Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www3.niaid.nih.gov/)
Office of Research on Women’s Health (ORWH), http://orwh.od.nih.gov/ 

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

Announcement Type
The Funding Opportunity Announcement (FOA) is a reissue of RFA-AI-07-002.

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

Request For Applications (RFA) Number:  RFA-AI-10-013

Catalog of Federal Domestic Assistance Number(s)
93.855

Key Dates
Release Date:  June 16, 2010
Letters of Intent Receipt Date: September 7, 2010
Application Receipt Date: October 7, 2010
Peer Review Date: February, 2011
Council Review Date: May, 2011
Earliest Anticipated Start Date:  July, 2011
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: October 8, 2010

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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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 renewal 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 centers that integrate clinical and basic research to conduct studies on the mechanisms underlying the onset and progression of asthma and allergic diseases including allergic rhinitis, chronic rhinosinusitis, atopic dermatitis and food allergy. The overarching goal of the program is to improve the understanding of the pathogenesis and diagnosis and treatment of asthma and allergic diseases, and to provide a rational foundation for the development of effective treatment and prevention strategies.

Background

Asthma and allergic diseases are among the major causes of illness and disability in the United States for all ages; the trend of the diseases is still on the 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. Major allergic disease types include asthma, allergic rhinitis, chronic rhinosinusitis, atopic dermatitis, and food allergy. Asthma affects 7.3% of adults and 9.4% of children, with more than 23 million people in the US having this disease. Worldwide, number of people with asthma is predicted to increase by more than 100 million by 2025. Allergic rhinitis is estimated to affect approximately 60 million people in the US. Chronic rhinosinusitis is one of the leading forms of chronic disease in the US. Thirty-one million people suffer from chronic rhinosinusitis, leading to roughly 15 million doctor visits and 200,000 sinus surgical procedures each year. Atopic dermatitis affects 10% to 20% of children and 1% to 3% of adults in the US. Food allergy affects about 6 to 8% of children under the age of four, and more than 3.7% of adults in the US. More significantly, food allergy is the most frequent single cause of emergency room visits for anaphylaxis and accounts for 34 to 52% of these visits. As the adverse impact of asthma and allergic diseases on public health continues to grow, there is an urgent need for the development of novel approaches to treat and, eventually, prevent these diseases.

Research during the past decades has increased our understanding of the pathogenesis of asthma and allergic diseases. A Th2-dominant immune response was long considered as the underlying mechanism of many allergic diseases. New evidence now also supports the idea that the innate immune system plays a central role in these diseases. Additional types of T cell responses (e.g. Th17) are further likely to contribute to these diseases. Other disease triggers such as viral infections, environmental pollutants, and/or other stimuli, interact with various susceptibility factors involved in innate immunity and epithelial/mucosa functions and together contribute to the pathogenesis of asthma and allergic diseases. It is widely believed that specific environmental exposures lead to the expression of allergic phenotypes in previously unaffected, but genetically predisposed individuals.

These research activities have so far only had a modest impact on therapy.  Currently, the management of asthma is complex and treatment regimens for rhinitis and chronic rhinosinusitis are aimed at controlling inflammation and alleviating symptoms.  Effective control of asthma poses stringent compliance requirements, and severe asthma is still difficult to control. In addition, most of the drugs currently used to treat asthma and allergic diseases have a number of undesirable side effects and, in some cases, overuse can actually lead to worsening of the disease. Advancement in many research areas outside asthma and allergy, however, presents important opportunities to gain fundamental knowledge about allergic diseases in humans. Additional promising opportunities are in clinical studies of patients with asthma and allergic diseases. 

The NIAID AADCRC program, established more than three decades ago as the first targeted research program in the field of asthma and allergic disease, is the cornerstone of NIAID's efforts to promote innovative, multidisciplinary clinical and basic research on asthma and allergic diseases. Supported by a multi-project grant mechanism, the program aims to leverage expertise provided by centers around the US through collaborations among researchers. The program currently supports 15 AADCRC U19 grants, 11 of them will end by mid-2011.

Research Objectives and Scope

Consistent with overall goals of the AADCRC program, the objective of this FOA is to support multidisciplinary and multi-project research programs with the focus on pathogenesis of asthma and allergic diseases in humans. Applications considered to be responsive to this FOA must be composed of a minimum of three interrelated research projects structured around a central scientific theme that is clearly relevant to the pathogenesis of, and intervention strategies for asthma and allergic diseases.

This FOA will focus on allergic diseases with high public health impact. These include asthma, allergic rhinitis, chronic rhinosinusitis, atopic dermatitis and food allergy. In order to stress the integration and focus of the applications on human disease-related mechanisms, NIAID requires that the majority of the proposed research in each application be qualified as NIH human subjects research.  (For the NIH definition of human subjects research, please see the NIH Office of Extramural Research Human Subjects website http://grants.nih.gov/grants/policy/hs/index.htm)

The NIAID seeks to receive applications under this FOA that are highly integrated and synergistic. Component projects within a single U19 application should not only relate to a central theme relevant to asthma or other allergic diseases, but also relate to the other component projects within the same application. In order to achieve this objective, NIAID highly recommends applications be drafted using one of the two models provided below. 

MODEL A

The grant application focuses on the role of an immunologic mechanism/pathway that is hypothesized to be an important pathobiologic process in asthma or other allergic diseases.  This mechanism/pathway may involve a single molecular species or several interrelated species, selected genes, a cell type, a micro-organism or a group of micro-organisms, an environmental factor or a group of environmental factors (such as allergens, adjuvants and pollutants).  The grant application will include projects that address this pathway from various perspectives including clinical studies or clinical trials, genetics, systems biology approaches, mathematical modeling, in vitro work, and animal models.  The majority of the proposed research should utilize human material (including primary human cells, biologic samples, and clinical data). Any proposed animal studies must be of relevance to human asthma and allergic diseases and the rationale for using animal studies should be based on a sound scientific need and on inability to address the hypothesis using human material.  

MODEL B

The grant application is centered around one or more clinical trials (interventions) or clinical studies (cross-sectional or short-term longitudinal observational studies, genetic studies) that test a novel therapeutic approach or mechanistic hypothesis in asthma or other allergic diseases.  The clinical trial(s) or study(ies) constitute the source of material that supports the conduct of a series of associated in vitro studies that test the central hypothesis of the grant in a comprehensive manner.  The grant application will include projects that address the clinical trial(s) or study(ies) from various perspectives including mechanistic studies, genetics, systems biology approaches, and mathematical modeling.  Animal models may be utilized in parallel to the clinical trial(s) or study(ies), only if they provide more in-depth hypothesis testing on outcomes that cannot be assessed in human trials or studies. Such animal studies should represent a minor component of the overall U19 application.

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

This FOA will not support:

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

Clinical Research Projects (required)

The majority of research proposed must meet the NIH definition of clinical research (http://grants.nih.gov/grants/policy/hs/index.htm) and should involve individuals with clinically defined asthma and/or allergic diseases, or should involve specimens from such individuals. Healthy volunteers may be included in proposed clinical studies only as controls. 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). Clinical trials, if proposed, are limited to Phase I or Phase II trials. See Section IV.6.B. Specific Instructions for Individual Research Projects, “a. Clinical trial project”, for detailed NIH definition of clinical trials. Studies using human specimens obtained from relevant ongoing or completed clinical studies or clinical trials may be proposed.

Core Facilities

Administrative Core (required): An administrative core is a resource to the multi-project grant, providing overall management, coordination and supervision of the Program.  As part of the administrative core, 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, 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.

Infrastructure and Opportunity Fund Management Core (required)

All U19 applications must include an Infrastructure and Opportunities Fund Management plan in the core. Under this FOA the AADCRC steering committee and NIAID will establish a single Infrastructure and Opportunity Fund of up to $500,000 per year to support new clinical research projects and resource development projects, led by or through collaborations with other AADCRC investigators, to capitalize on emerging opportunities in the pathophysiology and therapy of primary focus illnesses including asthma, allergic rhinitis, chronic rhinosinusitis, atopic dermatitis and food allergy. The Infrastructure and Opportunity Fund will support new research opportunities not proposed at the time of the awards. Investigators outside of the AADCRC program will be permitted to receive Infrastructure and Opportunity Fund support only through collaboration with AADCRC investigators. The Steering Committee will establish goals, priorities, and evaluation criteria for use of the funds.  After all grants have been awarded, one U19 awardee institution will be selected by the NIAID to manage the Infrastructure and Opportunity Fund for the entire AADCRC program (see Specific Instructions for Cores section).

Applications that do not include an Administrative Core and an Infrastructure and Opportunity Fund Management Core will be considered nonresponsive and will not be reviewed.

Scientific Core(s), Clinical Trial Core, Data Administration 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.  If the application proposes to conduct more than one clinical trial or clinical study, a Clinical Trial Core may be proposed.  This Core will be responsible for the organizational and regulatory aspects of the clinical trials and studies and may include data administration and analysis functions; alternatively, data administration and analysis may be conducted under a separate Data Administration and Analysis Core.

The Cores should present a clear picture of the facilities, techniques, and skills these cores 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 that will utilize each scientific core should be included in the Core budget.

Statistical Design, Analysis and Data Management and Safety Monitoring for Clinical Trials

This FOA will not support a separate, centralized stand-alone statistical and clinical coordinating center.

The applicant is responsible for including the costs of all support for statistical design, data collection, 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.

Steering Committee

NIAID, in conjunction with the Principal Investigators (PI) of all AADCRC grants will establish a Steering Committee to serve as the governing body for all AADCRC activities. All Principal Investigators must serve on the Steering Committee.  For multi-PI applications only one PI per AADCRC grant will be allowed to serve on the Steering Committee at a time.  Members of the Steering Committee will be required to accept and implement common guidelines and procedures approved by the Steering Committee. Steering Committee components and responsibilities are further described under Section VI.2.A.7.  Cooperative Agreement Terms and Conditions of Award - Collaborative Responsibilities. 
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. 

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the multi-project cooperative agreement (U19) award mechanism. The Principal Investigator (PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator (PI) 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. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The estimated amount of funds available for support of approximately 8 centers awarded as a result of this announcement is $12.4 million for fiscal year 2011. Future year amounts will depend on annual appropriations.

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 for current grantees is $1 million.  Although the financial plans of 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.

NIH grants policies as described in the http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm for instructions).

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

An investigator can serve as a PI on only one AADCRC award or application.  This includes all PIs of a multiple-PI application. In addition, the PI of each AADCRC U19 application (and every PI of a multi-PI application) must also serve as a Project Leader, and is required to commit a minimum of 25% total level of effort in AADCRC activities.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. An institution may not submit more than one application.  Current AADCRC awardees (except for renewal applications) may not submit an application for this FOA. 

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

Renewals.   Renewal applications are permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The most current 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) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

All applicants must read “6. Other Submission Requirements and Information” for specific instructions when preparing U19 applications. 

Applications with Multiple PIs 

When multiple PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PIs. NIH requires one PI be designated as the “contact PI” for all communications between the PIs and the agency. The contact PI must meet all eligibility requirements for PI status in the same way as other PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PI may be changed during the project period. The contact PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PIs listed on Form Page 1-Continued. When inserting the name of the PI in the header of each application page, use the name of the “Contact PI, et. al.” The contact PI must be from the applicant organization if PIs are from more than one institution.

All individuals designated as PI must be registered in the eRA Commons and must be assigned the PI role in that system (other roles such as SO or IAR will not give the PI the appropriate access to the application records). Each PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PI Leadership Plan: For applications designating multiple PIs, the section of the Research Plan, entitled “Multiple PI Leadership Plan” must be included. A rationale for choosing a multiple PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PIs and other collaborators. 

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

Additional information is available in the PHS 398 grant application instructions.

NOTE: Multiple PIs are not allowed on individual Projects or Cores.

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: September 7, 2010
Application Receipt Date: October 7, 2010
Peer Review Date: February, 2011
Council Review Date: May, 2011
Earliest Anticipated Start Date:  July, 2011

3.A.1. Letter of Intent

A letter of intent is not required but is requested for the funding opportunity.

Prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

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

3.B. Sending an Application to the NIH

Applications must be prepared using the forms 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:

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

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the NIAID.  Incomplete and/or 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 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 checked 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 NIH Grants Policy Statement.

All clinical research awards under this FOA are subject to the NIAID Clinical Terms of Award (see details at http://www.niaid.nih.gov/ncn/sop/ctoa.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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 renewal 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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements and Information

The following section supplements the instructions found in the PHS Form 398 for preparing the multi-project grant application (U19). 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 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 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 – Describes 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 Form PHS 398.  The multi-project grant application should be assembled and paginated as one complete document.

1. Form Page 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.

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs.  The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page-Continued.

2. Form Page 2

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.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the PD(s)/PI(s) 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. 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 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. 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. 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 Format Page

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

7. Resources Format Page

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

8. Program Overview (Research Objectives and Strategic Plan)

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.

If the application is a renewal, this section should also highlight past performance and the major accomplishments from the prior funding period as described in the PHS 398 Instructions.  In addition to discussing results from individual projects, describe the synergy and collaborations that occurred within the Program.  For individual research projects and cores that will be continued as part of a renewal application, additional details should be provided in the progress report section of the Research Strategy within each research project and core. 

9.  Leadership Plan for Multiple PDs/PIs (required if applicable)

Applications designating multiple PDs/PIs for the overall Program must include a new section, entitled “Multiple PD/PI Leadership Plan”, as part of the Program Overview.  This Plan must describe: a rationale for choosing a multiple PD/PI approach; the governance and organizational structure of the leadership team and the research projects and cores; communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts; the administrative, technical, and scientific roles and responsibilities for the PDs/PIs and other collaborators.  If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should also be delineated.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

10. Checklist.

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

11. 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.  

12. Resource Sharing Plan. One Resource Sharing plan, placed at the end of the application, is to be submitted for the entire application.

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:

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

Research Strategy

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):

Project Number and Title:  (e.g., 1. Preclinical Evaluation of HIV 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  Federal-wide 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: (e.g., $700,000)

Applicant Organization (full address)

2. Form Page 2

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

List the performance sites where the research will be conducted.

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

3. Form Page 3

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

4. Budget Pages (PHS 398 Form Pages 4 and 5)

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

5. Research Strategy

Specific Aims (Limited to 1 page.)

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

Research Strategy (Limited to (12) pages.)

Use this section to describe how the proposed research will contribute to meeting the program's goals and objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary 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 and progress reports for renewal projects as part of a renewal application must be included as part of the approach section.

Non-clinical research projects

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 projects

a. Clinical trial project: 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.

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

Study design, including:

Feasibility:

b. Clinical Study projects

For applications proposing a clinical study (non-interventional) 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. The Approach section of all clinical study projects must address the following aspects of the study:

Feasibility, including:

In addition, the following information is required and should be presented under “Section E. Protections for Human Subjects”:

1)    Listing of all interventional agents (FDA approved or not) to be used in the trial with anticipated adverse experiences

2)    Methods for adverse event identification, recording and reporting (including serious adverse events and unexpected events)

3)    Plan for independent clinical monitoring of the trial (including site monitoring visit schedule and content)

4)    Individual subject and study stopping rules

5)    For clinical study proposals that plan to obtain human samples from an associated clinical study/trial not supported by the proposed AADCRC project the additional information also needs to be included:

Human Samples Documentation

A) Documentation of the ability to acquire human samples, including written agreements between the PI, the applicant institution, the clinical study/trial sponsor(s), including drug companies, if applicable, and the IND sponsor (if not one of the above) to be used in the studies proposed by the application. This documentation should be supplied in the form of letter(s) of support.

B) A statement that the subjects from whom samples were obtained from the associated clinical study/trial not supported by the proposed AADCRC project have been consented and the material they have provided can be used by the AADCRC project.

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 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). 

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

Research Strategy

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):

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 Federal-wide 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

Direct Costs (e.g. $50,000)

Total Costs (e.g. $70,000)

Costs Requested for the Entire Budget Period

Direct Costs (e.g. $212,323)

Total Costs (e.g. $297,252)

Applicant Organization (ABC University; 111 Main Street; Anywhere, Else 99999)

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. 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.

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

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

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

4. Budget Pages (PHS 398 Form Pages 4 and 5)

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

5. Research Plan

Specific Aims (Limited to 1 page.)

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

Core Research Strategy (Limited to 6 pages.)

Use this section to describe how the proposed core activities will contribute to meeting the program'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 multi-project 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 cores and progress reports for renewal cores in a renewal application must be included as part of the approach 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).

D. Additional requirements

Infrastructure and Opportunity Fund Management (IOFM) Core (required, Limited to (6) pages.)

The IOFM plan must include: (1) an administrative structure, including proposed level of effort for all staff; (2) proposed methods/procedures to support the Steering Committee in funds disbursement, reporting, and monitoring (e.g. time interval for establishment and renewal of subcontracts, invoices to be paid, and plans for handling subcontract administration delays); (3) the experience/qualifications of the PI and all proposed IOFM Core staff; (4) documentation of institutional commitment to the administration of the opportunity fund.

A separate budget for the IOFM Core must be provided and is not to be included in the total budget of the AADCRC.

Reviewers of the grant application will be asked to provide comments on the IOFM Core, but the review will not influence the overall score of the application.

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

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

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

Scored Review Criteria 

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

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the rationale for the relevance of the proposed animal models to human asthma and/or allergic diseases sound and with high scientific merit? If a clinical trial(s) is proposed, is there potential for the clinical trial to significantly advance the prevention and/or treatment of asthma and/or allergic diseases?

Investigator(s).  Are the 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-PI, Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the clinical project leader have both the expertise/capabilities and demonstrated experience to support the clinical research activities proposed in the U19 applications as a whole? Does the clinical project leader have the experience and expertise to guide and/or assist in the development and preparation of documentation required for clinical research as well as experience with regulatory activities, including IND applications, recruitment and retention of study participants, medical monitoring, and safety oversight and reporting?  Do the investigators commit adequate effort to successfully fulfill the proposed projects’ needs?

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? If a clinical trial(s) is proposed, 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?  If animal studies are included, is the choice of animal model justified? 

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.

Additional Review Criteria for U19 Applications

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Review Criteria for Evaluating the Overall U19 Application

Review Criteria for an Administrative Core

Review Criteria for Scientific and Clinical Cores

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of overall scientific and technical merit, 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.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications.  Resubmission applications are not applicable to this FOA.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.  For renewal applications, what are the accomplishments and progress achieved during the prior funding period?

Revision Applications.  Revision applications are not applicable to this FOA.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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.

IOFM Core.  The Plan for an Infrastructure and Opportunity Fund Management will not be factored into determining the overall impact/priority score. Reviewers will comment on the appropriateness and clarity of the following elements: 1) the experience, level of commitment and availability of the IOFM core leader and staff who manage the IOFM Core; 2) the plans for administration, fiscal accountability, and reporting of opportunity funds; 3) the plans for supporting the Steering Committee and for interacting with members of AADCRC in receipt of opportunity funds.

Applications from Foreign Organizations.  Applications from Foreign Organizations are not applicable to this RFA.

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his 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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See 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 Notice of Award. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 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.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigators of the AADCRC will have the primary responsibility for:  defining the research objectives, approaches and details of the projects within the guidelines of the FOA and for performing the scientific activity. PIs are expected to assure compliance with NIH clinical research policy and NIAID Clinical Terms of the Award in all AADCRC U19 supported research activities.

Principal Investigators agree to participate in the cooperative research program, including serving on the Steering Committee, participating in Steering Committee meetings and teleconferences, 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.”

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.

The institution chosen by NIAID after award of the U19 grants to manage the IOFM must agree to take responsibility for managing the funds, including the disbursement, administration, and reporting on the use of the IOFM as approved by the Steering Committee.

Clinical Research Responsibilities

In accordance with NIH policy, all clinical trials performed through the AADCRC must be conducted in accordance with the International Conference on Harmonization (ICH) Good Clinical Practices and applicable Federal regulations.  All individuals involved in clinical research projects are expected to provide current GCP certification prior to project initiation.

1. Protocol Development, Implementation, and Oversight

a. Protocol Development. The U19 grant applications should not contain fully developed and IRB-approved clinical study or trial protocols, but should only provide the information that is requested in Section “6.Supplemental Instructions for the Preparation of Multi-Project Applications.B.7.Clinical Research Project” of this FOA.  After awards are made and with the participation of the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) staff, AADCRC Principal Investigators will fully develop the clinical research protocols for projects supported by this FOA.  AADCRC protocols will utilize the protocol templates provided by NIAID.

b. Protocol Review and Approval. All clinical research protocols will be reviewed by NIAID and, depending on their level of complexity and risk, will be further reviewed by the NIAID DAIT Clinical Research Committee and by the NIAID DAIT Data and Safety Monitoring Board (DSMB).  Prior to initiation, all clinical research protocols must be approved by an assigned NIAID DAIT Medical Officer.

c. Data and Safety Monitoring. NIAID requires any protocols deemed to possess more than minimal risks as determined by NIAID be reviewed and monitored by an independent NIAID Data and Safety Monitoring Board (DSMB). Information will be provided to the Principal Investigator, the Project Leader and the Steering Committee.

2. Investigational New Drug Applications (IND)

It is the responsibility of the Principal Investigator to contact Regulatory Authorities and obtain guidance as to the need for an IND for interventions (whether to be used for therapeutic or mechanistic purposes) that are planned to be employed in any clinical study or trial, if these interventions are not approved for the specific indication (including medical condition, age range, dose range) for which they will be used in the research project.  In most cases of clinical trials under the FOA where an IND is required, either an awardee or the organization supplying the investigational agent or device will serve as the IND/IDE (Investigational Device Exemptions) sponsor.  The sponsor of an IND is responsible for the development, assembly, and submission of all required regulatory documents, and will have to provide NIAID all required information in following NIH clinical research guidance. This includes but is not limited to all communications with the FDA (or other regulatory authority) and the IRB.  In rare cases, NIAID retains the right to become the IND/IDE sponsor.  If the NIAID is the IND/IDE sponsor, then the NIAID is responsible for the development, assembly, and submission of all required regulatory documents, unless this responsibility is otherwise delegated by the NIAID.

3. Site Monitoring

IND holders in clinical trials supported by this FOA 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.  Clinical trials will require independent monitoring through a safety and data monitoring plan that NIAID will have to approve.  An independent Medical Monitor should be included in such a plan.   

4. Safety Reports

IND holders in clinical trials supported by this FOA will be responsible for submitting complete safety reports for the FDA and for annual DSMB safety review.

5. Access to Data

Data must be available for external checking against the original source documentation as required by federal regulation.

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, per policies established by the AADCRC steering committee.

2. A.2. NIH Responsibilities

NIH project Scientists

NIH-designated Project Scientists will have substantial scientific/programmatic involvement that is above and beyond normal program stewardship in awards, as described below:  the Project Scientist may provide guidance and support in the design of research activities, may serve as a resource for protocol design and development, may provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities, may advise in the selection of sources or resources, may advise in management and technical performance. Two NIAID Project Scientists will be non-voting members of the Steering Committee and participate in all Steering Committee activities, including conference calls, subcommittees and special committees. However, the role of the NIAID Project Scientists will be to facilitate and not direct activities. It is anticipated that decisions in all activities will be reached by consensus and that the NIAID Project Scientists will participate in this process.

Clinical Research Oversight

1. Protocol Development, Approval, and Oversight. DAIT staff will participate with AADCRC Principal Investigators in the development, reviewing, and approval (as mentioned above) of clinical research protocols for projects supported by this FOA.

2. IND Applications. For clinical trials under this FOA where NIAID is not the IND holder, NIAID will provide guidance on the development and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the FDA or other applicable health authorities. NIAID retains the right to have NIAID serve as the IND sponsor.

3. Site Monitoring. If NIAID holds the IND for clinical trials supported by this FOA, 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, but the financial and organizational responsibilities for data and safety site monitoring and medical monitoring lie with the Principal Investigator of the U19 grant.

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

5. 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.

6. Access to Data. The NIH Project Scientists 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.

7.  Performance Monitoring. The NIH Project Scientists will review the performance of each participating AADCRC through consideration of annual reports, site visits, and compliance with NIH procedures.

Additionally, an NIAID program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This stewardship includes monitoring program progress, approving changes and concurring in proceeding into study implementation stage. Release of each yearly funding increment for AADCRC U19s will be based on a review of progress. The Government, via the NIAID Program Official, will have access to data generated under this Cooperative Agreement 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.  However, awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Steering Committee

A Steering Committee will serve as the governing board for AADCRC grantees. All participants in the AADCRC program are bound by the policies and procedures developed by the Steering Committee; adoption of such policies and procedures requires a majority vote.  Awardees under this FOA will be required to accept and implement policies approved by the Steering Committee.

Membership in the Steering Committee will include the PI of each AADCRC U19 award, a designated representative in the case of Multiple PI award, and the two NIH Project Scientists.  The chair will be chosen by a majority vote of the Steering Committee, with years determined by the committee. The Steering Committee meetings will be organized by the Chair of the Steering Committee.  Each U19 center will have one vote. The two NIH Project Scientists may not serve as the Chair of the Steering Committee but as non-voting members.

Steering Committee responsibilities will include:

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 a designated representative for multiple PI awards) 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.4. Dispute Resolution 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 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

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.

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
6610 Rockledge Drive, Room 6605
Bethesda, MD 20892-6601
Telephone: (301) 496-8973
FAX: (301) 480-5824
Email: gdong@niaid.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

Leslie Boggs
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2110, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-7614
FAX: (301) 402-6450
Email: boggsl@niaid.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (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.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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/archive/archive/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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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