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)
National Cancer Institute (NCI) (http://www.nci.nih.gov)
National Eye Institute (NEI) (http://www.nei.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov)
National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)

Title: Bioengineering Research Partnerships (BRP) [R01]

Announcement Type
This is a reissue of PAR-04-023, which was previously released November 18, 2003.

• April 6, 2007 - This PAR has been reissued as (PAR-07-352).
• June 20, 2006 (NOT-HL-06-131) - This notice is to inform prospective investigators that NHLBI has areas of focus in heart, lung, blood and sleep research for this Program Announcement

Program Announcement (PA) Number: PAR-06-459

Catalog of Federal Domestic Assistance Number(s)
93.286, 93.394, 93.395, 93.396, 93.867, 93.172, 93.837, 93.838, 93.839, 93.846, 93.866, 93.865, 93.173, 93.121, 93.113, and 93.853.

Key Dates
Release Date: June 12, 2006
Letters of Intent Receipt Date(s): August 20, 2006 and December 20, 2006
Application Receipt Date(s): September 20, 2006 and January 22, 2007
Peer Review Date(s): February- March, 2007 and June-July, 2007
Council Review Date(s): May-June, 2007 and September-October, 2007
Earliest Anticipated Start Date(s): August, 2007 and December, 2007
Additional Information To Be Available Date (Url Activation Date): None
Expiration Date: January 23, 2007

Due Dates for E.O. 12372
Not applicable

Additional Overview Content

Executive Summary

• This program announcement (PA) is being issued in conjunction with PA-06-419, BIOENGINEERING RESEARCH GRANTS, and PA-06-418, EXPLORATORY/DEVELOPMENTAL (R21) BIOENGINEERING RESEARCH GRANTS.
• This funding opportunity will use the NIH R01 research grant award mechanism.
• Participating Institutes and Centers (ICs) of the National Institutes of Health (NIH) invite applications for R01 awards to support Bioengineering Research Partnerships (BRPs) for basic, applied, and translational multi-disciplinary research that addresses important biological or medical research problems.
• In the context of this program, a partnership is a multi-disciplinary research team that applies an integrative, systems approach to develop knowledge and/or methods to prevent, detect, diagnose, or treat disease or to understand health and behavior.
• The partnership must include appropriate bioengineering or allied quantitative sciences in combination with biomedical and/or clinical components.
• BRP may propose design-directed, developmental, discovery-driven, or hypothesis-driven research at universities, national laboratories, medical schools, large or small businesses, or other public and private entities or combinations of these entities.
• It is expected that a BRP will have a well-defined goal or deliverable that will be achieved based on objective milestones specified in the initial application.
• 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. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.
• Eligible organizations include: Domestic for-profit or non-profit organizations; Domestic public or private institutions such as universities, colleges, hospitals, and national laboratories; Units of state and local governments; Eligible agencies of the Federal government; Large or small businesses; Faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization. Foreign institutions are not eligible to apply as Principal Investigators. However, BRP collaborative projects may include work at a foreign site when the expertise at the foreign site is not present in the United States.
• Eligible principal investigators include any individual with the leadership skills, knowledge, and resources necessary to carry out the proposed research and manage the overall effort. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for NIH support.
• Applicants may submit more than one application, provided they are scientifically distinct.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

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
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

Many of today's biomedical problems are best addressed using a multi-disciplinary approach that extends beyond the traditional biological and clinical sciences. Bioengineering integrates principles from a diversity of technical and biomedical fields and crosses the boundaries of many scientific disciplines represented throughout academia, laboratories, and industry. The creativity of interdisciplinary teams is resulting in new basic understandings, novel products, and innovative technologies for addressing biomedical problems.

Recognizing the importance of bioengineering in public health, the Bioengineering Consortium (BECON) was established in 1997 as a focus for bioengineering activities at the NIH. To facilitate communication between the allied and biomedical disciplines and to provide input from the scientific community on research needs and directions, the BECON has held annual two-day symposia on emerging topics of interest related to bioengineering including bioengineering (1998), bioimaging, (1999), nanotechnology (2000), reparative medicine (2001), biosensors (2002), and team science (2003). Summaries of the proceedings and recommendations of these symposia are available on the Internet at http://www.becon.nih.gov/becon_symposia.htm.

Discussions and recommendations of symposia participants aided in the formulation of the BRP, BRG, and EBRG program announcements. It is expected that some applications submitted in response to the BRP, BRG, and EBRG PAs will focus on technology development rather than on proving or disproving scientific hypotheses. In support of this approach, NIH instructions to applicants and review criteria emphasize that a project may test a stated hypothesis, create a novel design, solve a specific problem, or develop new technology.

The primary objective of this program announcement is to encourage basic, applied, and translational bioengineering research that could make a significant contribution to improving human health. Bioengineering integrates physical, engineering, and computational science principles for the study of biology, medicine, behavior, or health. It advances fundamental concepts, creates knowledge from the molecular to the organ systems level, and develops innovative biologicals, materials, processes, implants, devices, and informatics approaches for the prevention, diagnosis, and treatment of disease, for patient rehabilitation, and for improving health. Some BRP projects may propose research that could lead to a novel device as a product. Partnership with companies that have relevant expertise or that may eventually be involved in commercialization is appropriate under the BRP program.

A second objective is to encourage collaborations and partnerships among the allied quantitative and biomedical disciplines. A BRP must bring together the necessary physical, engineering, and computational science expertise with biological or clinical expertise and resources to address a significant area of bioengineering research within the mission of the NIH. In addition to the benefits to be derived from the research, the collaborations and partnerships can create opportunities for trans-disciplinary communication and training for a new generation of scientists capable of interacting across traditional technical boundaries.

Applications for a BRP award should focus bioengineering research on an area of basic, applied, translational, behavioral, or clinical research that supports the missions of the participating NIH institutes and centers and where progress is likely to make a significant contribution to improving human health. Some NIH institutes and centers have indicated that they will only consider BRP applications in specific focus areas or use different budget caps. These institutes and focus areas are available at http://www.becon.nih.gov/becon_brpareas.htm.

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 NIH R01 research grant award mechanism(s).

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

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the 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.

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:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Foreign Institutions: Foreign institutions are not eligible to apply as Principal Investigators. However, BRP collaborative projects may include work at a foreign site when the expertise at the foreign site is not present in the United States.
• Domestic Institutions
• Faith-based or community-based organizations
• Indian/Native American Tribal Government (Federally Recognized)
• Indian/Native American Tribal Government (Other than Federally Recognized)
• Indian/Native American Tribally Designated Organizations

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.

This initiative is not part of the Multiple Principal Investigator policy (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-06-036.html).

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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) 710-0267, 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.

The Research Plan, Sections A-D must not exceed 40 pages.

This Funding Opportunity Announcement (FOA) is not part of the pilot multiple-PI program (NOT-OD-06-069). Only one Project Director/Principal Investigator (PD/PI) must be designated on the face page of each application.

SPECIAL REQUIREMENTS

BRP ORGANIZATIONAL STRUCTURE, LEADERSHIP, AND MANAGEMENT: An organizational structure that clearly defines the partnership and relationships among the various components must be developed and described in the application. The BRP size, structure, and mode of operation should match the needs and scope of the proposed research. NIH policy requires that a single PI be designated on the face page of all applications submitted in response to this FOA. While this individual is responsible for the scientific and technical aspects, as well as the proper conduct of the project, the structure of the BRP may involve more than one individual in developing the application and in making decisions concerning planning, management, staffing, and resource allocation. In recognition of the essential intellectual and/or technical contributions of the lead scientists responsible for developing and implementing the goals of the proposal, the BRP organizational structure must include a Leadership Statement that specifies the roles of the individuals that provide major intellectual and/or technical contributions. The PI has the responsibility and authority to use BRP funds in the most productive way to achieve the goals defined at the time of the award. To accomplish these tasks, the PI in collaboration with other individuals identified in the Leadership Statement can adjust funding among BRP participants to support new partners or to reduce support to existing partners as needed. The BRP should establish a Scientific Steering Group that consists of representatives from each of the partnering organizations and meets regularly to discuss project status, problems, and directions. Those individuals identified in the Leadership Statement , who together would have the intellectual and leadership responsibilities normally attributed to the PI, would likely be members of the Scientific Steering Group. Applications lacking a clear leadership plan may be returned without review.

BRP PI MEETING: BRP PIs will meet annually in Bethesda, Maryland, to share results, to ensure that the NIH has a coherent view of the advances in these fields, and to have an opportunity for collective problem solving among the PIs. The cost of participating in this annual meeting should be included in the BRP budget.

APPLICATION PREPARATION INSTRUCTIONS:

1. Identify in the Description the name(s) of the institution(s) leading the BRP and other participating institutions. The Description should clearly indicate the area(s) of bioengineering research that will be the focus of the BRP, the planned multi-disciplinary approach, and the specific objective of the project.

To provide recognition of the essential contributions of partners who provide significant intellectual leadership to the BRP project, applicants are strongly encouraged to include information about Lead Investigators in the description, which is a publicly accessible document. Lead Investigators are those who provide essential scientific, engineering, technical, and visionary leadership to the effort. In the past, applications might have listed such individuals as Key Personnel. Include in the description the following information about each Lead Investigator: name, institution if different from the applicant organization, and one sentence about the leadership role. The description of the roles of Lead Investigators should be provided in greater detail in the narrative for personnel in the budget section.

The Lead Investigators will usually include the Principal Investigator and a subset of the Key Personnel. The following information is provided to clarify the roles of the various individuals who are to be named on this page. NIH grants policy requires that each application designate a single Principal Investigator (PI) who (1) is responsible for the overall scientific and technical direction of the effort and (2) serves as the contact person with whom NIH staff will interact. Lead Investigators provide essential scientific, engineering, technical, and visionary leadership to the effort. Key Personnel are those individuals who contribute in a substantive way to the scientific or engineering development or execution of the project.

3. Provide an organization chart (OC) that clearly defines the partnership and relationships among its various components must be included with the application. A program plan (PP) should accompany the OC and list major tasks with a timeline of quantitative milestones for the entire project period. The structure and function of the Scientific Steering Group should be described in this section. The OC and PP must not exceed one page each. This information should be included in the Research, Design, and Methods section of the application.

4. BRP Budget Items - A separate budget for each partner at a subcontract/consortium institution, and when appropriate for clarity, for each partner within the grantee institution must be included. Include a summary budget for all BRP participants with partners at non-grantee institutions shown as consortium arrangements. It is understood that this is an initial budget, and that the PI has the responsibility to reallocate funds during the project to accomplish the BRP goals.

The NIH ICs will not provide annual support in excess of $2 million total cost for any year for new applications. Direct cost inflationary increases following the first year may be included, but the maximum total cost request level of $2 million per year must be observed. Some NIH ICs may have budget caps of less than $2 million total cost. Please see the following website for additional institute specific budgetary restrictions: http://www.becon.nih.gov/becon_brpareas.htm.

The PI is expected to devote a minimum of 25% effort to the BRP. The percent effort requested for all personnel should be limited to time devoted specifically to BRP activities and not to other research projects. Information documenting the level of effort on BRP activities should be included in the application. The need for all requested personnel costs should be thoroughly justified.

There will be an annual BRP PI meeting at a date and location to be determined by NIH staff. Applicants should include travel funds specifically for these meetings in the BRP budget request.

Applicants may request and justify additional travel funds. Travel funds could be used to promote collaboration among BRP partners at different institutions or at a distant site, for travel of external advisors to the BRP site, and/or for BRP partners to attend scientific meetings essential to the progress of the project and for which other funds are not available.

Other expenses can be requested including costs necessary for the central administration and fiscal management of the BRP including relevant and reasonable costs for reprints, graphics, and publications. Administrative support (a secretary or an administrative assistant) may be requested only for matters directly pertaining to the BRP.

With regard to projected funding by source, some BRP applicants may anticipate or receive commitments for significant funding from sources other than the NIH; e.g., from a collaborating company. In this case, applications should describe the source, annual amount, and use of the other funding.

5. Resources - The application should describe the equipment and facilities available for the proposed BRP.

If the BRP entails an institutional commitment of resources across boundaries in the institution or anticipates the provision of institutional resources, letters from appropriate senior-level individuals describing their agreements to support those commitments must be included.

Where appropriate, describe the shared facilities to be established including specific major research instruments and plans for the development of instruments. Describe plans for maintaining and operating the facilities including staffing, provisions for user fees, and plans for ensuring access to outside users. Distinguish between existing facilities and those still to be developed.

6. Research Plan

A. Specific Aims A BRP may propose design-directed, developmental, discovery-driven, or hypothesis-driven research. Thus, the application should state the hypotheses, designs, problems, and/or needs that will drive the proposed research. Describe the specific aims in the appropriate area of bioengineering research and the milestones for the project period. Describe the expected applications of the bioengineering research that will improve human health. One page is recommended.

B. Background and Significance - Briefly describe the area of bioengineering research that is the focus of the BRP. Critically evaluate existing knowledge and approaches that have been or are being applied in the area and specifically describe how the proposed BRP approach will advance the field. State concisely the importance and health relevance of the research proposed to achieve the Specific Aims.

C. Preliminary Studies and Rationale - Preliminary studies that support the proposed research should be described in the application.

D. Research Design and Methods - A BRP should focus on a systems approach for bioengineering research aimed at a significant advance in biology or medicine. The research plan should be sufficiently long term (five to ten years) and comprehensive to justify organizing a BRP and adaptable enough to permit change as the research proceeds. The integrative systems approach and its appropriateness for the proposed project should be described including plans for collecting, analyzing, and interpreting data. A timetable of events including quantitative milestones or other evaluative criteria should be included. The contributions of each partner and how these will be integrated and organized to accomplish the specific aims of the project should be described. Potential technical challenges and possible alternative approaches to achieve the aims of the project should be discussed. Plans for enhancing the abilities and opportunities for investigators and trainees to work across disciplinary boundaries should also be included. If the proposed BRP research is closely related to ongoing research, explain how the research activities of the BRP will complement but not overlap the existing research.

7. Applications should include a plan for making available to the research community any technologies developed or enhanced by work conducted as part of the program announcement. The plan should include ordering of authors and provision for publication/recognition of the contributions of each essential co-author. This plan should be described in the Research Design and Methods section of the application. Investigators using PHS funds are required to make unique research resources readily available for research purposes to qualified individuals within the scientific community when the results have been published. The intent of this policy is not to discourage, impede, or prohibit the organization that develops the unique research resources or intellectual property from commercializing the products. It is strongly encouraged that technology transfer officials from each participating organization be members of the BRP or the Scientific Steering Group.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): August 20, 2006 and December 20, 2006
Application Receipt Date(s): September 20, 2006 and January 22, 2007
Peer Review Date(s): February-March, 2007 and June-July 2007
Council Review Date(s): May-June, 2007 and September-October 2007
Earliest Anticipated Start Date(s): August, 2007 and December, 2007

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity, however applicants are strongly encouraged to provide a letter of intent. The letter of intent is to be sent by the date listed above and at the beginning of this document.

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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 should be sent to:

Albert Lee, Ph.D.
Extramural Science Programs
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892
Telephone: (301) 451-4772
FAX: (301) 480-1614
Email: alee@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application 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 five 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).

3.C. Application Processing

Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.

Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.

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/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

Section V. Application Review Information

1. Criteria

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review groups convened by CSR in accordance with the review criteria stated below.

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

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique
• Receive a second level of review by an appropriate national advisory council or board.

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

The NIH review criteria have been expanded to ensure that the BRP application is evaluated appropriately. The score should reflect the overall impact that the BRP award could have on the selected area of bioengineering research based on consideration of the five criteria given below. The emphasis on each criterion can vary from one application to another depending on the nature of the application and its relative strengths. An application need not be strong in all categories to be judged likely to have major technical or scientific impact and thus deserve a high priority score. For example, an investigative partnership may propose to perform important work that by its nature is not innovative but is essential to advance a field.

A BRP may propose design-directed, developmental, discovery-driven, or hypothesis-driven research at universities, national laboratories, medical schools, large or small businesses, or other public and private entities.

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? In addition, reviewers will consider the following: If the specific aims of the BRP are achieved, will they provide significant advances in the selected area of bioengineering research? Is the research likely to have a significant impact on other areas of research? Will the technological advances have a significant impact on human health?

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? In addition, reviewers will consider the following: Are the BRP engineering, scientific, and clinical approaches and methods adequately developed, well-integrated, and appropriate to the aims of the project? Is a timetable with adequate research milestones proposed? Are appropriate specifications and evaluation procedures provided for assessing technological progress? Is the plan for sharing or disseminating technologies developed or enhanced under this program announcement adequate? Is the plan for technology transfer involving each partnering organization adequate? Does the application describe arrangements that facilitate the fruitful participation of a partner at a distant site? If partnership with industry or small business is included, does this positively affect the research goals and technology dissemination?

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? In addition, reviewers will consider the following: Does the BRP propose new approaches, explore new research paradigms, or represent new concepts that combine engineering, physical, and biological/clinical sciences? Will the proposed approaches or concepts solve current scientific or technical problems in novel ways?

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)? In addition, reviewers will consider the following: Is the PI capable of coordinating and managing the proposed BRP? Are the investigators (partners) appropriately trained in their disciplines and capable of conducting and contributing to the management of the proposed interdisciplinary work?

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? In addition, reviewers will consider the following: Does the scientific and technological environment in which the work will be done contribute to the probability of success? Does the partnership create potential opportunities to foster trans-disciplinary communication and training across traditional scientific and technical boundaries?

2.A. Additional Review Criteria:

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

Additional Considerations: Is the proposed partnership adequate for the research? Is the partnership strategy well planned and documented? Is there evidence that the partners from academia or industry can work together effectively, have an impact on achieving the research goals, and disseminate the developed technology?

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

2.D. Sharing Research Resources

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

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

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

BRP applications will compete for available funds with all other recommended applications. Funding decisions will be based on the quality of the proposed research as determined by peer review, availability of funds, and the institute’s programmatic priority for the focus of the proposed research.

2. Administrative and National Policy Requirements

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

3. Reporting

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

NIH BECON scientific and financial contacts listed at the following Web site should be contacted for answers to questions about scientific or financial issues: http://www.nibib.nih.gov/Funding/Bioengineering/Contacts

2. Peer Review Contacts:

Eileen Bradley, Ph.D.
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 435-1179
FAX: (301) 480-2241
Email: bradleye@csr.nih.gov

3. Financial or Grants Management Contacts:

NIH BECON scientific and financial contacts listed at the following Web site should be contacted for answers to questions about scientific or financial issues: http://www.nibib.nih.gov/Funding/Bioengineering/Contacts

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/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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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