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 Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov/)

Title: Limited Competition: Coordinating Center For The Beta Cell Biology Consortium (U01)  
 
Announcement Type
This limited competition FOA is a reissue of NOT-DK-04-011.

Request For Applications (RFA) Number:  RFA-DK-09-504

Catalog of Federal Domestic Assistance Number(s)
93.847

Key Dates
Release Date: October 16, 2009
Letters of Intent Receipt Date: November 23, 2009
Application Receipt Date: December 21, 2009
Peer Review Date(s): February/March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
Expiration Date: December 22, 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
   D.  Application Assignment
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

Background:

Type 1 and type 2 diabetes (T1D and T2D) result from the anatomical or functional loss of insulin-producing beta cells of the pancreas.  Replacement of these cells through transplantation and/or regeneration could offer lifelong treatment for diabetes.  Major obstacles in implementing treatment include the lack of sufficient islet cell tissue for transplantation, the absence of a means to increase residual beta cell mass, and the inability to prevent the immune system from destroying of newly introduced/generated beta cells in the diabetic environment found in the recipient patient. The generation of an alternative source of pancreatic islet cells derived from human stem/progenitor cells or from reprogrammed progenitor/adult cells could provide a limitless source of islet cells for cell replacement therapies. Alternatively, the identification of molecules that can stimulate beta cell regeneration could lead to the replenishment of functional beta cell mass without the need for transplantation. Finally, the development of better animal models of the human T1D using patient-derived tissues could lead to a better understanding of disease progression, strategies to protect engrafted or regenerated beta cells from autoimmune destruction, and preclinical platforms to test the efficacy of novel cell-replacement protocols.

The BCBC is a science consortium of cooperative agreements that originated in 2001 through RFA-DK-01-014, http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-01-014.html . The consortium was created by the NIDDK as a direct response to recommendations of the Congressionally-established Diabetes Research Working Group that developed a strategic plan for research in diabetes and called for an increase in basic research on the control and regulation of islet cell differentiation, growth and development. Accordingly, the BCBC has brought a team-based approach to the generation of new research tools, reagents, and technologies vital for developing new cellular therapies in diabetes. In view of the consortium’s success at accelerating discoveries and generating research resources in the areas of beta cell development, generation of beta cells from stem cells and beta cell regeneration, the NIDDK has decided to support a new version of this collaborative effort through funding of new, outstanding projects in specific scientific areas described above through RFA-DK-09-011,(http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-09-011.html).

In addition to investigator-initiated research projects, the BCBC supports an administrative infrastructure, the BCBC Coordinating Center that performs many vitally important functions that contribute to the functional integrity and ongoing administrative infrastructure for the consortium. First, the Coordinating Center ensures effective communication by organizing biannual investigator meetings, maintaining a website with databases of vital research resources, distributing announcements, and organizing teleconferences. Second, it helps develop and provide new research tools to both the BCBC and the broader research community by overseeing several core facilities whose purpose has been resource generation and data processing/analysis. Third, it stimulates scientific progress by organizing and routing funding to the recipients of a variety of special programs that support new investigator-initiated research projects that complement the research projects proposed by the investigators in their original applications for membership to the BCBC.

The BCBC will be comprised of awardees from RFA-DK-09-011, as well as the existing BCBC Coordinating Center (BCBC CC). The purpose of this Limited Competition is to renew funding for the BCBC Coordinating Center for a period of 5 years.

In order to be successful, the applicant will have to present an efficient plan and strategy to fulfill all responsibilities, functions and activities required from the BCBC Coordinating Center as listed below:

Organize bi-annual BCBC retreats:

The Coordinating Center will facilitate exchange of information and help foster collaborations between BCBC members through the planning and organization of a variety of meetings and events. As soon as the composition of the new consortium will be known (May 2010), the Coordinating Center will organize a “kick-off” retreat for all BCBC investigators, to introduce all members to BCBC policies and mode of  operation, to develop a strategic plan for future collaborative interactions, and to initiate the development of shared resources such as cores and databases. Following this “kick-off” retreat, the Coordinating Center will help ensure effective communication between consortium participants by organizing two scientific meetings every year: 1) a large scientific retreat in the spring that postdoctoral fellows, graduate students and external speakers can attend, and 2) a smaller investigator-only planning meeting in the fall, where collaborative projects, shared resources and planning of future consortium activities will be discussed.

Maintain and update the existing BCBC website: www.betacell.org:

Key functions of the BCBC website include the sharing of information, reagents and databases between BCBC members, and between the BCBC and the scientific community at large. Resources generated and/or listed by the consortium currently include antibodies, adenoviruses, genetically manipulated mouse strains and mESC lines, as well as microarray and quantitative PCR datasets. Informatics tools developed by the Coordinating Center also help with data gathering, data mining, as well as with the review and management of special funding programs. The Coordinating Center will continue to meet the changing and expanding needs of the BCBC and the community at large by increasing its collection of shared reagents, protocols and databases, by improving the overall description and distribution of these resources, and by developing new informatics tools for data mining, data management and general administrative support. The Coordinating Center will also continue to improve on the development of separate interfaces for BCBC PIs and non-member scientists, to ensure confidentiality and promote the early sharing of preliminary research information and novel reagents between BCBC investigators.

Oversee BCBC core facilities and databases:

During the last funding cycle, the Coordinating Center has been responsible for the development and oversight of key core facilities and operations, including an Antibody Generation Core, a Mouse and Embryonic Stem Cell Transgenic Core, and a Functional Genomics Core. Future needs for the consortium are likely to include an Antibody Core (with an emphasis on the generation of new antibodies, and the better characterization of existing or new antibodies), a Mouse Transgenic Core and a Stem Cell Core. The exact nature and function of these cores will be determined following assessment of the specific needs of the consortium during the “kick-off” retreat in the summer of 2010. It is also anticipated that the need for specific core activities will change during the 5 year funding cycle. The Coordinating Center will be responsible for terminating obsolete core activities and/or setting-up new core activities following recommendations by the Steering Committee and the Executive Committee of the BCBC. The Coordinating Center will also ensure open sharing and distribution of all reagents developed by the BCBC Cores.

Develop and provide advanced bio-informatic search tools:

The Coordinating Center has spent a considerable effort annotating gene expression studies developed by BCBC investigators and others, as well as developing search tools for genes, their transcripts, and their profiles in expression studies. New tools are likely to be needed for the analysis of genome-wide profiling of epigenetic marks during pancreatic development or during the differentiation of stem/progenitor cells towards the beta-cell phenotype. Complex cellular imaging datasets reflecting gene expression patterns or transient signaling events are also likely to be generated during the next funding cycle. New tools and annotation protocols will have to be developed so that information can be retrieved and analyzed across datasets that are different by nature. Likewise, the Coordinating Center will have to develop new search and analysis tools that can lead to analyses between BCBC-generated data collections and other relevant databases available thru the web, as well as new interfaces that can allow the seamless sharing of data with other NIH-sponsored consortia.  

Manage the solicitation, review and awards of special funding programs:

The BCBC has used, and will continue to use, at least three special funding programs to support new research projects to complement the research effort as described by BCBC PIs in their original U01 applications. The purpose of these programs is to foster collaborations and increase synergy between BCBC investigators; to adapt the research effort to new development in the fields of beta cell development, beta cell regeneration and stem cell biology; and to support interactions with non-BCBC investigators. These three programs are:

The Coordinating Center will continue to be responsible for the advertisement of these various programs, the receipt of the applications through its online submission system (SPOT), the archiving of the external reviews and the routing of funding to recipients of the CBP, P&F and SCRBCB awards via annual subcontracts. The administration of the peer-review process for these special programs will remain the purview of NIDDK Program staff. NIDDK Program staff may also ask the Coordinating Center to help with the organizing and funding of BCBC-initiated research programs other than the three established programs listed above.

Manage committee meetings and progress reports:

To help with the management of the consortium, NIDDK staff and the Coordinating Center are helped by three administrative bodies:

The Coordinating Center will organize the monthly conference calls of the BCBC EC, as well as the bi-annual SC meetings. On a regular basis, the Coordinating Center will gather progress reports on shared activities (cores, website development, etc…) and special programs (CBP, P&F, SCRBCB) to be discussed by the EC and be shared with the SC. The Coordinating Center may also be asked to write reports on the general activity and progress of the consortium to be used by NIDDK staff or the EEC.

Provide administrative assistance:

The Coordinating Center will provide administrative assistance with all types of communications required for the proper functioning of the consortium, as well as the writing of documents related to BCBC activities. These may include e-mail announcements to BCBC investigators about ongoing activities, events and funding decisions; website postings on new programs, events or guidelines; BCBC retreat handbooks; written reports, posters and slide presentations describing the BCBC research effort; ad-hoc teleconferences between various parties to discuss BCBC-related issues.

Facilitate interactions with other centers and consortia:

The BCBC Coordinating Center may be asked by NIDDK staff to help facilitate interactions and collaborations between the BCBC and other relevant team-based research structures such as NIH-sponsored Centers and Consortia. Such interactions may include joint scientific events and/or integration of research databases.

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 U01 award mechanism(s).
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".

2. Funds Available

The estimated amount of funds available for support of a single project awarded as a result of this announcement is $5.0 million for fiscal year 2010. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

This FOA is a limited competition for continuation of the BCBC Coordinating Center which was previously reviewed in response to NOT-DK-04-011.  Any application awarded as part of that announcement is eligible to apply for continuation.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

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

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

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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.

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
Letter of Intent Receipt Date: November 23, 2009
Application Receipt Date: December 21, 2009
Peer Review Date(s): February/March 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:

Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Bethesda, Maryland 20817 (for courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@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:

Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Bethesda, Maryland 20817 (for courier service)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the 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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

To promote the development of a collaborative program among BCBC investigators, the principal investigator of the BCBC Coordinating Center will be expected to organize Steering Committee meetings twice a year.  A major goal of these meetings is to facilitate progress by providing a forum that will lead to sharing skills, ideas, technology, data, and biological reagents.  At the meetings, the Steering Committee will discuss quality assurance, bioinformatics, coordination, sharing and distribution of reagents, collaborative projects, and new developments in the field.

During the course of the funding period, technologies will improve and the rate of progress and scope of the research of the consortium may change.  It is expected that the principal investigator of the Coordinating Center, in consultation with NIDDK program staff, will make necessary adjustments to accommodate the changing research environment, to remain focused on appropriate goals, to maintain excellent coordination with the other projects funded under companion RFA-DK-09-011. The BCBC is expected to serve as a genuine resource to the community, so the investigators must be willing to think of themselves as resource-generating.

Throughout the funding period, input will be sought from experts within the BCBC, the BCBC EEC, the NIDDK Beta Cell Working Group, participants in other NIH-sponsored initiatives, and from the broader research community.

Data and Reagent Sharing: the BCBC Coordinating Center must include technology transfer and sharing plans for both data and unique research resources that are generated by the projects in concordance with the BCBC policies http://www.betacell.org/about/policies.php .  It is expected that resources developed by the BCBC will be made available to the broader scientific community, after a propriety period, at no charge other than the cost of reproduction and distribution.  The applicant must indicate his willingness to distribute research tools to the wider community including antibodies, transgenic mouse strains, mouse ES cell lines, and other reagents. A distribution plan should be included. 

The grant application must also include a statement indicating the applicant’s willingness to abide by the Cooperative Agreement Terms and Conditions of the Award as described below in Section VI.2.A "Award Administration Information".

Research Plan Page Limitations

Sections 2-5 of the Research Plan Attachments of the PHS 398 Research Plan component may not exceed 25 pages, including all tables, graphs, figures, diagrams, and charts.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: 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

Review Process

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

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

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

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five 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?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

The BCBC Coordinating Center will focus on overseeing the generation of important reagents and tools and facilitating challenging research in a cooperative spirit that might be considered too descriptive, ambitious, risky, or less likely to succeed as an individual R01 project grant.

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?

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? 

Experience with managing the BCBC Coordinating Center: In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score:

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.

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.

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 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).

Selection Process

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

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

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the 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 will have the primary responsibility for:

Sharing Among BCBC Members:

The BCBC requires the sharing of all new mouse strains, reagents and data with other BCBC-funded participants prior to the initial peer-reviewed publication describing development of the resource, reagent or data. Sharing with other BCBC members prior to publication will be considered a collaboration, and will require 1) the written consent of the originating investigator, 2) agreement by the collaborating investigator to co-authorship status with the originator on the initial publication utilizing the new resource, and 3) a statement that there will be no transfer of the new resource to a third party without the written permission from the originator. The BCBC is committed to ensuring free and unencumbered sharing of information and resources within the consortium. Individuals found to be in breach of BCBC sharing policies may be subject to sanctions, including possible termination of their U19/U01 award by the NIDDK.

Ownership of ES Cell Lines, Mice, and Renewable Resources: one year after the creation of a new resource (ES cell clone, mouse strain, antibody, modified cell line, DNA construct, viral vector, protocol, or any other new reagent) or following the characterization and initial peer-reviewed publication announcing its development, whichever comes first, the resource will be freely distributed to investigators at academic institutions who want to make use of the resource for non-commercial research. ‘Freely distributed” is defined as unencumbered distribution patterned after practices of NIH-sponsored repositories, where distribution is carried out without regard to the requestor’s identity or experimental designs.

Distribution: the BCBC core facility or BCBC investigator responsible for generating the resource will be responsible for distribution to investigators prior to its submission to a central repository. The Executive Committee of the BCBC reserves the right to transfer mice generated with BCBC funds directly to an NIH supported mouse repository, such as the MMRRC (www.mmrrc.org ) for the purpose of immediate cryopreservation. The Executive Committee of the BCBC also reserves the right to transfer specific renewable resources such as DNA constructs, monoclonal antibodies, genetically modified cell lines, and viruses for the purpose of facilitating distribution within the BCBC and to the scientific community at large.

Information about new resources developed by the BCBC will be posted on the BCBC website as soon as they become available. Additionally, all mice developed through the BCBC will be posted at the International Mouse Strain Resource or IMSR (http://www.findmice.org//index.jsp ).

Sharing Between the BCBC and the Research Community:

Sharing of Mice: following the characterization and initial peer-reviewed publication announcing development of the modified mouse strain, mice will be freely distributed to investigators at academic institutions wanting mice for non-commercial research. We define “freely distributed” as an unencumbered distribution patterned after practices of NIH-sponsored repositories, where distribution is carried out without regard to the requestor’s identity or experimental designs. Individual requests for shipment of mice generated by this program to AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accredited institutions will be honored. The recipient investigators will provide written assurance and evidence that the animals will be used solely in accord with their local IACUC review; that animals will not be further distributed by the recipient without consent of the BCBC investigator who generated the mouse strain; and that animals will not be used for commercial purposes. All modified mouse strains that are generated by BCBC funding will be deposited at an NIH supported mouse repository, such as the MMRRC (www.mmrrc.org ). NIH supported repositories cryopreserve embryos or sperm and distribute the frozen embryos or mice to biomedical researchers.

Mouse Nomemclature and Husbandry: BCBC investigators will use standard nomenclature and receive approval from the Mouse Genome Informatic (MGI) nomenclature committee. To facilitate sharing and distribution of the transgenic/knockout mice and associated resources developed by the BCBC, mice will be maintained in a specific pathogen free facility. This facility will maintain the mice free of specific micro-organisms and pathogens (e.g. pinworms, mouse hepatitis virus (MHV), Sendai virus, mycoplasma, mites, etc.). Should the transgenic/knockout mice become infected with any of these micro-organisms, requestors will be made aware of the contamination within the line and mice will be re-derived through embryo transfer prior to shipment.

Sharing of Reagents and Intellectual Property Issues: other research tools generated through BCBC funding, including renewable resources such as DNA constructs, monoclonal antibodies, genetically modified cell lines, etc, will be freely distributed upon request to qualified academic investigators for use in non-commercial research.

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 NIDDK Program Director identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award and will serve as the NIDDK Project Scientist.

The NIDDK Project Scientist will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination.  The dominant role and primary responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK Project Scientist.

The NIDDK Project Scientist will have substantial involvement in the project above and beyond normal stewardship and monitoring of the award, as described below:

2.A.3. Collaborative Responsibilities (optional)

BCBC Executive Committee (EC)

BCBC Steering Committee (SC)

BCBC External Evaluation Committee (EEC):

An independent External Evaluation Committee has been established by the NIDDK. The External Evaluation Committee will review periodically interim progress of the U01s and BCBC Coordinating Center and report to NIDDK staff. Members of the External Evaluation Committee may also be asked on an ad hoc basis to participate to the peer review of applications for new research initiatives such as the Collaborative Bridging Program, the Pilot and Feasibility Program and the Seeding Grant Program.

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 arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS 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:

Olivier Blondel, Ph.D.
BCBC Program Director
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 796
Bethesda, MD 20892
Telephone: (301) 451-7334
FAX: (301) 480-0475
Email:
ob25p@nih.gov

2. Peer Review Contacts:

Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: fc15y@nih.gov

3. Financial or Grants Management Contacts:

Todd Le
Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 726
Bethesda, MD 20892
Telephone: (301) 594-7794
FAX: (301) 594-9523
Email: tl139s@nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

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

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

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

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

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

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

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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