NEUROSCIENCES TECHNOLOGY DEVELOPMENT NIH Guide, Volume 26, Number 38, November 21, 1997 PA NUMBER: PA-98-012 P.T. National Center for Research Resources PURPOSE The mission of the Biomedical Technology area of the National Center for Research Resources (NCRR) is to support research to identify, create and develop innovative technologies and to provide these technologies for biomedical research. Areas of emphasis are biomedical engineering, biomedical computing, and technologies for the study of structure and function at all levels of living systems. The purpose of this program announcement (PA) is to encourage submission of new research project grant (R01) applications to develop new (or enhance existing) technologies, methods, or instrumentation for the study of the biology of the brain, with special emphasis on approaches that are appropriate for investigating dynamic changes with time, the fourth dimension. Recently, several new technologies from microscopic to tomographic approaches have enabled significant progress in this area. Examples include application of multi-photon imaging of cellular processes and magnetic resonance imaging of the brain as a whole or of microscopic regions. However, the contributions of these approaches to providing biological information with suitable spatial and temporal resolution are in early stages of development. It is an opportune time to capitalize on these beginnings to engage other sophisticated and sensitive image acquisition and analysis methodologies, as well as encourage the development of appropriate strategies for integrating the large amounts of data that are derived from such imaging systems. This solicitation is intended to include any novel or emerging technology suitable for studying the brain, including: magnetic resonance imaging, microscopic imaging, physiological tracer imaging, image processing/manipulation/fusion, modeling/simulation, and database access/analysis. Since such imaging approaches must ultimately be linked to brain function, approaches such as: electrophysiological recording, mass spectrometry, cartography, virtual reality/environments, and visualization must similarly be developed in ways which permit mapping onto imaging results/databases. The special requirements imposed on studies of the brain suggest general thrusts for methodological and technical developments. These include: hierarchical brain modeling (simulation), multiscale (time/space) data acquisition and integration, development of reporter/indicator molecules, novel detectors, nanotechnology, data visualization approaches, and application of bioinformatics approaches. Increasing the speed of data processing, ultimately to the level of real-time, is urgently required. Under these general areas, applications are solicited for specific technological innovations and enhancements such as creation and delivery of new labels and dyes; federated data bases and search engines; higher field electrical and optical imaging, MEG, and other tools; higher temporal/spatial resolution, larger field-of view cameras; more efficient microscopies for use in the living brain; stereo, non-invasive (or non-destructive) stimulators; techniques that bridge interfaces (e.g. dyes that work with MR, confocal, and other modalities); image analysis tools such as intelligent segmentation and registration; and virtual or augmented visualization. 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 PA is related to several of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic nonprofit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply. MECHANISM OF SUPPORT Support of this activity will be through the National Institutes of Health (NIH) research project grants (R01) mechanism. Indirect costs will be provided. RESEARCH OBJECTIVES The purpose of this PA is to provide the opportunity to: o explore new approaches, test imaginative new ideas or to challenge existing paradigms in technologies to stimulate innovative research to study the biology and function of the brain; o develop significant enhancements to existing technology important to neuroscience research; or o translate a scientific concept into the basis for a future technology that leads to the solution of important neuroscience research problems. The research sought should be innovative with the potential to have significant impact on brain research, especially in areas relating to dynamic 3-D imaging. 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 are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human 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 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff also may provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and prepared according to the instructions provided. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: asknih@od.nih.gov. C. SPECIFIC INSTRUCTIONS 1. Face Page of the application: Item 2. Check the box marked ~YES~ and type the number and title of this program announcement. 2. Description: As part of the description, identify concisely the technology or methodology to be developed; its innovative nature; its relationship to presently available capabilities and its expected impact on brain research. Research Plan: Item a., Specific Aims. The instructions for this section suggest that the applicant state ~the hypotheses to be tested. Since the goal of this program announcement is to develop innovative technologies, hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. Item b: Under Background Significance, elaborate on the innovative nature of the proposed research. Clarify how the technology development proposed in this project is a significant improvement over existing approaches. Explain the potential of the proposed technology for having a broad impact on neuroscience research or on improved human health. Clearly identify how the project, if successful, would result in new capabilities for research, and how these capabilities would differ from existing technologies. Use the mailing label in the application kit to mail the original and five copies of the application to: CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications not adhering to application instructions described above and those applications that are incomplete will be returned to the applicant without review. An initial review group convened by the CSR in accordance with NIH peer review procedures will evaluate applications that are responsive to the program announcement, for scientific and technical merit. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications, will be discussed, assigned a priority score, and receive a second level review by the appropriate National Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score. Significance Does the study focus on the development of an important technology? If the technological aims of the project are achieved, will it have a significant impact in advancing neuroscience? Approach Are the experimental and engineering approaches adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation Does the project propose new technological approaches or explore new research paradigms in engineering, instrumentation, physical sciences, mathematics or computer science as applied to neuroscience or challenge existing paradigms in these fields? 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)? Environment Does the scientific and technological 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? Investigators should be aware that NIH urges applicants to give added attention, where feasible and appropriate, to the inclusion of minorities and women in study populations. If minorities and/or women are not included in a given study involving human subjects, a clear rationale for their exclusion must be provided. The initial review group will also examine the adequacy of the proposed means for protecting against or minimizing potential adverse effects upon humans, animals or the environment. In addition to review of the merit of the application, the review committee will also examine the appropriateness of the requested budget. AWARD CRITERIA The award of grants is contingent on the receipt of applications of high scientific merit; relevance to the mission of the Biomedical Technology area of the NCRR; and the availability of appropriated funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Subject areas: bioengineering, biomedical computing Dr. Richard DuBois Biomedical Technology National Center for Research Resources 6705 Rockledge Drive Room 6160, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 FAX: (301) 480-3659 Subject areas: imaging, molecular structure and function Dr. Abraham Levy Biomedical Technology National Center for Research Resources 6705 Rockledge Drive Room 6160, MSC 7965 Bethesda, MD 20892-79652 Telephone: (301) 435-0755 FAX: (301) 480-3659 Subject areas: electron microscopy, mass spectrometry Dr. Mary Ann Markwell Biomedical Technology National Center for Research Resources 6705 Rockledge Drive Room 6160, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 FAX: (301) 480-3659 Subject areas: all other Dr. Karl Koehler Biomedical Technology National Center for Research Resources 6705 Rockledge Drive Room 6160, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 FAX: (301) 480-3659 Or send an email inquiry to: BTAdir@ep.ncrr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Judith Musgrave Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Room 6086, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: judithm@ep.ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.371. Awards are made under authorization of the Public Health Service Act, Title III, Part A (Public Law 78- 410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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