To support hypothesis, design, technology, or devise-driven research relation to the discovery, design, development, validation, and application of technologies related to biomedical imaging and bioengineering.

The program includes biomaterials (biomimetics, bioprocessing, organogenesis, rehabilitation,

credit:

tissue engineering, implant science, material science, interface science, physics and stress engineering, technology assessment of materials/devices), biosensors/biotransducers (technology development, technology assessment, development of algorithms, telemetry), nanotechnology (nanoscience, biomimetics, drug delivery systems, drug bioavailability, microarray/combinatorial technology, genetic engineering, computer science, technology assessment), bioinformatics (computer science, information science, mathematics, biomechanics, computational modeling and simulation, remote diagnosis and therapy), imaging device development, biomedical imaging technology development, image exploitation, contrast agents, informatics and computer sciences related to imaging, molecular and cellular imaging, bioelectrics/biomagnetics, organ and whole body imaging, screening for diseases and disorders, and imaging technology assessment and surgery (technique development and technology development).

In fiscal year 2007, approximately 830 awards were made; and in fiscal year 2008, approximately 838 awards will be made.

Uses and Use Restrictions

Research Grant funds may be used for salaries, consultation, equipment, travel and other usual costs, subject to Federal regulations applicable to the grant.

Individual National Research Service Awards (NRSAs) are made directly to individuals for research training in specified areas related to the mission of NIBIB.

Institutional NRSAs may be made to institutions to enable them to accept individuals for research training.

Each individual who receives a NRSA postdoctoral fellowship or traineeship is obligated upon termination of the award to comply with certain service and payback provisions.

Small Business Innovation Research (SBIR) Phase I grants are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process.

Only Phase I awardees are eligible to apply for Phase II support.

Small Business Technology Transfer (STTR) Phase I grants are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application.

Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of the Phase II application.

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Eligibility Requirements

Applicant Eligibility

Any corporation, public or private institution or agency, or other legal entity, either nonprofit or for-profit, may apply for a research grant.

An applicant for an individual NRSA must be a citizen of the United States or lawfully admitted for permanent residence.

Those on temporary or student visas are not eligible.

An eligible institution for an institutional NRSA must be capable of providing predoctoral and/or postdoctoral research training opportunities for engineers, bioengineers or other.

SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit; are not dominant in the field in which research is being proposed; and have no more than 500 employees).

Primary employment (more than one-half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project.

In both Phase I and Phase II, the research must be performed in the United States or its possessions.

To be eligible for funding, a grant application must be reviewed for scientific merit and program relevance by a scientific review group and a national advisory council.

STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development.

At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution.

In both Phase I and Phase II, the research must be performed in the U.S.

or its possessions.

To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.

Beneficiary Eligibility

Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.

Credentials/Documentation

Credentials/Documentation: Each applicant for research projects must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. For an individual NRSA, the applicant's academic record, research experience, citizenship, and institutional sponsorship should be documented in the application. For an institutional NRSA, the applicant organization must show the objectives, methodology and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for awards, and detailed budget justification for the amount of grant funds requested. Costs will be determined in accordance with OMB Circular No. A-21, Cost Principles for Educational Institutions and OMB Circular No. A-87 for State and local governments. For-profit organizations' costs are determined in accordance with Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations 45 CFR, Part 74, Subpart Q. For SBIR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. Use of PHS 398 (Rev. 5/01; updated 8/8/03) and associated forms are required for all applications submitted to the NIH.

Aplication and Award Process

Preapplication Coordination

Not applicable.

This program is excluded from coverage under E.O.

12372.

Application Procedures

Application Form PHS 398 (Rev. 5/01; updated 8/8/03) is the standard form. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, Telephone: (301) 435-0714, E-mail: grantsinfo@nih.gov . Alternatively, the application kit can be obtained on the World Wide Web, http://grants.nih.gov/grants/funding/phs398/phs398.html. Completed applications should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. The standard application forms, as furnished by PHS and required by 45 CFR Part 92 for State and local governments, must be used for this program. The same application form will be used for all types of applications including training (NRSA), both individual and institutional, and SBIR/STTR. The training (NRSA) program is subject to the provisions of 45 CFR Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" home page at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: Telephone: (301) 206-9385; Fax: (301) 206-9722; E-mail: a2y@cu.nih.gov . The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710.

Award Procedures

All applications for research or training are reviewed for scientific merit by an appropriate initial review group and then by a national advisory council. All applications favorably recommended compete for available funds on the basis of scientific merit and program emphasis. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines

Research Grants: February 1, June 1, and October 1. Renewals: March 1, July 1, and November 1. Individual NRSAs: April 5, August 5, and December 5. Institutional NRSA's: January 10, May 10 and September 10. SBIR or STTR: April 1, August 1, and December 1.

Authorization

Public Health Service Act; Title IV, Sections 401(b)(1) and 467z; Public Law 106-505.

Range of Approval/Disapproval Time

Research Grants: From 6 to 9 months. NRSAs: From 6 to 9 months. SBIR/STTR: About 7-1/2 months.

Appeals

A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page http://grants2.nih.gov/grants/guide/notice-files/not97-232.html .

Renewals

Research Grant applications submitted for renewal are reviewed and selected for funding on a competitive basis. NRSA awards may be made for 1 to 5 years. No individual may receive more than 5 years of aggregate NRSA support beyond the predoctoral level, and no individual may receive NRSA support for more than 3 years of support beyond the postdoctoral level. Institutional awards may be renewed.

Assistance Considerations

Formula and Matching Requirements

None.

Length and Time Phasing of Assistance

Research Grant awards are usually made annually with no project periods to exceed 5 years in length. NRSA Institutional awards may be made for up to 5 years, and Individual awards may be made for up to 5 years at the predoctoral level, 3 years at postdoctoral level, and 2 years at senior level. Normally SBIR and STTR Phase I awards are for 6 months and Phase II awards are for 2 years.

Post Assistance Requirements

Reports

Progress reports are required each year.

An annual financial status report is required 90 days after the end of the budget period.

Special reports may be requested by DHHS.

Terminal reports are required 6 months after the end of the project period.

Recipients of NRSAs are required to file termination reports to ascertain compliance with the service and payback provisions.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Nonprofit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal officials.

Records

Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last financial status report for the report period.

Financial Information

Account Identification

7560898; 7570898; 7580898.

Obigations

(Grants) FY 07 $298,314,000; FY 08 est $300,463,000; and FY 09 est not reported.

Range and Average of Financial Assistance

$2,000 to $2,190,831; $328,181.

Regulations, Guidelines, and Literature

42 CFR 52; 45 CFR 74; 45 CFR 92; PHS Grants Policy Statement, DHHS Publication No. (OASH) 94- 50,000, (Rev.) April 1, 1994. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institute of Health for Small Business Technology Transfer (STTR) Grant Applications.

Information Contacts

Regional or Local Office

None.

Headquarters Office

Program Contact: William Heetderks, MD, PhD, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone Number: (301) 496-9388. Facsimile: (301) 480-4973. Business Contact: Chris Hollingsworth, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone Number: (301) 451-6773. Facsimile: (301) 480-4530. Use the same numbers for FTS.

Criteria for Selecting Proposals

The major elements in evaluating proposals include assessments of: (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator 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 (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? (6) the appropriateness of the proposed budget and duration in relation to the proposed research; (7) the relevance and importance to announced program objectives; (8) the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated; (9) the adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application; and (10) the adequacy of the proposed plan to share data, if appropriate. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget requested for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a)safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.