Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Allergy and Infectious Diseases (NIAID)
Funding Opportunity Title	International Centers of Excellence for Malaria Research (ICEMR) Competitive Revision (U19)
Activity Code	U19 Research Program Cooperative Agreements
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-AI-11-046
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.855; 93.856
FOA Purpose	This FOA solicits competitive revision applications for active International Centers of Excellence for Malaria Research (ICEMR) awards. The goal is to foster collaborations between immunologists and ICEMR investigators and utilize the established cohorts to: define the cellular and molecular events involved in the generation of protective immunity; identify possible mechanisms to induce long-term immunity; elucidate mechanisms of immune pathogenesis and protection, and mechanisms of immune-mediated interruption of transmission; and/or determine correlates of protective immunity to malaria. Applicants will propose a new immunology project to increase the research activities of a current ICEMR award (http://www.niaid.nih.gov/LabsAndResources/resources/icemr/Pages/programOverview.aspx).

Posted Date	August 10, 2011
Letter of Intent Due Date	December 12, 2011
Application Due Date(s)	January 12, 2012
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	April, 2012
Advisory Council Review	May, 2012
Earliest Start Date(s)	July, 2012
Expiration Date	January 13, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose

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 (http://www.niaid.nih.gov/LabsAndResources/resources/icemr/Pages/default.aspx). Ultimately, such a broad-based, multidisciplinary approach is expected to integrate clinical and field research with laboratory, molecular and genomic methods to enhance the basic research underpinnings for effective malaria elimination and 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.

Competitive revisions support new or additional activities not identified in the current award and reflect an expansion of the scope of the parent grant-approved activities. By fostering collaborations between immunologists and ICEMR investigators, the goal is to expand understanding of critical aspects of human immunology pertinent to malaria using state-of-the-art immunological methods to determine mechanisms of immunity including those that impact on malaria transmission, and identify correlates of protection to natural malaria infection and disease in endemic areas. Competitive revision applications from ICEMR grantees are expected to expand the proposed ICEMR research in the identification and characterization of the cellular and molecular events involved in the generation of protective immunity, determination of the requirements for induction of long-term protective immunity, elucidation of mechanisms of immune pathogenesis and immunologic factors that contribute to reduced malaria transmission, and/or identification of correlates of protective immunity to malaria. Development of new collaborations between ICEMR investigators and immunologists not currently funded through the ICEMR program is strongly encouraged.

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 are not sustainable in many locations and are associated with the emergence and spread of both parasite drug resistance and vector insecticide resistance. No licensed malaria vaccine exists, and while 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. Our current understanding of the human immune responses to Plasmodium parasites in particular is incomplete. This lack of fundamental knowledge regarding protective immunity to malaria hampers the identification of correlates of immune-mediated protection, which are critical for rational design, development, and evaluation of vaccines.

The ICEMR program is designed to fill critical knowledge gaps in the generation and maintenance of human protective immunity to Plasmodium infection, and identify mechanisms and correlates of immune protection relevant to control of clinical disease and interruption of malaria transmission. This timely initiative focuses on recent scientific and technological advances in immunology (e.g., microarray analysis of human immune responses, multi-color flow cytometry, cytokine profiling) in the leading global health priority of malaria research which is expanding in geographically diverse areas, thereby facilitating access to appropriate, well-characterized clinical samples. Anticipated results will accelerate development of a pipeline of promising vaccine candidates. Furthermore, the identification of immunologic mechanisms and correlates of immune-mediated protection will enhance our ability to understand and assess malaria as an important comorbidity in at-risk special populations residing in malaria-endemic areas, and contribute to improved clinical management and evaluation of malaria interventions in such populations. Increased knowledge of the underlying mechanisms that govern the development and maintenance of protective immunity will provide much needed information that can be applied to the development of improved vaccines for use in naive populations and the most susceptible and at-risk groups.

Research Objectives and Scope

Competitive revisions to the ICEMR program are intended to provide additional support for a new Research Project that addresses the understudied area of the human immune response. The overall objective is to foster collaborations between immunologists and ICEMR investigators to enhance the understanding of the generation and maintenance of protective immunity against naturally acquired malaria and immune factors affecting infection, disease development and transmission, which are critical for the development of effective interventions.

The program will provide immunologists with access to clinical samples and expertise in malaria, and provide malariologists the opportunity to work with immunologists using sophisticated immunological techniques to study human immune responses. Correlates of immune protection can be linked to clinical outcomes such as: frequency of clinical malaria episodes; cumulative changes in hemoglobin levels over time attributable to malaria infection; strain-specific immunity and intervals between strain-specific infections and/or changes in transmission dynamics; and activation of specific immune cell subsets after malaria infection.

New research projects supported by this initiative will focus on identification of immune-mediated mechanisms of protection against infection and disease, and of interruption of transmission, and correlates of immune-mediated protection in people from malaria-endemic regions with natural infections.

Use of innovative state-of-the-art techniques and cutting edge immunological methods, and collaborations with investigators having demonstrated expertise in these approaches, are highly encouraged.

Areas of research interest include, but are not limited to:

• Elucidation of innate immune responses and mechanisms that correlate with protection from clinical malaria infection or disease.
• Identification of the types of antigen-presenting cells and examination of their functional capacity for activation of T and B cells against Plasmodium.
• Characterization of B cell effector responses that correlate with immune protection and elucidation of the mechanisms required for the generation of long-term protective humoral immunity.
• Characterization of T cell effector responses that correlate with protective immunity and elucidation of the mechanisms required for the generation of long-term protective cell-mediated immunity.
• Characterization of the role of immunological factors in severe malaria.
• Characterization of the proinflammatory and anti-inflammatory immune effector responses in regions of differing endemicity.
• Characterization of the role of immunological factors in transmission dynamics, including those affecting gametocytogenesis.
• Characterization of the immunological factors contributing to malaria relapse resulting from reactivation of dormant liver stages (hypnozoites).
• Determination of the immunological impact of intervention/control programs.

The following research will NOT be supported by this FOA:

• Studies of the immunology of malaria in pregnancy
• Studies involving animal models
• Supplements to existing individual ICEMR Research Projects
• Addition of new cores to the existing ICEMR awards

Note: The competitive revisions submitted in response to this FOA will need to make use of the existing cohorts funded by the ICEMR grants, with modifications of the protocols as needed. Cohorts funded under other auspices may be used to supplement the ICEMR cohorts if needed for the proposed study design; the PD/PI, however, will need to demonstrate how use of a secondary ongoing study strengthens the ICEMR site and how the proposed state-of-the-art technology will over time be transferred to the ICEMR site. It is understood that the PD/PI for this competitive revision is the same as the parent grant.

Note: Funding may be used to supplement the existing ICEMR cores in order to support the studies proposed in the competitive revision application.

Note: The immunology Project Lead is expected to attend the ICEMR Annual Workshops with the Leads on the existing ICEMR projects.

Funding Instrument	Cooperative Agreement
Application Types Allowed	Revision The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIAID intends to commit a total of $2 million in FY 2012 to fund approximately 6 - 10 awards in response to this FOA.
Award Budget	The Total (direct plus indirect) Cost requested for an ICEMR competitive revision may not exceed $250,000 per year.
Award Project Period	Applicants may request support for multiple years not to exceed the remaining number of years on the parent ICEMR grant.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Eligible institutions are current NIAID awardees of the ICEMR program.

Eligible foreign institutions are current NIAID awardees of the ICEMR program.

Applicant organizations must complete the following registrations as described in the PHS398 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

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 completed by 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.

Eligible PD/PI(s) are current NIAID awardees of the ICEMR program.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit up to three separate competitive revision applications to this FOA for each ICEMR award, provided that each application is scientifically distinct.

NIH 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. NIH will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, 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.

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Annie Walker-Abbey
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3126, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express Delivery zip: 20817)
Telephone: (301) 451-2671
FAX: (301) 480-2408
Email: aabbey@niaid.nih.gov

Applications must be prepared using the PHS 398 research grant application forms and 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)

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

Dr. Annie Walker-Abbey
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3126, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express Delivery zip: 20817)
Telephone: (301) 451-2671
FAX: (301) 480-2408
Email: aabbey@niaid.nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Supplemental Instruction for the Preparation of Competitive Revisions to Multi-Project Applications

Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for Competitive Revisions to multi-project applications consisting of research projects interrelated by a common theme.

A. Specific Instructions for the Overall Application

1. Form Page 1 - Face Page
Applicants must list the parent grant title and parent grant number followed by the term Competitive Revision as the title of the overall application.

2. Form Pages 2. 3. 4, and 5

Not applicable

3. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all currently funded projects and the proposed new project should be placed at the end of the application with the PD/PI first, followed by those of other key personnel in alphabetical order.

4. Checklist

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

B. Specific Instructions for an Individual Research Project

For an individual Research Project include:

1. Cover Page

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

Applicant Organization (full address)
Example: Cover Page Format (for each Project)
Project Number and Title:
Name of Project Leader: (e.g., Jones, Roberta A.)
Human Subjects: (Yes or No)

If Yes:

Exemption number, -or-
IRB Approval Date (e.g., 12/13/2011, or "Pending"), and Federal wide Assurance (FWA) number
Vertebrate Animals: (Yes or No)

If Yes:

IACUC Approval Date (e.g., 11/17/2011, or Pending) and Animal welfare assurance number:
Proposed Period of Support:
From: (mmddyy - e.g., 07/01/2012)
To: (mmddyy - e.g., 06/30/2119)
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: (e.g., $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 PHS Form 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 Project Leader, followed by other key project 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. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398. Budget format should be same as that used in parent grant. Budget may not exceed time period of parent grant; any no cost extension should be in place before submission.

5. Research Plan

For Revision applications, include a 1-page Introduction.

Specific Aims (Limited to 1 page.)

List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the project's relationship to the multi-project program goals and how it relates to other projects.

Research Strategy (Limited to 12 pages for Research Project)

Use this section to describe how the proposed research activity will contribute to meeting the program's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary goal of the ICEMR, and how studies of the underlying mechanisms of the development and maintenance of protective immunity enhances the ICEMR sites capacity for contributing to strategies supporting interventions. Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information. Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy. Preliminary Studies for new projects must be included as part of the approach section.

6. Resources

Provide information on resources available for the project. Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport.) If there are multiple performance sites, describe the resources available at each site. Describe any special facilities used for working with biohazards or other potentially dangerous substances.

7. 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).

8. Select Agent Research (if applicable)

As directed in the PHS 398 Instructions, provide a description of all facilities where the Select Agent(s) will be used in the project. Describe the procedures that will be used to monitor possession, use and transfer of the Select Agent(s). Describe plans for appropriate biosafety, biocontainment, and security of the Select Agent(s). Describe the biocontainment resources available at all performance sites.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the PHS398 Application Guide, with the following modifications:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

Eligible foreign institutions are current NIAID awardees of the ICEMR program.

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NIAID, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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).

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? Will the project enhance the research capacity for cutting edge immunologic studies at the endemic sites?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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 proposed project bring in new immunological collaborators with strong human immunology expertise?

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? Does the proposed project make use of innovative state-of-the-art techniques and cutting edge immunological methods?

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?

Does the Project propose synergistic interactions with the Parent grant? Has the PD/PI clearly demonstrated that any non-ICEMR cohort strengthens the application?

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?

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

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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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 Human Subjects Protection and Inclusion Guidelines.

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.

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

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).

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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIAID , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority score.
• Will receive a written critique.

Applications will be assigned to the NIAID and 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 by the National Advisory Allergy and Infectious Diseases Council. 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.

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. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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.

The PD(s)/PI(s) 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:

• Planning, direction, and execution of the proposed project;
• Organizing, attending and chairing the workshop and Steering committee activities;
• Assuring compliance of all projects within the application with applicable Federal, State, and Local regulations;
• 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.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

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 Scientific Advisory Group (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.

Areas of Joint Responsibility include:

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.

Dispute Resolution:

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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, 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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Dr. Tonu Wali
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3205, MSC-6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
Telephone: (301) 402-9896
FAX: (301) 402-0659
Email: twali@niaid.nih.gov

Dr. Annie Walker-Abbey
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3126, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (Express Delivery zip: 20817)
Telephone: (301) 451-2671
FAX: (301) 480-2408
Email: aabbey@niaid.nih.gov

Victoria P. Connors
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2122, MSC-7614
6700 B Rockledge Drive
Bethesda, MD 20892-7614 (Express Delivery zip: 20817)
Phone: (301) 402-5065
FAX: (301) 493-0597
Email: vp14v@nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 Part 52 and 45 CFR Parts 74 and 92.