Discovery and Applied Research for Technological Innovations to Improve Human Health

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

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

credit: c/o coolhunting
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).

Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.

Office - None.

Program Contact: Christine Kelley, PhD, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD 20892.

Telephone Number: (301) 451-4778.

Facsimile: (301) 480-4973.

Business Contact: Joe Mosimann, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892.

Telephone Number: (301) 451-4247.

Facsimile: (301) 480-4530.

Use the same numbers for FTS.




Selected Recipients for this Program


RecipientAmount Start DateEnd Date
Northwestern University $ 131,344   2019-09-012024-08-31
Trustees Of The University Of Pennsylvania, The $ 2,734,697   2009-04-012024-07-31
New York University $ 8,480,681   2014-09-302024-07-31
University Of Pittsburgh The $ 3,279,272   2009-04-012024-07-31
University Of Texas At San Antonio, The $ 148,104   2019-07-232024-06-30
University Of Chicago, The $ 3,494,354   2009-03-012024-06-30
University Of California, San Diego $ 2,614,130   2009-07-012024-06-30
Massachusetts General Hospital, The $ 2,520,000   2019-08-152024-06-30
Leland Stanford Junior University, The $ 2,439,134   2008-09-302024-06-30
Brigham And Women's Hospital, Inc., The $ 2,100,020   2014-07-012024-06-30



Program Accomplishments

Fiscal Year 2016: 718. Fiscal Year 2017: 764 awards are anticipated. Fiscal Year 2018: 601 awards are anticipated.

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.

Indirect costs are paid at negotiated rates for most grant mechanisms.

Exceptions are: conference grants (R13 and U13) receive no indirect costs; Training (T), Fellowship (F), and Career (K) awards receive an 8% indirect cost rate; R25 grants receive an 8% indirect cost rate; and SBIR/STTR grants are limited to a 40% indirect cost rate unless the grantee organization negotiates a higher rate.

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. 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 SF424 (R&R) Adobe Version B series or PHS 398 (Rev. 11/2007), and associated forms are required for all applications submitted to the NIH. 2 CFR 200, Subpart E - Cost Principles applies to this program.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. Application Forms SF424 and PHS 398 (Rev. 11/2007) are the standard forms. Application kits are available on-line at http://grants1.nih.gov/grants/oer.htm . Completed applications should be submitted via Grants.gov (http://www.grants.gov) or 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. 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. SBIR and STTR grant applications should be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) SBIR/STTR Application Guide.

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

Contact the headquarters or regional office, as appropriate, for application deadlines.

Authorization

Public Health Service Act, Title IV, Section 401(b)(1) &464z.

Range of Approval/Disapproval Time

> 180 Days. Research Grants: From 6 to 9 months. NRSAs: From 6 to 9 months. SBIR/STTR: About 7.5 months.

Appeals

From 30 to 60 days. 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://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-064.html.

Renewals

> 180 Days. 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

Statutory formulas are not applicable to this program. Matching requirements are not applicable to this program. MOE requirements are not applicable to this program.

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 6-12 months and Phase II awards are for up to 2 years. See the following for information on how assistance is awarded/released: Normally, awards are released each fiscal year.

Post Assistance Requirements

Reports

No program reports are required.

Cash reports are not applicable.

Annual Progress Reports are required.

Instructions are found: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-09-139.html.

Annual financial status reports are required.

Performance monitoring is not applicable.

Audits

In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. For nongovernmental grant recipients, audits are to be carried out in accordance with the provisions of 2 CFR 200. 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

75-0898-0-1-552.

Obigations

(Project Grants (Discretionary)) FY 16 $27,998,000; FY 17 est $292,486,000; and FY 18 est $225,680,000

Range and Average of Financial Assistance

FY16 Actual Range: $1,467 - $2,242,720; Avg.: $389,944 FY17 estimate Range: $234 - $2,241,498; Avg.: $382,835 FY18 estimate Range: $3,000 - $1,899,165; Avg.: $375,507.

Regulations, Guidelines, and Literature

42 CFR 52; 45 CFR 75; 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. Program Contact: Christine Kelley, PhD, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD 20892. Telephone Number: (301) 451-4778. Facsimile: (301) 480-4973. Business Contact: Joe Mosimann, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892. Telephone Number: (301) 451-4247. Facsimile: (301) 480-4530. Use the same numbers for FTS.

Headquarters Office

David T. George, Ph.D. 6707 Democracy Boulevard, Bethesda, Maryland 20892 Email: georged@nih.gov Phone: 3014969474 Fax: 3014800675

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.



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