Full Text RR-94-005 BIOENGINEERING FOR DISEASE PREVENTION AND CONTROL NIH GUIDE, Volume 23, Number 33, September 16, 1994 RFA: RR-94-005 P.T. 34 Keywords: BIOMEDICAL ENGINEERING Disease Prevention+ Disease Control+ National Center for Research Resources The Whitaker Foundation Application Receipt Date: December 9, 1994 PURPOSE The National Center for Research Resources (NCRR) and The Whitaker Foundation invite investigator-initiated research project grant applications for the research and development of devices, instruments, and methodologies for the prevention and control of disease and disabling conditions, and the reduction of health care costs and risks. This solicitation is limited to novel, cost-effective bioengineering approaches in the following areas: (1) microsensors, (2) physiological monitoring, and (3) drug delivery systems. The Whitaker Foundation (Whitaker) is a private, non-profit foundation that encourages and supports biomedical engineering research and training. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Bioengineering for Disease Prevention and Control, is related to the priority area of disease prevention. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or "Healthy People 2000" Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, public and private, non-profit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT The mechanism of NCRR support for this program will be the individual research project grant (R01) and the total project period may not exceed four years (three years for foreign applicants). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The NCRR and Whitaker plan to make several awards each in Fiscal Year 1995. The earliest possible award date is July 1, 1995. Because the nature and scope of the research proposed in response to this RFA will vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NCRR and Whitaker anticipate making a total of six to eight awards for project periods of up to four years and anticipate that each will set aside $1 million for the initial funding period. Funding in response to this RFA is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCRR, the award of research grants pursuant to this RFA by NCRR is contingent on the availability of funds appropriated for Fiscal Year 1995. RESEARCH OBJECTIVES Background The recent explosion of new knowledge in both the physical and biological sciences offers unprecedented opportunities to develop devices, sensors, instruments, and novel methods for use in basic research and clinical care. Many of these technologies, if used appropriately, also should reduce health care costs. The overall goal of this program, jointly announced and sponsored by the NCRR and Whitaker, is to stimulate the development of new or improved technologies that (1) have the potential to prevent or detect disease and/or disabling conditions in the early stages, when often they can be most efficiently and effectively treated; (2) will reduce the length of hospital stay or eliminate the need for in-patient care altogether; (3) will transfer health care procedures from the hospital to the home or an ambulatory environment; and (4) will provide acute and/or rehabilitation therapy based upon the specific physiological or functional need of the patient. Objectives and Scope The objective of this program is to stimulate technological research and development of novel, cost effective bioengineering approaches to the prevention, treatment, or rehabilitation of disease or disabling conditions. Applications need to be based on sound scientific, engineering, and medical rationale. There must be a clearly identified target patient population to which the research is addressed. Since work in technological innovation typically involves many disciplines (e.g., physics, chemistry, biology, engineering), applicants should consider using appropriate multidisciplinary teams in many cases. Research supported under this program is restricted to the following areas: o Microsensors. The emphasis is on devices that are non-invasive, minimally invasive, miniature, stable, and durable. o Physiological monitoring. The emphasis is on innovative detection and accurate readout. The monitoring must be a cost effective alternative to current practices. o Drug delivery systems. The emphasis is on automating the delivery of the accurate amount of medication when needed by the patient. STUDY POPULATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving humans subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (59 FR 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the NIH program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). These forms are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone (301) 710-0267. Instructions relating to the preparation of investigator-initiated R01 grant applications are provided with the PHS 398 form. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. The completed original and three permanent, legible copies of the PHS 398 including the Checklist and appendix material must be delivered by December 9, 1994, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the complete application including Checklist and appendix material must be sent to: Dr. Chhanda Ganguly Office of Review National Center for Research Resources Westwood Building, Room 10A15 Bethesda, MD 20892 Applications must be received by December 9, 1994. Any application received after this date will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Timetable Application Receipt Date: December 9, 1994 Initial Review: February/March 1995 Council Review: June 1995 Earliest Award Start Date: July 1, 1995 Applicants are requested to submit a brief letter with their application, co-signed by the institutional official, authorizing that their application and summary statement be made available to Whitaker. The absence of this authorization letter will preclude the possibility of funding by Whitaker. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NCRR. Incomplete applications will be returned to the applicant without further consideration. If NCRR staff find that the application is not responsive to this RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR in accordance with the peer review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to this RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be promptly notified. The following review criteria will be used by the Office of Review, NCRR to evaluate the scientific and technical merit of each application: o Originality or uniqueness of the approach(es) proposed. o Merit of the research plan for developing and testing the proposed device or method. o Appropriateness of the target patient population that will be addressed. o Project staffing with appropriate disciplines and training/prior experience, and adequate facilities and equipment to successfully achieve the stated goals. o Rational assessment of the anticipated health care cost reduction resulting from the application of the proposed technological innovation. A second level of review will be provided by the National Advisory Research Resources Council (NARRC), whose review may be based on policy considerations as well as scientific merit. Only applications recommended by NARRC may be considered for funding by the NCRR. Grants made by Whitaker need to be approved by its Foundation Governing Committee. AWARD CRITERIA The anticipated earliest award date is July 1, 1995. Applications judged meritorious may be eligible for funding by either the NCRR or by Whitaker. Whitaker is not required to base its funding solely on the priority assigned by the NCRR peer review group, and may use its own peer review process to determine which projects it will fund. Factors to be considered by both sponsors include scientific and technical merit, project content, and program relevance. The NCRR will administer grants funded by NIH in accordance with PHS policies. Grants funded by Whitaker will be subject to that foundation's policies, except that the indirect cost allowance of NIH will apply. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Richard DuBois, Ph.D Biomedical Research Technology Program National Center for Research Resources 5333 Westbard Avenue, Room 8A-15 Bethesda, MD 20892 Telephone: (301) 594-7934 Peter Katona, Sc.D. Biomedical Engineering Programs The Whitaker Foundation 901 15th Street, N.W. Washington, DC 20005 Telephone: (202) 408-1505 Direct inquiries regarding fiscal matters to: Mr. Paul Karadbil Office of Grants and Contracts Management National Center for Research Resources 5333 Westbard Avenue, Room 849 Bethesda, MD 20892 Telephone: (301) 594-7955 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.371, Biomedical Research Technology. Awards will be made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78-410, as amended, 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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