Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Allergen Epitope Research and Validation Centers (U19)

Activity Code

U19 Research Program – Cooperative Agreements 

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-11-013

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855; 93.856  

FOA Purpose

The purpose of this FOA is to capitalize on the availability of well characterized T cell allergen epitopes to study allergen-specific immune responses.. As part of the characterization and validation of these allergen T cell epitopes, there is a need to conduct mechanistic studies that focus on the progression and/or changes in the severity of seasonal or perennial allergic diseases (e.g. seasonal allergic rhinitis, asthma exacerbations triggered by pet dander), as well as the changes resulting from therapeutic intervention in allergic disease, such as immunotherapy for seasonal, perennial, or food allergies. Programs should focus on mechanistic assessment of T cell allergen epitopes to illuminate the T cell phenotypes, their function and contribution to allergen-specific T-cell memory.  Limited novel T cell allergen epitope identification will also be supported under this FOA, but only as a companion to, and extension of, mechanistic studies of T cell responses to existing allergen epitopes.

Key Dates
Posted Date

April 7, 2011

Letter of Intent Due Date

June 22, 2011

Application Due Date(s)

July 22, 2011   

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November, 2011   

Advisory Council Review

 January, 2012 

Earliest Start Date(s)

 June, 2012 

Expiration Date

July 23, 2011 

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The National Institutes of Allergy and Infectious Diseases (NIAID) invites new applications from single institutions, or consortia of institutions, to participate in research using T cell allergen epitopes to examine human T cell immune responses during the progression of, and/or changes in the severity of, allergic diseases that have high public health impact (e.g., allergic rhinitis, asthma, food allergy). The purpose of this FOA is to capitalize on the availability of T cell allergen epitopes, including those available through the NIAID-funded Immune Epitope Database and Analysis Resource (IEDB; www.iedb.org). Applicants are encouraged to submit research programs that propose to validate and study immune responses to allergens at the level of epitope-specific T cell subsets.  Epitope validation is defined as the ability of these reagents to successfully track the numbers and functions of allergen-specific T cells in allergic humans during changes in their clinical conditions. These programs should include mechanistic studies, using state of the art techniques (e.g., gene expression microarray analysis, multi-color flow cytometry and tetramer analysis) to illuminate the T cell phenotypes, their function and contribution to allergen-specific T cell memory.  Limited T cell allergen epitope identification will also be supported under this FOA, but only as a companion to, and extension of, mechanistic studies of T cell responses to existing allergen epitopes.  This initiative also seeks T cell epitope validation programs that include comparative or interventional studies in humans. 

Background

Research supported and conducted by the NIAID, a component of the National Institutes of Health (NIH), strives to understand, treat and ultimately prevent the myriad infectious, immunologic, and allergic diseases that afflict millions of people.  The NIAID Division of Allergy, Immunology and Transplantation (DAIT) promotes and supports research to enhance the understanding of the causes and mechanisms that lead to the development of immunologic diseases and to generate an expanded knowledge base that can be applied to the development of improved measures of diagnostics, treatment, and prevention.  As part of its research mission to improve the understanding and treatment of allergic diseases, DAIT announces this new funding resource to support the validation and characterization of T cell allergen epitopes.

Allergic diseases are among the major causes of illness and disability in the United States for all ages and the incidence trend of these diseases continues to rise. A recent nationwide survey found that more than half (54.6%) of all U.S. citizens test positive to one or more allergens, which is thought to be a predictor for eventual development of allergic conditions (Arbes, et al; J Allergy Clin Immunol 8:377-383, 2005).  The increasing prevalence of certain allergic diseases highlights the need for a better understanding of the mechanisms that underlie these disease processes, as well as the urgency of developing novel therapeutics to treat these diseases.  Research during the past several decades has increased our understanding of the pathogenesis of allergic diseases and supports the premise that a variety of T cell responses (e.g. Th1, Th2, Treg, and Th17) are likely to contribute to these diseases.

In FY 2007, DAIT supported the initiative entitled "Allergen & T Cell Reagent Resources for the Study of Allergic Diseases" with two 5-year contract awards. One project utilized an algorithm-based high-throughput screening approach to identify novel T cell epitopes from over 400 known allergens. The second project used a tetramer-based screening of eight (8) clinically-important allergens. Both contractors used these reagents to study the functional phenotype of epitope-specific T cells in human peripheral blood. These projects have resulted in the identification of many novel T cell allergen epitopes for peanut, alder tree pollen and timothy grass.  Detailed information about these recent allergen epitopes, and the assays used to initially validate the epitopes using blood from individuals with confirmed allergies, as well as an exhaustive literature citation of allergen epitopes, is available to the medical and scientific community through the NIAID-supported IEDB (www.iedb.org). 

As part of the further characterization and validation of these allergen T cell epitopes, there is a need to conduct mechanistic studies focused on the progression and/or changes in the severity of allergic diseases (e.g. allergic rhinitis, asthma, food allergy), the changes resulting from therapeutic intervention in allergic disease (such as immunotherapy), and the changes resulting from seasonal exposure to some allergens (such as pollen). Projects are sought that focus on a mechanistic assessment of T cell allergen epitopes to illuminate the T cell phenotypes, their function and contribution to allergen-specific T-cell memory.  The further characterization and validation of epitope-specific immune responses that lead to activation or regulation of T cell subsets will improve our understanding of allergic disease mechanisms, and could promote the development of new peptide-based immunotherapies.

Research Objectives and Scope

Consistent with overall objectives of the NIAID-DAIT mission, the goal of this FOA is to support multidisciplinary and multi-project research programs focusing on mechanistic studies that further characterize and validate allergen T cell epitopes during the progression and/or changes in the severity of allergic diseases (e.g. allergic rhinitis, asthma, food allergy), and/or the changes resulting from therapeutic intervention of allergic disease, such as immunotherapy.  For the purpose of this FOA, epitope validation is defined as the ability of epitope-based reagents (e.g. epitope-MHC tetramers) to track the numbers and functions of allergen specific T cells in allergic humans during changes in their clinical conditions. Limited new T cell allergen epitope identification will also be supported under this FOA, but only as an extension of mechanistic studies of T cell responses using known allergen epitopes. These mechanistic studies include, but are not limited to:

The NIAID seeks U19 applications under this FOA that are highly synergistic. Component projects within a single U19 application should relate to a central theme relevant to a clinically important allergic disease, and should also relate to the other component projects within the same application. Applications considered to be responsive to this FOA must be composed of a minimum of two interrelated research projects (but no more than four projects) structured around a central scientific theme that focuses on the characterization and validation of allergen T cell epitopes in allergic diseases.

All applications must focus on human disease-related mechanisms and should involve subjects with physician-diagnosed asthma and/or allergic diseases, or specimens obtained from such individuals. NIAID requires that the majority of the proposed research program in each application meet the definition of NIH clinical (human subjects) research. For the purposes of this FOA, a “majority of the proposed research program” is judged based on the entire application. Thus, each project is not required to include clinical research, rather the major focus of the application as a whole must include clinical research. For the NIH definition of clinical (human subjects) research, please refer to the NIH Office of Extramural Research Human Subjects website http://grants.nih.gov/grants/policy/hs/index.htm. Healthy non-allergic subjects may be included in the proposed clinical studies, but only as controls. This FOA will support new phase I and II clinical trials. If proposed, these clinical trials should focus on immune-based therapies and/or interventions by allergen challenge. Applicants with projects that propose to use or develop novel sample sparing technologies are encouraged to apply.

Applicants may also propose animal models if they are directly related to the clinical research proposed. Such proposed animal studies must be relevant to human allergic conditions, be required because an appropriate human model doesn’t exist, and cannot represent the majority of the research plan of the overall program.  All animal use studies must comply with the NIH guidelines for the use of animals; http://grants.nih.gov/grants/olaw/olaw.htm

All applications must include experimental approaches that characterize the phenotype and function of epitope specific T cell subsets and should include one or more of the following:

Additionally, research leading to the identification/characterization and validation of new/novel allergen T cell epitopes will be supported by this FOA. However, such a project may not comprise a majority of the overall research program effort. Similarly, the development of sample sparing technologies to improve analytical capacities where blood volumes are limiting will also be supported by this FOA, but such projects may not comprise a majority of the overall research program effort.

For projects proposing to further characterize and validate an existing allergen T cell epitope(s), investigators must provide preliminary or published data demonstrating that these epitopes meet the following criteria:

This FOA will not support:

Applications proposing such studies will be considered non-responsive and will not be reviewed

Core Facilities

Administrative Core (required): An administrative core is a resource to the multi-project grant, providing overall management, coordination and oversight for the Program.  As part of the administrative core, provide an administrative plan that includes a description of the structure and roles of administrative staff, including the training and experience of proposed staff and the functions to be performed; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research-related travel and training will be budgeted.  Funding for the overall administrative efforts, including secretarial, and/or other administrative services, publication expenses resulting from collaborative efforts, and communication expenses, should be requested in this core.  A fully developed and well-described Administrative Core plan is required even if no additional funds for the core are requested in the overall budget.

Applications that do not include an Administrative Core will be considered non-responsive and will not be reviewed. 

Scientific Core(s), Clinical Trial Core, Data Management and Analysis Core (optional):  Such cores may be proposed if they support the multi-project grant as a whole and directly support at least two of the proposed research projects.  The application must indicate which specific projects each Core will support.  Scientific Cores should be limited to providing standard assays, reagents, technologies, or other available services to the investigators.  Examples of Scientific Cores may include technical (e.g. flow cytometry, multiplex cytokine assays, biopsy/sample collection), bioinformatics, or other non-administrative activities that directly support the research programs. Furthermore, for an application proposing to conduct more than one clinical trial or clinical research study, applicants may consider proposing a Clinical Trial Core.  This Clinical Trial Core should describe the oversight, program management, safely monitoring, and regulatory activities needed to safely conduct a clinical trial or study.  The Clinical Trial Core may include data management and analysis functions (e.g. database development, data cleaning, and statistical analyses). Alternatively, data management and analysis functions may be described as part of a separate Data Management and Analysis Core.

All Cores should present a clear picture of the facilities, techniques, and skills that they will provide, and should describe the role of the Core Leader and each of the key participants.  The apportionment of dollars or percentage of dollars that will be required to support each component research project that will utilize each scientific core should be included in the Core budget.

Note: The applicant is responsible for including the costs of all support for study design, protocol development, data collection, data analysis and management, clinical site monitoring, medical monitoring, project management and quality assurance of the proposed clinical trials in the application budget. For responsibilities associated with Investigational New Drug (IND) applications and sponsorship, the awardee is required to comply with NIH and U.S. Food and Drug Administration (FDA) regulatory requirements for data and clinical monitoring, reporting, and the protection of human subjects. See Section VI.2. - Cooperative Agreement Terms and Conditions of Award below. The NIAID retains the right to be the IND sponsor in selected clinical trials.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAID intends to commit approximately $2.8 million in total costs in FY 2012 to fund two to three new awards in response to this FOA..

Award Budget

Because the nature and sc,ope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award may vary.  Budgets for total costs not to exceed $1.4 million per year may be requested.  

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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.

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

Note that the multiple PDs/PIs option may be used only for the Overall P01.  The multiple PDs/PIs option is not available for the leadership roles of the individual research projects or cores within the multi-project application.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.     

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Paul Amstad, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3121, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Fedex Zip 20817-7616
Tel:  301-402-7098
Fax: 301-480-2408
E-mail: pamstad@niaid.nih.gov

Application Submission

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

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

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

Paul Amstad, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3121, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Fedex Zip 20817-7616
Tel:  301-402-7098
Fax: 301-480-2408
E-mail: pamstad@niaid.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

Research Strategy for the Program Overview is limited to 12 pages.

Research Strategy for each Individual Research Project is limited to 12 pages.

Research Strategy for each Core(s) is limited to 6 pages.

Research Plan

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

Supplemental Instruction for the Preparation of Multi-Project Applications

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

The supplemental instructions for multi-project applications below are divided as follows:

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

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

C. Specific Instructions for Cores – Describes modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the Core.

A. General Instructions

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

1. Face Page

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

2. Description


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

Project/Performance Sites

List the performance sites where the research will be conducted.

Key Personnel

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

3. Table of Contents

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

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

4. Composite Budget

Do not use Form Page 4 of PHS Form 398.  Instead, using the suggested format presented below, prepare a Composite Budget For All Proposed Years of Support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.)

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850

 

 

 

 

 

 

5. Total Direct Costs for the Entire Budget Period

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below).  If the FOA allows for budget requests beyond 5 years, use a second Form Page 5 to reflect the additional budget years requested. 

6. Biographical Sketch

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

7. Resources

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

8. Center Program Overview (Research Objectives and Strategic Plan)

Specific Aims (Limited to 1 page.)

List in priority order, the broad, long-range objectives and goals of the proposed Center. Concisely and realistically describe the hypothesis or hypotheses to be tested.

Overall Research Strategy (Limited to 12 pages)

This narrative section summarizes the overall research plan for the multi-project application and is limited to (12) pages.  The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another.  This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.  As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme.  Summarize the special features in the environment and/or resources that make this application strong or unique.

9 Checklist

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

10. Appendix Materials

Refer to Section IV.6. “Appendix Materials” below, for instructions on submitting appendix materials.

For each project or core in the multi-project application, 3 publications plus other approved material are allowed. 

B. Specific Instructions for Individual Research Projects

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.

For each individual Research Project, include:

Face page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Research Plan

Resources

1. Cover Page

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

2. Description

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

Project/Performance Sites

List the performance sites where the research will be conducted.

Key Personnel

Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.

3. Table of Contents

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

4. Detailed Budget for Initial Budget Period

Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.

5. Individual Research Project Research Plan

(a minimum of two individual research projects are required)

Specific Aims (Limited to 1 page.)

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

Research Strategy (Limited to 12 pages.)

Use this section to describe how the proposed research will contribute to meeting the Center’s goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary theme of the application.

Organize the Research Strategy in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for new projects must be included as part of the approach section, and must be contained within the page limits of the Research Strategy section.

Describe the research design conceptual procedures, and analyses to be used to accomplish the specific aims of the project. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss associations with clinical project(s). Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project.

Clinical research (required)

a. Clinical trials (optional): The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral human subjects research involving an intervention to modify behavior (such as diet, physical activity, cognitive therapy, etc.) fits this definition. Research with human subjects to develop or evaluate clinical laboratory tests (imaging or molecular diagnostic tests) might be considered as a clinical trial if the test will be used for medical decision making, or if the test itself imposes more than minimal risk for subjects.

In the spirit of the above definition, any study that involves interventions aiming at understanding mechanisms of disease (e.g., allergen challenges, experimental exposure of humans to an inflammatory mediator or to a rhinovirus), or any study that involves an intervention for which the FDA will require an IND application will also be considered a clinical trial.

In general, a clinical trial should be presented as an individual project of the U19 application. This FOA will not support the continuation of ongoing (active) clinical trials. The applicant will be allowed to propose a new clinical trial that shares most aspects of study design and is highly related to a previous clinical trial if the new trial intends to validate and extend the results obtained in the earlier trial. For the purpose of this FOA, a new trial is defined as one that has not previously recruited subjects. An ongoing trial is defined as one in which recruitment has not yet closed, or subjects are still enrolled in the trial. If two trials are highly related and share most aspects of study design, they can be presented within the same individual project.

Note: This FOA only supports Phase I and II clinical trials.

The Approach section of all clinical trial projects must address the following aspects of the proposed trial(s):

Feasibility:

b. Clinical studies (required unless a clinical trial is proposed instead): For applications proposing a clinical research study (non-interventional) involving the use of human samples, such samples may be obtained from planned clinical studies or clinical trials that are ongoing or completed and sponsored by any source of support. The Approach section of all clinical study projects must address the following aspects of the study:

Feasibility, including:

As applicable, the following information is required and should be presented under “Section E. Protections for Human Subjects” for projects involving Clinical Trials/Studies:

For clinical research study projects that plan to obtain human samples from an associated (ongoing or planned) clinical study/trial not supported by the proposed project, additional human samples documentation information is also required:

6. Resources

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

7. Biographical Sketch

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

C. Specific Instructions for Core(s)

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.

For each individual Core, include:

Cover page (see special instructions, below)

Description & Key personnel (PHS 398 Form Page 2)

Table of Contents (PHS 398 Form Page 3)

Budget Pages (PHS 398 Form Pages 4 and 5); with budget justifications

Core Services Plan

Resources Format Page

1. Cover Page

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

The following are specific instructions for sections of the PHS 398 application form that are to be completed differently than usual.  For all other items in the core application, follow the usual PHS 398 instructions.

2. Description

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

Project/Performance Sites

List the performance sites where the core activities and services will be conducted.

Key Personnel

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

3. Table of Contents

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

4. Budget Pages

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398.

5. Individual Core Services Plan

Specific Aims (Limited to 1 page.)

List in priority order, the broad, long-range objectives and goals of the proposed Administrative and Educational Core, Bioinformatics Core, or Scientific Cores. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the core’s relationship to the Program’s goals and how it relates to the individual research projects or other cores in the application.

Core Services (limited to 6 pages)

Use this section to describe how the proposed core activities will contribute to meeting the Center's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims.  In addition, this section should indicate the relevance of the core to the primary theme of the application.

Organize the Plan  in the specified order as stated in the PHS 398 Instructions, Section 5.5.  Make sure to start each section with the appropriate section heading in order, Significance, Innovation, Approach, and include the appropriate information.  Experimental details should be cited using the Bibliography and Reference Cited section and need not be detailed in the Research Strategy.  Preliminary Studies for new cores and progress reports must be included as part of the approach section and must be contained within the page limits of the Core Services  Plan section.

6. Resources

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

7. Biographical Sketches

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

Resource Sharing Plan

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

Appendix

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

Foreign Organizations

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

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

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the program proposed).

Is the program as a whole scientifically compelling? Are there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the program? Are the overall program goals significant and focused on studies that meet the objectives of the FOA? Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently? Do(es) the PI/PD(s) have the leadership and scientific ability to develop an integrated and focused research program? Will the PI/PD(s) and other Project/Core Leaders devote adequate time and effort to the program? Is there adequate evidence of sufficient institutional support for the PD/PI(s) in terms of laboratory space, equipment and other resources? For applications designated multiple PDs/PIs, is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PDs/PIs? Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate?

Scored Review Criteria - Individual Research Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Is the program as a whole scientifically compelling? Are there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the program? Are the overall program goals significant and focused on studies that meet the objectives of the FOA? Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently? Do(es) the PI/PD(s) have the leadership and scientific ability to develop an integrated and focused research program? Will the PI/PD(s) and other Project/Core Leaders devote adequate time and effort to the program? Is there adequate evidence of sufficient institutional support for the PD/PI(s) in terms of laboratory space, equipment and other resources? For applications designated multiple PDs/PIs, is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PDs/PIs? Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate?

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?If the aims are achieved, could the results be applied to diagnosis, treatment, or prevention of allergic diseases?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?Is the level of effort of the PD/PI or U19 Project Leader sufficient to ensure success of the program?  Is there adequate scientific, clinical and technical expertise needed to design, conduct, monitor, and interpret the outcomes from any clinical trials, if applicable? Are the clinical staff and study coordinator(s) sufficiently experienced in the execution of clinical trials of the nature and size proposed, if applicable?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are there sufficient preliminary data to support the proposed research projects? Are the source and procedures for the collection of clinical samples or proposed biospecimens clearly described and are all the logistics and feasibility issues addressed and adequately justified? Are the data collection, management, and resources adequate for the proposed studies? If the project involves clinical trials, does the study design adequately address the safety of participants to the proposed intervention?

If the project involves the use of animal models, do those models directly relate to the clinical studies proposed? Are the proposed animal studies relevant to human allergic disease? Are they needed because an appropriate human model is not available?   

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Scored Review Criteria – Cores

Reviewers will consider each of the review criteria below in the determination of scientific merit. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a core that by its nature is not innovative may be essential to advance a field.

     Review Criteria for Administrative Core

Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed program? Is the management plan for fiscal accountability and communication within the program appropriate? Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate? Are the experience, level of commitment, and availability of the administrative Core Leader and the administrative staff adequate to manage the program? Are plans for communication among the members of the U19 adequate to facilitate collaborative activities?

     Review Criteria for Scientific, Clinical, and Data Management and                                

     Analysis Cores (if applicable)

Is provision of resources and core services for the individual research projects critical and justified? Is the relationship of a Scientific Core to the central focus of the overall program        strong? Is the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate? Are the qualifications, competence, and commitment of the Core      Leader(s) and key personnel appropriate? Does the Clinical Core Leader have both the expertise/capabilities and demonstrated experience to support the clinical research (or clinical trial, if applicable) activities proposed in the U19 applications? Does the Clinical Core Leader have the experience and expertise to guide and/or assist in the development and preparation of documentation required for clinical research/trials as well as experience with regulatory activities, including IND applications, recruitment and retention of study participants, medical monitoring, and safety oversight and reporting? Does the Data Management and Analysis Core Leader have both the expertise/capabilities and the demonstrated experience to support the data management and analysis activities proposed in the U19 application? Are the statistical analysis methods, database resources, data entry and validation resources appropriate to support the studies proposed in the U19 application?

Additional Review Criteria - Projects and Cores

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

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project or core involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not applicable.  

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council l. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

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

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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

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

The PD(s)/PI(s) will have the primary responsibility for:

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

Areas of Joint Responsibility include:

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Michael Minnicozzi, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Room 6601, MSC-6601
6610 Rockledge Drive
Bethesda MD 20892-6601
Tel: 301-496-8973
minnicozzim@niaid.nih.gov

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

Michael Minnicozzi, Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Room 6601, MSC-6601
6610 Rockledge Drive
Bethesda MD 20892
Tel: 301-496-8973
minnicozzim@niaid.nih.gov

Peer Review Contact(s)

Paul Amstad, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3121, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Fedex Zip 20817-7616
Tel:  301-402-7098
Fax: 301-480-2408
E-mail: pamstad@niaid.nih.gov).

Financial/Grants Management Contact(s)

Cassandra Fields
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 2245, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-594-6355
Email: fieldscass@mail.nih.gov  

Section VIII. Other Information

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

Authority and Regulations

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.