Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Environmental Protection Agency (EPA) (http://www.epa.gov/)
Food Allergy Project (FAP) (http://www.foodallergyproject.org/)
Food Allergy and Anaphylaxis Network (FAAN) (http://www.foodallergy.org/ )

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
National Center for Environmental Research (NCER) (http://es.epa.gov/ncer/)

Title:  Exploratory Investigations in Food Allergy (R21)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (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-07-032

Catalog of Federal Domestic Assistance Number(s)
93.855, 66.509

Key Dates
Release/Posted Date:  August 23, 2007
Opening Date:  November 9, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):November 9, 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):  December 10, 2007
Peer Review Date(s): March 2008  
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): August, 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 11, 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
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The purpose of this FOA is to support high impact, innovative exploratory/developmental investigations to determine the mechanisms of and risk factors associated with IgE-mediated food allergy and related co-morbid conditions, focusing on ex vivo studies with human specimens and on studies with current or new animal models of food allergy. Areas for research focus may include: pathogenesis, biomarkers and genetic components of food allergy and severe food allergy; food allergens and their epitopes including molecular characteristics, relative potency, and matrix effects; and pathogenesis, biomarkers, genetics, mechanistic studies, and risk assessment in animal models. Investigators who have no prior history of receiving independent NIH funding in food allergy research, or have no history of receiving such funding after January, 2003, are encouraged to apply to this FOA.

This initiative is supported by the co-sponsoring U.S. Federal agencies, the NIH and EPA, as well as by the Food Allergy Project and the Food Allergy and Anaphylaxis Network . All applications must be submitted using the electronic SF424 (R&R) format for the R21 grant mechanism and in accordance with the SF424 (R&R) Application Guide. Applications will be assigned by the NIH Center for Scientific Review to a NIAID Special Emphasis Panel for peer review following NIH guidelines. Post-review, NIAID and EPA Program Officials will determine assignment of meritorious applications to either NIH or EPA for funding considerations. Applications under consideration for EPA funding will undergo an EPA Programmatic Review (for details see section V.2.B) and the EPA may request additional information not required at the time of application submission (for details see section VI.2).

Background

Food allergy is emerging as a major public health problem that affects 3-4% of adults and 6-8% of children in the United States, and appears to be increasing in prevalence.  For example, the prevalence of peanut allergy increased from 0.4% in 1997 to 0.8% in 2002. Food allergy is also associated with severe reactions, and is the most common cause of emergency room visits for anaphylaxis. Even though food allergic subjects attempt to avoid known allergens, reactions from accidental exposure are relatively common and in a two-year period, approximately 50% of food allergic subjects will have an accidental exposure that leads to an allergic reaction. Allergies to peanuts and tree nuts, the most common causes of life-threatening allergic reactions, persist throughout life in the majority of subjects. Despite the risk of allergic reactions and even severe reactions, there is no current treatment other than allergen avoidance and symptomatic treatment of severe reactions.

In March 2006, at the request of Congress, the NIAID convened an ad hoc panel of nationally recognized experts in allergy and immunology to review current basic and clinical research efforts related to food allergies. The panel made recommendations to the Secretary of the Department of Health and Human Services for enhancing and coordinating food allergy research activities. The recommendations of the 2006 NIH Expert Panel on Food Allergy Research can be found at: (http://www3.niaid.nih.gov/healthscience/healthtopics/foodAllergy/ReportFoodAllergy.htm).

Research objectives identified in this FOA that are responsive to several of these Expert Panel recommendations are briefly described below:

1) Pathogenesis of food allergy: Current research suggests that food allergy is mediated by antigen-presenting cells that process food allergen peptides into complexes associated with MHC class II molecules. The complexes are then presented to allergen-specific receptors on T cells, which promote the production of IgE antibodies by allergen-specific B cells. There is very little information available concerning methods to predict which food proteins are likely to be allergenic. While the molecular and cellular mechanisms that regulate these immune responses may be similar to responses to other allergens, these mechanisms have not been fully explored in the context of food allergy. Regulation of IgE responses to food may have unique control mechanisms. The normal response to foods is oral tolerance, and the tolerant state is maintained by a complex relationship between gut microbial flora and the immune cells of the gut, including inhibitory signals provided by the innate immune system. It is possible that sensitization occurs in the gastrointestinal tract in food-allergic patients. However, the mechanisms by which oral tolerance is bypassed are unknown. Intriguing findings from human studies suggest other sites of sensitization, such as the skin. These findings have demonstrated that cutaneous exposure to topical preparations containing peanut oil increases the likelihood of developing peanut allergy, and that mutations of genes associated with skin barrier function may be associated with increased risk for allergy, including food allergy.

2) Pathogenesis of severe food allergy and food-induced anaphylaxis: Severe food allergy may be mediated by the same pathways as milder forms of food allergy. Anaphylaxis as a result of food allergy is most likely dependent on several factors: the concentration of IgE antibody bound to receptors on mast cells, the concentrations of allergens bound to IgE antibodies that are bound to receptors on mast cells, the levels of mediators released by mast cells in response to IgE cross-linking, and the sensitivity of end organs to the released mediators. Thus, quantitative assays of IgE antibodies to food allergens are predictors of the likelihood of an allergic reaction upon exposure to that food. However, IgE antibody levels do not predict reaction severity. Abnormalities of any component of these events may increase the risk of anaphylaxis. Recent data suggest that individuals with a deficiency of the enzyme platelet activating factor (PAF) acetylhydrolase have a higher risk of anaphylaxis to peanuts. This suggests that PAF-mediated pathways, which represent events that follow IgE-mediated mast cell activation, may also be critical in human anaphylaxis. Further studies will be needed to determine the reproducibility of this finding and to discover whether pathway defects leading to high concentrations of PAF and other mediators also increase the risk of anaphylaxis.

3) Epidemiology of food allergy and severe food allergy: Food allergy is strongly associated with both atopic dermatitis and asthma. The mechanisms underlying these associations are not fully understood, although altered skin barrier function has been postulated to increase the likelihood of cutaneous sensitization, a possible route of sensitization to food allergens. Among inner city children with asthma, those who have IgE antibodies to foods have more severe asthma than those who lack these antibodies, an observation suggesting that there are associations, currently unexplained, between the pathogenesis of food allergy and asthma.

In addition to atopic dermatitis and asthma, eosinophilic gastroenteritis is another co-morbid condition linked to food allergy. In this disease, a high proportion of patients have IgE antibodies to foods, but the precise relationship of food allergy to this disease is uncertain. Few studies have addressed predictive factors for severe reactions to foods, but some data suggest that further investigation may be able to increase the number of useful biomarkers. Thus, individuals who require only a low dose of food allergen to trigger an allergic response (that is, have a low threshold) have a higher risk of severe reactions. IgE antibody levels do not predict reaction severity, but the breadth of epitope recognition by IgE antibodies may predict severity. In addition, as discussed above, levels of PAF acetylhydrolase may be a marker of severe reactions. Biomarkers that distinguish subpopulations of food-allergic individuals, including those with or without co-morbid diseases, and biomarkers that predict severity of reactions, would greatly facilitate advances in food allergy research.

4) Genetics:  Advances in genetics and genomics, including the completion of the Human Genome Project (http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml) and the HapMap project (http://www.hapmap.org/), are creating opportunities to define the genetics of human food allergy. Several recent studies have identified possible links between genetic variability and allergic disorders. Examples include a deficiency of filaggrin, a skin and mucosal barrier protein associated with both atopic dermatitis and asthma, and a deficiency in a serine protease inhibitor, SPINK5, which in some patient populations is associated with atopic dermatitis and food allergy.

5) Food Allergens and Epitopes: The majority of well-characterized inhalant and food allergens are water-soluble proteins. Recent studies indicate that lipids and lipid-carbohydrate complexes (e.g., glycolipids extracted from cypress pollens) can trigger immune and allergic responses. Other studies suggest that lipids and glycolipids activate the immune system via interacting with CD1d molecules on antigen-presenting cells and stimulating production of NKT cells. Neither lipid food allergens, nor activated NKT cells in food allergy, have as yet been identified. Recent studies using advanced technologies, including X-ray crystallography and nuclear magnetic resonance, have provided insights into the structure of proteins and should provide new information on the structure of food allergen epitopes. IgE antibodies are produced to both linear and conformational epitopes of food allergens, and production of antibodies to linear epitopes is associated with persistence of disease. Analysis of epitope structure and epitope selection by the immune system may eventually allow useful predictions about the future course of food allergy.

6) Animal Models and Pre-Clinical Studies in Animal Models: Rodent models of food allergy do not mimic all the features of human food allergy, but some newer rodent models display important characteristics of the human disease. These models are useful for studying the role of interactions between genes and the environment (including microbial flora) in food allergy pathogenesis and the mechanisms that mediate induction of oral tolerance versus IgE-mediated immune responses. These newer models are also useful for preclinical evaluation of new approaches to prevent and treat food allergy. Such preclinical evaluations have demonstrated the therapeutic potential of some agents, such as allergens genetically modified to reduce IgE binding epitopes, allergens coupled to ligands recognized by Toll-like receptor (TLR) proteins and other components of the innate immune system, probiotics, and agents administered by sublingual and other routes of administration that reduce the risk of severe allergic reactions.

7) Support of Investigators in Food Allergy: The NIH Expert Panel on Food Allergy Research recognized the need to recruit more investigators to the field of food allergy research.

EPA’s mission is to minimize risks to human and ecological health. Under the authorization of the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA), the EPA Science to Achieve Results (STAR) Program is participating with NIAID in this FOA to support research that will improve safety assessment for potential dietary allergens including pesticidal proteins introduced into food through genetic engineering.

To date, no adverse health effects attributed to genetically engineered foods have been documented in the human population. However, the majority of soybeans, as well as large proportions of corn, canola, and cotton crops produced worldwide are genetically engineered with novel proteins for pest resistance. The National Research Council (NRC) (NRC, 2004; Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects) has recommended improving the safety assessment of all foods for unintended health effects, including the assessment of genetically engineered crops intended for human consumption. The EPA Office of Research and Development (ORD), Biotechnology Research Program, established in 2005, focuses on five key issues of greatest importance, one of which is the potential allergenicity of novel pesticidal proteins introduced into the food supply by genetic engineering.

EPA research interests in food allergy include: developing and applying methods, identifying biomarkers, and evaluating protein characteristics associated with food allergy. EPA is also interested in the relative allergenic or sensitization potencies of proteins and mechanisms that lead to the sensitization and induction of food allergy. Such methods are outlined in a conceptual and practical framework for risk assessments using a decision-tree analysis that was first proposed in 1996 (Metcalfe et al., 1996) and revised by the World Health Organization (WHO) and Food and Agriculture Organization of the United Nations (FAO) (FAO/WHO, 2001). The results of the research will be used to improve the prediction of dietary allergens and evaluate the potential allergenicity of novel proteins introduced into the food supply.

The specific Strategic Goal and Objective from EPA’s Strategic Plan (http://www.epa.gov/ocfo/plan/2006/entire_report.pdf) that relate to this solicitation include:  Goal 4: Healthy Communities and Ecosystems, Objective 4.4: Enhance Science and Research. Expected outputs include reports, presentations, and articles in peer-reviewed journals summarizing data and analyses that will help determine the mechanisms of and risk factors associated with IgE-mediated food allergy and related co-morbid conditions. Additional outputs include improved methods to assess potential allergenicity of novel, pesticidal proteins in food.  The desired outcomes of the proposed awards are research results that will improve human health safety assessment of novel, pesticidal proteins incorporated into food as well as an improved understanding of the mechanisms underlying the induction of food allergy.

Research Objectives and Scope 

The overall objective of this FOA is to support innovative exploratory/developmental studies of the underlying mechanisms and risk factors associated with IgE-mediated food allergy. Preliminary data are not required, but expertise in, and a plan for applying immunologic, genetic, biochemical and molecular biological principles to food allergy research should be evident. Research areas supported by this FOA include, but are not limited to, the following:

Research of interest primarily to NIAID:

Research of interest to both NIAID and EPA:

Research of interest primarily to EPA:

Research areas NOT supported by this FOA include:

Non-responsive applications will not be reviewed.

Clinical trials will also NOT be supported by this FOA. However, studies using human samples may be included if they are within the research objectives and scope of the FOA, and if they do not involve clinical intervention and/or are performed with samples obtained from ongoing clinical trials supported outside of this FOA. Plans to address all regulatory agency requirements and the protection of human subjects must be described in the application. For any questions concerning clinical studies under this FOA, applicants are encouraged to contact the Program Officer (Section VII.1).

Applications submitted in response to this FOA should be exploratory and novel.  These studies should break new ground or extend previous discoveries toward new directions or applications. Applications must describe projects distinct from those supported through the Research Project Grant (R01) mechanism, such as long-term projects and projects designed to increase knowledge in a well-established area. Information on the R01 program can be found at http://grants.nih.gov/grants/funding/r01.htm. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields will NOT be considered for support and are better suited for the R03 small grant mechanism. Information on the R03 program can be found at http://grants.nih.gov/grants/funding/r03.htm. 

Investigators who have no prior history of receiving independent NIH funding in food allergy research, or have no history of receiving such funding after January, 2003, are encouraged to apply. Support for training, fellowship, and mentored career development awards are not considered independent research support. This FOA encourages not only junior investigators in the early phase of their independent research career, but also established investigators from related fields who wish to apply their skills to the field of food allergy research.

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. It also uses the modular as well as non-modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are 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).

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

The R21 is not renewable and competing renewal (formerly “competing continuation”) and resubmission applications will not be accepted.

EPA will make grant awards through the STAR Program.

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.

It is anticipated that $2.5 million per year will be available from NIAID, the Food Allergy Project and the Food Allergy and Anaphylaxis Network for this FOA and that 8-10 new awards will be made. It is anticipated that $1 million per year will be available for this FOA from the EPA STAR program, and that an additional 4 new awards will be made by the EPA.

The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this FOA. The EPA reserves the right to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made.  Any additional selections for awards will be made no later than four months after the original selection decisions.

Under a grant, EPA scientists and engineers are not permitted to be substantially involved in the execution of the research. However, EPA encourages interaction between its own laboratory scientists and grant Principal Investigators after the award of an EPA grant for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities.  This interaction must be incidental to achieving the goals of the research under a grant.  Interaction that is “incidental” does not involve resource commitments.

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:

Institutions eligible to receive funding through the EPA include:

Eligible nonprofit organizations include any organizations that meet the definition of nonprofit in OMB Circular A-122.  However, nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.

The following are NOT eligible to receive assistance agreements from the EPA:

The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere.(See Section VI.1 for additional EPA requirements).

Agency policy prevents EPA technical staff and managers from providing individual applicants information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA RFAs, nor will they endorse an application or discuss in any manner how the Agency will apply the published evaluation criteria for this competition. 

1.B. Eligible Individuals

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

Investigators who have no prior history of receiving independent NIH funding in food allergy research, or have no history of receiving such funding after January, 2003, are encouraged to apply to this FOA.  Support for training, fellowship, and mentored career development awards are not considered independent research support. This FOA encourages not only junior investigators in the early phase of their independent research career, but also established investigators from related fields who wish to apply their skills to the field of food allergy research.

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. EPA does not require cost sharing.

3. Other-Special Eligibility Criteria

An applicant may serve as PD/PI on only one application submitted in response to this FOA.

An institution may submit more than one application as the applicant institution.

For an application to be eligible for funding consideration by the EPA, a project’s focus must consist of activities within the statutory terms of EPA’s financial assistance authorities; specifically, the statute(s) listed in Section VIII below. Generally, a project must address the causes, effects, extent, prevention, reduction, and elimination of environmental toxicants such as pesticides. These activities should relate to the gathering or transferring of information or advancing the state of knowledge.  Applications should emphasize this “learning” concept, as opposed to “fixing” an environmental problem via a well-established method.  Applications dealing with other topics which are sometimes included within the term “environment” must relate to the statutorily required purpose of pollution prevention and/or control.


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.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist 
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate required budget component.) 
Research & Related Budget (required for foreign applications)

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

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

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

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

Under EPA policy, foreign organizations are not eligible to apply as the primary applicant. For EPA Eligibility Requirements see Section III.1.A.

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 Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, 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 and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

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 not 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: October 9, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 9, 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): December 10, 2007
Peer Review Date(s): March 2008  
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): August 2008

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:

Kenneth Santora, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3146, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616

Telephone: (301) 451-2605
Fax: 301-480-2408
Email: ksantora@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. 

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

NIAID

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.

EPA

All award decisions are subject to the availability of funds.  In accordance with the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301 et seq., the primary purpose of an assistance agreement is to accomplish a public purpose of support or stimulation authorized by federal statute, rather than acquisition for the direct benefit or use of the Agency.  In issuing a grant, the EPA anticipates that there will be no substantial EPA involvement in the design, implementation, or conduct of the research.  However, the EPA will monitor research progress through annual reports provided by grantees and other contacts, including site visits, with the Principal Investigator.

If you wish to submit applications for more than one funding opportunity you must ensure that the research proposed in each application is significantly different from any other that has been submitted to the EPA or from any other financial assistance you are currently receiving from the EPA or other federal government agency.

Collaborative applications involving more than one institution must be submitted as a single administrative package from one of the institutions involved.

EPA awards funds to one eligible applicant as the “recipient” even if other eligible applicants are named as “partners” or “co-applicants” or members of a “coalition” or “consortium”. The recipient is accountable to EPA for the proper expenditure of funds.

Funding may be used to provide subgrants or subawards of financial assistance to fund partnerships provided the recipient complies with applicable requirements for subawards or subgrants including those contained in 40 CFR Parts 30 or 31, as appropriate. Successful applicants must compete contracts for services and products and conduct cost and price analyses to the extent required by the procurement provisions of these regulations. The regulations also contain limitations on consultant compensation. Applicants are not required to identify contractors or consultants in their application. Moreover, the fact that a successful applicant has named a specific contractor or consultant in the application does not relieve it of its obligations to comply with competitive procurement requirements. Please note that applicants may not award sole source contracts to consulting, engineering, or other firms assisting applicants with the application based solely on the firm's role in preparing the application. 

Successful applicants cannot use subgrants or subawards to avoid requirements in EPA grant regulations for competitive procurement by using these instruments to acquire commercial services or products from for-profit organizations to carry out its assistance agreement. The nature of the transaction between the recipient and the subawardee or subgrantee must be consistent with the standards for distinguishing between vendor transactions and subrecipient assistance under Subpart B Section .210 of OMB Circular A-133, and the definitions of “subaward” at 40 CFR 30.2(ff) or “subgrant” at 40 CFR 31.3, as applicable. EPA will not be a party to these transactions.

Each proposed project must be able to be completed within the project period and with the initial award of funds.  Applicants should request the entire amount of money needed to complete the project.  Recipients should not anticipate additional funding beyond the initial award of funds for a specific project.

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.”

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:

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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

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

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.

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.”

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 the National Institute of Allergy and Infectious Diseases (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
PD/PI(s) and other key personnel 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 PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) 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:

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 the “Human Subjects Sections” of the PHS398 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 the “Human Subjects Sections” of the PHS398 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 adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R). 

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 and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed. 

Programmatic Review (EPA): for applications under consideration for funding through the EPA. Applications receiving scores of outstanding, excellent, or very good as a result of the NIH peer review process and that meet EPA eligibility criteria will then undergo an EPA programmatic review, as described below. The EPA programmatic review will be conducted by technical experts from the EPA, including individuals from the Office of Research and Development (ORD) and program and regional offices familiar with the science proposed.

After the peer review, those applicants who received scores of outstanding, excellent, or very good as a result of the peer review process will be asked to provide additional information for the programmatic review pertaining to the proposed Lead Principal Investigator's (PI) "Past Performance and Reporting History.” The applicant must provide the EPA Project Officer with information on the proposed Lead PI's past performance and reporting history under prior Federal agency assistance agreements in terms of: (i) the level of success in performing each agreement, and (ii) how progress towards achieving the results intended under each agreement was reported.  This information is required only for the proposed Lead PI's performance under Federal assistance agreements initiated within the last three years that were similar in size and scope to the proposed project. 

The specific information required for each agreement is shown below, and must be provided within two weeks of EPA's request.  A maximum of three pages will be permitted for the response; excess pages will not be reviewed.  Note: If no prior past performance information and/or reporting history exists, you will be asked to so state.

1.   Name of Granting Agency.

2.   Grant/Cooperative agreement number.

3.   Grant/Cooperative agreement title.

4.   Brief description of the grant/cooperative agreement.

5.   A description of how the agreement is similar in size and scope to the proposed project and whether or not it was successfully performed; if not successfully performed, provide an explanation.

6.   Information relating to the proposed Lead PI's past performance in reporting on progress towards achieving the expected results (outputs/outcomes) under the agreement.  Include the history of submitting timely progress/final technical reports, describe how progress towards achieving the expected results was reported/documented, and if such progress was not being made, provide an explanation of whether, and how, this was reported. 

7.   Total (all years) grant/cooperative agreement dollar value.

8.   Project period.

9.   Technical contact (project officer), telephone number, and E-mail address (if available).

The purpose of the programmatic review is to assure an integrated research portfolio for EPA and help determine which applications to recommend for award.  In conducting the programmatic review, the EPA will consider information provided by the applicant and may consider information from other sources, including prior and current grantors and agency files.

The internal programmatic review panel will assess:

1.   The relevance of the proposed science to EPA research priorities.

2.   The proposed Lead PI's past performance (under Federal agency assistance agreements initiated within the last three years that were similar in size and scope to the proposed project) in two areas:  First, in successfully performing these prior Federal assistance projects, including whether there is a satisfactory explanation for any lack of success.  Second, in reporting progress towards achieving results under these agreements, including the proposed Lead PI's history of submitting timely progress/final technical reports that adequately describe the progress toward achieving the expected results (outputs/outcomes) under the agreements.  Any explanation of why progress towards achieving the results was not made will also be considered.  Applicants whose proposed Lead PI has no relevant past performance and/or reporting history, or for whom this information is not available, will be evaluated neither favorably nor unfavorably on these elements.

Final funding decisions are made by the National Center for Environmental Research Director based on the results of the peer review and internal programmatic review.  In addition, in making the final funding decisions, the NCER Director may also consider program balance, available funds, and the Congressionally-mandated Experimental Program to Stimulate Competitive Research (EPSCOR) (see http://es.epa.gov/ncer/other/).  Applicants selected for funding will be required to provide additional information listed below under “Award Notices.” The application will then be forwarded to EPA’s grants administration office for award in accordance with the EPA’s procedures.

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.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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.”

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.”       

Applications under consideration for funding through the EPA:

Applicants to be recommended for funding by EPA will be required to submit additional certifications and an electronic version of the revised project abstract. They may also be asked to provide responses to comments or suggestions offered by the peer reviewers, a revised budget, and/or to resubmit their application.  EPA Project Officers will contact Principal Investigators to obtain these materials.  Before or after an award, applicants and awardees may be required to provide additional quality assurance documentation.

The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector.  Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere. A written justification for federal involvement will be required.  In addition, an appropriate form of assurance that documents the commitment, such as a letter of intent from the Federal Agency involved, should be included.

Non-profit applicants that are recommended for funding under this announcement are subject to pre-award administrative capability reviews consistent with Section 8b., 8c. and 9d. of EPA Order 5700.8 - Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/award/5700_8.pdf). In addition, non-profit applicants that qualify for funding may, depending on the size of the award, be required to fill out and submit to the Grants Management Office the Administrative Capabilities Form with supporting documents contained in Appendix A of EPA Order 5700.8.

The official notification of an award will be made by the Agency’s Grants Administration Division.  Applicants are cautioned that only a grants officer is authorized to bind the Government to the expenditure of funds; preliminary selection by the NCER Director in the Office of Research and Development does not guarantee an award will be made.

For EPA awards, disputes related to this assistance agreement competition will be resolved in accordance with the dispute resolution procedures set forth in 70 FR 3629, 3630 (January 26, 2005) which can be found at http://www.epa.gov/ogd/competition/resolution.htm .  Questions regarding disputes may be referred to the EPA scientific/research contact identified below.

EPA Quality Assurance Statement:

For any project involving data collection or processing, conducting surveys, environmental measurements, modeling, or the development of environmental technology (whether hardware-based or via new techniques), EPA will require a statement on the processes that will be used to assure that results of the research satisfy the intended project objectives. This is not required for application submission, but will be required for any applications that EPA chooses to recommend for funding. More detailed information on requirements can be found at http://es.epa.gov/ncer/guidance/qa.html.

EPA:

By submitting an application in response to this solicitation, the applicant grants the EPA permission to make limited disclosures of the application to technical reviewers both within and outside the Agency for the express purpose of assisting the Agency with evaluating the application.  Information from a pending or unsuccessful application will be kept confidential to the fullest extent allowed under law; information from a successful application may be publicly disclosed to the extent permitted by law.

In accordance with 40 CFR 2.203, applicants may claim all or a portion of the application as confidential business information (for example, hypotheses or methodologies contained in the research narrative that the applicant wishes to protect from possible public disclosure). EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2. Applicants must clearly mark applications or portions of applications they claim as confidential. If no claim of confidentiality is made, the EPA is not required to make an inquiry to the applicant as otherwise required by 40 CFR 2.204(c) (2) prior to disclosure.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

Expectations and responsibilities of EPA STAR Program grantees are summarized below:

See http://www.epa.gov/ncer/guidance for the full terms and conditions associated with an award, including which activities require prior approval from the EPA.

1. Meetings: Recipients of EPA STAR Program grants will be expected to participate in an All-Investigators Meeting (also known as a progress review) with EPA scientists and other grantees to report on research activities and discuss issues of mutual interest. 

2. Approval of Changes after Award: Prior written approval is required from the EPA if there will be a significant change from the work described in the application.  Examples of these changes are contained in 40 C.F.R. 30.25.  Note: prior written approval is also required from the EPA for incurring costs more than 90 calendar days prior to award.

3. Human Subjects: A grant applicant must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects.  These requirements are given in 40 C.F.R. § 26.  For observational studies involving children or pregnant women or nursing mothers please refer to Subparts B & D of 40 C.F.R. § 26.  U.S. Department of Health and Human Services regulations at 45 CFR § 46.101(e) have long required "... compliance with pertinent Federal laws or regulations which provide additional protection for human subjects."  EPA’s regulation 40 C.F.R. Part 26 is such a pertinent Federal regulation.  Therefore, the applicant's Institutional Review Board (IRB) approval must state that the applicant's study meets the EPA's regulations at 40 CFR § 26.  No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s IRB approval of the project and the EPA has also provided approval.  Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports. 

4. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156.  The recipient must also agree to abide by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training" (50 Federal Register 20864-20865. May 20, 1985).

5. Data Access and Information Release: After award, all data (including primary and secondary or existing data) must be made available to the NCER Project Officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and non-specialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data.  If requested, the data products and their metadata must be provided to the NCER Project Officer in a standard exchange format no later than the due date of the grant's final report or the publication of the data product's associated results, whichever comes first.

Congress, through OMB, has instructed each federal agency to implement Information Quality Guidelines designed to "provide policy and procedural guidance...for ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by Federal agencies." The EPA's implementation may be found at http://epa.gov/quality/exmural.html#genreqts.  These procedures may apply to data generated by grant recipients if those data are disseminated as described in the Guidelines.

The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public 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.  If such data are requested by the public, the EPA must ask for it, and the grantee must submit it, in accordance with A-110 and the EPA regulations at 40 C.F.R. 30.36.

6. Acknowledgement of EPA Support: EPA’s full or partial support must be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications.  Any documents developed under this agreement that are intended for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:

“This publication [article] was developed under STAR Research Assistance Agreement No. [EPA grant number] awarded by the U.S. Environmental Protection Agency.  It has not been formally reviewed by the EPA.  The views expressed in this document are solely those of [name of recipient] and the EPA does not endorse any products or commercial services mentioned in this publication.”

A graphic that may be converted to a slide or used in other ways, such as on a poster, is located at http://es.epa.gov/ncer/guidance/star_images.html.  EPA expects recipients to use this graphic in oral and poster presentations.

7.  Exchange Network: EPA, states, territories, and tribes are working together to develop the National Environmental Information Exchange Network, a secure, Internet- and standards-based way to support electronic data reporting, sharing, and integration of both regulatory and non-regulatory environmental data.  States, tribes and territories exchanging data with each other or with EPA, should make the Exchange Network and the Agency's connection to it, the Central Data Exchange (CDX), the standard way they exchange data and should phase out any legacy methods they have been using.  More information on the Exchange Network is available at http://www.exchangenetwork.net/. 

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:

Marshall Plaut, M.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3093, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 435-4425
Fax: 301-402-0175
Email: mplaut@niaid.nih.gov 

Susan Laessig, Ph.D.
National Center for Environmental Research
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., Room 8723F
Washington, DC 20460
Telephone: (202) 343-9617
Fax: (202) 233-0677
Email: laessig.susan@epa.gov

2. Peer Review Contact:

Kenneth Santora, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3146, MSC-7616

6700 B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 451-2605
Fax: (301) 480-2408
Email: ksantora@niaid.nih.gov

3. Financial or Grants Management Contacts:

Lisa Scott-Morring
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2122, MSC 7614
6700 B Rockledge Drive 
Bethesda, MD 20892-7614
Telephone: (301) 451-3697
Fax: (301) 493-0597
Email: scottli@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46; 40 CFR 26) 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 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.

EPA Authority and Regulations

The authority for this RFA and resulting awards is contained in the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r.

For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102(2)(F).

Applicable regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants).  Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220, OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225, OMB Circular A-102 (Grants and Cooperative Agreements With State and Local Governments), OMB Circular A-110 (Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations) relocated to 2 CFR Part 215, and OMB Circular A-122, (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230.

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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