EXPIRED
DEVELOPMENT OF TECHNOLOGIES FOR SALIVA/ORAL FLUID BASED DIAGNOSTICS Release Date: January 2, 2002 RFA: RFA-DE-02-002 National Institute of Dental and Craniofacial Research (http://www.nidr.nih.gov/) Letter of Intent Receipt Dates: March 11, 2002 Application Receipt Dates: April 11, 2002 PURPOSE The National Institute of Dental and Craniofacial Research (NIDCR) invites Cooperative Agreement Applications (U01) for outstanding multidisciplinary research aimed at the development of new technologies, for which proof-of-principle exists, or for the advancement of existing technologies for simultaneous multi-analyte detection in saliva and other oral fluids. The focus of such diagnostic technologies will primarily be in the areas in which saliva or other oral fluid based diagnostics can have a major impact: i) oral diagnostics (e.g., periodontal diseases, dental caries and oral cancers), ii) systemic disease diagnosis (e.g., autoimmune diseases, cardiovascular disease and cancers), iii) drug monitoring, (e.g., drug compliance, pharmacokinetics and pharmacogenomics) and iv) identification of potentially lethal agents (e.g., anthrax bacillus or chemical agents) dispersed by bioterrorists. Because of the nature of the research required to stimulate the development and transition of current diagnostic technologies (e.g., miniaturized analytical systems, microfluidics, microsensors) for the detection of saliva/oral fluid derived markers, it is expected that potential applicants will include investigators with expertise in technology development, chemistry, engineering, physics, biology, bioinformatics and clinical sciences. The development of saliva/oral fluid based diagnostic technology projects is likely to be design-directed rather than hypothesis-driven research. Therefore, rather than presenting a hypothesis and an experimental plan to test it, applicants should address: i) the design goals (a detailed statement of what the development of the device/method will accomplish), ii) the design tasks (description of the status of the device/method prior to funding and additional design aspects that will be completed during the funding period), iii) the program plan (includes the overall plan, with a timetable, for accomplishing and coordinating design, fabrication, and testing, achieving robust operation and high quality data), and iv) the anticipated barriers and approaches for overcoming them. 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 Request for Application (RFA), "Development of Technologies for Saliva/Oral Fluid Based Diagnostics" is related to one or more of the NIDCR priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at: http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted from domestic institutions, 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, and faith-based organizations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications from foreign institutions will not be accepted. However, subcontracts to foreign institutions will be considered. All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to grants awarded under this RFA. MECHANISM OF SUPPORT This RFA will use the NIH cooperative research (U01) award mechanism of support, an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients" activity by involvement in the activity and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed below under "TERMS AND CONDITIONS OF AWARD." The total requested project period for an application submitted in response to this RFA may not exceed 4 years. This is a one-time solicitation. At this time, the NIDCR has not determined whether or how this solicitation will be continued beyond the present RFA. The maximum dollar request is limited to $1.00 million in total costs for the initial budget period and $4.2 million in total costs for the entire project period. The anticipated award date is September 30, 2002. FUNDS AVAILABLE For Fiscal Year 2002, $3.00 million in total costs will be committed to fund applications submitted in response to this RFA. It is anticipated that 2-3 awards will be made. Proposed funding levels are subject to change due to budgetary, administrative and/or scientific considerations, and are dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDCR, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background The composition of saliva and of other oral fluids reflects tissue fluid levels of therapeutic, hormonal, immunological or toxicological molecules, as well as the presence of markers for infectious and neoplastic diseases. These fluids provide sources for assessment and monitoring of systemic health and disease states and exposure to environmental, occupational, or abusive substances as well as to agents dispersed by bioterrorists. Proof-of-principle has been established regarding the use of saliva and other oral fluids to monitor a number of systemic diseases and conditions as well as substance abuse. The analysis of these fluids, therefore, has great diagnostic potential in a variety of clinical situations. Oral fluid based diagnostics may, in many instances, prove more accurate and less expensive, than current methodologies. Moreover, they are non-invasive. Although oral fluids, particularly saliva, have been used for the diagnosis of some diseases, progress has not met expectations. In 1993 a conference supported by the NIDCR was held to explore the possibilities for maximizing the utility of saliva as a diagnostic medium. The conference report stated that the development of new technologies with increased sensitivity and accuracy would undoubtedly increase the use of saliva in diagnostics. To date, remarkable technological advances are promising to revolutionize the field of diagnostics as we now know it. Techniques that are emerging from a combination of miniaturization technologies and discoveries in many different fields of biology, chemistry, physics and engineering are expected to lead to high throughput, automated, portable, low cost, more efficient, and rapid biochemical analyses. Miniaturization of diagnostic technologies will be able, with minute amounts of body fluids, to yield critical patient information reflecting health and disease status. Scientists predict that pocket-sized analyzers ("lab- on-a-chip") that can perform multiple operations in parallel in non- laboratory settings such as battlefields, airports, factories, hospitals, clinics or homes will be developed. Current technologies provide a basis for these kinds of tests/devices that will allow the simultaneous assessment of multiple analytes in health and disease and will provide clinicians with new prevention and therapeutic strategies. The NIDCR, realizing the potential of new technologies and advanced instrumentation in the development of saliva and other oral fluid-based diagnostics sponsored a workshop on "Development of New Technologies for Saliva and Other Oral Fluid Based Diagnostics" on September 12-14, 1999. The purpose of this workshop was to capitalize on recent and future developments in this field. More than 100 individuals from university and industry with expertise in salivary and oral biology, instrumentation, engineering and clinical sciences participated. Their charge was to develop a set of recommendations to help the NIDCR create a research program in the area of oral fluid based diagnostics. Briefly, these experts recommended a need to: 1. Establish new interdisciplinary/collaborative programs combining dental, medical, biological, chemical and engineering sciences to create innovative technologies such as microfluidics, recognition chemistry, and computer engineering for oral fluid based diagnostics, 2. Foster academic-industry partnerships and broaden interactions with government laboratories, 3. Increase emphasis on training of a new cadre of individuals with expertise that can facilitate collaborations among disciplines (single or multi-institution based) to train graduate students, postdoctoral fellows, and clinical fellows. The summary of the recommendations of the workshop participants has been published on the NIDCR"s home page http://www.nidr.nih.gov/about/strat-plan/Biomat_Biomet_Tiss_Eng.PDF. SCOPE To be eligible for support under this program, a technology must have been developed to the stage that proof-of-principle has been demonstrated. To warrant the investment that will be needed to accomplish the requested goals, the technologies involved must be able to contribute to automated, low cost, more efficient, and rapid analyses for simultaneous multi-analyte detection. This program will support the range of activities required to drive the development and transition of current diagnostic technologies (e.g., miniaturized analytical systems, microfluidics, microsensors) for the detection of saliva/oral fluid derived markers. Included are the development of technologies and fabrication of devices for simultaneous multi-analyte detection in saliva or other oral fluids that will allow assessment of multiple conditions regarding diagnosis, prognosis, pharmacokinetics, prediction of adverse pharmacological interactions and identification of potentially lethal agents dispersed by bioterrorists. This may involve: 1. Design and fabrication of high density sensor technology for the collection, detection, and discrimination of closely related molecules or conditions, 2. Studies on the improvement of detection systems, ( e.g., development of more sensitive assays and rare event monitoring techniques), 3. Development of laboratory or home based diagnostic systems to evaluate individual patients or populations at risk, 4. Use of new, highly sensitive technologies to improve the sensitivity to proteomic and genomic material in saliva, and 5. development of computer programs and algorithms for acquisition and input of dissimilar sets of data, and for data entry, storage and analysis. Accomplishing these activities will require the participation of multidisciplinary teams that will include investigators such as biologists, chemists, technology developers, engineers, computer scientists and clinicians. The NIDCR anticipates that projects supported by this RFA may not result directly in a commercial-grade product. However, a plan for technology dissemination would strengthen the application. NIDCR will not provide the substantial amount of funding that will likely be required to support the commercialization. Since such additional investment is likely to come from the private sector and because of the important expertise available in the private sector to accomplish the tasks required of such projects, its participation in projects is encouraged, although not required. SPECIAL REQUIREMENTS In order to ensure maximum progress in the projects funded by this initiative and to realize the maximum potential of saliva as a diagnostic and monitoring fluid, several special activities will be required of the funded investigators. The Principal Investigators are expected to present a cost-effective plan to recruit and apply the appropriate expertise needed to meet project goals and to shift resources as requirements change. For example, substantial engineering capacity may be required early in the project, but not later, while device testing may be modest initially, but escalate later. The research plan must describe how effective communication between the various components will be established and maintained, the information flow by which input from various perspectives will be gathered and used to implement the research plan, and how decisions will be made on resource deployment. Principal Investigators will be expected to attend Steering Committee meetings (see below) and participate in conference calls on a regular basis. Budget requests should include funds to support travel of the PI and one other investigator to attend the scheduled Steering Committee meetings. Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research and delivery of health care. Thus, the NIH is interested in ensuring that the information about new methods, technologies, and computer software that is developed through this program becomes readily available to the research community for further research and development, with the expectation that this will eventually lead to information and products that improve the health of the public. For this reason, applicants should develop and propose specific plans for sharing the data, materials, and software generated through the grant. These plans should be consistent with the policies of their institutional offices of technology transfer. NIH has developed guidance on developing such policies, information is available at: (http://www.ott.nih.gov/policy/rt_guide_final.html). The scientific review group will evaluate the adequacy of the proposed plans for sharing data. Comments on the plan and any concerns will be presented in an administrative note in the Summary Statement. The adequacy of the plan will be considered by NIDCR program staff and will be important in determining whether the grant shall be awarded. The sharing plan as approved, after negotiation with the applicant when necessary, will be a condition of the award. Evaluation of non- competing continuation applications will include assessment of the effectiveness and timeliness of research resource release. Applicants are reminded that the grantee institution is required to disclose each invention to NIH within two months after the inventor discloses it in writing to grantee institutional personnel responsible for patent matters. TERMS AND CONDITIONS OF AWARD These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, PHS regulations at 42 CFR Part 52 and DHHS grant administration regulations at 45 CFR Parts 74 and 92, as applicable, and other DHHHS, PHS, and NIH Grant Administration policy statements. As stated above, the administrative and funding instrument used for this program is a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, NIDCR"s purpose is to work with the PI as a partner to assist and stimulate planning and implementation. NIDCR will not assume primary direction, responsibility, or a dominant operating role in the research. The primary role and total responsibility for this program resides with each Principal Investigator. The NIDCR, as noted below, will share specific tasks and activities in completing the agreement. 1. Awardee Rights and Responsibilities o The PI will have primary authority and responsibility to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award. In addition, the PI agrees to follow the common protocols developed by the Steering Committee. o The PI will assume responsibility and accountability to the awardee organization officials and to the NIDCR for the performance and proper conduct of the research supported by the project in accordance with the terms and conditions of the award. o The PI will serve as a voting member of the Steering Committee, will attend the Planning Meeting and two Steering Committee meetings in the first year, and two Steering Committee meetings a year in subsequent years. o The PI will be responsible for sharing with the investigators funded through this initiative and with the NIDCR staff: i) standardized saliva and/or oral fluid samples and specific markers, ii) information on new developments and/or methods for solving obstacles in instrumentation design and development, and iii) knowledge on regulatory issues related to the development and review by the Food and Drug Administration (FDA) of the new diagnostic technologies. o The PI will establish an Internal Advisory Committee to provide scientific and administrative oversight. The Internal Advisory Committee will be composed of the lead institute personnel, and other technical or research personnel. The committee is expected to meet at least monthly. Minutes of these meetings will be made available to NIDCR staff upon request. The Internal Advisory Committee is charged with both prioritizing projects and periodically reviewing the different activities to ensure that the objectives outlined in the application are being met. o Awardees will retain custody of, and have primary rights to, the data developed under these awards, subject to Government rights of access consistent with current HHS and NIH policies. o Upon completion of the project, the PI is expected to put all study design materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NIDCR, for the conduct of research at no charge other than the costs of reproduction and distribution. 2. NIDCR Staff Responsibilities The dominant role and prime responsibility for the project as a whole resides with the awardees although specific tasks and activities in carrying out the studies will be shared by awardees and the NIDCR. The Institute will designate a Program Scientist who will have substantial scientific-programmatic involvement during conduct of this activity. Alternatively, the Program Director responsible for normal stewardship may function as a Program Scientist. The NIDCR Program Scientist will be a voting member of the Steering Committee and its subcommittees. o The NIDCR Program Scientist will be responsible for making additional links among the engineering and instrumentation developers and the oral biology scientist, use the information of the Steering committee to coordinate and facilitate the research activities for the saliva/oral fluid based diagnostic technologies, and attend and participate in all meetings of the Steering Committee. o NIDCR Program Scientist will help the Steering Committee to develop and draft operating policies and policies addressing recurring situations that require coordinated action. o NIDCR will designate a Program Director and a Grants Management Specialist to provide administrative oversight of the cooperative agreement. o The NIDCR Program Director will review the scientific progress of the individual grants for compliance with operating policies developed by the Steering Committee, and may recommend to the NIDCR to withhold support, suspend, or terminate an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee. o NIDCR reserves the right to require the transfer of appropriate reagents, tools and pertinent data that are generated as the result of participation in research supported under these awards to an eligible third party, in order to advance the research. Collaborators supported under these awards must be informed of this right. o Support or other involvement of industry or any other collaborators in any study performed by the awardees may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to, and concurrence by the NIDCR. 3. Collaborative Responsibilities (Steering Committee) o The NIDCR Program Scientist and PIs of the projects funded under this RFA will be responsible for forming a Steering Committee as defined below. The Steering Committee will act as the main governing board that will review the progress of the research activities, develop collaborative protocols, identify technological impediments to the progress of prototype detection systems to "real-time" diagnostic systems using saliva as a diagnostic medium, select strategies to surmount them, and identify opportunities for sharing techniques and tools developed within each individual project. The Steering Committee will advise NIDCR Program Staff of scientific developments and opportunities that may enhance the achievement of the program. o The Steering Committee will be composed of the PI from each project funded through RFA DE-02-002, and the NIDCR Program Scientist .The PI from each project will have one vote and the NIDCR Program Scientist will have one vote. o The Steering Committee may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed. o There will be two meetings of the Steering Committee annually, both in the Bethesda, MD area, at times agreed upon by the Steering Committee and the NIDCR. The first meeting of the PIs funded under this RFA will be a Planning Meeting in the Bethesda, MD area soon after grants are awarded. At the Planning Meeting the Steering Committee will be formed and select a chairperson from among the members who represent the awardees. At the Planning Meeting the Steering Committee may: (a) draft a charter to detail policies and procedures and develop a process for monitoring compliance with the policies and procedures and for recommending that the NIDCR Program Director act on evidence of non-compliance with Steering Committee policies, (b) agree upon the terms of the charter, and (c) discuss the approaches that were proposed in the project applications and any relevant new information, and set initial priorities for the projects to be pursued. 4. Arbitration Any disagreement that may arise on scientific and programmatic matters within the scope of the cooperative agreement and between award recipients and NIDCR may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Principal Investigator, a second member selected by NIDCR, and, the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is subject to appeal in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. 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 sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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, names of other key personnel and, if applicable, participating institutions, as well as the number and title of this RFA. 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 allows NIDCR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to: Eleni Kousvelari, DDS, D.Sc. Chief, Cellular & Molecular Biology, Physiology & Biotechnology Branch Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN 18A Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: [email protected] APPLICATION PROCEDURES/SPECIAL INSTRUCTIONS Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. However, the form PHS 398 should be modified as follows. Biosketches and "Other Support" pages should be included for all personnel. Page limitations have been increased to a maximum of 40 pages from the usual 25 page limit for the "Research Plan" of an application. This 40 page limit is an absolute maximum. However, applicants are encouraged to be concise and use fewer pages. Budget pages, budget justifications, material transfer agreements, and letters from collaborators and consultants and their biosketches are not included in this page limit. Applicants should divide the "Research Plan" into the following sections: o Description of the diagnostic area (autoimmune disease, periodontal disease, identification of lethal agents, oral cancers etc.), for which such a prototype will be developed, o Description of the existing technology of which proof-of-principle exists (status of the device/method prior to funding), o Description of the design aspects/plans that will be completed during the period of the award, o Description of how the technologies to be developed will contribute to automated, low cost, more efficient, and rapid simultaneous biochemical analysis for multi-analyte detection. In the last three sections listed above, the roles and expertise of all key personnel, collaborators, and consultants who are associated with this part of the application should be well documented. Applicants must provide methods to maintain records, establish, standardize, and distribute protocols and provide for quality control and budgetary oversight. Applicants also should include the description of the internal advisory board consisting of the Principal Investigator and other key personnel that will oversee the daily operation of the activities. Applicants should state their willingness to collaborate and share data freely with the other investigators supported by this RFA and the wider research community. Applicants should discuss their willingness to serve on the Steering Committee and should state their willingness to follow the common protocols that will be developed by the Committee. Applicants should also describe how they would comply with the involvement of NIDCR Program Scientists to work together cooperatively. BUDGET INSTRUCTIONS Applicants who have additional funds to support ("leverage") the proposed project should indicate the source of funds (institutional, NIH grant number etc.) that permit them to accomplish the project goals. Subcontract budgets should be a separate page, and the subcontract indirect costs should be calculated and listed in the usual place as part of the total costs of the budget. Applicants must budget for travel and per diem expenses for participation in the Steering Committee, subcommittees, workshops, and symposia. Applicants should budget for at least two meetings in the Bethesda, MD area each year. The RFA label should be affixed to the bottom of the face page of the application with the RFA number typed on the label. The RFA label is available in the PHS 398 (rev. 5/2001) application form. 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 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 express/courier service) At the time of submission to CSR, two additional copies of the application must be sent to: H. George Hausch, Ph.D. Acting Director, Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: [email protected] Applications must be received no later than April 11, 2002. 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 General Considerations Applicants are encouraged to submit and describe their specific concepts concerning the most appropriate means of accomplishing the goals of the cooperative study. Applications are expected to address issues identified under "SPECIAL REQUIREMENTS", "TERMS AND CONDITIONS OF AWARD" and "SPECIAL INSTRUCTIONS". All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. Other factors considered to be important for review include demonstrated expertise in technology development, a multi-disciplinary team of collaborators, substantial interactions among collaborating researchers, demonstration of appropriate facilities and resources, willingness to share data and reagents freely. Review Process Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete applications will be returned to the applicant 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 NIDCR in accordance with the review criteria stated below. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Dental and Craniofacial Research Advisory Council. Review Criteria To ensure that the applications for this Program are evaluated appropriately, the standard NIH review criteria have been adapted to be more appropriate for proposals that are design- rather than hypothesis- driven. The score should reflect the overall impact that the award would have on the accomplishment of NIDCR"s goals, based on consideration of the following five criteria. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of the goals of this research program. (1) Significance: Does this proposal address an important problem? If the aims of the application are achieved, will the new technology result in efficient and cost-effective accomplishment of diagnostic technologies based on saliva and/or other oral fluids? (2) Approach: Is the proposed approach likely to yield the desired results? Has proof-of-principle of the underlying technology been achieved? Are the advantages of the proposed technology over competing technologies clearly articulated? Are the design principles clearly articulated and likely to be achieved? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are plans in place to monitor and document the quality of the products? Are plans clearly in evidence and appropriate for establishing and maintaining effective partnership between technology developers and experienced users? Is the project timely and likely to remain at the state-of-the- art level throughout the period of requested support? Are plans for information dissemination and technology transfer adequate? (3) Innovation: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Are the experiences of the PI and team members appropriate to the tasks and well balanced, and is there evidence of firm commitment to the project from each of the key parties of the collaboration? Is the PI capable of coordinating and managing the proposed project? Is there evidence of interdisciplinary/ multidisciplinary collaborations? Is there evidence that the team members can work together effectively? Do the PI and team members have a track record of developing useful technology? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following, to the extent that these issues pertain to a particular application: o The adequacy of plans to include genders, minorities and their subgroups, and children 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, and o Provisions for the safety of the research environment. Schedule Letter of Intent Receipt Date: March 11, 2002 Application Receipt Date: April 11, 2002 Peer Review Date: May 2002 Council Review: August 2002 Earliest Anticipated Start Date: September 2002 AWARD CRITERIA The following award criteria will be considered in making award decisions: o Quality of the proposed project as determined by peer review, o Availability of funds, and o Contribution to program goals. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Eleni Kousvelari, DDS, D.Sc. Chief, Cellular & Molecular Biology, Physiology & Biotechnology Branch Division of Basic & Translational Sciences National Institute of Dental & Craniofacial Research National Institutes of Health Building 45, Room 4AN-18A Bethesda, MD 20892-6402 Telephone: 301-594-2427 Fax: 301-480- 8318 Email: [email protected] Direct inquiries regarding fiscal matters to: Martin R. Rubinstein Grants Management Officer Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-38 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Fax: (301) 480-8301 email: Martin.Rubinstein@ nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121, Oral Diseases and Disorders Research Awards. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH 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 PHS strongly encourages all grant 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
| ||||||
![]() |
Department of Health and Human Services (HHS) |
![]() |
||||
NIH... Turning Discovery Into Health® |