SUPPLEMENTS TO SUPPORT NIDCR DNA MICROARRAY FACILITIES Release Date: March 27, 2000 RFA: DE-00-003 National Institute of Dental and Craniofacial Research http://www.nidcr.nih.gov/ Letter of Intent Receipt Date: April 15, 2000 Application Receipt Date: May 15, 2000 THIS RFA 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 RFA. PURPOSE The National Institute of Dental and Craniofacial Research (NIDCR) announces the availability of competitive supplements to assist institutions with establishing DNA microarray facilities. The DNA microarray facilities must be designed to support research relevant to the NIDCR. The DNA microarray facility must be located at a site receiving an NIDCR grant and serve as a resource for a minimum of five NIDCR-funded research projects. For the purpose of this initiative, each project within a multi-project grant can be considered as a qualifying research project. Requests for DNA microarray facilities to support Candida species research are ineligible for this announcement and should respond to RFA DE-00-004, SUPPLEMENTS TO SUPPORT CANDIDA DNA MICROARRAY FACILITIES. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), SUPPLEMENTS TO SUPPORT NIDCR DNA MICROARRAY FACILITIES, is related to the focus area, Oral Health. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Institutions having a NIDCR-funded research project (R01), MERIT award (R37), program project (P01), Center Core (P30), Comprehensive Center (P60), and having at least two years remaining on the grant, are eligible to receive a supplement for a DNA microarray facility. The collaborating sites that would use the array facility must also have an NIDCR-funded grant, and have at least two years remaining on the grant. Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) competitive supplement award to a peer-reviewed, funded project. 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 RFA may not exceed two years. This RFA is a one-time solicitation. The earliest possible award date is December 1, 2000. FUNDS AVAILABLE The NIDCR intends to commit approximately $1.5 million in FY 2001 to fund six (6) DNA microarray facilities in response to this RFA. Applicants may request up to two years of support; the requested budget may not exceed $250,000 total costs in year 1 and $100,000 total costs in year 2. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background This competitive supplement program is issued in response to recommendations developed at several recent NIDCR Workshops and the NIDCR Advisory Council. The workshop participants and Council members expressed a growing need in the research community for access to high quality and affordable microarray technology. The need for such technology is also based in part on the soon-to-be-completed sequences of several NIDCR-supported microbial genomes (http://www-sequence.stanford.edu/group/candida/) as well as the human and mouse genomes. Scope The DNA microarray facilities must be designed to support research relevant to the mission of the NIDCR. The DNA microarray facility must be located at a site receiving an NIDCR grant. A minimum of five NIDCR-funded research projects must be served by the activities of the array facility. For the purpose of this initiative, each distinct project within a multi-project grant (e.g., Program Project or Center) can be considered as a qualifying research project. Requests for supplements are limited to one per institution. Requests must be limited to the purchase of equipment, supplies, and technical personnel critical to the DNA microarray facility. There is no restriction to the type of array technology that the applicants may select. Appropriate use of the support includes, but is not limited to, purchase of DNA arrayers and readers, as well as robotic equipment for automation; and, with strong justification, computers and software for informatics. Since these supplements are intended to assist institutions, it is expected that the applicant institutions will also provide support for personnel, equipment, and supplies associated with the establishment and operation of the facility. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women, 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 is provided 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: https://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDCR staff to estimate the potential review workload and avoid conflict of interest in the review process. The letter of intent receipt date is listed in the heading of this RFA and is to be sent to the program staff listed under INQUIRIES. APPLICATION PROCEDURES Requests must meet the criteria required for all supplements: the project period of the grant to be supplemented must have at least two years remaining at the time of award. The other participating sites must have a NIDCR-funded projects with at least two years remaining at the time of award. Applicants may request up to two years of support; the requested budget may not exceed $250,000 total costs in year 1 and $100,000 total costs in year 2. The applicant should provide the following: 1. A description of five or more NIDCR-funded research projects that will benefit from the presence of a microarray facility, including how the array technology will enhance ongoing research projects. A signed letter of collaboration from each participating site should be submitted with the application. Collaborations with less research intense institutions is encouraged. 2. A detailed description of the administration and management of the DNA microarray facility. Important consideration should be given to setting priorities for the facility workload, cost-sharing considerations, and ensuring broad access by five or more NIDCR-funded projects listed in Item 1. 3. Documentation of strong institutional commitment to support the microarray facility, including continued support for the facility and the technology after the time period of the supplement. Applicants must document the resources and environment available at the institution to effectively operate the facility, including support for personnel, equipment, supplies, and availability of laboratory space. 4. Under the standard Modular Grant Application instructions, only a justification for key personnel has been required. However, due to the nature of this RFA, a narrative justification should be provided for all personnel, equipment or supplies. A detailed budget for these requests, however, is not needed. The application should be developed using the PHS Form 398 (revised 4/98) Face Page, Biosketch of the Principal Investigator, and Resources Form Page 8. The Research Plan should address points 1 through 4 above and must not exceed FIVE pages. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form, PHS 398 (revised 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications must request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. In this RFA, the modular grant application format has been applied to additional grant activities (R37, P01, P30, and P60) that are not part of the standard NIH model. The modular budget request must be in accordance with the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. For this RFA, Total Costs may not exceed $250,000 in year 1 and $100,000 in year 2. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include a Letter of Intent to establish a consortium. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 title and number of this RFA must be typed in Item 2 on the face page of the application form, and the YES box must be marked. The RFA number must be typed on the label as well. The sample RFA label available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in the pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three (3) signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH SUITE 1040 6701 ROCKLEDGE DRIVE, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two (2) additional copies of the application must be sent to: Dr. H. George Hausch Scientific Review Branch Division of Extramural Research National Institute for Dental and Craniofacial Research 45 Center Drive, Room 4AN-38D- MSC 6402 Bethesda, MD 20892-6402 Applications must be received by the application receipt date listed in the heading of this RFA. 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 this 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness by the CSR and NIDCR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCR in accordance with the review criteria stated below. A process will be used by the initial review group in which all applications receive a written critique but only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups and children, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of study subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. SCHEDULE: Letter of Intent Receipt Date: April 15, 2000 Application Receipt Date: May 15, 2000 Peer Review Date: July 2000 Council Review: September 2000 Earliest Possible Start Date: December 1, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: o-scientific merit (as determined by peer review) o-availability of funds o-programmatic priorities INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issue or questions from potential applicant is welcome. Direct inquiries regarding programmatic issues to: (For microbial pathogens) Dennis Mangan, Ph.D. Infectious Diseases Branch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-32F Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301) 480-8318 Email: Dennis.Mangan@nih.gov (For craniofacial genetics) Judy Small, Ph.D. Craniofacial Anomalies and Injuries Branch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-24J Bethesda, MD 20892-6402 Telephone: (301) 594-2425 FAX: (301) 480-8318 Email: Judy.Small@nih.gov (For head and neck cancer) Ann L. Sandberg, Ph.D. Neoplastic Diseases Branch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-24A Bethesda, MD 20892-6402 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: Ann.Sandberg@nih.gov (For bone and neurobiology) Kenneth A. Gruber, Ph.D. Chief, Chronic Diseases Branch National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-18C Bethesda, MD 20892-6402 Telephone: (301) 594-4836 FAX: (301) 480-8318 Email: Kenneth.Gruber@nih.gov Direct fiscal inquiries to: Martin Rubinstein Grants Management Branch National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-44 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 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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