Cores must give a clear description of the facilities, techniques, and skills that the Core will provide to research projects, and the role of the Core Leader and key personnel.  A budget must be provided for each Core.  The apportionment of dollars, or percentage of dollars, that will be required to support each research project should also be presented.

NOTE: Applications without the above required components will be considered non-responsive and will not be reviewed.

Scientific Advisory Group (SAG)

Applicants must propose to establish, plan and coordinate the activities of a Scientific Advisory Group (SAG) to review Center progress and provide scientific advice with respect to the scientific direction of the Center, progress and performance of ongoing research projects, and proposed Special Projects.  Up to five SAG members representing the scientific areas of expertise relevant to the Center’s research projects shall be selected by the Principal Investigator.  Up to four additional Federal and non-Federal experts may be selected by the Program Officer to participate in SAG activities in an advisory capacity when appropriate. The SAG will meet annually and the PD/PI shall plan, organize and conduct annual SAG meetings and prepare reports of the meeting content, relevant discussions and SAG recommendations. Funds for travel and accommodations of the SAG members should be included in the budget request of the Administrative Core. All travel should follow NIH travel guidelines.

Applicants should not contact nor identify individuals who might be invited to serve on the advisory board for their ICEMR program.

Annual Workshops

Each Center will be responsible for hosting one workshop during the life of the grant that will have the participation of all of the ICEMR program Centers.  These workshops are intended to identify areas of collaboration among Centers.  The focus of the workshops will include determining how the expertise, facilities, and other resources of the Centers can contribute to ongoing or new projects; sharing of reagents and assays; and identifying opportunities for clinical research involving participating sites.

The workshop participants will include the PD/PI for each Center, key Center scientific staff, the NIAID Program Officer, and other NIAID scientific staff.  Up to ten additional Federal, and non-Federal experts, selected by the NIAID Program Officer, may participate in an advisory capacity, when appropriate.  The workshops shall be held annually beginning at the end of year one. Costs associated with hosting one workshop and travel costs for up to ten selected experts when hosting the workshop must be included in the second year budget. Annual travel costs for the PD/PI and key Center staff to attend these workshops must be included in the Administrative Core.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Multi-project Cooperative Agreement (U19) award mechanism(s). The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present FOA.

2. Funds Available

NIAID intends to commit $13.8 million in total costs for fiscal year 2010 to fund 7-12 new grants in response to this FOA.  An applicant may request a project period of up to 7 years. Applicants are encouraged to propose an annual budget that is reasonable and appropriate for the scope of the proposed research. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications.  Applicants may submit only one application.

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

Renewals.  Renewal applications are not permitted in response to this FOA

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Supplemental Instructions for the Preparation of Multi-Project Applications

The following section supplements the instructions found in the PHS Form 398 for preparing the multi-project grant application. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research grant (R01) applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme. 

The supplemental instructions below are divided as follows:

A. General Instructions – addresses collaborative efforts among research projects, the administrative and organizational structure as well as the overall facilities and environment, and the overall budget.

 
B. Specific Instructions for Individual Projects – describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

C. Specific Instructions for Core Units – Cores must provide services or resources to support at least two research projects. Instructions describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

A. General Instructions

All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.

1.  Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

2.  Form Page 2

Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program. Do not exceed the space provided.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

3.  Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g. Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4.  Composite Budget

Do not use Form Page 4 of the PHS 398. Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)

SAMPLE: Consolidated Direct Cost Budget for Five Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850



5.  Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.

6.  Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the Principal Investigator first, followed by those of other key personnel in alphabetical order.

7.  Other Support Format Page

Do not complete. (Any required information will be requested from successful applicants prior to grant award.)

8.  Resources Format Page

Do not complete. Essential information is to be presented in the individual research project and core sections of the application.

9.  Program Overview (Research Objectives and Strategic Plan)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 25 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.

10. Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application.

11. Resource Sharing Plan

One Resource Sharing Plan, placed at the end of the application, is to be submitted for the entire application.

B. Specific Instructions for Individual Research Projects

1.  Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page):

Project Number and Title: (e.g., 1. Preclinical Evaluation of HIV Microbicides)

Name of Project Leader: (e.g., Jones, Roberta A.)

Human Subjects: (Yes or No)
If Yes, exemption number:
(or)
IRB Approval Date: (e.g., 12/13/2006,or "Pending")
(and)
Federalwide Assurance  (FWA) number:

Vertebrate Animals: (Yes or No)
If Yes, IACUC Approval Date: (e.g., 11/17/2006, or Pending)
(and)
Animal welfare assurance number:

Proposed Period of Support:
From: (mmddyyyy - e.g., 07/01/2007)
To: (mmddyyyy - e.g., 06/30/2112)

Costs Requested for Initial Budget Period: (e.g. 07/01/2007-06/30/2008)
Direct Costs: (e.g., $ 150,000)
Total Costs: (e.g., $162,000)

Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2112)
Direct Costs: $700,000

Applicant Organization:
(full address)

2.  Form Page 2

Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute towards attainment of the multi-project program objectives.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

3.  Form Page 3

Prepare a Table of contents for the research project using Form Page 3 of the PHS 398.

4. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

5.  Research Plan (Items 2-5 cannot exceed 25 pages)

6.     Appendix. Do not create an appendix for an individual project.

7.    Resource Sharing Plan. Do not create a resource sharing plan for an individual project.

For all other items in the individual research project application, follow the usual PHS 398 instructions.

C.  Specific Instructions for Cores

All Cores

Cover Page. The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:

Core Letter and Core Title
(e.g., A. Monoclonal Antibody Production Core)

Name of Core Leader
(e.g., Smith, Robert A.)

Human Subjects (Yes or No)
If Yes, Exemption Number
(or)
IRB Approval Date (e.g., 5/14/2006, or Pending)
(and)
Federal Wide Assurance (FWA) number

Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/2007, or Pending)
(and) Animal welfare assurance number

Proposed Period of Support
From: (mmddyyyy, e.g., 07/01/2007)
To: (mmddyyyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period
(e.g., Direct Costs: $50,000)
(e.g., Total Costs: $70,000)

Costs Requested for the Entire Budget Period
(e.g., Direct Costs: $212,323)
(e.g., Total Costs: $297,252)

Applicant Organization
(full address)

Form Page 2. Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

Form Page 3. Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.

Biographical Sketches. Do not repeat the biographical sketches of participating investigators since this information will be located at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

Core Research Plan (Items 2-5 cannot exceed 25 pages)

Appendix. Do not create an appendix for a core.

Resource Sharing Plan. Do not create a resource sharing plan for a core.

For all other items in the individual core application, follow the usual PHS 398 instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: August 28, 2009
Application Receipt Date: September 29, 2009
Peer Review Date: January, 2010
Council Review Date: May, 2010
Earliest Anticipated Start Date:  September, 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Dr. Annie Walker-Abbey

Division of Extramural Activities
National Institute of Allergy and Infectious Diseases 
Room 3126, MSC-7616
6700 B Rockledge Drive

Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone: (301) 451-2671
FAX: (301) 480-2408
Email: aabbey@niaid.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Dr. Annie Walker-Abbey
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases 
Room 3126, MSC-7616
6700 B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone: (301) 451-2671
FAX: (301) 480-2408
Email: aabbey@niaid.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A.

In the first year of the award, requested budgets in the Administrative Core must include funds for travel by the PD/PI, Project Leaders and Core Leaders to participate in a reverse site visit start-up meeting in the U.S. at a location determined by NIAID staff.

Correspondence from Local Collaborators

A letter of collaboration or support from each of the endemic area sites’ participating investigators should be included in the Appendix of the submitted applications and co-signed by the institutional official responsible for binding the organization to such an agreement.

Overall Research Plan

In the description of the overview of the application (before describing the individual research projects), overall research goals and objectives, collaborative arrangements and capacity building sections should be included. 

Provide a separate detailed description of each of the proposed research projects, including:

1)    the background and significance of the research proposed;

2)    evidence of a significant burden of malaria at the sites where the studies will be conducted and how it relates to the proposed study;

3)    a description of the epidemiology of malaria at each of the sites to show that there is site to site variation in the epidemiology and transmission of disease;

4)    the research question(s) to be addressed;

5)    a description of the facilities available as needed for the proposed research project;

6)    the proposed research design and methodology;

7)    description of the technologies, approach, or techniques to be employed

8)    timelines for all study activities (including obtaining clearances from in-country human subject review boards, obtaining clearances from in-country use of research animal review boards, and analysis of final study data)

The following page limitations are recommended for individual research projects and cores:

Research Plan for Individual Projects with Clinical Studies

Projects that are clinical studies should present the concept of the proposed research to include the hypothesis, study objectives, potential clinical sites, target population(s), detailed study design and procedures, sample size justification and data analysis methods.  The application should provide sufficient detail to allow the reviewers to judge the scientific and technical merit. Samples may be derived from clinical studies or clinical trials that are planned, ongoing or completed and sponsored by any source of support. For studies that are not a part of this application provide a synopsis of the clinical study through which the samples were/will be obtained, a copy of the informed consent form and IRB approval, and a written agreement between the PD/PI of the clinical study and the applicant PD/PI outlining the access, ownership, analysis and release of data resulting from the proposed studies.  As noted previously, clinical trials will not be supported under this FOA.

MILESTONES FOR INDIVIDUAL RESEARCH PROJECTS AND SCIENTIFIC CORES

For each individual research project, applicants must provide well-described, quantifiable, and scientifically justified milestones for all study activities, including protocol development, development of Standard Operating Procedures, goals for collection and analysis of field samples, parasite isolates, obtaining clearances from in-country human subject review boards, obtaining clearances from in-country use of research animal review boards, study completion, and analysis of final study data.

Milestones should be presented via a Gantt chart or equivalent, with associated timelines and identified outcomes. Milestones must specify the outcome(s) for each activity.  It is recognized that milestones associated with more basic science-oriented projects may be difficult to quantify; however, in those cases, applicants should develop quantifiable outcomes. Milestones should be integrated with the overall goals of the proposed program. Applicants should include plans for periodically revisiting and revising milestones and timelines, if needed, as new information becomes available, challenges to the proposed development path are encountered, and research outside the Center goals modifies the science proposed.

Milestones and timelines should be placed at the end of the Research Plan section for each individual research project and fall within the 25 page limit.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH 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 five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria.  Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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? Is the proposed research relevant and important to the foreign [non-U.S.] countries or region?  Is the work likely to impact on the public health or policy of the foreign country?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, 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? Does the PD/PI have experience leading a multidisciplinary team and demonstrate the ability to establish and manage administrative functions at the endemic sites?  Is there substantial and appropriate integration of endemic country scientists into the research plan?

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 the 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? Are plans for collaboration adequate? Does the applicant (1) possess the capability to evaluate the changing landscape of malaria, (2) provide the flexibility necessary to respond to changes in the parasite population, mosquito vectors, epidemiologic shifts, and the availability of new or improved control interventions, (3) provide a process for assessing ongoing research projects and modifying, redirecting and/or curtailing ongoing research projects to reflect such changes/shifts?  Are the overarching Center milestones applicable to the overall program, feasible within the proposed time frames, and integrated with the milestones for individual research projects and cores?  Do they provide quantifiable measures for the achievement of intended outcomes for the program as a whole in a timely manner?

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?  Are the field sites and/or clinical facilities appropriate for the research? Is there a process to identify, evaluate the capabilities of, and add new field sites based on the emerging needs and/or changing epidemiological conditions within the geographic region?   

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score:

Review Criteria for Cores

Administrative Core

Data Management and Biostatistics Core

Shared Resource Cores (if applicable)

Review Criteria for Evaluating the Overall Application

The following items will be considered in the determination of the overall scientific and technical merit and impact/priority score for the entire application in addition to the standard review criteria:

Overall score:  a single numerical impact/priority score will be assigned to the whole application after consideration of all of the elements.  The overall score for the application will be based primarily on the scientific merit of the individual components, with additional consideration of the overall synergy and integration of all the components, the overall program organization, and the capabilities of the associated personnel. 

Additional Review Criteria.  As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that 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.

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.

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.

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.

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

Budget and Period Support.  Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agent Research.  Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The PD/PI will have the primary responsibility for:  defining the research objectives, approaches and details of the projects and cores within the guidelines of the FOA and retains primary responsibility for the performance of the scientific activity and understands the role of the Program Officer and NIH Project Scientist in the cooperative agreement mechanism. The PD/PI will be responsible for:

1.    Planning, direction, and execution of the proposed project;

2.    Organizing, attending and chairing the workshop and Steering committee activities;

3.    Assuring compliance of all projects within the application with applicable Federal, State, Local, regulations;

4.    Assuring compliance with all applicable DHHS/NIH/NIAID policies for conduct of research and clinical trials.

All awardees are required to perform, one-time during the lifetime of the award, the duties of organizer and host of an annual workshop meeting to be attended by all awardee PD/PIs, Project Leaders, key personnel, and NIAID staff. 

All awardees proposing clinical research must comply with Federal, State and Local regulations regarding clinical research and monitoring of clinical trials, and oversee that all training requirements for the protection of human subjects are in compliance.  When clinical studies or pre-phase I trials are a component of the research conducted, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study.  AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.  All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects and conduct of clinical research.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

The PD/PI will ensure that on-site administrative structure, scientific capacity and training are available to enable endemic sites to perform the research activities proposed in this grant.

The PD/PI will ensure that studies conducted under this cooperative agreement utilize/employ a multidisciplinary approach that integrates clinical and field aspects with laboratory, molecular and genomic methods.  The PDs/PIs will evaluate the changing landscape of malaria, provide the flexibility necessary to respond to changes in the parasite population, mosquito vectors, epidemiologic shifts, and the availability of new or improved control interventions. The PDs/PIs will provide a process for assessing ongoing research projects and modifying, redirecting and/or curtailing ongoing research projects to reflect such changes/shifts, and identify, and evaluate the capabilities new field sites based on the emerging needs and or changing epidemiological conditions within the geographic region.

Awardees will retain custody of and have primary rights to the software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH/NIAID Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

During performance of the award, the NIH Project Scientist will provide appropriate assistance, advice, and guidance by: participating in scheduled meetings and teleconferences that may include, but are not limited to, Steering Committee meetings and teleconferences to discuss program coordination and/or progress; participating in annual meetings and SAG deliberations; participating in the design of the activities; facilitating collaboration with other NIAID-supported research resources; and advising in project management and technical performance.  However, the role of the NIH Project Scientist will be to facilitate and not to direct the activities.  It is anticipated that the NIH Project Scientist will offer advisory input.  The NIH Project Scientist will facilitate liaison activities for partnerships, and provide assistance with access to NIAID-supported resources and services. Other appropriate NIH program staff assistance will be coordinated by the NIH Project Scientist, which may include Medical Officer(s), clinical operations and regulatory staff and other expertise as required.  The NIH Project Scientist, with support of the appropriate staff and expertise, will provide coordination and assistance to the awardee to meet the requirements for clinical protocol content and conduct. 

The Government, via the NIH Project Scientist, will have access to all data generated under this Cooperative Agreement and may periodically review the data and progress reports.  NIAID staff may conduct data analyses and use information obtained from the data for the preparation of internal reports on the activities of the study.  However, awardees will retain custody of and have primary rights to all data developed under these awards.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

The NIAID Parasitology and International Programs Branch will provide overall coordination of the ICEMR Program.  The NIAID Project Scientist will coordinate with the PDs/PIs and hold regular program-wide discussions to facilitate program goals. Some ICEMR may develop common research interests; research focus groups may be formed to pursue coordinated research activities. 

In addition, the PDs/PIs and the NIAID Project Scientist will participate in the collaborative work of the Centers and may hold special meetings to address, for example, common training needs, develop cross-Center initiatives, or host invited speakers.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dr. Malla Rao
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5095, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 451-3749
FAX: (301) 402-0659
Email: mrao@niaid.nih.gov

2. Peer Review Contacts:

Dr. Annie Walker-Abbey
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases 
Room 3126, MSC-7616
6700 B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone: (301) 451-2671
FAX: (301) 480-2408
Email: aabbey@niaid.nih.gov

3. Financial or Grants Management Contacts:

Ann Devine
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2114, MSC-7614
6700 B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5601
FAX: (301) 493-0597
Email: adevine@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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NIH Funding Opportunities and Notices


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