Program Descriptions
Program Number
93.286
Title
Discovery And Applied Research For Technological Innovations To Improve Human Health
Federal Agency
NATIONAL INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Authorization
Public Health Service Act; Title IV, Sections 401(b)(1) and 467z; Public Law 106-505.
Status
Active
Objectives
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, 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).
Types of Assistance
Project Grants.
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.
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.
Application and Award Process
Preapplication Coordination
Not applicable. This program is excluded from coverage under E.O. 12372.
Application Procedure
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 http://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 Procedure
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.
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
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.
Obligations
(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.
Program Accomplishments
In fiscal year 2007, approximately 830 awards were made; and in fiscal year 2008, approximately 838 awards will be made.
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.
Web Site Address
http:/www.nibib.nih.gov
Related Programs
93.394, Cancer Detection And Diagnosis Research
93.395, Cancer Treatment Research
93.396, Cancer Biology Research
93.306, Comparative Medicine;
93.867, Vision Research
93.172, Human Genome Research
93.837, Cardiovascular Diseases Research
93.838, Lung Diseases Research
93.839, Blood Diseases And Resources Research
93.866, Aging Research
93.273, Alcohol Research Programs
93.855, Allergy, Immunology And Transplantation Research
93.856, Microbiology And Infectious Diseases Research
93.846, Arthritis, Musculoskeletal And Skin Diseases Research
93.864, Population Research;
93.865, Child Health And Human Development Extramural Research
93.929, Center for Medical Rehabilitation Research;
93.279, Drug Abuse And Addiction Research Programs
93.173, Research Related To Deafness And Communication Disorders
93.121, Oral Diseases And Disorders Research
93.847, Diabetes, Digestive, And Kidney Diseases Extramural Research
93.848, Digestive Diseases and Nutrition Research;
93.849, Kidney Diseases, Urology and Hematology Research;
93.113, Environmental Health
93.821, Cell Biology and Biophysics Research;
93.859, Biomedical Research And Research Training
93.862, Genetics and Developmental Biology Research and Research Training;
93.242, Mental Health Research Grants
93.853, Extramural Research Programs In The Neurosciences And Neurological Disorders
93.361, Nursing Research
93.879, Medical Library Assistance
Examples of Funded Projects
(1) Studies to fully utilize multiple forms of information (MRI and EEG); (2) Construction and investigation of a scanning equalization digital radiography (SEDR) system to over come the problems with projection x-ray imaging; (3) Utilization of functional magnetic resonance imaging (IMRI) technique based on the blood oxygen level dependent (BOLD) contrast to provide a robust and noninvasive tool for studying functional processing of neural network at physiological and pathological conditions; (4) Development of two complimentary intervention devices for treating stroke victims: mechanical clot extraction system and a neurovascular stent; (5) Development of molecular array biosensors using metallic nanoparticle clusters to capture in parallel a large number of molecular species from very small samples typical of most collection procedures; and (6) Production of nanoparticles containing agents that will have cell and tissue specificity, and demonstration of the effectiveness of these nanoparticles in attaining the intended specificity in tissue permeation and localization.
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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