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)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)

Title: Non-Human Primate Islet/Kidney Transplantation Tolerance (U01, U19)

Announcement Type
This RFA is a renewal with modifications of RFA-AI-01-006, which was released on January 25, 2001, and of RFA-AI-04-049, which was released on August 20, 2004.

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

Request For Applications (RFA) Number: RFA-AI-06-018

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.847  

Key Dates
Release Date: May 10, 2006
Letters of Intent Receipt Date: August 22, 2006
Application Receipt Date: September 22, 2006
Peer Review Date(s): February, 2007
Council Review Date(s): May, 2007
Earliest Anticipated Start Date(s): July, 2007
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/
Expiration Date: September 23, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism of Support
  2. Funds Available

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite new or competitive renewal applications from single institutions and consortia of institutions to participate in the Non-Human Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) program. The overarching goals of the NHPCSG are to: (1) evaluate preclinical safety and efficacy of existing and newly developed candidate immune tolerance induction regimens; and (2) 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 islet and kidney model grants in the NHPCSG will expire in FY2007.  This Request for Application (RFA) solicits only applications for research projects studying NHP models of islet and/or kidney transplantation tolerance.

Background

Organ or tissue 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 results in significant morbidity and has thus far not significantly enhanced long-term graft survival. The overwhelming leading cause of graft failure, both short- and long-term, is immune-mediated graft rejection. Advances in immune tolerance induction 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 NPH immune system and physiology to those of humans.

For purposes of this RFA, immune tolerance is defined as the lack of a pathogenic immune response to allogeneic organs or tissues in the absence of ongoing immunosuppressive therapy. 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 who enthusiastically endorsed the conceptual framework, scope and timeliness of the plan and encouraged the NIAID to take a leadership role at NIH in designing and directing major research programs in immune tolerance, particularly with respect to the application of tolerance induction strategies for the treatment of human disease. 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) and expanded it in 2002 (RFA AI-01-006, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-01-006.html ). In addition, due to the rising costs and decreasing supplies of specific pathogen-free (SPF) Cynomolgus macaques and Indian Rhesus macaques, NIAID established breeding colonies of these monkey species to help support the research efforts of the NHPCSG. In 2004, NIAID expanded the scope of the NHPCSG to include heart and lung transplantation models, reflecting the significant need to improve outcomes in heart and lung transplantation and reflecting the view that graft rejection is an immunological disease with issues that are shared across all organs and tissues. In addition, studies from each organ may offer unique insights into various facets of immune tolerance induction and graft rejection. Currently, the NHPCSG consist of three islet/kidney U19s, six islet/kidney U01s, one heart U01, and one heart/lung U19. The NHPCSG islet and kidney transplantation awards will expire in FY 2007.  

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.

Therefore, this RFA solicits new or competitive renewal applications for NHP islet and kidney models of transplantation tolerance to continue this expiring portion of the NHPCSG program.

Research Objectives and Scope

All research projects to be supported under this RFA are limited to NHP islet and/or kidney transplantation models. Specifically, this RFA calls for the use of any NHP species for allogeneic studies of islet and/or kidney 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 human clinical trials;

(3) Studies to define 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) Studies to develop, evaluate, and validate 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 devoted to (3) and/or (4) above.

Because the long-range goal of this RFA is to develop and evaluate candidate tolerogenic approaches for transplantation in humans, NIAID and NIDDK expect that there will be reciprocal communication between the NHPCSG and NIH funded clinical trials programs. In addition, this interaction may result in potential opportunities to develop and participate in initial safety and efficacy pre-clinical studies. See Section VI.2.A.3 “Collaborative Responsibilities” below for additional discussion of potential opportunities and policies.

This RFA will not support:

Applications not meeting these requirements will be considered non-responsive to this RFA and will be returned without review.

Steering Committee

Principal Investigators of all NHPCSG grants awarded under this RFA must serve on the Steering Committee. Members of the Steering Committee will be required to accept and implement common guidelines and procedures approved by the Steering Committee. Steering Committee responsibilities are further described under Section VI.2.A.3 , Cooperative Agreement Terms and Conditions of Award – “Collaborative Responsibilities”.  

Discretionary Funds

To capitalize on emerging opportunities, discretionary funds will be provided to support: development of a website to facilitate communications between NHPCSG members and with the research community; new pilot and feasibility research projects led by NHPCSG members; and, if required, research resource development projects. The Steering Committee will establish goals, priorities, and evaluation criteria for the use of the discretionary funds. Applicants may include a Discretionary Fund and Website Management Core (Optional) to administer this fund and establish and maintain a website. One awardee will be selected by NIAID and NIDDK to carry out this function. See Section VI.2.A.3 , “Collaborative Responsibilities” for a detailed description of discretionary fund distribution and management.

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 Program Director makes final decisions regarding allocation of this resource. 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 this resource 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 Section IV.6  Other Submission Requirements under “All Applications”. Applicants should provide documentation that they can reasonably obtain the monkeys required for their studies through other sources. Costs for purchasing animals through other sources should be included in the proposals due to the possibility that NIAID animal resources may be inadequate to meet all of the research needs of the NHPCSG.  In addition, NIAID may elect to implement a cost recovery program in the future.

Applicants are strongly encouraged to contact program staff listed under WHERE TO SEND INQUIRES well in advance of the anticipated application submission date to allow staff to assess responsiveness to this RFA and provide appropriate guidance as needed.

See Section IV. 6. Other Submission Requirements for important considerations and requirements in preparation of applications.

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 Cooperative Agreement (U01) and multi-project Cooperative Agreement (U19) award mechanisms.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The NIH U01 and U19 are cooperative agreement award mechanisms. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIAID and NIDDK provide support of 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 estimates, see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

Cost Sharing is not required.

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

3. Other-Special Eligibility Criteria

An institution may submit more than one application. A Principal Investigator may serve as a Project Leader in a multi-project application (U19) or as a collaborator in another application provided there is no scientific overlap with the application submitted by the Principal Investigator. However, an investigator may be Principal Investigator on only one application.   

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 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 on line 2 of the face page of the application form and the YES box must be checked.

 3. Submission Dates and Times

Applications must be submitted on or before the receipt date described below (Section IV.3.A).

3.A. Submission, Review and Anticipated Start Dates

Letters of Intent Receipt Date: August 22, 2006
Application Receipt Date: September 22, 2006
Peer Review Date(s): February, 2007
Council Review Date(s): May, 2007
Earliest Anticipated Start Date: July, 2007

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

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 (for express/courier service; non-USPS service)
Tel. 301-402-7098
Fax: 301-480-2408
Email: pamstad@niaid.nih.gov

3.B. Sending an Application to the NIH

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

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

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

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

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 (for express/courier service; non-USPS service)
Tel. 301-402-7098
Fax: 301-480-2408
Email: pamstad@niaid.nih.gov

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

3.C. Application Processing

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

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

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  (http://grants.nih.gov/grants/policy/policy.htm).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

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

Discretionary funds will be awarded to a single NHPCSG institution selected by NIAID and NIDDK to be responsible for disbursement, management and reporting on discretionary fund projects and website development approved by the Steering Committee. Discretionary fund expenditures will be restricted until a process for review/ranking of proposals and disbursement of funds is established and approved by the Steering Committee and NIAID and NIDDK staff, and until a plan for the website development has been reviewed and also approved by the Steering Committee and NIAID and NIDDK staff.

6. Other Submission Requirements

Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the web at: http://www.niaid.nih.gov/ncn/grants/multibron.htm .

A. Special requirements of U19 applications under this RFA:

B. Special Requirements of U01 applications:

C. Special Requirements of all applications:

1.  Document availability or expected availability of all critical non-commercially available reagents and therapeutic agents proposed.

2.  Document reasonable expectation of availability of animals proposed for studies from sources other than the NIAID breeding colonies.

3.  Document commitment to the collaborative group, signed by the Principal Investigator and the applicant institution, to participate in the cooperative research program, including serving on the Steering Committee, adhering to Steering Committee polices and decisions; and accepting the participation and assistance of NIH staff in accordance with the guidelines described in SectionVI.2.A  Cooperative Agreement Terms and Conditions of Award.

4.  Document commitment to design and conduct NHP research in addition to the studies funded in the initial application, under circumstances in which the Steering Committee, NIAID, and NIDDK recommend and/or approve such studies, contingent on provision of funds for such studies. The time-frame within which such additional projects are initiated and completed will be negotiated and agreed upon jointly between the awardees, potential sponsors, NIAID, and NIDDK, when applicable.

5.  Document that all NHPs received from the NIAID NHP breeding colonies will be used only for the expressed purposes of the individual cooperative agreements funded through this RFA or proposals approved by the Steering Committee and NIAID Program Director.

6.  Demonstrate the scientific and technical expertise required to design, conduct and analyze NHP studies responsive to this RFA. The Principal Investigator must have substantial experience related to the scope and objectives of the RFA.

7. A clear research plan and project goals to be completed during the award period. The applicant must clearly state the interim 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.

8. A conceptual framework providing rationale for the proposed approach to tolerance induction, overall study design, and the relevance to human transplantation.

9. Justification that the proposed approach is appropriate and timely for studies in NHPs.

10.Justification for the numbers of animals proposed and a detailed animal care section.

11.A description of mechanistic and/or biomarker studies and immune assays to be incorporated as an integral part of the non-human primate treatment protocols, including the rationale for the selection of the mechanistic and biomarker studies, proposed techniques, and the overall design of such studies.

12.  Description of, and rationale for, the proposed source, quantity and number of NHP samplings/biopsies required; methodologies proposed to collect and analyze samples; and a discussion of how the results of the proposed studies will contribute to improvements in the capacity to utilize immune and/or surrogate biomarkers to predict the induction, maintenance or loss of tolerance.  Use of new technologies, including minimally invasive and non-invasive approaches, is encouraged. 

13.  A plan detailing the acquisition and preparation, if applicable, of the solid organs, tissues or cells to be used in the studies. All related costs required should be included in the application and fully justified.

14.   The application must also include a 1-2 page synopsis (may be included as appendices) of the proposed treatment protocol(s) to assess safety and efficacy.

15.  For purposes of budget preparation include the costs for acquiring monkeys. Assume for purposes of this application that NHPs will not be provided by the NIAID breeding facility. However, when available, costs for NHPs from the NIAID breeding colonies will be assumed by the NIAID, but all shipping, handling, and special testing fees will be the responsibility of the grantee. In future years NIAID may institute a partial cost recovery program for provision of the NIAID NHPs.

16.  All applications must use a non-modular budget format.

17.  Competing renewal applications must include a section addressing progress during the previous grant funding.

D. Special Requirements: Discretionary Fund and Website Management Core (Optional):

Applicants proposing to manage the discretionary fund and develop and maintain a website must include in the application a detailed plan to support the responsibilities associated with the disbursement, administration and reporting on the use of discretionary funds and for the development and maintenance of a website. Such applications must include a plan for the Discretionary Fund and Website Management Core describing: (1) an administrative structure, including proposed level of effort for all staff; (2) proposed methods/procedures to support the Steering Committee in soliciting, evaluating, prioritizing, selecting and monitoring progress of discretionary fund projects; (3) proposed design and uses of a website to accommodate both secure and public use; (4) detailed plans for maintenance of a website; (5) the experience/qualifications of the Principal Investigator and all proposed Discretionary Fund and Website Management Core staff; (4) proposed procedures, format and timing for reporting on the status of discretionary fund use; (5) documentation of institutional commitment to the administration of the discretionary fund. A separate budget for the Discretionary Fund and Website Management Core must be provided and is not to be included in the total budget of the U01 or U19 proposal. The Discretionary Fund and Website Management Core will be evaluated by the review panel, but will not influence the overall score of the application.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Each U01 application and each research project in a U19 application will be evaluated using the following criteria:

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the approaches timely and justified for NHP research?  

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

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

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

For U19 applications, the following added criteria will be used:

For Cores:

For the overall application:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

Period of Support: The appropriateness of the requested period of support in relation to the proposed research.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The reasonableness of the research resource sharing plan will be assessed by the reviewers. However, reviewers will not factor the proposed research resource sharing plan into the determination of scientific merit or the priority score.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

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

2. Administrative and National Policy Requirements

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

The following Terms and Conditions will be incorporated into the NoA and will be provided to the Principal Investigator and 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 (U01) or the multi-project cooperative agreement (U19) "assistance" mechanisms (rather than "acquisition" mechanisms such as a contract), 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 reside with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the RFA (AI-06-08) and for performing the scientific activity. Specifically, awardees have primary responsibility as described below.

The Principal Investigators will determine and coordinate the project activities scientifically and administratively; set project goals and timelines to achieve the proposed goals; accept and implement common guidelines and policies set forth and approved by the Steering Committee; attend Steering Committee meetings; participate in all Steering Committee activities; and serve as a voting member of the Steering Committee, as outlined below under Collaborative Responsibilities; and participate in the cooperative nature of the group.  Release of each funding increment by NIAID and NIDDK will be based on a review of progress towards achieving the previously agreed upon research goals.    Awardees must comply with NIH Data and resource sharing requirements.

All awardees, upon acceptance of an award, agree to participate in all studies, including those that involve collaborations with biotechnology and pharmaceutical companies, as specified by the Steering Committee. NIAID and NIDDK intend to support the peer-reviewed studies proposed in the awarded grant applications.  However, under special circumstances the Steering Committee will establish guidelines and review procedures, and will evaluate and determine redirection or modification of the peer-reviewed proposals or provide recommendations to the NIH when applicable and necessary. In addition, the Steering Committee will establish guidelines for proposal and review procedures for new pilot or collaborative projects when applicable. These policies are in keeping with the terms and conditions of the cooperative agreement mechanism.

All non-human primates obtained from the NIAID breeding colonies may be used only for the expressed purposes of the individual Cooperative Agreements funded through this RFA or proposals approved by the Steering Committee. Costs for non-human primates from the NIAID breeding colonies will be assumed by the NIAID, but all shipping, handling, and special testing fees will be the responsibility of the grantee. It is possible that in future years NIAID will institute a partial cost recovery program for the NIAID non-human primate breeding colony monkeys for research use. However, provision of NHPs from the NIAID breeding colonies to NHPCSG investigators is determined by availability, scientific priority, and recommendations by the Steering Committee. NIAID does not guarantee availability of animals to NHPCSG investigators, particularly when the special requirements of a study are limiting, e.g. full or half sibling pairs that are major histocompatibility antigen “haplotype” matched. The NIAID Program Director makes final decisions regarding allocation of this resource. 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 this resource to the research community. 

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.

Discretionary Fund and Website Management (Optional)

The awarded institution and Principal Investigator selected by NIAID and NIDDK to administer the discretionary fund and website must agree to take responsibility for managing the funds. These responsibilities include the disbursement, administration and reporting on the use of discretionary funds as approved by the Steering Committee and the establishment and maintenance of the NHPCSG website, both secure and public portions.

2.A.2. NIH Responsibilities

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

The NIAID Project Scientist and NIDDK Project Scientist may periodically review data and progress reports and use the information 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.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   The NIAID Project Scientist with the assistance from other NIAID and NIDDK scientific program staff, as determined by research topic and relevant expertise, will have substantial scientific/programmatic involvement through provision of technical assistance, advice and coordination above and beyond normal program stewardship for grants including, but not limited to: participating in the design of the activities; advising in the selection of sources or resources; advising in management and technical performance; or participating in the preparation of publications for collaborative programs when and if applicable.

The NIAID Project Scientist will serve as a liaison/facilitator between the awardee, pharmaceutical and biotech industries, and other government agencies and will serve as a resource of scientific and policy information related to the goals of the awardee's research. However, the role of NIH will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and the NIH staff will be given the opportunity to offer input into this process. The manner of reaching this consensus and the final decision-making authority will rest with the Steering Committee, except where stated in this RFA.

The NIAID Project Scientist and NIDDK Project Scientist will serve as a voting member of the Steering Committee, schedule the first meeting of the Steering Committee, actively assist the Chair in developing the meeting agendas, and ensure coordination of Steering Committee activities and implementation of recommendations, decisions and policies.

The NIAID Project Scientist, NIDDK Project Scientist and other NIH staff will provide final approval for Discretionary Fund proposals recommended by the Steering Committee.                                                

2.A.3. Collaborative Responsibilities

The Steering Committee

Membership of the Steering Committee will include the NIAID Project Scientist, the NIDDK Project Scientist, each U01/U19 Principal Investigator, and an additional project investigator from each U19 award. The PI awardees will be incorporated into the existing Steering Committee. A Chairperson will be selected by the Steering Committee from among the non-federal Committee members at the first Steering Committee meeting held after awards. Each Steering Committee member will be expected to participate in all meetings and activities, e.g., conference calls and special subcommittees as required, and will be required to accept and implement common guidelines and procedures approved by the Steering Committee.

In order to most efficiently utilize research resources and exchange scientific information to rapidly respond to new pre-clinical opportunities the Steering Committee will actively pursue communications with NIH funded transplantation clinical trial networks to facilitate collaborations and assess priorities.

The Steering Committee or a designated subcommittee will establish or modify current guidelines for the dispersal of discretionary funds. These guidelines include a process for:

Annual Report: The Steering Committee or a designated subcommittee will prepare an annual report, beginning at the completion of year 2 of the award, containing the following information: an executive summary, progress of ongoing and newly-initiated projects, including milestones met or not met and future directions; manuscripts published, in press, and in preparation; presentations at regional, national, and international meetings; other activities of the group; data submitted to databases; future plans; impediments; and recommendations. The first such report will be submitted to the NIAID Project Scientist not later than 3 months after the year 2 notice of award, or a time agreed upon by the NIAID Project Scientist and yearly thereafter.

In addition, the Steering Committee will:

2.A.4. Arbitration Process

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Kristy Kraemer, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectio
us Diseases
Room 3043, 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 (for express/courier service; non-USPS service)
Tel. 301-402-7098
Fax: 301-480-2408
Email: pamstad@niaid.nih.gov

3. Financial or Grants Management Contacts:

Ms. Christy Leake
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2242, MSC-7614
6700B  Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5937
FAX: (301) 480-3780
Email: CLeake@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.
 
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 scientific merit or the priority score.

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Allergy, Immunology and Transplantation Research and No. 93.847, Diabetes, Endocrinology and Metabolism Research, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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