MURINE ATLAS OF GENITOURINARY DEVELOPMENT RELEASE DATE: December 22, 2003 PA NUMBER: PAR-04-042 January 27, 2011 - This PAR has been reissued as (RFA-DK-11-001). EXPIRATION DATE: March 18, 2004 unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.849, 93.865 LETTER OF INTENT RECEIPT DATE: February 18, 2004 APPLICATION RECEIPT DATE: March 18, 2004 THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of this PAR 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 Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS PAR The genitourinary tract (GU) is the organ system most commonly affected by congenital birth defects, and many reports suggest that some of these birth defects (i.e. hypospadias and cryptorchidism) are increasing. Many signaling cascades key to normal embryonic development also play key regulatory roles in adult diseases. In addition, developmental factors are likely to be important in regenerative processes. Thus, investigations defining normal embryonic development have significant clinical relevance, given the significant health impact of congenital and acquired diseases of the genitourinary organs. Currently, genitourinary developmental research is limited by a paucity of cell specific markers for key lineages within the developing GU tract, incomplete understanding of the normal three dimensional cellular structure of the major organs of the GU tract (kidney, ureter, bladder, urethra, prostate, testis, epididymis, vas, penis, ovary, uterus, and vagina), incomplete understanding of the morphogenetic events that occur during organogenesis, and the lack of a detailed integrative database to assimilate complex temporal and spatial expression data. To address these issues, the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) and the National Institute of Child Health and Human Development (NICHD) invite Cooperative Agreement Applications through this PAR and a companion Request for Applications (RFA DK-04-006) for projects that will contribute to an anatomical and gene expression atlas of the developing murine GU tract (Murine Atlas of GU Development, MAGUD). The specific goals of the MAGUD Projects will be: 1) to develop a low resolution gene expression atlas of all genes expressed within the developing murine GU tract, 2) to perform high resolution anatomic gene expression studies using available or newly generated molecular tools, and 3) to produce an integrated, continuously updated database that will provide the entire research community with access to the data as it is generated. This PAR invites applications for the first two of these goals; applications for the database are invited through the companion RFA. The components of the atlas project will work together as a consortium. It is expected that the consortium will serve as a resource to provide reagents and data to the research community. RESEARCH OBJECTIVES Background: In September, 2001, NIDDK convened a working group of its National Advisory Council to develop strategic plans for several cross- cutting areas of research, including Stem Cells and Developmental Biology. The working group made several recommendations, with the overall goals of providing new strategies for repairing or replacing damaged organs and generating new insights into pathologic processes underlying developmental defects and disease. Similar goals were also voiced by the Bladder Research Progress Review Group, convened by NIDDK in 2002, which emphasized the need for a more thorough understanding of organogenesis so that tissue degeneration, neural dysfunction, and congenital malformations might be prevented and treated. A fundamental contribution to these overall goals is a solid understanding of how organs develop in the embryo. It is from such an understanding that experimentally manipulated development or regeneration can be evaluated. If cell therapies are to be developed to replace or repair damaged tissue, we must know the catalog of cell types for each organ, the genes that mark these cells as well as those that are required for their function, the regulatory factors that induce or maintain the various cell types, and the developmental and anatomic relationships of each cell type to its neighbor. For certain tissues, for example the hematopoietic lineages, a substantial literature exists which provides this fundamental knowledge. However, for the kidney and the genitourinary (GU) tract, markers are lacking for several physiologically or anatomically defined cell types, the developmental processes that establish functional domains is not described, and the genesis of organ anatomy at the molecular/cellular level is not understood. This lack of fundamental description of these organs is a major obstacle to the pursuit of stem cell research and the design of novel therapies: without knowledge of the cell types within an organ, it is impossible to determine whether putative therapies are effective at regenerating them or restoring their functionality. For these reasons, the NIDDK asked a panel of advisors in January, 2003, to articulate the needs for fundamental description of the developing kidney and GU tract. The panel recommended that the following three objectives be combined to form a Murine Atlas of Genitourinary Development (MAGUD): o High throughput in situ hybridization analyses to define the expression pattern of genes expressed in the developing kidney and GU tract o High resolution gene expression analyses to define gene expression during developmental time, the overlap in gene expression patterns, and the correlation between boundaries of gene expression and boundaries of anatomic or functional domains o Development of a database to house and annotate the above data and to provide rapid access of this data to the entire research community SPECIFIC OBJECTIVES: This PAR requests applications for the first two of these objectives. The relevant tissues for this initiative are the developing murine kidney, ureter, bladder, urethra, prostate, testis, epididymis, vas, penis, ovary, uterus, and vagina. The general goal of the MAGUD projects will vary, depending on which of the above objectives they are designed to address. Examples of the types of projects that may be supported include, but are not limited to: 1) Large scale spatial analysis of gene/protein expression via whole mount in situ hybridization or other in situ approaches or via libraries of antibodies. It is expected that this type of approach will provide near- genome-wide analysis of gene expression in the relevant organs at a single time during development, expanding to a second time point if possible. 2) Low resolution analysis of gene expression through developmental time, using high throughput strategies but focusing on a restricted set of genes. This approach may be suited to study the expression of a given class of gene products, e.g., transmembrane proteins. This type of approach may be especially suited for the urologic organs, for which studies examining gene expression at multiple developmental stages are particularly lacking. 3) High resolution, three dimensional analysis of a set of genes or gene products using, for example, tagged gene constructs, antibodies, or section in situ hybridization. Various types of imaging may be useful, including confocal microscopy, optical tomography, micro-MRI, or light microscopy. The goal is to produce three dimensional representations of gene expression patterns and relate them to functional, anatomical, or molecular hallmarks. 4) Analysis of gene expression and morphogenesis in real time using organ explants labeled with GFP or similar tags for gene constructs. Labeled tissues may be generated via knock-ins, transgenic, or other methods. It is expected that tools may need to be developed to allow these studies to be conducted. This PAR will support the development of these tools, with the understanding that they will be rapidly shared with the general public. It is also expected that these studies will be very effective at generating hypotheses. For example, discovery of sequential activation of gene expression in identical patterns might suggest a regulatory relationship between the first and subsequent genes. Hypothesis generation is a goal of the initiative. However, experiments to test these hypotheses are suitable for R01 applications and fall beyond the scope of the current initiative. Likewise, projects designed to test hypotheses based on previously generated data are unsuitable for this PAR. MECHANISM(S) OF SUPPORT This PAR will use the NIH U01 award mechanism. This PAR is a one-time solicitation. The expected receipt date is March 18, 2004. It is anticipated that the award size of grants funded through this PAR will vary depending on the complexity of the project. Projects that are focused on the description of a few genes in a given organ compartment may require a budget typical of an R01 (<$250,000 direct costs), while projects that have a broader scope both in terms of numbers of genes to be examined and organs to be included in the analysis will require a larger budget (up to approximately $600,000 direct costs). Applicants requesting more than $500,000 in direct costs for any one year must receive prior approval from NIH (see SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR, below). This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (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 budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award.” Plans for continuation of the cooperative agreements beyond the initial five year period are indefinite. 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 Domestic or foreign institutions/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. SPECIAL REQUIREMENTS Consortium Steering Committee: Applicants must indicate their willingness to be part of a MAGUD consortium consisting of representatives from projects funded through this PAR, RFA DK-04-006 (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-04-006.html) and NIH staff. Applicants must be willing to participate in the steering committee for this consortium, which will meet semi-annually and may meet additionally in subcommittees or through telephone conference calls. A major goal of these meetings will be to facilitate progress by establishing communication between the participating labs so that skills, ideas, technology, data, and reagents are exchanged. The participants at the meeting will work together to establish database vocabularies and annotation criteria and to provide feedback regarding ease of use and database utility. Participants will discuss progress toward each project, quality assurance, coordination of projects, data and reagent sharing, and means of informing the research community of progress. This consortium is expected to serve as a genuine resource to the community, so the investigators must be willing to think of themselves as resource-generating. Throughout the funding period, input will be sought from experts within the MAGUD consortium, other NIDDK- or NICHD-sponsored initiatives, and from the broader research community. During the course of the funding period, technologies will improve, and the rate of progress and focus of work supported by the cooperative agreement may change. It is expected that the Principal Investigator(s), in consultation with NIH program staff, the Steering Committee, and the External Advisory Board (see below) will make any necessary adjustments to accommodate the changing research environment, to remain focused on appropriate goals, to maintain excellent coordination with the other projects, and to incorporate new technological advances. Data and Reagent Sharing: All applications to the NIH requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. In addition, this PAR and its companion RFA have special requirements for sharing. All applications submitted through these announcements must include sharing plans for both data and unique research resources that are generated by the projects. Applicants must indicate their willingness to distribute research tools to the wider community, including probe sets, antibody libraries, transgenic or knock-in mouse strains, cell lines, and other reagents. Likewise the applicants must describe their willingness to submit data generated through this project to the MAGUD database. It is expected that data will be released to the database as soon as they are validated. This PAR and its companion RFA have two additional requirements regarding research resources produced in proposed projects: (1) Applicants are required to include in their application a specific plan by which they will share research resources with the wider scientific community, as well as copies of all Material Transfer Agreements used by all institutions involved in the application. (2) Applicants are required to include a plan addressing if, or how, they will exercise their intellectual property rights while making available to the broader scientific community patentable research resources. These plans must be consistent with the policies of their institutional offices of technology transfer. The scientific review group will evaluate the adequacy of the proposed plans for sharing and data access. Comments on the plan and any concerns will be presented in an administrative note in the Summary Statement. The adequacy of the plan will be considered by NIH program staff and will be important in determining whether the grant application will be awarded. The sharing plan as approved, after negotiation with the applicant when necessary, will be a condition of the award. Evaluation of non-competing continuation applications will include assessment of the effectiveness of research resource release. TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) and to the institutional official at the time of award. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines; HHS Grant Administration Regulations at 45 CFR Parts 74 and 92; and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U01), an "assistance", rather than an "acquisition", mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement 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 awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIDDK Project Scientist. 1. Awardee Rights and Responsibilities o The PI will have primary authority and responsibility to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award. o The PI will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported by the project in accordance with the terms and conditions of the award. o The PI will serve as a voting member of the Steering Committee, will attend the Planning Meeting and a Steering Committee meeting in the first year, and two Steering Committee meetings a year in subsequent years. o The awardee will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and subcommittees. o The PI will be responsible for close coordination and cooperation with the other MAGUD projects and with NIH staff. o Awardees will retain custody of, and have primary rights to, the data developed under these awards, subject to Government rights of access consistent with current HHS and NIH policies. However, all awardees must adhere to PHS policy for the distribution of unique research resources produced with PHS funding as described under Special Requirements. The NIH Project Scientists, on behalf of the NIDDK and the NICHD, will have the same access, privileges and responsibilities regarding the collaborative data as the other members of the Steering Committee. o NIH reserves the right to require the transfer of appropriate cell lines, reagents, tools and pertinent data that are generated as the result of participation in research supported under these awards to an eligible third party, in order to preserve these materials and data about them and/or to continue the research. Third parties supported under these awards must be informed of this right. o Within the first three months of the award period, the PI will be responsible for establishing written milestones for the project, in negotiation with NIH Project Staff. o Support or other involvement of industry or any other third party in any study performed by the project -- e.g., participation by the third party; involvement of project resources or citing the name of the project or the NIH support; or special access to project results, data, findings or resources -- may be advantageous and appropriate. However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification to, and concurrence by, NIH. o Upon completion of the MAGUD projects, the PIs are expected to put all study design materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NIH, for the conduct of research at no charge other than the costs of reproduction and distribution. 2. NIH Staff Responsibilities The NIH Project Scientists will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The dominant role and prime responsibility for the project as a whole resides with the awardees, although specific tasks and activities in carrying out the studies will be shared by awardees and the NIH. o NIDDK will designate a Project Officer and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. o NIDDK will form an External Advisory Committee, comprised of NIDDK and NICHD Project Staff and other NIH extramural staff with relevant scientific expertise or who manage research grant programs that relate scientifically to the goals of the MAGUD projects, and outside advisors picked by the NIDDK and the NICHD. The External Advisory Committee will meet regularly to review the progress of the atlas projects and to advise NIH Project Staff of scientific developments and opportunities that may enhance the achievement of the MAGUD goals. o The NIDDK and NICHD Project Scientists will be members of the Steering Committee and, as determined by that committee, its subcommittees. o The NIDDK and NICHD Project Scientists will coordinate and facilitate the MAGUD projects, attend and participate as voting members in all meetings of the Steering Committee, and provide liaison between the Steering Committee and the External Advisory Committee. o The NIDDK and NICHD Project Scientists will help the Steering Committee develop and draft operating policies. o The NIDDK and NICHD Project Scientists will review the scientific progress of the individual MAGUD projects, review projects for compliance with operating policies developed by the Steering Committee, and may recommend to the NIDDK and/or NICHD to withhold support, suspend, or terminate an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee. 3. Collaborative Responsibilities Steering Committee - The NIH Project Scientists and PIs of the atlas projects funded under this PAR and RFA DK-04-006 will be responsible for forming a Steering Committee as defined below. An arbitration system, as detailed below, will be available to resolve disagreements among members of the Steering Committee. The Steering Committee will be the main governing board of the MAGUD projects. It will develop collaborative protocols, identify technological impediments to success and strategies to overcome them, develop shared software tools for disseminating information about the projects, and identify opportunities for sharing techniques and tools developed within each individual project. o The Steering Committee will be composed of the PI from each atlas project funded through this PAR and RFA DK-04-006, the NIDDK Project Scientist, and the NICHD Project Scientist. The PI from each MAGUD project will have one vote. The NIDDK and NICHD Project Scientists will each have one vote. The Steering Committee will select a chairperson who will be someone other than an NIH staff member. o The Steering Committee may, as it deems necessary, invite additional, non- voting scientific advisors to meetings at which research priorities and opportunities are discussed. The NIDDK reserves the right to augment the scientific or consumer expertise of the Steering Committee when necessary. o There will be two Steering Committee meetings annually, both in the Washington, DC, area at times agreed upon by the Steering Committee and the NIH. o The first meeting of the PIs from atlas projects funded under this PAR and RFA DK-04-006 will be a Planning Meeting in the Washington, DC, area December 8-10, 2004. At the Planning Meeting, the Steering Committee will be formed and select a chairperson from among the members who represent the awardees. At the Planning Meeting, the Steering Committee may: (a) draft a charter to detail policies and procedures, a process for monitoring compliance with the policies and procedures, and a process for recommending that the NIH Project Administrators act on evidence of non-compliance of any Consortium component with Steering Committee policies; (b) agree upon the terms of the charter; (c) discuss the approaches that were proposed in the project applications and any relevant new information, and set initial priorities for the projects to be pursued and for new technologies to be developed; (d) devise a plan for working with the MAGUD database developers to establish annotation criteria and to provide ongoing input into database design. o At the second and subsequent meetings, the Steering Committee will refine the MAGUD scientific objectives and implementation as necessary, consistent with progress in the individual projects and other laboratories. o The Steering Committee will plan workshops to which non-MAGUD participants will also be invited to (a) enable the atlas projects to explore scientific or technologic innovation that occurs during the course of the project, (b) inform the research community of the progress made toward development of the atlas, and (c) inform the research community of any technological advances related to implementation of a MAGUD project. The NIH Project Scientists, the External Advisory Committee, and other NIH staff will provide the Steering Committee with advice on participants for the workshops and symposia. o The Steering Committee may establish subcommittees as it deems appropriate; the NIH Project Scientists will serve on subcommittees as they deem appropriate. 4. Arbitration Any disagreement that may arise on scientific and programmatic matters within the scope of the cooperative agreement and between award recipients and NIH may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the MAGUD Principal Investigator; a second member selected by NIH; and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PAR 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: Betsy Wilder, Ph.D. Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Rm. 623 Bethesda, MD 20892-5457 Phone: (301)594-7717 FAX: (301) 480-3510 Email: firstname.lastname@example.org Susan Taymans-McClure, Ph.D. Center for Population Research/Reproductive Sciences Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Rm. 8B01 Bethesda, MD 20892-7510 Phone:(301)496-6517 FAX: (301) 496-0962 Email: email@example.com o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Rm. 752 Bethesda, MD 20892-5452 Phone: (301) 594-8897 FAX: (301)480-3505 Email: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: Carolyn Kofa Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Rm. 727 Bethesda, MD 20892-5456 Phone: (301)594-7687 FAX: (301)480-3504 Email: email@example.com Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Room 8A17 Bethesda, MD 20892-7510 Phone:(301)496-5482 FAX: (301) 402-0915 Email: firstname.lastname@example.org 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 PAR 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 IC 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: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. 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. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS The PHS Form 398 should be modified as follows. Response to the requirements described in the “Special Requirements” section should be appended to the “Research Plan” section of PHS Form 398 and will not be included within the 25 page limit for that section. Applicants who have additional funds to support (‘leverage’) the application should indicate the source of funds (institutional, R01, P01, P30, etc.) that permit them to accomplish the project goals. Subcontract budgets should be a separate page, and the subcontract direct and indirect costs should be calculated and listed as consortium/contractual costs, which are considered in the usual place as part of the direct costs of the applicant organization. Additionally subcontracts require a separate detailed budget. APPLICATION RECEIPT DATE: Applications must be received on or before the application receipt date, March 18, 2004 . If an application is received after that date, it will be returned to the applicant without review. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 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, Rm. 1040 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) APPLICATION PROCESSING: Applications must be received by March 18, 2004. 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete and/or nonresponsive applications will not be reviewed. Applications that are complete and responsive to the PAR will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the National Diabetes and Digestive and Kidney Diseases and National Child Health and Human Development Advisory Councils. 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. SIGNIFICANCE: The application should address the problem outlined in the PAR. The application should demonstrate how the study would advance scientific and/or medical knowledge. Do the genes chosen for high resolution analysis mark distinct cell populations? Can the expression of these genes be correlated to anatomic landmarks? Are gene sets chosen for high throughput studies well justified? Will the tools to be generated be generally useful by the community? 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? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: INTERACTIONS: Are there adequate plans for effective interaction and coordination among Consortium components and the NIH? Are the proposed plans to share data and tools adequate? Do the investigators state their willingness to collaborate extensively and share information fully? Are the Material Transfer Agreements straightforward? Do the investigators state their willingness to abide by the priorities and policies agreed upon by the Steering Committee? Have the applicants proposed sound strategies for communication with the Atlas Database PI, the other MAGUD projects, and with the NIH? All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the PAR. Although the technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. Other factors considered to be important for review include demonstrated expertise in relevant technologies; demonstration of appropriate facilities and resources; willingness to share data and reagents freely. Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the cooperative study, and they are expected to address issues identified under “SPECIAL REQUIREMENTS,” ”TERMS AND CONDITIONS OF AWARD” and ”SPECIAL INSTRUCTIONS” sections of the PAR. CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS: Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. http://grants.nih.gov/grants/policy/data_sharing REASONABLENESS OF THE PROPOSED BUDGET AND DURATION APPROPRIATE IN RELATION TO THE PROPOSED RESEARCH: Is the budget reasonable for the scope of work proposed? SCHEDULE Letter of Intent Receipt Date: February 18, 2004 Application Receipt Date: March 18, 2004 Peer Review Date: July, 2004 Council Review: September 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Applications recommended by the NDDK Advisory Council will be considered for award based upon o scientific and technical merit as determined by peer review; o the importance of the proposed gene sets and tissues to be analyzed; o the degree of originality and innovation; o the creativity of the approaches and technologies; o the likelihood for substantial contribution by the applicants to a successful collaborative effort; o the evidence for willingness to work cooperatively; o program balance; and o the availability of funds. REQUIRED FEDERAL CITATIONS SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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. 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. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm 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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