COMPARATIVE GENETICS OF STRUCTURAL BIRTH DEFECTS RELEASE DATE: August 7, 2003 RFA Number: RFA-HD-03-024 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865 (NICHD), 93.121 (NIDCR) LETTER OF INTENT RECEIPT DATE: October 20, 2003 APPLICATION RECEIPT DATE: November 19, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent 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 genomic sequences for a number of invertebrates and vertebrates, including man, are completed or nearing completion. For the developmental biology community to maximize its ability to efficiently and effectively use this publicly available data, systematic research in the areas of functional and comparative genomics needs to be stimulated. A key component of functional and comparative studies must be examinations of a given genetic pathway in more than one animal model. These comparisons, under controlled conditions, will allow us to elucidate which genes, gene products, genetic networks, and molecular cascades are conserved and which are of critical importance in normal and abnormal development. The purpose of this RFA is to solicit applications or competitive supplements for individual research projects that will examine a family of genes or gene products, known to be important in development, in two or more animal models. These approaches will help us to understand which genes, gene products and modifications are of general importance in increasing our understanding of normal and abnormal development, as well as allow us to catalog such differences and similarities. These studies will enable us to better understand the faithfulness with which developmental processes are conserved across species. RESEARCH OBJECTIVES Background Animal models have long provided fertile ground for research into the causes of structural birth defects. Studies supported by the NICHD and NIDCR on human as well as on mammalian models such as mouse and rat, and nonmammalian models, such as chick, zebrafish, frog, fly, and worm, have made major inroads into increasing our knowledge of normal and abnormal development. While the arena of developmental biology is rapidly advancing, and collaborative, translational efforts are increasing, there still is a lack of cross-fertilization between scientists who are trained in and continue to use a single animal model system. This is mirrored in the physical disconnect that is seen in animal model-specific databases, which may not be user- friendly to scientists outside that community. The field of comparative genomics examines a given family of genes and/or gene products in several organisms to identify commonalities and differences. In general, comparisons between different animals are drawn from studies that were performed by different groups of investigators in different settings and experimental conditions. From these kinds of studies, we have instances where 1) a gene is expressed in similar spatial and temporal patterns in two animal models, 2) a highly conserved region shows divergent gene expression patterns either temporally, spatially or both in two animal models, or 3) a gene shown to be important in one model has no ortholog in another model. For developmental biology to continue advancing, we need researchers with the appreciation for and understanding of a number of animal models. We need to be able to determine which of the genes, gene products, and developmental cascades are important to pursue. By taking advantage of comparative genomics approaches, we will have the framework to analyze and prioritize in a meaningful way, the vast amount of information generated by the sequencing efforts. With the upcoming completion of the sequencing of a number of genomes, the need for scientists with the ability to take advantage of comparative genomics has become more urgent. Research Objectives and Scope The objective of this RFA is to broaden the range, power, and utility of the recently acquired genomic sequences for human, mouse, zebrafish, fly, and worm, as well as any other genomes, such as Xenopus tropicalis, that will be available by the start date of this initiative. The goal of this RFA is to develop projects comparing genes, gene products, or pathways, that are known to be important and well understood in one animal to another, less- characterized model in order to determine if general developmental principles apply across species. We expect that this solicitation will encourage researchers from different animal model communities to collaborate and to collectively explore those genes, proteins, networks, and modifications that have universal importance. Objectives to be addressed in applications submitted in response to this RFA include, but are not limited to: o Proposals to examine, in different animal models, genes or gene products that have been shown to be altered in a human structural birth defect. These may include, but are not limited to: neural tube defects, craniofacial anomalies, limb and skeletal defects, and genitourinary abnormalities. o Proposals to compare pathways that are well understood in one model to the same pathways in another model organism that has not been thoroughly defined to determine if the same developmental principles apply. o Proposals to determine whether genomic sequence is a good indicator of conserved function across animal models. o Proposals to determine the extent of consistency of temporal and spatial expression patterns across species. Examples of projects that would be responsive to this RFA include, but are not limited to: o An investigator or group of investigators requests support to examine the function and/or expression of specific genes in more than one model system (R01). o An expert in one model organism examines the function/expression of specific genes in that system and includes a subproject in which the same genes are examined in a related animal model system by experts in that system (R01). o An investigator who is funded to examine the function/expression of specific genes in one model system requests support to examine the same genes in another system (supplement to existing R01). o An investigator requests support to determine whether a gene known to be important in one model is present in another model (supplement to existing R01 or R21). MECHANISM OF SUPPORT This RFA will use the NIH Research Project Grant (R01) and Exploratory/Developmental Grant (R21) award mechanisms. In addition to applications for new R01s, applications for competitive supplements to existing R01s (with at least two years of funding remaining at the time of award) supported by the NICHD or the NIDCR will be accepted. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 01, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. Information about the Exploratory/Developmental Grant (R21) mechanism can be found at https://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. This RFA uses just-in-time concepts. It also uses the modular budgeting format (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The participating ICs intend to commit approximately $2.5 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2004 to support five to eight new and/or competing continuation grants in response to this RFA. An applicant for an R01 may request a project period of up to five years and a budget for direct costs of up to $250,000 per year. An applicant for an R21 may request a project period of up to two years with a combined budget for direct costs of up to $275,000 for the two-year period. An applicant for a supplement to an existing R01 may request a project period equal to the number of years remaining on the parent grant at the time the supplement would be awarded, and a budget for direct costs of up to $125,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs 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 meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage 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: o Direct your questions about scientific/research issues to: Deborah B. Henken, Ph.D. Developmental Biology, Genetics, and Teratology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 480-0303 Email: henkend@mail.nih.gov Rochelle K. Small, Ph.D. Developmental Biology and Mammalian Genetics Program National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-18D, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-9898 FAX: (301) 480-8318 Email: rochelle.small@nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: kh246t@nih.gov Mary Daley Chief, Grants Management Officer National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN44B, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4808 FAX: (301) 480-3562 Email: md74u@nih.gov 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 the ICs 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: Deborah B. Henken, Ph.D. Developmental Biology, Genetics, and Teratology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 480-0303 Email: henkend@mail.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 https://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. SUPPLEMENTAL INSTRUCTIONS: SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://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 https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 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 be marked. The RFA label is also available at: https://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 of the application must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the ICs. Incomplete 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 ICs in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board. 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: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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: 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? 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: 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 20, 2003 Application Receipt Date: November 19, 2003 Peer Review Date: February/March 2004 Council Review: June 2004 Earliest Anticipated Start Date: July 01, 2004 AWARD CRITERIA 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 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 https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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 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 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 https://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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