RFA-HD-01-008: DEVELOPING THE POTENTIAL OF XENOPUS TROPICALIS AS A GENETIC MODEL

Department of Health
and Human Services (HHS)

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DEVELOPING THE POTENTIAL OF XENOPUS TROPICALIS AS A GENETIC MODEL Release Date: January 31, 2001 RFA: RFA-HD-01-008 Trans-NIH Xenopus Working Group (http://www.nih.gov/science/models/xenopus) National Institute of Child Health and Human Development, NICHD (http://www.nichd.nih.gov/) National Institute of Neurological Disorders and Stroke, NINDS (http://www.ninds.nih.gov/) National Institute of Environmental Health Sciences, NIEHS (http://www.niehs.nih.gov/) National Institute of General Medical Sciences, NIGMS (http://www.nigms.nih.gov/) National Institute of Mental Health, NIMH (http://www.nimh.nih.gov/) Letter of Intent Receipt Date: May 16, 2001 Application Receipt Date: July 11, 2001 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 This Request for Applications (RFA) solicits research grant applications to examine the feasibility of using Xenopus tropicalis for standard genetic manipulations. The research proposed should optimize the conditions required to perform efficient, large-scale mutagenesis, and should use the optimized parameters to perform small-scale mutagenesis, phenotyping, and gene cloning, identification, and characterization. Mutant animals, protocols, and data produced by these projects should be made available to the scientific community. We anticipate that the mutants, data and procedures developed by the projects funded under this RFA will enable Xenopus tropicalis to play a significant role in identifying and characterizing genes that regulate cellular and developmental processes. Over the past few years, the National Institutes of Health (NIH) has asked a broad representation of the biomedical research community to recommend which non-mammalian models would help to elucidate the bases of human health and disease. The community has repeatedly recommended that Xenopus be a component of the NIH strategy. For example, Xenopus was one of the five models highlighted at the NIH Non-Mammalian Models Meeting in 1999. The NIH responded to the community’s recommendations by establishing the Trans-NIH Xenopus Initiative. Development of the X. tropicalis system has been one of the community’s highest priorities. Accordingly, this RFA is a major component of the NIH Xenopus initiative. The entire initiative is described on the NIH Xenopus Website (http://www.nih.gov/science/models/xenopus). 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) is related to one or more priority areas. Potential applicants may obtain "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS 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) Individual Research Project Grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is April 1, 2002. Specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The participating Institutes intend to commit up to approximately $2.25 million in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2002 to fund up to six new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $250,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award also will vary. Although this program is provided for in the financial plans of the participating Institutes, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background The NIH is interested in helping to develop and support tools and resources to improve the ability of model organisms to elucidate the genetic mechanisms that regulate normal and abnormal biological processes. To accomplish this goal, the NIH has held a series of workshops at which a broad representation of the biomedical research community provided advice and recommendations. The workshops participants recommended which animal models were most likely to provide insights into biological processes, and which tools and resources would improve the ability of those models to make significant contributions to biomedical research. The NIH progress and plans for implementing the community’s recommendations are described on the NIH Model Organism Website (http://www.nih.gov/science/models/). This RFA solicits applications to develop critical research tools and resources for one of the animal models, the amphibian, Xenopus tropicalis. The amphibian has a long and illustrious history as a major model system for elucidating cellular and developmental processes. For the past few decades, Xenopus laevis has been the predominant amphibian used because it possesses many unique advantages. These advantages include the production of large embryos in large numbers, external development, and rapid development. The embryos also recover well from experimental manipulations, and their cells and identified regions can be excised and cultured in a simple salt solution. These advantages have enabled Xenopus to clarify two areas of vertebrate biology: embryonic development and cell biological processes. In the former area, Xenopus has led the way in identifying the mechanisms of early fate decisions, patterning the basic body plan, organogenesis, and signaling pathways in development. Contributions to cell biology and biochemistry include seminal work on chromosome replication, chromatin and nuclear assembly, cell cycle components, cytoskeletal elements, and intercellular and intracellular signaling pathways. In addition, Xenopus is well suited to identify novel expressed genes that regulate developmental processes, and it has been widely utilized to characterize the activities of genes that are broadly expressed across vertebrates. Xenopus advantages and wealth of research findings have been combined with molecular techniques, such as in situ hybridization, antisense oligonucleotides, dominant negative proteins, and expression cloning. These advantages, findings, and techniques make Xenopus laevis an important model for elucidating the cellular and molecular mechanisms that control much of vertebrate biology. Despite Xenopus advantages for cellular and molecular studies, it has not been used for classical genetic studies because the species of the Xenopus genus that has been used by researchers, X. laevis, is pseudotetraploid and has a long generation time (one two years). However, several years ago researchers began examining the related diploid species, X. tropicalis, which has a short generation time (three five months). X. tropicalis maintains the advantages of X. laevis and has performed successfully in preliminary genetic studies. Additionally, it shows a high degree of sequence similarity and functional interchangeability with X. laevis. Thus, procedures, probes, and reagents developed in one species can be used in the other species. However, detailed examinations must be performed to establish that X. tropicalis is amenable to genetic manipulations such as insertional and chemical mutagenesis, and to optimize these procedures. This RFA solicits projects to optimize the procedures to mutagenize and phenotype X. tropicalis, and to create and characterize mutants with interesting phenotypes. The mutants, data, and procedures developed by these projects will enable X. tropicalis to play a significant role in identifying and characterizing genes that regulate cellular and developmental processes. Additionally, verification that X. tropicalis is amenable to genetic manipulations will lead to large-scale mutagenesis and phenotyping projects, to the production of resources for gene mapping, such as PACs, BACs, and radiation hybrid panels, and, ultimately, to sequencing the X. tropicalis genome. These genetic resources will enable X. tropicalis to become an extremely important model for studying developmental and cell biological processes because they will enable researchers to examine the cellular, molecular, and genetic aspects of a process in a single model. Information generated by these studies will be of great benefit to the entire biomedical research community. Scope Projects sought by this RFA should optimize the methodologies required to use X. tropicalis in large-scale screens and should perform preliminary studies using the optimized procedures. Each project should be designed to identify the optimal parameters required to perform mutagenesis and should perform pilot screens using the optimized parameters. The pilot analyses should develop and use breeding and screening strategies to identify and characterize a limited number of mutants. The strategies may include the use of haploids and gynogenic diploids, and projects may include aims to optimize techniques to generate these animals. Interesting mutants should be used to clone, identify, and characterize the mutant genes. Additionally, the project should devise and implement mechanisms to share with the biomedical research community the methodologies, genetic and phenotypic data, and the mutants. Projects may propose to use any methodology to generate mutations. Examples of relevant projects include, but are not limited to, those that perform: Insertional Mutagenesis Optimize the procedures required to perform efficient insertional mutagenesis to achieve a high rate of integration and long-term transgenic viability. Examples of strategies include gene traps, enhancer traps, and insertion of retroviruses. Use the optimized mutagenesis protocols to identify and characterize interesting mutants. Develop breeding and screening strategies to reveal insertions in different types of genes, such as recessive genes, essential genes, maternal effect genes, and genes that are expressed in particular spatial and temporal patterns. Clone, identify, and characterize the mutated genes. Chemical Mutagenesis Identify the most efficient means to perform chemical mutagenesis by optimizing the relevant parameters such as mutagen dose and exposure duration. Perform chemical mutagenesis on a limited scale. Develop breeding and screening strategies to identify dominant and recessive mutations. Devise and perform phenotypic screens to identify mutants with interesting phenotypes, such as those described below. Develop procedures to characterize mutants with interesting phenotypes. Devise and perform assays, such as expression cloning, to clone and identify the mutations. The goal should be to optimize the procedures for mutagenesis and phenotyping, and to perform limited mutagenesis, phenotyping, and gene identification, not to perform saturation mutagenesis. Phenotypes of interest include: o Alterations in embryonic patterning, o Alterations in organogenesis and organ function, o Alterations in limb formation and patterning, o Alterations in the expression pattern of known genes, o Alterations in nervous system development and function, and potential models of neurological disorders, o Alterations in toxicity (due to environmental/industrial chemicals/agents). SPECIAL REQUIREMENTS Four additional areas must be addressed in the application. These are described in the following sections. Research Resources Restricted availability of unique research resources, upon which further studies are dependent, can impede the advancement of research. The sharing of biomaterials, data, and software in a timely manner, on the other hand, has been an essential element in the rapid progress that has been made in the genetic analysis of mammalian genomes. NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published [NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps), Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.nih.gov/od/ott/RTguide_final.htm)]. Biomaterials (e.g., transgenic and mutant animals, preserved sperm and embryos) and other patentable research resources (e.g., mutagenesis protocols, and genetic and phenotypic data for all mutant strains) produced in projects funded by this RFA are expected to be made available and distributed to the broader scientific community. The NIH is interested in ensuring that the research resources developed through this RFA become readily available to the research community for further research, development, and application, in the expectation that this will lead to products and knowledge of benefit to the public. For this reason, NIH is concerned that patents on mutant embryos and sperm, mutagenesis protocols, and genetic and phenotypic data for all mutant strains and other research resources might have a chilling effect on the future development of products and information that may improve the public health. At the same time, NIH recognizes the rights of grantees to elect and retain title to subject inventions developed under Federal funding under the provision of the Bayh-Dole Act. For applications submitted in response to this RFA, there are two special requirements regarding research resources produced in the proposed project: (1) Applicants must include a specific plan by which they will share research resources with the wider scientific community. (2) Applicants must 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 (e.g., transgenic and mutant animals, mutagenesis protocols, and genetic and phenotypic data for all mutant strains). Applicants are encouraged to discuss their proposed plans for addressing these requirements with their institutional offices of technology transfer. Each of the two requirements is discussed in detail below. Plan to Share Research Resources: To address the joint interests of the government in the availability of, and access to, the results of publicly funded research, NIH requires applicants who respond to this RFA to propose detailed plans for sharing the research resources generated through the grant. The resources to be shared include all materials developed in projects funded under the RFA, including, but not limited to, mutant animals, mutagenesis protocols, and genetic and phenotypic data for all mutant strains. For this purpose, it is the opinion of NIH that dissemination of such data and materials via individual laboratories and Internet sites is not sufficient, as it would force interested investigators to search several different data collections to make use of the results of this initiative. It is preferable that data, protocols, technologies, and biomaterials generated with grants funded under this RFA be placed in common, public repositories and databases that are widely accessible by investigators in the scientific community. Your data and biomaterials sharing plan should include each of the following components: (1) A plan to establish and make available a comprehensive database containing detailed results from the phenotypic screens, (2) a plan to make the data available to an appropriate centralized database when one becomes available, (3) a plan to make available the methodologies used to perform the mutagenesis and the phenotypic screens, (4) a plan to make available transgenic and mutant animals (including their embryos, oocytes, and sperm) with a) phenotypes that are not of interest to investigators associated with your project, and b) phenotypes that are of interest to investigators associated with your project, (5) a plan to make the transgenic and mutant animals identified in 4a and 4b available to an appropriate centralized stock center when one becomes available, (6) a distribution timeline. The scientific review group will evaluate the adequacy of the proposed plan 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 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. Intellectual Property Rights: NIH is interested in ensuring that the research resources developed through this RFA become readily available to the research community. With regard to patentable research results, such as methodologies, transgenic and mutant animals identified through genetic and phenotypic screens, embryos, oocytes and sperm for these mutants, and genetic and phenotypic data for all mutant strains, the NIH requires applicants who respond to this RFA to develop a plan addressing if, or how, they will exercise their intellectual property rights while making available to the broader scientific community research resources produced in projects funded under this RFA. This is expected to include an elaboration of the applicant’s anticipated plans to generate, or not generate, patents and/or exclusive or non-exclusive licensing of biomaterials and other patentable subject matter created in projects funded under this RFA. This plan is also expected to include disclosure of any pre- existing agreements involving intellectual property rights, including options to for-profit research sponsors that are associated with biomaterials and data that may be generated. The requirement for this plan is in addition to the requirement for the plan for sharing and disseminating research resources described in the previous section. The scientific review group will evaluate the adequacy of the proposed plan for handling intellectual property rights. Comments on the plan and any concerns will be presented in an administrative note in the summary statement. The adequacy of the proposed plan will be considered by NIH program staff to determine whether the grant shall be awarded. The 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 awardee’s adherence to the proposed plan. Applicants also are reminded that the grantee institution is required to disclose each subject invention to NIH within two months after the inventor discloses it in writing to grantee institutional personnel responsible for patent matters. The awarding Institutes reserve the right to monitor awardee activity in this area to ascertain if patents or patent applications on mutants identified through genetic and phenotypic screens, embryos and sperm for these mutants, genetic and phenotypic screens, mutagenesis protocols, and genetic and phenotypic data for all mutant strains or other patentable subject matter are adversely affecting the goals of this RFA. Principles and guidelines for recipients of NIH research grants on obtaining and disseminating biomedical research resources can be found at http://www.nih.gov/od/ott/RTguide_final.htm. Additional Requirements o During the course of the award period, the Principal Investigators will be required to meet with NIH staff to review and share scientific progress. Other scientists external to and knowledgeable about these studies also may be invited to participate. Application budget requests should include travel funds for the Principal Investigator to attend annual meetings in the metropolitan Washington, D.C. area. Principal Investigators are also encouraged to plan periodic meetings to exchange information with one another. The funding for those meetings should come from other sources. o Propose a strategy to enable your project to interact with the other projects funded under this RFA. This strategy should include procedures to make your results, progress, and plans available to the other projects, and procedures to keep you informed of the results, progress, and plans of the other projects. Examples include web sites, newsletters and other communications. These proposals will form the basis for the development of procedures to ensure that these projects interact. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet 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 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 NIH staff to estimate the potential review workload and plan the review. Send the letter of intent to Dr. Steven Klein, at the address listed under INQUIRIES, below, by May 16, 2001. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, E-mail: Grantsinfo@nih.gov. Application Instructions 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 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) 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, identical to the figures in Items 7a and 7b for this RFA. 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 http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for the project year. This is not a Form Page. o Under Personnel, list ALL 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 F & A), rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all 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 the 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: http://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 budget period. o The applicant should provide the name and telephone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Submission Instructions The RFA label available in the PHS 398 (rev. 4/98) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-01-008. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. 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. Submit a signed, typewritten original of the application, including the Checklist, and five 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) Applications must be received by July 11, 2001. 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 by the CSR and for responsiveness to the RFA by NICHD. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. 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 CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the appropriate National Advisory Councils or Boards. 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: What is the expected impact of the proposed mutagenesis, breeding and screening strategies on the use of Xenopus to study biological processes? Will the mutants produced by this project be useful for studying biological processes? (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 methods? 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, applications responding to this RFA will be assessed with respect to the following criteria. This evaluation will be presented in an administrative note in the summary statement, and will not factor into the numerical score: o Exportability and accessibility: What is the likelihood that the transgenic and mutant animals, and the phenotypic information generated by the project will be made widely available in a timely fashion to the scientific community? What is the likelihood that patentable research results will be widely available to the scientific community, given the proposed plan to exercise (or not to exercise) intellectual property rights regarding transgenic animals, mutant animals, embryos and sperm for these animals, mutagenesis protocols, and genetic and phenotypic data? o Adequacy of the plan to share research resources and the plan to exercise (or not exercise) intellectual property rights regarding patentable research resources. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: 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: May 16, 2001 Application Receipt Date: July 11, 2001 Peer Review Date: November 2001 Council Review: January 2002 Earliest Anticipated Start Date: April 2002 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific and technical merit of the proposed project as determined by peer review, o Cost effectiveness of the proposed strategy, o Adequacy of plans to make widely available to the research community all research resources developed during this project, o Adequacy of plans to exercise (or not exercise) intellectual property rights while permitting wide availability to the research community of patentable research resources (e.g., transgenic and mutant animals, mutagenesis protocols, and genetic and phenotypic data for all mutant strains) developed during this project, o Program priorities and program balance, o Availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. The letter of intent should be sent to: Dr. Steven Klein 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 E-mail: KleinS@Exchange.nih.gov A complete listing of contacts for both programmatic and fiscal/administrative inquiries may be found at http://www.nichd.nih.gov/rfa/HD-01-008/hd-01-008.htm AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 (NICHD), 93.862 (NIGMS), 93.113 and 93.114 (NIEHS), 93.242 (NIMH), and 93.853 (NINDS). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies 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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