INTERNATIONAL COLLABORATIVE ORAL HEALTH RESEARCH PLANNING GRANT RELEASE DATE: January 16, 2003 PA NUMBER: PAR-03-059 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. A replacement R21 (PAR-06-219) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: January 17, 2006, unless reissued. National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Dental and Craniofacial Research (NIDCR) will provide grant support for planning and protocol development of biomedical, epidemiological and behavioral studies in priority international research areas as identified in the Institute's Strategic Plan and facilitated by the Office of International Health (OIH), in consultation with the international research community. The purpose of this initiative is to bring together international researchers through collaborative partnerships that conduct research according to common protocols. The planning grant is intended to provide support for the development of a refined study design, organizational plan, detailed protocol criteria, and budget, for implementation of cross-national studies whose rationale and basic design are considered scientifically meritorious, and which cannot be accomplished solely within the U.S. (For the purposes of this PA, "cross- national" means that at least three (3) countries are involved.) After these are completed, planning grant awardees may submit applications to conduct the full-scale study, in collaboration with international funding partners. RESEARCH OBJECTIVES Dental, oral and craniofacial diseases and disorders are among the most common health problems affecting the people of the United States and around the world. The burden imposed by a variety of dental, oral and craniofacial diseases and disorders range from birth defects such as cleft lip and palate, which occurs in every 1 in 525 to 714 live births, to injuries to the head and face, resulting in nearly 20 million emergency room visits per year, to devastating head and neck cancers, accounting for 8000 deaths and over 30,000 new cases per year in the U.S. alone. In the U.S., the treatment of over 1.2 million cancer patients each year can lead to painful mouth ulcers, mucositis, rampant dental caries, fungal infections, impaired taste and loss of function of the salivary glands. Oral infections still remain common in our populations. Dental caries is experienced by 45% of school children and 94% of adults have experienced this infection at some point in life. Periodontal infections occur in 90% of individuals older than 13 years and may be associated with other systemic diseases or conditions such as diabetes, cardiovascular disease, respiratory infections, and pre-term/low birth weight babies. Orofacial pain is likely to have been experienced by over 20% of adults in the past six months, is a major component of temporomandibular joint diseases (TMD) for at least 6% of adults, and is a major component of Bell's palsy, trigeminal neuralgia and fibromyalgia. Salivary gland dysfunction in the form of Sjogren's syndrome affects between 1 and 4 million Americans while over 30,000 individuals who have cystic fibrosis are also at higher risk for concomitant salivary gland dysfunction. Further, over 500 prescription drugs have xerostomic (dry mouth) side effects, increasing the risk for both bacterial and fungal oral infections as well as other oral conditions. Oral candidiasis is commonly found in HIV- infected patients. These health issues, though prevalent in the U.S., know no geographic boundaries. Oral conditions affect populations around the globe. Some of these conditions are more prevalent in certain countries or regions, while others are found in virtually all countries, but to varying degrees. There are many research topics that require international collaboration for questions to be appropriately addressed. For example, there are many areas of research that, because of limited access to patient populations within any single country, can only be conducted by international teams of scientists with access to large groups of people with the disease/condition to be studied. Similarly, there are areas of research where progress would be enhanced with the addition of unique scientific expertise only found internationally. The purpose of this initiative is to bring together international researchers through collaborative partnerships that investigate these special research issues according to common protocols. In pursuing new scientific opportunities, the NIDCR organizes its work into the following areas of research: o Microbiology and Microbial Pathogenesis Program The objective of this program is to support basic and translational research on the role of oral microbes in health and disease. To this end, three broad scientific areas have been identified that will provide the basis for rapid development of knowledge of the etiology, pathogenesis, diagnosis, treatment, and prevention of oral infectious diseases. These interrelated areas are: (i) Biofilms and Microbial Ecology, (ii) Microbial Genomics, and (iii) Microbial Virulence and Disease Pathogenesis. o Immunology and Immunotherapy Program This program supports basic and translational research on the immune aspects of oral diseases. To this end, the program is composed of six major areas of research: host responses to microbes, head and neck cancer immunology, autoimmunity, antimicrobial agents and immunotherapy, biomarkers, and vaccines. o AIDS and Immunosuppression Program This program supports basic and translational research on HIV infection and AIDS to advance understanding of the underlying molecular and genetic mechanisms that result in the transmission of HIV and development of oral complications associated with HIV-infection and AIDS. o Biotechnology and Biomaterials Program The purpose of this program is to support basic and translational research on synthetic restorative materials, biomimetics and tissue engineering. o Developmental Biology and Mammalian Genetics Program Through this program, the Institute supports basic and translational research to understand the development of tooth and bone, and to identify the genetic and environmental contributions to craniofacial disorders. The objective of this scientific program is to elucidate the underlying causes of craniofacial disorders, thereby advancing the fields of diagnosis, treatment, and prevention. o Epithelial Cell Regulation and Transformation Program This program supports basic and translational research on the molecular mechanisms of oral epithelial cell regulation, and investigations on the molecular events involved in the initiation of oral epithelial cell transformation to premalignant and malignant lesions and mucositis. This program also supports and encourages basic and translational research related to early diagnosis, prevention, and treatment of oral neoplasias. o Physiology, Pharmacogenetics and Injury Program This program supports basic and translational research on normal and abnormal functions of the salivary gland, tooth and bone; physiology and cell biology of injury, trauma and wound healing; and pharmacogenetics of drugs used in treatment of salivary as well as tooth and bone disorders. o Molecular and Cellular Neurobiology Program The Institute supports basic and translational research on neurophysiology; tissue innervation; neuropathies with specific emphasis on Temporomandibular Joint Disorders (TMDs); the development of biomarkers for use in diagnostics and prognostics; and the development of therapeutics. o Behavioral and Social Sciences Research Program This program supports basic behavioral and social science research relevant to oral diseases, health promotion, and health care. The research supported draws on the expertise of sociologists, psychologists, anthropologists, public health and health policy experts, health services researchers, economists, and dental researchers and includes a number of multi- disciplinary projects. Other topics for international research include traditional health beliefs and practices, systems of health care financing, and targeted community-based health promotion/disease prevention programs which would serve to reduce health disparities within a society. o Population Sciences Program This program supports research aimed at: (1) describing the distribution of oral, dental and craniofacial diseases and disorders; (2) understanding risk and protective factors of these diseases and disorders and their interactions; (3) identifying oral health disparities among population sub- groups and (4) developing and evaluating interventions for prevention, early detection, and treatment of oral diseases and disorders. Applications to plan and conduct clinical trials must be submitted under a different process. Please refer to the Clinical Trial topic area at http://www.nidcr.nih.gov/. Applications under this PA must contain research planning proposals which fit within these strategic areas. Further information about these research topics may be obtained from NIDCR's website at http://www.nidcr.nih.gov/research/sponsoredresearch.asp. In each of these priority areas, a broad-based coalition of scientific talent is envisioned to encompass research needs in areas from molecular biology to the translational patient-oriented, epidemiological, behavioral, social and related health promotion sciences as may be appropriate for the research questions involved. The product of these research planning grants would be the enhanced or new infrastructure needed to enable submission of full-scale studies in the given subject area. These applications could then be submitted as investigator-initiated projects to the US government and/or any other potential collaborating funding agency, institution or foundation. Those applications coming subsequently to the NIH also will be peer-reviewed according to standard NIH procedures. Applicants should note that NIDCR funding of a planning grant does not imply a commitment by NIDCR to fund the proposed full-scale study. Applicants for research planning grants may request funds for activities such as but not limited to: o Travel expenses of individuals from multiple sites to planning meetings for the project. o Preliminary studies to guide selection of and/or refine research agenda, questions, and hypotheses. o Analyses of existing data needed for refinement of study design and protocols. o Preparation of detailed protocols. These protocols must be included in the Final Report for this award. The planning grant proposal should describe: o Importance and relevance of the scientific question. Describe the research project(s) under consideration and the potential for advancing the science and improving health. o The principal hypotheses to be tested, and the rationale for doing so. o Justification of the need for a global approach. Is the problem global in nature? Why is a multicountry project necessary to answer the question? Why can't the question be answered with a single-site study? o The organizational approach and timetable to be followed in building an international coalition, defining the research agenda and developing a specific international collaborative research protocol. o The participants in the planning process, their roles in the development of the plan, and their experience in related studies. o Ability of the Principal Investigator to bring together the necessary international network. While the actual building of the network is to be done after the planning grant is awarded, there must be clear evidence of commitment from researchers and institutions in other countries. Letters of commitment, including biosketches, by collaborating partners should be included. Describe the mechanism for identification and selection of additional collaborators. A proposal involving several (three or more) countries is expected. o Identifiable outcome of the grant. What products/documents are expected from the grant? How will this be used in developing the next stages of research? o Justification for the budget. Include specific plans for the use of the funds (e.g., salaries, meetings, travel, preliminary data collection, etc.) and the way in which this will be used to facilitate the expected outcomes and specific products of the planning grant. If applicable, describe other support from collaborating partners. MECHANISM(S) OF SUPPORT This PA will use the NIH R21 award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants may request up to $100,000 in direct costs per year for each of two years. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Kevin S. Hardwick, DDS, MPH Office of International Health National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AS13 Bethesda, MD 20892 Telephone: 301-594-2765 FAX: 301-402-7033 Email: kevin.hardwick@nih.gov Rochelle K. Small, PhD Developmental Biology and Mammalian Genetics Program Cellular and Molecular Biology, Physiology and Biotechnology Branch Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AN-18D 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-9898 Fax: (301) 480-8318 Email: Rochelle.Small@nih.gov Dennis F. Mangan, PhD Infectious Diseases and Immunity Branch Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AN-12J Bethesda, MD 20892-6402 Telephone: 301 594-2421 Fax: 301 480-8319 Email: Dennis.Mangan@nih.gov Yasaman Shirazi, PhD Epithelial Cell Regulation and Transformation Program Division of Basic & Translational Sciences National Institute of Dental & Craniofacial Research National Institutes of Health 45 Center Dr., Room 4AN-18C Bethesda, MD 20892-6402 Telephone: 301-594-4812 Fax: 301-480-8318 Email: yasaman.shirazi@nih.gov Eleni Kousvelari, DDS, DSc Cellular and Molecular Biology, Physiology and Biotechnology Branch Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AN-12K Telephone: (301) 594-2427 Fax: (301)480-8318 Email: Eleni.Kousvelari@nih.gov Patricia S. Bryant, PhD Behavior and Social Sciences Research Program Clinical, Epidemiology and Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental and Craniofacial Research Building 45, Room 4AS-43A 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2095 Fax: (301) 480-8318 Email: Patricia.Bryant@nih.gov Maria Teresa Canto, DDS, MPH Population Sciences Program Clinical, Epidemiology and Behavioral Research Branch Division of Health Promotion and Population Sciences Building 45, Room 4AN-43B 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-5497 Fax: (301) 480-8318 Email: Maria.Canto@nih.gov o Direct your questions about peer review issues to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2904 Fax: (301) 480-8303 Email: HauschG@mail.nih.gov o Direct your questions about financial or grants management matters to: Mary Daley Chief Grants Management Officer National Institute of Dental and Craniofacial Research Building 45, Room 4AN-44B 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: 301-594-4808 Fax: 301-480-3562 Email: md74u@nih.gov SUBMITTING AN APPLICATION 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: GrantsInfo@nih.gov. As with most applications to NIH, the research plan is limited to 25 pages. Publications may not be submitted, but color/glossy photographs and other appendix material (surveys, questionnaires, etc.) is permitted. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on standard receipt dates. See (http://grants.nih.gov/grants/dates.htm) SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SENDING AN APPLICATION TO THE NIH: 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) In order to facilitate the review of applications assigned to the NIDCR, the applicant must, at the same time, mail or deliver two copies of the application to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F MSC 6402 Bethesda, MD 20892-6402 APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates listed above. The 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. A special emphasis panel convened by NIDCR in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique. o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. o Receive a second level review by the National Advisory Dental and Craniofacial Research 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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 you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (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 you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 is 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: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 PA 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. 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 side. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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, 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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