SMALL GRANT PROGRAM FOR THE NIDCR Release Date: February 14, 2001 PA NUMBER: PAR-01-053 National Institute of Dental and Craniofacial Research Application Receipt Dates: April 3 and August 3, 2001 December 3, 2001; April 3 and August 3, 2002 December 3, 2002; April 3 and August 3, 2003 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 This Program Announcement (PA) supersedes all previous announcements of the National Institute of Dental and Craniofacial Research (NIDCR) Small Grant (R03) Program under PA 91-036 (DE) and its extensions. The NIDCR Small Grant (R03) Program has been modified to provide support ONLY to new investigators for pilot research that is likely to lead to a subsequent Individual Research Project Grant (R01) application. The research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCR: craniofacial anomalies and injuries; infectious diseases and immunity; neoplastic diseases; chronic diseases; biomimetics, bioengineering, and tissue engineering; and clinical, behavioral and health promotion research. The Small Grant Program is designed to support basic and clinical research of scientists who are in the early stages of establishing an independent research career. 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) " SMALL GRANT PROGRAM FOR THE NIDCR," is related to the priority area of 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 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. Foreign institutions and United States organizations located in foreign countries are not eligible to apply for this program. Individuals defined as New Investigators and eligible for the NIDCR Small Grant Program include former and current : (1) recipients of Individual Research Career Development Awards, such as the Mentored Clinical Scientist Development Award (K08), Scholar Development and Faculty Transition Award (K22) and the Mentored Patient Oriented Research Career Development Award (K23); (2) appointees in Institutional Research Career Development Award programs, such as the Dentist Scientist Award (K16) and the Mentored Clinical Scientist Development Program Award in Dental, Craniofacial and Oral Health Research (K12); (3) recipients of individual National Research Service Awards (NRSA), such as the Predoctoral Dental Science Fellowship (F30) and the Postdoctoral Fellowship (F32) awards; and (4) trainees in the Institutional NRSA program (T32). However, any current support by the F32 and T32 mechanisms must be terminated before support in the NIDCR Small Grant Program begins. Individuals who are current or previous recipients of NIH Research Project Grants (R01, R03, R15, R21, R29, R55, P01, and P20) and Center Grants (P50 and P60) as well as principal investigators of research subprojects of Program Project (P01) and Center (P50 and P60) awards are not eligible for the R03 mechanism. Other NIH and Federal grant supported activities may also preclude eligibility for this award. Potential applicants are advised to contact the NIDCR program staff listed under INQUIRIES in order to ascertain eligibility for this program. Individuals who are planning to re-enter research careers and are ineligible for the R03 award as defined above should consider applying under the NIH re-entry supplement program described in PA-99-106. Only one small grant application from an individual Principal Investigator will be considered by NIDCR per receipt date and only two revisions of a previously reviewed small grant application may be submitted. The work proposed may not overlap significantly with the aims of currently supported projects in which the applicant has participated during the last five years. However, the proposed work may be an extension of previously supported projects in which the applicant has participated. Applications for research focused on projects outside the NIDCR mission will not be accepted for potential funding by NIDCR. Other questions about eligibility may be directed to one of the program officials listed under INQUIRIES. MECHANISM OF SUPPORT This program will use the NIH small grant (R03) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed two years. The NIDCR small grant is a $50,000 per year direct cost award. The Small Grant funds may not be used to supplement projects currently supported by Federal or non-Federal funds, or to support thesis or dissertation research. These grants may not be renewed. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: https://grants.nih.gov/grants/funding/modular/modular.htm. RESEARCH OBJECTIVES The R03 mechanism described in this program announcement will support research and/or development relevant to all the branches, offices and programs of the NIDCR Division of Extramural Research. 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/sciprog.htm In brief, the different branches and offices at the NIDCR support research in: (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) sequence analysis of the entire genome of oral microorganisms; (d) genetic determinants of host susceptibility to infection; (e) basic and applied research related to oral cancers; (f) basic and clinical studies on neurobiology, pathogenesis, diagnosis, treatment or prevention of pain; (g) autoimmunity; (h) 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 (i) 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at https://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: https://grants.nih.gov/grants/guide/notice-files/not98-024.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. APPLICATION PROCEDURES 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. 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. FACE PAGE: Item 2, type "NIDCR Small Grant Program" in "Title" box, and check the "YES" box, indicating response to Program Announcement. Item 6: Up to a total of two years of support may be requested. Items 7a and 7b: These items should be completed indicating Direct Costs ($50,000) and Total Costs [$50,000 plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b: These items should be completed indicating the Direct (i.e., either $50,000 or $100,000) and Total Costs (i.e., either $50,000 or $100,000 plus F&A) for the entire proposed period of support. 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. 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. NARRATIVE BUDGET JUSTIFICATION Prepare a Modular Grant Budget Narrative page. For sample pages, see: https://grants.nih.gov/grants/funding/modular/modular.htm. At the top of the page, enter the total direct costs requested for each year (i.e., $50,000). This is not a Form Page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the proposed project. Under the NIDCR Small Grant Program, a minimum of 25% effort of the PI must be committed to the project. The PI may request salary support, but significant justification together with Institutional commitment should be provided. Salary support may also be requested for technical support staff. 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. The Small Grant Program overall research budget may also include small equipment, supplies, and travel. These grant funds may not be used to support thesis or dissertation research. 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 and organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and role on the proposed project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested $50,000 direct cost amount. Include the Letter of Intent to establish a consortium. 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: https://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 then any honors. o Provide information, including overall goals and responsibilities on research projects ongoing or completed during the last three years and identify all sources of previous and current research funding. o List selected peer-reviewed publications with full citations. OTHER SUPPORT Do not complete this section. It is not required and will not be accepted with the application. RESEARCH PLAN Do not exceed a total of 10 pages inclusive of the following sections: Specific Aims; Background and Significance; Preliminary Studies/Progress Report (or other 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. For revised applications, an additional introduction (not to exceed one page) is permitted. This introduction should respond to the comments and concerns of the Initial Review Group delineated in the summary statement. Applications that exceed the page limit or requirements for type size and margins will be returned to the investigator. (Refer to PHS 398 application for details.) The 10 page limit does not include information regarding safety and ethical issues related to subjects in research (Human Subjects, Inclusion of Children as Participants in Research, Vertebrate Animals) or Consortia and Literature Cited (Section E-I). APPENDIX Appendix materials may not be used to circumvent the page limitations. However, letters of support may be used to describe the Institutional support for the Principal Investigator (including salary and percent effort available for research), to establish the Principal Investigator's research as separate and distinct from those of a former mentor, or to denote collaborative or consultant relationships. Up to three publications, submitted manuscripts or abstracts may also be included. Five copies of appendix materials should be submitted. (Refer to PHS 398 application for additional Appendix guidelines.) 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 each budget period. The applicant should provide the name and telephone number of the individual to contact concerning fiscal and administrative issues if additional information is required following initial review. Use the mailing label in the application kit to mail the original and three copies of the application to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) To ensure that the application is received in sufficient time for the review, send an additional two copies of the application to: Chief, Scientific Review Branch National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44 Bethesda, MD 20892 Schedule Application Receipt Dates: Dec 3, Apr 3, and Aug 3 NIDCR Committee Review: Feb/Mar, Jun/Jul, and Oct/Nov Council Review: May, Oct, and Jan Earliest Funding: Aug, Jan, and May If the receipt date falls on a weekend, it will be extended to the following Monday; if the date falls on a holiday, it will be extended to the following business day. The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 Applications will be reviewed for completeness and for responsiveness to this PA by NIH staff. Incomplete and/or non-responsive applications may be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH procedures by a scientific review group (SRG) convened by the NIDCR. As part of the initial review, all applications will receive a written critique. Those applications deemed to have the highest merit, generally the top-half of applications under review, will be discussed, assigned a priority score, and receive a second level of review by the NIDCR Advisory Council. Review Criteria The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made 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 the assignment of the overall score. (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? The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformity with the NIH Guidelines for the Inclusion of Women and Children as Subjects in Clinical Research. AWARD CRITERIA The awarding of grant funds is contingent on: (1) the receipt of applications of high scientific merit; (2) responsiveness to this Program Announcement, including the eligibility of investigators; (3) relevance to the mission of the NIDCR; and (4) the availability of funds. INQUIRIES Inquiries concerning this program announcement are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Rochelle K. Small Craniofacial Anomalies and Injuries Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24K Bethesda, MD 20892-6402 Phone: (301) 594-9898 Fax: (301) 480-8318 Email: rochelle.small@nih.gov Dr. Dennis Mangan Infectious Diseases and Immunity Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-32F Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301) 480-8318 Email: dennis.mangan@nih.gov Dr. Ann Sandberg Neoplastic Diseases Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24A Bethesda, MD 20892-6402 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: ann.sandberg@nih.gov Dr. Eleni Kousvelari Biomaterials and Biomimetics and Tissue Engineering Branch 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: eleni.kousvelari@nih.gov Dr. Kenneth Gruber Chronic Diseases Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-18C Bethesda, MD 20892-6402 Telephone: (301) 594-4836 FAX: (301) 480-8318 Email: ken.gruber@nih.gov Dr. Norman Braveman 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 Dr. Maryann Redford Director, Clinical Trials Program Office of Clinical, Behavioral and Health Promotion Research National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24B Bethesda, MD 2089-6402 Telephone:(301) 594-5588 FAX: (301) 480-8318 Email: maryann.redford@nih.gov Dr. Guo H. Zhang Director, Salivary and Bone Research Program 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 Dr. Patricia Bryant Director, Behavioral and Health Promotion Research Program 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 Rubinstein Grants Management Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-44A 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 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, and 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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