This Program Announcement expires on April 30, 2004, unless reissued. EXPLORATORY/DEVELOPMENTAL (R21) RESEARCH GRANTS Release Date: May 2, 2001 PA NUMBER: PA-01-087 National Institute of Dental and Craniofacial Research (http://www.nidcr.nih.gov) THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The objective of this Exploratory/Developmental Grant (R21) mechanism is to encourage applications for one-time grants to support for innovative, high risk/high impact research requiring preliminary testing or development, exploration of the use of approaches and concepts new to a particular substantive area, research and development of new technologies, techniques or methods, or initial research and development of data upon which significant future research may be built. Applications will be considered as high impact if they demonstrate the potential for ground-breaking, precedent-setting significance, and high risk because they either lack sufficient preliminary data to ensure their feasibility, or involve using a new model system or technique. While this program announcement is intended to encourage innovation and high impact research, and while minimal preliminary data are expected to be described in the application, applications should clearly indicate that the proposed research and/or development is scientifically sound, that the qualifications of the investigators are appropriate, and that resources available to the investigators are adequate. 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 Program Announcement (PA), "NIDCR EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM," is related to several areas of emphasis in the oral health and oral health-related health promotion and disease prevention objectives. Potential applicants may obtain a copy of "Healthy People 2010" at: http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or 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 Under this program announcement, applicants for the R21 award may request direct costs of up to $100,000 per year for up to two years. The R21 cannot be renewed, if sufficient data are generated during the term of the award, investigators could then apply for further funding through regular research grant, e.g., the research project grant (R01) mechanism. Specific application instructions have been modified to reflect the purpose and nature of this mechanism, as well as to accommodate the "Modular Grant" and "Just-In-Time" streamlining efforts being implemented by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at the website http://grants.nih.gov/grants/funding/modular/modular.htm. RESEARCH OBJECTIVES The research objectives of the R21 mechanism described in this program announcement is to support: 1) innovative, high-risk research, requiring preliminary testing or development, 2) exploration of new approaches or concepts to a particular substantive area, 3) research and development of new technologies, techniques or methods, or 4) initial research and development of data upon which significant future research may be built, i.e., the data should have a high level of impact on the field. The research and/or development can be relevant to any of the branches, offices and programs of the NIDCR Division of Extramural Research (DER). The branches, offices and programs comprising the Division of Extramural Research at NIDCR are described in more detail on the website http://www.nidcr.nih.gov/research/extramural/index.htm. In brief, the DER at the NIDCR provides support for: (a) basic and clinical research on the processes that affect normal and abnormal development of craniofacial structures, (b) basic studies on the ecological, molecular, biological and physiological factors contributing to microbial virulence, colonization and transmission, (c) genetic determinants of host susceptibility to infection, (d) oral manifestations of HIV infection and AIDS, (e) basic and applied research related to head and neck cancers, (f) basic and clinical studies on neurobiology, pathogenesis, diagnosis, treatment or prevention of pain, (g) autoimmunity, (g) biomimetics, tissue engineering, instrumentation development and refinement (i.e., saliva based diagnostic technologies), and development of methods to improve biomaterials for the repair of orofacial structures, and (h) clinical, behavioral and health promotion studies related to craniofacial, oral and dental health. 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 is 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: 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants with the modifications noted below. Application kits are available at most institutional offices of sponsored research and may be obtained 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. Applications are also available on the World Wide Web at: http://grants.nih.gov/grants/oer.htm. APPLICATION INSTRUCTIONS 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 following instructions are to be used in conjunction with the information accompanying application form PHS 398 (rev. 4/98), they refer only to selected items in the application form. All PHS 398 requirements should be followed, with the exception of those items affected by the following instructions. Applications not conforming to the requested format will be returned to the applicant without review. Applications will be accepted at the standard receipt dates as indicated in the PHS 398 kit. o FACE PAGE- Item 2, Check the box marked Yes and type the number and title (NIDCR Exploratory/Developmental Grant [R21] Program) of this program announcement. o Item 6: Up to a total of two years of support may be requested. o Items 7a and 7b: These items should be completed indicating Direct Costs and Total Costs [Direct Costs plus Facilities and Administrative (F&A) costs] for the initial budget period. o Items 8a and 8b: These items 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. 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) 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. 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 key 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. o Complete the educational block at the top of the form page, o List position(s) and any honors, o Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, o List selected peer-reviewed publications, with full citations o OTHER SUPPORT- Do not complete this section. It is not required and will not be accepted with the application. o RESEARCH PLAN- Do not exceed a total of 10 pages inclusive of the following sections: Specific Aims, Background and Significance, Preliminary Studies/Progress Report (evidence of feasibility), and Research Design and Methods. Pertinent subject selection and recruitment information (e.g., inclusion of women, minorities, children), as it impacts on study design, should also be included. Tables, figures and photographs are included in the 10 page limitation. o Item a, SPECIFIC AIMS- The applicant should begin with a statement that justifies the designation of the application as an Exploratory/Developmental Research Grant as defined under the PURPOSE section of this program announcement. The instructions for this section suggest that the applicant state the hypotheses to be tested. Since some applications submitted in response to this program announcement may also be design- or problem- driven (e.g., development of novel technologies), or need-driven (initial research to develop a body of data upon which future research will build), hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. Thus, the application should state the hypotheses, design, problem and/or need which will drive the proposed research. Submission of a proposal under this program announcement precludes concurrent submission to the NIH of another application containing substantially the same research proposal. o Item b, BACKGROUND AND SIGNIFICANCE- In this section it is important to identify clearly how the application addresses the specific objectives of this program announcement. For example, identify briefly how this application relates to the purpose of the R21 mechanism as stated in this program announcement (i.e., highly innovative, high risk/high impact research, exploration of the use of approaches and concepts new to a particular substantive area, research and development of new technologies, techniques or methods, or initial research and development of a body of data upon which significant future research may be built). o Item c, PRELIMINARY STUDIES/PROGRESS REPORT- Minimal preliminary data are expected for an Exploratory/Developmental Grant application. o Item d, RESEARCH DESIGN AND METHODS- Fully describe the research design and methods. In many cases, an Exploratory/Developmental Grant mechanism will support novel research in an area or the research and development of new technologies. Where appropriate, specific criteria by which to judge the feasibility of novel approaches (including milestones that will mark progress) should be explicitly described in this section. o APPENDIX- Appendix materials may not be used to circumvent the page limitations. Up to ten publications, submitted manuscripts or abstracts may be included. Five copies of appendix materials should be submitted. (Refer to PHS 398 application for additional Appendix guidelines.) 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. 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. Submit a signed original of the application and five exact photocopies, including the checklist, 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for completeness by the Center for Scientific Review (CSR). Incomplete applications will be returned to the applicant without further consideration. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate National Advisory Council or Board. 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 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 the initial review group will examine: o the potential for ground-breaking, precedent setting significance of the proposed research, with particular emphasis on novel and innovative approaches that clearly require additional preliminary data for their value to be established, and, o the potential to stimulate new concepts or approaches regarding important to biomedical/behavioral problems, or provide a technique/system of wide applicability. The initial review group will examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women, Children and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o the quality of the proposed project as determined by peer review, and, o the availability of funds. INQUIRIES Potential applicants are encouraged to call the staff members listed in the program announcement regarding the areas of science that NIDCR supports. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Rochelle K. Small, Ph.D. Craniofacial Anomalies and Injuries Branch National Institute of Dental and Craniofacial Research Division of Extramural Research Natcher Building, Room 4AN-24K Bethesda, MD 20892 Phone: (301) 594-9898 Fax: (301) 480-8318 Email: rochelle.small@nih.gov Dennis Mangan, Ph.D. Infectious Diseases and Immunity Branch National Institute of Dental and Craniofacial Research Division of Extramural Research Natcher Building, Room 4AN-32F Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301) 480-8318 Email: dennis.mangan@nih.gov Ann L. Sandberg, Ph.D. Neoplastic Diseases Branch National Institute of Dental and Craniofacial Research Division of Extramural Research Natcher Building, Room 4AN-24A Bethesda, MD 20892-6402 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: ann.sandberg@nih.gov Eleni Kousvelari, DDS, D.Sc. Biomaterials and Biomimetics and Tissue Engineering Branch National Institute of Dental and Craniofacial Research Division of Extramural Research Natcher Building, Room 4AN-18A Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: eleni.kousvelari@nih.gov Kenneth Gruber, Ph.D. Chronic Diseases Branch National Institute of Dental and Craniofacial Research Division of Extramural Research Natcher Building, Room 4AN-18C Bethesda, MD 20892-6402 Telephone: (301) 594-4836 FAX: (301) 480-8318 Email: kenneth.gruber@nih.gov Guo H. Zhang, Ph.D. Chronic Diseases Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-18B Bethesda, MD 20892-6402 Telephone: (301) 594-0618 FAX: (301) 480-8318Phone: Email: guo.zhang@nih.gov Norman Braveman, Ph.D. Office of Clinical, Behavioral and Health Promotion Research National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24C Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: norman.braveman@nih.gov Maryann Redford, D.D.S, MPH Director, Clinical Trials Program Office of Clinical, Behavioral & Health Promotion Research Promotion Research National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24B Bethesda, MD 20892 Phone:(301) 594-5588 E-mail: maryann.redford@nih.gov Patricia Bryant, Ph.D. Director, Behavioral and Health Promotion Research Office of Clinical, Behavioral, and Health Promotion Research National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24E Telehone: (301)595-2095 FAX: (301) 480-8318 Bethesda, MD 20892 Email: patricia.bryant@nih.gov Direct inquiries regarding fiscal matters to: Mr. Martin R. Rubinstein Grants Management Branch Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN- 44A Bethesda, MD 20892-6402 Telephone: 301-594-4800 FAX: (301) 480-8301 E-mail: 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 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 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 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, a 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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