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BIOLOGICAL MECHANISMS OF NOISE-INDUCED HEARING LOSS Release Date: May 30, 2000 RFA: DC-00-002 National Institute on Deafness and Other Communication Disorders (http://www.nidcd.nih.gov/) National Institute on Aging (http://www.nih.gov/nia/) Letter of Intent Receipt Date: July 15, 2000 Application Receipt Date: September 21, 2000 THIS RFA USES MODULAR GRANT AND JUST-IN-TIME CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The purpose of this Request for Applications (RFA) is to solicit research grant applications addressing the biological mechanisms of noise-induced hearing loss (NIHL). The focus of this RFA is to understand the biological consequence of noise as a primary cause of hearing loss. Research opportunities include identifying mechanisms of cellular injury and survival, understanding genetic factors influencing susceptibility, and identifying pharmacologic avenues for protection and rescue from NIHL. The fundamental goal of this research is improved diagnosis, treatment and prevention of NIHL. Although not participating in this RFA, the National Institute on Environmental Health Sciences has a strong interest in the environmental factors influencing NIHL. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA "Biological Mechanisms of Noise-Induced Hearing Loss" is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) exploratory/development grant (R21) mechanism. This mechanism is designed to support feasibility/pilot studies leading to an R01. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed two years. This RFA is a one-time solicitation. For administrative reasons, all applications received in response to this solicitation will be assigned initially to the National Institute on Deafness and Other Communication Disorders (NIDCD). Following discussions among the participating Institutes and before review, applications will be reassigned to the Institute(s) or Federal Agency in DHHS that is programmatically most appropriate. Because the scope of some of the research projects proposed in response to this RFA encompasses the interests of several NIH Institutes, applications may receive dual assignments based on established PHS guidelines. Awards will be made and managed by NIDCD and/or the other participating Institutes or DHHS Federal Agencies. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining procedures of the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE It is anticipated that NIDCD will have approximately $750,000 total costs and NIA will have approximately $250,000 total costs available for this initiative in Fiscal Year 2001 and that up to seven (7) awards will be made. Applications submitted in response to this RFA must not exceed $100,000 per year in direct costs and the total project period may not exceed two (2) years. The earliest anticipated date of award is August 1, 2001. Although the financial plans of the NIDCD and NIA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds for this purpose and the receipt of meritorious applications. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Facilities and Administrative costs will be awarded at the negotiated rate. RESEARCH OBJECTIVES Background Noise-induced hearing loss (NIHL) continues to be a major public health issue. Ten million Americans have already suffered irreversible damage from noise, and thirty million more are exposed to dangerous levels of noise each day. Although various aspects of NIHL have been under investigation for several decades, a comprehensive and systematic understanding of the biological mechanisms of NIHL remains elusive. A workshop, Research Opportunities on the Biology of Noise-Induced Hearing Loss was held in Washington, D.C. on December 11 and 12, 1998 to identify current research opportunities addressing NIHL. Twelve invited scientists presented their ideas for research opportunities in NIHL. Included in this RFA are a number of potential areas for investigation identified by workshop participants. Scope and Objectives Historically, issues central to the study of NIHL include subject variability in response to experimentally-induced hearing loss. In addition to variability observed within experimental groups, incongruities between experimental paradigms, varying levels of noise exposure and the time frames selected for the assessment of NIHL damage, and the use of different animal models have made comparisons of studies difficult. Current biomedical research on the cellular, molecular and genetic factors contributing to human disease presents significant opportunities to advance our understanding of NIHL. Limiting the variance in NIHL research may require the use of additional biological markers and measures, the use of cloned animals or the selection of an animal model with the least variance for study. While animal models with low variance may be especially necessary in research studies investigating underlying biological mechanisms, they may be less appropriate for a clinical model of NIHL in humans given the inherent and significant variance in NIHL seen from patient to patient. Thus, several models may be required based on their ability to shed light on differing aspects of NIHL. Both temporary threshold shift (TTS) and permanent threshold shift (PTS) are dynamic processes with primary and secondary effects. Examination of the transitional phases between TTS and PTS in the acquisition of NIHL is required since measurements of these states made at fixed intervals may not be representative of the balance between the inherent reparative and damage processes of the system. Understanding the cellular and molecular biological basis of TTS and PTS, identifying lesions potentially recoverable by pharmacological intervention, and defining when in the reparative process intervention should occur are important issues to be answered. Studying gene expression changes as well as investigating acoustic trauma as it relates to the final common pathway(s) for other forms of traumatic injury or disease should provide insight into the basic biological mechanisms of NIHL. This RFA solicits research applications in the following areas: o The study of cell injury, cell death and cell survival as related to NIHL. Illustrative examples include: determining the role and site of action of free-radical generation and those of reactive oxygen species, e.g., the reactive oxygen species cascade and metabolites in NIHL, analyzing gene expression in NIHL as well as its relationship to aging and cell death pathways, assessing the dynamic changes that correspond to noise-induced cell injury, with focus on the impact of structural and functional changes at the cellular level, further defining inner ear stress defenses including heat shock proteins, excitotoxic antagonists, and neurotrophins, and identifying the role of cell death pathways, including apoptosis and necrosis activated in response to acoustic injury. o Investigations of susceptibility to NIHL focusing on genetic or environmental factors. Illustrative examples include: identifying genetic factors leading to increased NIHL susceptibility or resistance in humans and in animal models, studying transgenic animals that exhibit NIHL predisposition or NIHL resistance, and identifying or correlating susceptibility to age related hearing loss with susceptibility to acoustic trauma. o Investigations focused on protection and rescue from NIHL. Illustrative examples include: biological protection from inner ear stressors and the activation of inner ear stress defenses, studies of pharmacologic manipulations and interventions preventing/reducing NIHL, developing drug delivery systems for rapid intervention in NIHL, designing assays to identify susceptibility to NIHL, as well as identifying the cellular mechanisms of protective paradigms. 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 was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, and is available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites and anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit 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 a subsequent application, the information that it contains allows Institute staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by July 15, 2000 to: Dr. Craig Jordan Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 Fax: (301) 402-6250 Email: [email protected] APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. The form is available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: [email protected]. It is also available at: http://grants.nih.gov/grants/funding/phs398/phs398.html The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 in section 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies 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 courier/overnight mail service) At the time of submission, send TWO additional copies of the application and five (5) sets of appendices to: Dr. Craig Jordan Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 496-8683 Fax: (301) 402-6250 Email: [email protected] Applications must be received by September 21, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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 CSR 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 for completeness by CSR and for responsiveness to this RFA by the NIDCD. Those applications that are complete and responsive to this RFA will be evaluated for scientific and technical merit by the appropriate review group convened by the NIDCD in accordance with the criteria stated below. 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by the NIDCD National Advisory Council and/or the National Advisory Council on Aging. . Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques, to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the criteria will be addressed and considered by reviewers in assigning an overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (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 methods? 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o 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. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: July 15, 2000 Application Receipt Date: September 21, 2000 Peer Review: January 2001 Council Review: May 2001 Earliest Anticipated Start Date: August 1, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Amy Donahue Chief, Hearing and Balance/Vestibular Sciences Section Scientific Programs Branch National Institute on Deafness and other Communication Disorders 6120 Executive Blvd MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 Fax: (301) 402-6251 E-Mail: [email protected] Dr. Judith Finkelstein Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 Fax: (301) 496-1494 Email: [email protected] Direct inquiries regarding fiscal issues to: Ms. Sherry Dabney Grants Management Officer Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 Fax: (301) 402-1758 Email: [email protected] Mr. Joe Ellis Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Fax: (301) 402-3672 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No.93.866 (NIA), 93.173 (NIDCD). 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. Awards will be administered under PHS grants policy as stated in the NIH Grants Policy Statement (October 1, 1998). PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the nonuse 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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