NIDCD-NSBRI PROGRAM FOR THE SUPPORT OF VESTIBULAR RESEARCH Release Date: June 16, 1998 PA NUMBER: PAS-98-081 P.T. National Institute on Deafness and Other Communication Disorders National Space Biomedical Research Institute Application Receipt Date: September 28, 1998 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health (NIH) and the National Space Biomedical Research Institute (NSBRI) invite research project grant applications for the support of ground-based research on the dynamic adaptation of central vestibular functions. The purpose of this initiative is to promote the application of cellular and molecular biologic approaches and advanced systems-level approaches to the understanding of vestibular adaptation. This research is expected to contribute to one or both of the following goals: 1) understand the neural basis of the autonomic responses that accompany acute vestibular dysfunction, motion sickness and responses to altered gravitational environments, and 2) facilitate the development of targeted approaches for the management of balance and vestibular disorders, motion sickness and adaptation to altered gravitational environments. The NSBRI was established by the National Aeronautics and Space Administration at the Baylor College of Medicine in April 1997 as a consortium of seven institutions for the conduct of biomedical research necessary to support human health in the exploration and development of space. Further information on the mission and the research components of the NSBRI is available on the World Wide Web at http://www.nsbri.org. 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 Program Announcement (PA), NIDCD-NSBRI Program for the Support of Vestibular Research, is related to the priority areas of physical activity fitness, educational and community-based programs, unintentional injuries, occupational safety and health, diabetes and chronic disabling diseases, clinical prevention services and human resource development. 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 domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Applications from minority individuals, women and individuals with disabilities are encouraged. MECHANISM OF SUPPORT The mechanism of support shall be the individual investigator-initiated research grant (R01) award. Although a scored application responsive to this initiative may be awarded by either the NIDCD or the NSBRI, individual grant awards will not be cofunded. Hence, the grant awards made by the NIDCD and the NSBRI will be separate and mutually exclusive. Upon authorization from the applicant investigator and the applicant institution (see "SPECIAL REQUIREMENTS"), the grant application, the summary statement and related materials will be released to the NSBRI. The NIDCD and the NSBRI will both employ the same criteria in the award of applications for this program (see "AWARD CRITERIA") and confer during this process to ensure that there is no overlap in funding. FUNDS AVAILABLE The NIDCD has committed up to $400,000 total costs (direct cost plus facilities and administrative allowance (indirect cost)) to this initiative for FY 99 (Year One). The NSBRI has committed up to $400,000 total costs for FY 99, as well. It is anticipated that a total of three to six awards for up to five years each will be made in FY 99. Awards made by the NIDCD will be administered according to NIH policy. RESEARCH OBJECTIVES Background Changes in vestibular function play a key role in numerous clinical disorders of balance and spatial orientation on Earth and in the spatial orientation and motor performance of space travelers during and after flight. However, the mechanisms responsible for vestibular adaptive changes are not well understood. The cellular and subcellular properties of many neurons within the vestibular system have been characterized anatomically and physiologically, and there is evidence implicating the involvement of both excitatory amino acid and peptide neurotransmitters in vestibular function. However, there have been no comprehensive studies of the neurochemical organization of the vestibular nuclear complex and the central vestibular pathways, nor has there been sufficient application of systems approaches and models to relate stimulus parameters and behavior to vestibular adaptation . These studies are needed in order to understand the recovery of vestibular function following injury (vestibular compensation) and the adaptation of the vestibular system to altered gravitational environments, including microgravity and centrifugation. The NIDCD signed a Memorandum of Understanding with the NSBRI on June 6, 1997 for the joint support of ground-based research in the vestibular system relevant to the research missions of both the NIDCD and the NSBRI. This research will be applicable to the health of space travelers and to vestibular disorders on Earth. Scope Changes in vestibular function, through modifications of the processes of learning and adaptive plasticity, underlie both treatment approaches to vestibular disorders and adaptation to altered gravitational environments. These changes take place through a combination of cellular and integrated neural network modifications. Very little is known about the cellular- and molecular- level processing of signals from the vestibular and nonvestibular motion sensors in the central vestibular pathways, about the changing roles of neural circuits during and following adaptation, and about the integrated neural network modifications that lead to a new adapted state. It is now possible to identify specific relay neurons in vitro and to determine how their cellular properties contribute to the processing of vestibular and visual information and how this processing is modified by cerebellar or brain stem inhibitory mechanisms. It is also possible to use advanced systems approaches to model integrated neural network responses. Knowledge of the key cellular- and systems-level events underlying vestibular compensation and dynamic adaptation will provide a solid basis for the improved rehabilitation of patients with balance disorders and for management of the sensorimotor and perceptual difficulties associated with space travel, particularly during long-duration space missions. The purpose of this initiative is to promote the application of cellular and molecular biologic approaches and advanced systems-level approaches to the understanding of adaptive functions (e.g., learning and adaptive plasticity) within the central vestibular pathways. This will afford the opportunity to merge and maximize the efforts of cellular and systems neuroscience. Applications submitted in response to this PA may either encompass a continuum of approaches from reductionistic to systems-level and integrated systems-levels, or may focus on one level of analysis. Applicants will define how their proposed research will contribute to one or both of the following goals: 1) understand the neural basis of the autonomic manifestations that accompany acute vestibular dysfunction, motion sickness and responses to altered gravitational environments, and 2) facilitate the development of targeted pharmacotherapeutic, physical rehabilitative and/or behavioral approaches for the management of balance and vestibular disorders, motion sickness and adaptation to altered gravitational environments. SPECIAL REQUIREMENTS Annual Meetings The principal investigators (PIs) supported through this initiative will meet annually for one day with the Neurovestibular Adaptation Team of the NSBRI and with program officials of the NSBRI and the NIDCD to review the progress and to discuss the future plans of their research projects. The Neurovestibular Adaptation Team is headquartered in the Boston area at the present time. In addition, the PIs will participate in an annual three- to four-day NSBRI- sponsored workshop/retreat or symposium, which will usually be held in the Houston, TX area. These events will facilitate communication and collaborative interactions among the investigators supported through this initiative and the investigators comprising the Neurovestibular Adaptation Team and the other research teams of the NSBRI. Budget requests for travel should reflect the costs associated with these two annual meetings and should include a statement indicating that this travel is a special requirement of this PA. Letter of Authorization In order for an application to be considered for funding by the NSBRI, the applicant must submit a brief letter of authorization, co-signed by the Principal Investigator and the official signing for the applicant institution, authorizing the NIDCD to release the application, the summary statement and all related materials to the NSBRI. These materials will be shared with the NSBRI when available. Applications without such authorization will not be considered for funding by the NSBRI. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of 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 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 may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff will, on request, provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research, Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, FAX 301/480-0525, email: GrantsInfo@nih.gov; and from the NIDCD program administrator listed under INQUIRIES. The PHS 398 form is also available electronically on the NIH Home Page at http://www.nih.gov/grants/phs398/phs398.html. The PA title and number (NIDCD-NSBRI Program for the Support of Vestibular Research, PAS-98-081) must be typed in Section 2 of the face page of the application form and the "Yes" box must be checked. Instructions for completing the application are found in the PHS 398 kit. Submit the signed, original application and five exact photocopies and five collated sets of appendix materials, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) There is only one receipt date for this PA. Applications must be postmarked by the receipt date of September 28, 1998. If the application submitted in response to this PA is substantially similar to a grant application already submitted to the NIH for review, but not yet reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review (CSR) in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score and receive a second-level review by the National Deafness and Other Communication Disorders Advisory Council and the NSBRI. Review Criteria o Significance: Does this study address an important problem relevant to this PA? 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? o 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? o 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? o 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)? o 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? o Appropriateness of the proposed budget and duration in relation to the proposed research. o For Studies Involving Human Subjects: Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Up to a total of six research grants will be awarded separately by NIDCD and NSBRI in response to this PA. The anticipated date of award is August 1, 1999. The following criteria will be considered by both the NIDCD and the NSBRI in making their funding decisions: o Responsiveness of the proposed project to the purpose of this PA; o Quality of the proposed project, as determined by peer review; o Program priorities of the NIDCD and the NSBRI within the research purview of this PA; and o Availability of funds for this initiative. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues and to respond to questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Daniel A. Sklare, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C - MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1804 FAX: (301) 402-6251 Email: daniel_sklare@nih.gov Ronald J. White, Ph.D. Associate Director National Space Biomedical Research Institute One Baylor Plaza, NA-425 Houston, TX 77030 Telephone: (713) 798-7412 FAX: (713) 798-7413 Email: rwhite@bcm.tmc.edu Direct inquiries regarding fiscal matters to: Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B - MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: sh79f@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under the authority of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grant policies and Federal Regulations at 42 CFR 52 and 45 CFR Part 74. 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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