EXPIRED
ORAL MICROBIOLOGY/IMMUNOLOGY OF TYPE 1 DIABETES Release Date: January 30, 2001 RFA: RFA-DE-01-001 National Institute of Dental and Craniofacial Research (http://www.nidcr.nih.gov) Letter of Intent Receipt Date: March 12, 2001 Application Receipt Date: April 12, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT 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 RFA is to encourage submission of applications for two year exploratory grants (R21) that will broaden research on the oral microbiology and immunology of Type 1 diabetes. In particular, research is needed on the oral microflora, cytokines and antibodies in the subgingival crevice. Applications that propose an integrated effort from investigators with expertise in a variety of scientific disciplines, or are from women, underrepresented minority or disabled scientists are particularly encouraged. 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 Applications (RFA), ORAL MICROBIOLOGY/IMMUNOLOGY OF TYPE 1 DIABETES, is related to the priority area, Oral Health. 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 Research projects will be supported with the exploratory/developmental research grant (R21). The Exploratory/Developmental research mechanism (R21) is used for support of creative, novel, and/or high risk/high payoff approaches that could produce innovative advances in this field. This includes feasibility studies, protocol planning, and the incorporation of new disciplines and technologies. This mechanism provides the means to acquire the necessary pilot information, to attract talented new investigators from related disciplines, and to foster the development of interdisciplinary, inter-institutional collaborative efforts among investigators with diverse training and expertise. Applicants may request $100,000 in direct costs per year for up to two (2) years of support. The anticipated award date is August 2001. These awards are not renewable. If desired, the specific aims of the R21 project may be incorporated into a traditional research project grant application (R01) submitted prior to the termination of the R21 award. This RFA is a one-time solicitation. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The NIDCR intends to commit approximately $500,000 in FY 2001 to fund 3 to 4 grants in response to this RFA. An applicant may request a project period of up to two (2) years and a budget of up to $100,000 direct costs per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background Nearly 16 million people in the United States have diabetes, a leading contributing factor for severe and extensive periodontal (gum) diseases. Recent studies indicate that diabetes alters the immune system and connective tissue, making the patient more susceptible to oral tissue destruction and inflammation. Bacterial pathogens in the gingival crevice appear to utilize the weakened host to colonize, grow and induce periodontal disease. Type 2 diabetes accounts for about 90 percent of diabetes cases in the United States. Type 2 is most common in people who are overweight, inactive, age 40 and older, and have a family history of diabetes. About 10 percent, or 1.6 million of people with diabetes, have type 1, formerly known as juvenile onset diabetes or insulin-dependent diabetes. This form of diabetes, which usually occurs in children and adults under age 30, develops when the body's immune system attacks the insulin-producing cells of the pancreas. Periodontal infections occur more frequently in both Type 1 and Type 2 forms of diabetes. The Workshop on Oral Diseases and Diabetes, held December 1999, concluded that, in order to advance the diagnosis, prevention and treatment of periodontal diseases in these patients, more data are needed on the oral microbiology and immunology of diabetes and recommended that the NIDCR support research on these topics. A summary of this workshop is available on the NIDCR website: http://www.nidcr.nih.gov/news/strat-plan/Oral_Diseases&Diabetes.pdf. The current initiative is intended to encourage grant proposals to explore the microbiology and immunology of Type 1 diabetes. These R21 grants are expected to help grantees obtain preliminary data for new or competing R01 applications. Applications that address health disparities are particularly encouraged. Applications that capitalize on the strengths of collaboration between clinicians and scientists to maximize the potential for discovering novel approaches relevant to oral infections of Type 1 diabetes are strongly encouraged. Other The present initiative seeks applications that focus specifically on the oral microbiology and immunology of Type 1 diabetes. Applications from broadly interdisciplinary teams are appropriate and encouraged. Research on Type 2 diabetes will be considered only if the results would directly apply to Type 1 diabetes. Examples of research topics that would be responsive to this RFA include, but are not limited to: o Novel animal models (genetically characterized mice, SCID mice, gene knockout mice) to dissect the mechanisms of pathogenesis and to study oral infectious diseases associated with diabetes; o Natural history of oral infections in diabetes from a microbial perspective; o Large scale, state-of-the-science DNA probe analyses to identify and compare the microflora in patients with diabetes to that found in healthy controls; o Microbe-host cell molecular interactions; o Etiology and pathogenesis of pulpal and periapical infections in patients with diabetes; o Effect of diabetes treatments on the oral microflora; o Immune response within the oral cavity of the diabetes patient, including, for example, synthesis, structure and secretion of sIgA; number and type of lymphocytes; innate immune responses; and cytokines, lymphokines, and antibodies; and, These examples are meant to be illustrative of the general types of research approaches that would be considered appropriate for this RFA, and are not restrictive. 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report 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 member listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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 this 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 NIDCR staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. H. George Hausch (see address below) by March 12, 2001. APPLICATION PROCEDURES Applicants are strongly encouraged to contact NIDCR staff members with any questions regarding the responsiveness of their proposed project to the goals of this RFA or the preparation of their applications. Applications are to be submitted on the grant application for PHS 398 (rev. 4/98). These forms are available at most institutional offices of sponsored research; 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: grantsinfo@nih.gov; and on the internet at http://grants.nih.gov/grants/funding/phs398/phs398.html The instructions accompanying PHS 398 must be followed as far as possible but some modifications are necessary. The Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed ten (10) pages. No appendix material may be submitted. Graphs, diagrams, tables, charts and photographs must be included in the body of the application. Original glossy photographs should be included in the original application sent to the Division of Research Grants, NIH, and in the two copies sent to the Scientific Review Branch, National Institute of Dental and Craniofacial Research. Applicants are reminded that the type size limitations specified in the General Instructions of PHS 398 must be observed. Applications not conforming with these instructions will be returned to the applicant without review. MODULAR APPLICATION DETAILS: Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts. Complete and detailed instructions and information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to maximum of $100,000 direct costs per year for two (2) years. The direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: For item 2, check YES, and insert Number DE-01-001, Oral Microbiology/Immunology of Type 1 Diabetes. For item 6, the maximum project period is two (2) years, and for item 7a, the maximum request is $100,000 direct costs. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative, F&A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations; o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o PAGE LIMITATION - In keeping with the pilot/feasibility nature of the requested studies the Research Plan (specific aims, background and significance, preliminary data and research design and methods) is limited to 10 pages. Tables and figures must be included in the 10-page limitation. o APPENDIX - An appendix or additional supporting materials will not be accepted with the exception of originals of photos used in the application. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. 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. 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. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been 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. Therefore, an application that is essentially identical to one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the Checklist, and three (3) 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, two (2) additional copies of the application must be sent to Dr. H. George Hausch in the NIDCR Scientific Review Branch at the address listed below. Applications must be received by April 12, 2001. If an application is received after that date, it will be returned to the applicant without review. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete and/or non-responsive 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 NIDCR Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written 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 these goals. Each of these criteria will be addressed and considered in assigning the 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 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 method? 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. (Additional scientific/technical merit criteria specific to the objectives of the RFA and the mechanism used must be included if they are to be used in the review.) Schedule Letter of Intent Receipt Date: March 12, 2001 Application Receipt Date: April 12, 2001 Peer Review Date: June 2001 Council Review: August 2001 Earliest Anticipated Start Date: August 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 encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dennis Mangan, Ph.D. Infectious Diseases and Immunity Branch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-32F Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301) 480-8318 Email: Dennis.Mangan@nih.gov Direct inquiries regarding review issues to: H. George Hausch, Ph.D. Scientific Review Branch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: (301) 594-2904 FAX: (301) 480-8303 Email: George.Hausch@nih.gov Direct inquiries regarding fiscal matters to: William Powell Grants Management Branch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44K Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: William.Powell@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.
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