Full Text DC-96-001 DYSOSMIA AND DYSGEUSIA: MECHANISMS, ASSESSMENT, AND TREATMENT NIH GUIDE, Volume 24, Number 13, April 7, 1995 RFA: DC-96-001 P.T. 34 Keywords: 0765050 Treatment, Medical+ National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: June 1, 1995 Application Receipt Date: July 11, 1995 PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) is soliciting research applications for basic and clinical studies focused on the causes, diagnosis, and treatment of dysosmia and dysgeusia (i.e., distortions of olfaction and gustation or spontaneous chemosensation without identifiable chemosensory stimuli). Support for these studies will be through the Exploratory/Developmental Grant mechanism (R21). These pilot project/feasibility studies provide flexibility for developing highly creative research approaches for which substantial preliminary data are not yet available. 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), Dysosmia and Dysgeusia: Mechanisms, Assessment, and Treatment, is related to the priority area of nutrition. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the Federal government. Applications from minority individuals, women, and individuals with disabilities are encouraged. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions are allowable, with sufficient justification. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) Exploratory/Developmental Grant mechanism (R21). This pilot project/feasibility study mechanism provides flexibility for developing highly creative research approaches for which substantial preliminary data are not yet available. Although preliminary data as evidence of feasibility are not a requirement, the applicant bears the responsibility for developing a sound research plan. Support will be limited to a maximum of two years. The R21 grants are not renewable, but future project continuation is possible through other grant mechanisms, such as the individual research project (R01) and program project (P01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. This RFA is a one-time solicitation, with an anticipated award date of December 1, 1995. The levels and time frames for support of R21 awards indicated here are specific to this solicitation. FUNDS AVAILABLE It is anticipated that approximately $350,000 (direct plus indirect costs) per year will be available beginning in fiscal year 1996 for the support of meritorious applications submitted in response to this solicitation. This level of funding should permit the support of two or three applications, depending on their cost. RESEARCH OBJECTIVES Dysosmia is a distortion of olfaction (e.g., a normally pleasant odorant is perceived as unpleasant) or the perception of an odor for which there is no chemosensory stimulus. Dysgeusia is a distortion of gustation (e.g., a normally pleasant tastant is perceived as unpleasant) or the spontaneous perception of a taste for which there is no chemosensory stimulus. Dysosmia and dysgeusia occur commonly and may or may not be associated with a loss of chemosensory sensitivity. Dysosmia and dysgeusia may occur spontaneously or only be evoked by chemosensory stimuli in the environment. Dysosmia and dysgeusia can impair food intake and, consequently, nutritional status. Dysosmia and dysgeusia have been attributed to a diversity of medical conditions, agents, and events, including upper respiratory infection, nasal and paranasal sinus disease, head trauma, psychiatric conditions, toxic chemicals, medications, and dental procedures. Idiopathic dysgeusia has frequently been associated with another disorder of oral sensation, burning mouth syndrome. Few studies have been reported on the systematic assessment and treatment of dysosmia and dysgeusia, and difficulties in determining their causal mechanisms have hindered etiologic and anatomic diagnosis, prognosis, and treatment. Although a number of approaches to treatment of these dysfunctions have been suggested, none are as yet widely accepted and used. This initiative encourages research designed to contribute to the understanding of the etiology and mechanisms of dysosmia and dysgeusia and to the development of approaches to etiologic and anatomic diagnosis, prognosis, treatment, and other therapeutic interventions. A broad range of research extending from the molecular to the behavioral levels of basic and clinical research is applicable to this program. Examples of possible research approaches are listed below and are in no way considered all inclusive. o Use of contemporary imaging techniques in studies of chemosensory dysfunction; application of biochemical and molecular probes in studies of biopsy material, secretions, and body fluids. o Refinement of psychophysical tests, such as tests of taste function for specific regions of the tongue, and development of taste tests for identifying quality-specific dysgeusias, such as salty taste. o Development of experimental models of dysosmia and dysgeusia, including the induction of these dysfunctions under controlled conditions. o Use of topical anesthetics and quality-specific taste modifiers to identify the origin of dysgeusias within the nervous system; use of these agents as potential treatments for dysgeusia. 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 provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (FR 59 14508-14513) to correct typesetting and errors in the earlier publication, and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994. Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by June 1, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NIDCD staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard MSC 7180 Rockville, MD 20892-7180 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892-7180, telephone 301/710-0267; and from the NIH program administrator listed under INQUIRIES. The RFA label available in the PHS 398 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. Send a signed, typewritten original of the application, including the Checklist, and three exact single-sided copies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC-7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express or courier service) At the time of submission, two additional copies of the application and all five copies of the appendices must also be sent to the Chief, Scientific Review Branch, at the address listed under LETTER OF INTENT. Applications must be received by July 11, 1995. If an application is received after that date, it will be returned to the applicant. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by DRG staff for completeness and by NIDCD for responsiveness. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDCD. The second level of review will be provided by the National Deafness and Other Communication Disorders Advisory Council. As part of the initial merit review, a process (triage) will 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 the 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 notified. Review criteria for this RFA are: o Scientific or technical merit and originality of proposed research; o Appropriateness and adequacy of the experimental approaches and methodologies proposed to carry out the research; o Availability of resources necessary to perform the research; o Appropriateness of the proposed budget and study duration in relation to the proposed research; o 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 ill also be evaluated. AWARD CRITERIA The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review; o Availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA and request are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jack Pearl, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-C 6120 Executive Boulevard MSC 7180 Bethesda MD 20892-7180 Telephone: (301) 402-3464 FAX: (301) 402-6251 Email: Jack_Pearl@nih.gov Direct inquiries regarding fiscal matters to: Sharon Hunt Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Room 400-B 6120 Executive Boulevard MSC 7180 Bethesda MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Schedule Letter of Intent Receipt Date: June 1, 1995 Application Receipt Date: July 11, 1995 Scientific Review Date: August 1995 Advisory Council Date: September/October 1995 Earliest Award Date: December 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. Awards are made under authorization 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 grants policies and Federal Regulations 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 routing 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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