ENHANCING RESEARCH INFRASTRUCTURE AND CAPACITY BUILDING FOR U.S. DENTAL INSTITUTIONS RELEASE DATE: August 6, 2003 RFA Number: RFA-DE-04-008 National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) LETTER OF INTENT RECEIPT DATE: March 14, 2004 APPLICATION RECEIPT DATE: April 14, 2004 CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.121 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Cooperative Agreement Terms and Conditions of Award o Where to Send Inquiries o Letter of Intent o Supplemental Instructions o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The initiative to be supported through this RFA is designed to provide the necessary resources for dental schools to implement comprehensive institutional plans to enhance their research infrastructure. This RFA follows from and represents Phase II of the previously issued RFA DE- 03-006, "Planning Awards for the Improvement of Research Infrastructure in U.S. Dental Schools" that utilized the R24 mechanism (http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-03-006.html). However, any dental institution may respond to this RFA regardless of whether they received a R24 planning award. RESEARCH OBJECTIVES Background A large portion of dental, oral and craniofacial research is performed in the nation's dental schools. However, data indicate that the bulk of NIDCR funding to dental schools goes to relatively few such institutions. Therefore the research infrastructure and workforce capacity of many dental schools need to be strengthened in order to help them take advantage of the new opportunities in research and to remain competitive and full participants in the modern research enterprise. For oral, dental and craniofacial diseases and disorders, there are numerous research opportunities and challenges. These diseases and disorders are among the most common problems affecting the health and well being of the U.S. population. As highlighted in the U.S. Surgeon General's Report "Oral Health in America," oral health is essential to general health and means much more than healthy teeth. This report and the subsequent "National 'Call to Action' to Promote Oral Health" stress the need for accelerating research in basic, applied and clinical areas (http://www.nidcr.nih.gov/sgr/oralHealth.asp). The challenge is to understand the orofacial complex diseases caused by the interaction of multiple genes with environmental and behavioral variables and to translate research findings into improved care and healthier lifestyles. NIDCR has expanded its research support portfolio to address these complex interactions in the genesis of oral, dental and craniofacial diseases and disorders. The growth in the scientific areas of interest has been accompanied by a parallel shift in research emphasis from traditional disciplines to new approaches involving molecular medicine and other tools of modern biomedical research. These have been highlighted in the NIDCR Strategic Plan, which can be found at (http://www.nidcr.nih.gov/about/strat-plan/draft011603.asp). Research opportunities identified in the Plan include (1) advancing the understanding of the processes underlying oral, dental and craniofacial diseases through studies related to genetics, structure and function of oral tissues and cells, communication between and within cells, biocompatible materials, gene and environment interactions, pharmacogenetics) and (2) preventing, diagnosing, treating and eliminating oral, dental and craniofacial disorders (e.g., through research related to the development and validation of biomarkers, clinical research and trials, population- based, genetics, social and behavioral research). Of special importance is the application of basic science advances to clinical research. These areas of scientific opportunity require not only an appropriate research infrastructure, but also cross-disciplinary interactions between investigators with solid skills and competencies in new and expanding areas of science. Additional information about current and future NIDCR research priorities is found on the NIDCR home page at http://www.nidcr.nih.gov. Objectives and Scope The objective of this RFA is to enable U.S. dental schools to strengthen their research capabilities by recruiting and retaining outstanding research personnel, obtaining appropriate equipment and materials to perform the highest quality science, and establishing institutional linkages that augment and expand their research capacity. Applicants are expected to have previously identified one or more areas of scientific focus, completed an assessment of research infrastructure needs for the selected research areas and, from the needs assessment, developed a comprehensive plan to expand and sustain the research infrastructure. For this RFA, critical research infrastructure needs may include recruiting, supporting and mentoring clinical, basic, translational, behavioral or other research investigators in tenure- track (or equivalent) positions; recruiting outstanding experienced scientists for tenured positions; retraining senior scientists as necessary; and providing a well-organized biomedical research environment that includes technical support personnel, appropriate equipment, supplies, shared resources, and inter- and intra- institutional linkages. During this award, the institutions will be expected to implement the proposed strategies in their plan for enhancing research infrastructure and capacity building. At the end of the funding period the awardees will be expected to have strengthened their capability to prepare and submit scientifically meritorious research project grant applications and to have initiated or enhanced research training and career development programs relevant to the mission of the NIDCR. This initiative is part of a larger NIDCR effort that is attempting to create a momentum at U.S. dental schools for conducting scientific investigations, for developing an interest among students and junior faculty to pursue careers in research, for stimulating an increased understanding and appreciation among educators and future practitioners for the importance of research, and for pursuing the transfer of scientific findings to clinical practice. Specific information on the application requirements is described in the section under SUPPLEMENTAL INSTRUCTIONS. MECHANISM OF SUPPORT This RFA will use the NIH U24 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is September 1, 2004. This RFA uses just-in-time concepts. It also uses the non-modular budgeting format because a detailed, categorical budget is needed for purposes of review. See http://grants.nih.gov/grants/funding/modular/modular.htm for a discussion of budget formatting. The NIH U24 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIDCR staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE The NIDCR intends to commit approximately $9.0 million total cost over FY 2004 and FY 2005 to fund six new grants in response to this RFA. An applicant may request a project period of up to two years and a budget for direct costs of up to $1 million per year plus applicable facilities and administrative (F&A) costs to enable the dental institution to implement the IEP. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each grant will vary. Although the budget plans of the NIDCR project 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. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Non-profit organizations only. For-profit organizations are not eligible to apply. o Public or private dental institutions. However, only dental institutions that received LESS THAN $6 MILLION from the NIDCR in FY 2001 are eligible to submit an application. This information can be obtained from the internet at www.nidcr.nih.gov/research/supportedSchools/rank2001dental.htm. o Domestic only. Foreign Institutions are not eligible to apply. The applicant Institution is encouraged to propose collaborative affiliations with other entities, including dental, medical, public health, engineering and graduate institutions. The collaboration can be with entities from within the parent institution as well as outside institutions (for example, with recipients of Minority Infrastructure Grants from NIDCR) and should be for the purpose of facilitating and addressing the objectives outlined in this RFA. Institutions can apply for a U24 award if they have not received a R24 planning award. However, they must provide documentation that they have previously completed a needs assessment and developed an infrastructure improvement plan that meets the specifications of the R24 planning award. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The Institution should designate a Principal Investigator who preferably is a faculty member with NIH research funds or a senior official, such as Associate Dean/Director for Research. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to serve as a Principal Investigator. SPECIAL REQUIREMENTS There are a number of Special Requirements and Provisions with which each institution must comply: o Applications for this initiative must include four parts. PART 1 contains the results of an Assessment of Critical Needs to enhance the dental school's research infrastructure in one or more scientific areas. PART 2 is a comprehensive, institution-wide Infrastructure Enhancement Plan (IEP) based on the Assessment of Critical Needs and represents the desired infrastructure for the area(s) of research identified in Part 1. PART 3 is a description of how the IEP will be implemented, including an evaluation plan. PART 4 contains written institutional commitment to this entire program by the leadership of the university or Academic Health Science Center (e.g., President of the health science center or Chancellor of university) to help support the development of the dental school's research infrastructure and enhance the school's capacity to carry out research throughout the two-year funding period and beyond the award. This part also should document the support for institutional linkages and/or collaborations. o To facilitate the successful implementation of the IEP, the Principal Investigator must organize an Internal Advisory Committee and an External Scientific and Program Advisory Committee. Internal Advisory Committee The Internal Advisory Committee (IAC) should consist of individuals from the dental school as well as other components of the academic health science center and parent institution or university (for example, the schools of medicine, public health, engineering and graduate studies). All such individuals should be from components of the parent institution that were integral partners in conducting the Assessment of Critical Needs and in developing the Infrastructure Enhancement Plan. (The IAC was referred to in the R24 Planning Award RFA as "Internal Planning Committee.") The IAC has responsibility for assisting the Program Director in directing and monitoring the activities of the U24 program. This committee must define the chain of responsibility for decision-making and administration beginning at the level of the Dean and including all key staff (e.g., Sponsored Programs Administrator and Department Chair). The IAC will establish a time- line for proposed activities. This committee must also develop opportunities for information exchange, seminar presentations, and research training opportunities for faculty and students. External Scientific and Program Advisory Committee The External Scientific and Program Advisory Committee (ESPAC) will be composed of at least six distinguished senior scientists and collaborating partners from outside the dental school. (The ESPAC was referred to in the R24 Planning Award RFA as the "External Advisory Committee.") The specific types of expertise and names of ESPAC members must be included in the application. Members can include faculty at other dental schools, medical schools, public health schools, etc. They also can include representatives from private industry and public or private foundations. The Principal Investigator, NIDCR staff, other ex-officio members and consultants are non-voting members of this Committee. This Committee must provide an objective and multidisciplinary perspective, expert attention to the many factors during the course of implementing the research infrastructure program, and considerable judgment to assess the progress made by the institution, making recommendations for the future direction of the Infrastructure and Capacity Building initiative and providing advice and guidance about personnel matters and the allocation of resources on at least a semi-annual basis. Additional members with specific scientific or evaluation expertise may be added to ensure an adequate review of the research infrastructure program. The chair of the Committee will be elected by and from the Advisory Committee. The Committee's recommendations, in the form of written semi-annual reports, are to be submitted to the Principal Investigator and NIDCR. These reports will be used by the Principal Investigator to guide and direct the development of the grant and for evaluation purposes. The Principal Investigator generally will be expected to accept and implement the recommendations of the ESPAC. In those situations where the recommendations are not feasible to implement, the Principal Investigator must provide a thorough explanation and rationale to the NIDCR. o Each dental school is limited to applying for only ONE Research Infrastructure and Capacity Building award. o For each collaborative partner there must be written "Letters of Support" from a senior official of the institution illustrating the type of support to ensure that these partnerships will have the maximum chance for success. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following Terms and Conditions will be incorporated into the notice of grant award and will be provided to the principal investigators and to the appropriate institutional officials at the time of award. The following special terms of award are in addition to, and not instead of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Part 74 and 92, and other DHHS, PHS, and NIH grant administration policies. F&A costs are calculated and awarded for cooperative agreement awards the same as for grants. The administrative and funding instrument used for this program is a cooperative agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIDCR scientific and/or programmatic involvement with the grantee is anticipated during performance of the activity. Under the cooperative agreement, the NIDCR supports and/or stimulates the recipient's activity by being involved in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDCR Program Director. These are summarized below: 1. Awardee Rights and Responsibilities a) Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. b) Awardees will retain custody of and have primary rights to data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. c) The Principal Investigator must organize an Internal Advisory Committee (IAC). The IAC should consist of individuals from the dental school as well as other components of the academic health science center and parent institution or university that were integral partners in conducting the Assessment of Critical Needs and in developing the Infrastructure Enhancement Plan. The IAC has responsibility for assisting the Program Director in directing and monitoring the activities of the U24 program. The IAC will establish a time-line for proposed activities. This committee also must develop opportunities for information exchange, seminar presentations, and research training opportunities for faculty and students. d) The Principal Investigator must organize an External Scientific and Program Advisory Committee (ESPAC). The ESPAC will be composed of at least six distinguished senior scientists and collaborating partners from outside the dental school. Members can include faculty from other dental, medical and other relevant schools, as well as representatives from private industry and public or private foundations. Additional members with specific scientific or evaluation expertise may be added to ensure an adequate review of the research infrastructure program. The Principal Investigator, NIDCR staff, other ex-officio members and consultants are non-voting members of this Committee. The ESPAC must provide an objective and multidisciplinary perspective, expert attention to the many factors during the course of implementing the research infrastructure program, and considerable judgment to assess the progress made by the institution. The ESPAC can make recommendations for the future direction of the Infrastructure and Capacity Building initiative and provide advice and guidance about personnel matters and the allocation of resources on at least a semi- annual basis. The chair of the Committee will be elected by and from the Advisory Committee. The Committee's recommendations, in the form of written semi-annual reports, are to be submitted to the Principal Investigator and NIDCR. These reports will be used by the Principal Investigator to guide and direct the development of the grant and for evaluation purposes. e) Awardees agree to follow the advice and recommendations of the External Scientific and Program Advisory Committee, whenever possible, in meeting the intent of this initiative. In those situations where the recommendations are not feasible to implement, the Principal Investigator must provide a thorough explanation and rationale to the NIDCR. f) The Principal Investigator and collaborators/partners should plan for regular meetings to discuss the progress and direction of its activities and to ensure that the necessary interactions are taking place. g) The Principal Investigator, collaborative partners, and other designated individuals will attend an annual meeting to be organized by NIDCR staff in Washington, DC. h) The Principal Investigator will submit annual progress reports (including recommendations of the External Scientific and Program Advisory Committee) to the NIDCR that describe activities and accomplishments during the previous funding period. 2. NIDCR Staff Responsibilities The NIDCR Program Director, who is responsible for normal program stewardship, will have, in addition, substantial programmatic involvement in the award performance period, as follows: a) Work closely with the Principal Investigator to facilitate collaborations with other NIDCR-funded research scientists, components of the health science center and parent university and other dental institutions, and to leverage the resources available for this effort. b) Facilitate the awardee's development of the institutional environment, resources and other infrastructure and administrative areas. c) Assist the Principal Investigator to gain access to fiscal and intellectual resources provided by the NIH, industry, private foundations and other federal funding agencies. d) Together with the ESPAC, will help the grantee institution and Principal Investigator establish reasonable time lines to achieve the developmental goals of this initiative. e) Provide assistance in reviewing and commenting on all major institutional changes prior to implementation to assure consistency with the goals of this RFA. f) Monitor institutional commitments and resources to ensure that the program receives the maximum opportunity for stabilization and success. g) Organize an annual meeting of all funded Principal Investigators or their designees to share progress and research insights that may benefit all of the projects. h) Assist, where warranted, in data analyses, interpretations and the dissemination of study findings to the research community and other dental institutions. 3. Arbitration When an agreement between an awardee and NIDCR staff cannot be reached on scientific or programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the awardee, one person selected by NIDCR staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CRF Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: Direct your questions about scientific/research issues to: Dr. James A. Lipton Special Assistant for Research Infrastructure and Curriculum Development, Office of the Director National Institute of Dental and Craniofacial Research Natcher Building, Room 4AS-25J Bethesda, Maryland 20892-6401 Telephone: (301) 594-2618 Fax: (301) 480-8322 e-mail: James_Lipton@nih.gov Direct your questions about peer review issues to: Dr. H. George Hausch Acting Director, Division of Extramural Activities 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 your questions about financial or grants management matters to: Ms. Mary Daley Grants Management Officer, Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44B Bethesda, MD 20892-6401 Telephone: (301) 594-4800 Fax: (301) 402-1517 Email: Mary_Daley@nih.gov Pre-application consultations with NIDCR staff is encouraged. In addition, there will be at least one Technical Assistance Workshop, currently planned for October or November, 2003, conducted by NIDCR staff to which interested faculty and research administrators will be invited. Topics to be discussed will include this RFA, the application procedure and review process. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and Title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of 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 by the date listed at the beginning of this document. The letter of intent should be sent to Dr. H. George Hausch at the address listed above. SUPPLEMENTAL INSTRUCTIONS: Allowable Costs NIDCR recognizes that institutions are different and require different types of research infrastructure activities and initiatives, depending upon particular needs and circumstances. Accordingly, this announcement provides general rather than specific guidance on the types of developmental activities appropriate under the Research Infrastructure and Capacity Building Award. Support may be requested for, but is not limited to, the following: o Administrative costs (not to exceed 20% of the total direct costs per year) for managing the program, such as salaries for key personnel and equipment to support an administrative structure. o Planning and evaluation may include the travel costs for key personnel to perform internal and external activities; travel and per diem for the ESPAC members, consultants, workshops, seminars, retreats and other forums to strengthen, stabilize and consolidate interactions and cooperation in areas of existing high priority. o Regular meetings to discuss the progress and direction of project activities and to ensure that the necessary interactions are taking place. o Attendance at an annual meeting to be organized by NIDCR staff in Washington, DC. o Developmental costs for the purchase of equipment (any purchases greater than $50,000 per year require justification). Make sure to include a detailed list of equipment and specific reasons for their need. o Costs for resources (e.g., laboratory materials and personnel) shared with other components of the university, health science center, or institutions external to the dental school; costs for establishing other types of intra- and inter-institutional collaborative links to enhance the research program (e.g., with senior scientists, use of libraries and computer/information facilities, etc.). o Recruitment of junior and senior research faculty, including start-up packages, salary, equipment, supplies, etc. o Establishing and conducting pilot programs in research training and career development, faculty development and release time including special courses or seminars. o Data management and statistical analysis needs. o Travel and per diem for an annual 1 - 2 day meeting of Program Directors to meet with staff from NIDCR and other Institutes/Centers. Direct costs for construction, renovation or for salaries for teaching or other non-research activities are NOT allowable in this grant. Costs for the performance of research projects also will NOT be provided through the U24 award. Application Requirements The application should contain the following: Part 1 - Critical Needs Assessment Summary: This covers the results of an Assessment of Critical Needs to enhance the dental school's research infrastructure in one or more scientific areas. The applicant should specify the area(s) of research focus that will be developed or strengthened as well as the rationale for their selection. Where more than one research area is identified, these areas should be complementary and there should not be any overlap among the specific areas. o Describe the approach that was used for assessing the capacity of your school, as well as any other departments in the university or collaborating institutions, to conduct state-of-the-art investigations in basic, clinical, behavioral and other research related to oral, dental and craniofacial health; o Identify the specific area(s) of research strength to be pursued in this award and the rationale for their selection (the process should build on the existing strengths and expertise at the applicant institution and collaborating parts of the parent university or external institutions, if any); o Provide a description of all research activities that currently exist in the areas of research strength at the dental school as well as in the academic health center, including schools of medicine and public health or at institutions at additional sites deemed by the applicant institution to fall within a feasible distance for frequent interactions and research collaborations; Part 2 - the Institutional Infrastructure Enhancement Plan: This is a comprehensive, institution-wide Infrastructure Enhancement Plan (IEP) based on the Assessment of Critical Needs and represents the desired infrastructure for the area(s) of research identified in Part 1. Achieving the capacity to address the identified research area(s) is the goal and the objectives specify how this goal will be reached. The IEP must address the critical research infrastructure needs, including the recruitment and retention of personnel with relevant expertise, such that the dental school's capability to perform outstanding research is improved, as measured by the future receipt of research project grants from the NIH and other funding sources. The IEP should describe the strategy to create, improve or enhance the necessary research infrastructure. The following must be included. a) Research Resources: o The existing infrastructure. This MUST include human resources (e.g., researchers and support personnel), equipment, physical structure, space layout, shared resources and infrastructure pertinent to the research focus of the institution. This information will be used as part of a future evaluation for the institutional accomplishments through the grant award. o Acquiring state-of-the-art research supplies and equipment, including the purchase of equipment, costs for shared resources and other related activities. o Establishing intra- and inter-institutional links to enhance the research program, including the development of shared research cores with collaborating institutions. Discuss how cooperative linkages and partnerships would be formed with these centers or institutions. Evidence of strong collaborations with research-intensive institutions is encouraged by the NIDCR both within and outside the parent university or Academic Health Center. o Creating or renovating research facilities (if indicated), using non- NIDCR dollars (for example, grants from the National Center for Research Resources (NCRR) of the NIH). b) Research Capacity and Personnel: o Creating a critical mass of researchers (clinical, basic, translational, behavioral, or some combination) in the selected area(s) of research, as appropriate. This can be done by identifying "magnet investigators" (either senior scientists currently at the university or established researchers at other institutions who will be recruited). A "magnet investigator" (1) must be recognized in her/his scientific field, (2) has been the principal investigator on at least three major NIH research or center grants, such as the R01, U01, P01, P50, or P60 awards (previous or current), (3) has extensive mentoring experience, (4) has received significant awards and honors from major research organizations, and (5) has published extensively in leading peer reviewed journals in a relevant scientific field. Indicate approximate number of these individuals to be recruited and specific type of expertise each individual will possess; how the individual(s) will be integrated into the institution; how she/he fulfills or will help to achieve the objectives of the grant; support that will be provided in terms of salary and benefits, supplies, equipment, space, technical staff, etc; time to be made available for mentoring junior and mid- level scientists; and approach to recruit individuals not presently at the institution. "Magnet investigators" should be able to attract postgraduate trainees, junior investigators and outstanding scientists to the institution. A second way of creating a critical mass of researchers in the area(s) of research described in Part 1 of this application is by recruiting, integrating, mentoring and supporting relatively junior scientists (e.g., through creation of tenure-track or equivalent positions). Junior scientists should be provided with at least two years of support (supplies, equipment, lab space, etc.) to enable them to start their research career. o Developing research training and career development programs for existing faculty, students and junior scientists. (c) Evaluation: o Performing ongoing evaluations and preparing interim reports. These can be in response to periodic assessments by NIDCR staff as well as by the IAC and ESPAC that are based on outcome measures developed and specified in the application, and through recommendations (resulting from semi-annual meetings) by the ESPAC. o Preparing a final report after completion of the U24 grant. The report will detail exactly what was done during the years of support and how the institution plans to continue its efforts after the award is completed Part 3 - Implementation of the Infrastructure Enhancement Plan: This consists of very detailed methods, outcome evaluation and costs of implementing each component of the Infrastructure Enhancement Plan described in Part 2. It is essential to include a time-line specifying the processes, steps and benchmarks for implementing the IEP. This is a particularly important part of the application. Parts 1, 2 and 3 should not exceed 35 pages in length. Any additional documents (e.g., strategic plan), reports (e.g., accreditation visits), manuals, etc., can be included in appendices. Part 4 Letters of Commitment and Support: The U24 application MUST include two sets of letters. The first consists of "Letters of Commitment" from the senior leadership of the parent institution (e.g., University President and/or Chancellor, Health Science Center President). The letters should detail the specific resources that the institution is willing to provide. For example, the institution may contribute complementary funds, resources in terms of release time for the PI; support for clerical and administrative personnel, travel, consultants and meetings; office and laboratory space; discretionary resources that will be made available to the Principal Investigator, guarantees of protected time for faculty and students to perform the research and training activities and other administrative responsibilities for the Principal Investigator and other key staff; and support to assist in the recruitment and performance of "magnet investigators." The letters must specifically indicate how the investigators and facilities will be supported after the U24 award period ends, such as through partnering and leveraging. The second set of letters consists of "Letters of Support" from any partner institutions with which the applicant has established linkages or collaborations. Since the objectives, methods, and contents of this application differ significantly from that which most applicants are familiar, specific instructions as to how the PHS 398 application should be prepared are available on the NIDCR web site at www.nidcr.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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/01) 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. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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) At the time of submission, two additional copies and all appendix material of the application must also be sent to: Dr. H. George Hausch Acting Director Division of Extramural Activities National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44F Bethesda, MD 20892-6402 APPLICATION PROCESS: Applications must be received on or before April 14, 2004. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to the RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS 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 Division of Extramural Activities (DEA) at NIDCR in accordance with the review criteria stated below. As part of the merit review, all applications will o Receive a written critique o Undergo a process in which those applications deemed to have scientific and technical merit will be discussed and assigned a priority score. o Receive a second level review by the NIDCR National Advisory Council. REVIEW CRITERIA For this RFA, the review criteria are not organized under the traditional headings of Significance, Approach, Environment, Investigator and Innovation typically used for NIH research grants. Reviewers will have to use considerable flexibility in determining the merit of a broad range of possibilities that can strengthen the research capabilities of dental schools, expand training and career development opportunities for faculty and students, and increase the effectiveness of dental schools in establishing partnerships or collaborations with other institutions. A well-prepared application should reflect a close, effective interaction between the Principal Investigator, the School's leadership and the faculty. Specific criteria for Part 1: o Assessment of Critical Research Needs: Appropriateness and adequacy of the process and methods used to assess institutional research needs, opportunities and the capacity to conduct biomedical, behavioral or clinical research on oral, dental and craniofacial health. o Area(s) of Research Enhancement: The rationale for selection of a particular area(s) of research for enhancement. If several areas have been identified, they can be complementary but no overlap should exist. Specific criteria for Part 2: o Adequacy and detail of the description of current research infrastructure to address specified areas of science: This should include appropriateness and adequacy of the description of all research activities, equipment, research space, etc., that currently exist in the dental school as well as in the academic health center, including school of public health or institutions at additional sites deemed by the applicant institution to fall within a feasible distance for frequent interactions and research collaborations. o Extent to which the plan builds on current institutional support for conducting research and significantly augments and improves the support of research: This includes adequacy of approach for acquiring state of the art research supplies and equipment; and feasibility of approach to establishing intra- and inter-institutional links to enhance the research program, including the development of shared research cores with collaborating institutions. o Specific details of plan for creating a critical mass of scientists in the selected area(s) of research: This should address (a) recruiting, integrating, mentoring and supporting relatively junior scientists and identifying internal scientists or procedures for recruiting and supporting established external "magnet" investigators who can attract postgraduate trainees and other outstanding scientists to the institution; (b) adequacy of plans for providing research training to existing institutional faculty; (c) extent to which the plan enhances institutional capacity and individual faculty research development plans and the degree to which the components enhance one another in achieving the overall objectives. o Likelihood that research projects in the designated research area(s) will emerge from this effort and that such projects will be of sufficient scientific merit to be successful in securing competitive NIH research project grant support. o Internal Advisory Committee: The appropriateness and adequacy of the specific faculty and scientists identified for the Internal Advisory Committee and their ability to contribute effectively to each aspect of this planning effort. o External Scientific and Program Advisory Committee: The adequacy of the qualifications and experience of each proposed member of the External Scientific and Program Advisory Committee to evaluate and monitor the progress of the program in achieving its priorities and objectives, to recommend midcourse changes in approaches and tactics, and to help evaluate the program and take advantage of new opportunities. o Quality and appropriateness of the organizational and administrative structure proposed: This includes likelihood to support meeting the goals of this solicitation; appropriateness of the collaborators and partners identified for achieving the goals/ objectives outlined in the RFA. o Evaluation: Adequacy of plans for performing ongoing evaluations and preparing a final report after completion of the U24 grant. Specific criteria for Part 3: o Qualifications of project personnel, especially the experience and time commitment of the Principal Investigator. o Supplies and Equipment: Justification of the proposed implementation of the IEP regarding supplies, equipment, lab space and linkages with research partners. Of special importance is the rationale for requested equipment. o Adequacy, feasibility and details of the proposed implementation approach for research investigators: recruitment and support of junior scientists; identification, recruitment and support of "magnet investigators" that are committed to the proposed research goals; and provision of research training to current institutional faculty. Assessment will be made of the qualifications of all individuals proposed for "magnet investigators" as well as any other scientists identified as potential mentors. o Adequacy of evaluation plans, especially delineation of specific outcome measures, potential benchmarks, procedures to prepare interim reports and their frequency, and approach to developing a final report. o Timeline: Inclusion of a timeline for implementation activities and the feasibility that the institution will accomplish its proposed goals according to the timeline. o Long-Term Stability and Potential Success: Extent to which the implementation will provide long-term stability to the scientific research activities of the dental institution. Expectations that dental school research staff will be successful in obtaining additional research project grants within a reasonable amount of time after the IEP has been implemented. o Appropriateness of all proposed costs. Specific criteria for Part 4: o Inclusion of "Letter(s) of Commitment" from the senior leadership of the parent institution that detail the resources the institution is willing to provide. The letters must specifically indicate how the investigators and facilities will be supported after the U24 award period ends, such as through partnering and leveraging. o Assurances of both direct and "in-kind" support and, specifically, the adequacy of the resources (e.g., discretionary resources, space, faculty positions, protected time for research, funds, etc.) that the dental school, parent institution/university and the institutions identified as collaborators or partners will provide to promote the successful achievement of the priorities and objectives of this program. These will be provided through "Letters of Support" from potential collaborating institutions. o The level of authority of institutional officials (e.g., university President and/or Chancellor or health science center President) and collaborators or partners committing to this effort that gives confidence that commitments will be stable and continue after grant support has ended. o The degree to which the letters of commitment and support address and fully support the priorities and objectives of the implementation plan. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 14, 2004 Application Receipt Date: April 14, 2004 Peer Review Date: May 2004 Council Review: August 2004 (special Council) Earliest Anticipated Start Date: September 2004 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 REQUIRED FEDERAL CITATIONS 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 a 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA 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 (NIDCR) Oral Diseases and Disorders Research Awards and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the 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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