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Part I Overview Information

Department of Health and Human Services

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

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

Title: Asthma and Allergic Diseases Cooperative Research Centers (U19)

Announcement Type
This is a reissuance of RFA-AI-05-027, previously released on May 25, 2005

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

Request For Applications (RFA) Number: RFA-AI-07-002

Catalog of Federal Domestic Assistance Number(s)
93.855

Key Dates
Release Date: December 7, 2006
Letters of Intent Receipt Date(s): April 13, 2007
Application Receipt Date(s): May 14, 2007
Peer Review Date(s): September, 2007
Council Review Date(s): January, 2008
Earliest Anticipated Start Date: March, 2008
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date: May 15, 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(s) of Support
2. Funds Available

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) invites new or competing continuation applications from single institutions and consortia of institutions to participate in the Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) program. The program will support integrated basic and clinical research centers to conduct studies on the immunologic mechanisms underlying the onset and progression of asthma and allergic diseases. The overarching goal of the program is to improve the diagnosis and treatment of asthma and allergic diseases, and to provide a rational foundation for the development of effective prevention strategies.

Background

Allergic diseases, including asthma, are among the major causes of illness and disability in the United States. Asthma affects more than 10% of the U.S. population, and approximately 80% of these asthmatic patients suffer from allergic asthma. The AADCRC program, established more than three decades ago, is the cornerstone of NIAID's efforts to promote innovative, multidisciplinary basic and clinical research on asthma and allergic diseases.

Asthma is a chronic disease of the lungs characterized by reversible airway obstruction and hyper-responsiveness associated with pulmonary inflammation. Research indicates that the pathogenic factors for asthma are linked to an imbalance between T helper type 1 (Th1) and T helper type 2 (Th2) immune regulation, leading to a Th2 dominant state in the airways. As a consequence, an increase in Th2 cytokines is often observed in asthma patients, and is thought to underlie increased IgE antibody responses to house dust mite and other indoor allergens, and lung eosinophilia. Numerous factors may contribute to the development of the Th1-Th2 imbalance. These include the interactions between the innate and adaptive immune systems, and between the host genetic background and environmental factors.

Although not well understood, it is thought that dendritic cells and other cells of the innate immune system bias adaptive immune responses in the direction of Th1 or Th2. Research on key receptors whose functions include pathogen recognition, e.g., Toll-like receptors, is beginning to uncover the role of such receptors in inflammation. Understanding the interaction between the innate and adaptive immune systems in asthma and allergic diseases should lead to new approaches for prevention and therapy.

Over the past decade, research on the genetic basis of asthma led to the identification of the specific chromosomal loci that correlate with asthma susceptibility. The range of putative asthma genes identified in these loci, in both humans and mice, includes immune response genes and genes that may confer tissue specificity to the underlying immune responses. Further research is needed to demonstrate the relevance of these novel genes to allergic diseases, understand gene-gene interactions, and determine the potential effects on host responses to environmental influences.

Interactions between environmental and infectious stimuli and various susceptibility genes involved in immunity and respiratory function contribute to the pathogenesis of asthma. It is now believed that specific environmental exposures may have led to the expression of asthmatic phenotypes in previously unaffected, but genetically predisposed individuals. While a significant challenge, understanding the precise role of viral and other infections and of environmental agents, including pollutants and allergens, on the development of asthma and allergy holds considerable promise for improved approaches for disease prevention and treatment.

Although the research solicited by this RFA concerns human allergies and asthma, animal models are of great value in supporting and advancing human research studies. Studies using animal models have helped to define the role of Th2 cells and cytokines in asthma and allergic diseases. In addition, animal models with defined genetic mutations or gene deletions are of growing importance in the study of asthma and allergic diseases, particularly in molecules related to the innate immune system. For example, murine models that are deficient in specific Toll-like molecules are the basis for recent important discoveries in innate immune system signaling in response to CpG and other innate immune system agonists that appear to play key roles in asthma and allergy triggering and control. Integration of new animal models with recent technical advances, such as gene chips for whole genome scanning, should facilitate the development of exciting new programs that combine both human and animal model studies, and rapidly advance the molecular understanding of asthma and allergy development, prevention, and treatment.

NIAID currently supports 15 asthma and allergic diseases centers programs.

Research Objectives and Scope

Applications considered to be responsive to the RFA must be structured around a central scientific theme that is clearly relevant to the immune mechanisms of, and intervention strategies for, asthma and/or allergic diseases. A minimum of two research projects is required per application. Proposals largely focused on human immune mechanisms are strongly encouraged.

Examples of relevant research include, but are not limited to, the following areas:

This RFA will not support:

Applications proposing such studies will be considered non-responsive and will be withdrawn from further consideration without peer review. The applicant will be informed of this action.

Clinical Research Projects

At least one project must propose a clinical study of individuals with clinically defined asthma and/or allergic diseases or a study involving human specimens from such individuals. Healthy volunteers may be included in proposed clinical studies. Clinical research projects must meet the NIH definition of clinical research. For the NIH definition of clinical research, please see the NIH Office of Extramural Research Human Subjects Website (http://grants.nih.gov/grants/policy/hs/index.htm).

These projects may include, but are not limited to: 1) mechanistic studies of human asthma and allergic diseases; 2) Phase I or Phase II clinical trials of preventive and therapeutic interventions, including immune-based therapies; and 3) development of new technologies and biomarkers for diagnosis. Studies using human specimens obtained from completed, ongoing or planned clinical studies or clinical trials may be proposed, but require a sound justification for the anticipated clinical relevance of the proposed study. Clinical trials, if proposed, are limited to Phase I or Phase II.

Statistical Design and Analysis and Data Management/Quality Control for Clinical Studies

This RFA will not provide support for a centralized stand-alone statistical and clinical coordinating center.

The applicant is responsible for including the costs of all support for statistical design, data collection and analysis, and management and quality assurance of the proposed clinical studies in their proposed 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 clinical monitoring and reporting and the protection of human subjects. See Section VI.2. - Cooperative Agreement Terms and Conditions of Award below.

Steering Committee

NIAID, in conjunction with the Principal Investigators funded under the previous RFA, has established a Steering Committee to serve as the governing body for all AADCRC activities. Principal Investigators awarded under this RFA must serve on the Steering Committee. Members of the Steering Committee will be required to accept and implement common guidelines and procedures approved by the Steering Committee. Steering Committee responsibilities are further described under Section VI.2.A.7. Cooperative Agreement Terms and Conditions of Award - Collaborative Responsibilities.

Discretionary Fund

Under the previous RFA, NIAID established a Discretionary Fund to support new clinical research projects and research resource development projects, led by AADCRC members, to capitalize on emerging opportunities, especially clinical and/or mechanistic studies of new therapies or preventive approaches as they relate to viral infections, environmental factors, or lung inflammation. The Steering Committee has established goals, priorities, and evaluation criteria for the use of the discretionary funds. Principal Investigators awarded under this RFA will have an opportunity to compete for discretionary funds and will be provided with details regarding discretionary fund management and the application process, as well as the scope of research supported by the funds. See Section VIII Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the multi-project cooperative agreement (U19) award mechanism.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH (U19) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI.2.A. "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The NIAID intends to commit approximately $6 million in FY 2008 to fund three to five new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. The average amount of annual direct costs ranged from $650,000 to $1,200,000 for awards made in FY2006 in response to the previous RFA-AI-05-027. Although the financial plans of the NIAID provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

NIAID will not award more than one AADCRC grant to an applicant institution, nor to an institution that is currently funded under the previous RFA-AI-05-027. This exclusion applies to Principal Investigators, but not to investigators at an applicant institution who wish to serve as a Project Leader in a multi-project application submitted by another institution in response to the current solicitation if there is no scientific overlap.

You may submit an application if your organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution 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.

2. Cost Sharing or Matching

Cost sharing is not required.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

An institution may submit only one application.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Essential elements of the multi-project cooperative agreement mechanism (U19) include: 1) a minimum of two interrelated individual research projects organized around a central theme; 2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; 3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort; 4) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded; 5) an Administrative Core, and 6) where necessary, support for scientific core resources or facilities, each of which shall be utilized by at least two research projects in order to facilitate the research effort.

Potential applicants are strongly encouraged to consult with the appropriate NIAID program contact listed in Section VII Agency Contacts during the early stages of preparation of the application.

Supplemental Instructions for the Preparation of Multi-project Applications

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

The supplemental instructions below are divided as follows:

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

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

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

A. General Instructions

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

1. Face Page

Items 1 - 15: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

2. Form Page 2

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

List the performance sites where the research will be conducted.

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

3. Form Page 3 - Table of Contents

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

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

4. Composite Budget

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

SAMPLE: Consolidated Direct Cost Budget for 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. Form Page 5

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

6. Biographical Sketch Format Page

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

7. Other Support Format Page

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

8. Resources Format Page

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

9. Program Overview (Research Objectives and Strategic Plan)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 25 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.

This Overview section should include: a clear and concise plan that depicts the interrelationships among the research groups, their relevant experience and expertise, and the contribution of each to the fulfillment of the objectives of this RFA; an organization chart of the U19 cooperative group showing the name, institution, and scientific disciplines of the Principal Investigator and of all key scientific and technical personnel, as well as a discussion of lines of authority and plans for the coordination of research projects; a summary of the special features in the environment and/or resources that make this application strong or unique; and a plan to ensure the maintenance of close cooperation and effective communication among members of the U19 group.

10. Checklist

One Checklist should be submitted for the entire application, and it should be placed at the end of the application. Individual projects and cores do not require a checklist.

11. Appendix

The Appendix is limited to a total of ten (10) documents or one hundred (100) total pages, whichever is less. All pages in reprints and other documents count as one page.

B. Specific Instructions for Individual Research Projects

1. Cover Page

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

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

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

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

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

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

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

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

Applicant Organization:
(full address)

2. Form Page 2

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

3. Form Page 3

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

4. Biographical Sketches

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

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

All clinical research projects should follow the instructions under Section IV.6.1. Research Plan for Clinical Research Projects.

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

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

C. Specific Instructions for Cores

1. All Cores

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

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

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

Human Subjects (Yes or No)
If Yes, Exemption Number
(or)
IRB Approval Date (e.g., 5/14/06, or Pending)
(and)
Federalwide Assurance (FWA) number

Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/07, or Pending)
(and) Animal welfare assurance number

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

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

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

Applicant Organization
(full address)

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

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

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

Core Research Plan (Items A-D cannot exceed 25 pages)

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

2. Administrative Core

Each application must provide for an Administrative Core headed by the Principal Investigator or other senior investigator and responsible for the overall management, coordination and supervision of the program. Provide an administrative plan that includes a discussion 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, expenses for publications demonstrating collaborative efforts, communication expenses, etc., should be requested here. Also see Section IV.6.2.Administrative Core for this RFA specific information.

3. Scientific Cores

A scientific core is a resource to the multi-project grant as a whole and must support at least two of the proposed research projects. The application must indicate the specific projects to be served by the Scientific Core(s). This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide and describe the role of the Scientific 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 which will utilize each scientific core should also be presented.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): April 13, 2007
Application Receipt Date(s): May 14, 2007
Peer Review Date(s): September, 2007
Council Review Date(s): January, 2008
Earliest Anticipated Start Date: March, 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 at the beginning of this document.

The letter of intent should be sent to:

Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: 301-435-9369
Fax: 301-480-2310
Email: [email protected]

3.B. Sending an Application to the NIH

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

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

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

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

Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: 301-435-9369
Fax: 301-480-2310
Email: [email protected]

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIAID. Incomplete and non-responsive applications will not be reviewed.

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

New, resubmitted (revised) and competing continuation applications must propose research projects that are not currently funded through other mechanisms.

Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigators must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 or competing continuation 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 or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Special requirements of this RFA include:

All applications must also include the following information:

1. Research Plan for Clinical Research Projects

a. Projects Proposing Clinical Trials

Concept Proposal: All clinical trial projects must provide a single detailed concept proposal addressing the following aspects of the proposed clinical trial (additional 10 pages will be allowed and will not count against 25-page limit per U19 instructions):

Study Title
Hypothesis to be tested
Study objectives
Population
Clinical sites
Intervention and comparators (if any)
Provision of investigational drugs and/or devices
Regimen
Study design, including:

- Eligibility/exclusion criteria
- Randomization/stratification plan
- Number of subjects
- Anticipated duration of recruitment phase
- Total study duration
- Primary endpoints/outcomes
- Secondary endpoints/outcomes
- Study visit schedule and primary evaluations, including laboratory evaluations
- Sample size justification
- Any proposed sub-studies
- Statistical analyses and data analyses plan

Data and safety monitoring plan

The concept proposal also must provide: 1) a plan for the management of the clinical trial that includes collection, storage, management, quality control, and reporting of study data and a system for adverse event reporting; 2) a description of the procedures and timeline for protocol development and implementation, including preparation of the manual of operations; 3) a description of the assistance to be provided in the preparation of Investigational New Drug applications; and 4) a plan for the recruitment and retention of study participants. In addition, the application must describe the overall approaches to overcoming obstacles and limitations with respect to these activities.

Applications that propose clinical trials but lack a Concept Proposal detailed as described above will be returned to the applicant without review.

b. Projects Proposing Clinical Studies Involving the Use of Human Samples

For applications proposing a clinical study involving the use of human samples, such samples may be derived from clinical studies or clinical trials that are planned, ongoing or completed and sponsored by any source of support. Applications must include:

1) a detailed description of the proposed clinical study in the Research Plan section of the application, including: hypothesis, study objectives, study population, relevance of the proposed study to clinical disease/patient outcome, statistical design and analysis plan, plan for management and quality control of data, and plan for receipt and storage of human samples.

2) documentation of the ability to acquire human samples, including written agreements between the Principal Investigator and the applicant institution, the clinical trial sponsor(s), including drug companies, if applicable, and the IND sponsor, if not one of the above, for the conduct of the proposed studies proposed in the application.

3) the complete clinical protocol and informed consent form(s) for the associated clinical study/trial from which samples will be obtained (to be provided as an appendix). NIH will treat as confidential any scientific, pre-clinical, clinical, or formulation data and information that the sponsor deems to be proprietary and confidential.

4) a draft consent form, where necessary, to obtain human samples not provided for in the associated clinical trial/study.

2. Administrative Core

A detailed plan, under the direction of the Principal Investigator, that addresses Program oversight, daily operations, promotion of collaborations, and participation in Steering Committee meetings and other AADCRC activities. The Administrative Core budget request should also include travel funds for the Principal Investigator to participate in annual Steering Committee meetings, and PI and subproject PIs to attend an annual two-day AADCRC scientific meeting to be held in conjunction with the Steering Committee meeting in Bethesda, Maryland.

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 without an administrative core plan will be considered non-responsive and will be withdrawn from further consideration without peer review. The applicant will be informed of this action.

3. Documentation of Commitment to the Collaborative Group

A written commitment, signed by the Principal Investigator and the applicant institution, to participate in the cooperative research program, including serving on the Steering Committee, adhering to Steering Committee policies and decisions, and accepting the participation and assistance of NIH staff in accordance with the guidelines described in Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award: NIH Responsibilities.

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 (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm). 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.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below.

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

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.

Review Criteria for the Overall Application

The following items will be considered in the determination of overall scientific merit and priority score for the entire application:

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

If peer reviewers deem that fewer than the required two research projects have substantial and significant merit, the application is recommended for no further consideration.

Review criteria for the overall application:

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 preventive 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?

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

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

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

Review Criteria for Individual Research Projects

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? Are the plans for statistical design and analyses of clinical studies, and overall strategy and approaches for data management and quality control sound and appropriate?

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

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

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

Review Criteria for Clinical Research Projects

For clinical studies involving human samples, is the rationale for the relevance of the proposed clinical study to human asthma and/or allergic diseases sound and with high scientific merit?

Review Criteria for a Concept Proposal for a Clinical Trial

Are the rationale and scientific merit of the concept proposal presented within the Research Plan sound and with high scientific merit? Is there potential for the clinical trial to advance the prevention and/or treatment of asthma and/or allergic diseases? Are the selection of the study population, the applicant’s plans for managing the proposed trial, including management and reporting of study data, procedures and the timeline for protocol development and implementation, plans for preparation of an Investigational New Drug application, and plans for recruitment and retention of study participants sound and feasible? Are the applicant’s overall approaches to overcoming obstacles and limitations sound and feasible?

Review Criteria for Cores

Administrative Core

Scientific Research Cores

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: 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/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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 will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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.

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 PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the multi-project cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for the project as a whole, including research design and conduct, data collection, quality control, data analysis and interpretation, preparation of publications, and collaborations with other awardees. Each PI will be a voting member of the Steering Committee, will participate in all Steering Committee activities, and will follow the policies and procedures developed by the Steering Committee.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must be committed to making the biological samples, diagnostic products, and other research tools, methods, data, and materials that they develop under AADCRC awards available to the AADCRC and the research community.

2.A.2. Monitoring Clinical Studies

If clinical research or clinical trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

All clinical research activities performed under this award must be in compliance with all U.S. Federal regulations, guidance and NIH policies applying to the conduct of research involving human subjects and regulatory application for new drug or biological licenses when applicable. These include, but are not limited to, U.S. Code of Federal Regulations (CFR) Title 21, Parts 11, 50, 54, 56, 312, 314, 601 and Title 45, Part 46; ICH guidance for Good Clinical Practice (GCP); and NIH grants policy (refer to http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). In addition, the Awardee must assure that all sites in the U.S. and outside the U.S. comply with the following:

a. Each institution engaged in human subjects research has a current, approved Assurance Number on file with the DHHS Office for Human Research Protections (OHRP).

b. Each protocol and informed consent document is approved by the responsible Institutional Review Board (IRB)/Ethics Committee (EC) prior to subject entry.

c. For Investigational New Drug (IND) studies, each local Investigator of Record has supplied a completed FDA Form 1572 to NIAID for each protocol conducted at each site.

d. Each study investigator and sub-investigator has provided current curriculum vitae to NIAID.

e. Each study participant (or legal representative) will sign an IRB/EC-approved protocol consent prior to entry on study as part of the Informed Consent Process.

All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for human subjects.

2.A.3. NIH Responsibilities

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

NIH Project Scientists, with the assistance from other NIAID and NIH scientific program staff as determined by research topic and relevant expertise, will have substantial scientific/programmatic involvement during the conduct of this activity through provision of technical assistance, advice and coordination above and beyond normal program stewardship for grants as detailed below.

The NIH Project Scientists will serve as two voting members of the Steering Committee, actively assist the Chair in developing the meeting agendas, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions and policies.

2.A.4 Clinical Research Responsibilities

The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as a liaison between pharmaceutical companies, the Food and Drug Administration (FDA), and AADCRC investigators. In accordance with NIH policy, all clinical trials performed through the AADCRC must be conducted in accordance with ICH Good Clinical Practices and applicable Federal regulations.

1. Clinical Trials Agreements (CTA). A CTA, describing the responsibilities and rights of each party, will be negotiated between the NIAID and pharmaceutical or device collaborators who provide an investigational agent or device for a clinical study. The agreement will include, but is not limited to, Investigational New Drug (IND) sponsorship, IND drug supply, safety and data monitoring, publication rights, and access to data. AADCRC PIs will be informed of relevant content of the CTA.

2. Investigational New Drug Applications (IND). For most clinical trials supported under this RFA, either NIAID or the organization supplying the investigational agent or device will serve as the IND/IDE (Investigational Device Exemptions) sponsor. Under certain circumstances, NIAID and an awardee may mutually agree to have the PI serve as the IND/IDE sponsor. If NIAID holds the IND for clinical trials supported by this RFA, DAIT will provide oversight on the development, assembly, and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the FDA or other applicable health authorities.

3. Site Monitoring. If NIAID holds the IND for clinical trials supported by this RFA, DAIT will be responsible for monitoring compliance with good clinical research practices, regulatory compliance, accurate protocol implementation, internal quality assurance, and test agent accountability at the clinical research sites. In studies where NIAID does not serve as the IND sponsor, NIAID will review status and results of clinical trials, and provide oversight of data and safety monitoring.

4. Safety Reports. If NIAID holds the IND for clinical trials supported by this RFA, DAIT will be responsible for reporting of safety information in accordance with FDA requirements. An NIAID Medical Officer will monitor the clinical trials and serve as the Medical Monitor.

2.A.5 Protocol Development, Implementation, and Oversight

1. Protocol Development. DAIT staff will participate with AADCRC Principal Investigators in the development of clinical research protocols for projects supported by this RFA.

2. Protocol Review and Approval. All clinical research protocols must be approved by the DAIT Medical Monitor and the DAIT Clinical Research Committee.

3. Data and Safety Monitoring Board. DAIT requires any protocols deemed to possess more than minimal risks be reviewed by an independent NIAID Data and Safety Monitoring Board (DSMB). NIAID will use this independent DSMB to advise the NIAID on issues pertaining to appropriateness of clinical protocols and the conduct and safety of clinical research and clinical trials supported by this RFA. Information will also be provided to the Principal Investigator, the Project Leader and the Steering Committee. The DSMB will meet at least twice a year, by teleconference or in the Bethesda, MD vicinity. The NIH Project Scientist will be responsible for organizing DSMB meetings and teleconferences.

4. Study Termination. NIAID reserves the right to terminate or curtail a clinical study for any of the following reasons: (1) risk to subject safety; (2) the scientific question is no longer relevant or the objectives will not be met; (3) failure to comply with Good Clinical Practices, federal regulations, or Terms and Conditions of Award; (4) occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity; (5) risks that cannot be adequately quantified; (6) failure to remedy deficiencies identified through site monitoring; (7) substandard data; (8) inadequate progress in fulfilling the research agenda; (9) slow accrual; or (10) reaching a major study endpoint substantially before schedule with persuasive statistical significance.

5. Access to Data. The NIH Project Scientist or designee will have access to all data generated under this cooperative agreement, and may review the data as recorded on the case report forms or in a database. Data must be available for external checking against the original source documentation as required by federal regulation and DAIT as the IND sponsor. The NIH may provide public access to selected data sets generated with the use of public funds within a reasonable time after the primary analysis and publication.

2.A.6 Performance Monitoring

The NIH Project Scientist, together with the Steering Committee, will review the performance of each participating AADCRC through consideration of annual reports, site visits, and compliance with Steering Committee procedures.

Additionally, an agency program official of IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official will monitor program progress, approve changes, have access to data generated under these awards, and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.

2.A.7 Collaborative Responsibilities

A Steering Committee will serve as the governing board for the AADCRC, its actions and decisions will be determined by majority vote. Membership will include two NIAID Project Scientists and the Principal Investigators of the awardees under this RFA, as well as the continuing AADCRCs awarded under RFA-AI-05-027. Of the two NIAID voting members, one is designated as the asthma scientific coordinator, and one as the allergic diseases scientific coordinator. A Steering Committee Chair from among non-federal Steering Committee members will be elected by majority vote at the Steering Committee meeting. Each member will have one vote. All Steering Committee members must agree to participate in quarterly teleconferences, and annual face-to-face meetings. Members of the Steering Committee will be required to accept and implement common guidelines and procedures approved by the Steering Committee.

Responsibilities of the Steering Committee include the following:

2.A.8 Meetings

NIAID will arrange quarterly Steering Committee teleconferences, and annual face-to-face meetings in conjunction with the annual AADCRC scientific meeting. The annual AADCRC scientific meeting is open to the members of AADCRC. The annual scientific meeting is a forum for members of AADCRC to provide the latest update on their research, exchange ideas and information, and discuss collaborations among members of AADCRC. Meeting participants will identify the group's tangible resources, capabilities, and needs to advance the AADCRC's overall goals. The PI of each AADCRC or their designated representative is required to make an oral presentation on current and planned activities and projects. The two-day scientific meeting will be held each year in Bethesda, Maryland.

2.A.9 Arbitration Process

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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:

Gang Dong, M.D., Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3101, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-8973
FAX: (301) 402-0175
Email: [email protected]

2. Peer Review Contacts:

Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Phone: 301-435-9369
Fax: 301-480-2310
Email: [email protected]

3. Financial or Grants Management Contacts:

Heidi Young
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2247, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 496-7075
FAX: (301) 480-3780
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citation: No. 93.855, Immunology, Allergy, and Transplantation Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

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