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://www3.niaid.nih.gov

Title:  Immune Mechanisms of Viral Control (R21)

Announcement Type
New

NOTICE: Applications submitted in response to this Request for Applications (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-AI-07-008

Catalog of Federal Domestic Assistance Number(s)
93.855,93.856

Key Dates
Release/Posted Date: December 12, 2006
Opening Date: January 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): February 28, 2007
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  March 29, 2007
Peer Review Date(s): June, 2007 
Council Review Date(s): August, 2007
Earliest Anticipated Start Date(s): September, 2007
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 30, 2007

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
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

Goal

This FOA will support the first phase of a two-stage program to expand understanding of the underlying mechanisms of immunity to viral infection and vaccination. The first phase to be awarded in fiscal year 2007 will use R21 exploratory/developmental grants to address key questions related to viral immunity. The second phase, planned for award in fiscal year 2009, will support a substantially larger effort involving collaborative teams funded through U01 and U19 single and multiple project cooperative agreement grants. While NIAID expects R21 awardees to generate preliminary data and establish collaborations that will facilitate highly competitive applications for the second phase of the program, funding under the first phase of the program will not be a prerequisite for applications under future research announcements.

All applications must propose studies of the immune system in the context of infection by at least one of the NIAID Category A, B, or C viruses (for list see http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm). Although the use of NIAID Category A, B or C viruses is required, additional viruses that may serve to elucidate immune mechanisms may also be included in the proposed studies. Research using human samples is encouraged, and animal models are permitted with adequate justification of their relevance to human diseases. However, studies on HIV/AIDS are excluded from this FOA. Clinical trials will not be supported in the R21 phase.

It is not the purpose of this program to apply conventional immunological concepts to the development of improved viral vaccines or therapies. For example, proposals to apply standard serological analyses of vaccination protocols in the absence of an in-depth analysis of immune mechanisms will be judged non-responsive.

Background

This program seeks to discover and define the immune mechanisms that underlie effective responses to viral infection and vaccination, and provide potential new targets for future vaccine and therapeutic drug development. Host defenses against viruses engage both innate and adaptive immune mechanisms, but the underlying processes and the interactions of these two parts of the immune response are incompletely understood. The innate immune system rapidly responds to viral pathogens through relatively invariant receptors, such as the Toll-Like Receptors (TLR) 3, 7, and 8. Cells of the innate immune system, such as dendritic cells (DC), macrophages, Natural Killer (NK) cells, NKT cells, and γδ T cells are activated upon TLR signaling and produce anti-viral molecules such as Type I interferons or cytokines. Additionally, the activation of a B cell subset results in the production of natural antibodies. The adaptive immune response begins as antigen-specific T and B cells become activated, expand in number, and acquire effector functions such as antibody production, cytokine production, and the ability to lyse virally-infected cells or otherwise limit intracellular reservoirs.

Many recent advances and techniques in the last decade have been adapted to studies of immunity to viruses and viral antigens. These include the use of single cell assays, peptide/MHC tetramer staining to track antigen-specific cells, and new imaging techniques that can detect T cell-DC interactions. Other technical advances to understand viral immunity have utilized flow cytometry to sort subsets of lymphocytes, biochemical analysis of innate immune signaling pathways, and adjuvant properties to induce protective immunity.

Genomics, proteomics, and systems biology approaches have led to the discovery of new molecules and novel functions of known proteins in the immune response. This initiative encourages the use of a wide variety of state of the art approaches to questions of immunity to viral infection.

Unique challenges and opportunities exist in the study of immunity during viral infection. Viral tropisms reflect differences in regional immunity and the differential expression of specific receptors used by viruses to initiate cell attachment and entry. In addition, viruses have evolved specific virulence mechanisms that enable them to evade or disable protective immune mechanisms at the level of innate and adaptive immunity. Examples of immune evasion include the down-regulation of MHC molecules on antigen presenting cells (APC) and the production of viral homologs that interfere with immune responses, for example, mimics of interleukin-10 and complement control proteins that are found in several distinct viruses. Additionally, viral replication and the sites of infection will impact the course of the immune response. Thus, research on the immune system using viruses can reveal aspects of immune function that will not be readily evident with model antigens systems.

Research Objectives and Scope

Immune recognition of infected cells, antiviral defenses, and mechanisms of viral clearance in different tissues are among the major research areas in need of further study; several specific areas of interest and examples are briefly described below. These and other research areas may be addressed in response to this FOA in the context of defining new immune mechanisms relevant to viral disease in humans.

Earliest immune events in viral infection. The initial response to a pathogen involves recognition by, and activation of the innate immune system, which begins within minutes of exposure. The mammalian innate immune system detects pathogens through distinct families of pattern-recognition receptors (PRRs), which recognize pathogen associated molecular patterns (PAMPs) of pathogens. Specific TLRs recognize single- or double-stranded RNA molecules characteristic of many viruses; recently, other PRR families were also shown to be involved, such as the RIG-Like Receptor (RLR) helicases. Innate responses are often critical in determining the ultimate outcome of infection or success of vaccination, and uncontrolled inflammatory responses can cause serious immune-mediated pathology. Many of the protective stimulatory/inflammatory signals generated through the TLRs and other PRRs are countered by negative regulators, such as the N1L protein of vaccinia acting as an antagonist of TLR signaling. The early innate immune responses against most viruses that are pathogenic to humans are incompletely defined in terms of the key cells involved, such as DC, macrophages, natural killer (NK) cells, NK T cells, γδ-T cells, neutrophils, and B-1 B cells. Many soluble effectors produced by cells of the innate immune system have anti-viral activity or activate pathways of innate and adaptive immunity, such as Type 1 IFNs, cytokines, or natural antibodies. Mechanisms by which most viruses activate or interfere with innate immune responses are not well understood, but early events may play a critical role in determining the outcome of certain viral infections. Examples of research in this area include, but are not limited to:

Innate/adaptive immune interface. The generation of protective immunity appears to be an outcome of a tightly regulated – but as yet poorly understood – transition from innate to adaptive immunity. Innate immune responses can significantly influence the course of infection, modifying the types and magnitude of antibody and T cell responses. As the immune response to viral infection or vaccination matures with time, the innate response leads to activation of the adaptive immune system, and expansion of viral antigen-specific T and B cells. This transition to adaptive immunity is a highly dynamic and complex process. In some cases, antibody and cytokine responses do not lead to a protective response or clearance of the virus, or there may be a failure to down-regulate acute inflammatory responses and transit to an adaptive response. Important areas for further research include studies on mechanisms that induce or repress inflammation, that bias immunity to the most effective type of T cell response or antibody isotype, or that promote optimal viral antigen uptake, processing, and presentation to T cells.  DCs play a key role in both the innate and adaptive responses, but can also initiate tolerogenic responses. A better understanding of DC subsets, costimulatory molecules and signaling pathways is needed to optimally define immune mechanisms of viral control. Examples of research in this area include, but are not limited to:

Mucosal immunity. Many viruses cause primarily respiratory, gastrointestinal, or urogenital infection, and variant strains may differ in their site of entry, tissue or cellular tropisms, and their capacity to injure particular tissues. Mucosal epithelial cells comprise the initial barrier to pathogen entry and mucosal tissues differ greatly in terms of their local environment and susceptibility to colonization and infection. Viral pathogens that enter or target the mucosa include those for poliomyelitis, influenza, rotavirus, and genital papilloma virus; however, there is little comprehensive information on the recognition of viruses and the development of protective immunity. Immunity at mucosal surfaces must serve several purposes, from maintaining sterility in the lungs and upper genital tracts, to achieving a dynamic coexistence with over 1014 bacteria in the intestines. Hyper-reactivity of the mucosal immune system to commensal organisms, foods, or pathogens can be lethal or highly debilitating and immune responses must be tightly controlled. The innate immune detection of viruses by PRRs in the mucosal system is not well understood, but will depend on the route of entry of the virus and the cells or tissues that are infected. Adaptive immunity in mucosal systems is similar to that seen other parts of the body, but there are populations of specialized cells that function in mucosal immunity. Specialized DC and M cells appear to play a key role in tolerance to commensal organisms, but their function in antiviral immunity is not clear. A discrete population of CD8 T cells, the intraepithelial lymphocytes, may interface directly with viruses in mucosal tissues. The role of B cells in mucosal immunity includes not only the production of IgM, IgG, but also of secretory IgA, which provides protective functions, such as virus neutralization and formation of antigen-antibody complexes to block entry of viruses across epithelial barriers. The mucosal tissues of the respiratory, gastrointestinal, and urogenital systems differ in many regards, such as architecture, APC types, the viruses and antigens likely to be encountered, and their capacity to release specific cytokines and chemokines. Furthermore, the presence of additional factors such as surfactants and mucosal enzymes, as well as pH and redox variation in mucosal sites, may influence the local immune response and the stability or degradation of soluble mediators, cytokines, adjuvants and other vaccine components. It will be important to understand the similarities and differences in initiating and regulating innate and adaptive immunity in response to viruses in the mucosal sites that serve as major entry points of infectious pathogens. Examples of research in this area include, but are not limited to:

Immune memory. Both natural infection and vaccination may result in long-term protection upon subsequent exposure to the same virus, or to closely related viruses, due to the generation and maintenance of long-term T and B cell immune memory. However, the many differences often observed between infection and vaccination in the antigen specificity, diversity, magnitude, and duration of memory T and B cells suggest that the impact upon the immune system of viral entry, replication and clearance imprints long-term memory cell responses. Both inflammation and exposure to adjuvants influence the development of memory T cells. Although viral infections generally stimulate strong innate immune responses that should lead to robust adaptive immunity,  some infections cause T cells to become unresponsive and unable to develop an effective memory repertoire. The roles that innate immunity and viral evasion factors play in the development of memory in subsets of B cells, and how B-1 B cells and marginal zone B cells can function in effective B cell memory, are examples of important questions that are addressed most directly in studies of viral infections. Examples of research in this area include, but are not limited to:

Immune status of individuals. Immune function and the ability to generate protective immune responses varies with age and underlying health status. Elderly people have a limited repertoire of memory T cells that appear to be functionally compromised as compared to those of young adults. In adults, thymic output of naïve T cells and bone marrow production of new B cells declines with age resulting in limited repertoires of memory cells to pathogens, such as viruses. Very young children have a naïve repertoire of T cells and subsequently do not have good memory responses. Many chronic diseases involve immune dysfunction or require treatments that cause immunodepletion or immunosuppression -- such as transplantation, cancer or certain autoimmune diseases -- and are characterized by heightened susceptibility to infection, or altered requirements for successful vaccination. In other instances, there are major differences in the evolution of infectious diseases and the outcome of therapy in different populations, e.g. African Americans, non-white Hispanic Americans and Native Americans as compared to Caucasians. Detailed research is needed on the specific immune mechanisms that define these differences so that the defects in viral immunity can be understood, and the potential to develop more effective treatments and vaccination strategies might be realized for all populations. Examples of research in this area include, but are not limited to:

Clinical studiesClinical trials will not be supported by this FOA. However, clinical studies to evaluate innate and adaptive immunity in vivo or in vitro may be included. Applicants should describe how such studies will help to identify and characterize the underlying immune mechanisms and may employ licensed or experimental vaccines or other types of compounds administered to human subjects. Protocol synopses for clinical studies must be provided in the application, to include: (1) a rationale for the study; (2) a summary of the research that supports the protocol; (3) statistical calculations and considerations in determining sample size; (4) criteria for including or excluding human subjects; and (5) discussion of risks and benefits. Methods to address all regulatory requirements and the protection of human subjects must be described in the application.

Because the R21 grant mechanism is for a 2 year period, applicants proposing clinical studies must:

Areas Excluded from the FOA

Projects that simply apply conventional immunological tools to the study of viruses or projects that focus on non-immune mechanisms of viral pathogenesis as opposed to the elaboration of immunological mechanisms are EXCLUDED under this FOA.

Proposed work should NOT be primarily focused on the development of new technologies, reagents, or animal models. Such activities may be included as necessary parts of the project if well justified by the research aims and methods.

Projects using non-mammalian animal systems are not responsive to this FOA.

All applications MUST propose studies of the immune system in the context of infection by at least one NIAID Category A, B, or C virus (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm). Although the use of NIAID Category A, B or C viruses is required, additional viruses that may serve to elucidate immune mechanisms may also be included in the proposed studies.  However, studies on HIV/AIDS are EXCLUDED.

Clinical trials will not be supported by this FOA.

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 Announcement (FOA) will use the Exploratory/Development (R21) award mechanism.  The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. U.S. institutions must use the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are a U.S. institution submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

At this time, it is not known if this FOA will be reissued.

2. Funds Available

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project. Direct costs are limited to $275,000 over a two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.

NIAID intends to commit approximately $4 million dollars in FY 2007 to fund 15-20 applications.

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.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

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

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist 
PHS398 Modular Budget (U.S. institutions)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (section 14 of the PHS398 Research Plan component), must be included. The governance and organizational structure of the research project should be described, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs, including responsibilities for human subjects or animal studies as appropriate.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

 When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are note required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: January 28, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): February 28, 2007
Application Submission/Receipt Date(s):  March 29, 2007
Peer Review Date(s): June, 2007 
Council Review Date(s): August, 2007
Earliest Anticipated Start Date(s): September, 2007

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:

Quirijn Vos, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3118, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)

Telephone: (301) 451-2666
Fax: (301) 480-2408
Email: qvos@niaid.nih.gov   

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

In order to expedite the review, applicants are requested to notify the NIAID Referral Office by email (aczarra@niaid.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

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.

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.

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: are necessary to conduct the project, and 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 the NIH Grants Policy Statement.

6. Other Submission Requirements


PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following requirements for R21 applications:

Clinical Studies:

Clinical trials will not be supported by this FOA. However, clinical studies to evaluate innate and adaptive immunity in vivo or in vitro may be included. Applicants should describe how such studies will help to identify and characterize the underlying immune mechanisms and may employ licensed or experimental vaccines or other types of compounds administered to human subjects. Protocol synopses for clinical studies must be provided in the application, to include: (1) a rationale for the study; (2) a summary of the research that supports the protocol; (3) statistical calculations and considerations in determining sample size; (4) criteria for including or excluding human subjects; and (5) discussion of risks and benefits. Methods to address all regulatory requirements and the protection of human subjects must be described in the application.

Because the R21 grant mechanism is for a 2 year period, applicants proposing clinical studies must:

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Grantees shall make data generated through the R21 available through relevant public databases, such as the NIAID-supported Immune Epitope Database (IEDB at http://www.immuneepitope.org/home.do), the Mouse Genome Informatics (MGI at http://www.informatics.jax.org), or the Immunology Database and Analysis Portal (MMPORT at https://www.immport.org/immportWeb/home/home.do).

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Mutant mice and reagents generated through the R21 shall be made available to the wider research community through existing resource centers, such as the NIAID Taconic Exchange program (http://www.taconic.com/wmspage.cfm?parm1=16), the National Center for Research Resources (NCRR Mutant Mouse Regional Resource Centers (www.mmrrc.org), or the NIAID Biodefense and Emerging Infections Research Resources Repository (www.beiresources.org).  

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 in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs?  Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?  

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed.  See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated.  See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate. 

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Model Organism Sharing Plan:  Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations

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/her Summary Statement (written critique) via the NIH 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.

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 Section IV.5., “Funding Restrictions.”       

2. Administrative and National Policy Requirements

Clinical trials will not be supported by this FOA. However, clinical studies to evaluate innate and adaptive immunity in vivo or in vitro may be included. Applicants should describe how such studies will help to identify and characterize the underlying immune mechanisms and may employ licensed or experimental vaccines or other types of compounds administered to human subjects. Protocol synopses for clinical studies must be provided in the application, to include: (1) a rationale for the study; (2) a summary of the research that supports the protocol; (3) statistical calculations and considerations in determining sample size; (4) criteria for including or excluding human subjects; and (5) discussion of risks and benefits. Methods to address all regulatory requirements and the protection of human subjects must be described in the application.

Because the R21 grant mechanism is for a 2 year period, applicants proposing clinical studies must:

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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:

Lynda Chiodetti, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases 
Room 3009, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 451-3119
Fax: (301) 480-2391
Email: lchiodetti@niaid.nih.gov  

2. Peer Review Contacts:

Quirijn Vos, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3118, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)

Telephone: (301) 451-2666
Fax: (301) 480-2408
Email: qvos@niaid.nih.gov    

3. Financial or Grants Management Contacts:

Victoria Connors
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2122, MSC-7614
6700B Rockledge Drive 
Bethesda, MD 20892-7614

Telephone: (301) 402-5065
Fax: (301) 493-0597
Email: vp14v@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 (45 CFR 46) 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.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and 93.856, Microbiology and Infectious Diseases Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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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