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 Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)

Title: Point-of-Care Technologies Research Network (U54)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-EB-06-002

Catalog of Federal Domestic Assistance Number(s)
93.286

Key Dates
Release Date:  October 4, 2006
Letters of Intent Receipt Date(s): December 18, 2006
Application Receipt Date(s): January 17, 2007
Peer Review Date(s): June-July, 2007
Council Review Date(s): September, 2007  
Earliest Anticipated Start Date: September 30, 2007  
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: January 18, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose of this RFA:

The National Institute of Biomedical Imaging and Bioengineering invites applications for Research Centers in the area of point-of-care (POC) technologies.  The U54 mechanism will be used to create a national research network that works to build expertise in the development of integrated systems that address unmet clinical needs in point-of-care testing through the creation of multidisciplinary partnerships.  Each POCT Center will perform five core functions (as described below) to create a dynamic structure that facilitates the translation of emerging technologies into clinical application.  The Centers will work jointly to create a Research Network with broad expertise in the development of point-of-care technologies.

Point-of-care testing refers to the timely provision of clinical diagnostic information, often in decentralized settings such as in the physician’s office or in the patient’s home.  The potential for point-of-care testing to profoundly change the way health care is delivered was addressed in a recent NIBIB/NHLBI/NSF workshop on “Improving Health Care Accessibility Through Point-of-Care Technologies (http://www.nibib.nih.gov/publicPage.cfm?pageID=4534).  Significant improvements in health care accessibility, quality, and cost are possible through merging of scientific expertise in the miniaturization, imaging, and informatics sciences with knowledge of specific clinical needs in decentralized health care settings.  Workshop participants identified several challenges to realizing advances in the field, including the need for a mechanism to facilitate assessment of clinical opportunities in point-of-care testing to guide the development of emerging technologies, and the need for infrastructure to provide for the creation of multidisciplinary research collaborations that facilitate clinical testing early in the development process.  There exist specific challenges with the development of point-of-care devices that require significant strengthening of the technology/clinical interface, including the need to identify the clinical benefits of performing an analysis at the point-of-care versus in the central laboratory, a need to consider integration of point-of-care devices into the health care delivery system, and technical requirements specific to the development of devices for use by generalists, such as component integration, user interfaces, and connectivity.

Through a combination of in-house effort and collaboration, the U54 Research Centers will cover facets of the development of point-of-care technologies ranging from exploratory research through early stage clinical testing.  Clinical trials will not be covered within the context of this RFA, although it is expected that the Research Centers will establish collaborations within the broader clinical research community to facilitate late-stage clinical studies and to assist with overcoming technology adoption challenges.  The scope of work covered within each Center will include in-house clinical testing of prototype point-of-care devices; collaborations with physical scientists, biochemical scientists, computational scientists, and engineers on exploratory technology development projects; assessment and communication of unmet clinical needs in point-of-care testing; creation of training opportunities for technology developers on clinical issues related to the development of point-of-care devices; and development of external partnerships (e.g., technology, clinical, industry, and regulatory) necessary to move enabling technologies toward clinical applications. 

Physical scientists, biochemical scientists, computational scientists and engineers interested in seeking Center funding for the development of novel point-of-care technologies and systems will have opportunities throughout the initial five-year project period to interact collaboratively with the POCT Research Centers as described in Core 2.

Research Objectives:

The need to improve the quality and accessibility of care while reducing costs is widely recognized as a significant challenge currently faced by the nation’s health care system.  Adding to this challenge is the need to reduce health disparities and provide care for an aging populationA recent National Academy of Engineering/Institute of Medicine (NAE/IOM) report (“Building a Better Delivery System: A New Engineering/Health Care Partnership”) has suggested that significant improvements in health care delivery can be achieved through adoption of a patient-centered approach.  A critical aspect of this goal is the development of low-cost point-of-care microsystems that can be integrated into the health care delivery system through information and communications technologies. Recent efforts in the design and microfabrication of electronic, optical, mechanical, and fluidic components for sensors and imaging devices have led to major advances in sample analysis, with the ability to manipulate cells on the single cell level and detect single biomolecules in a sample.  But the incorporation of these components into fully integrated systems that can handle all aspects of analysis still remains a challenge, as does providing the necessary connectivity of the analytical devices to clinical information systems and matching these devices to clinical need to facilitate integration into the health care system.

This RFA provides for the establishment of a Point-of-Care Technologies (POCT) Research Network that will work to bridge the technology/clinical gap and provide the partnerships and expertise necessary for the application of enabling technologies, such as novel sensors, lab-on-a-chip devices, non- and minimally invasive monitoring approaches, and imaging technologies, to pressing clinical needs in point-of-care testing.  A major aspect of this effort is a focus on integrating components and devices to create systems that have the necessary connectivity and usability within a given health care environment.

Potential Centers could be structured around themes that address the coupling of promising technologies with clinical needs and opportunities in specific health care settings such as:

Alternatively, Centers could be focused on disease groupings for which point-of-care technologies have significant potential to address future health care challenges, such as cardiovascular and neurological disease.

The above lists are intended to be exemplary rather than exhaustive or prescriptive. 

The structure of a Research Center should take into account the full range of technology and clinical partnerships necessary to facilitate the identification and integration of enabling technologies into devices that address defined clinical needs and health care delivery challenges that are specific to the intended use in a given care setting.

Organizational Structure:

Each POCT Research Center will be comprised of five Cores: (1) In-house Clinical Testing of Prototype Point-of-Care Devices; (2) Collaborative Exploratory Projects (3) Clinical Needs Assessment and Dissemination (4) Training; and (5) Administration.  It is expected that the Research Centers will support projects that cover all stages of development, from exploratory research through clinical testing of prototype devices, with the distribution of funds across these projects varying according to Center focus, budget period, and availability of meritorious projects.  For the initial grant period of the Center (up to five years), technology development efforts comprising Cores 1 and 2 will be supported with grant funds.  The selection of projects for funding beyond those presented in the initial grant application, will be made in consultation with the Center’s Scientific Subcommittee of the Network Steering Committee, which will be formed from NIBIB staff, the Center PI, and external scientific experts.  The details of the full governance structure is provided in Section VI.2.A, “Cooperative Agreement Terms and Conditions of Award”.  Although Center institutions can receive funding for exploratory collaborative projects, it is expected that the majority of funds for exploratory projects in Core 2 will be used to fund projects outside of the U54 awardee institution.  It is anticipated that beyond the initial grant period, projects in Cores 1 and 2 will be funded externally through future program announcements or through the submission of investigator-initiated applications.

Core 1: In-house Clinical testing of Prototype Devices
Budget Limit for Core 1: $500,000 Total Direct Costs

One to two projects for clinical testing of prototype devices should be identified for technologies that have significant potential to address a clinical need in point-of-care testing, with the clinical testing plan provided for evaluation of these technologies.  Information should be provided regarding the potential clinical impact that the technologies can have on improving human health.  The appropriateness of the technologies for the proposed heath care application should be described, with potential characteristics including the provision of low-cost testing, robustness for use by generalists, and multiplexing capabilities for the creation of versatile platforms.  A plan should be provided that details the process that will be followed to assist with transitioning the tested prototypes to the next stage of clinical testing (external to the Research Center).  It is expected that the project period for projects funded under Core 1 will be up to two years to allow for several technologies to be tested and moved into the next stage of clinical testing during the five-year grant period.  Exceptions to this are possible if justification is provided for an extended project period.  Therefore, adequate funds should be budgeted in later years of the grant period to allow for transitioning or retiring current projects and recruiting and selecting new clinical testing projects. 

A maximum of $500,000 direct costs can be budgeted in each year for the funding of clinical testing projects. The budget for Core 1 should take into account the overall budget limit of $1.2 M direct costs per year and the proposed emphasis of the Center (i.e., the distribution of funds and effort across the five Cores).  It is anticipated that this distribution will change based on the availability of meritorious projects for funding through Cores 1 and 2. 

A detailed plan for the process by which new projects will be solicited, reviewed, and funded must be provided.  If this process is expected to differ from the approach suggested for Core 2 (see below), provide the details of the plan for selecting new projects for Core 1.

Core 2: Plan for Identifying Collaborative Exploratory Projects
Budget Limit for Core 2: $600,000 Total Direct Costs

A plan should be presented that documents the process that will be used to identify and select meritorious collaborative exploratory projects for funding through the Center, with the first round of awards to be made in Year 1 of the grant period.  This plan should include sample criteria that might be used to select exploratory projects that are appropriate for the theme identified in Core 3, as well as examples of the technology areas that are expected to have a significant impact on the goals of the Center.  Specific collaborative exploratory projects should not be identified in the application.

A maximum of $600,000 direct costs can be budgeted in each year for the funding of 3-4 exploratory technology development projects. As with Core 1, the budget for Core 2 should take into account the overall budget limit of $1.2 M direct costs per year and the proposed emphasis of the Center (i.e., the distribution of funds and effort across the five Cores, with this distribution subject to change based on the availability of meritorious projects). Each collaborative project should have a duration of no more than two years in the exploratory phase, with direct costs up to $150,000 each year.  When appropriate, promising technologies developed in Core 2 can be transitioned beyond the exploratory two-year period to the clinical testing phase (Core 1). 

Core 3: Clinical Needs Assessment and Dissemination

Core 3 will define the theme of the Research Center through the selection of a specific disease or health care setting emphasis area.  Plans should be provided for assessment of clinical needs and opportunities as appropriate for the selected theme of the Center.  In addition, plans for disseminating the information to the technology development community through various means should be detailed in the application.  While it is not required that the leaders for Cores 1 and 3 be at the same institution, applicants will have to present a convincing plan for effective collaboration at a distance.

Core 4: Training

Training of physical scientists, biochemical scientists, computational scientists, and engineers on clinical issues related to the development of point-of-care devices is critical to accelerate the translation of enabling technologies into clinical use.  In Core 4, each Center should propose specific and detailed plans to provide training opportunities to technology developers across various career levels, either through individual training opportunities such as fellowships or sabbatical opportunities, or through workshops that target broader audiences. 

Core 5: Administration

An administrative plan appropriate for effective management of a complex Center structure should be presented in Core 5.  In this section, specific plans should be included for the integration of activities within and across Cores, and for ensuring responsiveness to members of the research community who wish to access the Center.  A Network Steering Committee will be created from NIBIB staff and Center PIs to provide scientific and administrative oversight.  In addition, each Center will form a Scientific Subcommittee of the Network Steering Committee that will consist of NIBIB staff, the Center PI, and external scientific experts, to perform Center functions, including the review and selection of projects to be funded under Cores 1 and 2.  The remaining Center PIs will serve in an advisory capacity for the respective scientific subcommittee.  Applicants can provide information regarding the proposed expertise of members of the both committees, but potential members must not be approached for membership until after an award has been made. Names of potential members must not be included in the application.

Additionally, applicants should include information within Core 5 that discusses existing external partnerships or, alternatively, the nature of new partnerships that will be established to facilitate the identification of emerging technologies, the integration of these technologies into systems suitable for use in clinical settings, and the transitioning of prototype devices into clinical research networks for later stage clinical testing.  The development of integrated systems for point-of-care testing applications is a complex process involving technologists, clinical researchers, end users, manufacturers, and regulatory agencies, among others.  Although the full spectrum of activities ranging from early stage technology development through technology adoption will not be addressed in the context of the POCT Research Networks, establishing the necessary external partnerships early in the process can help accelerate the development and adoption of point-of-care technologies.  External partners might include engineering centers with expertise in component integration, clinical research networks, user-based networks, industry researchers or manufacturing centers, and regulatory bodies.  It is not expected that all Center will need to establish relationships with each entity listed, but that the full spectrum of expertise will be provided across the network of Research Centers.  This section should include information about the proposed role these existing or potential partners will play in helping the Center accomplish its goals.  Partners can be identified by name if letters of support are provided; otherwise applicants should discuss broadly the nature of the partnerships that will be sought to accomplish the goals of the U54 without providing specific names.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U54 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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

The NIH (U54) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".  

2. Funds Available

The National Institute of Biomedical Imaging and Bioengineering intends to commit $6,000,000 in FY2007 to fund up to three new Centers in response to this RFA.  An applicant may request a project period of up to five years and a budget for direct costs up to $1.2 M in each budget year.  These direct costs do not include the facilities and administration costs for subcontracts (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-040.html).  Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary.  Although the financial plans of the NIBIB provide support for this program, awards pursuant to the RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 

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:

Foreign institutions and for-profits organizations are not eligible to apply, but both organizations can participate as subcontractors or collaborators in any of the Cores.

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 or the provision of matching funds is not required for this program.

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

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

3. Other-Special Eligibility Criteria

The Principal Investigator of each Center must devote at least 25% of his or her effort.  Applications from Principal Investigators not devoting at least 25% effort will be returned without peer review.

An individual may be a principal investigator on only one application submitted to this initiative.

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): December 18, 2006  
Application Receipt Date(s): January 17, 2007  
Peer Review Date(s): June-July, 2007
Council Review Date(s): September, 2007  
Earliest Anticipated Start Date: September 30, 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:
 
Brenda Korte, Ph.D.
Program Director, Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering/NIH/DHHS
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892
Telephone: (301) 402-1231
FAX: (301) 480-4973
Email: kortebr@mail.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:

David T. George, Ph.D.
Director, Office of Scientific Review
6707 Democracy Boulevard, Suite 920
NIBIB/NIH/DHHS
Bethesda, MD 20892-5469 (20817 for FedEx and Courier services)
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: GeorgeD@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.

Submit a complete application.  Incomplete applications will be grounds for the NIH to return the application without peer review.  An application will be returned if it is illegible, if the instructions were not followed, or if the material presented is insufficient to permit an adequate review.

The application must be complete and accurate at the time of submission as there is no guarantee that the Scientific Review Administrator will accept or the peer reviewers will consider late material.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute of Biomedical Imaging and Bioengineering 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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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

6. Other Submission Requirements

Due to the complex nature of this initiative, applicants are strongly encouraged to contact program staff to discuss submission of an application to this RFA.

The application for a Point-of-Care Technologies Research Center must include the following five Cores: (1) conducting in-house clinical testing of prototype point-of-care devices; (2) collaborating with physical scientists, biochemical scientists, computational scientists, and engineers on exploratory technology development efforts; (3) completing clinical needs assessments in areas anticipated to advance the field of point-of-care testing and disseminating clinical needs information to the technology development community; (4) providing training to physical scientists, biochemical scientists, computational scientists, and engineers on clinical issues related to the development of point-of-care devices; and (5) providing an administrative Core to ensure that the large Center achieves its goals.  Additionally, applicants should include a section within the grant application that identifies entities with which external partnerships will be established in the context of Core activities, with a description of the proposed role these partners will serve in assisting the Center to achieve its overall goals.  

It is recognized that the applications submitted in response to this RFA will be longer and more complex than many other NIH applications.  For clarity, the Research Plan must be divided into sections according to the above-defined five Cores.  It is not necessary to subdivide each of these Cores into the traditional a-d format specified in the PHS 398 application. 

The overall page limitation for Cores 1 through 5 is 60 pages.

The following are suggested page limits per Core:
Core 1 (In-house Clinical Testing of Prototype Devices): 30 pages
Core 2 (Plan for Identifying Collaborative Exploratory Projects): 10 pages
Core 3 (Clinical Needs Assessment and Dissemination): 10 pages
Core 4 (Training): 5 pages
Core 5 (Administration): 5 pages

The budget should be completed as described in the instruction sheet for the PHS 398 application.  The budget section should begin with an overall budget for the Center, followed by budget forms for each of the five Cores.  Budget pages should be provided for any sub-contractual or consortium arrangements.  Estimated costs for the projects to be selected through Cores 1 and 2 in future years of the grant period should be included in the “Other Expenses” section of the budget form.  Each budget page should be labeled clearly.  The budget justification should follow the forms for Core 5 and should include the justification for key personnel and equipment.  The Principal Investigator must devote at least 25% effort to the project.

The annual progress report for the U54 award will use the standard PHS 2590 form.  Supplementary information may be requested as an attachment to the standard progress report as deemed necessary by NIBIB program staff or the Scientific Steering Committee.

Because of the complexity of the POCT Research Centers, program staff will likely conduct periodic administrative site visits.  U54 Centers should be prepared for an annual site visit as well as an annual grantees meeting, and should include associated expenses in the budget (e.g., travel expenses for collaborators).

Intellectual Property Plans are just-in-time requirements, and as such, it is not necessary to include a final plan in the grant application.  Final plans will be expected prior to an application being awarded.  Applicants are encouraged to confer with their institutions’ technology transfer office(s) on the development of a final Intellectual Property Plan for submission prior to award.  If applicants or their representatives require additional guidance in preparing such plans, they are encouraged to contact NIBIB staff for additional information.

Plan for Sharing Research Data

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

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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

Sharing Research Resources

NIH policy 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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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

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 the NIBIB 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.

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

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)? Is the expertise of Center staff appropriate for the multidisciplinary nature of the effort?

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?

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

2.A. Additional Review Criteria:

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

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

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy 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/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

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

3. Anticipated Announcement and Award Dates

N/A  

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/archive/grants/policy/nihgps_2003/index.htm).

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

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

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement (NIH U54), 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.

The Point-of-Care Technologies Research Network consists of the Center awardees under RFA-EB-06-002.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility to define objectives and approaches of the Center and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the studies.  The primary responsibilities of the awardees are to:

Principal Investigators and Center staff as appropriate are expected to participate in an annual grantees meeting.

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

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. This individual may also serve as a NIBIB Project Scientist.

The NIBIB Program Director will:

2.A.3. Collaborative Responsibilities

The NIBIB Project Scientist and the PIs of each Center funded under this RFA will be responsible for forming a Network Steering Committee and a Center Scientific Subcommittee to accomplish the goals of the individual Research Centers and the Network in general.  The Network Steering Committee will act as the main governing board that will review the progress of the research activities, develop collaborative protocols, identify technological impediments to the progress, select strategies to surmount them, and identify opportunities for sharing techniques and tools developed within each individual project.  The Network Steering Committee will:

The Network Steering Committee will be composed of the PI from each project funded through RFA-EB-06-002 and the NIBIB Project Scientist.  Subcommittees of the Network Steering Committee will be created for each Center to perform Center functions, including the review and selection of projects to be funded under Cores 1 and 2.  These Scientific Subcommittees will consist of the Center PI, the NIBIB Project Scientist, and scientific experts from the field who are not part of the Center.  The remaining Center PIs will serve in an advisory capacity for the respective Scientific Subcommittee.

Each Network Steering Committee member will have one vote and will be required to accept and implement policies approved by the Committee.  The Network Steering Committee may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed.

The Network Steering Committee will meet once a year at a minimum, with additional meetings scheduled as necessary to accomplish the goals of the Research Center Network. 

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. It will have three members: a designee of the Network 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. The annual progress report for the U54 award will use the standard 2590 form as well as supplementary information as agreed upon by the Network Steering Committee.  This additional information may include the progress made within the Center as well as the relationship between the Center and collaborators.

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:

Brenda Korte, Ph.D.
Program Director, Division of Discovery Science and Technology
National Institute of Biomedical Imaging and Bioengineering/NIH/DHHS
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892
Telephone: (301) 402-1231
FAX: (301) 480-4973
Email: kortebr@mail.nih.gov

2. Peer Review Contacts:

David T. George, Ph.D.
Director, Office of Scientific Review
6707 Democracy Boulevard, Suite 920
NIBIB/NIH/DHHS
Bethesda, MD 20892-5469 (20817 for FedEx and Courier services)
Telephone: (301) 496-8633
FAX: (301) 480-0675
Email: GeorgeD@nih.gov
 
3. Financial or Grants Management Contacts:

Mr. Angelos Bacas
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd, Suite 900, MSC 5469
Bethesda, MD 20892
Telephone: (301) 451-4785
FAX: (301) 451-5735
Email: bacasa@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ 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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