Bioengineering Research Partnerships.

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. The Principal Investigator (PI) also serves as the project manager and must be capable of leading the proposed effort. 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 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. On 11 October 2001, the NIH issued a related program announcement (PA) PA-02-011 (http://grants.nih.gov/granrs/guide/pa-files/PA-02-011.html) for Bioengineering Research Grants (BRGs). The BRGs differ from the BRPs in that the research will be performed in a single laboratory, by a single investigator, or by a small group of investigators. On 16 January 2003, the NIH issued another related PA (PA-03-058), (http:// grants.nih.gov/grants/guide/pa-files/ P A-03-058.html) for Exploratory/Developmental (R21) Bioengineering Research Grants (EBRG). The EBRGs differ from the BRPs in that (1) the research will be performed in a single laboratory, by a single investigator, or by a small group of investigators and (2) the projects are high-risk/high-payoff in nature (R21 mechanism) as compared to the R01-type grants supported by the BRP program.

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 PAs. 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" (PHS 398 instructions for the research plan).

The primary objective of this PA 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 on an area of basic, applied, translational, behavioral, or clinical research in bioengineering 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. These institutes and focus areas are available at http:// www.becon.nih.gov/becon-brpareas.htm.

This PA uses the NIH R01 award mechanism. As an applicant, you are solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular budgeting as wall as the non-modular budgeting 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. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.govlgrantslpolicy/nihgps_2001/part_i_1.htm.

The initial period of support of a BRP award may be up to five years. The award may be competitively renewed for a total of up to ten years of NIH funding. Competing renewal and revised applications for BRP grants are to be received at the NIH on the same receipt dates as new BRP applications.

For new grants, the maximum total (direct plus facilities and administrative [F&A] costs) budget to be awarded in any year is $2 million. The number of awards and level of support will depend on the number of applications of high scientific merit that are received and the availability of funds. Funding in subsequent years will be contingent upon satisfactory progress during the preceding year(s) and the availability of funds. Applicants are strongly encouraged to discuss budget requests with NIH scientific and financial contacts listed under WHERE TO SEND INQUIRIES prior to submission. Grantees have the authority to extend the duration of a BRP grant on a no-cost basis. This extension provides additional time to use funds that remain available at the end of the project period to continue pursuing the aims of the grant. Grantees should notify the Grants Management Officer of the awarding institute or center of the no-cost extension as early as possible and before the expiration of the grant.

Research Focus Areas: Applicants are strongly advised to contact IC scientific program staff listed under WHERE TO SEND INQUIRIES to discuss the relevance of their proposed work to the institute's mission before preparing a detailed research application. Detailed information on research missions and programs for each NIH institute and center is available on the participating ICs Web sites, which are listed at the beginning of this PA. Some NIH institutes and centers have indicated that they may only want to consider BRP applications in specific focus areas. As they are available, these institutes and focus areas will be posted at http://www.becon.nih.gov/ becon_brpareas.htm.

Letter of Intent: Prospective applicants are asked to submit a letter of intent that includes the following information: Number and title of this PA; Descriptive title of the proposed research; Name, address, telephone number, and e-mail address of the Principal Investigator; List of participating institutions and key personnel. 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 NIH staff to estimate the potential review Workload, plan the review, and evaluate programmatic impacts of the proposals. The letter of intent should be sent to: Dr. Richard E. Swaja, National Institute of Biomedical Imaging and Bioengineering (NIBIB), 6707 Democracy Boulevard, Suite 200, Bethesda, MD 20892-5469 USA, 301-451-4779 fax: [phone], email: [e-mail]

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. 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.

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 Pls. The cost of participating in this annual meeting should be included in the BRP budget.

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling 866-705-5711 or through the web site at http:l/www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 is available at http:/ /grants.nih.gov/grants/funding/phs398/ phs398.html in an interactive format. For further assistance contact GrantsInfo, 301-435-0714, e-mail: [e-mail].

Application Receipt Dates: New and competing renewal applications submitted in response to this PA will be accepted on January 21, 2004; August 20, 2004; January 20, 2005; August 19, 2005; January 20, 2006; and August 22, 2006. These are the dates that applications must be received at the NIH.

Applications must be received on or before the receipt dates described as listed on the first page of this PA. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Contact: Dr. Richard E. Swaja, NIBIB, 6707 Democracy Boulevard, Suite 200, Bethesda, MD 20892-5469 USA, 301-451-4779, fax: [phone], e-mail: [e-mail]; Dr. Eileen Bradley, Center for Scientific Review, NIH, 6701 Rockledge Drive, Bethesda, MD 20892-0001, 301-435-1179, fax: [phone], e-mail: [e-mail]