Part I Overview Information


Department of Health and Human Services

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

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

Title:  Non-Human Primate Heart/Lung Transplantation Tolerance (U01, U19)

Announcement Type
This is a reissue of RFA-AI-04-049

Request For Applications (RFA) Number:  RFA-AI-09-041

Catalog of Federal Domestic Assistance Number(s)
93.855

Key Dates
Release Date:  August 14, 2009
Letters of Intent Receipt Date: November 17, 2009
Application Receipt Date:  December 17, 2009
Peer Review Date:  April, 2010
Council Review Date:  May, 2010
Earliest Anticipated Start Date:  July, 2010
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date:  December 18, 2009

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  
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
  
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) invites new or competitive renewal applications from institutions to participate in the heart and lung models portion of the Non-human Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) program. The overarching goals of the NHPCSG are to: (1) develop novel donor-specific tolerance induction regimens; (2) evaluate the  preclinical safety and efficacy of existing and newly developed candidate immune tolerance induction regimens; (3) develop and validate biomarkers for the induction, maintenance and/or loss of immune tolerance or for the prediction of graft rejection; and (4) elucidate the mechanisms underlying the induction, maintenance, and/or loss of tolerance in non-human primate (NHP) models of islet, kidney, heart, and lung transplantation. The currently funded heart and lung model grants in the NHPCSG will expire in FY2010.  This FOA solicits new or competing renewal applications for research projects studying only NHP models of heart and/or lung transplantation tolerance. All qualified investigators are invited to apply; prior funding under this program or other NIAID or NIH mechanisms is not required.

Background

Organ transplantation is the preferred treatment for many end-stage organ diseases when other therapies have failed or are unavailable. However, despite significant advances in immunosuppressive medications over the past 15 years that have led to one-year graft survival rates that approach or exceed 90% for most organs, long-term graft survival and, in many cases, patient survival remains poor for all organ transplants. In addition, life-long, global immunosuppressive therapy, while necessary for protection of the allograft from immune injury, is associated with significant morbidity including toxic effects that contribute to late graft failure. The immune response and drug toxicity are the leading causes of graft failure.  Advances in the induction of immune tolerance will eventually provide valuable new therapeutic strategies, which should eliminate the need for this life-long, global immunosuppressive therapy, increase long-term graft survival and life expectancy, and improve health-related quality of life. NHP transplantation studies are critical to the design of scientifically sound and ethically acceptable clinical trials, due, in part, to the close approximation of the NHP immune system and physiology to those of humans. For purposes of this FOA, immune tolerance is defined as the lack of a pathogenic immune response to allogeneic organs or cells in the absence of ongoing immunosuppressive therapy, while maintaining normal protective immune function. Research targeted to the induction of immune tolerance in solid organ and islet transplantation is a high scientific priority for the NIAID. In 1997, the NIAID initiated a scientific planning process designed to accelerate research in this area.  In 1998, the NIAID convened an Expert Panel for Research on Immune Tolerance that enthusiastically endorsed the conceptual framework, scope and timeliness of the plan and encouraged the NIAID to take a leadership role at the NIH in designing and directing major research programs in immune tolerance, particularly with respect to clinical immune tolerance research programs. Two subsequent panels, the NIAID Expert Panel on Ethical Issues in Clinical Trials of Transplant Tolerance  and the Expert Review Panel for NIAID's Extramural Transplantation Research Program identified NHP tolerance research as an essential step to provide "...critical data on safety, toxicity and potential efficacy that can not be obtained ethically in human clinical trials”.

In response to these recommendations, NIAID and NIDDK formally established a program in NHP models of kidney and islet transplantation in 1999 (RFA AI-99-003, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-99-003.html), expanded it in 2002 (RFA AI-01-006, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-01-006.html ), and renewed the kidney and islet portion of the NHPCSG in 2007 (RFA AI-06-018, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-06-018.html ). In addition, due to the rising costs and decreasing availability of specific pathogen-free (SPF) Cynomolgus macaques (Macaca fascicularis) and Indian Rhesus macaques (Macaca mulatta), NIAID established breeding colonies of these monkey species to help support the research efforts of the NHPCSG. In 2004, NIAID and NIDDK established a Discretionary Fund with the Special Statutory Funding Program for Type 1 Diabetes Research appropriation to capitalize on emerging opportunities through the funding of new pilot and feasibility studies using islet and kidney models and to fund a secure website for NHPCSG administrative activities.

In 2004, following the expansion of scope of human clinical trials supported by NIAID to include organs and tissues beyond kidney and islet transplantation, the NHPCSG scope was similarly expanded to include heart and lung transplantation models. This reflects the need to improve outcomes of human heart and lung transplantation as well as the view that graft rejection is an immunological disease with issues that are shared across all organs and tissues (RFA AI-04-049, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-04-049.html ). Studies in any type of organ transplant may offer unique insights into various facets of immune tolerance induction and graft rejection. Therefore, what is learned regarding tolerance induction and graft rejection in one organ may inform the development of therapeutic strategies for other organs and tissues.

The clinical outcome of heart and lung transplantation underscores the need for further research into the immunobiology of thoracic organ transplantation. Five-year graft survival rates in the range of 73% among heart transplant recipients are similar to the 71% and 81% graft survival seen in deceased and living donor kidney transplant recipients, respectively. Patient survival rates are more discrepant – 74% in heart versus 85% and 93% in deceased and living donor kidney – due, in part, to the availability of dialysis for those with a failed kidney, and the absence of a comparable life support system for heart recipients with a failed graft. In addition, chronic rejection in heart transplantation is often “silent,” with the initial presentation resulting in death. In contrast to monitoring of kidney function, non-invasive monitoring of cardiac function is not sensitive to the development of chronic rejection. Lung transplantation has an extremely poor five-year graft survival rate of approximately 46%, with similarly poor patient survival rates. It may be that the lung’s primary role in the host defense against airborne pathogens and its unique immune environment contribute to increased immune injury after lung transplantation.

In 2005, two external scientific advisory panels (NIDDK Meeting on the Special Statutory Funding Program for Type 1 Diabetes Research and NIH Expert Panel on Transplantation) reviewed the NHPCSG program and concurred that continued support of this pre-clinical research program is a critical and high priority area of transplantation research. Currently, the NHPCSG consist of two islet/kidney U19s, five kidney U01s, one heart U01, and one heart/lung U19. The NHPCSG heart and lung transplantation awards will expire in FY 2010. Therefore, this FOA solicits new or competing renewal applications for NHP heart and lung models of transplantation tolerance to continue this expiring portion of the NHPCSG program.

Research Objectives and Scope

Research projects to be supported under this FOA are limited to NHP heart and/or lung transplantation models. Specifically, this FOA calls for the use of any NHP species for allogeneic studies of heart and/or lung transplantation. While individual approaches may vary significantly, the research scope of the applications is restricted to, and must be clearly relevant to the following broad areas:

(1) Development of novel candidate, donor-specific tolerance induction regimens or refinement of existing regimens;

(2) Assessment of the safety and/or efficacy of existing and newly developed candidate immune tolerance regimens in preparation for clinical trials;

(3) Definition of the underlying mechanisms of action of the therapeutic approaches under investigation and/or the mechanisms of induction, maintenance and/or loss of tolerance; and

(4) Development, evaluation, and validation of biomarkers for the induction, maintenance and/or loss of immune tolerance and/or for the onset of acute or chronic graft rejection.

All U01 and U19 applications must contain at least one candidate tolerogenic approach. U01 applications must have at least one aim devoted to (3) and/or (4) above. U19 applications must have at least one aim in each project or one project completely devoted to (3) and/or (4) above.

This FOA will NOT support:

Applications not meeting these requirements will be considered non-responsive to this FOA and will not be reviewed.

Applicants are encouraged to contact NIAID program staff, listed below under Section VII. 1. Agency Contacts, well in advance of the application submission date to discuss the proposed research program. This will allow staff to assess responsiveness to this FOA and provide appropriate guidance as needed with regard to this initiative. Discussion with program staff does not guarantee funding of an application.

Steering Committee

The currently established NHPCSG Steering Committee serves as the governing body of the entire NHPCSG and responsibilities include identifying scientific opportunities, emerging needs, and impediments; preparing cumulative progress reports, when requested by the NIAID Project Scientist; and overseeing group collaborations whenever applicable. The voting membership of the Steering Committee is comprised of one U01/U19 PD/PI from each U01 and U19 award, and one additional U19 project leader from each U19 award, to be selected by the U19 PD(s)/PI(s). The Steering Committee will meet at least once annually. Unless agreed to by the NIAID Project Scientist, annual meetings will be held in Bethesda, MD. Budget requests should include travel funds to attend Steering Committee meetings for the PD(s)/PI(s) and for one project leader for U19 projects. For more information about the Steering Committee composition and responsibilities, please see Section VI.2.A.3 “Collaborative Responsibilities”.

The PD/PI must document commitment to participate in the NHPCSG, by serving as a voting member on the Steering Committee signed by the PD/PI and the applicant institution, to participate in the cooperative research program, including serving on the Steering Committee, adhering to Steering Committee polices 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.

Non-human Primate Resources

The NIAID owns and maintains specific pathogen-free (SPF) NHP breeding colonies of Cynomolgus macaques (several countries of origin) and Indian Rhesus macaques to support the studies funded through the NHPCSG.  Provision of NHPs from the NIAID breeding colonies to NHPCSG investigators is determined by availability, scientific priority, and recommendations by the Steering Committee. The NIAID Project Scientist makes final decisions regarding allocation of these resources. The Steering Committee provides scientific advice and recommendations to the NIAID regarding breeding strategies and other considerations to assure the optimum long-range value of these resources to the research community.  NIAID does not guarantee availability of animals to NHPCSG investigators, particularly when special NHP requirements of a study are limiting, e.g. full or half sibling pairs that are major histocompatibility antigen “haplotype” matched. See SectionIV.6. “Application and Submission Information.”

Additional Information for Single Project (U01) Applications

A U01 application may contain only one project, although a project should be comprised of several specific aims. Administrative or Scientific Cores are not allowed in U01 applications.

Additional Information for Multi-Project (U19) Applications

Research Project: If submitting a multi-project (U19) application, at least two research projects must be proposed for the application to be considered responsive.

A. Administrative Core (required)

Each application should provide for an Administrative Core headed by the contact PD/PI of the application who is responsible for the overall program management, communication, coordination and supervision of the Program. This core may provide administration, promotion of collaborations, and participation in Steering Committee meetings and other NHPCSG activities. The following conditions apply:

B. Scientific Core(s) (optional)

One or more Scientific Cores may be proposed in a U19 application.  Each Scientific Core must serve as a resource for at least two research projects. The application must indicate the specific projects to be served by the Scientific Core(s). This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide and describe the role of the Scientific Core Leader and each of the key participants. The apportionment of dollars or percentage of dollars that will be required to support each component research project that will utilize each scientific core should also be presented.

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 NIH cooperative agreement award mechanism (U01 and U19).  The Project Director/Principal Investigator (PD/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 Project Director/Principal Investigator (PD/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".

The total project period for applications submitted in response to this FOA may not exceed five years. 

At this time, NIAID has not determined whether this solicitation will be continued beyond the present FOA.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plan of the IC(s) provides 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://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

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

More than one PD/PI, or multiple PDs/PIs, may be designated on the application.  However, only one U19 Project Leader or Core Leader may be designated for each project or core within the application.

A PD/PI, multiple PD/PI, or U19 Project or Core Leader may serve as a collaborator or a U19 Project or Core Leader for another application provided there is no scientific overlap with the application submitted by the PI, multiple PD/PI, or U19 Project or Core Leader. However, an investigator may only be a PD/PI or multiple PD/PI on one application, including PD/PIs with grants in the current islet/kidney portion of the NHPCSG.

The PD/PI or multiple PD/PI is expected to commit substantial time and effort to ensure success of the program and should commit a minimum effort of 1.8 calendar months per year. U19 Project Leaders should commit a minimum effort of 1.2 calendar months per year.

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 submit more than one application as the applicant institution, provided they are scientifically distinct.

Resubmissions.  Resubmissions will not be accepted for 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 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

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.

Applicants should follow PHS398 instructions when preparing single project applications (U01). For preparing multi-project applications (U19) applicants should follow the Supplemental Instructions for the Preparation of Multi-Project Applications below.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs 

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

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

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

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, 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 PDs/PIs and other collaborators. 

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

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

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
Application Receipt Date:  December 17, 2009
Letters of Intent Receipt Date: November 17, 2009
Peer Review Date:  April 2010
Council Review Date:  May 2010
Earliest Anticipated Start Date:  July 2010

3.A.1. Letter of Intent  

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

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

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

The letter of intent should be sent to:

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 (U.S. Postal Service or regular mail)
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone:  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 (U.S. Postal Service or regular mail)
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone:  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.). An application received after that date is considered late and will not be reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. 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.

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.

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

Supplemental Instructions for the Preparation of Multi-Project Applications (U19 applicants only)

The following section supplements the instructions found in Form PHS 398 for preparing multi-project grant applications (U19).  Additional instructions are required because the Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.  Applicants preparing single project applications (U01) should follow the PHS Form 398.

The order of presentation should be as follows:

The supplemental instructions below are divided as follows:

A.  General Instructions

B.  Specific Instructions for Individual Projects

C.  Specific Instructions for Cores

A.  General Instructions

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

1.  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.

2.  Form Page 2

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

List the performance sites where the research will be conducted.

Under "Key Personnel", list the PD/PI(s) of the multi-project application, followed by the Project and Core Leaders of the component research projects and cores, 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 with regard to proposed projects and administrative 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 the administrative core. A page reference should be included for the budget for each project and the administrative core. Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4.  Composite Budget

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

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

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850

 

 

 

 

5.  Form Page 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below).

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 PD/PI(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 identifies and describes the overall focus of the proposed Program and summarizes the general research plan for this multi-project application. This is an important section wherein the investigative team can provide the concept of the program by stating the general problem area and then defining their strategic plan. This section should include a brief discussion of the central theme, goals, and objectives of the Program, the organizational structure of the proposed Program, the participating institutions/organizations, and the role of all participating members. The position of each project and the administrative core in the overall scheme should be clearly presented as well as how the individual projects contribute to the Program’s overarching theme or approach. 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 that will be continued, additional details should be provided in the Progress Report section of the Research Plan within each research project and core.

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

For applications designating multiple PDs/PIs, a section entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, 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 program should be delineated for the PDs/PIs and other collaborators including responsibilities for human subjects and animal studies as appropriate.

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

10.  Checklist

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

11.  Appendix Materials

For each project or core in the multi-project application, 3 unpublished but accepted manuscripts plus other approved material are allowed. For additional information, see Section IV.6 “Other Submission Requirements and Information”.

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.

Each individual Research Project must include:

1.  Cover Page

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

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

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

Human Subjects: (Yes or No)

If Yes:

Exemption number, -or-

IRB Approval Date (e.g., 12/13/2006,or "Pending"), and  Federalwide Assurance (FWA) number

Vertebrate Animals: (Yes or No)

If Yes:

IACUC Approval Date (e.g., 11/17/2006, or Pending) and Animal welfare assurance number:

Proposed Period of Support:

From: (mmddyy - e.g., 07/01/2007)

To: (mmddyy - e.g., 06/30/2112)

Costs Requested for Initial Budget Period: (e.g. 07/01/2007-06/30/2008)

Direct Costs: (e.g., $ 150,000)

Total Costs: (e.g., $162,000)

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

Direct Costs: (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 the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute towards attainment of the multi-project program objectives.

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.  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).

6.  Resources Format Page

Provide information on resources available for the project.

7.  Research Plan (Items 2-5 cannot exceed 25 pages)

Item 2 -- Specific Aims: 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. This section is typically one page.

Item 3 -- Background and Significance: 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.

Item 4 -- Preliminary Studies/Progress Report: Follow the approach best suited to your application.

Item 5 -- Research Design and Methods: Describe the research design, procedures, experiments, and materials necessary to accomplish the specific aims. Discuss potential problems with your approach and present alternatives. Justify your proposed techniques and explain how they are better than the existing technology. Provide a timetable with contingency plans.

8.  Appendix

All appendix material should be collated as one body of material and submitted on CD as described below in Section IV.6.

C.  Specific Instructions for Cores

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.

Each Core must include:

1.  Cover Page

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

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

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

Human Subjects (Yes or No)

If Yes,

Exemption Number, -or-

IRB Approval Date (e.g., 5/14/06, or Pending), and Federalwide Assurance (FWA) number

Vertebrate Animals (Yes or No)

If Yes,

IACUC Approval Date (e.g., 4/15/07, or Pending), and Animal welfare assurance number

Proposed Period of Support

From: (mmddyy, e.g., 07/01/2007)

To: (mmddyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period

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)

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 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 core using Form Pages 4 and 5 of the PHS 398

5.  Biographical Sketches

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

6.  Resources Format Page

Provide information on resources available for the core.

7.  Core Research Plan

Note: Items 2-5 cannot exceed 10 pages for the Administrative Core and 15 pages for each Scientific Core.

Item 2 –Specific Aims: List in priority order the broad, long-range objectives of the proposed core.  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.

Item 3 - Background and Significance:  Use this section to describe how the proposed core activities will contribute to meeting the goals and objectives and explain the rationale for the 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 grant.

Item 4 -- Preliminary Studies/Progress Report: Describe the proposed core's services and expertise in providing those services for the program. Show how the core will further the program's goals.

Item 5 -- Research Design and Methods: State the roles and responsibilities of the administrative core leader and functions of the proposed core. Include a detailed description of the core's facilities, approaches, support, and plans for prioritizing its services.

8.  Appendix

All appendix materials should be collated as one body of material and submitted on CD as described below in Section IV.6.

Supplementary Information for applications involving purchase of animals

1.    Costs for purchasing animals through other sources should be included in the Budget Proposal due to the possibility that NIAID animal resources may be inadequate to meet all of the research needs of the NHPCSG or meet the special requirements of projects.  In addition, NIAID may elect to implement a cost recovery program in the future and/or decrease the award by the amount budgeted for purchase of animals when these animals are supplied through the NIAID colonies.  However, when NHPs are provided by the NIAID colonies, costs for all shipping, handling, and special testing fees will be the responsibility of the grantee. In future years NIAID may implement a cost recovery program for provision of the NIAID animals.

2.    Assume for purposes of the research plan that NHPs will not be provided by the NIAID breeding facility.

3.    Although Foreign institutions are not eligible to apply, they are eligible for inclusion as collaborators.  Note that animals from the NIAID breeding colonies may not be available for shipment to non-US sites, depending on the specific country’s import regulations and cost considerations.

Special Requirements for all U01 Applications and Individual Research Projects in U19 Applications:

Following items 2-5 of the Research Plan and within the 25 page Research Plan page limit of single project (U01) applications, and individual research projects in a multi-project (U19) application, applicants should include the following:

1.  A section titled Timelines and Milestones with clearly stated interim and long-term objectives and milestones to be achieved during the project, identify impediments or critical decision points that could require a revision in the work plan, and provide a detailed timeline for the attainment of each goal for each proposed research project.

2.  A section titled Reagent Availability: provide the source of and timeline for the availability or expected availability of all critical non-commercially available reagents or therapeutic agents proposed. In addition provide letters of commitment documenting the availability and anticipated timelines for supplying the reagents 

3.  Where appropriate, include a synopsis and treatment diagram/timeline of the proposed treatment protocol(s).

Special Requirements for U19 applications under this FOA:

As part of the Program Overview section in multi-project U19 applications, applicants must provide: a clear and concise plan that depicts the interrelationships among the research groups, their relevant experience/expertise, and the contribution of each to fulfillment of the objectives of this FOA; and an organizational chart of the U19 cooperative group showing the name, organization, and scientific discipline of the PD/PI and of all key scientific and technical personnel, as well as a discussion of lines of authority and plans for the coordination of research projects. If the application is from a consortium of institutions, the applicant must provide a plan to assure the maintenance of close cooperation and effective communication among members of the U19 cooperative group. 

Research Plan Page Limitations

See Section IV.2, “Content and Form of Application Submission” for research plan page limitations.

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 of the Research Plan component. 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: Regardless of the amount requested, investigators 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

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 following will be considered in making funding decisions:

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. 

Review Criteria for the Determination of the Scientific Merit of U01 Applications and Individual U19 Projects

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 core review criteria, and additional review criteria (as applicable for the project proposed). 

Core 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? What is the likelihood that the results of the proposed studies will be translated into or contribute to new approaches that are timely for future studies in NHPs and relevant to human transplantation?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is the level of effort of the PD/PI, multiple PDs/PIs and/or U19 Project Leader sufficient to ensure success of the program? Is the NHP transplantation expertise of the key personnel sufficient to ensure success of the program?

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Are reagents or therapeutics needed for the conduct of the study available or is it reasonable to assume they will be developed or available in the proposed time-frame? Are the approaches timely and justified for NHP research?

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?  Are appropriate and sufficient animal housing and care facilities and personnel available to the investigators to carry out the proposed work?

Additional Review Criteria for U19 Multi-Project Applications:

Overall Scientific Merit and Impact of the Multi-Project U19 ApplicationThe following items will be considered in the determination of the overall scientific and technical merit and impact/priority score for the entire multi-project application:  Is the program as a whole scientifically compelling? Will the coordination and synergy of the individual research projects and cores lead towards the achievement of the central objectives of the U19? Will the integration of the individual projects into a single program be more beneficial than pursuing each project independently?  Does/Do the PD(s)/PI(s) have the leadership and scientific ability to develop an integrated and focused research program?  Will the PD(s)/PI(s) and other Project/Core Leaders devote adequate time and effort to the program?  For renewal applications, what are the accomplishments and progress achieved during the prior funding period? For applications designated multiple PDs/PIs, is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PDs/PIs? 

Administrative Core:  Reviewers will consider each of the criteria below in the determination of merit.  Is the administrative and organizational structure appropriate and adequate to the attainment of the objective(s) of the proposed program?  Is the management plan for fiscal accountability, contractual agreements, and communication within the program appropriate?  Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate? Are the administrative plans for the management of projects, including plans for resolving conflicts, appropriate? Are the experience, level of commitment, and availability of the Administrative Core Leader and administrative staff adequate to manage the program?

Scientific Cores (if applicable):  Reviewers will consider each of the criteria below in the determination of scientific and technical merit: Is provision of resources and core services for the individual Research Projects critical and justified? Is the relationship of a scientific core to the central focus of the overall program strong?  Are the quality of the relevant facilities or services provided and criteria for prioritization and usage appropriate?  Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?

Additional Review Criteria.  As applicable for the project proposed, reviewers will consider the following additional items in the determination of 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.  If applicable, the committee will evaluate the acquisition, preparation and care of the solid organs, tissues or cells to be used in the studies and the proposed methods source, quantity and number of NHP samplings/biopsies required.

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.

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.

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.

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.

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (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).

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/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 Investigator (PD/PI) will have the primary responsibility for:  defining the research plan, approaches, details, and goals within the guidelines of this FOA; setting project goals, milestones, and timelines to achieve the proposed goals; overseeing/performing the scientific activities of the plan; ensuring successful completion of milestones within the timeframe and budget proposed; cooperating with NIAID programmatic, technical, and administrative staff; and administratively managing the U19 or U01.

Each U01 and U19 will have one and two votes on the existing NHPCSG Steering Committee, respectively. Each PD/PI will attend Steering Committee meetings and serve as a voting member of the Steering Committee. However, only one PD/PI, if multiple PDs/PIs, will be a voting member per award and, for the initial year, the voting member will be the Contact PI, but may rotate to another PD/PI in subsequent years to be determined by the multiple PD(s)/PI(s) of the award. Other PD/PIs from multi-PD/PI award will be non-voting members of the Steering Committee.  In addition, each U19 PD/PI will appoint one Project Leader from their U19 to be a voting member of the Steering Committee. The Project Leader voting membership may rotate between Project Leaders at the U19 PD/PI’s discretion. The PDs/PIs will participate in all Steering Committee activities, attend Steering Committee meetings, and will follow the policies and procedures developed by the Steering Committee. Other members of the U awards may serve as non-voting members as determined by the Steering Committee.

NIAID intends to support the peer-reviewed studies/specific aims proposed in the awarded grant applications.  However, under special circumstances (e.g. duplicative or overlapping specific aims between two awardees), the Steering Committee will establish guidelines and review procedures for modification of the peer-reviewed aims or initiation of new projects, and will evaluate and determine opportunities for collaboration with outside investigators and redirection of resources when applicable and necessary. In addition, all awardees, upon acceptance of an award, agree to participate in all collaborative studies, including those that involve collaborations with biotechnology and pharmaceutical companies, as specified by the Steering Committee and which may be requested by NIAID. This policy is in keeping with the terms and conditions of the cooperative agreement mechanism. Any recommendations that result in a change in the scope of a research project must be approved by the NIAID program Official and Grants Management Specialist.  

The PD/PI will ensure that all non-human primates obtained from the NIAID breeding colonies are used only for the expressed purposes of the individual Cooperative Agreements funded through this FOA or proposals approved by the Steering Committee. A letter from the PI stating compliance with this policy will be required prior to award.

All NHPCSG investigators, including collaborators with effort on the U awards, are eligible to apply for future Discretionary Fund awards. These Discretionary Fund awards are administered by the Steering Committee as part of the NHPCSG program and are not part of the current FOA or applications. Until such time as Discretionary Funds are provided for heart and lung model studies, the Discretionary Fund may only support studies that use islet or kidney models and that  meet the guidelines established by the NHPCSG Steering Committee. The PD/PI of each U01 or U19 will be responsible for ensuring that all Discretionary Fund awards adhere to the rules and guidelines of the NHPCSG Steering Committee.

The PD/PI will be responsible for the timely submission for publication of manuscripts (co)authored by members of the grant and supported in part or in total under this Agreement.  All publications and presentation abstracts resulting from work done in this consortium will be submitted to the Program Officer at least one week prior to journal submission for review, and within two weeks of acceptance for publication so that an up-to-date summary of the cooperative program accomplishments can be maintained and NIAID press releases can be prepared, if applicable.  Publications or oral presentations of work performed under this Agreement are the responsibility of the PD/PI and appropriate Project Leaders and require acknowledgement of NIAID support. Timely publication of major findings is encouraged.

Awardees are expected to make new information and materials, including research samples, tools, materials, methods, data, and animal models developed under the NHPCSG grants known and available to the research community and other members of this program in a timely manner through publications, web announcements, and reports to the NIAID or other mechanisms, subject to the rights described below.

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.

2. A.2. NIH Responsibilities

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

A program official from the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as the NIAID Project Scientist for this program.  The NIAID Project Scientist will serve as facilitator of NHPCSG activities and scientific endeavors and provide advice, technical assistance, and guidance on technical and management issues, such as reviewing progress and subcommittee requirements. The NIAID Project Scientist will serve as liaison/facilitator in identifying potential sources of reagents or other resources, and identifying potential collaborations to further the goals of the NHPCSG. The NIAID Project Scientist will also serve as a resource of scientific and policy information related to the goals of the awardee’s research. However, the role of the NIAID Project Scientist will be to facilitate and not to direct the NHPCSG activities.

The NIAID Project Scientist allocates/approves the NHPs from the NIAID breeding colonies for the individual research projects, based on the number of animals proposed in the peer-reviewed studies. In some instances, animals required for Steering Committee recommended Discretionary Projects are given a priority. 

The NIAID Project Scientist will serve as a non-voting member of the Steering Committee and will assist with scheduling the meetings and teleconferences of the Steering Committee and subcommittees, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies. It is anticipated that decisions in most Steering Committee activities will be reached by consensus and the NIAID Project Scientist will be given the opportunity to offer input into the process, but the manner of reaching this consensus and the primary decision-making responsibility will rest with the Steering Committee, except where stated in this FOA.

As detailed under PD/PI Responsibilities, NIAID intends to support the peer-reviewed studies/specific aims proposed in the awarded grant applications.  However, the NIAID Project Scientist will evaluate scientific overlap among successful applicants and under special circumstances (e.g. duplicative or overlapping specific aims between two awardees), the NIAID Project Scientist may request modification of the peer-reviewed aims and/or may direct the Steering Committee to establish guidelines and review procedures for modification of the peer-reviewed aims or initiation of new projects.

Additionally, a NIAID Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Grant Award.  The assigned NIAID Program Officer may also serve as the NIAID Project Scientist. This stewardship role will include monitoring program progress and approving changes. The Government, via the NIAID Program Officer, 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.

Release of each annual funding increment by NIAID will be based on an NIAID review of progress towards achieving the previously agreed upon research goals, interim objectives and milestones. It is recognized that project goals may require revision and re-negotiation during the course of the project period. The NIAID reserves the right to terminate or curtail a study (or any individual award) in the event of a substantial shortfall in study milestones or other major breach of the approved project.

2.A.3. Collaborative Responsibilities 

The NHPCSG Steering Committee will serve as the governing board for awardees of this program. Each U01 and U19 will have one and two votes, respectively. At a minimum, voting membership of the Steering Committee will include each U01/U19 Principal Investigator, one additional individual Project Leader from each U19 award, to be named by the U19 PD/PI and which may be rotated to other U19 Project Leaders, at the discretion of the U19 PD/PI. A single PD/PI from each multiple PD/PI grant award will serve as a voting member of the Steering Committee.  In addition, selected scientists other than the awardees may serve as voting members when additional expertise is required for committee breadth and balance, to be determined by majority vote of the Steering Committee. A Chairperson will be selected by the NHPCSG Steering Committee voting members from among the voting Committee members. Note for purposes of this FOA, U19 Core Leaders are not considered Project Leaders.

The NHPCSG Steering Committee can appoint additional non-voting members by majority vote.  In addition, the NIAID Project Scientist may appoint two external scientists as an Advisory Working Group (acting in a scientific advisory capacity to NIAID) to the Steering Committee as non-voting members. The NIAID Project Scientist and the NIDDK Program Official will also serve as non-voting members. 

The NIAID Project Scientist will schedule the meetings of the NHPCSG Steering Committee and actively participate with the Chair in developing the meeting agendas. The NHPCSG Steering Committee will meet in person at least annually, usually in the Bethesda, MD area. Additional meetings may be held via teleconferences. Proposed budgets should include travel costs for the PI to attend these meetings.  Each Steering Committee member will be expected to participate in all meetings and activities, e.g., conference calls and special subcommittees as required.

Awardee members of the NHPCSG Steering Committee will be required to accept and implement common guidelines, policies and procedures approved by the Steering Committee. A letter from each PI stating compliance to all policies and guidelines established by the Steering Committee will be required prior to award.

The NHPCSG Steering Committee or a designated subcommittee will prepare a cumulative group progress report, when requested by the NIAID Project Scientist and generally at the completion of the second year of funding and either annually or biannually after the first report. This progress report will, at a minimum, contain the following information: project overviews; cumulative progress of ongoing and newly-initiated projects; manuscripts published, in press, and in preparation; presentations at regional, national, and international meetings; other activities of the group; and future plans.  The first such report will be submitted to the NIAID Project Scientist no later than four months after the NIAID Project Scientist requests a report, or a time agreed upon by the NIAID Program Official and the Steering Committee Chair.

The Steering Committee will:

Cooperation with other NIH-Sponsored Programs

In order to efficiently utilize research resources and rapidly exchange scientific information to promote the NHPCSG objectives, it is anticipated that cooperation or opportunities to collaborate with other NIH funded programs, including clinical trials programs, will be initiated in future years and will be coordinated and facilitated by the NIAID Program Official.

2.A.4. Dispute Resolution

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

3. Reporting

Awardees will be required to submit the 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:

Kristy Kraemer, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 6405, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-5598
FAX: (301) 480-0693
Email: kkraemer@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 (U.S. Postal Service or regular mail)
Bethesda, MD 20817-7616 (for express/courier service; non-USPS service)
Telephone:  301-402-7098
FAX: 301-480-2408
E-mail: pamstad@niaid.nih.gov

3. Financial or Grants Management Contacts:

Artisha Wright
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2246, MSC-7614
6700B Rockledge Drive

Bethesda, MD 20892-7614
Telephone: 301-451-4580

Fax: 301-493-0597
Email:
ARWright@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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

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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